DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 6-11, 15-20, 27, 29-30, 32, and 35-36 are withdrawn.
Claims 1, 3, 5, 12-14, 21-22, and 25 are pending and represent all claims currently under consideration.
Priority
This application is a 371 of PCT/US2023/011740, which claims priority to PRO 63/303,757.
Claims 1, 3, 5, 12-14, 21-22, and 25 are considered to have an effective filing date of 01/27/2022.
Election/Restrictions
Applicant’s election without traverse of Group I and the species “biguanide” in the reply filed on 06/29/2026 is acknowledged.
Claims 27, 29-30, 32, and 35-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and claims 6-11 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/29/2026.
Information Disclosure Statement
The information disclosure statement filed 07/26/2024 has been considered.
Claim Objections
Claims 1, 13-14, and 25 are objected to because of the following informalities. Appropriate correction is required.
Regarding claim 1, “polyethylene” should read “a polyethylene”, and “polyethylene copolymer” should read “a polyethylene copolymer”.
Specification
The use of the terms Millipore Sigma, PerkinElmer, Living Image, Sigma-Aldrich, Molecular Devices, SoftMax, Jackson Laboratories, SpectraMax, Seahorse, MILLIPLEX, Luminex, xPONENT, RayBiotech, and mitoSOX, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig 4A, 4B, 4C, 9A, and 9B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 5 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.
Regarding claim 5, it is unclear what the metes and bounds of the claim are, because the claim requires multiple different ranges. For the purpose of examining the prior art, it is the Examiner’s interpretation that “and” was intended to read “or”, and that each range is an alternative limitation.
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.
Claims 1, 3, 5, 12-14, 21-22, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar (US 20160213694 A1), further in view of Hanes (US 20200246274 A1; IDS reference, 07/26/2024), and as evidenced by PubChem (Metformin).
Regarding claim 1, Kumar teaches a pharmaceutical formulation for treating diabetes and inflammation (Kumar, page 2, paragraphs 0010-0011) comprising a therapeutically effective amount of an anti-diabetic drug (Kumar, claim 9), which can be metformin (i.e., a biguanide as defined by the instant claim 13; Kumar, claim 10). Kumar further teaches the presence of a polymeric coating (Kumar, page 14, paragraph 0150), and exemplifies a coating comprising polyethylene glycol (Kumar, page 33, paragraph 0310). Kumar teaches in some embodiments, the beads (i.e., the composition) comprise 12-25% of the active agent by weight (Kumar, page 17, paragraph 0188), which lies within the claimed weight range. Kumar teaches the formulation may be in a form of a liquid suspension or solution (Kumar, page 13, paragraph 0145), and teaches active agents can be dissolved at concentrations of 1 mg/ml in such formulations (Kumar, page 22, paragraph 0224). As evidenced by PubChem, Metformin has a molecular wight of 129.16 g/mol, which would result in a molar concentration of about 7.7 mM and is within the claimed range.
Hanes teaches a system for treating inflammation (Hanes, abstract) wherein a composition comprises a polymeric coating (Hanes, pages 20-21, paragraph 0168), and teaches exemplary polymers include polyethylene glycol and polyethylene (Hanes, page 19, paragraph 0157).
Kumar and Hanes are both considered to be analogous to the claimed invention, because Kumar, Hanes, and the instant invention are in the same field of compositions for treating inflammation. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the polyethylene glycol coating of Kumar for a polyethylene coating as taught by Hanes to be a reasonable alternative, because Kumar teaches polymer based systems as a type of controlled release system and states that many other types are known to those of ordinary skill in the art and are suitable for use with the active agents of the present formulation (Kumar, page 19, paragraph 0206).
Regarding claim 3, Kumar and Hanes together teach all of the elements of the current invention as applied to claim 1. As above, Kumar teaches the formulation may be in a form of a liquid suspension or solution (Kumar, page 13, paragraph 0145), and teaches active agents can be dissolved at concentrations of 1 mg/ml in such formulations (Kumar, page 22, paragraph 0224). As evidenced by PubChem, Metformin has a molecular wight of 129.16 g/mol, which would result in a molar concentration of about 7.7 mM and is within the claimed range.
Regarding claim 5, Kumar and Hanes together teach all of the elements of the current invention as applied to claim 1. As above, Kumar teaches in some embodiments, the beads (i.e., the composition) comprise 12-25% of the active agent by weight (Kumar, page 17, paragraph 0188), which overlaps the claimed range of about 0.02 wt% to about 21 wt%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 12, Kumar and Hanes together teach all of the elements of the current invention as applied to claim 1. As above, Kumar teaches a therapeutically effective amount of an anti-diabetic drug (Kumar, claim 9), which can be metformin (i.e., a biguanide as defined by the instant claim 13; Kumar, claim 10).
Regarding claim 13, Kumar and Hanes together teach all of the elements of the current invention as applied to claim 12. As above, Kumar teaches a therapeutically effective amount of an anti-diabetic drug (Kumar, claim 9), which can be metformin (i.e., a biguanide from the claimed list; Kumar, claim 10).
Regarding claim 14, Kumar and Hanes together teach all of the elements of the current invention as applied to claim 13. As above, Kumar teaches in some embodiments, the beads (i.e., the composition) comprise 12-25% of the active agent by weight, and teaches optimization work typically involves lowering loading levels (Kumar, page 17, paragraph 0188). Therefore, it would be reasonable for one of ordinary skill in the art to optimize the amount of active agent to be lower than 12% as suggested by Kumar, and it would be reasonable to expect such an optimization could result in an amount which is about 11 wt% or lower as claimed.
Regarding claim 21, Kumar and Hanes together teach all of the elements of the current invention as applied to claim 1. Kumar teaches many types of controlled release systems are known to those of ordinary skill in the art and are suitable for use with the present formulation, including polymer based systems (Kumar, page 19, paragraph 0206). Hanes teaches polymer systems to include systems in which the composition is contained within the matrix (i.e., the active ingredient is incorporated into the polymer system; Hanes, page 20, paragraph 0161). It would have been prima facie obvious to one of ordinary skill in the art to utilize a polymer system as specified by Hanes, because Kumar teaches such systems are known in the art.
Regarding claim 22, Kumar and Hanes together teach all of the elements of the current invention as applied to claim 1. As above, Kumar teaches many types of controlled release systems are known to those of ordinary skill in the art and are suitable for use with the present formulation, including polymer based systems (Kumar, page 19, paragraph 0206). Kumar further teaches in some embodiments the active agent is spray layered on complex particles with enteric coatings (i.e., the active ingredient is coated onto the polymer coating; Kumar, page 18, paragraph 0195).
Regarding claim 25, Kumar and Hanes together teach all of the elements of the current invention as applied to claim 1. Kumar teaches suitable filling agents to include calcium phosphate (Kumar, page 15, paragraph 0173).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHASITY P JANOSKO whose telephone number is (703)756-5307. The examiner can normally be reached 7:30-3:30 ET.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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