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 status
In the reply on 12 February 2026 Applicant has canceled claims 1-21 and added new claims 24-42. Therefore, claims 3-6 and 13-27 are pending.
Election/Restrictions
Applicant’s election without traverse of Group 3, claim 22 drawn to A method for preventing or treating a degenerative brain disease in the reply filed on 12 February 2026 is acknowledged. The new claims 24-42 are within the scope of the elected invention.
Applicant has cancelled non-elected claims 1-21 and 23 of Groups 1-2 and 4 on 12 February 2026 is acknowledged.
Claims 22 and 24-42 are under current examination.
Priority
This application was filed 09/11/2023 and is a 371 application of PCT/KR2022/003444 filed on 03/11/2022, which claims benefit to the foreign application KR10-2021-0032759 filed on 03/12/2021.
Filing of a certified untranslated copy of the KR10-2021-0032759, filed Document has been viewed in this session 09/11/2023is acknowledged. MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 03/11/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/11/2023, 12/04/2024, 04/22/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
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.
Anticipated by Kim’504
Claims 22, 24-29, 34, and 37-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al., (US20190099504A1; published on Apr. 4, 2019; cited in PTO892, hereinafter “Kim’504”).
Regarding claims 22, 24-28, 34, 37-40 and 42, Kim’504 provides a method for relieving or treating neurological disorder (e.g., epilepsy, concussion, cerebral palsy, Parkinson's disease, Alzheimer's disease [0087]), comprising injecting a AAV vector composition comprising comprise a physiologically acceptable carrier [0081-0085] with a gene encoding glutamate decarboxylase (GAD, e.g., GAD65) ([0010], [0013] of Kim’504), a gene encoding interleukin-10 (IL-10) ([0011] of Kim’504), or a gene encoding a combination of GAD and IL-10 to a space between the inside of an intervertebral foramen and the dura mater surrounding the spinal cord and spinal nerve in need thereof ([0008]-[0009], [0015], [0084] of Kim’504).
Kim’504 furthermore teaches that the AAV comprises the IL-10 protein or the gene encoding the same and the GDNF protein or the gene encoding the same ([0154], Table 4, [0164], [0175] of Kim’504).
MEPE 2112.02(I) states “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).” Furthermore, MPEP 2112.01 (II) states “when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).” In here, in the prior art Kim’504 discloses the AAV vector comprising encoding AAV5-hGAD65 and AAV5-hGDNF/hIL-10 composition for the method of alleviating degenerative brain disease comprising administering the same to a subject in need thereof. Therefore, POSITA would anticipate that the administrating the Kim’504 composition will able to prevent the degenerative brain disease and have an effect of ameliorating motor abnormalities caused by neuronal cell death and improving cognitive ability and memory.
Regarding claim 29, Kim’504 discloses that the carrier includes a viral vector and a non-viral vector such as a plasmid, lipid, nanoparticle, micelle or liposome [0054].
Regarding claim 41, Kim’504 discloses that the neurons are sensory neurons [0036].
Accordingly, Kim’504 anticipates the instant claims 22, 24-29, 38- and 40-42.
Anticipated by Kim’160
Claims 22, 24-29, 31, 34, 36, and 38-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al., (WO2017052160; published on Mar. 30 2017; cited in PTO892, hereinafter “Kim’160”).
Regarding claims 22, 24-28, 40 and 42, Kim’160 discloses a treating neuropathic disorder, comprising an adeno-associated virus (AAV) vector [0036] comprising glutamate decarboxylase (glutamate decarboxylase, glutamic acid decarboxylase, GAD) and an anti-inflammatory cytokine (IL-10), or a gene encoding the same, and a method for alleviating comprising a step of administering the same to a subject in need thereof [0019].
MEPE 2112.02(I) states “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).” Furthermore, MPEP 2112.01 (II) states “when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).” In here, in the prior art Kim’160 discloses the AAV vector comprising encoding GAD and IL-10 or a gene encoding the same composition for the method of alleviating comprising a step of administering the same to a subject in need thereof. Therefore, POSITA would anticipate that the administrating the Kim’160’s AAV vector encoding GAD and IL-10 gene will able to prevent the degenerative brain disease and have an effect of ameliorating motor abnormalities caused by neuronal cell death and improving cognitive ability and memory.
Regarding claim 29, Kim’160 discloses that the carrier includes a viral vector and a non-viral vector such as a plasmid or liposome [0035].
Regarding claims 31, 34 and 36, Kim’160 discloses that synergistic efficacy of AAV-GAD65 and AAV-IL-10 combination administration [0028], wherein the gene encoding IL-10 comprises a base sequence represented by SEQ ID NO: 10, which is 100% identical to instant claim SEQ ID NO: 2 (See ABSS result filed on 11 Mar 2026 and claim 9 of Kim’160) and the gene encoding GAD comprises a base sequence represented by SEQ ID NO: 5, which is 100% identical to instant claim SEQ ID NO: 10 (See ABSS result filed on 11 Mar 2026 and claim 7 of Kim’160).
Regarding claims 38-39, Kim’160 discloses that the administering comprises administering comprises administering an injection comprising a physiologically acceptable carrier (claim 13, 14).
Regarding claim 41, Kim’160 discloses that the neurons are motor neurons [0013].
Accordingly, Kim’160 anticipates the instant claims 22, 24-29, 31, 34, 36, and 38-42.
Anticipated by Hitti
Claims 22, 24-29, 37-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hitti et al. (Parkinsonism and Related Disorders 66 (2019) 16–24, cited in IDS filed 09/11/2023; hereinafter “Hitti”).
Regarding claims 22, 24-28 and 37, Hitti discloses a gene therapies for the treatment of brain disease (i.e., Parkinson's disease) comprising an adeno-associated virus (AAV) vector comprising a glial cell line-derived neurotrophic factor (GDNF) gene and a glutamate decarboxylase (GAD), and a combination of the therapies exhibits synergistic effects in the treatment of Parkinson's disease (see Fig. 1; p. 19 (¶ 3.2. Approach #2); p. 20 (¶ 3.3. Approach #3); and p. 21 (¶ 3.5. Future directions).
Regarding claim 29, Hitti discloses that the plasmid transfection techniques involve the delivery of circular DNA constructs (plasmids) carried by liposomes, nanoparticles, electroporation, or other physical means (p. 17 right col. 2nd ¶).
Regarding claims 38-42, Hitti discloses that the optimizing the delivery of gene therapy vectors with injection catheter designs. This administrative could limit reflux and enhance target tissue spread of ameliorating motor abnormalities caused by neuronal cell death (p. 22 left col. 3rd ¶). Therefore, gene therapy improving cognitive ability and memory (p. 19 (¶ 3.2. Approach #2)). Although, Hitti does not disclose that administering comprises a pharmaceutical composition further comprising a physiologically acceptable carrier, however POSITA could anticipate that the vectors with injection catheter designs will have physiologically acceptable carrier such as buffer.
Accordingly, Hitti anticipates the instant claims 22, 24-29, 37-42.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 22, 24-42 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al., (US20190099504A1; published on Apr. 4, 2019; cited in PTO892, hereinafter “Kim’504”), in view of Kim et al., (US20190255152A1, Pub. Date: Aug. 22, 2019; cited in IDS filed 09/11/2023; hereinafter “Kim’152”).
As previously stated, regarding claims 22, 24-29, 34, and 37-42, Kim’504 provides a method for relieving or treating neurological disorder (e.g., epilepsy, concussion, cerebral palsy, Parkinson's disease, Alzheimer's disease [0087]), comprising injecting a AAV vector composition comprising comprise a physiologically acceptable carrier [0081-0085] with a gene encoding glutamate decarboxylase (GAD, e.g., GAD65) ([0010], [0013] of Kim’504), a gene encoding interleukin-10 (IL-10) ([0011] of Kim’504), or a gene encoding a combination of GAD and IL-10 to a space between the inside of an intervertebral foramen and the dura mater surrounding the spinal cord and spinal nerve in need thereof ([0008]-[0009], [0015], [0084] of Kim’504). Kim’504 furthermore teaches that the AAV comprises the IL-10 protein or the gene encoding the same and the GDNF protein or the gene encoding the same ([0154], Table 4, [0164], [0175] of Kim’504).
Although regarding claims 30-33, 35-36 Kim’504 does not specifically teach the IL-10, GDNF and GAD protein comprises an amino acid or nucleic acid sequence represented by SEQ ID Nos as listed in instant claims. However, such was known in the prior art.
With respect to claims 30-33, 35-36 Kim’152, disclose a method of alleviating or treating pain (e.g., autonomic nervous system symptoms, migraine [0074]) comprising a pharmaceutical composition contains AAV vector encoding two or more selected from the group consisting of GAD65, IL-10, and a gene encoding GDNF (abstract, [0068-0069]). Furthermore, Kim’152 teaches that the gene encoding IL-10 comprises an amino acid sequence represented by SEQ ID NO: 9, which is 100% identical to instant claim SEQ ID NO: 1 (See ABSS alignment result (attached) and [0056]-[0057], claim 8 of Kim’152) and a nucleic acid sequence represented by SEQ ID NO: 10, which is 100% identical to instant claim SEQ ID NO: 2 (See ABSS alignment result (attached) and [0056]-[0057], claim 9 of Kim’152); the gene encoding GAD protein comprises an amino acid sequence represented by SEQ ID NO: 1, which is 100% identical to instant claim SEQ ID NO: 7 (See ABSS alignment result (attached) and [0051]-[0052], claim 6 of Kim’152) and nucleic acid sequence represented by SEQ ID NO: 2, which is 100% identical to instant claim SEQ ID NO: 8 (See ABSS alignment result (attached) and [0052], claim 7 of Kim’152); gene encoding GDNF comprises an amino acid sequence represented by SEQ ID NO: 48, which is 100% identical to instant claim SEQ ID NO: 4 (See ABSS result filed on 11 Mar 2026 and [0060]-[0061], claim 10 of Kim’152) and nucleic acid sequence represented by SEQ ID NO: 49, which is 100% identical to instant claim SEQ ID NO: 5 (See ABSS result filed on 11 Mar 2026 and [0060]-[0061], claim 11 of Kim’152).
MPEP 2143 (A) states that combining prior art elements according to known methods to yield predictable results. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395. Accordingly, it would have been obvious to practice the treating method of Kim’504 and include the IL-10, GDNF and GAD protein comprises an amino acid or nucleic acid sequence as taught by Kim’152 with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Kim’152 because the pharmaceutical composition of the Kim’152 exhibits an excellent analgesic effect at a dosage lower than that of individual administration since genes are co-administered, and thus conventional side effects and toxicity can be reduced (abstract of Kim’152). The POSITA would have had a reasonable expectation of success in combining the teachings of Kim’504 and Kim’152 because each of these teachings both successfully generated method to treating neuronal damage of brain. Therefore, the products and method as taught by Kim’504 et al. in view of Kim’152 et al. would have been prima facie obvious over the products and method of the instant application. In regard to the reasonable expectation of success in doing so, include the IL-10, GDNF and GAD sequences of Kim’152 had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
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/MASUDUR RAHMAN/Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684