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 .
The examiner acknowledges receipt of response to restriction requirement filed 11/03/2025 and IDS filed 10/25/2023.
Original claims 1-22 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, in the reply filed on 11/03/2025 is acknowledged.
Claims 14-22 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Claims 1-13 are under consideration.
Priority
This application claims benefit of 63/342,292 filed 05/16/2022.
Information Disclosure Statement
The IDS filed 10/25/2023 has been considered by the examiner.
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 9 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 9 has included cytochrome and cytochrome c-553 in parenthesis. Each of cytochrome and cytochrome c-553 appear to be referring to the same D-lactate dehydrogenase. It appears that the claim is attempting to limit the D-lactate dehydrogenase to broad cytochrome and then to a specific cytochrome in the same claim. Further, glyoxalase is placed in parenthesis after D-lactate dehydratase and it is unclear if the claims is intending to limit the D-lactate hydratase to glyoxalase 3.
Correction is respectfully requested.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mathiowitz et al., (US 20210162013 A1).
Claim 1 lowers blood glucose by administering L-lactate monomer to a mammal. The “which inhibits or at least reduces D-lactate transport across the intestinal barrier” is the effect of the administered composition comprising the L-lactate monomer. L-lactate monomer is defined in claim 2 to be poly-DL-lactide or poly-L-lactide.
Mathiowitz discloses administering GLP-1 or analogues, which meets the limitation of therapeutic agent of claim 11 and GLP-1 of claim 12, to a mammal to reduce fasting blood glucose (see the whole document with emphasis on the abstract; paragraphs [0201]-[0204], [0232]-[0235]); the GLP-1 or the GLP-1 analogue is entrapped in one or more biodegradable polyesters namely poly-L-lactic acid, poly-D-lactic acid, poly-D,L-lactic acid, poly-L-lactide, poly-D-lactide, and poly-D,L-lactide (paragraphs [0009], [0082]), which meets the limitation of lactate monomer of claim 1 and specific monomer of claims 2 and 5. Mathiowitz teaches that GLP-1 encapsulated in PLA, PIN/PLA GLP-1) is effective in reducing blood glucose levels in diabetic mice (paragraph [0088]). With regards to “which inhibits or at least reduces D-lactate transport across the intestinal barrier,” it is the administered composition that effects the inhibition or reduction of the D-lactate transport across.
Therefore, for claims 1, 2, 5, 11 and 12, administration of GLP-1 (examined claims 11 and 12) encapsulated in poly-D,L-lactide and/or poly-L-lactide (examined claims 1 and 2 and 5) reduces or lowers blood glucose teaches the elements of the claims.
Mathiowitz teaches all the elements of claims 1-2, 5 and 11-12.
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.
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) 1-2, 3-4, 7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mathiowitz et al., (US 20210162013 A1) as applied to claims 1 and 2.
Claims 3 and 4 depend on claim 2 which depends of claim 1.
Claims 1 and 2 have been described above as being anticipated by Mathiowitz.
Mathiowitz teaches that the average molecular weight of the polymer ranges from about 1 kDa to about 200 kDa and up to specific polymers having molecular weights of about, 1 kDa, 2 kDa, 3 kDa, 4 kDa, 5 kDa, 6 kDa, 7 kDa, 8 kDa, 9 kDa, 10 kDa, 11 kDa and 12 kDa (paragraph [0091]). Molecular weight of lactide is 144.12 g/mole or Da
(https://en.wikipedia.org/wiki/Lactide#:~:text=All%20lactides%20are%20colorless%20or%20white%20solids.,has%20the%20formula%20%5BCH(CH%203)CO%202%5D%202)
Thus, for a 7 kDa, the number of units of lactide is 7000/144.12 = about 48 monomers; for a 9 kDa, the number of lactides units of lactide is 9000/144.12 = about 62 monomers. Therefore, lactides monomers in the polylactide of Mathiowitz ranges from about 21 (3 kDa) to 83 (12 kDa) and these ranges are points within the claimed range.
Mathiowitz differs from claims 3 and 4 in that Mathiowitz does not specifically state the number of units of lactide monomers of the polylactide. However, before the effective date of the invention the artisan guided by the teachings of Mathiowitz would reasonably expect that the number of the lactide units of the disclosed polylactides would be calculated to predictably lie within the claimed range.
For claim 7, Mathiowitz teaches that polymer concentrations in the composition is at 0.01 to about 50% (paragraph [0092]). Mathiowitz differs from claim 7 by not teaching the amount of the polymer administered with respect to the weight of the mammalian subject. However, it is reasonable to expect that the artisan would use the polymer in effective amounts in relation to the wight of the mammalian subject (paragraph [0203]) that would be predictably sufficient to alleviate symptoms.
For claim 13, Mathiowitz contemplates using hydrogel (paragraph [0108]).
Therefore, Mathiowitz renders claims 3-4, 7 and 13 prima facie obvious.
Claim(s) 1 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mathiowitz et al., (US 20210162013 A1), as applied to claim 1, and as evidenced by Tayama Kenji (JP 2001204440 A1, PE2E Trans, using PE2E translation).
Claim 6 depends on claim 1. Claim 1 has been described above to be taught by Mathiowitz.
Mathiowitz teaches that the polymers also include copolymers of polyethylene glycol (PEG) and the polyester and PLA-PEG is named as pegylated polymer (paragraph [0085]). Mathiowitz does not identify PEG as non-digestible. However PEG is known to be non-digestible as evidenced by example 2 of Tayama Kenji (JP 2001204440 A1, PE2E Trans). The composition of Mathiowitz is in particulate form comprising polymeric particles encapsulating the GLP-1 and the particles are microparticles ranging in sizes of less than 1000 micron (paragraphs [0024], [0029]-[0039]). It is the non-digestible microparticles that promote dwell time in the intestinal lumen.
Therefore, before the effective date of the invention the artisan would reasonably expect that the pegylated polyester PLA-PEG, which is PLA bound to nondigestible moiety, administered to the mammalian subject would reasonably promote dwell time in the intestinal lumen as it is the non-digestible microparticles that promote dwell time in the intestinal lumen.
Thus, Mathiowitz as evidenced by Tayama Kenji renders claim 6 prima facie obvious.
Claim(s) 1 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mathiowitz et al., (US 20210162013 A1), as applied to claim 1, in view of Talasniemi et al., “Analytical investigation: Assay of D-lactate in diabetic plasma and urine” in Clinical Biochemistry 41 (2008) 1099-1103 (submitted in 1449), and Borisovich (RU 2736783 CI) and Kyung Pyo Kang et al., “D-Lactic Acidosis in Humans: Review of Update” in Electrolyte and blood pressure 4:53-56, 2006.
Claim 8 depends of claim 1. Claims 9 and 10 depend on claim 8.
Mathiowitz has been described above to teach all the elements of claim 1.
For claim 8, Mathiowitz does not teach that the composition used to lower/reduce blood glucose level in diabetic patients contains an agent that promotes metabolism of D-lactate.
Claim 10 narrows the agent in claim 8 to D-lactate metabolizing enzyme. Claim 9 narrows the agent in claim 8 to D-lactate dehydrogenase.
Talasniemi teaches that D-Lactate concentration is significantly increased in the blood of diabetic animals and patients leading to acidosis, first full paragraph, left column of page 1100.
Borisovich teaches that the accumulation of lactic acid leads to D-lactate acidosis (lines 7 and 8 of the first full paragraph at page 7 of the Eng translation).
Kyung Pyo Kang teaches that D-lactate dehydrogenase metabolizes D-lactate (second full paragraph of left column of page 54 of Kyung Pyo Kang).
Therefore, before the effective date of the invention, the ordinary skilled artisan would be motivated to include D-lactate dehydrogenase to the composition of Mathiowitz with the reasonable expectation of predictably metabolizing D-lactate to relieve D-lactate acidosis; D-lactate accumulates in diabetic patients causing acidosis. D-lactate dehydrogenase is a D-lactate metabolizing enzyme meeting the limitation of claims 10 and 8 and the D-lactate dehydrogenase enzyme of claim 9.
Therefore, Mathiowitz in combination with the teachings of Talasniemi, Borisovich and Kyung Pyo Kang renders claims 8-10 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613