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 .
Priority
The instant application was filed 17 November 2023 and is the national stage entry of PCT/IB2022/055412 filed 10 June 2022. The Applicant claims priority to foreign application IT102021000015239 filed 10 June 2021. An English copy of the foreign document has not been provided. Therefore, the effective filing date of the instant application is 10 June 2022.
Election/Restrictions
Claims 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 23 December 2025.
Applicant's election with traverse of Group III (claims 13, 14, 16-19) in the reply filed on 23 December 2025 is acknowledged. The traversal is on the ground(s) that there is no serious search burden. This is not found persuasive because the different inventions would require numerous search queries and classification searches.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
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 13, 14, 16-19 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.
Regarding claim 18, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 13, 14, 16-19 depend from withdrawn claim 1, which also recites “preferably.”
Claim 14 recites “belching, flatulence, distension or swelling of the abdomen, abdominal pain, and meteorism.” It is unclear if the patient has all of these symptoms or if this is a list of alternatives. The Applicant should clarify and correct to “or” if intended to be alternative ailments.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 13, 14, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (CN 112826872 A).
Li teaches a composition comprising activated carbon and adsorbed (entire teaching; pg. 4, para. 11) chitosan (pg. 4, para. 1), where the chitosan is deacetylated to a degree of 50-100% (pg. 4, para. 12). The composition is used as a method for expelling toxins and harmful gas from the gastrointestinal tract and can be prepared as a capsule, pill, tablet, or granule (abs; entire teaching), addressing claims 13 and 14. Activated carbon having a strong adsorption capacity, especially for organic substances, is interpreted as chitosan inherently adsorbing onto the activated carbon (pg. 4, para. 11; pg. 7, para. 2). The granule (abs) or powder particle may have a size of 0.5-1 mm (pg. 13, para. 2). It is interpreted that the majority of or all of the particles have a size in this range, which is therefore capable of passing through an aperture size of 1.19 mm, addressing claim 18. The components in the composition capable of reducing cholesterol (pg. 6, para. 5) is interpreted as addressing claim 19.
Claim(s) 13, 14, 16, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (CN 112826872 A) and JP 3585043 B2.
In regards to claim(s) 13, 14, 18, and 19, Li, as applied supra, is herein applied in its entirety for its teachings of a composition comprising activated carbon and adsorbed chitosan to treat gastrointestinal conditions.
Li does not specifically teach the specific surface area or pore volume in claim 16.
JP ‘043 teaches a composition comprising activated carbon with a specific surface area of 800-2000 m2/g and a pore volume of 0.2-1 mL/g (pg. 2, para. 10).
Since Li does not specifically teach the specific surface area or pore volume in claim 16, one of ordinary skill in the art would have been motivated to use the teaching from JP ’043 with a reasonable expectation of success. JP ‘043 teaches that compositions with these specific surface area and pore volume ranges result in fewer side effects and better adsorption performance (pg. 2, para. 8). A skilled artisan would have been motivated to combine the teachings for the additional benefit of better adsorption and fewer side effects in Li’s composition to treat gastrointestinal issues, therefore leading to an improved product.
Claim(s) 13, 14, 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (CN 112826872 A), JP 3585043 B2, Liu (Low Molecular Weight Chitosan Accelerates Glucagon-like Peptide-1 Secretion in Human Intestinal Endocrine Cells via a p38-Dependent Pathway, Journal of Agricultural and Food Chemistry, 2013).
In regards to claim(s) 13, 14, 18, and 19, Li and JP ‘043, as applied supra, is herein applied in its entirety for its teachings of a composition comprising activated carbon and adsorbed chitosan to treat gastrointestinal conditions.
Li does not specifically teach a molecular weight for chitosan in claim 17.
Liu teaches that low molecular weight chitosan (around 2 kDa) had better hypolipidemic effect and better binding capacity (pg. 4855, left column).
Since Li does not specifically teach a molecular weight for chitosan in claim 17, one of ordinary skill in the art would have been motivated to use the teaching from Liu with a reasonable expectation of success. Liu teaches that low molecular weight chitosan (around 2 kDa) had better hypolipidemic effect and better binding capacity. A skilled artisan would have been motivated to combine the teachings for the additional benefit of better binding capacity and a better hypolipidemic effect in Li’s composition to treat gastrointestinal issues and high cholesterol, therefore leading to an improved product.
In regards to the amounts of activated carbon and chitosan in claim 17, Li teaches chitosan in various amounts and quantities, such as 5 parts, 15 parts, 10-60 parts, 10-80 parts, or 20-70 parts (throughout Examples and Embodiments). Li also teaches activated carbon in various amounts and quantities, such as 1 part, 5 parts, 10 parts, 20, parts, or 25 parts (throughout Examples and Embodiments). That being said and in lieu of objective evidence of unexpected results, the amounts of components can be viewed as a variable that achieves the recognized result of successfully making the activated carbon and chitosan composition, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable range of amounts can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of chitosan and activated carbon as nonobvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613