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 .
Election/Restrictions
Claims 1-6, 10 are pending.
Applicant’s election of Group I (claims 1-6) and species of gene encoding a Cdo protein in the reply filed on 01/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The species election between gene coding a Cdo protein and a Cdo protein is withdrawn. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions species, as set forth in the Office action mailed on 11/13/2025, is hereby withdrawn and the species is hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1-6 is examined here, and claim 10 is withdrawn.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Since no certified English translation has been furnished, and the Foreign Priority Application, filed 10/27/2020, and the PCT application (PCT/KR2021/013970), filed on 10/12/2021, is in foreign language. The WIPO/PCT publication submitted is in foreign language with English abstract, dated 5/5/2022.
Based on the English translation of the abstract (relevant language: use of Cdo protein or gene encoding Cdo for the treatment of neuromuscular diseases caused by damage to motor nerves, particularly muscle stem cells and neuromuscular junctions, due to aging, oxidative stress and the like). Cl. 4 will receive the priority to 05/05/2022. Cl. 1 is not explicitly disclosed, i.e. “protecting motor neurons.” Thus cl. 1-3, 5-6 will receive the priority to the instant application filing of 04/26/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Dates 07/24/2023 and 01/26/2025 were filed before the mailing date of the first Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
Color photographs and color drawings (Fig. 1A, 4, 5, 6, 9, 10, 11, 13) are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because of the following informalities: drawing have Fig. 1A and 1B, but the description of drawings lacks designation of panels 1A, 1B; simply adding Fig. 1A and 1B will overcome the objection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
Claims 1-3 rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
The term “protecting” in claim 1 is a relative term which renders the claim indefinite. The term “protecting” or “protection” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Although claim 2 recites “protection of motor neuron cells prevents damage to motor neurons due to aging, oxidative stress and inflammation,” the processes of “aging, oxidative stress, and inflammation” are not sufficiently defined in the claims nor specification and are also normal physiological processes at all ages from birth to death, thus to the extent which the processes switch to resulting damage to the motor neurons is unclear since a skilled artisan does not know what is outside the scope of the claim. The term lacks definiteness; i.e. the “metes and bounds” of protection that prevents damage to motor neurons.
Claims 1-2 are rejected for failing to overcome indefiniteness, dependent claim 3 is also rejected for failing to overcome the indefiniteness.
Improper Markush Group
Claim 6 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush group that includes Huntington’s disease is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Huntington’s disease is not known as a motor neuron disease (see Kanai et al., 2008, Movement Disorders, 748-751: “HD is characterized by progressive chorea, rigidity, and dementia; however, involvement of the motor neurons in genetically proven cases is uncommon” (pg. 749))
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (2013, Nature Neuroscience, 16, 571-581, “Kang”) and Wang et al. (2016, Glia, 64, 1021-1033, only the abstract is provided, “Wang”).
Kang discloses that amyotrophic lateral sclerosis (ALS) is an adult-onset neurodegenerative disease exhibiting death of motor neurons with progressive muscle weakness and is linked to glial cell dysfunction (pg. 571, relevant to instant cl. 3 (damaged motor neurons) and cl. 4-6 (neuromuscular disease ALS)). Kang discloses that in ALS patients and in SOD1 (G93A) mouse model of ALS, glial cells called oligodendrocytes, and their progenitor cells, NG2+, appear dysfunctional and also affects motor neuron survival (pg. 571). Oligodendrocytes protect neurons by providing myelin sheathing and metabolic support (pg. 571, relevant to instant cl. 1). Kang demonstrates progressive degeneration of oligodendrocytes in the spinal cord of SOD1 (G93A) mouse model of ALS and human ALS patients by exhibiting abnormal morphologies and failing to fully differentiate, as demonstrated by increased demyelination (Pg. 571, 576-577). Kang discloses that the oligodendrocytes provide metabolic support to neurons (pg. X, relevant to cl. 1). Kang also discloses that vulnerability to oligodendrocytes may be exacerbated by the presence of pro-inflammatory cytokines (pg. X, relevant to cl. 2). Kang also discloses that oligodendrocyte loss is expected to have negative effect on the survival of motor neurons in ALS disease (pg. 571). Deletion of SOD1 gene in NG2+ cells, which differentiate into oligodendrocytes, delayed onset of the disease, thus confirming the role of oligodendrocytes in ALS (pg. 577).
Kang does not disclose administering gene encoding Cdon or Cdon protein to a subject in need.
Wang demonstrates a role of Cdon in oligodendrocyte differentiation and myelination by overexpressing full length Cdon to show increased oligodendrocyte branching and contact point numbers with axons when cocultured with dorsal root ganglion neurons (abstract, relevant to instant cl. 3).
One of the KSR rationale that may be used to support a conclusion of obviousness is that there is 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. Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the filing date of the claimed invention to have modified the ALS mouse model of Kang by over-expressing the full-length Cdon of Wang and arrive at the claimed invention with a reasonable expectation of success. Based on the success of Wang by overexpression of Cdon to demonstrate improved oligodendrocyte differentiation and myelination, along with increased contact point numbers with axons when co-cultured with dorsal root ganglion neurons, a skilled artisan would reasonably expect success by administering the full-length Cdon of Wang to the ALS mouse model of Kang to improve myelination of axons, thus protecting the damaged motor neuron axons by preventing damage due to inflammation and to increase reinnervation and to treat the neuromuscular disease ALS. Thus, cl. 1-6 are obvious.
Allowable Subject Matter
No claim allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEYUR A. VYAS whose telephone number is (571)272-0924. The examiner can normally be reached M-F 9am - 4 pm (EST).
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/KEYUR A VYAS/Examiner, Art Unit 1637
/Soren Harward/Primary Examiner, TC 1600