DETAILED ACTION
Applicants’ arguments, filed 18 August 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 1-3, 5-7, 9-13, and 15-20 are pending.
Claims 15-20 are withdrawn from consideration due to a restriction requirement.
Claims 1-3, 5-7, and 9-13 are subject to substantive examination.
Claim Rejections - 35 USC § 112(a) – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-7 and 9-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite that the psyllium is substantially free of particles greater than 250m. This appears to be new matter because the term “250m” is not adequately supported by the original application as filed.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5-7 and 9-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the phrase “250m.” It is unclear how this term further limits the claim scope because it is unclear what the letter “m” stands for in this case. For the purposes of examination under prior art, the examiner will proceed with examination with the understanding that the phrase “250m” actually refers to “250 μm.”
Claim Interpretation
Claim 1 recites the units “gf.” This refers to “gram force.” 1 gf is 9.80665 millinewtons or 0.00980665 newtons. See Tang (US 2011/0303043 A1), paragraph 0060. As such, 1 Newton is about 101.97 gram-force.
Claim 4 recites less than about 20% of a binding agent. The examiner notes that a composition with zero binding agent has less than about 20% of a binding agent. As such, a composition with zero binding agent is understood to read on the claimed requirement.
Claim Rejections - 35 USC § 103 – Obviousness
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) 1-3, 5-7 and 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pflaumer et al. (US Patent 5,095,008).
Pflaumer et al. (hereafter referred to as Pflaumer) is drawn to cookies comprising psyllium, as of Pflaumer, title and abstract. The composition of Pflaumer has the following components, as of columns 15-16, relevant table reproduced below.
PNG
media_image1.png
144
414
media_image1.png
Greyscale
PNG
media_image2.png
164
418
media_image2.png
Greyscale
The percentage of psyllium in the above reproduced composition is the following:
61.20
85
+
26.28
+
3
+
1
+
120
+
28.8
+
14
+
61.2
+
3.72
+
2
+
85
+
110
=
11.3
%
As such, the percentage of psyllium in the composition of Pflaumer is about 11.3%, which is in the claimed range.
As to claim 1, the claim requires a soft chewable composition. Pflaumer describes the composition as a cookie. The skilled artisan would have understood a cookie to have been a soft chewable composition.
As to claim 1, the claim requires that the psyllium is substantially free of particles greater than 250 μm. There does not appear to be evidence in Pflaumer that the psyllium is present as a particle sized greater than 250 μm.
As to claim 1, the claim requires less than 20% of a binding agent selected from a particular group. Pflaumer teaches about 0.6% to about 35% of non-pregelatinized starch, as of Plfaumer, column 4 lines 19-23. This overlaps with the required range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). Additionally, Pflaumer teaches 14 grams of pregelatinized starch in the above-reproduced table, which is about 3% starch. This is understood to read on the required less than 20% of starch.
As to claim 1, the claim requires 0.10% to about 20% of a processing aid, which is a high melting point fat having a melting point in a particular range. Pflaumer teaches a shortening which may be hydrogenated palm oil. This may be present in an amount of from about 10% to about 35%. See Pflaumer, column 6 lines 22-43. The skilled artisan would have understood the hydrogenated palm oil of Pflaumer to have had the required melting properties even if this was not explicitly disclosed by Pflaumer. In support of this position, the examiner notes the instant specification on the paragraph bridging pages 23-24, which discloses hydrogenated palm oil as a processing aid with the required properties. Products of identical chemical composition can not have mutually exclusive properties. See MPEP 2112.01(II). (In this case, the identical chemical composition being referred to by the examiner is that of the hydrogenated palm oil itself, not of the entirety of the composition.) The overlap of amounts results in a prima facie case of obviousness; see MPEP 2144.05(I), as applied above.
As to claim 1, the claim requires a carbohydrate in a particular percentage range. Pflaumer teaches sugar in a range from about 25% to about 40%, as of Pflaumer, column 5 lines 9-21. This is within the claimed range.
As to claim 1, the claim requires a humectant in a particular percentage range. Pflaumer teaches invert sugar in a range from about 25% to about 40%, as of Pflaumer, column 5 lines 9-21. This is within the claimed range. The skilled artisan would have understood invert sugar to have been a humectant in view of the instant specification on the bottom paragraph of page 24. As such, the invert sugar of Pflaumer would have read on the required humectant even if Pflaumer did not recognize the invert sugar for this purpose. Something which is old (e.g. invert sugar) does not become patentable upon the discovery of a new property (e.g. that invert sugar is a humectant), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II).
As to claim 1, the claim recites specific values of a hardness parameter at specific water activities. Pflaumer is silent as to hardness and water activity. Nevertheless, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same. See MPEP 2112(V). In this case, the reasoning provided by the examiner in support of inherency is that Pflaumer teaches a composition that is a cookie, and the skilled artisan would have expected that a cookie would have had a hardness parameter that would have rendered it a soft chewable composition. This is understood to be sufficient to shift the burden to applicant in accordance with MPEP 2112(V).
As to claims 2-3, Pflaumer teaches 28.80 grams of flour, which is about 5.3%. The examiner understands flour to be a processing aid in view of Pflaumer, column 5 lines 22-32.
As to claim 5, Pflaumer’s teaching of 11.3% psyllium is understood to read on the additional requirement of this claim.
As to claim 6, Pflaumer appears to be silent regarding the springiness parameter. Nevertheless, the composition of Pflaumer has the same elements as the claimed invention. As such, the skilled artisan would have expected that the composition of Pflaumer would have had the required springiness parameter even if this was not specifically disclosed by Pflaumer. Something which is old (e.g. the composition of Pflaumer) does not become patentable upon the discovery of a new property (e.g. the springiness parameter), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). See also MPEP 2112(V).
As to claim 7, the claim requires from about 1 g to about 45 g of psyllium. Pflaumer teaches 61.20 grams of psyllium in Example 1 on columns 15-16. Nevertheless, elsewhere in the reference, Pflaumer teaches an amount as low as 5% psyllium as of column 11 lines 65-66. The total mass of the composition of Example 1 of Pflaumer is about 540 grams, and 5% of 540 grams is 27 grams. As such, the examiner understands Pflaumer as suggesting a range from a minimum of 27 grams of psyllium to a maximum well above 61 grams of psyllium. This range overlaps with the claimed range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 7, in the alternative, Pflaumer teaches an amount of psyllium that differs from the claimed amount. 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a psyllium composition that is soft and chewable are taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable range of the amount of psyllium by routine experimentation.
As to claim 10, Pflaumer teaches ingestion of six cookies per day, as of column 16 lines 23-31.
As to claim 11, Pflaumer teaches treating gastrointestinal disorders, as of column 16 lines 23-31, which the examiner understands to read on promoting digestive wellness.
As to claim 12, Pflaumer teaches about 5-15 grams of psyllium material as of column 15 lines 18-25. This overlaps with the claimed range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). in the alternative, 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a psyllium composition that is soft and chewable are taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable range of the amount of psyllium by routine experimentation.
As to claim 13, Pflaumer teaches ingestion of cookies at three regularly spaced intervals during the day as of column 16 lines 23-31.
The examiner has not rejected claim 9 here because, while Pflaumer teaches fructose, it is not clear that the fructose of Pflaumer is liquid.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pflaumer et al. (US Patent 5,095,008) in view of Myatt et al. (US 2003/0215501 A1).
Olinger is drawn to a chewable tablet composition comprising psyllium. See the rejections above over Olinger by itself. Olinger teaches a sweetener at least as of column 7 lines 20-30. Pflaumer is drawn to a cookie comprising psyllium. See the rejections over Pflaumer by itself. Pflaumer also teaches sugars, e.g. as of column 16 lines 50-55, which appear to be used for sweetening.
Olinger does not teach liquid fructose, and Pflaumer does not appear to teach liquid fructose.
Myatt et al. (hereafter referred to as Myatt) is drawn to a chewable composition comprising a gel-forming extract of psyllium, as of Myatt, title and abstract. The composition of Myatt may include high fructose corn syrup as a sweetening agent, as of paragraph 0066 of Myatt.
Myatt is understood to differ from the claimed invention because Myatt teaches a polysaccharide isolated from psyllium seed husks. This is understood to differ from the required psyllium because the process of isolating said polysaccharide would have been expected to have retained only part of the psyllium and to have removed a different part of the psyllium.
It would have been prima facie obvious for one of ordinary skill in the art for the skilled artisan to have combined the high fructose corn syrup of Myatt with the compositions of Olinger and/or Pflaumer. Olinger is drawn to a psyllium chewable tablet composition, and includes a sweetener. Pflaumer is drawn to a cookie comprising psyllium, and also includes a sugar for sweetening. High fructose corn syrup would have been a sweetener, as taught by Myatt. As such, the skilled artisan would have been motivated to have included the high fructose corn syrup of Myatt in the composition of Olinger and/or Pflaumer in order to have predictably acted as a sweetener with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (e.g. high fructose corn syrup, as of Myatt) for incorporation into a composition (the psyllium chewable tablet of Olinger or the psyllium cookie of Pflaumer), based on its recognized suitability for its intended use (acting as a sweetener). See MPEP 2144.07. See also MPEP 2143, Exemplary Rationale A.
Response to Arguments
Applicant presented arguments regarding the previously applied rejection over Pflaumer, as of applicant’s response on 18 August 2025 (hereafter referred to as applicant’s response), page 6. Applicant has argued that Pflaumer does not teach the ingredients required by the instant claims; namely, the high melting point fat, the carbohydrate, and the humectant. The examiner disagrees. Pflaumer teaches all of these elements; see the applied rejection above.
Applicant has presented arguments regarding the previously applied rejection over Pflaumer in view of Myatt on page 7 of applicant’s response. Applicant has argued that Myatt does not overcome the deficiencies of Pflaumer. This is not persuasive because Pflaumer is not deficient, for the reasons set forth above. As no arguments are provided regarding Myatt, this rejection has been maintained.
Applicant has presented arguments regarding the Olinger reference throughout applicant’s response. These arguments have not been addressed because the rejections over Olinger have been withdrawn by the examiner. Additionally, applicant’s arguments regarding the previously applied anticipation rejection over Pflaumer has have not been addressed substantively in view of the withdrawal of the previously applied anticipation rejection over Pflaumer.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612