Ex Parte Epshtein et al

Patent Trial and Appeal Board

Jan 17, 2017

10522651 (P.T.A.B. Jan. 17, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/522,651 01/22/2005 Oleg Iliich Epshtein 841/007 7491
83336 7590 01/19/2017
PFRPtAMFNT fr r’FPFDA T T P
EXAMINER
163 Madison Ave., PAK, MICHAEL D
Suite 220-036
Morristown, NJ 07960 ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
01/19/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mcepeda@ pergamentcepeda. com
lmacqueen@pergamentcepeda.com
sshankar@pergamentcepeda.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte OLEG ILICH EPSHTEIN,
EVGENY DANILOVICH GOLDBERG, and
ALEXANDR MIKHAILOVICH DYGAY1
Appeal 2014-006750
Application 10/522,651
Technology Center 1600
Before TAWEN CHANG, RACHEL H. TOWNSEND, and DEVON
ZASTROW NEWMAN , Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
homeopathically potentized form of tumor necrosis factor alpha (TNF-a),
which have been rejected as being directed to nonstatutory subject matter,
indefinite, lacking in written description, not enabled, and anticipated. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm. We designate the affirmance of the written description
rejection as a new ground of rejection.
1 Appellants identify the Real Party in Interest as Dr. Oleg Epstein. (Appeal
Br. 2.) We note that Appellants use both Epshtein and Epstein to refer to the
inventor Dr. Oleg Epstein. We refer to the inventor throughout as Epshtein.
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STATEMENT OF THE CASE
Treating autoimmune diseases by introducing antibodies to various
cytokines, which regulate the course of inflammatory processes, such as
antibodies to the tumor necrosis factor alpha (TNF-a), is a well-known
practice. (Spec. 1.) “The therapeutic effect... is based on cytokine binding
(inactivating).” (Id.)
According to the Specification, Appellants’ “invention is directed at
... the treatment of inflammatory, including autoimmune, diseases, . . .
ensuring the anti-inflammatory effect by modification rather than by binding
(inactivation) of a cytokine.” (Id.) Further according to the Specification,
the treatment employs “an activated form of ultra-low doses of [antibodies to
the tumor necrosis factor alpha] . . . prepared by multiple consecutive
dilutions and by exposure to external factors.” (Id.)
Claims 3 and 5—10 are on appeal. Claim 3 is representative and reads
as follows:
3. A medicament effective in correcting a pathologic
immune reaction, said medicament comprising a
homeopathically potentized form of at least one monoclonal
polyclonal or natural antibody to a recombinant human or
heterologous tumor necrosis factor alpha (TNF-a), wherein said
homeopathically potentized form of antibody is prepared by
homeopathic methodology that includes multiple consecutive
dilutions.
(Appeal Br. 14.)
The following grounds of rejection by the Examiner are before us on
review:
1. Claims 3 and 5—10 under 35 U.S.C. § 101 as being directed to
nonstatutory subject matter.
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2. Claims 3 and 5—10 under 35U.S.C. § 112, second paragraph as
being indefinite.
3. Claims 3 and 5—10 under 35U.S.C. § 112, first paragraph as
containing subject matter which was not described in the
specification.
4. Claims 3 and 5—10 under 35U.S.C. § 112, first paragraph as
not being enabled.
5. Claims 3 and 5—10 under 35 U.S.C. § 102 as being anticipated
over Le.2
(Appeal Br. 3.)
DISCUSSION
§101
The Examiner finds that the claims are directed to a homeopathically
potentized form of a naturally occurring antibody which is limited by a
particular process of making it, namely dilution of the antibody. (Non-Final
4—5; Ans. 9.)3 The Examiner contends that “[wjhatever is the structural
form [of the naturally occurring antibody] after the series of dilution[, it] is a
naturally occurring form from the naturally occurring antibody originally
used.” (Ans. 9.) Regarding the method of creating this form, the Examiner
finds that the “steps relating to the dilution of antibody are well-understood”
and amounts to “instructions that are well-understood, routine, conventional
activity, previously engaged in by those in the field” and, thus, “add nothing
2 Le et al., US 5,698,195, issued Dec. 16, 1997.
3 Although Appellants appeal from a non-final rejection, the pending claims
have been rejected at least twice. Consequently, the Appeal is properly
filed. 35 U.S.C. § 134(a).
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specific to the natural principle that would render it patent-eligible.” (Ans.
4.)
We agree with the Examiner’s factual findings and conclusion that
claim 3 is directed to nonstatutory subject matter.
Appellants’ argument that the claimed antibodies are not nonstatutory
subject matter because “[i]t is well established that claims to antibodies are
patentable” and that the process of multiple dilutions “is not a natural
process” (Reply Br. 2) is not well founded. Determination of subject matter
eligibility involves a two-step test. First, one must determine if the claimed
subject matter is directed to a judicially recognized exception, such as a
product of nature, i.e., natural phenomenon. Mayo Collaborative Serves, v.
Prometheus Lab., Inc. 132 S.Ct. 1289, 1293, 1297 (2012); Ass’n for
Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2116 (2013).
If it does, the next step is to determine if the claims recite additional
elements that transform the nature of the claim. Genetic Tech. Ltd. v. Merial
LLC, 888 F.3d 1369, 1374 (Fed. Cir. 2016)
We disagree with Appellants’ blanket statement that “claims to
antibodies are patentable.” The Supreme Court has clearly indicated that
naturally occurring material that is isolated from its natural environment is
unpatentable. See Myriad, 133 S.Ct. at 2118 (finding claims to isolated
DNA unpatentable). Antibodies that are unaltered by genetic or chemical
manipulation are naturally occurring.
Claim 3 recites a composition that can be “a homeopathically
potentized form” of a “natural antibody to a recombinant human or
heterologous tumor necrosis factor alpha (TNF-a).” (Claim 1.) Appellants’
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Specification does not specifically define the term “homeopathically
potentized form.” However, it does disclose that “homeopathic potentisation
technology” provides “ultra low or low doses” of antibody by “consecutive
multiple dilutions and [subjecting them] to an external mechanical factor”
such as “vertical shaking.” (Spec. 2.) In light of this, we determine that the
broadest reasonable interpretation consistent with the Specification of the
term “homeopathically potentized form” as would be understood by one of
ordinary skill in the art is that the claimed form refers to an antibody that is
present in an ultra low or low dose prepared at least by consecutive multiple
dilutions. Appellants do not disagree; indeed they confirm as much in their
brief, noting that the claimed “form of antibody is prepared by multiple
consecutive dilution of the initial antibody until potentization is achieved.”
(Appeal Br. 4.)
Such an antibody is altered less than the nucleic acid in Myriad, it is
chemically unchanged: there is no chemical bond severing such as was done
to release the nucleic acid from the chromosome in Myriad, but simply
separation of the antibody from its natural environment and subsequent
dilution to low dose or ultra low dose. Appellants argue that in the process
for making the claimed antibody “to TNF-alpha, the inventor raises
polyclonal antibodies in rabbit” and then “the inventor does multiple
consecutive dilution in accordance with homeopathic technology.” (Reply
Br. 2.) Regardless of whether the Specification describes raising polyclonal
antibodies in rabbit (Spec. 2), Claim 3 recites a composition that can be “a
homeopathically potentized form” of a “natural antibody.” (Claim 3.) A
natural antibody is a product of nature. The fact that it is present in the
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formulation in a low or ultra low dose is analyzed under the second step in
the subject matter eligibility determination.
We note that in addition to reciting that the natural antibody to TNF-
alpha is present in a “homeopathically potentized form,” claim 3 recites a
process step by which the homeopathically potentized form of the natural
antibody must be made, i.e., “multiple consecutive dilutions.” (Claim 3.)
That process step does not add anything to transform the nature of the
antibody of claim 3.4 Indeed, it is nothing more than an explicit recitation of
one step the Specification teaches is used to create the low or ultra low dose
of antibody that is the “homeopathically potentized form.” There is no
argument made that the dilution of an antibody creates a new structural form
of the antibody or alters the natural antibody in any structural way, nor is it a
novel step in preparing antibodies for use in therapeutics, as the Examiner
found (Ans. 4). Thus, isolating the natural antibody to TNF-a and
subjecting it to “multiple consecutive dilution” to achieve a low or ultra low
4 At oral argument, Appellants’ representative asserted that the potentization
process results in there being no antibodies left in the diluent but which
diluent has a new activity. (Oral Hearing Tr. 4:20-5:7 (“you take a serum
with antibodies, and you dilute it until there is no more antibodies left in
that. You create a new activity by this process. . . . This solvent obtains new
property”).) This is a new argument, which we do not consider, see e.g., Ex
parte Borden, 93 USPQ2d 1473, 1473-74 (BPAI 2010) (“informative”)
(absent a showing of good cause, the Board is not required to address
argument in Reply Brief that could have been presented in the principal
Brief), except to note that it is inconsistent with the teachings in the
Specification that homeopathic potentization technology provides for a low
or ultra low dose of antibody and that “this procedure gives the required
dose (potency)” (Spec. 2).
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dose of the antibody is not found to result in an inventive concept that
transforms the natural phenomenon of the natural antibody to TNF-a into a
patentable invention.
Claims 5—10 have not been argued separately and therefore fall with
claim 3. 37 C.F.R. § 41.37(c)(l)(iv).
§ 112, second paragraph
The Examiner finds that the term “homeopathically potentized form”
is “ambiguous and confusing because the metes and bounds of the term is
not clear [in that] [i]t is not clear when a compound is [a] homeopathically
potentized form.” (Ans. 5; Final Action 6.) The Examiner further notes,
citing Goldacre,5 that “[i]t is not clear to all skilled in the art that such form
is clear” in light of the art indicating that “homeopathy produced no
statistically significant benefit over placebo” and “it is not clear what the
product is that is giving the placebo effect.” (Ans. 10; Final Action 7.)
The Examiner further finds that the methodology of creating the
homeopathically potentized form recited does not make clear the metes and
bounds because “it is not clear when a compound becomes homeopathically
potentized since the dilution of Le . . . does not appear to be a
homeopathically potentized [form] when diluted” and “Goldacre was not
able to determine the metes and bounds of a homeopathically potentized
[form] from his studies.” (Ans. 10—11.) In short, according to the
5 Goldacre et al., Comment: Benefits and risks of homeopathy, 370 Lancet
1672-73 (Nov. 17, 2007)
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Examiner, while the claim language may make “clear the genesis of the
claimed ‘homeopathically potentized form’ of antibody,” “it is not clear
when such homeopathic methods are used what is the product which is
acting on the placebo effect that is being claimed” and Appellant “has not
defined what the product is when the product is in ‘homeopathically
potentized form.’” (Final Action 7—8).
Appellants argue that evidence of record provided by the second
Declaration of Dr. Epshtein (dated Feb. 4, 2012), including results of clinical
trials establishes that the claimed form of antibodies to TNF-a have a
biological effect different from placebo, and thus the Examiner’s reliance on
Goldacre is improper. (Appeal Br. 5—6; Reply Br. 3.)
Appellants further argue that the excerpt of the German Homeopathic
Pharmacopeia6 provided during prosecution specifically refers to
formulations that are obtained by “potentization” and “describes standard
homeopathic preparation technologies for various known homeopathic
preparations” and for each described method indicates “the necessary
potentization methodology,” thereby establishing that “the meaning of the
term homeopathic potentization or activation was well defined to one skilled
in the art at the time of filing of the application.” (Appeal Br. 6.) Appellants
also note that the first Declaration of Dr. Epshtein (dated Nov. 12, 2009) and
the Declaration ofNikolayev, (dated Nov. 12, 2009) both filed during
prosecution, state unequivocally “that the term ‘homeopathic potentization’
has a well-defined meaning in the homeopathic art,” and support a finding
6 German Homeopathic Pharmacopeia (GHP), Translation of the 5th
Supplement (1991) to the 1978 edition, pp. 23, 31—38.
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that the term is known to those of skill in the art. (Appeal Br. 6—7.)
According to Appellants, that meaning is “that the homeopathically
potentized form of the antibody of the application on appeal are prepared by
homeopathic methodology that includes multiple consecutive dilutions.”
(Appeal Br. 7.)
The Supreme Court explained that the standard for determining
whether a claim is indefinite is whether the claim “inform[s] those skilled in
the art about the scope of the invention with reasonable certainty.” Nautilus,
Inc. v. Biosig Instruments, 134 S. Ct. 2120 (2014). We agree with the
Examiner that claim 3 is indefinite. The Specification explains that one of
ordinary skill in the art can make ultra low or low doses of TNF- a antibody
through “homeopathic potentisation technology” and that this “technology”
“gives rise to a uniform decrease in the concentration” of the antibody
“through consecutive dilution of 1 volumetric part of the initial matter
(antibodies) in 9 volumetric parts (for decimal dilution, D) or in 99
volumetric parts (for centesimal dilution, C) of a neutral solvent with
multiple vertical shaking of each solution.” (Spec. 2.) This is consistent
with the discussion in the GHP and Appellants’ argument that the GHP
describes homeopathic preparation technologies. However, a discussion as
to how one prepares the claimed homeopathically potentized form of the
antibody does not describe the boundaries of what that form of the antibody
is with reasonable certainty. “The indefmiteness inquiry is concerned with
whether the bounds of the invention are sufficiently demarcated, not with
whether one of ordinary skill in the art may find a way to practice the
invention.” ePlus, Inc. v. Lawson Software, Inc., 700 F.3d 509, 519 (Fee.
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Cir. 2012). One of ordinary skill in the art is not informed by the description
in the Specification or the GHP with reasonable certainty what the attributes
of the homeopathically potenitzed form of TNF-a antibody are as compared
to any other diluted TNF-a antibody such as is taught by Le so as to be able
to distinguish a homeopathically potentized form from any other diluted
form of TNF- a antibody. In other words, that the Specification may
identify a method of making an ultra low dose or low dose of an antibody by
dilution methods known to those of ordinary skill in the homeopathic art is
insufficient to inform one of ordinary skill in the art with reasonable
certainty the metes and bounds of what is a homeopathically potentized form
of TNF-a antibody.
The statement by declarant Epshtein that “homeopathic potentization”
has a well-defined meaning to one of skill in the art because potentization is
known to refer to dilution technology used in homeopathy (Epshtein
Declaration dated Nov. 12, 2009, ^6—10), and the statement by declarant
Nikolayev that “[hjomeopathic potentization” “is generally understood as
‘creating the desired homeopathic potency’ th[r]ough homeopathic
technology” (Nikolayev Declaration dated Nov. 12, 2009 17) also do not
establish that one of ordinary skill in the art would be reasonably certain of
the metes and bounds of the claimed homeopathically potentized form of
TNF-a antibody. Both statements simply indicate that serial dilution is the
known methodology by which homeopathic preparations are made; neither
statement is sufficient to provide information as to what one of ordinary skill
in the art would have understood with reasonable certainty as being a
homeopathically potentized form of TNF-a antibody.
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At oral argument, Appellants’ representative indicated that the only
way to know when one has “something that’s been diluted enough to be a
potentized form” “is to dilute and test the material in the biological — in the
biologically acceptable model.” (Oral Hearing Tr. 8.) Appellants’
representative noted that for every medical compound, there is a threshold
concentration below which the compound will not be biologically active,
and that if one had a dilution that is above the threshold concentration and
the antibody achieved a therapeutic effect it would not be a homeopathic
potentized form. (Oral Hearing Tr. 16.) Even if true, Appellants have not
provided sufficient evidence establishing there is such a biologically
acceptable model for determining positive homeopathic results in treating
pathologic immune reaction. And in any event, the pertinent issue is
whether the Specification discloses to one of ordinary skill in the art
adequate standards for determining the boundaries of the claim. The
Specification does not provide a standard for evaluating whether a given
dilution of TNF-a antibody has reached the stage of homeopathic
potentization, i.e. the requisite ultra low or low dose. As the Examiner
noted, “one skilled in the art has the technology to measure the quantity of
TNF-alpha antibody by a number of methods whereas the specification does
not use known techniques to determine the concentration of the antibody.”
(Ans. 10.)
While it is true that “patentable inventions cannot always be described
in terms of exact measurements, symbols and formulae,” it is nevertheless
also true that “[i]f the subject matter of the patent is such that the
patentee ... is incapable of ascribing reasonable limits to his claims,
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regardless of intrinsic merit[,] his invention cannot be patented.” Georgia-
Pacific Corp. v. United States Plywood Corp., 258 F.2d 124, 136 (2d Cir.)
In light of the foregoing, we affirm the Examiner’s rejection of claim
3 under 35 U.S.C. § 112, second paragraph. Claims 5—10 have not been
argued separately and therefore fall with claim 3. 37 C.F.R.
§ 41.37(c)(l)(iv).
§ 112, first paragraph: Written Description
According to the Examiner, “[i]f one skilled in the art cannot envision
the generic claim from the specific example then it lacks written
description.” (Final Action 9; Ans. 5—6.) The Examiner contends that “the
essential feature of the invention is not clear because the structure which
makes an antibody homeopathically potentized is not disclosed.” (Final
Action 8.) The Examiner further contends that “[hjomeopathically
potentized antibody cannot be envisioned by one skilled in the art” and
“[t]he nexus between the method of making the product and resulting
product which is ‘homeopathically potentized form’ is not disclosed in a
manner that one of skilled in the art can determine what is the product
claimed.” (Final Action 9.)
We agree with the Examiner’s conclusion that the Specification fails
to adequately describe the claimed invention, but for slightly different
reasons. Consequently, we designate our affirmance as a new ground of
rejection.
“[T]he test for sufficiency [of the written description] is whether the
disclosure of the application relied upon reasonably conveys to those skilled
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in the art that the inventor had possession of the claimed subject matter as of
the filing date.” AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010). Identifying the structure of a claimed compound is not the
only way to establish possession, as Appellants note (Appeal Br. 7). The
written description requirement can be met by “showing that an invention is
complete by disclosure of sufficiently detailed, relevant identifying
characteristics ... i.e., complete or partial structure, other physical and/or
chemical properties, functional characteristics when coupled with a known
or disclosed correlation between function and structure, or some
combination of characteristics.” Enzo Biochem, Inc. v. Gen-Probe Inc., 296
F.3d 1316, 1324 (Fed. Cir. 2002). But, while Appellants have provided
(a) preparation of “potentiated” antibodies to TNF-a by
homeopathic technology including starting materials (e.g., at
page 2, 3rd and 4th paragraph), (b) administration of the
activated or potentiated form of the antibody to TNF-a to
patients (e.g., Examples 3 and 4 ), and (c) biological effects of
such administration in an animal model (e.g., Examples 1 and
2)
(Appeal Br. 7), there is no disclosure of sufficient relevant identifying
characteristics of the claimed homeopathically potentiated form of TNF-a
antibody. There is no identification of the structure or any physical
properties of the claimed form. To the extent any chemical properties are
deemed to be described because biological effects are shown, there is no
indication of any known or determined structure to function/activity
relationship regarding any observed biological effects. Thus, not only have
Appellants not provided the structure of the claimed antibody, Appellants
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have also not provided any other sufficiently detailed, relevant identifying
characteristics.
We therefore affirm the rejection of claim 3 under 35 U.S.C. § 112,
first paragraph as not being adequately described in the Specification.
Claims 5—10 have not been argued separately and therefore fall with claim 3.
37C.F.R. §41.37(c)(l)(iv).
§ 112, first paragraph: Enablement
The Examiner finds that the Specification does not reasonably enable
the skilled artisan to make and use the claimed homeopathically potentized
form of antibody without undue experimentation. (Final Action 11—13.)
The Examiner contends that
The state of the art is such that one skilled in the art prior to the
time of the invention found that homeopathically potentized
form are no better than placebo (Goldacre (Lancet, 2007)).
Goldacre (Lancet, 2007) disclose that homeopathy produced no
statistically significant benefit over placebo. The amount of
direction provided in the specification is limited to diluting
TNF antibodies. One skilled in the art cannot discern where the
product is produced which results in a treatment which is
different from placebo. One skilled in the art would require
empirical experimentation in order to determine the difference
between placebo effect and the treatment due to the potentized
homeopathically form. In view of the extent and the
unpredictability of the experimentation required to practice the
invention as claimed, one skilled in the art could not make the
invention without undue experimentation.
(Id.)
We agree with the Examiner’s factual findings and conclusion that
that the invention recited in claim 3 is not enabled. Like Appellants (Appeal
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Br. 10), we understand the Examiner’s enablement rejection to focus on the
lack of an enabling disclosure as to how to use the claimed composition for
effective correction of a pathologic immune reaction. Appellants contend
that “office has not provided any evidence showing that the homeopathically
potentized forms of antibodies of the present invention are not useful for
correcting pathological immune reaction” and that enablement is established
by clinical trial evidence submitted in the second Declaration of Dr.
Epshtein (dated Feb. 4, 2012) and a 2010 article by Dr. Montagnier.
(Appeal Br. 10-11.) In particular, Appellants note that
the file wrapper contains evidence that the homeopathically
potentized form of antibodies to TNF-alpha has biological
activity different from placebo. See Epstein Declaration II and
Exhibits submitted with the Declaration. The study described in
the Epshtein Declaration II is double-blind, placebo-controlled
study clearly demonstrating that the effect of Artrofoon is not a
placebo effect. In contrast to the information in the Goldacre
article, the information in the Epshtein Declaration II pertains
directly to the specific homeopathically potentized form of the
application on appeal.
(Appeal Br. 10.) Appellants note further that the article by Dr. Luc
Montagnier
makes reference to his experimental research that
confirms that homeopathic medicine that uses doses of
substances that undergo sequential dilution with vigorous
shaking in-between each dilution has biological effects.
(Appeal Br. 11.) Appellants contend that the article by Goldacre is
insufficient to countermand the foregoing “un-contradicted evidence.”
(Appeal Br. 10.)
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As the Examiner notes, however, “[n]o evidence has been presented
that the data presented in [the second] Epstein Declaration is representative
of [a] model for placebo effect.” (Ans. 14.) One of the studies relied upon
in Goldacre to render the conclusion that “homoeopathy produced no
statistically significant benefit over placebo” was “Comparative study of
placebo-controlled trials of homeopathy and allopathy.” (Goldacre 1673 n.
5.) The Examiner thus has presented evidence to countermand Appellants’
position that the claimed invention is necessarily more than a placebo effect
because clinical trial evidence was provided that “morning stiffness and the
total intensity of pain were significantly reduced” in patients with Reiter
disease and because there were accompanying “positive dynamics of
laboratory indicators: the CRP has significantly decreased by the third
month of treatment [and a] significant decrease of TNF-a [and] downward
trend of IL-ip were observed by the sixth month” in those treated for
arthritis (Appeal Br. 5—6). For this reason, we disagree with Appellants that
“there is no requirement” for “empirical experimentation in order to
determine the difference between placebo effect and the treatment due to
homeopathically potentized form” of the claimed antibody (Reply Br. 5). As
the Examiner noted, “[w]ithout such control data, the experiment is
unpredictable as to the effect of the homeopathically potentized effect as
taught by Goldacre (Lancet, 2007) which had placebo effect.” (Ans. 14.)
Furthermore, Appellants do not contest the Examiner’s position that the
animal model “is not [a] predictable model that one skilled in the art can
replicate.” (Ans. 14.) Nor do Appellants contest that the control requires a
low dose dilution of the TNF-a antibody but one that is not homeopathically
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potentized in order to appropriately assess placebo effects. (Id.) As one
commentator has noted: “A randomised trial of ‘solvent only’ versus
‘infinite dilutions’ is a game of chance between two placebos.” Jan P
Vandenbroucke, 350 Lancet 824 (Sept. 20, 1997). That is, some fraction of
patients will improve without any treatment, and this improvement does not
evidence efficacy of the compound but simply represents the natural healing
ability of the human body.
Appellants’ reliance on the Montagnier article is also unavailing as the
article does not discuss therapeutic results; nor does it indicate what level of
dilution is referred to, but rather simply states that “we cannot go further
than a 10'18 dilution” without losing the electromagnetic signals.
Montagnier 1733.
We therefore affirm the rejection of claim 3 under 35 U.S.C. § 112,
first paragraph as not being not enabled. Claims 5—10 have not been argued
separately and therefore fall with claim 3. 37 C.F.R. § 41.37(c)(l)(iv).
§102
The Examiner finds that Le “disclose[s] anti-TNF antibodies used for
treatment of rheumatoid arthritis [and] teach[es] numerous method[s] of
therapeutic administration with different dosages.” (Final Action 15; Ans.
8.) According to the Examiner, these dosages involve dilution of the
antibody. (Ans. 16.) Thus, the Examiner concludes that “Le . . . uses the
TNF-alpha antibody and functions to treat rheumatoid arthritis [the] same as
claimed.” (Ans. 16.)
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For reasons stated above, we cannot determine the scope of claim 3
and 5—10 on appeal. Before a proper review of the rejection can be
performed, the subject matter encompassed by the claims on appeal must be
reasonably understood without resort to speculation. See In re Steele, 305
F.2d 859, 862-63 (CCPA 1962); In re Wilson, 424 F.2d 1382, 1385 (CCPA
1970). Accordingly, we reverse pro forma the prior art rejection of claim 3.
Cf. Ex parte Gutta, 93 USPQ2d 1025, 1036 (Bd. Pat. App. & Int.
2009) (precedential). This is a technical reversal rather than one based upon
the merits of the Section 102 rejection.
SUMMARY
We affirm the following rejections:
1. Claims 3 and 5—10 under 35 U.S.C. § 101 as being directed to
nonstatutory subject matter.
2. Claims 3 and 5—10 under 35 U.S.C. § 112, second paragraph as
being indefinite.
3. Claims 3 and 5—10 under 35 U.S.C. § 112, first paragraph as
containing subject matter which was not described in the
specification.
4. Claims 3 and 5—10 under 35 U.S.C. § 112, first paragraph as
not being enabled.
Because our reasoning regarding the rejection for lack of written description
differs to some degree from the Examiner’s, we designate our affirmance of
this rejection as New Grounds of Rejection.
We reverse the rejection of claims 3 and 5—10 under 35 U.S.C. § 102
as being anticipated over Le.
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TIME PERIOD FOR RESPONSE
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new grounds of
rejection to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new Evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the examiner, in which
event the prosecution will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same Record. . . .
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED. 37 C.F.R, $ 41.50(b)
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