DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-30 are pending and currently under consideration.
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 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 9345661 B2 (9/15/25 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the patent claims are both drawn to (i) highly concentrated pharmaceutical formulations comprising Trastuzumab and at least one hyaluronidase enzyme wherein the formulations comprise the same components in overlapping concentrations, (ii) injection devices comprising said formulations, (iii) methods of treating the same cancer population by administering said formulations, and (iv) kits comprising said formulations.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9968676 B2 (9/15/25 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the patent claims are both drawn to (i) highly concentrated pharmaceutical formulations comprising Trastuzumab and at least one hyaluronidase enzyme wherein the formulations comprise the same components (other than the presence of Pertuzumab in the patent formulations) in overlapping concentrations, (ii) injection devices comprising said formulations, (iii) methods of treating the same cancer population by administering said formulations, and (iv) kits comprising said formulations. It is noted formulations of the patent claims recite formulations comprising 100-150 mg/ml of a combination of Trastuzumab and Pertuzumab, while the instant claims recite 120 +/-18 mg/ml Trastuzumab. Obvious formulations of the patent claims include formulations comprising any proportions of Trastuzumab and Pertuzumab encompassed by the patent claims, including formulations comprising 105 mg/ml Trastuzumab and 25 mg/ml Pertuzumab – which is a species encompassed by the instant claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12427193 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
In particular regards to instant claims 13 and 27, and the patent claims, instant claims and the patent claims are both drawn to methods of administering highly concentrated pharmaceutical formulations comprising Trastuzumab and at least one hyaluronidase enzyme wherein the formulations comprise the same components in overlapping concentrations to treat HER2 positive cancers by administering said formulations. It is noted the patent claims specify the HER2 positive cancers are breast cancers, which render the patent claims species of instant claims.
In particular regards to instant claims 11, 12, 14, 15, 26, and 28, the patent claims do not specifically recite the administered formulations are in vials of kits comprising instructions or are in injection devices for “subcutaneous” administration. However, it would be obvious to provide the formation in vials and injection devices for subcutaneous administration because the patent specification discloses the recited formulations are to be administered subcutaneously using injection devices (lines 63-67 of column 3 and lines 39-47 of column 4, in particular) and vials provide obvious means for storing/containing the formulations prior to injection. Further, generating a “kit” for a given method with instructions provides two services: 1) a variety of different reagents have been assembled and pre-mixed specifically for a defined set of experiments. Thus, one need not purchase gram quantities of numerous different reagents when each of which may be needed in only microgram amounts, when beginning a series of experiments. When one considers all of the unused chemicals that typically accumulate in weighing rooms, desiccators, and freezers, one quickly realizes that it is actually far more expensive for a small number of users to prepare most buffer solutions from the basic reagents. In actuality, a kit format saves money and resources for everyone by dramatically reducing waste. 2) The other service provided in a kit is quality control. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to combine the reagents (including the recited formation in vials and injection devices for subcutaneous administration) of the patent method into a kit format since a kit provides a quality control, saves money, and saves resources.
Further, formulations of instant claims 1-8, 10, 16-25, 29, and 30 are obvious in view of the patent method claims because the formulations of the instant claims are required by the methods of the patent claims. Regarding instant claim 9 that specifies the hyaluronidase enzyme is rHuPH20, the patent discloses claimed embodiments of recited formulations include those wherein the recited hyaluronidase enzyme is rHuPH20 (lines 48-60 of column 6, in particular).
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642