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 .
Receipt is acknowledged of IDS filed on 05/12/2022.
Claims 39-57 have been added.
Claims 39-57 are pending.
Claims 1-38 are cancelled.
Claims 39-45 and 51-55 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Species 1 in the reply filed on 01/22/2025 is acknowledged.
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.
Claim 46 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.
Claim 46 recites a method of modulating an oral microbiota of a companion animal, comprising: administering an edible pet food product comprising one or more sulfur containing amino acids to the animal, wherein the one or more sulfur containing amino acids comprises at least about 0.5g/l,000kcal methionine or methionine-related amino acid and at least about at least about 1.25g/I,000kcal cysteine or cysteine-related amino acid. It is unclear if only one amino acid is required or the two listed amino acids are required, methionine and cysteine. Please clarify.
For examination purposes, the claim is interpreted to only need one amino acid.
The dependent claims fall therewith.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 46-50 and 56-57 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of copending Application No. 17/040,445 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application recites, a method for treating or preventing dilated cardiomyopathy in a dog, comprising feeding the dog a diet according to claim 1 (claim 19), wherein the dog diet is a diet composition for an adult dog, said composition comprising; a combination of methionine and cysteine, wherein the methionine and cysteine are supplied as free amino acids, wherein the cysteine is present in an amount such that the weight ratio of methionine: cysteine is from 1:0.8 to 1:2.5 w/w, wherein the amount of methionine is about 0.25 to about 0.64 g per 1000 kcal of the diet composition; and b) taurine in an amount from about 0.125 to about 0.5 g per 1000kcal of the diet composition; wherein the diet composition is in a solids-in-gravy form (claim 1). Which reads on a method of modulating an oral microbiota of a companion animal, comprising: administering an edible pet food product comprising one or more sulfur containing amino acids to the animal, wherein the one or more sulfur containing amino acids comprises at least about 0.5g/l,000kcal methionine or methionine-related amino acid.
Although the reference is silent about modulating an oral microbiota, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. /n re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient, a companion animal such as a dog, is being administered the same active agent, methionine, by the same mode of administration in the same amount roughly 0.5g/100kcal, in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, the references teaches, either expressly or inherently, each and every limitation of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 46-50 and 56-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by FRIESEN (US 2006/0073192).
Regarding claim 46, FRIESEN teaches a method of administering a composition comprising methionine and cysteine (claim 1 and 3). The composition comprises 3.5g/Mcal (which is 3.5g/1,000kcal) of methionine (page 9, table 8), which reads on at least about 0.5g/1000kcal methionine.
Regarding claim 47, the composition is given daily (page 3, paragraph 0023).
Regarding claim 48-49, the composition can be given daily for 60 days (page 7, paragraph 0049), which reads on administered at least 5 times.
Regarding claim 50, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).). Therefore, since the prior art teaches the same composition at the same concentration for the same purpose and administered the same way, it would inherently also have this property of wherein modulating the oral microbiota comprises increasing the number of species of or prevalence of bacteria associated with good oral health.
Regarding claim 56, the composition is given in an amount effective (claim 6). Furthermore, it is given in the same concentration as the instant claims and therefor would be an amount effective.
Regarding claim 57, the composition is given to a dog (claim 2).
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.
Claims 46-50 and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over FAHIM (JPH 03135915A).
Regarding claim 46, FAHIM teaches a method of administering an edible food product for improving oral health (example 2). The product works as an antibacterial (page 1, paragraph 4) and controls harmful bacteria by-products that handle the immediate cause of bad breath, without killing all the oral microflora (page 1, paragraph 4), which reads on modulating the oral microbiota. The product contains sulfur amino acids, such as methionine and cysteine (page 2, paragraph 6).
The reference does not specifically teach the concentrations of cysteine and methionine as claimed by the Applicant. The concentrations of cysteine and methionine is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal concentrations of cysteine and methionine in order to best achieve desired results, such as having a concentration high enough to control harmful bacteria by-products that handle the immediate cause of bad breath, without killing all the oral microflora. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the concentrations of cysteine and methionine would have been obvious at the time of Applicant’s invention.
Regarding claim 47, FAHIM teaches the product is applied daily (page 2, paragraph 12).
Regarding claim 48-49, FAHIM teaches the product was applied daily for a week (page 3, paragraph 1), which reads on at least 5 times.
Regarding claim 50, FAHIM teaches the product works as an antibacterial (page 1, paragraph 4) and controls harmful bacteria by-products that handle the immediate cause of bad breath, without killing all the oral microflora (page 1, paragraph 4). Since the product kills the amount of harmful bacteria, while not affecting the amount of bacteria associated with good oral health, this means that the prevalence of the good bacteria, since harmful bacteria was eliminated, would be higher after administration.
Regarding claim 56, FAHIM teaches the product was administered is administered to improve oral health (page 2, paragraph 16), which reads on an amount effective to improve oral health of the animal.
Regarding claim 57, FAHIM teaches the composition can be given to dogs (page 3, paragraph 2).
Conclusion
No claims are allowable.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618