DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8 have been canceled.
Claims 9-23 are pending in the instant application.
Applicant’s election without traverse of the invention of group I, drawn to two chain polypeptides that mimic the structure of factor X in the reply filed on July 13, 2026 is acknowledged. Upon review of the prior art, the restriction requirement among groups I and II as set forth in the restriction requirement mailed 5/14/2026 has been withdrawn. Applicant is reminded that since the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 9-23 are under examination in this office action.
Information Disclosure Statement
The IDS forms received 11/8/23 and 7/13/2026 are acknowledged and the references cited therein have 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 9-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,845,966. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate what has been presently claimed.
It should be noted that the instant application is the child of the application which became the ‘966 patent, related as a continuation, and thus all SEQ ID numbers and their underlying biological sequences are necessarily identical.
Issued claim 1 recites a pharmaceutical composition comprising a two chain polypeptide, wherein the composition comprises the polypeptides of SEQ ID NOs:4, 5, 8, and 9 at the same ratios as is recited in instant independent claim 14. Given that issued claim 1 recites that less than 10% of the heavy chains are SEQ ID NO:9, this value lies within the larger range for the polypeptide of SEQ ID NO:9 as recited in instant claim 9. With regard to instant claim 14, while the instant pending claim recites that the heavy and light chain are “obtained by cleaving a single chain polypeptide expressed from a polynucleotide comprising the nucleic acid sequence of SEQ ID NO:7” and the issued claims do not recite SEQ ID NO:7, applicant has claimed a product and not a method for making a product. As is expressly discussed in MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Given that the polypeptide chains of SEQ ID NOs:4, 5, 8, and 9 are all present in the exact same ratios when comparing issued claim 1 to instant claim 14, there is no structural difference in the claimed product when comparing that which is claimed to that which was previously issued. The issued claims also recite narrower subranges for the recited peptides (for example compare instant claim 16 to issued claim 2, and instant claim 18 to issued claim 4) as well as lyophilization (see issued claim 9) and the presence of excipients including sucrose, mannitol, and L-arginine acetate (compare instant claim 21 to issued claims 10-12). Additionally, the issued claims recite the administration of their pharmaceutical composition comprising two chain polypeptides to treat anticoagulation in a patient previously administered Xa inhibitors (see issued claim 13).
Claims 9-23 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,954,504. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate what has been presently claimed.
It should be noted that the instant application is the grandchild of the application which became the ‘504 patent, all continuity relationships being continuations, and thus all SEQ ID numbers and their underlying biological sequences are necessarily identical.
Specifically, the issued claims recite a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a plurality of two chain polypeptides which have been obtained by processing the single chain polypeptide precursor of SEQ ID NO:2 (and note that the polynucleotide of SEQ ID NO:7 encodes the polypeptide of SEQ ID NO:2, see for example paragraph [0094] in example 1 of the instant application as well as the genetic code), with the percentages and SEQ ID numbers for the various light and heavy chains being identical to those recited in instant independent claim 14. Indeed, other than minor grammatical modifications, the only differences of note are that there are some differences in the use of “comprising” versus “consisting of” language when discussing various polypeptides identified by SEQ ID number and in that the issued claims indicate that the various proportions of the polypeptide sequences of SEQ ID NOs:4, 5, 8, and 9 are obtained by processing the single chain polypeptide of SEQ ID NO:2 whereas the instant claims say the precursor polypeptide is encodes by SQ ID NO:7, which as discussed above SEQ ID NO:7 encodes SEQ ID NO:2. Notably, it is the issued claims which appear to predominantly recite the narrower “consisting” language as compared to the more open “comprising” language of the instant claims and thus the issued claims anticipate that which is presently claimed. Further, given that the issued claims discuss various subsequences obtained from processing SEQ ID NO:2(i.e. same as encoded by SEQ ID NO:7) while instant claim 9 discusses only SEQ ID NO:9, the issued claims are necessarily more limited in scope than what independent claim 9 is claiming. Notably, the issued claims recite that the claimed pharmaceutical compositions are to be administered to patients previously treated with a factor Xa inhibitor for the purpose of reversing anticoagulation (see particularly claim 14).
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached on (571)272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1644
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1644
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