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 .
CONTINUING DATA
This application is a 371 of PCT/US2023/011241 01/20/2023
PCT/US2023/011241 has PRO 63/301,966 01/21/2022
Claims 1-4, 6-10, 12-18, 20-23 are pending.
Claim Interpretation
The claims recite a method of “inducing regeneration of cardiomyocytes” or “improving cardiac repair.” These limitations are in the preamble. MPEP 2111.02 states that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In this instance, the preambles merely state the purpose or intended use of the invention and the body of the claim fully sets forth all the limitations of the claimed invention. Thus, the preamble is not limiting. If the preamble were limiting, MPEP states that to satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. Thus, if Applicant successfully argues that the preamble is limiting in this instance, a prior art structure which is capable of performing the intended use meets the claim.
Claims 6 and 14-17 recite “wherein” clauses which state the intended result of the step positively recited. MPEP 2111.04 states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Thus, the “wherein” clauses of claims 6 and 14-17 are not given weight.
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.
Claim(s) 1-2, 6-8, 12-17, 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woodcock (US 5929039).
Woodcock teaches a method wherein ischemic rat hearts were perfused with neomycin, gentamicin, or streptomycin. See Table 1. This method anticipates claims 1, 2, and 6.
Woodcock teaches a method wherein ischemia was induced in rats and gentamicin was infused at 2.5-10 mg/Kg/min throughout the process. This method anticipates claims 7-8, 12-17, and 20-21.
Woodcock also teaches preventative therapy to reduce the likelihood of cardiac arrhythmia after myocardial infarction, comprising administering an aminoglycoside. The aminoglycoside is gentamicin, tobramycin, amikacin, netilmicin, kanamycin, streptomycin, or neomycin. Column 3 and first paragraph of column 4. The route of administration is oral, parenteral or buccal, and the effective amount is 1-100 mg/kg. Column 4. The subject is most preferably a human. Column 2, second to last paragraph. This method anticipates claims 7-8, 13-18.
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) 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodcock (US 5929039).
Woodcock teaches as set forth above, treatment using one of several aminoglycoside antibiotics. Woodcock does not teach treatment using two aminoglycosides.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out Woodcock’s method using a combination of two antibiotics. Woodcock teaches several antibiotics which can be used, and the skilled artisan would have expected a combination of antibiotics would also be effective because each is individually effective. See MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.”
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodcock (US 5929039).
Woodcock teaches as set forth above, but does not teach a schedule of three times per day to about every other week. Woodcock’s range of 1-100 mg/kg overlaps with the claimed range of 50-500 mg/kg/day.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer Woodcock’s aminoglycoside three times per day to every other week because Woodcock teaches that the administration is to prevent arrhythmia caused by infarction. The skilled artisan would have arrived at a dosing schedule using routine optimization and the results would have been predictable because the purpose of Woodcock’s method is known and mechanism of action is known. MPEP 2144.05 states that “[W]here 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.” It would have been obvious to one of ordinary skill in the art to administer Woodcock’s aminoglycoside in the claimed amount because the prior art amount and the claimed amount overlap. MPEP 2144.05 states that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
It is noted that Woodcock’s method is intended for preventing arrhythmia after infarction and the claims are drawn to inducing regeneration of cardiomyocytes or improving cardiac repair. MPEP 2144 states that the reason or motivation to modify the reference may suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”
Conclusion
Claims 1-3, 6-9, 12-18, 20-23 are rejected. Claims 4 and 10 are objected to as depending from a rejected base claim. Claims 4 and 10 were not rejected over Woodcock because Woodcock does not teach a combination of neomycin and paromomycin. The current specification teaches that the combination of paromomycin and neomycin was particularly effective [0094].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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