DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 04/23/2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 76-78
Withdrawn claims: None
Previously cancelled claims: 1-75, 79-80
Newly cancelled claims: None
Amended claims: 76
New claims: None
Claims currently under consideration: 76-78
Currently rejected claims: 76-78
Allowed claims: None
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.
Claims 76-78 are rejected under 35 U.S.C. 103 as being unpatentable over Stojanovic (US 2008/0260906) in view of Petco (“My dog has diarrhea after switching food too fast. What helps?, 2018, Petco, https://www.petco.com/content/content-hub/home/questions/00/1/160490.html?srsltid=AfmBOoq1UvTr_RaBQG2V-pvWXeW_sRU8xenk5k3VI68hQG3Xyk8vSx1V), Tractor (“4health Beef & Vegetable Stew Dog Food, 13.2 oz.”, 2017, Tractor Supply Co, https://web.archive.org/web/20170316055923/https://www.tractorsupply.com/tsc/product/4health-beef-vegetable-stew-dog-food-132-oz), and Berry (US 2016/0271188; previously cited ).
Regarding claim 76, Stojanovic teaches a method for treating intestinal dysbiosis (corresponding to improving the microbial ecology by reducing levels of pathogenic bacteria) [0097] comprising administering a pet food product comprising a probiotic and sugar beet pulp to a companion animal [0016]-[0017], [0022], [0066] for at least about three weeks [0102]. This time period falls within the claimed time period of at least 14 days. Stojanovic teaches that the product may be used to treat diarrhea [0084]; therefore, Stojanovic teaches that the companion animal may have reduced diarrhea incidence after receiving the pet food product.
Stojanovic teaches that the probiotic may be Bacteroides sp. [0026]; and that the pet food comprises the probiotic in an amount from about 1x105 to about 1x1014 CFU per gram, which is a range which includes providing 8x107 CFU per day to the companion animal [0031], [0111] which falls within the claimed range. Stojanovic teaches that the product may comprise 0.5 wt.% sugar beet pulp [0066] which falls within the claimed range.
Stojanovic teaches that the pet food product comprises probiotics to improve microbial balance in the gastrointestinal tract of the animal; and that the probiotic in its composition may be Bacteroides sp. [0025]-[0026], [0101]. Stojanovic also teaches that the pet food product may be administered to the companion animal according to the directions provided to the owner [0101]. Stojanovic does not disclose that the companion animal has received a dietary change prior to receiving the pet food product; that the companion animal is an adult, a senior, or a geriatric animal, or that the companion animal receives an amount of the pet food product that is at least 200 mg/kg body weight per day up to about 300 g pet food product per day. Stojanovic does not disclose that the probiotic is selected from the group consisting of Faecalibacterium prausnitzii, Bacteroides plebeius, and Holdemanella biformis. Stojanovic also does not teach that the companion animal has an increased abundance of one or more bacterium comprising the 16S rRNA described in present claim 76.
However, Petco teaches that diarrhea in dogs may be caused by intestinal dysbiosis resulting after a diet change (title; answer entitled “Most Helpful Answer”). Petco teaches that that the diarrhea may be treated by supplementing a diet with probiotic and fiber (answer entitled “Related Answers from Veterinarians”).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the method of Stojanovic to comprising administering the pet food product to a companion animal experiencing diarrhea caused by dysbiosis after a dietary change as taught by Petco. Since Stojanovic teaches that the companion animal receiving the pet food product may be experiencing diarrhea and intestinal dysbiosis [0084], [0097], but does not disclose a cause of the diarrhea and/or dysbiosis, a skilled practitioner would have been motivated to consult an additional reference such as Petco in order to determine a cause of the diarrhea and dysbiosis. In consulting Petco, the practitioner would find that the diarrhea and dysbiosis of the companion animal disclosed in Stojanovic may be the result of a dietary change and would find that supplementing a diet with probiotics and fiber such as the probiotics and sugar beet pulp of Stojanovic may treat the diarrhea and dysbiosis, thereby rendering the requirement that the companion animal received a dietary change prior to receiving the pet food product obvious.
The combination of Stojanovic and Petco does not teach that the companion animal is an adult, a senior, or a geriatric animal, or that the companion animal receives an amount of the pet food product that is at least 200 mg/kg body weight per day up to about 300 g pet food product per day. The combination of Stojanovic and Petco also does not disclose that the probiotic is selected from the group consisting of Faecalibacterium prausnitzii, Bacteroides plebeius, and Holdemanella biformis. Stojanovic also does not teach that the companion animal has an increased abundance of one or more bacterium comprising the 16S rRNA described in present claim 76.
However, Tractor teaches a pet food product comprising sugar beet pulp (1st line under “Ingredients”) wherein the pet food product may be fed to dogs older than one year of age (5th line under “Feeding Instructions”). Tractor also teaches that a container holding the pet food product contains 13.2 oz or 374 grams of the pet food product (title). Tractor teaches that animals weighing 10 lb. or less or 4.5 kg or less may receive ⅓-¾ of a can of the pet food product per day, thereby providing a range of amounts of pet food product administered to the companion animal that encompasses the claimed amounts (e.g., a 4.5 kg dog receiving ½ of a can of pet food product per day is receiving 41,579 mg/kg body weight per day and 187 grams of pet food per day which fall within the claimed ranges).
In regard to the encompassing ranges disclosed by Tractor, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
It would have been obvious for person of ordinary skill before the effective filing date of the present invention to have modified the method of Stojanovic to include administering the companion animal the pet food product in the amounts taught by Tractor. Since Stojanovic teaches that the pet food product comprising sugar beet pulp may be administered to the companion animal according to the directions provided to the owner [0066], [0101], but does not provide feeding instructions for such a pet food product, a skilled practitioner would have been motivated to consult an additional reference such as Tractor in order to determine suitable feeding instructions for a pet food product containing sugar beet pulp, thereby rendering the claimed feeding amounts obvious. Furthermore, in consulting Tractor, the practitioner would find that such a food product is suitable for companion animals after the age of one year old which includes adults, senior, and geriatric companion animals, thereby rendering the claimed age ranges of adult, senior, and geriatric obvious.
The combination of Stojanovic, Petco, and Tractor does not disclose that the probiotic is selected from the group consisting of Faecalibacterium prausnitzii, Bacteroides plebeius, and Holdemanella biformis. The combination of Stojanovic, Petco, and Tractor also does not teach that the companion animal has an increased abundance of one or more bacterium comprising the 16S rRNA described in present claim 76.
However, Berry teaches a method of treating intestinal dysbiosis in an adult companion animal (corresponding to household pets) wherein the method comprises administering a composition containing bacteria for the reconstitution, modulation, or creation of a beneficial bacterial flora in the gastrointestinal tract of the companion animal [0639], [0819], [0906]. Berry teaches that the bacteria may be Faecalibacterium pausnitzii, Bacteroides plebeius, and/or Holdemanella biformis (corresponding to Eubacterium biforme) ([0663]-[0664], Table 1 on pages 121-122 and 132).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the Bacteroides species of Stojanovic to be Bacteroides plebeius as taught by Berry. Since Stojanovic teaches that the pet food product comprises probiotics to improve microbial balance in the gastrointestinal tract of the animal; and that the probiotic in its composition may be Bacteroides sp. [0025]-[0026], [0101], but does not disclose a suitable species of Bacteroides, a skilled practitioner would have been motivated to consult an additional reference such as Berry in order to determine a suitable Bacteroides species for improving microbial balance, thereby rendering the claimed Bacteroides plebeius obvious. Furthermore, a skilled practitioner would readily recognize that the probiotic bacteria of Stojanovic may also comprise Holdemanella biformis and Faecalibacterium pausnitzii as taught by Berry since Berry discloses that Holdemanella biformis and Faecalibacterium pausnitzii are also probiotic bacteria to treat dysbiosis. Therefore, the claimed Holdemanella biformis and Faecalibacterium pausnitzii are also rendered obvious.
In regard to the companion animal having an increased abundance of a specific bacterium having a 16S rRNA as described in the present claim, since the combination of Stojanovic, Petco, Tractor, and Berry teaches embodiments which are the same method as claimed and instantly disclosed, the method disclosed by the combination of cited prior art would necessarily have the claimed ability to increase abundance of the specific bacterium described in present claim 76. It is noted that claim 76 is a recitation of an inherent characteristic wherein the method of the combination of Stojanovic, Petco, Tractor, and Berry is capable of comprising the claimed ability to increase abundance of the specific bacterium described in present claim 76 as a function of the ingredients in the pet food product and the administration of that product to a companion animal as claimed and as disclosed. Regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be present in the ingredient of the reference. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s function, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F .3d 1342, 1347, 51 USPQ2d 1943. 1947 (Fed. Cir. 1999). Furthermore, the Office does not have laboratory facilities to test claim limitations drawn toward results of practicing the method as claimed. Accordingly, such an ability to increase abundance of the specific bacterium described in present claim 76 does not serve to distinguish the product as claimed from the prior art and is thus considered obvious to one having ordinary skill in the art.
Regarding claim 77, Stojanovic teaches the invention as described above in claim 76, including the pet food product is a dietary supplement or a functional food (corresponding to a nutraceutical) [0068].
Regarding claim 78, Stojanovic teaches the invention as described above in claim 76. Stojanovic does not specifically disclose that the pet food product is a topper. However, the term “topper” does not imply any structural, functional, or manipulative difference between the claimed invention and that of the prior art; therefore, the term “topper” does not limit the claim and does not distinguish the claimed invention over the prior art process so that the pet food product of Stojanovic may be effectively categorized as a “topper”.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 76-78 over Giffard and Berry: Applicant’s amendments and arguments have been fully considered and the amendments are considered to overcome the rejections of claims 76-78 over Giffard and Berry provided in the previous Office Action. However, upon further consideration, a new ground(s) of rejection is made in view of Stojanovic, Tractor, Petco, and Berry.
Applicant amended claim 76 to recite that the method comprises the companion animal having received a dietary change prior to receiving the claimed pet food product and that the companion animal is an adult, a senior, or a geriatric animal. Applicant argued that neither Giffard alone nor Giffard in combination with Berry teaches a pet food product that is suitable for treating dysbiosis in an animal after the animal has had a dietary change (Applicant’s Remarks, page 4, 1st paragraph under section II – page 7, 1st paragraph; page 7, 3rd paragraph – page 8, 1st paragraph).
However, in the new grounds of rejection necessitated by the amendment of the claims, Giffard is no longer cited as prior art. Therefore, Applicant’s arguments related to Giffard and the combination of Giffard and Berry are moot.
Applicant argued that a skilled practitioner would not be able to select the claimed bacterial species from the list of Berry with any expectation of success of reducing diarrhea incidence in a dog that has received a dietary change prior to treatment without improper hindsight (Applicant’s Remarks, page 7, 2nd paragraph).
However, in the new grounds of rejection necessitated by the amendment of the claims, the combination of Stojanovic, Petco, Tractor, and Berry render the present claims obvious. As described above in the rejection of amended claim 76, Stojanovic teaches that the companion animal receiving the pet food product may be experiencing diarrhea and intestinal dysbiosis [0084], [0097], but does not disclose a cause of the diarrhea and/or dysbiosis. Therefore, a skilled practitioner would have been motivated to consult Petco in order to determine a cause of the diarrhea and dysbiosis. In consulting Petco, the practitioner would find that the diarrhea and dysbiosis of the companion animal in Stojanovic may be the result of a dietary change and would find that supplementing a diet with probiotics and fiber such as the probiotics and sugar beet pulp of Stojanovic and Berry may treat the diarrhea and dysbiosis, thereby rendering the requirement that the companion animal received a dietary change prior to receiving the pet food product and rendering treatment of diarrhea with probiotics obvious.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Since the amended claims are shown to be rendered obvious as described in the prior art rejections above and Applicant’s arguments have been shown to be moot or unpersuasive, the rejections of the claims stand as written herein.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Kelly Kershaw whose telephone number is (571)272-2847. The examiner can normally be reached Monday - Thursday 9:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki 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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/K.P.K./Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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