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 .
Claim(s) 1-10 are pending.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on September 20, 2024 and October 25, 2024 are being considered by the examiner. However, non-patent literature (NPL) #11 in IDS from September 20, 2024 were lined through and not considered. The information disclosure statement filed September 20, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The signed IDS forms are attached with the instant office action.
Specification
The abstract of the disclosure is objected to because it is not a single paragraph preferably within the range of 50 to 150 words in length. The abstract of the disclosure is roughly 38 words. A corrected abstract of the disclosure within the preferred ranges disclosed is required. See MPEP § 608.01(b).
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 10 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 10 is indefinite because it is unclear what “skeletal muscle homeostasis” means; it is unclear how “skeletal muscle homeostasis” is measured and how the applicant determines that “skeletal muscle homeostasis” has been restored. The specification does out provide a clear explanation of the term and thus, the metes and bounds of the claim are unclear.
Claim Rejections - 35 USC § 102
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) 1-3, 8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Civilette (JP 2021506230 A – English translation provided).
Civilette teaches a composition that comprises spermidine (abstract and claim(s) 1-3). Civilette teaches [that] the composition can induce autophagy in muscle, such as skeletal muscle (par. 0076). Civilette teaches [that the composition can be delivered] intramuscular[ly] (par. 0064). Civilette teaches [that] the recipient of administration can be an individual with sarcopenia (abstract). Civilette teaches [that the patient has at least one life-threatening condition selected from] homeostasis failure (par. 0078-0079).
The Civilette reference does not explicitly teach treating skeletal muscle atrophy however, sarcopenia is a type of skeletal muscle atrophy and therefore, the Civilette reference meets the claim limitations of claim(s) 2-3 and 8. In addition, the Civilette reference does not explicitly teach restoring skeletal muscle homeostasis however, Civilette does teach that the composition is good for administering to a subject who has homeostasis failure, thus, based on examiners interpretations means that the Civilette reference would also restore skeletal muscle homeostasis when a subject is administered the composition thus meeting the limitations of claim 10 in the present invention.
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.
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, 4-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Civilette (JP 2021506230 A – English translation provided) in view of Rinsch (WO 2014004902 A2) and SantAnna et al (Thieme, (Year: 2021), vol. 57, issue. 01, pp. 1-13).
The teachings of Civilette are above.
The Civilette reference does not teach that the subject has skeletal muscle damage which is a muscle strain, is due to myogenic disease and that the skeletal muscle is enhanced by suppression of degradation or promotion of synthesis of skeletal muscle (as stated within claim(s) 4-7 and 9 of the present invention).
Rinsch teaches [that the composition of the present invention that includes spermidine can be used for] muscular dystrophies ([muscular dystrophy is a type of myopathy; myopathy is also synonymous with the term myogenic]) [which] are a group of genetic, hereditary muscle diseases characterized by defects in muscle proteins. These defects result in progressive skeletal muscle damage (page 2, line 25 and page 23, lines 2-8).
SantAnna et al teaches [that] muscle injuries can be caused by stretching (abstract).
The composition as taught by Civilette can be modified to include additional teachings from Rinsch and SantAnna et al such as that the composition that contains spermidine can be used to treat muscular dystrophy (which is a myogenic disease) which also results in skeletal muscle damage as taught by Rinsch with further knowledge that over-stretching can cause skeletal muscle damage in the form of a muscle strain as taught by SantAnna et al. One of ordinary skill in the art would reasonably expect that overstretching can contribute to skeletal muscle damage thus making Civilette’s composition sufficient for treating a subject in need that is interested in enhancing skeletal muscle that encompasses treating skeletal muscle damage, muscle strain and types of myogenic diseases.
Furthermore, although the combination of the aforementioned references does not teach that the skeletal muscle is enhanced by suppression of degradation or promotion of synthesis of skeletal muscle (as stated within claim 7 of the present invention), it is intrinsic that ingestion of Civilette’s composition would have the intended effect. Moreover, the combination of the aforementioned references show that too, for example, if the composition that contains spermidine can treat sarcopenia, then that means that the composition is repairing components and removing unnecessary and/or damaged components within the muscles that would result in the skeletal muscle building back lost tissue as a result of sarcopenia thus meeting the claim limitation of claim 7 of the present invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
