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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statement (IDS), dated 09/01/2023, comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112 / 101
Claims 1 and 2 provide for an application of (aka ‘use of’) insulin-like growth factor-binding protein 2 (IGFBP2). Since the claim does not set forth any steps involved in the method/process, and so, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claims 1 and 2 are rejected under 35 U.S.C. 101 because the claimed recitation of an application of (aka ‘use of’), without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burgdorf (International Journal of Neuropsychopharmacology, 2017, 20(6), 476-484).
Claims can be interpreted as method of use of insulin-like growth factor-binding protein 2 (IGFBP2) in preparation of drugs for resisting mental disorders caused by early-life stress.
Burgdorf discloses a method, wherein rats are treated with a single injection of IGFBP2 (0.3 to 10 microgram/kg i.v.).
In the above, i.v. of IGFBP2 is interpreted as preparation of i.v. drug, i.e., IGFBP2 in the form of i.v., which reads applicants claimed limitation, which is preparation of drug.
The limitation “for resisting mental disorders caused by early-life stress” is intended use limitation that has no effect on the body of the claim if removed. Therefore, it does not further limit the broadest reasonable interpretation of claim(s). See MPEP 2111.02(II). Accordingly, the prior art does not have to show a treatment of the recited diseases or disorders, and so claims are fully anticipated.
In case, applicants amend the claims to method of treating claims, still Burgdorf discloses treating post-traumatic stress disorder by administering IGFBP2 [see abstract and Fig.1-5], wherein post-traumatic stress disorder is a major anxiety disorder and depression is one its characteristic features [see Introduction].
Accordingly, claims 1-2 are fully anticipated.
Nonstatutory Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application number 18/579,591.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims are drawn to an application of insulin-like growth factor-binding protein 2 in preparation of drugs for resisting mental disorders caused by early-life stress, wherein the mental disorders comprises anxiety and depression-like behavior.
Claims of copending application are drawn to use of insulin-like growth factor binding protein 2 in a preparation of drugs for treatment of neurological demyelinating diseases, wherein the drug enhance myelination levels.
In both cases, the ‘for resisting and for treating the recited condition’ followed by the ‘preparation of drugs’ is intended use limitation that has no effect on the body of the claim if removed. Therefore, it does not further limit the broadest reasonable interpretation of claim(s). See MPEP 2111.02(II).
Accordingly, claims are anticipated by the claims of copending application.
Conclusion
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658