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
Applicant’s election without traverse of Group II (claims 3-6 and 10) in the reply filed on 11/14/2025 is acknowledged.
Claims 7-9 have been canceled, claims 1-2 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 3-6 and 10 have been considered on the merits.
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.
Claim 6 is 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.
Claim 6 discloses the application of 2DG in the preparation of health care products for the prevention of myocardial infarction. The instant specification fails to provide any detailed written description with regard to the product for the prevention of myocardial infarction. There is no example shown in the instant specification what kind of health care products would necessarily and sufficiently “prevent” myocardial infarction.
It is not known in the art at the time of filing that there is any single drug or medicament capable of preventing myocardial infarction. The instant specification discloses Examples that are directed to the outcome of the 2DG, MSCs or 2DG+MSCs in mice that have been induced for myocardial infarction (mouse myocardial infarction model). While the examples show the effect of 2DG in combination of MSCs, however, there is no disclosure of using 2DG in a medication that prevents myocardial infarction.
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.”
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 and 10 are 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 and 10 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.
The term “synergistic stem cells” in claim 3 is not clear what subject matter this term intends to point out. There is no disclosure in the instant specification what the definition of the term is. Is it meant that any stem cells would produce a synergistic effect with 2-deoxy-D-glucose or there is a specific stem cells that would be synergistic with 2-deoxy-D-glucose? Clarification is required.
Claim 10 discloses “the drugs for the augmentation treatment” in line 1. There is no antecedent basis as this phrase is referring claim 1 and claim 1 is now withdrawn.
Claim 10 discloses “according to the claim 1”. As claim 1 has been withdrawn, it is indefinite because what limitation this phrase would point out. Clarification is required.
Claim 10 discloses “the preparation of drugs” in line 2. There is no antecedent basis for this phrase. Clarification is required.
Claim Interpretation
Claims 3-5 are interpreted as a method of preparing a composition comprising 2-deoxy-D-glucose. 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 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.
Claim 10 is interpreted the same as claim 3, which is a method of preparing a composition for the treatment of myocardial infarction.
Claim Rejections - 35 USC § 102
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 and 10 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 on9/15/2025).
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”) and the preparation of the culture medium comprising 2DG would read on the method of preparing a composition comprising 2DG 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.
Claim(s) 3-6 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (CN103800346A; published on 5/21/2014; IDS ref.)
Zhang teaches an application of glucalogue in preparing medicaments for treating cell death and diseases, and the diseases include ischemic reperfusion injury, and the glucalogue is 2-deoxyglucose (see Abstract). The preparing medicaments comprising 2-deoxyglucose taught by Zhang reads on the claimed application of 2DG in the preparation of drugs.
Claim(s) 3-6 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei et al. (2003, Journal of Cerebral Blood Flow and Metabolism)
Wei et al. teach a method of administering 2DG intravenously in hyperglycemic rats and this method resulted in the reduction of cerebral infarction (see entire document). The treatment with 2DG would inherently meet the method of preparing a composition comprising 2DG, and as it is intravenously administered, the 2DG of Wei et al. is an injectable preparation. The 2DG of Wei et al. is considered identical to the preparation comprising 2DG of the instant claims, the characteristics and results in the intended purpose of treating myocardial infarction disclosed in claim 5-6 would be inherent to the composition.
Thus, the reference anticipates the claimed invention.
Conclusion
No claims are allowed.
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.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631