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 5/26/2026 has been received and entered into the case.
Claims 7-10 have been canceled, claims 1-2 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 3-6 have been considered on the merits. All arguments have been considered.
Claim Rejections - 35 USC § 112 (maintained)
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 invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6 stand rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3-6 are directed to “an application”, and it appears this term is intended for “method” or “process”. However, the claims do not disclose any active steps how the method/process is carried out for the intended purpose of treating myocardial infarction. If claims 3-6 are directed to a method, then it is not clear if they a method of making or a method of using. The claims discloses “an application of 2-deosy-D-glucose in the preparation of drugs”, and this phrase appears to point out the claims as a method of preparing drugs (i.e. method of making), and yet the claims disclose “for treating myocardial infarction with synergistic stem cells” which is understood as the use of the drugs. Clarification is required.
Claim Interpretation
Claims 3-5 are interpreted as a method of preparing a composition comprising 2-deoxy-D-glucose and stem cells. The intended purpose of “treating myocardial infarction with stem cells” is not required for the method of making a composition comprising 2-deoxy-D-glucose and the stem cells, and thus, it does not provide any weight in determining patentability of the instant claims. The term “drug” is interpreted as a composition under the broadest reasonable interpretation. The term itself is directed to an intended purpose.
Claim 4 is directed to the composition being an injectable preparation. The term is interpreted as the composition made by the method of claim 3 can be injected, e.g. a solution.
Claim 5 discloses that 2-deoxy-D-glucose improves cardiac function and ventricular remodeling in stem cell treatment after myocardial infarction. This is interpreted as an intended outcome of the intended purpose of the composition which does not require any active step to be performed. Thus, claim 5 is interpreted the same as claim 3.
Clam 6 discloses intended purposes of the drugs, and thus, it is interpreted as a method of preparing a drug comprising 2-deoxy-D-glucose and stem cells.
Claim Rejections - 35 USC § 102 (modified)
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 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.
Claim(s) 3-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (WO2018/088693A1; IDS ref.; English translation was provided in the OA mailed on 9/15/2025).
Kim et al. teach a composition and a method to improve stem cell capacity using 2-deoxy-D-glucose (2DG) (p.2, Description). Kim et al. teach a culture medium comprising 2DG, and the method of culturing mesenchymal stem cells in the medium comprising 2DG under hypoxic condition. Thus, the culture medium comprising 2DG taught by Kim et al. read on the claimed composition (“drug”) comprising 2DG and mesenchymal stem cells and the culture comprising the culture medium comprising 2DG and mesenchymal stem cells in the culture would read on the method of preparing a composition comprising 2DG and stem cells as claimed.
As discussed in Claim Interpretation above, the intended purpose of treating myocardial infarction does not require any step to be performed and it does not limit the method of preparing a composition comprising 2DG. Regardless, it is expected that the composition taught by Kim et al. would treat myocardial infarction and produce the claimed effect as the composition of Kim et al. is identical to the claimed “drug”.
Regarding claim 4, the culture medium is a solution, and thus, it is considered as an injectable preparation.
Thus, the reference anticipates the claimed invention.
Response to Arguments
Applicant’s arguments with respect to the 112(a) rejection have been fully considered and are persuasive. The claim rejection under 112(a) has been withdrawn.
Regarding the 112(b) rejection, applicant stated that the instant amendment would overcome the rejection. The instant amendment failed to disclose any active step of the claimed method claims. Applicant is advised to amend the claims, for example, as shown below:
Claim 3. A method of preparing a drug for treating myocardial infarction comprising combining 2-deoxy-D-glucose and mesenchymal stem cells.
Claim 6. A method of preparing a drug for augmentation treatment of myocardial infarction comprising combining 2-deoxy-D-glucose and mesenchymal stem cells.
Applicant’s arguments with respect to the 102 rejection based on Zhang et al. have been fully considered and are persuasive, particularly based on the instant amendment as Zhang et al. do not teach stem cells. The claim rejection has been withdrawn. For the same reason, the 102 rejection based on Wei et al. is withdrawn.
Regarding the 102 rejection based on Kim et al., applicant alleged that Kim fails to teach or suggest at least the “drug comprises 2-deoxy-D-glucose and the stem cells”. The Examiner respectfully disagrees with this allegation. As discussed in the modified claim rejection under 102 based on Kim as shown above, the culture of MSCs in the presence of 2DG in the culture medium would be considered as the claimed “drug” comprising 2DG and stem cells. Thus, the teaching of Kim et al. anticipates the claimed subject matter.
Conclusion
No claims are 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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, JAMES SCHULTZ can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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