DETAILED ACTION
Background
The amendment dated June 24, 2026 (amendment) adding new claims 71-78 and cancelling claims 51-63 has been entered. Claims 64-78 as filed with the amendment have been examined. Claims 1-63 have been canceled.
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 .
Election/Restrictions
Applicant’s election without traverse of the pet food composition of group I and method for using, claims 64-78 in the reply filed on June 24, 2026 is acknowledged.
Although the election was made without traverse, no claims are withdrawn from further consideration because all claims drawn to a nonelected invention have been canceled
Drawings
The drawings are objected to because of the following informalities:
FIG. 5 is missing a label or unit for the x axes;
Each of the figures FIG. 22A, 22B and 22C and FIG. 23A, 23B AND 23C is missing a label or unit for the y axes; and,
Each of the figures is missing a label or unit in both of the x and y axes:: FIG. 3A, 3B AND 3C, FIG. 14A and 14B, FIG. 15A and 15B, FIG. 16A, 16B and 16C, FIG. 17A to 17J (all FIGs. 17), FIG.s 18A to 18F (all FIG.s. 18), FIG.s 19A to 19E (all FIGs. 19), FIG. 20A and 20B and FIGs 21A to 21D (all FIGs. 21).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 64, 68, and 76-77 are objected to because of the following informalities:
In claim 64, at line 3 before the “; and” at the end of the line spell out the acronym --neutral derived fiber (NDF)--; and,
at line 3 before the end of the line spell out the acronym --health index for pets (HIP)--;
In claim 68, at line 1 after “increasing” insert -- an amount of--; and,
at line 2 after “decreasing” insert -- an amount of--;
In claim 76, at line 2 after “reduce” insert -- an amount of--; and,
In claim 77, at line 2 after “increase” insert -- an amount of--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 64-78 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding instant claims 64, 70 and 71, the term “improves HIP” or health index for pets (HIP) in claim 64, the term “improving HIP” in claim 70 and the term “HIP” in claim 71 is indefinite because an HIP index is not clearly defined and the scope of the claim is not clear. The instant specification at [0084] and [0086] does not provide a definition the recited HIP, much less any actual guidance on how to determine or derive the HIP for an individual companion animal. Moreover, the record is devoid of any record of or reference to the use of allegedly interchangeable terminology that the instant specification discloses at ([0084]) including a "Wellness Index for Pets" (WIP), a "Diagnostic Index for Pets" (DIP), a "Longevity Index for Pets" (LIP), “and the like”. Even further, the term "or the like" renders a definition unclear because it includes elements not actually disclosed, thereby rendering the scope of the definition unascertainable. See MPEP § 2173.05(d). If there is any known index as disclosed, does it or does it not include a combination of indices?
The Office interprets an “improved HIP” as disclosed as referring to any single known, reproducible index or numerical measure of a health of a companion animal having clear and measurable units.
In claim 64, the content of crude fiber in wt% in line 4 and the content of total fiber in wt% in line 4 are each indefinite for lacking any basis or denominator. Is the amount of crude fiber a wt%, based on the total weight of the pet food composition, a wt% based on solids of the pet food composition, or a wt%, based on the total weight of something else in the composition? Further, is the amount of total fiber a wt%, based on the total weight of the pet food composition, a wt% based on solids of the pet food composition, or a wt%, based on the total weight of something else in the composition?
The Office interprets the amount of the recited crude fiber as being a wt%, based on the total weight of the pet food composition.
The Office interprets the amount of the recited total fiber as being a wt%, based on the total weight of the pet food composition.
Regarding instant claims 64 and 66, in claim 64 at line 3 and in claim 66, the content of NDF in wt% is indefinite for lacking any basis or denominator. Is the amount of NDF a wt%, based on the total weight of the pet food composition, a wt% based on solids of the pet food composition, or a wt%, based on the total weight of something else in the composition?
The Office interprets the amount of the recited NDF as being a wt%, based on the total weight of the pet food composition.
Regarding instant claim 70, the term “effective amount” is indefinite because no condition is specified. The proper test as to whether a use of “effective amount” is indefinite is whether or not one skilled in the art could determine specific values for the amount based on the disclosure. See In re Mattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975). In the instant case one cannot determine what one does not know. See MPEP 2173.05(c).III.
Regarding instant claim 71, the recited % HIP is indefinite for lacking units. Just what is being measured?
Regarding instant claims 73, 74 and 75, each claim recites the limitation "the fiber complex". There is insufficient antecedent basis for this limitation in the claim or in claim 64. The claims and claim 64 from which thy depend do not recite a fiber complex.
Regarding instant claim 73, 74 and 75, the recited content of NDF is indefinite for lacking units. Is the amount of NDF a wt%, a volume % or some other unit of percent?
The Office interprets the % of the recited NDF as being a wt%, based on the total weight of the fiber complex.
Regarding instant claim 75, the recited content of fiber complex is indefinite for lacking units. Is the amount of NDF a wt%, a volume % or some other unit of percent?
The Office interprets the % of the recited fiber complex as being a wt%, based on the total weight of the pet food composition.
Claim 78 recites the limitation "the anti-inflammatory cytokine" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 64 does not recite an anti-inflammatory cytokine. Further, it is not clear if the anti-inflammatory cytokine is included in the pet food composition or is induced after administering the food.
Claims 65, 67-69, 72 and 76-77 are rejected as depending from a rejected base claim.
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 64-78 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020/081774 A1 to Garzino et al. (Garzino), of record.
Garzino is equivalent to US2021/0352935 A1.
Unless otherwise disclosed, all % (percents) disclosed without units are considered to be a weight % (wt%), which is interchangeable with mass%.
The Office interprets an “HIP” as disclosed as referring to any single known, reproducible index or numerical measure of a health of a companion animal having clear and measurable units.
Regarding instant claims 64, 67 and 74, Garzino at Abstract discloses a pet food composition to limit adverse pet reactions, and (at page 6, 3rd to 5th full paragraphs) discloses feeding the food to pets (“a method for treating, preventing or ameliorating a symptom associated with obesity in a companion animal comprising administering to the animal a pet food composition to any companion animal in need thereof” in claim 67). Further, Garzino at Example 2 at pages 27-29 and the accompanying Tables 4 and 5 discloses dog food (Table 4) and cat food (Table 5) comprising L-carnitine, rosemary extract, DL-methionine, taurine and marigold extract (“anti-inflammatory component”) and, further comprising beet pulp (claim 74), pea fiber, psyllium seed husk and powdered cellulose.
Further, Garzino at Tables 4 and 5 discloses its pet food composition as comprising, respectively, 17.4 wt% and 1.5 wt% of crude fiber, based on the total weight of the dog food composition and 28.4 wt% and 29.5 wt% of nitrogen free extract (NFE) which is equivalent to soluble carbohydrate. In addition, Garzino at page 12, 1st, 2nd and last full paragraph discloses compositions having insoluble fibers, soluble fibers and about 31 wt% or 32 wt% or 33 wt% and up to about wt% of total fiber.
Further regarding instant claims 64 and 66, Garzino does not disclose the wt% of NDF in its Example 2 pet food composition or about 15 to about 25 wt% of NDF, based on the total weight of the dog food composition as in claim 64, comprising about 20 to about 25 wt% NDF based on the total weight of the dog food composition as in claim 66. However, with an NFE and crude fiber above 45 wt%, as well as psyllium, pea fiber, the claimed beet pulp and also insoluble fiber, the Office considers the pet food composition disclosed in Example 2 of Garzino to provide the claimed wt% total fiber exceeding 30 wt% and to provide the claimed fiber complex. The ordinary skilled artisan in Garzino would have found it obvious to make its pet food composition to have the recited amount of NDF as a wt%, based on the total weight of the dog food composition because Garzino discloses that it is desirable to include the claimed amount of total fiber and use the claimed beet pulp fiber in its pet food composition to reduce adverse reactions in a companion animal after eating the food.
Regarding instant claims 65, 68-73 and 75-78, the Office considers the pet food composition and method of Garzino to be substantially the same thing as the claimed pet food composition and method of administering it to a pet. Accordingly, absent a clear showing as to how the composition and effect of the pet food composition and method of Garzino differs from that as claimed, the Office considers the beet pulp, cellulose and soluble fiber pet food composition and method of Example 2 of Garzino to comprise a pet food composition comprising a weight ratio of NDF to crude fiber of at least about 3:2 as in claims 65 and 72; a method for increasing an amount of pancreatic peptide and/or decreasing an amount of ghrelin in a companion animal comprising administering a pet food composition to a companion animal in need thereof as in claim 68; a method for treating, preventing, or reducing the risk of developing metabolic endotoxemia comprising administering a pet food composition to a companion animal in need thereof as in claim 69; a method for improving HIP in a companion animal comprising administering an effective amount a pet food composition to a companion animal in need thereof as in claim 70; A pet food composition, wherein the pet food composition improves HIP by at least about 10% of some reproducible unit as in claim 71; a pet food composition, wherein the NDF comprises from about 55% to about 65% of the fiber complex as in claim 73; a pet food composition, wherein the fiber complex comprises greater than about 25%, based on the total weight of the pet food composition as in claim 75; a pet food composition wherein the fiber complex is present in an amount effective to reduce an amount of circulating lipopolysaccharide as in claim 76; a pet food composition, wherein the fiber complex is present in an amount effective to increase an amount of an anti-inflammatory cytokine as in claim 77; and, a pet food composition, wherein an amount of anti-inflammatory cytokine selected from: interleukin-1 receptor antagonist (IL-lard); interleukin-4 (IL-4); interleukin-6 (IL-6); interleukin-10(IL-10); interleukin-11 (IL-11); interleukin-13 (IL-13); transforming growth factor-beta (TGF-3); and a combination of two or more thereof is increased as in claim 78.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The foreign publication CZ33069 U1 to Stasnik et al. (Stasnik) is of record. Stasnik at pages 2-3 of the provided Clarivate machine translation discloses a pet food composition of wheat bran, maize and barley including 88wt% solids as crude fiber 163.77 g/kg; ADF 196.89 g/kg; NDF 285.66 g/kg. and cyanidine 3-glycoside.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki H Dees can be reached at (571) 270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791