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 1-41 are pending.
Claims 9-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/11/2026.
Claims 1-8 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 claims 4, 5, and 6.
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, 7, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill et al (WO 2017/218418) and Song et al (KR 102097112) (Examiner provided an additional copy for clarity, citations made from the Examiner provided document).
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 0.01-0.05% (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.
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).
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 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).
Claim(s) 1-8 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill et al (WO 2017/218418) and Song et al (KR 102097112) (Examiner provided an additional copy for clarity, citations made from the Examiner provided document) as applied to claims 1-4, 7, and 8 above, and further in view of Bell et al (Am J Physiol Gastrointest Liver Physiol, 2010).
The teachings of Hill and Song are set forth above.
Hill and Song, while teaching the instantly claimed composition, do not expressly teach sodium cholate in an amount of about 0.7%.
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 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.
Conclusion
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
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