DETAILED ACTION
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 .
Status of the Application
Claims 1-7 and 20-24 are pending
Claims 2, 7, 20, and 24 are withdrawn from examination as being drawn to a nonelected species.
Claims 1, 3-6, and 21-23 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/01/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of U.S. Provisional Application No. 63/177,632 filed on 04/20/2021, U.S. Provisional Application No. 63/203,819 filed on 07/30/2021, U.S. Provisional Application No. 63/261,151 filed on 09/14/2021, U.S. Provisional Application No. 63/263,262 filed on 10/29/2021, and PCT Application No. PCT/IB2022/053599 filed on 04/18/2022.
Election/Restrictions
Applicant's election with traverse of sodium phenylbutyrate (PBA), lixisenatide (LXD), and Parkinson’s disease (PD) in the reply filed on 06/12/2026 is acknowledged. The traversal is on the grounds that the claimed invention is possesses unity of invention. This is not found persuasive because the special technical feature of a method of treating a neurodegenerative disorder comprising the administration of a combination of two or more drugs selected from a chemical chaperone class of drugs, a glycolysis enhancer class of drugs, a glucagon-like-peptide-1 agonist (GLP-1) class of drugs, a glucocerebrosidase (GCase) inducer class of drugs, an iron chelator class of drugs, a mitochondrial antioxidant class of drugs, a cluster-Abelson ( c-Abl) tyrosine kinase inhibitor class of drugs and a bile acid class of drugs, does not make a contribution over the prior art in view of Liu et al. as presented below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 7, 20, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/12/2026.
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, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (Neuroprotective Effets of Lixisenatide and Liraglutide in the 1-METHYL-4-PHENYL-1,2,3,6-TETRAHYDROPYRIDINE Mouse Model of Parkinson’s Disease, Neuroscience, 2015, 303, pp. 43-50).
Liu et al. teaches “MPTP was injected once daily (20 mg/kg i.p.) for 7 days, and drugs were injected once-daily for 14 days i.p. When comparing exendin-4 (10 nmol/kg), liraglutide (25 nmol/kg) and lixisenatide (10 nmol/kg), it was found that exendin-4 showed no protective effects at the dose chosen. Both liraglutide and lixisenatide showed effects in preventing the MPTP-induced motor impairment (Rotarod, open-field locomotion, catalepsy test), reduction in tyrosine hydroxylase (TH) levels (dopamine synthesis) in the substantia nigra and basal ganglia, a reduction of the pro-apoptotic signaling molecule BAX and an increase in the anti-apoptotic signaling molecule B-cell lymphoma-2. The results demonstrate that in this study, both liraglutide and lixisenatide are superior to exendin-4, and both drugs show promise as a novel treatment of PD.” (see abstract).
Therefore, the reference is deemed to anticipate the instant claims above.
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.
Claims 6 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Neuroprotective Effets of Lixisenatide and Liraglutide in the 1-METHYL-4-PHENYL-1,2,3,6-TETRAHYDROPYRIDINE Mouse Model of Parkinson’s Disease, Neuroscience, 2015, 303, pp. 43-50) as applied to claims 1, 3, and 5 above, and further in view of Roy et al. (Sodium Phenylbutyrate Controls Neuroinflammatory and Antioxidant Activities and Protects Dopaminergic Neurons in Mouse Models of Parkinson’s Disease, PLoS ONE, 2012, 7(6), pp. 1-18, as disclosed in IDS).
The teachings of Liu et al. are presented above.
Liu et al. does not teach further administering sodum phenylbutyrate.
Roy et al. is drawn towards the therapeutic potential of sodium phenylbutyrate in the treatment of Parkinson’s disease (see abstract). Roy et al. teaches “The MPTP mouse model is particularly useful in testing new therapeutic intervention in PD. Because NaPB inhibits the production of proinflammatory molecules and ROS, hallmarks of neurodegenerative pathology, we decided to investigate the efficacy of NaPB in protecting nigrostriatal neurons in the MPTP mouse model of PD. Several lines of evidence presented in this manuscript clearly establish that NaPB is capable of protecting dopaminergic neurons from Parkinsonian toxicity.” (pg. 16, right column, first paragraph).
It would have been obvious to one of ordinary skill in the art to further administer sodium phenylbutyrate, as suggested by Roy et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since it is prima facie obvious to combine components known for the same purpose for their combined additive effects, with a reasonable expectation of success absent evidence of criticality of the particular formulation. Additionally, “[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, it would have been prima facie obvious to combine liraglutide, lixisenatide, and sodium phenylbutyrate in a composition cojointly to treat Parkinson’s disease.
Claims 4 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Neuroprotective Effets of Lixisenatide and Liraglutide in the 1-METHYL-4-PHENYL-1,2,3,6-TETRAHYDROPYRIDINE Mouse Model of Parkinson’s Disease, Neuroscience, 2015, 303, pp. 43-50) and Roy et al. (Sodium Phenylbutyrate Controls Neuroinflammatory and Antioxidant Activities and Protects Dopaminergic Neurons in Mouse Models of Parkinson’s Disease, PLoS ONE, 2012, 7(6), pp. 1-18, as disclosed in IDS) as applied to claims 1, 3, 5-6, and 21 above, and further in view of Friedhoff et al. (US 2016/0324852).
The teachings of Liu et al. and Roy et al. are presented above.
Liu et al. and Roy et al. do not teach formulating the active agents in an extended release or oral formulation.
Friedhoff et al. is drawn towards the combination of 5-HT6 receptor antagonists with other therapeutic agents for the treatment of a neurodegenerative disease (see abstract). Friedhoff et al. teaches such compositions comprising sodium phenylbutyrate (paragraphs 0109, 0227), which can be formulated for extended release and oral administration (paragraphs 0230, 0232, 0250, claim 9).
It would have been obvious to one of ordinary skill in the art to formulate the active agents in an extended release or oral formulation, as suggested by Friedhoff et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since such formulations allow for treatment of neurodegenerative diseases, such as Parkinson’s disease, for extended periods of time as taught by Friedhoff et al. (paragraphs 0025, 0052), with a reasonable expectation of success absent evidence of criticality of the particular formulation.
Conclusion
Claims 1, 3-6, and 21-23 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights