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 .
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 12 August 2025 has been entered.
Status of the Claims
Claims 22, 30-32, and 37-43 are pending, presented for examination and rejected as set forth below.
Claim Interpretation
Applicants’ claims are directed to methods of treating swallowing disorders by providing to a subject in need of such treatment an aqueous composition combining a B-glucan containing oat extract and carbohydrate in the form of isomaltulose, with the carbohydrate and oat extract are to be present in the composition in a weight ratio of about 1:1 to 30:1, where the B-glucan is present in the oat extract within a defined concentration range, the overall compositions of which are described as providing certain properties to the composition so that the viscosity and relaxation time of the resulting aqueous composition address certain physical parameters. Dependent Claim 30 specifies that the composition is to take the form of, among others, a “nutritional product.” Claims 31 and 32 specify the inclusion of additional components. Claim 37 specifies that the composition “consists essentially of” isomaltulose, beta-glucan, and water or milk; applicants are reminded that the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). Absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising.” PPG Industries v. Guardian Industries, 156 F.3d 1351, 1355, 48 USPQ2d at 1355 (Fed. Cir. 1998). As applicants have not identified what basic and novel characteristics of the invention additional components may not interfere with may be, Claim 37 is considered to recite a composition comprising the recited elements. Claim 38 specifies that the composition consists of isomaltulose, oat-derived beta-glucan, and water or milk. Claim 39 specifies that he composition does not contain milk oligosaccharides. Claims 40 and 41 narrow the range of isomaltulose to oat extract, with Claims 42 and 43 narrowing the concentration of beta glucan within the oat extract.
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 22, 30-32, and 37-43 are rejected under 35 U.S.C. 103 as being unpatentable over Popanita (WO2016/012403) in view of Buck (U.S. PGPub. 2016/0296544).
Popanita describes treating swallowing disorders in patients in need of such treatment by administering a nutritional product, an embodiment of which is to contain an aqueous solution which comprises beta-glucan in a concentration of from 0.01 wt% to 25 wt%. (Pg.16, L.33 – Pg.17, L.12). Popanita indicates that the beta-glucan to be used in the nutritional composition is derived from oat, owing to the beneficial properties such sources of beta-glucan provide in terms of altering sheer viscosity. (Pg.9, L.22-27). In view of applicants amendments to the claims, specifying that the beta-glucan is to be provided as an oat extract containing between 10-18%, or 12-16%, or 14% beta-glucan in the oat extract, Popanita appears to describe, as an “aqueous solution” of beta-glucan optionally obtained from oat sources, an oat extract containing a concentration of beta-glucan which encompasses, overlaps, and therefore renders obvious that of the amended claims. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). The aqueous solution is capable of providing to the product a shear viscosity of preferably less than 200 mPas when measured at a shear rate of 50s-1. The aqueous solution is capable of providing to the nutritional product a relaxation time that can be determined by a Capillary Breakup Extensional Rheometry (CaBER) experiment of preferably more than 10 ms (milliseconds) at a temperature of typically about 20° C. (Pg.7, L.21-30). Popanita also indicates that the aqueous solutions containing the beta glucans for use in the nutritional compositions may be diluted to obtain a desired consistency or mixed with additional ingredients as desired. (Pg.23, L.24-34). Because Popanita indicates that the only components required for these nutritional compositions are water and the beta-glucan, specifically indicating that any additional components are optional, it would have been prima facie obvious to a skilled artisan to select just water, beta-glucan, and a probiotic or saccharide as the nutritional component ingredients, addressing the newly added claims limited to compositions consisting of water or milk, beta-glucan, and isomaltulose as will be spelled out in greater detail below. Popanita indicates that optionally these compositions can include a source of carbohydrate, a prebiotic such as an isomalto-oligosaccharide, or any of the fiber, protein, amino acid, fat, probiotic, fatty acid, phytonutrient, or antioxidant as is recited by newly added Claim 31. (Pg.12). Indeed, a mixture of soluble and insoluble fiber is explicitly recited as a choice for the optional fiber component. (Id.). While Popanita does not particularly describe the concentration of either carbohydrate or prebiotic which find use in the compositions, applicants are reminded that Popanita describes each of the carbohydrates and prebiotics as providing desirable properties to the compositions into which they are incorporated. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Popanita to arrive at the carbohydrate:glucan ratio of Claims 22, 40, and 41. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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.).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of oat-derived B-glucan and carbohydrate such as sucrose or lactose to provide the dysphagia-treating aqueous composition and then use such a composition to treat a subject with a swallowing disorder, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected the claimed combination of oat-derived B-glucan and carbohydrate, and optionally fibers to provide the dysphagia-treating aqueous composition and then use such a composition to treat a subject with a swallowing disorder from within a prior art disclosure, to arrive at methods “yielding no more than one would expect from such an arrangement.”
However, while Popanita describes using combinations of oat-derived B-glucan, carbohydrate such as sucrose or lactose, and fibers to provide the dysphagia-treating aqueous composition and then using such a composition to treat a subject with a swallowing disorder, it does not describe using the isomaltulose of Claim 22 as the carbohydrate in such a composition or method of treating dysphagia.
This is cured by the teachings of Buck, which indicates that at the time of the instant application, isomaltulose was known to be useful in nutritional compositions as a source of carbohydrates. [0038].
On the basis of this knowledge available in the art at the time of the instant application, it therefore would have been prima facie obvious to have used isomaltulose as the carbohydrate source in the compositions and methods of treating swallowing disorders suggested by the teachings of Popanita. That is because Popanita explicitly describes incorporating a carbohydrate source into the dysphagia-treating compositions described, and Buck indicates that isomaltulose was at the time recognized as an alternative carbohydrate source for use in nutritional compositions. Because Popanita indicates that the only components required for these nutritional compositions are water and the beta-glucan, specifically indicating that any additional components are optional, it would have been prima facie obvious to a skilled artisan to select just water, beta-glucan, and a probiotic or saccharide as the nutritional component ingredients, addressing the newly added claims limited to compositions consisting of water or milk, beta-glucan, and isomaltulose.
Response to Arguments
Applicant's arguments filed 12 August 2025 have been fully considered but they are not persuasive.
Applicants arguments at first simply recite the elements recited by Claim 22 and assert that the art, alone or in combination, fails to teach the limitations claimed. As a threshold matter, this enumeration of claim limitations and a bald assertion they are not taught by the art has long been held legally insufficient to raise a proper objection to an Examiner’s prima facie case. In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[T]he Board reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.”).
Applicants next assert that nothing of the Popanita disclosure specify that any particular oat extract is either specified or guidance provided to obtain any particular oat extract to serve as the source of the beta glucans. With respect, no particular oat extract is required by the present claims, only that such extract contain beta glucans within a certain concentration range. As set forth above, Popanita establishes that oat is a preferred source of beta glucans for use in the nutritional compositions and methods of their use described. Popanita also teaches the skilled artisan that the beta glucans, such as those obtained from oat, are to be provided as aqueous solutions to be incorporated into such nutritional compositions, and that these solutions may contain between 0.01-25% by weight beta glucans. Popanita also indicates that these aqueous solutions of beta-glucan may be diluted or combined with additional ingredients as the skilled artisan deems necessary. As such, Popanita indeed suggests employing extracts of oat which contain beta glucans in concentrations of between 0.01-25%, a range overlapping and therefore rendering obvious the limitations of the newly amended claims, to be diluted and/or combined with additional ingredients per the teachings available to the skilled artisan, including not only the remainder of the Popanita disclosure, but also the analogous Buck reference.
For at least these reasons, applicant’s arguments are unpersuasive.
Conclusion
No Claims are allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614