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 .
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.
Election/Restrictions
Applicant’s election of species without traverse in the reply filed on 5/04/2026 is acknowledged.
Applicant elected compliant species of Autophagy disease: Alzheimer’s diseases.
Examiner found prior art for Alzheimer’s diseases, therefore Markush search was not extended to other species of Autophagy disease according to Markush search practices.
Elected species reads on claims 1, 4-12 and 24-25.
Please note claims 2, autophagy disease associates TECPR2, is not applicable to Alzheimer diseases therefore is not examined in this application.
Claim 2-3 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim.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 5/04/2026.
Current Status of 18/493,414
This Office Action is in response to the amended claims of 05/04/2026.
Claims 1-12 are original and 24-25 are new.
Claims 2-3 are withdrawn.
Claims 1-2, 4-12 and 24-25 are examined in this office action.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 10/24/2023. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 04/26/2021.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-12 and 24-25 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating Hereditary spastic paraparesis in patient with dexibuprofen, the specification and/or prior art does not reasonably provide enablement for enablement of the broad genus of Autophagy diseases. The specification and/or prior art do not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include:
(a) Breadth of the claims:
(b) Nature of the invention;
(c) State of the prior art;
(d) Level of one of ordinary skill;
(e) level of predictability art
(f) amount of direction provided by the inventor;
(g) existence of working examples;
(h) and Quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth and nature of the claims and Nature of the Invention
The instant claims are drawn very broadly to method of treating plurality of Autophagy diseases with dexiburprofen(claims 1-3, 5 and 7-19) without providing enablement for these plurality of diseases.
State of the prior art:
The genus of Autophagy diseases encompasses a plurality of diseases as stated in claims 1, 4-12 and 24-25. There are no one method that can treat all the Autophagy diseases (see claims 24-25). Moreover, some of these diseases are difficult to treat. For example, neuronal ceroid lipofuscinoses comprise a group of neurodegenerative lysosomal storage disorders caused by mutations in at least 13 different genes and primarily affect the brain and the retina of children or young adults. While various therapeutic strategies are currently being explored as treatment options for these fatal disorders, there is presently only one clinically approved drug that has been shown to effectively attenuate the progression of a specific form of neuronal ceroid lipofuscinosis, CLN2 disease. (Storch S. et.al. Current and Emerging Treatment Strategies for Neuronal Ceroid Lipofuscinoses. CNS Drugs. 2019 Apr;33(4):315-325)
Similarly, Alzheimer diseases is a neurodegenerative disorder that is difficult to treat. Prior art of Camins et.al. uses dexibuprofen for treating Alzheimer diseases (Autophagy diseases, applicant’s elected species) by decreasing the inflammatory response and the levels of amyloid plagues and neurofibrillary tangle, while enhancing memory (Camins et.al Redox Biology 13(2017) 345-352).
Level of one of ordinary skill/ Level of predictability art
A person of ordinary skill in the art is an artisan who is a medicinal chemist or a clinician who is treating various Autophagy diseases and have to navigate various drug for treating autophagy diseases. For example, an artisan skilled in the art would not be able to determine the course of treating neuronal ceroid lipofuscinosis, since there are no known treat for neuronal ceroid lipofuscinosis see above.
A person skilled in the art would not be able to envision treating or p all the Autophagy diseases with the experiments disclosed in the specification. (Wands factor (d). Although specification provide some guidance for treating Hereditary spastic paraparesis, the specification does not provide guidance for method of treating all autophagy diseases in claims 24-25 with dexibuprofen(wand faction (e)).
It would require undue experimentation and be undue burden to practice the claimed method of treating the breadth of Autophagy diseases, since no one method can treat all autophagy diseases 1, 4-12 and 24-25. Moreover, some of the diseases are rare and difficult to treat.
Applicant can overcome enablement rejection by narrowing the scope of “Autophagy diseases” to what the prior art and Specification actually show can be treated.
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.
Claims 1, 4 and 24-25 are rejected under 35 U.S.C. 102c as being anticipated Camins et.al. (Redox Biology 13(2017) 345-352.)
Camins et.al. discloses dexibuprofen for treating Alzeihmer diseases(Autophagy diseases, applicant’s elected species) by decreasing the inflammatory response and the levels of amyloid plagues and neurofibrillary tangle, while enhancing memory(pages 351-352, conclusion section), anticipating claims 1,4 and 24-25.
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.
Claims 1, 4-12 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over
Camins et.al. (Redox Biology 13(2017) 345-352.)
In view of
Pratico et.al. (Biological Psychiatry May 1, 2020; 87:797-807)
In further view of
Anisel et.al. (PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS 7th edition, 1999).
1. Determining the scope and contents of the prior art.
Camins et.al. teaches dexibuprofen for treating Alzheimer diseases(Autophagy diseases, applicant’s elected species) by decreasing the inflammatory response and the levels of amyloid plagues and neurofibrillary tangle, while enhancing memory(pages 351-352, conclusion section) teaching claims 1, 4 and 24-25 and partially teaching claims 5-12.
Pratico teaches use of metformin in improving cognitive ability in patients with AD (page 801, table 1), partially teaching claims 5-12.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Although Camins et.al teaching method of treating dexibuprofen for treating Alzheimer diseases, Camins et.al does not teach combination of dexibuprofen with another therapeutic agent.
Although Pratico et.al teaching method of improving cognitive ability in patients with Alzheimer diseases, Pratico does not teach combination of dexibuprofen with another therapeutic agent.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment modality for Alzheimer diseases(Autophagy disease).
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine dexibuprofen which decreases the inflammatory response and the levels of amyloid plagues and neurofibrillary tangle, while enhancing memory for treating AD,an Autophagy diseases (Camins pages 351-352, conclusion section) with metformin which improve cognitive ability in patients with AD (Pratico page 801, table 1) to increase the effectiveness of treating AD. It would be expected combination of dexibuprofen with metformin would be more effective in treating AD since both metformin and dexibuprofen improve memory and at the same time dexibuprofen decreases the inflammatory response and the levels of amyloid plagues and neurofibrillary tangle. Therefore, it would be prima facia obvious to combine teaching of Camins et.al. with the teaching of Pratico et.al (Claims 1, 4-5 and 24-25).
Claim 6 is directed to co-administering dexibuprofen with other therapeutic agent, it would be obvious for a person skill in the art to co-administer dexibuprofen with other therapeutic agent as routine experimentation.
Claim 7, is directed toward combining dexibuprofen and other therapeutic agent dispersed or dissolved together in pharmaceutically acceptable carrier. Examiner considers this to be route experimentation.
Claims 8-9 are directed to oral administration of dexibuprofen in tablet form, examiner consider administration of dexibuprofen in oral tablet form to be well accepted route for administration of medication, therefore is considered to be routine experimentation.
Regarding claim 10, would have been obvious to one of skill in the art to design the composition wherein the administration is intravenous or subcutaneous administration to administer via injection by routine experimentation.
Claims 11-12 are directed to dosage and concentration of dexibuprofen. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Conclusion
No claims are allowable as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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