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 21-40 are pending and are examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/25/2024 was considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-33 and 38-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-8 and 10 of U.S. Patent No. 11,839,644. Although the claims at issue are not identical, they are not patentably distinct from each other because they claim similar subject matter.
The Patent claims are drawn to methods of treating cutaneous or muscle incision pain in a mammal (which may be a human neonate, child, juvenile, young adult, or an adult) comprising administering human growth hormone to said mammal. Administration of human growth hormone prevents acute to chronic pain transition, at a dose of from about 0.1 mg/kg to about 2.5 mg/kg, or from about 1 mg/kg to about 1.5 mg/kg. The cutaneous or muscle incision pain is associated with a surgery, and the administering comprises administering human GH one to three days prior to surgery. The dose of human growth hormone is administered systemically, over a period of from 1 to 5 days, or 2 to 3 days, wherein if said dose is administered in a single day, said dose of human growth hormone is from about 0.3 mg/kg to about 6 mg/kg. The GH may be administered topically at a dose of from about 0.1 mg/kg to about 3 mg/kg, or from about 1 mg/kg to about 2 mg/kg to a site of cutaneous and/or muscle incision.
Thus, the Patent claims anticipates the instant calims 21-33 and 38-40.
Claims 34-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-8 and 10 of U.S. Patent No. 11,839,644.
The claims are drawn to a method of preventing acute to chronic pain transition caused by a surgical event in an individual in need thereof, comprising administering human growth hormone to prior to the surgical event, intravenously, subcutaneously, intramuscularly or intradermally.
The subject matter of the Patent claims were presented supra and, even though they mention systemic administration, they have not expressly mentioned the routes of systemic administration enumerated in the instant claims 34-37.
it would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have considered known and routinely used systemic administration regimes well-known in the art to deliver the systemic treatment instantly claimed with a reasonable expectation of success. This is because the skilled artisan would have used known and tested methods and a person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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