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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/06/2025, has been entered.
Claims 1-3, 5, 6, 8, 10-13, 15, 16 and 18 are pending.
Response to Arguments
Applicant argues in the pre-appeal brief request for review, filed 7/15/2025, that “the present application has demonstrated that a combination of linoleic acid and zinc with the ranges recited in instant claim 1 unexpectedly improve the condition of an animal’s skin.” Request at page 3. As support for the argument, Applicant cites Tables 1 and 4 the data for Diet C. See id. However, Applicant’s reliance on this data alone is misplaced because it is not commensurate with the scope of the claims. For instance, Diet B illustrates 6 g/Mcal of linoleic acid. This amount reads on “about 7 g/Mcal to about 9 g/Mcal,” as does 10 g/Mcal of Diet D. Furthermore, this data is based on diets feed to dogs whereas the claims are directed to “a health pet animal.”
As suggested by the Finke et al. reference listed on the IDS filed 10/06/2025, data from dog feeding experiment using particular dog breeds cannot necessarily be extrapolated to any pet much less any other breed of dog.
Based on the level of detail provided by Watson et al. with respect to amounts of linoleic acid and zinc, it would not require undue experimentation by one of ordinary skill in the art to arrive the claimed amounts of linoleic acid and zinc required to create a decrease in TEWL as claimed. Further, obtaining a decrease in TEWL would not be unexpected because Watson et al. teaches that the invention provides “reduced transepidermal water loss (that is, including improved skin barrier function),” col. 2, lines 38-39, and that “[t]he addition of zinc and/or linoleic acid can be used to produce advantageous aspect of the invention,” col. 5, lines 1-2, which would include “improved skin barrier function” as evidenced by Marsh (WO 98/56263) at page 2, line 21.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5, 6, 8, 10-13, 15, 16 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. In particular, the specification does not enable one skilled in the art to make the invention wherein the decrease in trans-epidermal water loss is infinite, i.e., without an upper limit. Insofar as claims 2, 3, 6, 8, 11-13, 15, 16 and 18 do not provide any limitation that would address the issue of infiniteness they are rejected.
Additionally, the specification does not enable one skilled in the art to make the invention commensurate in scope with the claims. In fact, the specification demonstrates non-enablement of the scope by describing Diet B and Diet D, which have linoleic acid amounts that read on the claimed amounts but yet do not demonstrate the claimed decrease in TEWL. Insofar as claims 3, 5, 6, 8, 11, 13, 15, 16 and 18 do not provide any limitation that would address the scope of enablement issue they are rejected.
Claim Rejections - 35 USC § 103
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) 1-3, 5, 6, 8, 10-13, 15, 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (U.S. Patent No. 6,177,107) in view of Fray et al. (U.S. Patent No. 7,297,677) and Mizuuchi et al. (US 2013/0059057).
Regarding claims 1 and 10, Watson et al. teaches a foodstuff or a dietary supplement comprising “zinc and/or linoleic acid.” Col. 4, lines 43. Zinc may be preferably at a concentration of 20 mg/400 kcal (current claims 5 and 15). See col. 4, lines 43-46. Linoleic acid may be included “at a concentration of at least 1.1 g/400 kcal, preferably at least 2.0 g/400 kcal, more preferably at least 4 g/400 kcal, most preferably at least 6 g/400 kcal.” Col. 4., lines 48-51. This disclosed range of linoleic acid reads on “linoleic acid in an amount ranging from 7 g/Mcal to 9 g/Mcal” (current claims 2 and 12). Further, the composition may be used in “a method for enhancing and/or improving the skin and coat condition of an animal” (current claim 10). Col. 6, lines 21-23. Although Watson et al. evaluated trans-epidural water loss over 12 weeks, Watson et al. is silent as to “decreases by more than 4.93 g/hr/m2 after 12 weeks of feeding the diet or foodstuff.” Nevertheless, Watson et al.’s foodstuff would be expected to decrease trans-epidermal water loss of a pet as claimed because it comprises the same materials and combination as recited by the instant claims. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990); see also In re Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (“[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”)
Watson et al. does not teach “at least one of arachidonic acid, EPA/DHA, or a combination thereof.”
Fray et al. teaches a composition preferably a pet food stuff for treating a skin disorder. See Abstract. “The foodstuff may optionally comprise one or more of pyridoxine, proline, one or more fatty acids or linoleic acid.” Col. 3, lines 41-42. Further, “[t]he foodstuff of the first aspect may comprise one or more polyunsaturated fatty acids. The polyunsaturated fatty acids
may include one or more omega-3 fatty acids (which include eicosapentaenoic acid (EPA), docasahexaenoic acid (DHA).” Col. 4, lines 15-18.
Fray et al. also does not teach arachidonic acid.
Mizuuchi et al. relates to “pet food which includes unsaturated fatty acid-containing oil and fat and has high storage stability and palatability.” Abstract. The unsaturated fatty acid is preferably α-linolenic acid, γ-linolenic acid, arachidonic acid, eicospentaenoic acid (EPA), or docosahexaenoic acid (DHA).” Para. [0022].
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Watson et al., Fray et al. and Mizuuchi et al. to arrive at the instantly claimed invention. In this instance, one of ordinary skill in the art would find motivation to combine at least the Watson et al. and Fray et al. references because they both teach pet foodstuffs for treating skin. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”) Further, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See, e.g., In re Linder, 457 F.2d 506, 507 (CCPA 1972); see also In re Dial, 326 F.2d 430,432 (CCPA 1964). In this instance, it would have been prima facie obvious to incorporate one or more fatty acids such as omega-3 fatty acids like EPA/DHA as taught by Fray et al. with the foodstuff of Watson et al. Additionally, it would have been prima facie obvious to incorporate arachidonic acid in addition to EPA/DHA in view of Mizuuchi et al.’s teaching of arachidonic acid, EPA and DHA are as an obvious preferred unsaturated fatty acid variants.
Regarding claims 3 and 13, “[p]referred linoleic acid sources include safflower oil, sunflower oil, soybean oil, other plant or animal oils/fats or a combination of two or more thereof.” Col. 4, lines 64-67.
Regarding claims 6 and 16, “[p]referred sources of zinc include zinc sulphate, zinc oxide, organic zinc complexes or a combination of two or more thereof.”
Regarding claims 8 and 18, Labrador retrievers were tested. See col. 9, lines 14-15.
Regarding claim 11, Watson et al. teaches a pet animal foodstuff comprising the claimed amounts of linoleic acid and zinc that provides a complete and balanced food for healthy animals while enhancing skin coat conditions. See col. 1, 58-61. Watson et al. also recognizes that “dietary deficiencies in zinc or linoleic acid produce deterioration in skin and coat conditions in dogs and cats.” Col. 1, lines 27-30. One of ordinary skill in the art would have readily envisioned that feeding a foodstuff comprising the claimed amounts of ingredients to a healthy pet and/or a pet in need of treatment for a skin disease or disorder would have improved the skin and hair conditions of both pets. See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (“when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated.”)
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614