Ex Parte Campbell et al

Patent Trials and Appeals BoardMay 6, 2019

13463127 - (D) (P.T.A.B. May. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/463, 127 05/03/2012 21839 7590 05/08/2019 BUCHANAN, INGERSOLL & ROONEY PC POST OFFICE BOX 1404 ALEXANDRIA, VA 22313-1404 FIRST NAMED INVENTOR Joy Campbell 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 0086030-000007 3389 EXAMINER EWOLDT, GERALD R ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 05/08/2019 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): ADIPDOC 1@BIPC.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOY CAMPBELL, RONALD E. STROHBEHN, ERIC M. WEA VER, BARTON S. BORG, LOUISE. RUSSELL, FRANCISCO JAVIER POLO POZO, JOHN D. ARTHINGTON, and JAMES D. QUIGLEY III 1 Appeal2018-003018 Application 13/463, 127 Technology Center 1600 Before JOHN G. NEW, RYAN H. FLAX, and RACHEL H. TOWNSEND, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. Â§ 134(a) involving claims directed to a method of treating gastrointestinal diseases related to chronic immune stimulation. Claims 1, 2, and 5 are on appeal as rejected under 35 U.S.C. Â§ 112, first paragraph, andÂ§ 103(a). We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. 1 Appellants identify the Real Party in Interest as "Lauridsen Group Inc." Appeal Br. 2. Herein we refer to the Substitute Specification of Dec. 28, 2012 ("Spec."); the Final Rejection of Feb. 17, 2017 ("Final Action"); the Appeal Brief of Aug. 11, 2017 ("Br."); and the Examiner's Answer of Nov. 27, 2017 ("Answer"). No Reply Brief was submitted by Appellants. Appeal2018-003018 Application 13/463, 127 STATEMENT OF THE CASE The Specification states: The primary source of nutrients for the body is blood, which is composed of highly functional proteins including immunoglobulin, albumin, fibrinogen and hemoglobin. Immunoglobulins are products of mature B cells (plasma cells) and there are five distinct immunoglobulins ["lg"] referred to as classes: M, D, E, A, and G. IgG is the main immunoglobulin class in blood. Intravenous administration of immunoglobulin products has long been used to attempt to regulate or enhance the immune system. Spec. 1:25-31. The Specification further states, "[a]ccording to the invention, a plasma composition comprising immunoglobulin, when administered orally, regulates and lowers nonspecific immunity responses and induces a lowering and regulation of serum IgG levels and TNF-a levels relative to animals not orally fed immunoglobulin or plasma fractions." Id. at 3:16-20. Claim 1 is representative and is reproduced below: 1. A method of treating gastrointestinal diseases related to chronic immune stimulation, comprising orally administering to a human subject afflicted with Crohn's disease, ulcerative colitis, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or HIV, a non-specific immunoglobulin concentrate that is a fraction derived from pig, bovine, ovine, poultry, equine, or goat blood, serum, or plasma, wherein the immunoglobulin concentrate is orally administered in combination with a pharmaceutically acceptable carrier, and wherein the immunoglobulin concentrate is administered in an amount that comprises 0.5-2.5% by weight of the subject's total dietary intake. Br. 17 (Claims Appendix). 2 Appeal2018-003018 Application 13/463, 127 The following rejections are appealed: Claims 1, 2, and 5 stand rejected under 35 U.S.C. Â§ 112, first paragraph, for lacking an enabling disclosure. Answer 2. Claims 1, 2, and 5 stand rejected under 35 U.S.C. Â§ 112, first paragraph, for lacking a written description (new matter added). Answer 5. Claims 1, 2, and 5 stand rejected under 35 U.S.C. Â§ 102(b), or alternatively, 35 U.S.C. Â§ 103(a), over Polo Pozo. 2 Answer 5. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Arguments made by Appellants in the Appeal Brief have been considered; arguments not so presented in the Brief are waived. See 37 C.F.R. Â§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BP AI 2010) (informative) ("Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived."). Except as otherwise indicated below, we adopt the Examiner's findings of fact and rationale as set forth in the Final Action and Answer. Final Action 2-7; Answer 2-12. Findings of fact set forth below highlight certain evidence. 2 EP 1 044 690Al (published Oct. 18, 2000) ("Polo Pozo"). 3 Appeal2018-003018 Application 13/463, 127 I. ENABLEMENT Relevant Law over, Relevant to the Examiner's rejection and Appellants' arguments there- Section 112 requires that the patent specification enable "those skilled in the art to make and use the full scope of the claimed invention without undue experimentation". . . . [S]ee also In re Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) ("[T]he spec- ification must teach those of skill in the art how to make and how to use the invention as broadly as it is claimed."). Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070-71 (Fed. Cir. 2005). As to the scope of the claimed invention, "the claims define the invention ... [ and] limitations from the specification are not to be read into the claims." Sjolund v. Musland, 847 F.2d 1573, 1582 (Fed. Cir. 1988). The Patent Office applies the broadest reasonable construction standard in prosecution proceedings. Cuozzo Speed Tech., LLC v. Lee, 136 S. Ct. 2131, 2145 (2016). Furthermore, "an invention may be enabled even though it has not been described." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 921 (Fed. Cir. 2004). Findings of Fact (FF) FF 1. The claims require: (1) treating by "orally administering to a human subject afflicted with [e.g.,] Crohn's disease ... "; (2) "a non-specific immunoglobulin concentrate that is a fraction derived from [ e.g.,] pig ... serum, or plasma"; (3) "the immunoglobulin concentrate is orally administered in combination with a pharmaceutically acceptable carrier"; and ( 4) "the immunoglobulin concentrate is administered in an amount that comprises 0.5-2.5% by 4 Appeal2018-003018 Application 13/463, 127 weight of the subject's total dietary intake." See Br. (Claims Appendix). FF2. Further to the preceding finding of fact, the claims do not require any specific result to be achieved by the recited method of treatment. All the claims require is the administration of the claimed non-specific immunoglobulin concentrate formulation, at the claimed dose, to a member of the claimed population ( which effects some treatment). Analysis The Examiner determined, regarding the invention defined by claims 1, 2, and 5, that "[t]he specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation." Answer 2. The Examiner premised this determination on the rationale that "biological methods which rely on previously undescribed and generally unpredictable mechanisms" require "'more detail as to how to make and use the invention in order to be enabling'." Id. ( citing MPEP Â§ 2164.03). Furthermore, the Examiner's determination is based on an interpretation of the claims as requiring an "effective treatment" for one of the recited disease states. Id. at 3. We conclude the Examiner's determination here is based on an incorrect claim interpretation. Under the broadest reasonable interpretation of the claims, no claim requires an "effective treatment." See FFl, FF2. All that is required by the claims is to administer the claimed non-specific immunoglobulin concentrate formulation, at the claimed dose, to a member of the claimed population, which effects some treatment of gastrointestinal 5 Appeal2018-003018 Application 13/463, 127 disease in that population. Id. There is nothing unpredictable or that would have been difficult for the skilled artisan to comprehend in such a method, which essentially consists of well-known steps (identifying a diseased population, formulating a non-specific immunoglobulin concentrate dose based on patient weight, and orally administering the dose). " [A] specification need not disclose what is well known in the art." Genentech Inc. v. Novo NordiskA/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997) (citation omitted). Therefore, we conclude the Examiner has not established that the claims lack an enabling disclosure. II. WRITTEN DESCRIPTION/NEW MATTER Relevant Law Relevant to the Examiner's rejection and Appellants' arguments there- over, "[t]he 'written description' requirement serves a teaching function, ... in which the public is given 'meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time."' University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916,922 (Fed. Cir. 2004) (citation omitted). Another "purpose of the 'written description' requirement is ... [to] convey with reasonable clarity to those skilled in the art that, as of the filing date[], [the applicant] was in possession of the invention." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563---64 (Fed. Cir. 1991 ); see also Enzo Biochem Inc. v. GenProbe Inc., 296 F .3d 131 6, 1329 (Fed. Cir. 2002). The requirement is satisfied when the specification "set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed." University of Rochester, 358 F.3d at 928. 6 Appeal2018-003018 Application 13/463, 127 "[ A ]pplicants have some flexibility in the 'mode selected for compliance' with the written description requirement" ( University of Rochester, 358 F.3d at 928), and it is well-settled that actual reduction to practice is not necessary to satisfy the requirement (id. at 926). Whether or not a specification satisfies the requirement is a question of fact, which must be resolved on a case-by-case basis (Vas-Cath, 935 F.2d at 1562-63), and it is the Examiner's "initial burden [to] present[ ] evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims" (In re Wertheim, 541 F .2d 257, 263 (CCP A 197 6) ). "The written description requirement is not met if the specification merely describes a 'desired result."' Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682 (Fed. Cir. 2015) (citing Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010)). Findings of Fact (FF) FF3. Further to the preceding findings of fact, the claims require treating by "orally administering to a human subject afflicted with [e.g.,] Crohn's disease ... ,"anon-specific immunoglobulin concentrate that is "administered in an amount that comprises 0.5- 2.5% by weight of the subject's total dietary intake." See Br. (Claims Appendix). Therefore, the scope of the claims spans administered doses of 0.5-2.5% by weight of total dietary intake that would be expected to result in some treatment. FF4. The Specification's disclosure regarding oral administration of a non-specific immunoglobulin concentrate at a dosage based on a percentage of the subject's total dietary intake can 7 Appeal2018-003018 Application 13/463, 127 potentially be found at Example 5, which describes feeding an array of formulations to mice. Spec. 26-34. Of eight dietary treatments, one was lg concentrate at 2.5% and one was lg concentrate at 0.5% ( for the sake of argument, we presume these percentages are based on the subjects' total dietary intake; however, this is not specified). FF5. Further to the preceding finding of fact, the Specification states, regarding TNF-a suppression, "[t]he immunoglobulin rich fraction suppressed TNF-a production at [0].5% but not at 2.5%." Id. at 31 :28-29 ( the Specification describes that TNF-a concentrations, and hints that IL-IO concentrations, are identifiers of effective treatment). No similar conclusion is stated with respect to IL- I 0 levels and any immunoglobulin concentrate dose. Id. at 26-34. FF6. Further to the preceding findings of fact, the Specification (Example 5) discloses TNF-a and IL- IO production results based on administration of the aforementioned eight dietary treatments, including lg concentrates of 2.5% and 0.5%, and indicates that, when fed these two lg concentrate doses, the respective productions of TNF-a and IL- IO each increased upon stimulation to a greater extent than a control treatment. Spec. 33 (tables 13 and 14); cf FF5. Analysis The Examiner determined "[t]he specification and the claims as originally filed do not provide support for: B) Regarding Claims 1 and 2, a method employing ' ... immunoglobulin concentrate ... in an amount that comprises 0.5-2.5% by weight of the subject's total dietary intake'." 8 Appeal2018-003018 Application 13/463, 127 Answer 5. Because this subject matter was added to the claims by amendment during prosecution, the Examiner identified that the written description rejection was for the introduction of new matter into the claims. Id. We agree with the Examiner's determination: the Specification does not support the "method of treating gastrointestinal diseases related to chronic immune stimulation, comprising ... immunoglobulin concentrate is administered in an amount that comprises 0.5-2.5% by weight of the subject's total dietary intake," as claimed. The Specification does not support that treatment could be expected over the claimed 0.5-2.5% by weight of the subject's total dietary intake range, as claimed. See FF3-FF6. And, the Specification is ambiguous, at best, weather the disclosed 0.5% and 2.5% samples tested reflect percentages based on total dietary intake. Appellants argue that the disclosed list of dietary treatments (1-8) of Experiment II (Example 5) in the Specification supports the claimed subject matter because "the cited Examples provided test subjects with dietary immunoglobulin concentrations that ranged from 0.5% to 2.5% of the diet." This is not persuasive. Even if the "lg concentrate, 2.5%" and the "lg concentrate, [0].5%" were intended to indicate percentages of daily intake by weight, which we can only assume arguendo because it is not specified, these represent only two specific points in the claimed 0.5-2.5% range and the Specification indicates specifically that only the 0.5% point was effective at reducing TNF-a production, while the 2.5% point was not (also, Spec. does not indicate that either point was effective at reducing IL- I 0 production). FF5. Disclosure of a single point, or even end points, in a claimed range does not disclose the range. See, e.g., In re Lukach, 442 F .2d 9 Appeal2018-003018 Application 13/463, 127 967, 969 (CCP A 1971) ( disclosure of points in a range is not disclosure of the range under the written description requirement). Appellants also argue that the data in the Specification shows "IL- I 0 production increased more significantly in subjects fed either 0.5% or 2.5% immunoglobulin concentrate (IL-IO production increase of 329 pg/ml and 274 pg/ml, respectively) as compared to subjects fed the control diet, which lacked immunoglobulin concentrate (IL-IO production increase of 156 pg/ml)" and that this supports the claimed subject matter. It is unclear exactly how this is so or how such data supports the claims because Appellants neither explain as much in their brief nor submit other evidence, e.g., a declaration of an expert, to explain it. Why the changes disclosed in the data of the tables in the Specification matter, or how they relate to the claimed treatment and dosage ranges, remain ambiguous. We find nothing in the record that persuades us that the Examiner's determinations regarding the claims' failings under the written description requirement are in error. III. ANTICIP A TION/0BVI0USNESS Relevant Law Relevant to the Examiner's rejection and Appellants' arguments there- over, "[a]nticipation requires that all of the claim elements and their limitations are shown in a single prior art reference." In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). Furthermore, regarding obviousness, "[ t ]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 10 Appeal2018-003018 Application 13/463, 127 U.S. 398,416 (2007). "[W]hen a patent claims a structure [or method] already known in the prior art that is altered by the mere substitution of one element [ or step] for another known in the field, the combination must do more than yield a predictable result." Id. (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). "[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. Moreover, "the discovery of an optimum value of a variable in a known process is normally obvious." In re Antonie, 559 F.2d 618, 620 (CCP A 1977). Exceptions to this rule include cases where (1) the results of optimizing a variable were unexpectedly good and (2) the parameter optimized was not recognized in the prior art as one that would affect the results. Id. Findings of Fact (FF) FF7. Polo Pozo discloses: applications of mixtures of gamma globulin-rich plasma proteins of animal origin for the preparation of medicinal compositions, food and dietary preparations: [a] suitable for the prevention and treatment of gastrointestinal disorders in human beings . . . ; [b] suitable for improving the immunological state of human beings ... ; [ c] suitable for the treatment of malabsorption processes in human beings ... , and [ d] suitable for the treatment of clinical conditions accompanied by malnutrition in human beings ... and that "[i]t is of particular interest that the immuno-globulins should be non-specific." Polo Pozo Abstract, ,r 21. FF8. Further to the preceding finding of fact, Polo Pozo discloses that the aforementioned gamma-globulin-rich plasma 11 Appeal2018-003018 Application 13/463, 127 proteins for treating humans are derived from bovine, ovine, goat, rabbit, and porcine plasma sources. Polo Pozo ,r,r 14, 31. FF9. Further to the preceding findings of fact, Polo Pozo discloses treating, inter alia, ulcerative colitis, Crohn's disease, and AIDS. Polo Pozo ,I 17. FFlO. Further to the preceding findings of fact, Polo Pozo discloses, "[ o ]ne advantageous form of application is obtained when the medicinal compositions, food and dietary preparations are usable dissolved in water, milk, juices, yoghurts and other foodstuffs. These other foodstuffs are preferably humanised milk, paps and other baby foods," i.e., orally administered formulations and pharmaceutically acceptable carriers. Polo Pozo ,r 19. FF 11. Further to the preceding findings of fact, Polo Pozo discloses that "[i]t is also an object of the invention to prepare a concentrate of the gamma globulin fraction of over 90 wt%," i.e., nearly pure or essentially so. Polo Pozo ,r,r 21, 31. FF12. While Polo Pozo teaches orally administering non- specific, non-human derived immunoglobulin concentrate to humans to treat, e.g., Crohn's disease, it does not expressly disclose a dose of such concentrate at 0.5-2.5% by weight of the subject's total dietary intake. Analysis The Examiner determined: [Polo Pozo] teaches the treatment of Crohn' s disease and ulcerative colitis comprising the oral administration of porcine, bovine, equine, ovine, or goat lg concentrate (see particularly, 12 Appeal2018-003018 Application 13/463, 127 the Summary of the Invention). It is unclear whether o[r] not the immunoglobulin concentrates of the reference meet the newly added weight limitation of the claims given the fact that the specification fails to disclose the specific composition of the lg concentrates taught therein. However, the optimization of the lg content of the lg concentrates of the claimed method comprises only routine optimization of the claimed method and is, thus, considered to be prima facie obvious to one of ordinary skill in the art at the time the invention. Said routine optimization does not render the claimed method patentably distinct. Answer 5; see also id. at 11-12. We discern no error in the Examiner's determination of obviousness. The claims would have been obvious over Polo Pozo. FF7-FF12. However, as the Examiner notes, Polo Pozo does not disclose each claim limitation, i.e., it does not disclose the claimed dosage range; therefore, even if such was a mere optimizable result-effective variable, Polo Pozo does not anticipate. We address Appellants' arguments below. Appellants argue: Claims 1 and 2 include a limitation requiring that "the non- specific immunoglobulin concentrate is administered in an amount that comprises 0.5-2.5% by weight of the subject's total dietary intake." In rejecting these claims as anticipated and/or obvious, the Examiner has not identified any disclosure in [Polo Pozo] that teaches or suggests the weight percent limitation of the present claims, and in fact [Polo Pozo] does not contain any disclosure that teaches or suggests the administration of such an amount of immunoglobulin concentrate. Br. 14--15. Appellants argue this distinguishes the claims as not anticipated and not obvious over Polo Pozo. Appellants' argument is not persuasive regarding obviousness. The Examiner determined that the dosage range of the active component, non- 13 Appeal2018-003018 Application 13/463, 127 specific lg concentrate, was obvious as a routinely optimizable variable. We agree. As noted above, "the discovery of an optimum value of a variable in a known process is normally obvious." In re Antonie, 559 F.2d at 620. Here, there is no persuasive argument or evidence presented by Appellants that the claimed dosage range produced unexpected results. Nor is there persuasive evidence that the claimed active component, i.e., non-specific immunoglobulin concentrate, was not a known, result-effective variable. Tailoring the dosage of an active component in a pharmaceutical formulation is accomplished by mere routine and obvious optimization. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007). For the reasons above, we are not persuaded the Examiner erred in making a prima facie case for obviousness. Nor are we persuaded that there is evidence rebutting such a case for obviousness. SUMMARY The enablement rejection under 35 U.S.C. Â§ 112, first paragraph, is reversed. The written description rejection under 35 U.S.C. Â§ 112, first paragraph, is affirmed. The alternative anticipation rejection under 35 U.S.C. Â§ 102 is reversed. The alternative obviousness rejection under 35 U.S.C. Â§ 103 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 14