DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s election without traverse of the invention of group I, claims 1-6 in the reply filed on September 4, 2026 is acknowledged. Upon review of the art the restriction requirement mailed May 5, 2026 has been withdrawn. Applicant is reminded that once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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 1-8 are under examination in this office action.
Information Disclosure Statement
The IDS forms received 11/2/2023 and 9/4/2026 are acknowledged and the references cited therein have been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "is coupled to the Fc fragment " in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 5 is recited as depending from claim 2, and neither claim 2 nor independent claim 1 recite any “Fc fragments”. Thus “the” Fc fragment does not have proper antecedent basis in the claim as presently constructed. Appropriate amendment, such as via claim dependency, to add sufficient antecedent basis is suggested.
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 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 8,153,590. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite pharmaceutical compositions comprising the two chain polypeptide of SEQ ID NO:13 and methods of administering such two chain polypeptides to reverse anticoagulation in patients previously treated with factor Xa inhibitors including apixaban (see all issued claims, particularly claims 1, 6, and 16). As evidenced by the enclosed sequence alignments, instant SEQ ID NOs:14 and 15 are subsequences that together cover the entire length of SEQ ID NO:13 at 100% identity, and given that the issued claims recite that SEQ ID NO:13 is a “two chain polypeptide” it is apparent that a two chain polypeptide of SEQ ID NOs;14 and 15 is the same thing as a two chain polypeptide of SEQ ID NO:13. See also Tables 12a-c of the instant application and note that all of the discussed SEQ ID numbers are identical when comparing the issued and instant claims (see also enclosed sequence alignments). Therefore, the issued claims anticipate the breadth of what is presently claimed.
Claims 1, 2, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8,455,439. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite pharmaceutical compositions and kits comprising the two chain polypeptide of SEQ ID NO:13 (see all issued claims, particularly claims 2 and 12). As evidenced by the enclosed sequence alignments, instant SEQ ID NOs:14 and 15 are subsequences that together cover the entire length of SEQ ID NO:13 at 100% identity, and given that the issued claims recite that SEQ ID NO:13 is a “two chain polypeptide” it is apparent that a two chain polypeptide of SEQ ID NOs;14 and 15 is the same thing as a two chain polypeptide of SEQ ID NO:13. See also Tables 12a-c of the instant application and note that all of the discussed SEQ ID numbers are identical when comparing the issued and instant claims (see also enclosed sequence alignments). Therefore, the issued claims anticipate the breadth of what is presently claimed.
Claims 1, 2, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,056,106. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite unit dose formulations comprising 0.2-1.0 mg of the two chain polypeptide of SEQ ID NO:13 in a pharmaceutically acceptable carrier (see all issued claims, particularly claim 1). As evidenced by the enclosed sequence alignments, instant SEQ ID NOs:14 and 15 are subsequences that together cover the entire length of SEQ ID NO:13 at 100% identity, and given that the issued claims recite that SEQ ID NO:13 is a “two chain polypeptide” it is apparent that a two chain polypeptide of SEQ ID NOs;14 and 15 is the same thing as a two chain polypeptide of SEQ ID NO:13. See also Tables 12a-c of the instant application and note that all of the discussed SEQ ID numbers are identical when comparing the issued and instant claims (see also enclosed sequence alignments). Therefore, the issued claims anticipate the breadth of what is presently claimed.
Claims 1, 2, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,675,335. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite pharmaceutical compositions comprising SEQ ID NOs:14 and 15 (see all issued claims, particularly claim 3). The biological sequences are identical when comparing the instant application to the issued claims (see enclosed sequence alignments). Therefore, the issued claims anticipate that which is presently claimed.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,388,401. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite an isolated two chain polypeptide comprising SEQ ID NOs:14 and 15, pharmaceutical compositions comprising said two chain polypeptide, and methods of administering such two chain polypeptides to reverse anticoagulation in patients previously treated with factor Xa inhibitors including apixaban and heparin (see all issued claims, particularly claims 1, 4, and 6). The biological sequences are identical when comparing the instant application to the issued claims (see enclosed sequence alignments). Therefore, the issued claims anticipate that which is presently claimed.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8,889,129. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious in view of that which was previously patented.
Specifically, the issued claims recite methods of reducing bleeding in a subject undergoing anticoagulation therapy with a factor Xa inhibitor (i.e. reverse the anticoagulant state in the subject) by administering a two chain polypeptide comprising SEQ ID NO:6 or 95% or more identical variants thereof that necessarily lack residues 6-39 of SEQ ID NO:6, i.e. the polypeptide sequence EEMKK GHLERECMEE TCSYEEAREV FEDSDKTNE. Such a sequence is identical to instant SEQ ID NO:13, which as discussed in earlier rejections a two chain polypeptide of SEQ ID NO:13 is identical to the two chain complex of SEQ ID NOs:14 and 15 (see alignments as well as tables 12a-c) apart from the active site S to A mutation (see alignment). Further, issued claim 22 explicitly states that the polypeptide consists essentially of SEQ ID NO:13 (and note that SEQ ID NO:13 does have the active site serine mutated to alanine). The issued claims recite methods of administering a product, and thus the product itself is obvious in view of methods that administer said product. Further, given that the issued methods are for in vivo therapy, artisans would know that any therapeutic polypeptide needs to be present in a pharmaceutical composition so that it can be administered to the subject. As such the instant claimed inventions are obvious in view of that which was previously patented.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 8,268,783. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
The issued claims recite an isolated 2 chain polypeptides obtained by removing the linker sequence from SEQ ID NO:21, a polypeptide sequence identical to SEQ ID NO:13 (which as discussed earlier is actually SEQ ID NO:14 and SEQ ID NO:15) apart from a) the presence of the linker sequence and b) the lack of the R429Q mutation (see all issued claims, particularly claim 9 and the enclosed sequence alignments). Notably, the claim reciting two chain polypeptides depends from claims that recite SEQ ID NO:21 and the R429Q mutation (see particularly issued claim 3) and thus issued claim 9 in actuality recites a two chain polypeptide 100% identical to SEQ ID NOs:14 and 15 when dependency is traced via issued claim 3. The issued claims also recite the administration of such polypeptides to patients previously treated with factor Xa inhibitors including apixaban (see particularly issued claims 19 and 23). Therefore the issued claims anticipate that which is presently claimed.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,109,046. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
The issued claims recite an isolated 2 chain polypeptide obtained by removing the linker sequence from SEQ ID NO:20, a polypeptide sequence identical to SEQ ID NO:13 (which as discussed earlier is actually SEQ ID NO:14 and SEQ ID NO:15) apart from the presence of the linker sequence (see all issued claims, particularly claims 1 and 2 and the enclosed sequence alignments). Methods of administering such polypeptides to patients previously treated with factor Xa inhibitors including apixaban are also claimed (see particularly issued claims 11 and 15). Therefore the issued claims anticipate that which is presently claimed.
Claims 1 and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,190,111. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
The issued claims recite an isolated 2 chain polypeptides obtained by removing the linker sequence from SEQ ID NO:22, a polypeptide sequence identical to SEQ ID NO:13 (which as discussed earlier is actually SEQ ID NO:14 and SEQ ID NO:15) apart from a) the presence of the linker sequence and b) the lack of the R429Q mutation (see all issued claims, particularly claim 1 and the enclosed sequence alignments). The issued claims also recite the administration of such polypeptides to patients previously treated with factor Xa inhibitors including apixaban to reverse anticoagulation (see particularly issued claim 7). Therefore the issued claims anticipate that which is presently claimed.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,954,503. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
The issued claims recite an isolated 2 chain polypeptides obtained by removing the linker sequence from SEQ ID NO:20, a polypeptide sequence identical to SEQ ID NO:13 (which as discussed earlier is actually SEQ ID NO:14 and SEQ ID NO:15) apart from the presence of the linker sequence (see all issued claims, particularly claim 5 and the enclosed sequence alignments). Methods of administering such polypeptides to patients previously treated with factor Xa inhibitors including apixaban to reverse anticoagulation are also claimed (see particularly issued claim 9). Therefore the issued claims anticipate that which is presently claimed.
Claims 1, 2, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,604,748. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims render obvious that which is presently claimed.
The issued claims recite methods of making a polypeptide product from an encoding nucleic acid, and recite that the polypeptide thus produced comprises a light chain of SEQ ID NO:4 (which is 100% identical to instant SEQ ID NO:14) and a heavy chain of SEQ ID NO:5 (which is 100% identical to instant SEQ ID NO:15, see all issued claims most notably claims 19, 20, and 27, and the enclosed sequence alignments). While it is true that the issued claims recite methods rather than products, given that the methods make the product in question the instant claimed products are very obvious. Also, the application giving rise to the ‘748 patent is in a lineage unrelated to that of the instant application, and thus there is no restriction requirement necessitating the filing of that which became the ‘748 patent separate from that which is presently claimed.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,765,726. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate and render obvious that which is presently claimed.
Specifically, the issued claims recite methods of reversing anticoagulation in a subject treated with factor Xa inhibitors by administering a two chain polypeptide comprising SEQ ID NOs:14 and 15 at a specific dose, with prior administration of inhibitors including apixaban being explicitly recited (see all issued claims, particularly claims 1, 13, and 16). While the issued claims recite only methods of treatment, given that the treatment methods necessarily administer a product, the product being administered is extremely obvious as logically an artisan must have the product before the artisan can administer said product, and artisans are well aware that polypeptides must be present in pharmaceutical compositions with carries such as buffers in order to actually be administered, and note that intravenous administration is explicitly claimed (see particularly claim 2). Thus the issued methods anticipate the breadth of the present claimed methods and render obvious the instant claimed products.
Claims 1, 2, and 6-8 are 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 that which is presently claimed.
The issued claims recite pharmaceutical compositions comprising a two chain polypeptide that comprises a light chain of SEQ ID NO:4 (which is 100% identical to instant SEQ ID NO:14) and a heavy chain of SEQ ID NO:5 (which is 100% identical to instant SEQ ID NO:15) as well as methods of administering such compositions to reverse anticoagulation in patients treated with factor Xa inhibitors (see all issued claims most notably claims 1 and 14 and the enclosed sequence alignments). Therefore the issued claims anticipate that which is presently claimed.
Claims 1, 2, and 6-8 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 that which is presently claimed.
The issued claims recite pharmaceutical compositions comprising a two chain polypeptide that comprises a light chain of SEQ ID NO:4 (which is 100% identical to instant SEQ ID NO:14) and a heavy chain of SEQ ID NO:5 (which is 100% identical to instant SEQ ID NO:15) as well as methods of administering such compositions to reverse anticoagulation in patients treated with factor Xa inhibitors (see all issued claims most notably claims 1 and 14 and the enclosed sequence alignments). Therefore the issued claims anticipate that which is presently claimed.
Claims 1, 2, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,028,382. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims render obvious that which is presently claimed.
Specifically, the issued claims recite methods for making a lyophilized pharmaceutical composition comprising a two chain polypeptide comprising SEQ ID NOs:4 and 5 which are 100% identical to instant SEQ ID NOs:14 and 15 respectively (see all issued claims as well as the enclosed sequence alignments). Notably such compositions comprise recited amounts of various excipients that are present, including arginine, mannitol, sucrose and polysorbate. While it is true that the issued claims are limited to methods of making a pharmaceutical composition and do not actually claim the composition thus made, the composition itself is exceedingly obvious in view of its method of manufacture. Further, there is no restriction requirement in the instant patent family which necessitated the filing of the application which became the ‘382 patent and as such no protections under 35 USC 121 appear applicable.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,195,774. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
The issued claims recite variants of the two chain polypeptide of SEQ ID NO:13 (which as discussed at length in earlier rejections is the same biological sequence as the polypeptides of SEQ ID NOs:14 and 15) which necessarily comprise a point mutation selected from a small Markush group (see all claims and the enclosed sequence alignments). Such biological sequence variants lie within the instant recited genera of polypeptides 95% identical to SEQ ID NOs:14 and 15. Therefore the issued claims anticipate that which is presently claimed.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,005,144. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
Specifically, the issued claims recite lyophilized pharmaceutical compositions comprising a two chain polypeptide, wherein the sequences are identical to instant SEQ ID NOs:14 and 15 (i.e. issued SEQ ID NO:2 is 100% identical to instant SEQ ID NO:14 while issued SEQ ID NO:3 is 100% identical to instant SEQ ID NO:15, see enclosed sequence alignments) and wherein such polypeptides are administered to reverse anticoagulation in patients treated with factor Xa inhibitors including apixaban (see all issued claims, particularly 7, and 17). Thus the issued claims anticipate what has been presently claimed..
Claims 1, 2, and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-23 of copending Application No. 18/505,022. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate that which is presently claimed.
Specifically, the copending application claims pharmaceutical compositions comprising two chain polypeptides that comprise SEQ ID NO:4 (which is 100% identical to instant SEQ ID NO:14) and SEQ ID NO:5 (which is 100% identical to instant SEQ ID NO:15), as well as methods of administering such compositions to reverse anticoagulation in patients previously treated with Factor Xa inhibitors (see all copending claims as well as the enclosed alignments). Therefore the copending claims anticipate the breadth of what is presently claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/909,369. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate that which is presently claimed.
Specifically, the copending application claims unit dose pharmaceutical compositions comprising two chain polypeptides that comprise SEQ ID NO:13 (which as discussed earlier in this office action is equivalent to the polypeptides of SEQ ID NO:14 and SEQ ID NO:15), as well as methods of administering such compositions to reverse anticoagulation in patients previously treated with Factor Xa inhibitors (see all copending claims as well as the enclosed alignments). Therefore the copending claims anticipate the breadth of what is presently claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/968,919. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate and render obvious that which is presently claimed.
Specifically, the copending claims recite methods of administering a two chain polypeptide of SEQ ID NO:13 (which as discussed supra is the same as SEQ ID NO:14 and SEQ ID NO:15) to reverse bleeding tendencies in patients previously treated with factor Xa inhibitors including apixaban, wherein the administer two chain polypeptide further comprises a point mutation as compared to the recited reference sequence chosen from a Markush group (see all copending claims, particularly 1 and 6). Thus, the copending claims anticipate the instant method claims and render obvious the instant product claims, as artisans cannot practice an administration method without first having the product in question. Thus, the products used in a method are exceedingly obvious in view of methods that administer the product in question.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 8,153,590, or claims 1-13 of U.S. Patent No. 8,455,439, or claims 1-8 of U.S. Patent No. 9,056,106, or claims 1-3 of U.S. Patent No. 10,675,335, or claims 1-19 of U.S. Patent No. 9,388,401, or claims 1-22 of U.S. Patent No. 8,889,129, or claims 1-25 of U.S. Patent No. 8,268,783, or claims 1-17 of U.S. Patent No. 9,109,046, or claims 1-10 of U.S. Patent No. 10,190,111, or claims 1-12 of U.S. Patent No. 10,954,503, or claims 1-27 of U.S. Patent No. 10,604,748, or claims 1-20 of U.S. Patent No. 10,765,726, or claims 1-14 of U.S. Patent No. 10,954,504, or claims 1-13 of U.S. Patent No. 11,845,966, or claims 1-9 of U.S. Patent No. 11,028,382, or claims 1-4 of U.S. Patent No. 12,195,774, or claims 1-8 of U.S. Patent No. 12,005,144, in view of Peters et al. (US 7,404,956).
The inventions of the issued patents have been discussed above and differ from that which is presently claimed in that the two chain polypeptides are not disclosed as being joined to a heterologous immunoglobulin Fc domain.
Peters et al. disclose fusion proteins wherein a protein of interest is joined to an immunoglobulin Fc domain to provide the advantage of increased half-life in vivo (see entire document, particularly the title, abstract, column 12, and claims). Notably, such fusion proteins can be produced as a generic fusion using recombinant molecular biology or can be produced by chemical conjugation of an Fc to a polypeptide of interest such as via disulfide bonds (see particularly columns 13-14 and 25-31). Notably, proteins of interest to which an Fc can be joined to make the constructs of Peters et al. include factor X/Xa (see particularly the paragraph bridging columns 16-17, column 33, and claim 50). The Fc are disclosed as being human IgG1 (see for example columns 19 and 20).
Therefore, it would have been obvious to artisans to add an Fc domain to the polypeptide products of the issued claims in order to gain the advantages of increased half-life as taught by Peters et al. Artisans would have a reasonable expectation of success in doing so as the joining of Fc domains to increase half-life was well known at the time of invention and in view of the large number of working examples concerning structurally unrelated proteins of interest being joined to an Fc domain.
Claims 3-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-23 of copending Application No. 18/505,022, or claims 1-11 of copending Application No. 18/909,369, or claims 1-8 of copending Application No. 18/968,919 in view of Peters et al. (US 7,404,956).
The inventions of the copending claims have been discussed above and differ from that which is presently claimed in that the two chain polypeptides are not disclosed as being joined to a heterologous immunoglobulin Fc domain.
Peters et al. disclose fusion proteins wherein a protein of interest is joined to an immunoglobulin Fc domain to provide the advantage of increased half-life in vivo (see entire document, particularly the title, abstract, column 12, and claims). Notably, such fusion proteins can be produced as a generic fusion using recombinant molecular biology or can be produced by chemical conjugation of an Fc to a polypeptide of interest such as via disulfide bonds (see particularly columns 13-14 and 25-31). Notably, proteins of interest to which an Fc can be joined to make the constructs of Peters et al. include factor X/Xa (see particularly the paragraph bridging columns 16-17, column 33, and claim 50). The Fc are disclosed as being human IgG1 (see for example columns 19 and 20).
Therefore, it would have been obvious to artisans to add an Fc domain to the polypeptide products of the copending claims in order to gain the advantages of increased half-life as taught by Peters et al. Artisans would have a reasonable expectation of success in doing so as the joining of Fc domains to increase half-life was well known at the time of invention and in view of the large number of working examples concerning structurally unrelated proteins of interest being joined to an Fc domain.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1644
