DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Acknowledgement is made to Applicant’s response filed on 03/11/2026.
Claims 1-4 and 6-41 are pending.
Claims 9-41 remain withdrawn.
Claims 1 and 6 are currently amended.
Claim 5 is cancelled.
Claims 1-4 and 6-8 are currently under consideration to the extent that they read upon Applicant’s elected species.
It is noted that Applicant elected DOCA, a dose of 75 mg/kg, pelleted form, a 50%-50% proportion of the diet, and the amounts of the diets articulated in originally filed claims 4, 5, and 6.
Withdrawn Rejections
The rejection of claim(s) 1-4, 7, and 8 under 35 U.S.C. 103 as being unpatentable over Hill et al (WO 2017/218418) and Song et al (KR 102097112) is withdrawn in view of Applicant’s amendment to incorporate claim 5 into claim 1.
The rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over Hill et al (WO 2017/218418) and Song et al (KR 102097112) and further in view of Bell et al (Am J Physiol Gastrointest Liver Physiol, 2010) is withdrawn in view of Applicant’s cancellation of said claim.
Rejections Maintained and Made Again in view of Applicant’s Amendments
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 6-8 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill et al (WO 2017/218418), Song et al (KR 102097112) (Examiner provided an additional copy for clarity, citations made from the Examiner provided document), and Bell et al (Am J Physiol Gastrointest Liver Physiol, 2010).
Hill teaches a combo diet comprising a pelleted diet composition comprising L-NAME (see entire document, for instance, [0097], [0099], and [00100]). The L-NAME is taught as being present in an amount of 75 mg/kg (see entire document, for instance, [0015]). The composition is taught as having carbohydrates, such as fructose, in an amount between 5% and 60% (see entire document, for instance, [0011] and [0051]), fat in an amount between 10 and 75% (see entire document, for instance, [0007]), protein in an amount of 10-30% (see entire document, for instance, [0010]), cholesterol in an amount of at least 0.4% (see entire document, for instance, [0009]). The composition is taught as further comprising fructose (see entire document, for instance, [0051]). Hill further teaches the use of salts (see entire document, for instance, [0098], Table 1).
Hill, while teaching the composition for modeling heart failure, and teaching the nitric oxide synthase inhibitor L-NAME as the inducing agent, does not expressly teach the use of DOCA as the inducing agent. Further, Hill does not expressly teach sodium cholate in an amount of about 0.7%.
Song teaches inducing hypertension utilizing either a nitric oxide synthase inhibitor or DOCA as the hypertensive agent (see entire document, for instance, page 2, second to last paragraph).
Bell teaches animal fructose-based diets comprising 0.7% sodium cholate (see entire document, for instance, page 4, third paragraph).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize either L-NAME or DOCA, as taught by Song, as the hypertensive agent of Hill. One would have been motivated to do so since Hill teaches the use of a nitric oxide synthase inhibitors to induce heart failure, wherein Song teaches that nitric oxide synthase inhibitors and DOCA are both useful hypertensive agents. There would be a reasonable expectation of success since both components are taught as being useful hypertensive agents.
It additionally would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize 0.7% sodium cholate in the diet composition of Hill. There would be a reasonable expectation of success in utilizing 0.7% sodium cholate in the diet of Hill since Hill is teaching an animal diet, wherein Bell teaches 0.7% sodium cholate is useful within an animal diet.
It further would have been obvious to optimize the amount of the components taught by Hill within the ranges taught by Hill, and thereby arrive at the instantly claimed invention. One would have been motivated to do so since Hill teaches ranges that overlap the instantly claimed ranges. It is noted that MPEP 2144.05 states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Response to Arguments
Applicant argues in the Remarks filed 09/22/2026 that Applicant does not believe that the prior art teaches the prior art teaches a 50-50 proportion of the two diets. Applicant’s argument is not found persuasive against the ground of rejection set forth above. Specifically, it is noted that the claims are directed to a product, not a method, wherein the instant claims claim a composition which comprises said components. For reference, if the claim recited a composition comprising 1A,1B, and 2C combined with a composition comprising 0A,2B, and 3C, the claims would ultimately be directed to 1A, 3B, and 5C, regardless of how the combination was achieved. In the instant fact pattern, if the carbohydrate is taught as being 39.8% in the custom diet and 33% in the standard diet, and the components are combined at 50:50 ratio, one would expect the new diet to comprise about 36.4% carbohydrate (namely (39.8%+33%)/2). It is noted that the amounts required by the 50:50 combination of the custom and standard diets are amounts that fall within the ranges taught by the prior art for the instantly required components. It is noted that Applicant mentions the there were some situations in which the animals prematurely died. It is noted that the assertion is not commensurate with the scope of the instant claims, for instance, independent claim 1 does not require the presence of DOCA.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
