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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed November 7, 2025 in reply to the First Office Action on the Merits mailed July 1, 2025. Claims 22, 23, and 26-39 have been amended; claims 1-21, 25, and 41 have been canceled; and claim 43 has been newly added. Claim 40 has been withdrawn. Claims 22-24, 26-39, 42, and 43 are under examination in the application.
Withdrawal of Prior Objection - Abstract
The abstract of the disclosure has been satisfactorily amended. Therefore, the objection to the abstract presented in the First Office Action on the Merits mailed July 1, 2025 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 112(d)
Claims 30 and 31 have been satisfactorily amended. Therefore, the 35 USC 112(d) rejection presented in the First Office Action on the Merits mailed July 1, 2025 is hereby withdrawn.
Claim Objections
Claims 22, 24, 27, and 29 are objected to because of the following:
i) In claim 22, there should be a comma between “solid” and “oral”. There should be a comma between “dry” and “homogeneous”. There is an extraneous colon between “wherein” and “the dry”.
ii) In claim 24, which depends from claim 22, the expression “has or is conditioned to have” should simply be “has”, consistent with claim 22.
iii) In claim 27, there should be a comma between “solid” and “oral”.
iv) In claim 29, (i), there should be a hyphen between “delayed” and “release”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 33 is 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 33 recites at least one broad limitation (e.g. dietary supplement) together with at least one narrower limitation (e.g. herbal supplement) that falls within the scope of the broad limitation in the alternative in the same claim, which is indefinite.
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 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 22, 23, 26-38, 42, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Carpanzano et al. (U.S. Patent Application Pub. No. 2016/0361261), in view of Anonymous (Basicmedical Key [online]; 2016).
Applicant Claims
Applicant’s elected subject matter is directed to a method of preparing a tablet comprising mixing a dietary supplement (i.e. the active) with a dry, homogeneous mixture comprising a protein (e.g. natural protein) powder and a polysaccharide (e.g. carrageenan) powder, and “formulating the mixture into a tablet; wherein the tablet comprises 5-50 wt% of the protein/polysaccharide mixture and further comprises microcrystalline cellulose; wherein the polysaccharide powder has e.g. a Hausner ratio greater than 1.31 and/or e.g. an angle of repose of greater than 35; and wherein the weight ratio of the polysaccharide powder to protein powder is 1:20 to 1:2.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Carpanzano et al. disclose a method of making e.g. a tablet comprising mixing e.g. a nutritional supplement (i.e. the active) with e.g. a dry mixture of powders comprising e.g. microcrystalline cellulose, a protein such as e.g. zein (i.e. a natural protein), and a polysaccharide such as e.g. carrageenan, wherein the mixture should be homogeneous and flowable; and compressing the resulting mixture to form a tablet; wherein the tablet can comprise 1-80 wt% of the protein/polysaccharide mixture, or about 0.1-20 wt% of each of the protein and the carbohydrate (i.e. as release-modifying agents) (paragraphs 0011, 0023, 0025, 0053, 0054, 0057, 0059, 0061, 0088, 0114, 0126, 0136, 0143, 0163, 0169, 0171, 0172, 0181, 0182, 0184, 0185).
Anonymous discloses that powders are flowable with e.g. a Hausner ratio of 1.00 to 1.34 and an angle of repose of <25 up to about 45.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Carpanzano et al. do not explicitly disclose that the polysaccharide powder has a Hausner ratio greater than 1.31 and/or an angle of repose of greater than 35. This deficiency is cured by the teachings of Anonymous.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Carpanzano et al. and Anonymous, outlined supra, to devise Applicant’s presently claimed method.
Carpanzano et al. disclose a method of making e.g. a tablet comprising mixing e.g. a nutritional supplement (i.e. the active) with e.g. a dry mixture of powders comprising e.g. microcrystalline cellulose, a protein such as e.g. zein (i.e. a natural protein), and a polysaccharide such as e.g. carrageenan, wherein the mixture should be homogeneous and flowable; and compressing the resulting mixture to form a tablet. Since Anonymous discloses that powders are flowable with e.g. a Hausner ratio of 1.00 to 1.34 and an angle of repose of <25 up to about 45, one of ordinary skill in the art would thus be motivated to employ a carbohydrate powder (as well as a protein powder) with a Hausner ratio of 1.00 to 1.34 and an angle of repose of <25 up to about 45, with the reasonable expectation that the resulting homogenous mixture of powders will be flowable.
Furthermore, the phenomenon of complex coacervation of proteins and anionic polysaccharides, such as e.g. carrageenan (i.e. an oil-insoluble polysaccharide) is well known in the art, as is the ability of e.g. protein-carrageenan coacervates to encapsulate oils, as well as the advantages of complex coacervates for controlled drug delivery upon oral administration (see e.g. de Kruif et al. Curr Opin Colloid Interface Sci. 2004; 9: 340-349) and Devi et al. Polym Bull. 2010; 65: 347-362). One of ordinary skill in the art, in following the teachings of the cited prior art, would arrive at a composition that is the same as Applicant’s presently claimed composition. Since the composition is the same, the properties must be the same as well, including the ability of the composition to form a protein/polysaccharide complex coacervate in situ upon immersion in gastric fluid, with all the properties described in the claims for the complex coacervates thus formed, e.g. sustained drug delivery, etc.
Carpanzano et al. disclose that the tablet can comprise 0.1-20 wt% of each of the protein and the polysaccharide. With e.g. 20wt% protein and 10wt% polysaccharide, the protein:polysaccharide weight ratio is 2:1.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered but they are not persuasive.
i) Applicant contends that “limitations of the presently claimed invention, namely the polysaccharide powder, prior to blending, having a Carr compressibility index greater than 25%, in the context of an oral delivery system, was determined to be non-obvious over Carpanzano in view of Anonymous in…parent application U.S. Pat. App. No. 17/604,282”; that “gastric protection and delay of active ingredient release was only observed in formulations containing a polysaccharide having a high Carr index” and “polysaccharides having a high Carr index are thought to produce stronger protein/polysaccharide coacervates leading to enhanced gastric protection”; that “formulations...all have a Carr index less than 25% and all exhibit poor gastric protection in disintegration”, and “a polysaccharide powder having the specific Carr index would confer gastric protection for the claimed process”.
The Examiner however, would like to point out the following:
1. In stark contrast to Applicant’s assertion, the presently claimed method does not require that the polysaccharide powder, prior to blending, has a Carr compressibility index of greater than 25% at all. On the contrary, this feature is merely optional.
2. Applicant has effectively admitted on the record that “gastric protection and delay of active ingredient release was only observed in formulations containing a polysaccharide having a high Carr index”, and that “formulations...all have a Carr index less than 25% and all exhibit poor gastric protection in disintegration”.
3. Applicant is advised to amend the present claims to require the limitation that the polysaccharide powder, prior to blending, necessarily has a Carr compressibility index greater than 25%, and to include all other limitations present in the allowed product claims from parent U.S. Appl. No. 17/604,282 (i.e. such that the present claims are directed to a method of making a patented product) to put the present claims into condition for allowance. In the meantime, the prior art rejection has been withdrawn with respect claims 24 and 39.
ii) Applicant contends that the 37 CFR 1.132 Declaration of Loic Henaux, Ph.D. discloses that “Applicant found no reason to measure the Carr index of the powder mixture after blending because this has no pertinence on the ability of the process…to provide gastric protection”; that “nowhere in Anonymous…is it taught or suggested to the person of ordinary skill in the art to add a polysaccharide powder having a Carr index of greater than 25% prior to blending to a powder mixture to increase the Carr index of the final blended powder mixture”; that “Applicant provided evidence that shows that blending two powders – one having a high Carr index and the other having a low Carr index – leads to unpredictable results” with “examples of unpredictability in the art pertain to simple mixtures containing only two ingredients”; that “it is unfathomable that a person of ordinary skill in the art would consider all the ingredients described by Carpanzano, choose to focus on a single type of ingredient…at the exclusion of all others…and hope to achieve predictable results in terms of increasing the Carr index of the blended powder mixture”; that “the Carr index of the powder mixture after blending has no pertinence on the ability of the process of the presently claimed invention to provide gastric protection”; that “the introduction of a polysaccharide having a high Carr index did not increase the Carr index of the formulation”; that “both rapid disintegration…and enhanced gastric protection…was observed in formulations having a high…or low…Carr index after blending”; moreover, “Carpanzano teaches away from combination with Anonymous”; that “the object of Carpanzano is…a free-flowing powder that can be compressed into tablets” and “in contrast, Anonymous itself at Table 11.1…describes that powder mixtures having a Carr index of greater than 25% have poor flowability” and thus “a person of ordinary skill in the art…would not seek to increase the Carr index of the powder mixture…because doing so would undoubtedly decrease flowability”.
The Examiner, however, would like to point out the following:
1. Again, as already noted, supra, “a polysaccharide powder having a Carr compressibility index of greater than 25% prior to blending” is simply not a required limitation that must be addressed. All of Applicant’s arguments with respect to a polysaccharide powder having a specific Carr compressibility index are not necessarily relevant since Applicant is merely arguing about an optional limitation.
2. In stark contrast to Applicant’s assertion, Carpanzano absolutely does not “teach away” from combination with Anonymous. Its unclear on what grounds Applicant has formulated this conclusion. Indeed, even if Carpanzano desires powders with good flowability, Anonymous expressly addresses the requisite characteristics of powders with good flowability.
3. Contrary to Applicant’s position, the prior art rejection is not based on e.g. selecting a polysaccharide powder with e.g. a high Carr compressibility, but selecting all other powders in the mixture with a low Carr compressibility index. It’s unclear where this assertion comes from. The general idea is to select the desired properties for all the powder components, including the polysaccharide powder.
For the foregoing reasons, the 35 USC 103 rejections are hereby maintained.
Conclusion
No claims are 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617