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 .
Claims 1-12 are pending and under consideration.
Information Disclosure Statement
The Information Disclosure Statement filed on 10/16/2024 has been considered.
Claim Objections
Claims 6-7 are objected to because of the following informalities:
Claims 6 and 7 are objected for the use of abbreviated phrases (NAOC, FBGL), which should be described for the first time followed by an abbreviated form placed in a bracket.
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.
Claims 1, 3-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of lowering the blood glucose level of a dog having diabetes, the method comprising administering a physiologically effective amount of a fusion protein of SEQ ID NO: 51 or a pharmaceutical composition thereof to the dog, does not reasonably provide enablement for a method of lowering blood glucose level of any dog (who may not have diabetes or hypoglycemia) comprising administering a physiologically effective amount of a fusion protein of SEQ ID NO: 51 or a pharmaceutical composition thereof to the dog. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
The instant claims are broadly drawn to a method lowering blood glucose level of any dog (who may not have diabetes or hypoglycemia) comprising administering a physiologically effective amount of a fusion protein of SEQ ID NO: 51 or a pharmaceutical composition thereof to the dog.
The state of the prior art and the predictability or lack thereof in the art:
Lancaster et al. (IDS, US Pat. No. 10,851,147) teach a fusion protein comprising insulin and Fc having ultra-long life for treating canine diabetes (abstract), wherein the insulin is linked to an Fc via a linker (see Fig 1). They teach that the fusion protein is formulated as a pharmaceutical composition at a concentration of 3 mg/ml (col. 5, lines12+). They teach that the target animal is a dog or cat and they have diabetes and that the fusion protein is administered at dose between 0.025 and 0.5 mg/kg/week (see col. 5, lines 17+). The art does not teach that a fusion protein of SEQ ID NO: 51 can lower blood glucose in any animal (not having hyperglycemia or diabetes). Therefore, it is unpredictable and would require a large amount of experimentation to lower blood glucose in any animal who are not in need thereof.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent. The specification of pages 41-46 disclose administering an insulin-Fc fusion protein to treat dogs having hyperglycemia. The specification does not teach administering an insulin-Fc fusion protein to any animal or any dog not having hyperglycemia. The art or the specification is devoid of any example where the administration of insulin-fc fusion proteins can treat a subject who may not have diabetes. Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to lower blood glucose using the claimed insulin-Fc fusion to treat any animal who are non-diabetic, the lack of direction/guidance presented in the specification regarding the same, the state of the prior art which establishes the unpredictability about lowering blood glucose in any subject, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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.
Claim 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 9-20 of U.S. Patent No. 11,186,623. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of method for lowering the blood glucose level of a dog, the method comprising administering a physiologically effective amount of a fusion protein or a pharmaceutical composition thereof to the dog, said fusion protein comprising an insulin polypeptide and an Fc fragment, wherein the insulin polypeptide and the Fc fragment are connected by a linker, wherein the Fc fragment comprises the amino acid sequence of SEQ ID NO: 32 and wherein the insulin polypeptide comprises the amino acid sequence of SEQ ID NO:16. The method of claim 1, in which the dog is diagnosed with diabetes, wherein the fusion protein is administered daily, twice weekly, or once weekly to the dog, wherein the fusion protein is administered once weekly to the dog at a dose between 0.025 and 0.5 mg/kg/week, wherein the fusion protein is administered to the dog subcutaneously, wherein the NAOC after a first subcutaneous injection in the dog is greater than 150% FBGL·days·kg/mg, wherein the ratio of the NAOC after the third weekly subcutaneous injection of the fusion protein in the dog to the NAOC after the first subcutaneous injection of the fusion protein in the dog is greater than 0.50, wherein the serum half-life of the fusion protein in the blood or serum of the dog upon administration is longer than about 3 days, wherein the time during which there is a statistically significant decrease in blood glucose level in the dog relative to a pre-dose level is longer than one of 2 hours, 6 hours, 9 hours, 12 hours, 18 hours, 1 day, 1.5 days, 2 days, 2.5 days, 3 days, 4 days, 5 days, 6 days, or 7 days, and wherein the fusion protein is present in the pharmaceutical composition at a concentration of about 3 mg/mL or greater and wherein the fusion protein is a homodimer are taught by claims 1-2 and 9-20 of U.S. Patent No. 11,186,623.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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