Olmarker et al.v.Olmarker et al. V. Olmarker et al. V. Olmarker et al. V. Tobinick V. Olmarker et al.

Patent Trials and Appeals Board

Jan 22, 2013

11788651 - (J) (P.T.A.B. Jan. 22, 2013)

-1-

Paper 616
Mail Stop Interference
P.O. Box 1450 Filed: 22 January 2013
Alexandria Va 22313-1450
Tel: 571-272-4683
Fax: 571-273-0042

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

EDWARD TOBINICK,
Junior Party
(Application 12/714,205),

v.

KJELL OLMARKER and BJÖRN RYDEVIK
Senior Party
(Patents 7,708,995, 7,811,990, 7,906,481, 8,057,792, and 6,649,589).

Patent Interference No. 105,866
(Technology Center 1600)

Before Richard Torczon, Sally Gardner Lane, and Deborah Katz, Administrative
Patent Judges.
Katz, Administrative Patent Judge.

JUDGMENT 1
2

-2-
Further to the Decision on Motions (Paper 615), finding all of Tobinick involved 1
claims 68, 69, and 71-80 unpatentable under 35 U.S.C. § 112, first paragraph, for lack 2
of sufficient written description, it is ORDERED that judgment is awarded against Junior 3
Party Tobinick. 4
FURTHER ORDERED that claims 68, 69, and 71-80 of Tobinick Patent 5
Application 12/714,205 are FINALLY REFUSED. 35 U.S.C. § 135(a). 6
FURTHER ORDERED that attention is directed to 35 U.S.C. § 135(c) Bd. R. 205 7
regarding the filing of settlement agreements. 8
FURTHER ORDERED that a copy of this JUDGMENT shall be placed in the files 9
of (1) Tobinick Patent Application 12/714,205, (2) Olmarker Patent 7,708,995, (3) 10
Olmarker Patent 7,811,990, (4) Olmarker Patent 7,906,481, (5) Olmarker Patent 11
8,057,792, and (6) Olmarker Patent 6,649,589. 12
13

-3-
cc (via e-mail):

Attorney for Tobinick:

Robert W. Hahl, Esq.
Richard A. Neifeld, Esq.
NEIFELD IP LAW, PC
Email: rhahl@neifeld.com
Email: rneifeld@neifeld.com

Attorney for Olmarker:

Todd R. Walters, Esq.
Christopher L. North, Esq.
Erin M. Dunston, Esq.
BUCHANAN INGERSOLL & ROONEY PC
Email: todd.walters@bipc.com
Email: christopher.north@bipc.com
Email: erin.dunston@bipc.com

-1-

Paper 615
Mail Stop Interference
P.O. Box 1450 Filed: 22 January 2013
Alexandria Va 22313-1450
Tel: 571-272-4683
Fax: 571-273-0042

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

EDWARD TOBINICK,
Junior Party
(Application 12/714,205),

v.

KJELL OLMARKER and BJÖRN RYDEVIK
Senior Party
(Patents 7,708,995, 7,811,990, 7,906,481, 8,057,792, and 6,649,589).

Patent Interference No. 105,866
(Technology Center 1600)

Decision on Motions – Bd. R. 125(a) 1
Before Richard Torczon, Sally Gardner Lane, and Deborah Katz, Administrative 2
Patent Judges. 3
Opinion by Katz, Administrative Patent Judge. Concurring opinion by Torczon, 4
Administrative Patent Judge. 5
6

-2-
I. Statement of the Case 1
The Interference is before a motions panel for consideration of the parties’ 2
pending non-priority motions. An oral argument was held on 4 December 2012. 3
(Transcript at Paper 614.) Robert Hahl represented Edward Tobinick and Todd Walters 4
represented Kjell Olmarker and Björn Rydevik. 5
A. The Parties 6
Edward Tobinick (“Tobinick”) is involved based on his Patent Application 7
12/714,205 (“the Tobinick ‘205 application”), which was filed 26 February 2010. 8
(Declaration, Paper 1, at 3.) Claims 68, 69, and 71-80, all of the pending claims of the 9
Tobinick ‘205 application (Tobinick Clean Copy of Claims, Paper 10,at 2), were 10
designated as corresponding to the Count (Declaration, Paper 1, at 5). 11
Tobinick represents that Tact IP, LLC is the real party-in-interest. (Tobinick 12
Notice of Real Party In Interest, Paper 11, at 2.) 13
Kjell Olmarker and Björn Rydevik (“Olmarker”) are involved based on the claims 14
indicated for the following U.S. Patents: 15
Patent Involved claims
7,708,995,
issued 04 May 2010
12 and 13
7,811,990,
issued 12 October 2010
13, 22, 31, 40, 45, 48,
49, and 51
7,906,481,
issued 15 March 2011
2, 20, 22, and 32
8,057,792,
issued 15 November 2011

10, 11, 23, and 24
6,649,589,
issued 18 November 2003
8, 18, 27, and 34
16

-3-
(Declaration, Paper 1, at 3-5; and Redeclaration, Paper 27, at 3.) 1
Olmarker represents that Sciaticon AB, BioAssets Development Corporation, 2
Cephalon, Inc., and Teva Pharmaceutical Industries, Ltd., are the real parties-in-3
interest. (Olmarker Notice of Real Party In Interest, Paper 8, at 2.) 4
II. Subject Matter and Count 5
Both Tobinick and Olmarker claim methods of inhibiting the action of a molecule 6
called TNF-α to achieve therapeutic results in patients with nerve disorders. The parties 7
agree that TNF-α inhibitors are molecules that inhibit TNF-α activity by either binding 8
directly to it or preventing its release and that such molecules have been previously 9
used to treat diseases such as rheumatoid arthritis and Crohn’s disease. (Andersson 10
Decl., Ex. 1060, §III, ¶ 23, p. 26, Weinberger Decl., Ex. 2097, ¶¶ 87, 88, 99.) TNF-α 11
inhibitors were previously known to include antibodies. (Andersson Decl., Ex. 1060, § 12
III, ¶ 23, p 26; Weinberger Decl., Ex. 2097, ¶ 98.) 13
The Count is claim 68 of the Tobinick ‘205 application, which recites: 14
A method of treating or alleviating one or more symptoms of a nerve 15
disorder mediated by nucleus pulposus in a mammal in need of such 16
treatment comprising the step of administering a therapeutically effective 17
amount of a TNF-α inhibitor to the mammal, wherein said TNF-α inhibitor 18
is an antibody that blocks TNF-α activity, wherein the antibody is 19
administered locally. 20
21
(Declaration, Paper 1, at 4; Tobinick Clean Copy of Claims, Paper 10, at 2.) Thus, the 22
subject matter of the Interference is limited to methods that relate to symptoms of a 23
nerve disorder mediated by nucleus pulposus tissue. The parties agree that the 24
nucleus pulposus is a jelly-like substance in the middle of a spinal disc, which can 25
become herniated, or displaced from its normal location in the disc. (Andersson Decl., 26

-4-
Ex. 1060, §III, ¶¶ 6, 13, and 19, p. 14, 20, and 23; Weinberger Decl., Ex. 2097, ¶ 66.) 1
The Count is also limited to method in which the antibody is “administered locally.” 2
III. Motions 3
Tobinick has filed five motions, as follows. 4
 Motion 1 for judgment against all of Olmarker’s involved claims under 5
35 U.S.C. §135(b). (Paper 172.) 6
 Motion 2 that Olmarker be denied benefit of International application 7
PCT/SE99/01671. (Paper 173.) 8
 Motion 3 that Olmarker be denied benefit of Swedish Applications 9
9803276-6 and 9803710-4. (Paper 174.) 10
 Motion 4 for permission to change the priority claims in application 11
11/262,528 (now Patent 8,119,127), application 10/269,745 (now Patent 6,982,089), 12
and application 10/236,097 (now abandoned). (Paper 238.) Tobinick’s requests in 13
this motion are contingent on the granting of Olmarker Motion 3, for judgment that 14
Tobinick’s involved claims are unpatentable over the prior art (Paper 163). (Tobinick 15
Motion 4, paper 238, at 2.) 16
 Motion 5 to exclude evidence. (Paper 363.) 17
Olmarker has filed 11 motions: 18
 Motion 1 for judgment against all of Tobinick’s involved claims under 19
35 U.S.C. §135(b). (Paper 161.) 20
 Motion 2 for judgment that all of Tobinick’s involved claims are 21
unpatentable under 35 U.S.C. §112, first paragraph, for lack of written description and 22

-5-
enablement. (Paper 162.) 1
 Motion 3 for judgment that all of Tobinick’s involved claims are 2
unpatentable under 35 U.S.C. §102 and or §103 over WO 00/18409. (Paper 163.) 3
 Motion 4 that Tobinick be denied benefit as to any U.S. patent application. 4
(Paper 165.) 5
 Motion 5 that additional Olmarker claims of the involved Olmarker patents 6
be designated as corresponding to the Count. (Paper 166.) 7
 Motion 6 that additional claims of Olmarker involved patent 6,649,589 be 8
designated as corresponding to the Count. (Paper 167.) 9
 Motion 7 to substitute a new Count for the current Count. (Paper 168.) 10
 Motion 8 for judgment that all of Tobinick’s involved claims are 11
unpatentable under 35 U.S.C. §102 and/or §103 over the publication Olmarker and 12
Larsson, “Tumor Necrosis Factor α and Nucleus-Pulposus-Induced Nerve Root Injury,” 13
23 Spine 2538 (1998). (Paper 240.) 14
 Motion 9 to introduce an additional claim to application 13/489,830 and 15
have it designated as corresponding to the Count. (Paper 241.) Olmarker’s request in 16
this motion is contingent on the granting of Tobinick Motion 1 for judgment against 17
Olmarker’s claims under 35 U.S.C. § 135(b). (Olmarker Motion 9, Paper 241, at 1.) 18
 Motion 10, requesting reconsideration of the Order – Contingent Motion 19
(Paper 236) and authorization to file a motion to add claims in response to Tobinick 20
Motion 1. (Paper 242.) 21
 Motion 11, requesting discovery, specifically communications between 22

-6-
Edward Tobinick and his counsel on issues relating to Tobinick Contingent Motion 4. 1
(Paper 270.) 2
We take up these motions in the order that secures the most just, speedy, and 3
inexpensive determination of the proceedings. Berman v. Housey, 291 F.3d 1345, 1352 4
(Fed. Cir. 2002); 37 C.F.R. § 41.125(a). Olmarker argues in its Motion 2 that all of 5
Tobinick’s involved application claims are unpatentable under 35 U.S.C. § 112, first 6
paragraph, for lack of adequate written description support. (Olmarker Motion 2, Paper 7
162, at 1.) Because Tobinick’s claims were copied from the Olmarker 7,708,995 and 8
7,811,990 patents for the purpose of provoking this Interference (see Olmarker Motion 9
2, Paper 162, at 2; Tobinick response to Olmarker MF1 1; Amendment filed in the 10
Tobinick ‘205 application, Ex. 1081, at 5), Olmarker’s Motion 2 presents a threshold 11
issue. See 37 C.F.R. § 41.201(2)(ii). We exercise our discretion under 37 C.F.R. 12
§ 41.125(a) to take up Olmarker Motion 2 first. 13
As discussed below, the preponderance of the evidence leads us to find that 14
Tobinick’s claims are not fully supported by a written description in the specification of 15
the Tobinick ‘205 application. Thus, Tobinick was not entitled to file the claims used to 16
provoke this Interference and the Interference was mistakenly declared. See Berman, 17
291 F.3d at 1353. In light of this decision, we do not reach Tobinick Motion 1, which is 18
directed to the alleged unpatentability of Olmarker’s claims under 35 U.S.C. § 135(b). 19
We note that Tobinick Motion 1 does not present a threshold issue under 20
§ 41.201 because Tobinick, as junior party applicant, has asserted that Olmarker’s 21
patent claims are unpatentable over claims of uninvolved Tobinick U.S. Patent 22

-7-
6,015,557. In this interference, Olmarker, not Tobinick, is the patentee who would be 1
entitled to repose. At best, Tobinick’s motion raises a patentability issue. See In re 2
Berger, 279 F.3d 975, 982 (Fed. Cir. 2002); Strelchenko v. Campbell, 2002 WL 3
1300267, at *2-3 (BPAI June 10, 2002) (Interference 104,809). Thus, in light of the 4
decision that Tobinick’s application claims lack written description support, we do not 5
consider Tobinick Motion 1. 6
In addition, though we consider Tobinick Motion 5 to exclude evidence, we do not 7
reach any of Tobinick’s or Olmarker’s other motions, because the issues raised are 8
moot in light of our decision that Tobinick’s claims are unpatentable for lack of written 9
description support. 10
IV. Analysis – Olmarker Motion 2 11
In its Motion 2, Olmarker argues that the Tobinick specification cannot provide a 12
written description of the subject matter Tobinick claims because, in part, it does not 13
describe treating “symptoms of a nerve disorder mediated by nucleus pulposus” with 14
antibodies “administered locally.” (Olmarker Motion 2, Paper 162, at 1.) Olmarker also 15
argues that the Tobinick specification does not provide sufficient enabling disclosure to 16
support the claimed methods. 17
Witnesses 18
Olmarker relies on the testimony of Gunnar Bengt Johan Andersson, M.D., 19
Ph.D., to support the arguments in Motion 2. (Declaration of Gunnar Bengt Johan 20
Andersson, M.D., Ph.D. (“Andersson Decl.”), Ex. 1060.) Dr. Andersson testifies that he 21
is currently a Professor and Chairman Emeritus in the Department of Orthopedic 22

1 “MF” indicates Material Fact.

-8-
Surgery and Professor in Spinal Deformities at the Rush University Medical College in 1
Chicago, IL. (Andersson Decl., Ex. 1060, § II, ¶ 6, p. 8.) Dr. Andersson testifies that 2
since 1975 he has served in many academic and administrative positions in medical 3
schools, specifically in departments of orthopedic surgery. (Andersson Decl., Ex. 1060, 4
§ II, ¶ 7, p. 9.) Dr. Andersson testifies that he obtained the degree of Candidate of 5
Medicine form the University of Zurich, Switzerland, a Medicine Licenciate Certificate 6
and a Ph.D. in Medical Science from the University of Göteborg, Sweden. (Andersson 7
Decl., Ex. 1060, § II, ¶¶ 3-5. p. 8.) Dr. Andersson also testifies that he has conducted 8
research in orthopedic medicine and has authored more than 300 original peer-9
reviewed and invited medical and scientific publications, many of which concern causes 10
and treatments of spinal disorders and symptoms associated with such disorders. 11
(Andersson Decl., Ex. 1060, § II, ¶ 10. p. 11-12; see also Curriculum Vitae Gunnar 12
Bengt Johan Andersson, M.D., Ph.D., Ex. 1061.) Dr. Andersson testifies that he is a 13
National Institutes of Health-funded researcher and has a grant to study degenerative 14
vertebral disc disease. (Id.) 15
Dr. Andersson is qualified to testify on the subject matter of the Interference. 16
Tobinick raises concerns about the scientific bases Dr. Andersson relies on and 17
an asserted bias. (Tobinick Opp. 2, Paper 300, at 4; see also Tobinick Motion 5, Paper 18
363, at 2 and 10-11.) Tobinick argues that because Dr. Andersson included a statement 19
reserving the “right to amend, supplement, or otherwise modify [his] opinions . . . .” 20
(Second Declaration of Gunnar Bengt Johan Andersson (“Second Andersson Decl.”), 21
Ex. 1085, §IV, ¶ 1, p. 28), his testimony is unreliable. (Tobinick Opp. 2, Paper 300, at 4; 22

-9-
see also Tobinick Motion 5, Paper 363, at 3, 10-11, and 13.) Olmarker argues that this 1
statement is consistent with the role an expert witness plays in a trial, where they have 2
an affirmative duty under the Federal Rules of Civil Procedure 26(a)(2), 26(a)(2)(E), and 3
26(e)(2) to supplement their disclosures, including written reports. (Olmarker Reply 2, 4
Paper 343, at 9.) 5
Dr. Andersson declares that his statements are believed to be true, with the 6
knowledge that willful false statements are punishable under 18 U.S.C. § 1001. 7
(Anderson Decl., Ex. 1060, § XIV, p. 150; Second Andersson Decl., Ex. 1085, § IV, ¶ 2, 8
p. 28.) Thus, we are not persuaded that Dr. Andersson’s testimony is generally 9
unreliable merely because he expressed a wish to reserve the right to modify it. We 10
address Tobinick’s concerns about specific, substantive statements made by Dr. 11
Andersson below. 12
Tobinick also argues that Dr. Andersson’s testimony is unreliable because he has 13
a financial interest in the outcome of the Interference and therefore is biased. (Tobinick 14
Opp. 2, Paper 300, at 4, see also Tobinick Motion 5, Paper 363, at 2 and 11.) Tobinick 15
relies on Dr. Andersson’s cross-examination testimony that in the past he received 16
money from the sale of BioAssets to Cephalon, a real party-in-interest to Olmarker and 17
that “there is a possibility that [he] will receive additional dollars in the future based on 18
the potential approval of the product by the FDA, and sales exceeding $500 million.” 19
(Deposition of Gunnar Andersson, M.D., Ph.D., 11 June 2012, p. 6, l. 17, through p. 7, l. 20
3; Tobinick Opp. 2, Paper 300, at 4, citing Weinberger Decl., Ex. 2097, ¶¶ 262-66.) We 21
note, that Olmarker similarly alleges that Tobinick’s witness, Dr. Alan Weinberger, M.D., 22
has a financial interest in the outcome of the Interference because he has a royalty-free 23

-10-
license to practice Dr. Tobinick’s patented methods. (See Olmarker Reply 2, Paper 1
343, at 10, citing Deposition of Alan Walter Weinberger, M.D., 20 September 2012, Ex. 2
1134, p. 10, l. 17, through p. 11, l. 17.) Because we review both witnesses’ testimony in 3
light of the support they provide for their opinions in the patent specifications at issue 4
and the medical and scientific literature, we do not disqualify either Dr. Andersson or Dr. 5
Weinberger solely on the basis of a possible financial interest in the outcome of the 6
Interference. 7
We note that Tobinick has also raised concerns about the conduct of Dr. 8
Andersson. (See Orders – Inequitable Conduct, Papers 369, 371.001, and 612; 9
Tobinick Statement pursuant to the Order – Inequitable Conduct (Paper 369), Paper 10
370.) We discuss these issues below, following our analysis of Olmarker Motion 2. 11
Tobinick relies on the testimony of Dr. Alan Weinberger, M.D., to support the 12
arguments it makes in against Olmarker’s Motion 2. (Tobinick First Declaration of Alan 13
Weinberger, M.D. (“Weinberger Decl.”), Ex. 2097.) Dr. Weinberger testifies that he is a 14
board-certified rheumatologist in private medical practice involving the evaluation and 15
treatment of patients with rheumatologic and other medical disorders, including non-16
surgical treatment of back and neck pain. (Weinberger Decl., Ex. 2097, ¶¶ 4-5.) Dr. 17
Weinberger testifies that he has expertise in and routinely uses biologic TNF inhibitors, 18
including for the treatment of back and neck pain. (Weinberger Decl., Ex. 2097, ¶ 6.) 19
Dr. Weinberger’s curriculum vitae indicates that he holds the academic positions of 20
Associate Clinical Professor of Medicine at the Center for Health Sciences, University of 21
California, Los Angeles and is an Attending Physician in the Rheumatology Clinic and 22
Service at Cedars-Sinai Medical Center, but does not indicate that he has conducted 23

-11-
any research or published any information relating to the subject matter of this 1
Interference. (Alan Weinberger, M.D., Curriculum Vitae, Ex. 2098.) 2
Dr. Weinberger is qualified to testify on the subject matter of this Interference. 3
Tobinick also relies on the testimony of Dr. M. L. Richardson, III, M.D., to support 4
its arguments. (Deposition of Marion L. Richardson, III, M.D., 25 June 2012 5
(“Richardson Deposition”), Ex. 2105.) Dr. Richardson testifies that he is a board-6
certified anesthesiologist with a sub-specialty in pain management and has been in 7
private practice since 1987. (First Declaration of Mel Richardson, M.D., (“Richardson 8
Decl.”) Ex. 2003, ¶ 1; see also Curriculum Vitae of M. L. Richardson, III, M.D., Ex. 9
2034.) Dr. Richardson testifies that he has been actively involved in the treatment of 10
spinal pain syndromes for more than two decades and is a Diplomat of both the 11
American Board of Anesthesiology and the American Academy of Pain Management. 12
(Id.) Dr. Richardson testifies that he was previously the Medical Director and Chief of 13
Staff at the Indian River Memorial Hospital Ambulatory Surgery Center and Chief of the 14
Department of Anesthesia at USAF Eglin Regional Hospital in Florida. (Id.) Dr. 15
Richardson does not indicate that he has conducted any research or published any 16
information relating to the subject matter of this Interference. (Id.) 17
Dr. Richardson is qualified to testify on the subject matter of this Interference. 18
19

-12-
Findings of Fact 1
The following findings of fact, as well as others relied upon in the discussion 2
above and below, are supported by a preponderance of evidence in the record. 3
1. Tobinick copied the involved claims from Olmarker patents 7,708,995 (“the 4
‘995 patent”) and 7,811,990 (“the ‘990 patent”). (Tobinick Application 12/714,205, 5
Amendment filed 27 June 2011, Ex. 1081, at 5.) 6
2. The Olmarker ‘995 patent uses the term “locally” to describe experiments 7
on the involvement of TNF-α in nucleus pulposus-induced effects, in which 8
[t]o assess if TNF-alpha may be involved in the nucleus pulposus induced 9
nerve root injury, the presence of TNF-alpha in nucleus pulposus-cells was 10
assessed and was studied if the nucleus pulposus-induced effects could be 11
blocked by doxycycline, a soluble TNF-receptor, and a selective monoclonal 12
TNF-alpha antibody, the latter administered both locally in the nucleus 13
pulposus and systemically. 14
15
(Olmarker ‘995 patent, Ex. 1046, 19:12-18; Olmarker Motion 2, Paper 162, at 9, MF 47; 16
Olmarker Reply 2, Paper 343, at 2.) 17
3. The Olmarker ‘995 patent provides details of experiments in which “[f]our 18
pigs received 100 mg of doxycycline intravenously, 8 pigs had a blocking monoclonal 19
antibody to TNF-alpha applied locally in the nucleus pulposus, and 4 pigs remained 20
non-treated (controls).” (Olmarker ‘995 patent, Ex. 1046, 17:44-47; Olmarker Reply 2, 21
Paper 343, at 2.) 22
4. The Olmarker ‘995 patent provides for administration of anti-TNF-α 23
antibody, wherein “the nucleus pulposus was mixed with 100 ul of a 1.11 mg/mL 24
suspension of the anti-TNF-alpha antibody used in series 1, before application.” 25

-13-
(Olmarker ‘995 patent, Ex. 1046, at 20:27-29; Olmarker Motion 2, Paper 162, at 9, MF 1
48.) 2
5. The Olmarker ‘995 patent contrasts local administration with systemic 3
administration as follows: 4
Two recently developed drugs for specific TNF-alpha inhibition were also 5
included in the study. Infliximab is a chimeric monoclonal antibody 6
composed of human constant and murine variable regions. Infliximab 7
binds specifically to human TNF-alpha. As opposed to the monoclonal 8
antibody used in series-2 for the 3-day observation period, infliximab was 9
not administered locally in the autotransplanted nucleus pulposus, but 10
instead was administered systemically in a clinically recommended dose 11
(4 mg/kg). 12
13
(Olmarker ‘995 patent, Ex. 1046, 27:12-20; Olmarker Motion 2, Paper 162, at 9, MF 49.) 14
6. Dorland’s Illustrated Medical Dictionary defines “local” as “[r]estricted to or 15
pertaining to one spot or part; not general.” (Dorland’s Illustrated Medical Dictionary, 16
772 (23rd Ed., 1957) (“Dorland’s Dictionary”) at 772, Ex. 1063; Olmarker Motion 2, 17
Paper 162, at 8.) 18
7. Dorland’s Illustrated Medical Dictionary defines “general” as “[a]ffecting 19
many parts or all parts of the organism, not local.” (Dorland’s Dictionary, at 552, Ex. 20
1064; Olmarker Motion 2, Paper 162, at 8.) 21
8. Dorland’s Illustrated Medical Dictionary defines “systemic” as “pertaining 22
to or affecting the body as a whole.” (Dorland’s Dictionary, at 1357, Ex. 1065; Olmarker 23
Motion 2, Paper 162, at 8.) 24
9. Stedman’s Medical Dictionary defines “local” as “[h]aving reference or 25
confined to a limited part; not general or systemic.” (Stedman’s Medical Dictionary for 26

-14-
the Health Professions and Nursing (7th Ed. 2012) (“Stedman’s Dictionary”), at 982, Ex. 1
2082; Tobinick Opp. 2, Paper 300, at 18.) 2
10. Olmarker’s witness, Dr. Andersson, testifies that based on dictionary 3
definitions “local” administration means administration directly to the site where the 4
medicine is intended to act, while “systemic” or “general” administration is administration 5
in which the medicine is broadly distributed before reaching the site of action, such as 6
being carried to the site of action by the vascular system. (Andersson Decl., Ex. 1060, 7
§ VI, ¶ 21, p. 57.) 8
11. Dr. Andersson testifies that “locally” in the specification of Olmarker’s ‘995 9
patent is consistent with the dictionary definition of the term “locally” because it is 10
exemplified in Olmarker’s specification by applying anti-TNF-α antibodies to the affected 11
nerve roots in the nucleus pulposus and by contrasting it with “systemic” administration. 12
(Andersson Decl., Ex. 1060, § VI, ¶ 22, p. 57.) 13
12. The specification of the Tobinick ‘205 application provides that 14
Perispinal administration is a novel new concept for a delivery method for 15
cytokine antagonists for treating neurological or neuropsychiatric 16
diseases. 17
18
(Tobinick ‘205 application, Ex. 1008, at 8:7-8.) 19
13. The specification of the Tobinick ‘205 application provides that 20
[f]or the purposes of this discussion, "perispinal" means in the anatomic 21
vicinity of the spine. For this discussion “anatomic vicinity” is generally 22
defined as within 10 centimeters, or functionally defined as in close 23
enough anatomic proximity to allow the therapeutic molecules of 24
consideration herein to reach the spine and/or the subarachnoid space 25
surrounding the spinal cord in therapeutic concentration when 26
administered directly to this area. 27
28
(Tobinick ‘205 application, Ex. 1008, at 8:10-14; Olmarker Motion 2, Paper 162, at 9.) 29

-15-
14. The specification of the Tobinick ‘205 application provides: 1
Perispinal administration includes, but is not limited to the subcutaneous, 2
intramuscular, interspinous, epidural, peridural, parenteral, or intrathecal 3
routes, and may be perilesional or alternatively, particularly when treating 4
diseases of the brain, remote from the ultimate site of pathology. 5
6
(Tobinick ‘205 application, Ex. 1008, at 2:8-11; Olmarker Motion 2, Paper 162, at 10.) 7
15. The specification of the Tobinick ‘205 application provides that 8
9
[a]natomically localized administration involving perispinal use includes, 10
but is not limited to the subcutaneous, intramuscular, interspinous, 11
epidural, peridural, parenteral or intrathecal routes. 12
13
(Tobinick ‘205 application, Ex. 1008, at 8:3-5; Olmarker Motion 2, Paper 162, at 9.) 14
16. The specification of the Tobinick ‘205 application provides that 15
[a]n example of one preferred embodiment for treatment of lumbar 16
radiculopathy due to disc herniation at the L 3-4 interspace is the 17
perispinal administration of etanercept 25mg by injecting through the skin 18
of the back, between the L3 and L4 spinous processes, to deliver 19
etanercept in anatomic proximity to the site of disc herniation. 20
21
(Tobinick ‘205 application, Ex. 1008, at 11:21-24; Olmarker Motion 2, Paper 162, at 9.) 22
17. The specification of the Tobinick ‘205 application provides: 23
Direct injection of these specific cytokine antagonists into the CSF 24
(intrathecal administration) is also a form of localized anatomic 25
administration and can be accomplished by the perispinal route. 26
27
(Tobinick ‘205 application, Ex. 1008, at 8:19-21 Tobinick Opp. 2, Paper 300, at 12.) 28
18. The specification of the Tobinick ‘205 application provides: 29
Epidural administration, for the purposes of this patent, is also a form of 30
perispinal administration, and, in certain clinical circumstances may be the 31
delivery method of choice, despite its greater difficulty and greater risk. 32
33
(Tobinick ‘205 application, Ex. 1008, at 9:3-6; Tobinick Opp. 2, Paper 300, at 12.) 34
19. The specification of the Tobinick ‘205 application provides: 35

-16-
In another preferred embodiment injection of the therapeutic molecule to 1
the anatomic area adjacent to the disc herniation is accomplished by 2
epidural injection. 3
4
(Tobinick ‘205 application, Ex. 1008, at 12:3-4; Olmarker Motion 2, Paper 162, at 10; 5
Tobinick Opp. 2, Paper 300, at 12.) 6
20. Olmarker’s witness, Dr. Andersson, testifies that Tobinick’s definition 7
effectively removes any functional distinction between local and systemic 8
administration. (Andersson Decl., Ex. 1060, §VI, ¶ 29, pp. 60-61.) 9
21. Tobinick’s witness, Dr. Richardson, testified that “transpinal 10
administration” is a “subcutaneous type injection where the medication is delivered via 11
the venous system called Batson’s plexus.” (Tobinick Opp. 2, Paper 300, at 20, citing 12
Richardson Deposition, Ex. 2105, at 11:12-16.) 13
22. Tobinick’s witness, Dr. Richardson, testified that in his clinical experience, 14
injection of steroid in the caudal region, that is at the bottom of the spine, is useful for 15
treating a disc herniation at a disc that may be four to six inches away at L3-4. 16
(Richardson Deposition, Ex. 2105, 48:3-17.) 17
18
Discussion 19
To determine if the Tobinick ‘205 specification provides sufficient support for 20
Tobinick’s copied claims, we first construe the claim terms, focusing on “administered 21
locally.” As the parties agree, “when a party challenges written description support for 22
an interference count or the copied claim in an interference, the originating disclosure 23
provides the meaning of the pertinent claim language.” Agilent Tech., Inc. v. Affymetrix, 24
Inc, 567 F.3d 1366, 1375 (Fed. Cir. 2009). (See Olmarker Reply 2, Paper 343, at 2; 25

-17-
Amendment in Tobinick application 12/714,205, filed 27 June 2011, at 6-8.) Tobinick 1
copied claims from Olmarker ‘995 and ‘990 patents (FF2 1; Tobinick Application 2
12/714,205, Amendment filed 27 June 2011, Ex. 1081, at 5.) Thus, we look to 3
Olmarker’s specification to construe the claim terms. We focus on the specification of 4
the ‘995 patent, noting that Tobinick does not raise, and we do not find, conflicting 5
disclosures in the ‘990 patent specification. 6
As Tobinick notes, the Olmarker specification describes experiments (called 7
“series-2”) in which some nucleus pulposus tissue is removed from a vertebral disc and 8
is immersed in a solution containing anti-TNF-α antibodies. The mixture is then applied 9
to surgically exposed, but otherwise healthy, nerve roots. (Tobinick Opp. 2, Paper 300, 10
at 17; see Olmarker ‘995 spec., Ex. 1046, at 17:41-48.) Thus, the Olmarker 11
specifications describe experiments in which antibody is administered directly to the 12
nucleus pulposus tissue and the nerve root. 13
The Olmarker specification uses the term “locally” to describe these experiments. 14
(FFs 2-4; Olmarker ‘995 specification, Ex. 1046, at 19:12-18, 17:44-47, and 20:27-29.) 15
This local administration is contrasted with “systemic” administration, such as 16
intravenous, in other experiments (called “series-3”). (FF 5; Olmarker ‘995 specification, 17
Ex. 1046, at 27:12-20; Olmarker Motion 2, Paper 162, at 9, and Olmarker Reply 2, 18
Paper 343, at 2.) 19
Tobinick argues that because these references to local administration are not 20
directed to therapeutic methods they do not limit the claim scope. (Tobinick Opp. 2, 21
Paper 300, at 17.) We are not persuaded that even if the methods used in the 22

2 “FF” indicates Finding of Fact.

-18-
experiments provided in the Olmarker specification are inappropriate for therapy, the 1
discussion is not at least somewhat useful for construing the claim terms. Tobinick’s 2
argument is not that Olmarker’s specifications do not support therapeutic methods in 3
general, only that the experimental conditions are not relevant to the claimed 4
therapeutic methods. If, though, the experiments demonstrate some of the 5
characteristics of the claimed methods they are relevant. Because the experiments 6
described in the ‘995 specification use anti-TNF-α antibody to investigate effects on the 7
nucleus pulposus and nerves these experiments are relevant to the claimed methods of 8
treatment and we do not ignore the use of the term “locally” in Olmarker’s specification. 9
Olmarker also cites to a medical dictionary definition of the term “local” as 10
meaning “restricted or pertaining to one spot or part; not general” to construe the claims. 11
(Olmarker Motion 2, Paper 162, at 8; FF 6.) According to Dr. Andersson, this definition 12
is consistent with the usage of “local” in the Olmarker specification because the 13
antibodies are applied to the nerve roots in the nucleus pulposus. (Olmarker Motion 2, 14
Paper 162, at 9; FFs 10 and 11; Andersson Decl., Ex. 1060, § VI, ¶¶ 21 and 22, p. 57.) 15
16
Tobinick relies on a different medical dictionary to define “local,” arguing that the 17
dictionary used by Olmarker is 50 years old. (Tobinick Opp. 2, Paper 300, at 17-18.) 18
The dictionary definition Tobinick relies on is not very different from the dictionary 19
definition on which Olmarker relies. Instead of reciting “one spot,” Tobinick’s dictionary 20
definition recites “confined to a limited part” and both definitions contrast “local” with 21
“general” or “systemic.” (Compare FF6, Dorland’s Dictionary at 772, Ex. 1063, with 22
FF9, Stedman’s Dictionary, at 982, Ex. 2082; see also FF 7, Dorland’s Dictionary, at 23

-19-
552, Ex. 1064, defining “local”, and FF 8, Dorland’s Dictionary, at 1357, Ex. 1065, 1
defining “systemic.”) Tobinick’s dictionary definition is not in conflict with the dictionary 2
definition put forth by Olmarker and we are not persuaded that it conflicts with Dr. 3
Andersson’s understanding of the claim term “administered locally” as being 4
administered directly to the site where the medicine is intended to act. 5
In light of these definitions and the use of the term “local” in Olmarker’s 6
specification, we construe Tobinick’s claims as being directed to administering TNF-α 7
inhibitor directly to the site where it is intended to act, that is, to the location where the 8
nucleus pulposus is causing the symptoms of the nerve disorder. The limitation 9
“administered locally” excludes systemic administration away from the site where the 10
TNF-α inhibitor is intended to act. 11
Olmarker argues that the concept of administering a drug locally, as described in 12
the Olmarker ‘995 patent specification, is contrary to the description of administering 13
treatments in the Tobinick ‘205 application. (Olmarker Motion 2, Paper 162, at 9.) The 14
Tobinick specification is directed to “perispinal” administration of cytokine antagonists. 15
(FF 12, Tobinick ‘205 application, Ex. 1008, at 8:7-8.) “Perispinal” is defined as being in 16
the “anatomic vicinity” of the spine, which is in turn defined as being within 10 17
centimeters or close enough to allow therapeutic molecules to reach the spine or 18
subarachnoid space. (FF 13; Tobinick ‘205 spec., Ex. 1008, at 8:10-14; see Olmarker 19
Motion 2, Paper 162, at 9.) Olmarker cites to portions of Tobinick’s specification that 20
define “perispinal” administration as including subcutaneous, intramuscular, 21
interspinous, epidural, peridural, parenteral, or intrathecal routes (FFs 14-16; Tobinick 22
spec., Ex. 1008, at 2:8-11, 8:3-5, and 11:21-24), which according to Olmarker does not 23

-20-
limit the route of administration at all. (Olmarker Motion 2, paper 162, at 9-10.) 1
Olmarker relies on Dr. Andersson’s testimony to argue that this definition does not 2
exclude systemic routes of administration, and, thus, does not describe local 3
administration. (Olmarker Motion 2, Paper 162, at 9, FF 18; Andersson Decl. Ex. 1060, 4
§ VI, ¶ 26-28.) 5
Tobinick opposes Olmarker’s arguments by pointing to the anatomic structure 6
called the “Batson’s plexus,” which, according to Drs. Richardson and Weinberger, 7
allows for molecules delivered by perispinal injection to be delivered directly to the 8
central nervous system. (Tobinick Opp. 2, Paper 300, at 19-20; FF 21, Richardson 9
Deposition, Ex. 2105, at 11:12-16, and Weinberger Decl., Ex. 2097, ¶¶ 110-123.) 10
We are not persuaded by the evidence provided by Tobinick that the ‘205 11
specification refers to administration through the Batson’s plexus. Even if, as Tobinick 12
appears to argue, such administration is “local,” Tobinick does not direct us to use of the 13
term “Batson’s plexus” in the specification of the ‘205 application. None of the evidence 14
that Tobinick cites indicates that one of skill in the art would consider “perispinal” 15
administration, or any of the other modes of administration referred to in the 16
specification of the ‘205 application, to be through the Batson’s plexus. Dr. Weinberger 17
testifies that the Batson’s plexus provides an explanation for the methods of delivery 18
provided in the ‘205 specification, but he does not testify that those of skill in the art 19
would have read the ‘205 specification and would have understood it to refer to 20
administration into the Batson’s plexus. (See Weinberger Decl., Ex. 2097, ¶¶ 110-123.) 21
Thus, without a specific disclosure of the Batson’s plexus in the ‘205 specification, we 22

-21-
are not persuaded that one of skill in the art would consider the specification to be 1
directed to administration to it. 2
Furthermore, even if those of skill in the art would have read the ‘205 3
specification to mean administration to the Batson’s plexus, Tobinick has not persuaded 4
us that it would result in a drug being “administered locally,” as this term is construed 5
from Olmarker’s specification. As noted in an exhibit relied upon by Dr. Weinberger, the 6
volume of the Batson’s plexus can be up to 1000 mL. (Olmarker Reply 2, Paper 343, at 7
3, citing Tobinick & Vega, “The Cerebrospinal Venous System: Anatomy, Physiology, 8
and Clinical Implications,” Medscape General Medicine (2006), Ex. 2158, at 6.) 9
Tobinick has not directed us to sufficient evidence to show that administration of a 10
molecule perispinally into any portion of the Batson’s plexus would result in 11
administration directly to the location where the nucleus pulposus is causing the nerve 12
disorder. (Olmarker Reply 2, Paper 343, at 3, Andersson; Fourth Declaration of Gunnar 13
Bengt Johan Andersson, M.D., Ph.D. (“Fourth Andersson Decl.”), Ex. 1135, at §III, ¶ 4, 14
p. 4.) 15
In addition, Tobinick’s arguments and evidence about the efficacy of perispinal 16
administration do not persuade us that Tobinick’s route of administration is the same as 17
the “local” administration provided in Olmarker’s specification. (Tobinick Opp. 2, Paper 18
300, at 20-21.) Whether or not the methods disclosed in Tobinick’s ‘205 specification 19
and those Dr. Tobinick performs are effective does not reveal if the disclosure supports 20
treatments “administered locally” as construed from Olmarker’s specification. 21
Tobinick argues that intrathecal and epidural routes of administration are 22
localized forms of administration disclosed in the specification of the ‘205 application. 23

-22-
(Tobinick Opp. 2, Paper 300, at 12; FFs 17 and 18, Tobinick ‘205 application, Ex. 1008, 1
at 8:19-21 and 9:3-6.) According to Olmarker, though, such injections are not described 2
as being administered directly to the site where the medicine is intended to act. For 3
example, epidural administration is described as being administered “to the anatomic 4
area adjacent to the disc herniation” (FF 19, Tobinick ‘205 application, Ex. 1008, at 5
12:3-4), instead of to the site of disc herniation. (Olmarker Motion 2, Paper 162, at 10-6
11.) Olmarker relies on Dr. Andersson’s testimony to argue that when administration is 7
at an anatomic area adjacent to the site of disc herniation, any functional distinction 8
between local and systemic administration is removed. (Id., FF 20, Andersson Decl., 9
Ex. 1060, §VI, ¶ 29, pp. 60-61.) 10
Tobinick opposes Olmarker’s argument by arguing that Dr. Andersson’s 11
testimony about the efficacy of intrathecal injection is wrong. (Tobinick Opp. 2, Paper 12
300, at 21.) Tobinick also cites Dr. Richardson’s testimony to assert that caudal 13
epidural injections (near the base of the spine) of steroids can allow the drug to diffuse 14
upwards through the epidural space to the site of disc herniation and that this is 15
considered to be a form of local administration. (Tobinick Opp. 2, Paper 300, at 23, 16
citing Richardson Deposition, Ex. 2105, at 48:3-17, FF 22.) Dr. Richardson’s testimony 17
does not indicate that such caudal epidural administration is local or at the site where it 18
is intended to act. Dr. Richardson does not refer to local administration, but only to the 19
efficacy of injecting steroids caudally. In fact, Dr. Richardson contrasts such caudal 20
injections with those that are administered at the site of disc herniation. (Richardson 21
Deposition, Ex. 2105, at 48:8-17: “And that's been my clinical experience many times 22
over thousands and thousands of patients where a caudal injection, which is way down 23

-23-
at the bottom of the spine where the epidural space starts, you inject the steroid there 1
and even though the patient has a disc at L3-4, which would probably be, I'd say, in 2
most patients, may be four to six inches away from the injection, you can still get a 3
clinical effect or pain relief from injecting it caudally as opposed to where the disc may 4
be herniated.” (emphasis added)). We are not persuaded by the evidence that Tobinick 5
presents that the disclosures of intrathecal and epidural administration in the ‘205 6
specification are disclosures of molecules “administered locally” as construed from the 7
Olmarker specification. 8
The balance of the evidence on this record persuades us that the specification of 9
the Tobinick ‘205 application does not describe a method of treatment wherein anti-10
TNF-α antibody is “administered locally” to treat or alleviate symptoms of a nerve 11
disorder mediated by nucleus pulposus. Olmarker has shown that the specification of 12
the ‘205 application is directed to administering TNF inhibitor near or adjacent to a 13
nerve disorder, but not directly to the site where the medicine is intended to act. 14
Because we are constrained under Agilent to use the Olmarker ‘995 patent specification 15
to construe Tobinick’s claims, we cannot find, based on this record, that the 16
specification of the ‘205 application provides written description for the methods claimed 17
by Tobinick. 18
Because the lack of sufficient written description in junior party Tobinick’s 19
application is a threshold issue, we do not reach the issue of whether the ‘205 20
application enables the methods claimed. 21

-24-
V. Additional Matters 1
In addition to the arguments discussed above, Tobinick requests that Dr. 2
Andersson’s testimony be excluded in Motion 5 to exclude evidence. (Paper 363.) In 3
general, Tobinick argues that the First Andersson Declaration should be excluded 4
entirely because “[e]ssentially all of the evidence supporting Olmarker’s assertion that 5
Tobinick’s disclosures would have been and still are unbelievable to one of ordinary skill 6
in the art are based on biased and unreliable testimony by Dr. Andersson.” (Tobinick 7
Motion 5, Paper 363, at 2.) As explained above, we do not rely on Dr. Andersson’s 8
testimony about the effectiveness or belief of effectiveness of Tobinick’s disclosures to 9
reach our decision that Tobinick’s involved claims are not supported by the specification 10
of the ‘205 application. We do not exclude Dr. Andersson’s testimony on these 11
grounds, as Tobinick requests. 12
Tobinick also points to specific testimony by Dr. Andersson, which it considers to 13
be factually incorrect and irrelevant. Tobinick cites to Dr. Andersson’s interpretation of 14
the term “epidural,” which Olmarker relied on in its Motion 2. (Tobinick Motion 5, paper 15
363, at 7.) As Tobinick notes, Olmarker relies on Dr. Andersson’s testimony to support 16
its Material Fact 70, which states: “The ‘205 Application does not limit the location of 17
epidural administration to the site of the herniation in reciting ‘injection of the therapeutic 18
molecule to the anatomic area adjacent to [a] disc herniation . . . by epidural injection.’ 19
Ex. 1060, pp. 60-61, § VI ¶ 29.” (Olmarker Motion 2, Paper 162, at MF 70.) Tobinick 20
cites to Dr. Weinberger’s Declaration, apparently in support of its argument. (Tobinick 21
Motion 5, Paper 363, at 7, citing Weinberger Decl., Ex. 2097, at ¶ 104.) Dr. 22
Weinberger’s testimony provides: 23

-25-
Both the spinal nerve roots and the spinal cord are located in the 1
intrathecal (subarachnoid) space. This is because both the spinal nerve 2
roots and the spinal cord are contained within the thecal membranes. The 3
thecal membranes consist of the dura (dura mater) and the arachnoid 4
membranes. Both the spinal nerve roots and the spinal cord are 5
surrounded by the cerebrospinal fluid. 6
7
(Weinberger Decl., Ex. 2097, ¶ 104.) Dr. Weinberger’s testimony also cites to a 8
publication authored by Dr. Olmarker and provides a diagram of the major neural 9
structures in the intrathecal space. Tobinick does not provide other explanation of why 10
Dr. Andersson’s testimony is factually incorrect and irrelevant. 11
It is not apparent to us how this testimony of Dr. Andersson is in conflict with Dr. 12
Weinberger’s testimony. The statement that Tobinick objects to does not discuss 13
epidural administration in general, but only epidural administration as provided in the 14
‘205 application. Dr. Weinberger’s testimony, though, refers only to the anatomy of the 15
spinal nerve roots and spinal cord in the intrathecal space. Tobinick has not provided 16
sufficient explanation of how Dr. Weinberger’s testimony demonstrates that Dr. 17
Andersson’s testimony is factually incorrect or irrelevant. 18
We note that the testimony of Dr. Andersson cited by Tobinick also states that 19
“Tobinick’s description of localized administration is poorly conceived and would not 20
guarantee that any medicine will reach the site of a disorder.” (Andersson, Decl., Ex. 21
1060, pp. 60-61, § VI ¶ 29.) We do not rely on this statement in our opinion and do not 22
offer any opinion of it. 23
Tobinick also cites to the Fourth Andersson Declaration and Olmarker’s reliance 24
on it in Tobinick’s motion to exclude evidence. (Tobinick Motion 5, paper 363, at 12-13.) 25
Tobinick does not provide specific arguments against particular statements made by 26

-26-
Dr. Andersson in his fourth declaration. Instead, Tobinick argues that “the scientific 1
errors made by Dr. Andersson were so numerous, and so significant, that his scientific 2
testimony is entirely unreliable,” citing to almost 70 paragraphs of testimony by Dr. 3
Weinberger. (Tobinick Motion 5, Paper 363, at 13.) Review of this testimony by Dr. 4
Weinberger does not persuade us that the testimony in Dr. Andersson’s fourth 5
declaration we relied on regarding local administration and the Batson’s plexus was 6
incorrect. (See Andersson Fourth Declaration, Ex. 1135, at §III, ¶ 4, p. 4.) Tobinick has 7
not provided sufficient argument or citation in its motion to persuade us otherwise. 8
Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1250, n.2 (Fed. Cir. 2008) 9
(quoting United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) (“Judges are not like 10
pigs, hunting for truffles buried in briefs.”)). 11
We do not rely on any of the other evidence that Tobinick cites to in its Motion 5, 12
and thus do not review Tobinick’s arguments regarding this evidence. 13
We also note that Tobinick has raised issues of inequitable conduct in this 14
Interference and prior Interference 105,842. (See Tobinick Statement pursuant to the 15
Order – Inequitable Conduct (Paper 369) (“Tobinick Statement”), Paper 370.) 16
Tobinick’s allegations relate to whether nucleus pulposus causes central nervous 17
system disorders and the prior art status of “the Le ‘488 application.” (Tobinick 18
Statement, Paper 370, at 6.) Because our opinion in this Interference does not hinge on 19
whether nucleus pulposus causes central nervous system disorders and the prior art 20
status of “the Le ‘488 application” was not raised in this Interference, we do not consider 21
Tobinick’s allegations. Furthermore, to the extent that Tobinick argues that that certain 22
Olmarker patent claims involved in this Interference should have been found 23

-27-
unpatentable in another interference, we decline to address these concerns in light of 1
our decision on the threshold issue of the lack of written description support for 2
Tobinick’s involved claims. 3
VI. Conclusion 4
We enter judgment against Tobinick ‘205 application claims 68, 69, and 71-80, 5
separately. 6
7

-28-
Torczon, Administrative Patent Judge, concurring. 1
This case underscores the peril in claim copying. 2
For more than a generation, claim copying has not been necessary to suggest an 3
interference. E.g., Aelony v. Arni, 547 F.2d 566, 570 (CCPA 1977) (claimed subject 4
matter need not even overlap). Nevertheless, patent practitioners persisted in copying 5
claims. Claim copying is a nuisance (inevitably leading to a mismatch between the 6
language of the claim and the disclosure with resulting confusion or otherwise unneeded 7
analysis), but it was essentially harmless. 8
Now claim copying is destructive to applicants and their counsel. Without any 9
basis in a statute or any justification in interference practice, a court opinion created a 10
surprising exception in written description law for copied claims, albeit only at the United 11
States Patent and Trademark Office. In re Spina, 975 F.2d 854, 856 (Fed. Cir. 1992); 12
Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366 (Fed. Cir. 2009); Koninklijke 13
Philips Elecs. N.V. v. Cardiac Sci. Operating Co., 590 F.3d 1326, 1332 (Fed. Cir. 2010); 14
but see Cultor Corp. v. A.E. Staley Mfg. Co., 224 F.3d 1328, 1332 (Fed. Cir. 2000) 15
(wisely declining to extend Spina to the district courts).3 16
Whether a doctrine, not compelled by statute or logic, messy to administer and 17
catastrophic to unwary applicants and patent practitioners should persist is a question 18
only the courts can resolve. Resolution is urgently needed. 19
20

3 For a catalogue of some of the difficulties that Agilent has created, see, e.g., Lazaridis
v. Eggleston, 2011 WL 1676301 (BPAI 2011) (dubitante opinion); Rilo v. Benedict, 2011
WL 729494 n.55 (BPAI 2011).

-29-
cc (via e-mail): 1
2
3
Attorney for Tobinick: 4
5
Robert W. Hahl, Esq. 6
Richard A. Neifeld, Esq. 7
NEIFELD IP LAW, PC 8
Email: rhahl@neifeld.com 9
Email: rneifeld@neifeld.com 10
11
12
Attorney for Olmarker: 13
14
Todd R. Walters, Esq. 15
Christopher L. North, Esq. 16
Erin M. Dunston, Esq. 17
BUCHANAN INGERSOLL & ROONEY PC 18
Email: todd.walters@bipc.com 19
Email: christopher.north@bipc.com 20
Email: erin.dunston@bipc.com 21