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 .
Status of the Claims
Claims 1, 4-6, and 8-15 are pending.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to application PCT/KR2021/015026, filed on 10/25/2021, and further claims priority to FOR application numbers KR10-2021-0065626 and KR10-2021-0142645, filed 5/21/2021 and 10/25/2021, respectively.
Information Disclosure Statement
All references from IDS(s) received on 2/21/2024 have been considered unless marked with a strikethrough.
Elections/Restrictions
Applicant’s election of species of muscular atrophy elected with traverse in the reply filed on 6/18/2026 is acknowledged.
Applicants reason for traversal includes the plurality of diseases share common pathophysiological characteristics and the treatment of the diseases is a single inventive concept because inotodiol provides a common therapeutic mechanism of treating these pathological conditions.
This is not found persuasive because: (1) since the instant application is a national stage entry of
PCT, the Examiner, who provided an explanation that the diseases do have different etiology and may respond differently to treatment, is within their own rights to determine unity and is not held to the standard of WIPO, and (2) the Examiner argues that the Applicant lists multiple “pathological conditions” which do not all universally apply to every disease listed and also does not mention a mechanism of action or explicit target for inotodiol to be used as treatment for all these diseases.
Therefore, the requirement is deemed proper and is therefore made FINAL.
Claims 1, 4-6, and 8-15 will be examined on their merits.
No anticipatory art was found of the elected species, however an obviousness-type 103 rejection can be found below.
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.
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.
Claims 1, 4-6, 9-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Maza, P. et al. (Front. Immunol., 2021, Sec. Nutritional Immunology, 12; “Maza”, published May 12, 2021) in further view of Feghali, R. et al. (Gene Expr. 2018 Jul 24;2(1):49–58.; “Feghali”).
Maza teaches that inotodiol has various biological activities, including antitumor, antiviral, and anti-inflammatory activities (Introduction, para. 3). Maza also teaches treatment with inotodiol increased the expression of surface maturation markers, including MHC-I, MHC-II, CD86, and CD40, on BMDCs without affecting the production of various cytokines, including TNF-α and IL-12p40 (abstract).
Maza also teaches inotodiol is a compound present in Chaga mushrooms and can be used as a pharmaceutical (Introduction, para. 3), as required by instant claim 15.
Maza fails to explicitly teach the use of inotodiol for treating muscular diseases.
Feghali teaches that MHC serves as a marker for increased differentiation of myoblasts, which leads to the generation of skeletal muscle. Feghali also teaches that reduced levels of MHC protein observed in older cultures correlates with detachment and atrophy (Results, para. 2).
Fegahli fails to teach inotodiol.
However, since the generation of skeletal muscle is heavily dependent on MHC, as taught by Feghali, and inotodiol is known to increase expression of MHC, it would be obvious to use inotodiol as a potential treatment for any muscular diseases affected by degeneration and atrophy.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the use of inotodiol for various diseases such as cancer, allergies, and inflammatory conditions, as taught by Maza, and use it in the treatment of muscular diseases. A person skilled in the art would be motivated to do so since the generation of skeletal muscle is heavily dependent on MHC, as taught by Feghali, and inotodiol is known to increase expression of MHC, it would be obvious to use inotodiol as a potential treatment for any muscular diseases affected by degeneration and atrophy. Therefore, claims 1, 4-6, 9-13, and 15 would be considered obvious to a person skilled in the art at the time.
Claims 1, 4-6, and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Maza, P. et al. (Front. Immunol., 2021, Sec. Nutritional Immunology, 12; “Maza”) in further view of Feghali, R. et al. (Gene Expr. 2018 Jul 24;2(1):49–58.; “Feghali”) and Baldwin, K. et al. (Front Physiol. 2013 Oct 11;4:284; “Baldwin”).
Claims 1, 4-6, 9-13, and 15 are taught by the combined teachings of Maza and Feghali and their teachings are incorporated herein.
Maza and Fegahli fail to teach an association of MHC or inotodiol with mitochondrial activity or glycolytic activity, as required by instant claims 8 and 14.
Baldwin teaches that MHC expression is associated with different types of oxidative and glycolytic activity (Figure 1).
Therefore, it would be obvious that if inotodiol is increasing MHC expression, it would regulate mitochondrial or glycolytic activity in different muscle fibers, depending on the MHC expression.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the use of inotodiol for various diseases such as cancer, allergies, and inflammatory conditions and use it in the treatment of muscular diseases because the generation of skeletal muscle is heavily dependent on MHC, as taught by Feghali, and inotodiol is known to increase expression of MHC, as taught by Maza. Further, it would be obvious that in increasing MHC expression, inotodiol would regulate mitochondrial and glycolytic activity in the muscle, since MHC expression is associated with different types of oxidative and glycolytic activity, as taught by Baldwin. Therefore, claims 1, 4-6, and 8-15 would be considered obvious to a person skilled in the art at the time.
Conclusion
Claims 1, 4-6, and 8-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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