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 .
Response to Amendments and Arguments
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/20/25 has been entered.
The response filed on 10/20/25 has been entered.
Applicant’s arguments filed 10/20/25 have been fully considered but they are not deemed to be persuasive.
Claims 17, 20, 25, 26 and 29-31 are pending in this office action.
The rejection of Claim(s) 17 under 35 U.S.C. 102(a2) as being anticipated by Jackson et al. (WO 2017117091) is withdrawn based on the amendment to the claim.
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) 17, 20, 25, 26 and 29-31 stand rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (WO 2017117091 IDS) in view of Brooda et al. (Br. J. Nutrition (2013) 1637-1646 from IDS) and Hooeffer et al. (see IDS) and further in view of Ritter et al. (WO 2015/153841).
With regards to instant claim 17, Jackson teaches changing/manipulating or treating the gut microflora in a mammal e.g. a companion animal a canid. (Canid- animals that includes the wolves, jackals, foxes, coyotes, and the domestic dog, see 0036) in need thereof (see 0007), by administering green tea (see 0038), beet pulp and cellulose (see 0038, see Table 2) wherein the amount in w/w% which is equivalent to grams i.e., cellulose is 3 grams, and green tea is 0.2 (see Table 2) , beet pulp is 1-3 w/wt% wherein the microbiome is a gastro-intestinal microbiome of the companion animal (see 0013, as required by instant claim 17 ie dysbiosis which is an imbalance of the microbiome living in the gastrointestinal tract) and the mammal is a domestic animal (i.e., dogs cats horses also a canid, see 0036, as required by instant claim 17). With regards to the limitation “wherein a fecal sample or a sample from a gastrointestinal tract from the canid comprises an increased abundance of at least three bacterial taxa selected from the group consisting of:Faecalibacterium, Blautia, Allobaculum, Butvricicoccus, Slackia, Lachnospira, and Ruminococcaceae relative to the abundance of said bacteria in the canid before the administration of the composition”, the claimed limitation appears to be a result or property of the administration of resveratrol. As such, the claimed limitations appears to be met by the prior art. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on the applicant to prove that the function of the product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
However Jackson fails to teach that the companion animal is a senior animal or a geriatric animal and fails to teach that the concentration of the green tea polyphenols. Although the Jackson reference fails to teach that the domestic animal is a geriatric or senior animal, it is within reason that older domestic animals can also be fed this composition because MPEP 2143 states "when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." Therefore that the skilled artisan would have had reason to try administering to elderly domestic animals as well with the reasonable expectation that one would be successful.
Brooda teaches with regards to instant claims 25 and 30 found or detected at least two bacterial taxa in a sample obtained from the companion animal i.e., kitten, dogs; wherein the presence of at least two bacterial taxa is indicative of a healthy , wherein the at least two taxa are Ruminococcaceae, Lachnospiraceae and Clostridiaceae (see fig.3) wherein the two groups are from Fusobacterium and clostridium(as required by instant claim 26) indicative of an unhealthy microbiome (see abstract, as required by instant claim ie. 30).
Honneffer, teaches that several cats and dogs found or identified bacteriodes, closteridium, fusobacteria in domestic animals and has more than 10 different bacteria identified (see pg 16490, rt col.) from the gastrointestinal gut (as required by instant claim 49) from faecal sample (see 16490, as required by instant claim 50). Because the Honneffer reference teaches there are more than 10 different bacteria found in the gut such as bacteroids, clostridium, etc thus reasonable that all the claimed bacteria will be present in the GI and varies in the amount based on the disease, absent factual evidence to the contrary.
Ritter teaches a composition comprising galacto-oligosaccharide that comprises beet fiber (see para 0253) at 0.1g/day to 10 g/day (see pg 30, para 0012
With regard to the concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
It would have been obvious to one of ordinary skill in the art to have combined the motivation to combine can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Section MPEP 2144.07. Additionally the same bacteria found in healthy domestic animals is the same found in unhealthy animals and differ only in amount in healthy candid versus unhealthy candid..
One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
Applicant argues that Jackson is silent on any method that treats dysbiosis in a canid, let alone suggesting any composition that is effective in shifting the microbiome in a canid gut to have increased abundance of the bacterial species recited in claim 17. Applicant also argues that Jackson is silent regarding the claimed method with a dietary regimen comprising at least three ingredients within the recited dosing ranges (grams/day) for each respective ingredient. Rather, Jackson is limited to teachings related to a diet composition with ingredients listed in weight percentages. As noted above, one skilled in the art cannot convert the weight percentages taught in Jackson to arrive at the claimed dietary regimen disclosing specific dosages for each claimed ingredient (grams/day). Additionally ,Applicant argues that Jackson is completely silent regarding any treatment method wherein the dietary regimen increases at least three of the bacterial taxa recited in claim 17. As the Examiner is aware, the present application demonstrates that the dietary regimen provides a beneficial shift in a microbiome to increase bacterial species associated with improved gut health.
Both Hooda and Honneffer fail to cure the deficiency of Jackson, as neither reference suggests a diet composition that is administered to a canid to treat dysbiosis.
In response Applicant’s argument is found unpersuasive. Dysbiosis as explained in the teaching of Hall is an imbalance of the microbiome living in the gastrointestinal tract) another word for dysbiosis Therefore Jackson treatment of gastrointestinal would have reasonable treat microbiome is a gastro-intestinal microbiome of the companion animal (see 0013). Applicant’s argument has been carefully considered and is found unpersuasive because the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (see MPEP 2144). Also With regards to while Jackson does not explicitly teach that administration of the composition comprises increased abundance of at least 3 bacterial taxa as recited, increase is due to the administration of the 3 ingredients. The claimed limitation appears to be a result or property of the administration of the compounds. As such, the claimed limitations appears to be met by the prior art. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on the applicant to prove that the function of the product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
In addressing the amounts, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Applicant has not shown the criticality of the amounts. Because the references teach that these actives are administered in a composition for the treatment of gastro-intestinal disorder and dysbiosis which is an imbalance of the microbiome living in the gastrointestinal tract, the combination of references would have been obvious to one of ordinary skill in the art to have used the method of treating gastrointestinal disorder such as dysbiosis
Double Patenting Held in abeyance per request.
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 17, 20, 25, 26 and 29-31 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 – 3, 5-8, 13, 22-32 and 43 of U.S. Patent Application No. 17766001. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· The claims of the instant is to a composition suitable for administration to a companion animal comprising at least one from the group consisting of beet pulp and/or chicory pulp to a total amount of from about 0.1 g/day to about 10 g/day; and cellulose from about 0.2 g/day to about 30.8 g/day and the claims of the instant are directed to a method of changing the microbiome of a companion animal by administering to the companion animal. It is reasonable to administer the instant composition to the companion animal of the copending claims with a reasonable expectation of success. Additionally both set of claims refer to detecting the bacterial taxa in samples obtained from the GI, wherein the bacterial taxa are the same or overlaps.
· Both applications recite using the same compositions and/or derivatives thereof.
Therefore the composition of the copending would have been used in the method claims.
In view of the foregoing, the copending application claims and the current application claims would have been obvious variations.
Claims 17, 20, 25, 26 and 29-31 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 – 3, 6-7, 17, 33 of U.S. Patent Application No. 17423751
Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows: The instant claims are directed to detecting four or more taxa in a candid which is not patentably distinct in detecting at least 2 bacterial taxa in the candid (see instant claim 32.)
It would have been obvious to one of ordinary skill in the art to have used the copending claims to practice the instant claims with a reasonable expectation because detecting method is determined by the skilled artisan. With regards to the SEQ ID it is within reasonable expectation that the SEQ ID would be the same when compared to the same candid.
In view of the foregoing, the copending application claims and the current application claims would have been obvious variations.
Claims 17, 20, 25, 26 and 29-31 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 – 3, 5-8, 13, 22-32 and 43 of U.S. Patent Application No. 17423663 Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims are directed to detecting four or more bacterial taxa and determining the microbiome in healthy and aged candid. Therefore it would have been prima facie obvious to analyze the bacterial different in the candid at different ages from young, adult age and a geriatric age.
In view of the foregoing, the copending application claims and the current application claims would have been obvious variations.
Claims 17, 20, 25, 26 and 29-31 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim of U.S. Patent Application No. 17423727. The copending is directed to detecting one or more bacterial taxa, Detection is not patentably distinct from the instant claims 22 and 32 for example). Therefore it would have been obvious to use a suitable detection method for the taxa known to one of ordinary skill in the art in identifying the taxa in various stages of the candid. With expectation of success in doing so..
In view of the foregoing, the copending application claims and the current application claims would have been obvious variations.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/SHIRLEY V GEMBEH/1/12/26