13372251 (P.T.A.B. Mar. 23, 2016)

Ex Parte Khoo et al

Patent Trial and Appeal BoardMar 23, 2016

13372251 (P.T.A.B. Mar. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/372,251 02/13/2012 23909 7590 03/25/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 FIRST NAMED INVENTOR Christina Khoo 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. 7964-03-HL 2267 EXAMINER BEL YA VSKYI, MICHAIL A ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 03/25/2016 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): Patent_Mail@colpal.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHRISTINA KHOO, WILLIAM DAVID SCHOENHERR and KATHY LYNN GROSS 1 Appeal2014-000187 Application 13/372,251 Technology Center 1600 Before DONALD E. ADAMS, ULRIKE W. JENKS, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1Appellants state the real party-in-interest is Hill's Pet Nutrition, Inc. App. Br. 3. Appeal2014-000187 Application 13/372,251 SUMMARY Appellants file this appeal under 35 U.S.C. Â§ 134(a) from the Examiner's Final Rejection of claims 16 and 17 as unpatentable under 35 U.S.C. Â§ 112, first paragraph for lack of enablement. 2 Claims, 16 and 17 also stand rejected as unpatentable under 35 U.S.C. Â§ 112, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention (this is a New Matter rejection). We have jurisdiction under 35 U.S.C. Â§ 6(b) We REVERSE. NATURE OF THE CLAIMED INVENTION Appellants' invention is directed to a method of detecting whether a cat is suffering from feline inflammatory bowel disease (IBD). REPRESENTATIVE CLAIM Claim 16 is representative of the claims on appeal and recites: 16. A method for determining if a feline is suffering from inflammatory bowel disease comprising: collecting lymphocytes from blood obtained from the feline as a first sample; collecting lymphocytes from blood obtained from a healthy feline as a second sample; 2 Claims 1-15 and 18-28 are canceled. App. Br. 12. 2 Appeal2014-000187 Application 13/372,251 App. Br. 17. exposing the second sample to an amount of a mitogen for a period of time; exposing the first sample to the same amount of the same mi to gen as the second sample for the same period of time as the second sample in the presence of from about 12.5 ÂµM to about 25 ÂµM docosahexaenoic acid or eicosapentaenoic acid; measuring the gene expression of one or more of the cytokines selected from the group consisting of interleukin-2 (IL-2) and interferon gamma (IFN-y); and comparing levels of gene expression in all samples, wherein if the level of gene expression in the second sample is similar to the level of gene expression in the first sample, then the feline is suffering from inflammatory bowel disease. ISSUES AND ANALYSIS For the reasons set forth below, we cannot adopt the Examiner's findings and conclusions that Appellants' claims are prima facie not enabled or contain new material. We address the arguments raised by Appellants on appeal below. A. The rejection of claims 16 and 17 under 35 U.S.C. Â§ 112, first paragraph, for lack of enablement Issue Did the Examiner err in concluding that a person of ordinary skill in the art would be unable to determine whether a feline has IBD from performing the steps of Applicants' claimed method? 3 Appeal2014-000187 Application 13/372,251 Analysis Appellants point to Table 3 of their Specification, which they argue discloses: (1) the level of IL-2 expression in phytohemagglutinin3 ("PHA")- treated samples from healthy cats was 1.03; and the level of interleukin-24 ("IL-2") IL-2 expression in the PHA + docosahexaenoic acid ("DHA")- treated samples from cats with IBD was 3; whereas: (2) the level of IL-2 expression in the PHA+DHA treated samples from healthy cats was 21.05, and the level of IL-2 expression in the PHA + EPA treated samples from healthy cats was 59.4. App. Br. 7. Appellants argue the values for samples from healthy cats were 2,105% higher (PHA + DHA) and 5,940% higher (PHA +EPA) than the values obtained with samples from healthy cats treated with PHA alone, whereas the values obtained with samples from IBD cats treated with (PHA + DHA) were only 300% higher than the values obtained with samples from healthy cats treated with PHA alone. Id. at 7-8. Appellants contend that one of ordinary skill in this art would easily be able to discern the difference between a less than three-fold increase as opposed to at least a 21-fold increase as compared to the control, without undue experimentation. Id. at 8. Appellants argue the data of Table III establishes that the differences in gene expression levels between samples from felines with IBD and those without IBD are so marked that if one were of ordinary skill in this art, that person could not fail to diagnose the presence of IBD. App. Br. 8. Appellants dispute the Examiner's conclusion that "one [of] skill in the art 3 A known mitogen. 4 A cytokine, the measured level of which acts as an indicator of IBD in the method of claim 16. 4 Appeal2014-000187 Application 13/372,251 would [not] be able to determine if a feline is suffering from IBD by just performing the method steps and comparing the levels of IL-2 expression as recited in the instant claims." Id. at 9 (quoting Final Act. 3). According to Appellants, whether the claims are enabled is not determined by considering the claim in a vacuum; rather, Appellants assert, the claims must be considered in light of the disclosures of the Specification. Appellants contend above, the Specification, and in particular the Examples, makes it clear that comparison of the recited levels of gene expression unambiguously determine the presence or absence of IBD in a feline. Id. Appellants also dispute the Examiner's finding that the Examiner inexplicably asserts that Appellants' Specification lacks working examples and, on that basis, concludes that the claims are speculative and overbroad. App. Br. 9 (Final Act. 3). Appellants assert that the Specification does have working examples and a detailed disclosure that fully enables the present claims. Id. Finally, Appellants argue that although the Examiner also concludes that the enablement is not commensurate in scope with the claim, the Examiner has failed to identify the subject matter that is considered not to be enabled, as required by the MPEP. App. Br. 9 (citing MPEP 2164.08). The Examiner acknowledges that, as Appellants argue, one skill in the art would be able to discern said difference between a less than three-fold increase as opposed to at least a 21-fold increase as compare to control. Ans. 4. However, the Examiner asserts the real issue is that the Specification provides only in vitro data to show the effects of DHA on the 5 Appeal2014-000187 Application 13/372,251 proliferation of lymphocytes isolated from healthy cats and cats with IBD (see table 1 in particular). Id. The Examiner finds the claims on appeal recite that to determine if a feline is suffering from IBD, the levels of gene expression of IL-2 and INF-g in lymphocyte from first and the second sample should be compared. Ans. 4. The Examiner finds the claims recite that, a feline is suffering from IBD, the level of gene expression ofIL-2 and/or IFN-y in the second (control) sample will be similar to the level of the same gene expression in the first (test) sample. Id. In other words, the Examiner finds, there is no recitation in the claims that the difference is at least 3 or 21-fold. Id. However, the Examiner finds, the data presented in Table III of Appellants' Specification indicates that the level of IL-2 expression in the first sample (cats with IBD + PHA + DHA) was 300% more than in the second sample (healthy cats+ PHA). Ans. 5. Therefore, the Examiner finds, although one skilled in the art would be able to see the difference in assay values for the samples from healthy versus IBD-afflicted animals, as disclosed by Table III, that artisan would not be able to determine if a feline is suffering from IBD by just performing the method steps and comparing the levels of IL-2 expression, as recited by the claims. Id. We are persuaded by Appellants' arguments. The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation. Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed.Cir.1986), cert. denied, S.Ct. 1606, (1987). In the instant appeal, the issue before the Board is whether the disclosures of the Specification would permit a person of ordinary skill to recognize 6 Appeal2014-000187 Application 13/372,251 whether the level of gene expression of IL-2 and/or IFN-y in the test sample was "similar" to that of the control (i.e., healthy cat) sample. As an initial matter, we disagree with the Examiner that the Specification lacks specific examples of the method recited in the claims and is only an in vitro test. See Final Act. 3; Ans. 4. The Specification discloses in its Example 1, that 11 healthy cats and 11 IBD-afflicted cats (diagnosed by other methods), maintained on a standard diet, were used in the study of Example 1 and that blood samples were drawn at 4, 5, and 6 weeks. Spec. 14. We do not disagree that the assay of levels of gene expression of the test and control animals was conducted in vitro, but we find that a person of ordinary skill would understand that that is how such assays of blood samples would be routinely and customarily conducted. Furthermore, Table 3 of Appellants' Specification shows the results of measuring levels ofIL-2 and/or IFN-y gene expression as compared to control values from the non- mitogen treated blood sample from a healthy cat. We now tum to the issue of whether the Specification would enable a person of ordinary skill in the art to determine if the level of gene expression in the second sample (control) is similar to the level of gene expression in the first (test) sample, [and thus determine if] the feline is suffering from inflammatory bowel disease, as required by claim 1. We find that it does. A modified version of Appellants' Table 3 of Appellant's Specification is reproduced below. 7 Appeal2014-000187 Application 13/372,251 , C,i,~ ,.;1.,1 ,h,_, ,, "Â·~) .. t.._.Â·, , ,.,., , ,J,L , ... , ".).1'.'< , ,, .. ,h , '"Â·"' Â·Â· ,.,." , ; ot~n~Â·w;Â·~1w;r"" Â· f Â·tr5T'"tÂ· u.9 ! zu s , Â· , Â· Â· ~ 1 . }Â§r-Â·1Â· (}.