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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/16/2026 has been entered.
Claims 1-15 are currently pending and under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a without significantly more (partially newly reapplied as necessitated by amendment). Claims 1-10 recite a prebiotic fiber blend comprising pumpkin, inulin, psyllium and a preservative and its inclusion in a pet food and supplement. Which are all natural products. Claims 11-15 recite a method of providing a digestive health benefit by administering the prebiotic fiber blend. Which is a natural function of the fiber blend and the individual ingredients of the blend.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a natural product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites a product of nature. In this case, applicant’s claims recite pumpkin, inulin, and psyllium, which are all natural products.
Thus, the claims do recite products of nature (pumpkin, inulin, and psyllium). MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”. MPEP section 2106.04 (c-I-B) states “the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart…”.
In this case, combining pumpkin, inulin, and psyllium together simply mixes two or three naturally occurring products together. Regarding the limitation of a preservative, there is no recitation of an amount or effective amount. Thus, a preservative can be part of the formulation in an amount that does not provide a preserving effect and does not provide anything markedly different. Combining pumpkin, inulin, and psyllium with a preservative without reciting an amount does not necessarily result in a markedly distinct change in the naturally occurring pumpkin, inulin, and psyllium. Thus, while the combination of pumpkin, inulin, and psyllium with a preservative itself may not be found in the nature, the pumpkin, inulin, and psyllium are found in nature as can a preservative (e.g. vitamin E, or citric acid). There is no evidence or reason to expect that combining pumpkin, inulin, and psyllium with a preservative absent an amount claimed changes the properties of each of the natural products. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the pumpkin, inulin, and psyllium with a preservative as commensurate in scope with the stated claims changes the structure, function, or other properties of the pumpkin, inulin, and psyllium with a preservative in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for pumpkin, inulin, and psyllium is the naturally occurring pumpkin, inulin, and psyllium and a preservative that can also be naturally occurring. Because, as discussed above, pumpkin, inulin, and psyllium is only a mixture of pumpkin, inulin, and psyllium found in the nature, combining them with a preservative absent an amount and the combination appears to maintain each naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations as claimed in claims 2-4, 6, 7, 10 and 15 produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, the claims are directed to composition with no additional ingredients in addition to the natural products. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the combination of extracts. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing pumpkin, inulin, and psyllium does not amount to significantly more than a combination of judicial exception because combining pumpkin, inulin, and psyllium is well-understood, routine, and conventional in the field for probiotic an symbiotic foods (See e.g. Szydlowaska et al. CyTA - Journal of Food Volume 17, 2019 - Issue 1). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
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 1-15 remain rejected under 35 U.S.C. 103 as being unpatentable over Bascharon (US10245293).
Bascharon teaches a composition comprising a prebiotic, wherein the prebiotic can be inulin (See e.g. column 3, lines 51-52), fiber, wherein the fiber can be pumpkin (See e.g. claim 6), pumpkin powder and/or seed, inulin and psyllium (See e.g. claim 9), can comprise two or more fiber sources (See e.g. column 5, lines 19-21) and the fiber can be present in an amount of 20% to about 40% (See e.g. column 5, lines 42-44)(which reads on claims 2-4 and overlaps with the range claimed in claim 10) or in an amount of about 5% to about 70% (See e.g. column 5, lines 38-39)(which overlaps with the range claimed in claim 7, 10). Bascharon further teaches a method of treating or preventing anal gland disease administering the composition to a dog the formulation (See e.g. claim 2). Bascharon further teaches that the composition can be a supplement or a food (See e.g. column 7, lines 66-67; column 8, lines 9-11)(which reads on claims 5). Bascharon further teaches that the composition can be administered as a regular feeding and daily and over a continued, long-term period (See e.g. col. 8, lines 1-24)(which reads on regular basis). Bascharon further teaches that the composition can contain anti-diarrhea agents (See e.g. claim 3) and can contain edible fats, preservatives (See e.g. col.9, lines 5-15 and 24), peanut butter, beef, pork, lamb, chicken, turkey, duck, venison, fish (see e.g. col 7, lines 19-22)(which reads on protein) and oligofructose, fructooligosaccharides and polydextrose (See e.g. col 3, lines 58-64)(which reads on carbohydrates). Bascharon further teaches preservatives (See e.g. column 9, lines 5-13).
It would have been obvious to modify the composition used in the method taught by Bascharon by combining pumpkin, inulin and, optionally, psyllium and to combine these ingredients with the additionally claimed ingredients including preservatives to provide a prebiotic blend and formulate a supplement and pet food composition for administration to a dog for treating diarrhea because at the time the invention was made, it was known that pumpkin, inulin and, optionally, psyllium were all useful ingredients that could be combined as part of a finite number of combination possibilities for oral administration to a dog in combination with an anti-diarrheal and preservatives and could contain the additionally claimed ingredients as clearly taught by the above reference.
Thus, an artisan of ordinary skill would reasonably expect that combining the instantly claimed ingredients would provide a safe and effective formulation for administration to a dog in the form of a food or supplement and as a blend and that combining these ingredients would an anti-diarrheal would provide treatment of diarrhea, particularly since the method does not require a patient population, so administering the formulation to a dog with intrinsically have the instantly claimed effect and would provide digestive health, since the formulation is the same as that claimed. This reasonable expectation of success would motivate the artisan to use the instantly claimed ingredients to make the instantly claimed blend, pet food and supplement, since the reference teaches that these are products made an that the formulation could be administered to a dog with an antidiarrheal, which would have the claimed effect of providing a digestive health benefit and treating diarrhea based upon the beneficial teachings of the reference.
Moreover, it would have been merely a matter of judicious selection to one of ordinary skill in the art at the time the invention was made to modify the referenced composition because it would have been well in the purview of one of ordinary skill in the art practicing the invention to pick and choose a concentration of phytoestrogen and the concentration of the product and the percentage amounts of the ingredients thereof to provide the instantly claimed formulation, since the amounts of the ingredients overlap or encompass those claimed. Thus, the claimed invention is no more than the routine optimization of a result effect variable.
Based upon the beneficial teachings of the cited references, the skill of one of ordinary skill in the art, and absent evidence to the contrary, there would have been a reasonable expectation of success to result in the claimed invention.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant's arguments filed 1/16/2026 have been fully considered but they are not persuasive.
Applicant argues that that claims are directed to a human-made combination, and not a naturally occurring product: A non-naturally occurring combination of pumpkin, inulin, and psyllium. Applicant further argues that pumpkin, inulin and psyllium do not occur together in nature in the claimed combination and their specific combination produces new and unexpected results that are not exhibited by the components alone. Applicant further argues that the data in the specification shows that the claimed prebiotic fiber blend provides unique digestive health benefits to canines, which are not seen in formulations lacking all the three claimed fiber sources. Applicant further argues that Applicant has amended the claims to include a "preservative". Such a composition does not naturally occur in nature and is akin to the "Pomelo Juice”.
This is not found persuasive because pumpkin, inulin, and psyllium are products of nature. As set forth above and in the previous Office Action, the combination of these ingredients, particularly in the absence of amounts, does not provide anything markedly different from what is found naturally. The claims are not commensurate in scope with the amounts of the ingredients that Applicant is pointing to in the specification. Furthermore, combining solids (pumpkin, inulin and psyllium) is analogous to combining fruits in a bowl. They remain intact and nothing new has been provided, particularly since each of the components retains its own properties. Regarding the pomelo juice example, the claims are to a beverage composition comprising pomelo juice and an effective amount of an added preservative. Further, in the pomelo juice example, the specification indicates that the preservative can be natural or non-natural in origin, but that regardless of its origin, when an effective amount of preservative is mixed with the pomelo juice, the preservative affects the juice so that it spoils much more slowly (spoils in a few weeks) than the naturally occurring juice by itself (spoils in a few days)”. Applicant’s claims do not recite or require an amount of preservative (or naturally occurring ingredients). Thus, the preservative can be in amount that does not provide these effects. Therefore, the rejection is maintained for the reasons of record and the reasons set forth above.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 1/16/2026 have been fully considered but they are not persuasive.
Applicant argues Bascharon fails to teach or suggest at least “[a] prebiotic fiber blend… comprising pumpkin, inulin and psyllium.” Applicant further argues that Bascharon discloses supplement compositions useful for treatment of anal gland disease comprising a probiotic, a fiber source, and an anti-inflammatory agent. (See Abstract). Bascharon further discloses broad lists of potential fiber sources: “The disclosure provides a composition as described above, wherein the fiber source provides bulk and firms up stools. The fiber source generally includes, but is not limited to, cellulose, pectins, gums, chitin, chitosan, β-glucans, hemicelluloses, inulins, oligofructose, fructooligosaccharides, lignin, polydextrose, psyllium, resistant dextrins, dandelion root, and resistant starch” and; “…the fiber source is selected from the group consisting of barley, flax seed, digestion resistant maltodextrin, beet pulp, guar gum, inulin, cellulose, larch arabinogalactan, methylcellulose, oat bran, oligofructose, pectin, pumpkin powder, pumpkin seed, psyllium, rice bran, wheat bran, wheat dextrin, and a combination thereof.”
Applicant further argues that Bascharon discloses 28 different fiber sources, any three of which could theoretically be combined, resulting in thousands of possible blends and that Bascharon provides no teaching or motivation to specifically select pumpkin, inulin and psyllium from this large list of possibilities.
This is not found persuasive because the sources of fiber taught by Bascharon specifically teaches “The fiber source generally includes. cellulose, pectins, gums, chitin, chitosan, β-glucans, hemicelluloses, inulins, oligofructose, fructooligosaccharides, lignin, polydextrose, psyllium, resistant dextrins, dandelion root, and resistant starch” (See e.g. col 3, lines 60-64). This is a finite number of alternatives and a specified embodiment. Further, col. 5, lines 24-29 specify pumpkin, psyllium and inulin can be found in combination as part of a list of finite ingredients. Finally, Bascharon.teaches preservatives. Therefore, it would have been obvious to combine the instantly claimed ingredients based upon the beneficial teachings of Bascharon. Therefore, the rejection is maintained for the reasons of record and the reasons set forth above.
Conclusion
No claims are allowed.
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 Amy L. Clark whose telephone number is (571)272-1310. The examiner can normally be reached M-F 8:00am-5:00pm.
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, Jennifer Michener can be reached at 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
Prosecution Insights