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 Claims
Claims 6-8 are pending (claim set as filed on 06/24/2026).
Priority
This application is a 371 of PCT/KR2023/006017 filed on 05/03/2023, which claims priority to foreign applications no.: (a) KR 10-2023-0024574 filed on 02/23/2023; and (b) KR 10-2022-0109086 filed on 08/30/2022.
Terminal Disclaimer
The terminal disclaimer filed on 06/24/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of application no.: 17/615,570 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawal of Rejections
The response and amendments filed on 06/24/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
Briefly, the previous indefiniteness rejection for lacking an essential active step has been withdrawn necessitated by Applicant’s amendment to include an active administration step. Furthermore, the previous double patenting rejection over application no. 17/615,570 has been withdrawn necessitated by Applicant’s filing of a terminal disclaimer as noted above.
Briefly, the previous anticipation by Chang has been withdrawn necessitated by Applicant’s amendments. However, the Chang reference is being reprised or made anew as an obviousness rejection for the reasons set forth below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC §103, Obviousness
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 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 non-obviousness.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (WO 2021/034162 A1 - cited in the IDS filed on 03/20/2025, which has a publication date of 02/25/2021, citations being made to the English equivalent of US 2022/0331368 A1) in view of Mouradian (Return of Stuttering After Stroke, 2000).
Chang discloses that a “stroke refers to a neurological symptom that occurs when a blood vessel supplying blood to a part of the brain is blocked (infarction) or burst (cerebral hemorrhage), resulting in damage to the nervous system of the part. Stroke can be divided into two main types; the first is the blockage of blood vessels, which damages a part of the brain that was supplied with blood by the blood vessels, called infarction. It is also called ischemic stroke or cerebral infarction” (see ¶ [0002]).
Chang teaches “a pharmaceutical composition comprising glia-like cells differentiated from human mesenchymal stem cells as an active ingredient for treatment of stroke. Specifically, as a result of injecting the glia-like cells differentiated from human mesenchymal stem cells (ghMSCs) of the present invention to cerebral infarction induced animal models” (see abstract & ¶ [0001]-[0002], [0011]-[0016]).
Regarding claim 7 pertaining to the MSC source, Chang teaches “the human mesenchymal stem cells can be adult stem cells derived from bone marrow, adipose tissue, blood, umbilical cord blood, liver, skin, gastrointestinal tract, placenta or uterus. More preferably, the human mesenchymal stem cells are bone marrow-derived mesenchymal stem cells” (see ¶ [0063]).
Regarding claim 8 pertaining to the passage-culture, Chang teaches “adult human mesenchymal stem cells (hMSCs) extracted from normal human bone marrow were cultured in low glucose Dulbecco’s modified Eagle’s medium (DMEM) supplemented with 10% fetal bovine serum. Cells (passages 6-12) were passaged 12 to 15 times in an environment of 37°C and 5% CO2 to obtain late-passage hMSCs” (see ¶ [0042], [0084]).
However, Chang does not specifically teach: wherein the cerebral infarction sequela is a chronic neurological condition that persists after completion of the cerebral infarction-associated pathogenic process, and comprises one or more selected from the group consisting of paralysis, dysphagia, and stuttering (claim 6’s last limitations as amended).
Obviousness Analysis: the MPEP 2141(III) states that “Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations. However, Office personnel must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art. The mere existence of differences between the prior art and an invention does not establish the invention’s non-obviousness”. In the instant case, the difference between the prior art and the claimed invention appears to be the stage of the cerebral infarction (i.e., acute vs. chronic phase, respectively). However, the instant specification’s guidance and definition of a chronic infarction sequela after completion of associated pathogenic process (see pre-grant specification publication at ¶ [0007]) does not provide for a quantitative or objective form of measurement. It is noted though that the instant specification does illustrate an experimental example of establishing a chronic stroke model, the specification at ¶ [0090] discloses:
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In comparison with the prior art of Chang at ¶ [0096] which discloses:
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400
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Therefore, the instant application and the prior art appear to be substantially similar with respect to oxygen-glucose deprivation conditions to induce an ischemic stroke model. Although there may be minor differences such as the reoxygenation duration, the differences do not appear to arise to level of patentably significance because there is no indication in Chang that would suggest the glia-like mesenchymal stem cells would not be applicable to either an acute or chronic phase of cerebral infarction sequela. Accordingly, it would have been at least “obvious to try” for an ordinary artisan to administer a glia-like cell hMSC to a chronic cerebral infraction sequela when there are only two phases of cerebral infarction sequela. MPEP 2141 states “obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success” because both the instant application and prior art of Chang provide similar explanation of the mechanism of action of the glia-like cells (e.g., expression of cytokine IGFBP-4). Said differently, the instant cells and prior art cells appear to be one and the same where it would be within the purview and envisionment of the ordinary artisan to extrapolate the teachings of Chang to treat the other type of cerebral infarction, the chronic phase.
Regarding the claim limitation pertaining to stuttering, although Chang does not identify stuttering, such symptom would have been readily apparent to one of ordinary skill in the art because stuttering is a common trait of stroke. The reference of Mouradian discloses that developmental stuttering may occur after a stroke (see page 120).
Conclusion
No claims were allowed.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (EST).
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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