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 .
Response to Amendment and Argument
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/29/25 has been entered.
The response filed on 9/25/25 has been entered.
Applicant’s arguments filed 9/25/25 have been fully considered but they are not deemed to be persuasive.
The double patenting rejection of Claims 1, 59-60, 64, 66, 100, 102, 104 and 110-126 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1, 4, 16, 31, 81, 111-112, 115-116, 120-123, 128-133 of U.S. Patent Application No. 16670845 is withdrawn. The application is abandoned.
Claims 1, 59—60, 64, 66, 100, 102, 104, 110-111, 113-114, 117-118, 121-126 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 9/29/25. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Maintained 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) 1, 59-60, 64, 66, 100, 102, 104,110-111, 113-114, 117-126 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wan et al. (WO 2018027127) in view of Niihara (US 2013/0178531) and Ganz et al. (US 20200138077).
With regards to instant claim 1, Wan teaches a composition comprising fibers, wherein the fibers are selected from one or more fibers, thus interpreted as comprising two or more fibers wherein the fibers including psyllium with another fiber from 0.001%-80%, 15% to 40%, alternatively 40% to 60%, alternatively 60% to 80%, (see pg 8, sec. under Fibers). Wan teaches the fibers that can be used are wheat dextrin, inulin, starches, pectin etc. (see under thickening agents and fibers, as required by instant claims 119-120). Wan also teaches their composition is in the form of a gummy (see Sec. under Tech. Field, as required by instant claim 121).
However, did not per se teach that the first fiber is from 40-60% and second fiber is from 45-55%, also fails to teach a method for improving intestinal health in a subject as required by instant claims. With regards to claims 113-114, 117, Wan teaches the composition of the fiber can be from 0.001%-80%, therefore the claimed ranges of the fibers would have been obvious over the recited ranges of the above claims with a reasonable expectation of success. Although Wan did not per-se teach having first, second, third, fourth and fifth fiber, it would have been obvious to one of ordinary skill in the art to choose a first, second, third, fourth and fifth fiber as Wan specifically teaches that naturally derived fiber is used, including one or more selected from naturally derived inulin, thus motivation to use more than one fiber in the composition with a reasonable expectation of success.
Niihara teaches a fiber supplement comprising psyllium fiber and wheat dextrin (see 0023) for improving intestinal health such as diverticulosis (see 0009, as required by instant claims 59-60, 64).
Ganz teaches a composition for treating gastrointestinal disease comprising two or more fibers wherein the fibers are psyllium and wheat dextrin., ie., first and second fiber (see abstract; 0003,0007 and 0094, as required by instant claims 1 and 119-120) for gut health (see same, as required by instant claims 59-60) restoring the bacteria metabolites such as SCFA i.e., short chain fatty acids, as required by instant claim 66) wherein the fibers are at a concentration from 2-6%wherein the gastrointestinal disease is flatulence, fecal incontinence diarrhea(see abstract’ 0274, as required by instant claim 100) wherein the composition is administered daily (see 0337, as required by instant claim 102) from 0.5-15 grams (as required by instant claims 104 and 110, see 0094) for treating irritable bowel syndrome IBS, as required by instant claim 111, see 0004), where the ratio of the first fiber to the second fiber is 1:1 (see 0013, as required by instant claims 117-118), packaged as a powder as required by instant claim 121).Ganz teaches that their composition comprise specifically a first and second fiber (see 0006). Thus one of ordinary skill in the art would have been motivated to have the fist, second, third, fourth and fifth fibers because Ganz does teach having 2 or mor fibers. 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 these methods with the reasonable expectation that at least one would be successful. Ganz specifically teach that their composition includes a third and fourth fiber (see 0014-0015).
One of ordinary skill in the art would have utilized the composition taught by Wan by incorporating Niihara and Ganz to formulate the composition for improving intestinal health because 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). Additionally one would have been motivated to use the fibers recited by instant claims 123 as both Wan and Ganz teach the fibers can be inulin, pectin potato starch (see 0015) and fourth fiber (see 0011).
Therefore it would have been obvious to one of ordinary skill in the art to have combined the above cited prior art to reach the instant claimed invention at the time the invention was filed.
Applicant argues that neither Wan, Niihara and Ganz do not disclose the instant claimed invention, specifically failed to teach the composition comprising a first fiber present in an amount of about 40% to about 60% w/w of the composition and a second fiber present in an amount of about 45% to about 55% w/w of the composition, let alone psyllium present in an amount of about 40% to about 60% w/w of the composition and wheat dextrin present in an amount of about 45% to about 55% w/w of the composition.
In response, the concentrations taught by Wan would have been obvious to one of ordinary skill in the art as, the concentration of the active ingredient is a result-effective variable, i.e., a variable that achieves a recognized result and, therefore, the determination of the optimum or workable dosage range would have been well within the practice of routine experimentation by the skilled artisan. Below is the analysis of the unexpected result.
Affidavit under 37 CFR 1.132
The Affidavit under 37 CFR 1.132 filed by Robert A. Ganz is insufficient to overcome the rejection of claims 1, 59-60, 64, 66, 100, 102, 104,110-111, 113-114, 117-126 based upon the above rejection as set forth in the last Office action because: There is no comparison with the closest prior art Wan. Applicant should note that showing only the one point that is the psyllium at 40-60% and dextrin 45-55%dextrin and the argument or statement that one of ordinary skill in the art would not have formulated a fiber composition in the amounts is found unpersuasive. Wan specifically teach using fibers including psyllium with another fiber from 0.001%-80%, 15% to 40%, alternatively 40% to 60%, alternatively 60% to 80%, (see pg 8, sec. under Fibers).
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. “[l]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. (MPEP 2141.03 (I)). “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Additionally Ex parte Gelles 22 USPQ 2d 1318 (at 1319): held that "[t]he evidence relied upon also should be reasonably commensurate in scope with the subject matter claimed and illustrate the claimed subject matter "as a class" relative to the prior art subject matter." Also in order to show unexpected result’s three major points that should be considered: the unexpected result must truly be unexpected, it must be commensurate in scope (show a trend representing the scope), and lastly a direct comparison with the closest prior art of record should be provided.
Examiner is not arguing the unexpected result shown, but fails to show that the unexpected result is truly as there are no comparison as to what the unexpected will be when other concentration are used.
Therefore Applicant’s affidavit is found unpersuasive.
The double patenting rejection of Claims 1, 59-60, 64, 66, 100, 102, 104 and 110-126 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1, 4, 16, 31, 81, 111-112, 115-116, 120-123, 128-133 of U.S. Patent Application No. 17713964
Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The copending claims recites a composition comprising a first, second, third, fourth and fifth fiber.
The withdrawn claims are drawn to a method of improving intestinal health in a subject. It would have been obvious to one of ordinary skill in the art to have used the composition in practicing the instant claims in view of the 103 rejection Above. The composition of the copending would have been used in the claimed method and therefore are part of the obvious variation.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 01/09/25