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 .
Applicant’s amendment and response filed on 10/28/2025 has been received and entered into the case.
Claim 2 has been canceled and claims 1 and 3-14 have been considered on the merits. All arguments have been considered.
Response to Amendment
The claim rejection under 35 USC 35 U.S.C. 102 has been withdrawn due to the instant amendment.
The claim rejection under 35 USC 35 U.S.C. 112(b) has been withdrawn due to the instant amendment.
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 and 3-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a method of treating Parkinson’s disease (PD) in a subject comprising a) identifying a subject having less than 10 hours of on-time per day; and b) administering a composition comprising a therapeutically effective amount of one or more vectors comprising a nucleic acid sequence encoding GAD to the subthalamic nucleus of the subject.
The scope of “treating” is defined in the instant specification referring to slowing down, relieving, ameliorating, or alleviating at least one of the symptoms of the disease or disorder, or reversing one or more symptoms of the disease or disorder after its onset (para. 27). The scope of the term “treating” therefore encompass not only relieving, ameliorating or alleviating a symptom of the disease but it would also encompass “curing” the PD based on the broad definition given (i.e. reversing one or more symptoms of the disease or disorder after its onset).
The instant specification fails to provide sufficient written description in order to “cure” the PD. The specification discloses improvement in terms of motor functions of the patients treated with the method measured by the on/off time and/or the scores of part III of the UPDRS. Thus, the claimed method would provide some improvement evident by the scores of part III of the UPDRS. However, this does not provide support that the inventor had possession on “curing” the PD in a patient selected as claimed.
It is known in the art that at the time of the filing, there is no cure for PD (see Mayo Clinic; 2024).
The instant claims do not particularly limit if the subject being treated with the claimed method is human or any other mammal. While the claims appear to be directed to human patients with PD, however, the scope of the “subject” of the instant claims is broad to encompass any mammal. While it is known in the art that an animal model of PD, e.g. rat model (see US 6780409 to During et al.), can be treated with GAD65 and GAD67, however, the step of identifying the subject having less than 10 hours of on-time per day, or scores on part III of the UPDRS in the off medication state is only disclosed and applicable to human. There is no disclosure in the instant specification how these criteria for human would be used for animals, or if there is any criteria for animals to determine the “on-time” or the scores of UPDRS part III.
Furthermore, the claims do not particularly define the species of the GAD being human or not. Thus, the scope of the nucleic acid sequence encoding GAD utilized by the claimed method would be from any mammalian source including human. However, the instant specification only discloses the use of human GAD65 and human GAD67.
M.P.E.P. §2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
M.P.E.P. § 2163 also recites, “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention… one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.” and further, “The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084.< Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art. In most technologies which are mature, and wherein the knowledge and level of skill in the art is high, a written description question should not be raised for claims >present in the application when originally filed,< even if the specification discloses only a method of making the invention and the function of the invention. See, e.g., In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) ("One skilled in the art would know how to program a microprocessor to perform the necessary steps described in the specification. Thus, an inventor is not required to describe every detail of his invention. An applicant's disclosure obligation varies according to the art to which the invention pertains. Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out."). In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.”
Claims 1 and 3-14 are 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 relieving, ameliorating, or alleviating at least one of the symptoms of Parkinson’s disease (PD), does not reasonably provide enablement for curing the PD. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The instant claims are directed to a method of treating Parkinson’s disease (PD) in a subject comprising a) identifying a subject having less than 10 hours of on-time per day; and b) administering a composition comprising a therapeutically effective amount of one or more vectors comprising a nucleic acid sequence encoding GAD to the subthalamic nucleus of the subject.
The scope of “treating” is defined in the instant specification referring to slowing down, relieving, ameliorating, or alleviating at least one of the symptoms of the disease or disorder, or reversing one or more symptoms of the disease or disorder after its onset (para. 27). The scope of the term “treating” therefore encompass not only relieving, ameliorating or alleviating a symptom of the disease but it would also encompass “curing” the PD based on the broad definition given.
The instant specification fails to provide sufficient written description in order to “cure” the PD. The specification discloses improvement in terms of motor functions of the patients treated with the method measured by the on/off time and/or the scores of part III of the UPDRS. Thus, the claimed method would provide some improvement evident by the scores of part III of the UPDRS. However, this does not provide support that the inventor had possession on “curing” the PD in a patient selected as claimed.
It is known in the art that at the time of the filing, there is no cure for PD (see Mayo Clinic; 2024).
It is highly unpredictable if the claimed method would necessarily and sufficiently cure the PD, particularly in the absence of any evidence in the instant specification or any known method in the art for the cure of the PD.
Therefore, in the absence of any working embodiment to show that the claimed method would be necessarily and sufficiently “cure” the PD in the human patients, and the lack of any “cure” for the PD known in the art taught by Mayo Clinic, it is highly unpredictable if the claimed method would be able to achieve “cure” for the PD in the human patients or any other subject encompassed. And therefore, undue experimentations would have been required for one skilled in the art to practice the claimed methods of curing the PD in the subject.
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 and 3-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over LeWitt et al. (2011, Lancet Neurol.; IDS ref.) in view of Scheel et al. (US2019/0060425; published on 2/28/2019; of record)
LeWitt et al. teach a method of treating advanced Parkinson’s disease by administering AAV2-GAD gene therapy by bilateral delivery in the subthalamic nucleus to the patients with advanced Parkinson’s disease (Summary). LeWitt et al. teach the patients are selected that they had progressive levodopa-responsive PD and an overnight off-medication unified PD rating scale (UPDRS) motor score (i.e. part III) of 25 or more (Summary: methods). For the step (a) of claim 1, LeWitt et al. teach that the patients were assessed for eligibility screening (Fig. 1, p.310).
While LeWitt et al. teach that the patients had on/off diary shown in Table 3, and the on state of the patient’s baseline was 8.3 (AAV2-GAD) or 9.1 (Sham), LeWitt et al. do not teach the step of selecting a human subject having less than 8 hours of on-time per day, LeWitt et al. do not particularly teach the step of selecting a human patient having the claimed on-time per day.
Scheel et al. teach a method for treating Parkinson’s disease and the method comprises administering or delivering AAV particles comprising a payload, AADC (Abstract) and an average on-time of the subject treated with the method includes 7.5 up to 7.9 hours (para. 486).
It would have been obvious to a person skilled in the art to select the patients having on-time less than 8, i.e. 7.5-7.9 as taught by Scheel et al., for the method of LeWitt et al. with a reasonable expectation of success. This is because the patients being treated by the method of LeWitt et al. is within the average range of 7.3 to 9.3 of on-time according to Table 3, and the patients having 7.5-7.9 taught by Scheel et al. would be within the range of the on-time for the patients being treated with LeWitt et al.
LeWitt et al. teach that AAV vectors delivering a mix of vector genomes of AAV-GAD65 and AAV-GAD67 at 1:1 vg/vg, at a final concentration of 1x1012 vg/ml (p.311, Procedures), and these teachings would meet the limitations of claims 5-11.
Regarding claims 12-14 directed to the increase of on-time as claimed, the wherein clauses of these claims are directed to the results of the method, and these limitations do not require any additional active step other than administering the GAD via viral vectors to the subject having the criteria as claimed. It is noted that LeWitt et al. teach the outcome obtained 6 months post treatment, which produced increased on-time (see Table 3), but they do not teach the results of 12 months post treatment as claimed. However, as LeWitt et al. teach the subject and the step identical to the claimed method, the results of the method taught by LeWitt et al. would be the same results as the claimed method. Thus, the teachings of LeWitt et al. would meet the limitations of the instant claims.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive. Regarding the 112(a) rejection, applicant argued that the broad interpretation of the term “treating” is incorrect because the term “cure” is explicitly defined in the specification as distinct from “reversing one or more symptoms”. The definition given to the term “cure” is not the issue here, and whether or not the term “treating” would encompass “cure”. The specification does not exclude “cure” from “treating” based on the definition given in the instant specification. As discussed in the claim rejection, the scope of “treating” is defined in the instant specification referring to slowing down, relieving, ameliorating, or alleviating at least one of the symptoms of the disease or disorder, or reversing one or more symptoms of the disease or disorder after its onset (para. 27). The scope of the term “treating” therefore encompass not only relieving, ameliorating or alleviating a symptom of the disease but it would also encompass “curing” the PD as reversing one or more symptoms of the disease or disorder after its onset would encompass curing. It is the Examiner’s position that the scope of “treating” would encompass “cure” as defined in the specification. Applicant is advised to amend the term “treating Parkinson’s disease (PD)” to “relieving, ameliorating, or alleviating at least one of the symptoms of Parkinson’s disease (PD)” to obviate the rejection under 35 U.S.C. 112(a).
As indicated above, the claim rejections under 35 U.S.C. 112(b) and 102 have been withdrawn, and thus, the applicant’s argument is moot.
Regarding the teaching of LeWitt in the 102 and 103 rejections, applicant alleged that the Examiner misinterpreted the teaching of LeWitt and LeWitt does not teach a particular subset of patients for treatment.
Applicant stated the range of 8.3+1.0 taught by LeWitt cannot be interpreted to mean that the baseline on-time ranges from 7.3 to 9.3 hours per day, and the standard deviation was calculated and the range was determined to between 4.3 and 12.3 hours. As the 102 rejection has been withdrawn, the teaching of LeWitt, regardless of interpretation of the average on-time range based on SE or SD, the 103 rejection is relied upon the teaching of Scheel. As discussed Scheel teaches that the patients being treated with gene therapy using AADC can be those having on-time ranges 7.5 up to 7.9 hours per day. Thus, it would have been obvious to a person skilled in the art to select those PD patients having on-time of 7.5-7.9 hours as a target patient group for the treatment taught by LeWitt, particularly when the baseline on-time of the treated patients of LeWitt is 4.3 up to 12.3 hours as alleged by applicant. 7.5-7.9 taught by Scheel is well within the range of 4.3-12.3 of LeWitt.
Applicant asserted that Scheel does not disclose or suggest selecting a human subject having less than 8 hours of on-time per day. Applicant alleged that the Scheel’s statement with regard to the subject having various on-time is presented as an incidental characteristics of the subject and not the criteria for selecting a human subject to be treated. The Examiner respectfully disagrees with this allegation. As Scheel teaches that characteristics of the PD patients to be treated with the gene therapy, although Scheel does not particularly teach to select patients having a specific on-time, one skilled in the art would recognize that the characteristics of the patients being treated would be a criteria for selecting the patients.
Applicant argued that Scheel does not teach GAD gene therapy, and it is acknowledged that Scheel’s method is directed to express AADC in Parkinson’s patients. While the gene therapy of Scheel is different from the claimed invention, however, the primary ref., LeWitt et al. teach the GAD gene therapy in Parkinson’s patients. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant asserted that there are unexpected results shown in Examples 1-3 of the instant application. According to Example 1, paragraph [0068] discloses the selection of patients, and this paragraph does not disclose any particular patient group having the claimed “on-time” baseline. Applicant further stated that the patients’ baseline on-time ranged from approximately 2 to 16 hours per day, and this statement is different as the instant claims require to select those less than 8 hours on-time per day. Thus, whether or not there is unexpected results, the study shown in Example 1 does not have the same scope as the claimed invention.
Based on the above discussion, it is the Examiner’s position that the combined teachings of LeWitt and Scheel would render the claimed invention obvious.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631