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 .
Election/Restrictions
Regarding the restriction requirement, Applicant's election, without traverse, of the invention of Group II in the reply filed on 07 July 2026 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-20 are pending. Claim 1-8 and 11-20 are withdrawn as being drawn to a non-elected invention.
Priority
The instant application claims priority as follows:
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
All references from the IDS(s) received 27 August 2024 have been considered unless marked with a strikethrough.
Claim Objections
Claim 9, and claim 10 through dependency, are objected to because of the following informalities: claim 9 depends from claim 1, which is withdrawn from consideration. Applicant elected Group II (claims 9 and 10) without traverse, and the restriction has been made final. Appropriate correction is required, such as amending claim 9 to independent form. The claims should be able to stand alone.
Claim Interpretation
Claim 9 has been interpreted, and examined, as if claim 9 incorporate all of the limitations of withdrawn claim 1.
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.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation (TSM) in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
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.
Rejections under 35 USC § 103
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Banasiewicz et al. (Gastroenterology Rev 2020; 15 (2): 119–125), Asano et al. ‘697 (US5605697A; issued 25 Feb 1997), Asano et al. 1994 (Microbial Ecology in Health and Disease, 7(5), 247–256 (1994)), and Riviere et al. (Front Microbiol. 2016 Jun 28;7:979).
Brief Discussion of the Cited References
Banasiewicz et al.
Banasiewicz et al. (Gastroenterology Rev 2020; 15 (2): 119–125) teach that “Butyric acid is increasingly used as a supportive agent in the treatment and prevention of exacerbations of various diseases and disorders of the digestive tract, such as diarrhoea (specific and non-specific), inflammatory conditions (non-specific bowel inflammation, diverticulitis, diversion colitis, radiation-induced bowel inflammation), functional disturbances (irritable bowel syndrome), dysbiosis, and post-surgery (resections, short bowel syndrome) or post-chemotherapy conditions.” Emphasis added. See page 119. Banasiewicz et al. teach that “150–300 mg/day is the most common dosage recommendation for currently available butyric acid products” and that “Very good clinical results of high doses of butyrate (2000 mg/day) were found in patients with mild to moderate Crohn’s disease.” See page 120. Banasiewicz et al. teach that doses “reaching 1350 mg/day or even 2000 mg/day, no adverse reactions or side effects were observed, and good tolerance of oral butyrate was underlined.” See page 123.
Asano et al. (‘697)
Asano et al. ‘697 (US5605697A; issued 25 Feb 1997) teach that “Since bifidobacteria must be encouraged to multiply in the intestine in order that their variegated actions may be exploited, much research into substances that could promote growth of bifidobacteria (hereinafter referred to as bifidus factors) is going on with great enthusiasm.” See column 1, lines 29-4. Asano et al. ‘697 teach that “a bifidobacterium growth promotant comprising gluconic acid, a nontoxic salt thereof and/or glucono- delta -lactone as an active ingredient. The bifidobacterium growth promotant of this invention has selective bifidobacterial growth promoting-activity and, at the same time, inhibits growth of deleterious bacteria. Moreover, its rate of digestion and absorption in the upper alimentary tract is so low that the promotant has very satisfactory characteristics as a bifidus factor. Therefore, the bifidobacterium growth promotant of this invention can be used per se or as an additive for various foods and drink to provide functional foods and drinks, thus being of great value from the standpoint of health improvement.” See abstract. Asano et al. ‘697 teach that “Gluconic acid, a salt thereof and/or glucono-δ-lactone, which as aforesaid has activity to promote growth of bifidobacteria, can be used as a bifidobacterium growth promotant, a Clostridium growth inhibitor, an intestinal function controlling agent, an intestinal putrefactive fermentation inhibitor, a prophylactic and therapeutic agent for diarrhea, a stool deodorant, a stool property improving agent or an anticonstipation drug in man and animals, and even as an animal growth promotant, among other uses. Emphasis added. See column 2, line 65, to column, line 6. Asano et al. ‘697 teach a “method of promoting the growth of bifidobacteria in a patient in need thereof which comprises: administering a bifidobacterium growth promoting amount of an agent selected from the group consisting of gluconic acid, a nontoxic salt of gluconic acid and glucono-δ-lactone.” See claim 3. Asano et al. ‘697 teach a “method of controlling intestinal function in a patient in need thereof which comprises: administering a bifidobacterium growth promoting amount of an agent selected from the group consisting of gluconic acid, a nontoxic salt of gluconic acid and glucono-δ-lactone.” See claim 6. Asano et al. ‘697 teach a “method preventing or treating diarrhea in a patient in need thereof which comprises: administering a bifidobacterium growth promoting amount of an agent selected from the group consisting of gluconic acid, a nontoxic salt of gluconic acid and glucono-δ-lactone.” See claim 12. Asano et al. ‘697 teach “administering at least 1.7 g of said agent per day” or “administering at least 9 g of said agent per day.” See claims 4, 5, 7, 8, 13 and 14.
Asano et al. (1994)
Asano et al. 1994 (Microbial Ecology in Health and Disease, 7(5), 247–256 (1994)) teach that “useful bacteria such as bifidobacteria are thought to inhibit the growth of harmful bacteria and stimulate immune function, so they are helpful for maintenance of human health” and that “Since the possible beneficial role of bifidobacteria became known, they have been used as dietary supplements or as starter cultures for yogurt and other cultured milk products in many areas of the world including Japan, Scandinavia and Europe.” See page 247. Asano et al. 1994 teach that “[t]he effects of ingestion of gluconate on human faecal bacteria was studied in ten healthy adult males. They ingested 9 g/d or 3 g/d of glucono-6-lactone (anhydrideof gluconic acid). With the 9 g/d ingestion, the number of bifidobacteria significantly increased (P<0.001), whereas C. perfringens decreased and Enterobacteriaceae remained constant. The concentrations of bifidobacteria also increased (W0.05) following 3 g/d ingestion.” See abstract.
Riviere et al.
Riviere et al. (Front Microbiol. 2016 Jun 28;7:979) teach that “Since decreased numbers of Bifidobacterium species and butyrate-producing bacterial species in the human colon have been reported in patients with diverse disorders and because the SCFAs produced by these species have beneficial effects (Table 1), these bacteria are potential candidates to be stimulated in the colon to prevent and restore a disturbed gut homeostasis.” See page 979. Riviere et al. teach that “bifidobacteria has been associated with beneficial effects for different digestive problems and disorders, encompassing acceleration of the gut transit time; improvement of lactose intolerance; prevention of antibiotic-associated diarrhea and necrotizing enterocolitis (in pre-term infants that usually harbor reduced numbers of bifidobacteria); and alleviation of IBS and IBD symptoms (Leahy et al., 2005; Di Gioia et al., 2014; Tojo et al., 2014; Saez-Lara et al., 2015).” Emphasis added. See page 979. Riviere et al. teach that a “strategy to increase bifidobacteria and butyrate-producing bacteria in the human colon is through the consumption of prebiotics, which are defined according to the ISAPP as ‘a selectively fermented ingredient that results in specific changes in the composition and/or activity of the gastrointestinal microbiota, thus conferring benefit(s) upon host health’ (Gibson et al., 2010).” See page 979.
Comparison Between the Claimed Invention and the Prior Art
With respect to claims 9 and 10, Banasiewicz et al. teach, among other aspects of the claimed invention, that administering butyric acid is a known for treatment for various diseases and disorders of the digestive tract, such as diarrhea, diverticulitis, irritable bowel syndrome, etc. Banasiewicz et al. teach that 150–300 mg/day is the most common dosage recommendation for currently available butyric acid products but that good clinical results of high doses of butyrate (2000 mg/day) were found in patients with mild to moderate Crohn’s disease.” Asano et al. ‘697 teach, among other aspects of the claimed invention, administering gluconic acid to promote the growth of bifidobacteria, control intestinal function, and treat diarrhea, etc. Asano et al. ‘697 teach administering gluconic acid at dosages of at least 1.7 g per day and of at least 9 g per day. Asano et al. 1994 expands on the teachings of Asano et al. ‘697, and adds, among other aspects of the claimed invention, administering gluconic acid at dosages of a 3 g per day and at 9 g per day. Riviere et al. reiterate that bifidobacteria has been associated with beneficial effects for different digestive problems and disorders, such as diarrhea. Riviere et al. further teach, among other aspects of the claimed invention, that bifidobacteria has been associated with beneficial effects for different digestive problems and disorders, such as alleviation of IBS and IBD symptoms.
Differences between the Claimed Invention and the Prior Art
With respect to claims 9 and 10, no cited reference expressly teaches a method comprising administering butyric acid and gluconic acid as a combination therapy for treating inflammatory bowel conditions. Regarding the ratio of butyric acid to gluconic acid (ba:ga) as set forth in claim 1 (upon which claim 9 depends), no cited reference, independently or collectively, teaches a butyric acid to gluconic acid in a weight ration of ranging from 4:1 to 60:1.
Conclusion of Obviousness
With respect to claims 9 and 10, applying KSR rationale (A) outlined above, it would have been prima facie obvious to combine one known element (namely, administering butyric acid, as taught by Banasiewicz et al.) along with another known element (namely, administering gluconic acid, as taught by Asano et al. ‘697 in view of Riviere et al.) to obtain the claimed methods for treating inflammatory bowel conditions, including irritable bowel syndrome (IBS). Owing to the cited teachings, one of ordinary skill in the art would have been motivated to combine the knowns elements and would had a reasonable expectation that the combined elements would be effective for treating inflammatory bowel conditions, including irritable bowel syndrome (IBS).
Applicant states the following: “The tests conducted clearly demonstrate the primary anti-inflammatory effect of gluconic acid, which is not secondary to and/or dependent on the prebiotic effect, as the in vitro model does not exhibit bacterial populations or those normally present in the human or animal intestine, or pathogens or contaminants of any kind, whether viral or fungal.” See line 20 of page 16 to line 4 of page 17 of the instant application. However, newly discovered results of known processes (in this case, administering gluconic acid) directed to the same purpose (in this case, treating inflammatory bowel conditions) are not patentable because such results are inherent. See In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012)).
Regarding the ratio of butyric acid to gluconic acid (ba:ga) weight ratio as set forth in claim 1 (upon which claim 9 depends), the examiner has examined claims 9 and 10, as if claim 9 incorporates all of the limitations of withdrawn claim 1, namely a method comprising administering a composition comprising butyric acid to gluconic acid in a weight ratio ranging from 4:1 to 60:1. Comparing the lowest dosage of butyric acid recited in Banasiewicz et al. with the highest dosage of gluconic acid recited in either of the two Asano et al. references results in a butyric acid to gluconic acid (ba:ga) weight ratio of 1:60. And comparing the highest dosage of butyric acid recited in Banasiewicz et al. with the lowest dosage of gluconic acid recited in either of the two Asano et al. references results in a butyric acid to gluconic acid (ba:ga) weight ratio of 20:17. That is, the butyric acid to gluconic acid (ba:ga) weight ratio calculated from the cited prior art ranges from 1:60 to 20:17; whereas, the claimed weight ratio ranges from 4:1 to 60:1. While the ranges do not overlap, given the broad range of the cited prior art ratios and the broad range of the claimed ratios, the examiner asserts that the closest points of the two neighboring ranges (20:17 vs 4:1) are close.
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See MPEP at 2144.05.
As such, the claimed invention was obvious at the time of filing.
Conclusion
No claim is currently allowable.
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/BSM/Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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