DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims Status
Claims 273-284, and 286-288 are pending.
Claims 273-284 and 286-288 have been amended.
Withdrawn Rejections
The rejection of claims 274-284 and 286-288 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to being dependent on a canceled claim is hereby withdrawn due to amendment.
The rejection of claims 273-283 and 286-288 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty of how many monomers need to be encoded is hereby withdrawn due to amendment.
The rejection of claims 273-291 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cary et al (US 20100266673) in view of Mammen et al (Angew. Chem. Int. Ed. (1998) 37 p2754-2794s) and Ito et al (Appl. Microbiol. Biotechnol. (2011) 90 p1691-1699) is hereby withdrawn due to a showing of unexpected results.
The rejection of claims 273, 274, 285, 286, 288 and 291 under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 2, 8, 12, 13, and 20 of prior U.S. Patent No. 11,117,952 is hereby withdrawn due to amendment.
The rejection of claims 273-283 and 285-191 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 20 of U.S. Patent No. 8,404,631 in view of Mammen et al (Angew. Chem. Int. Ed. (1998) 37 p2754-2794), Ito et al (Appl. Microbiol. Biotechnol. (2011) 90 p1691-1699), and the Sigma Aldrich E coli expression system manual (2005) is hereby withdrawn due to a showing of unexpected results.
The rejection of claims 273-283 and 285-191 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 10 of U.S. Patent No. 9,496,526 in view of Mammen et al (Angew. Chem. Int. Ed. (1998) 37 p2754-2794), Ito et al (Appl. Microbiol. Biotechnol. (2011) 90 p1691-1699), and the Sigma Aldrich E coli expression system manual (2005) is hereby withdrawn due to a showing of unexpected results.
The rejection of claims 273-283 and 285-191 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-14 of U.S. Patent No. 10,202,428 in view of Mammen et al (Angew. Chem. Int. Ed. (1998) 37 p2754-2794, cited by applicants) and Ito et al (Appl. Microbiol. Biotechnol. (2011) 90 p1691-1699) is hereby withdrawn due to a showing of unexpected results.
Maintained/Modified Rejections
Nonstatutory 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.
first rejection
Claims 273-284, and 286-288 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11-15, 20, and 21 of U.S. Patent No. 11,117,952. Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 is almost identical to examined claim 273, save for the number of copies (a non-patentable distinction, MPEP 2144.04(VI)(B)), so the properties of the polypeptides encoded by the nucleic acids must be identical. Thus, the competing claims anticipate examined claims 273-283. Competing claim 11 claims SEQ ID 7, identical with SEQ ID 7 of the examined claims, anticipating examined claim 284. Competing claims 12-15 describe a vector of the nucleic acid of claim 1, in host cell, and expressing a protein, anticipating claim 287. Competing claim 8 is identical with examined claim 285.
response to applicant’s arguments
Applicants state that they will address this issue once the claims are otherwise found allowable. However, until the rejection is overcome, it will remain valid.
second rejection
Claims 273-283 and 285-191 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 107, 121, 123, 124, 126-128, and 131-135 of U.S. Application No. 19/188,574 in view of the Sigma Aldrich E coli expression system manual (2005).
Competing claim 107 describes a use of an oxygen carrier to treat cancer. Competing claim 121 requires that the carrier be an H-NOX protein, while claim 123 requires that the protein correspond to SEQ ID 2, identical with SEQ ID 2 of the examined claims. Competing claim 124 describes a mutation in the protein, with claims 126 and 127 specifying L144F as the mutation. Competing claims 128 and 131-135 require a multimer, a trimerization domain, a bacteriophage T4 trimerization domain, a foldon domain, and SEQ ID 4, identical with SEQ ID 4 of the examined claims. Note that these claims together describe the protein encoded by the nucleotide of examined claims 273 and 285.
The difference between the competing claims and the examined claims is that the competing claims do not discuss nucleotides encoding the polypeptide.
The Sigma Aldrich guide discusses protein expression in E. coli (title). This uses a FLAG tag for affinity chromatography of FLAG fusion proteins (p1, 1st paragraph), with an enzyme cleavage site to remove the tag (fig 1, p1, middle of page) using a kit (p1, 2nd paragraph). The system places the appropriate DNA code of the protein of interest into a plasmid, which is expressed in E. coli, followed by isolation, purification, and optionally cleavage of the tag (fig 2, p2 all of page). This reference discusses expression of nucleotides in bacteria.
Therefore, it would be obvious to use the Sigma Aldrich system to express the protein of the competing claims, to provide the protein required for the method of the competing claims. As the document describes a kit; a generic system for expressing proteins using routine steps, an artisan in this field would attempt this process with a reasonable expectation of success. Note th
response to applicant’s arguments
Applicants state that they will address this issue once the claims are otherwise found allowable. However, until the rejection is overcome, it will remain valid.
third rejection
Claims 273-283 and 285-288 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 15-17 of U.S. Application No. 18/374,478 (US 20240165197) in view of the Sigma Aldrich E coli expression system manual (2005).
Competing claim 1 describes a method of treatment using an H-NOX protein. Competing claim 9 specifies that the protein comprises a T. tengcongensis H-NOX protein with a L144F mutation and a polymerization domain. Competing claims 15-17 describes a trimerization domain, specifically, a bacteriophage T4 fibrin foldon domain, while competing claim 17 requires that the domain have SEQ ID 4, identical with SEQ ID 4 of the examined claims. Note that this is the same polypeptide of examined claims 273 and 285.
The difference between the competing claims and the examined claims is that the competing claims do not discuss nucleotides encoding the polypeptide.
The Sigma Aldrich guide discusses protein expression in E. coli (title). This uses a FLAG tag for affinity chromatography of FLAG fusion proteins (p1, 1st paragraph), with an enzyme cleavage site to remove the tag (fig 1, p1, middle of page) using a kit (p1, 2nd paragraph). The system places the appropriate DNA code of the protein of interest into a plasmid, which is expressed in E. coli, followed by isolation, purification, and optionally cleavage of the tag (fig 2, p2 all of page). This reference discusses expression of nucleotides in bacteria.
Therefore, it would be obvious to use the Sigma Aldrich system to express the protein of the competing claims, to provide the protein required for the method of the competing claims. As the document describes a kit; a generic system for expressing proteins using routine steps, an artisan in this field would attempt this process with a reasonable expectation of success.
response to applicant’s arguments
Applicants state that they will address this issue once the claims are otherwise found allowable. However, until the rejection is overcome, it will remain valid.
fourth rejection
Claims 273-283 and 285-288 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 146 and 150-153 of U.S. Application No. 18/308,203 (US 20240026399) in view of the Sigma Aldrich E coli expression system manual (2005).
Competing claim 146 describes a method of treatment using an H-NOX protein comprising a T. tengcongensis H-NOX protein with a L144F mutation and a polymerization domain. Competing claims 150-153 describe a bacteriophage T4 fibrin foldon domain, where the domain has SEQ ID 4, identical with SEQ ID 4 of the examined claims. Note that this is the same polypeptide of examined claims 273 and 285.
The difference between the competing claims and the examined claims is that the competing claims do not discuss nucleotides encoding the polypeptide.
The Sigma Aldrich guide discusses protein expression in E. coli (title). This uses a FLAG tag for affinity chromatography of FLAG fusion proteins (p1, 1st paragraph), with an enzyme cleavage site to remove the tag (fig 1, p1, middle of page) using a kit (p1, 2nd paragraph). The system places the appropriate DNA code of the protein of interest into a plasmid, which is expressed in E. coli, followed by isolation, purification, and optionally cleavage of the tag (fig 2, p2 all of page). This reference discusses expression of nucleotides in bacteria.
Therefore, it would be obvious to use the Sigma Aldrich system to express the protein of the competing claims, to provide the protein required for the method of the competing claims. As the document describes a kit; a generic system for expressing proteins using routine steps, an artisan in this field would attempt this process with a reasonable expectation of success.
response to applicant’s arguments
Applicants state that they will address this issue once the claims are otherwise found allowable. However, until the rejection is overcome, it will remain valid.
fifth rejection
Claims 273-283 and 285-288 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18 of U.S. Patent No. 12,285,463 in view of the Sigma Aldrich E coli expression system manual (2005).
Competing claim 1 describes using an H-NOX protein comprising a T. tengcongensis H-NOX protein of SEQ ID 2 (identical with SEQ ID 2 of the examined claims) with a L144F mutation and a bacteriophage T4 fibritin foldon domain. Competing claim 18 specifies that the foldon domain comprise SEQ ID 4, identical with SEQ ID 4 of the examined claims. Note that these claims together describe the protein encoded by the nucleotide of examined claims 273 and 285.
The difference between the competing claims and the examined claims is that the competing claims do not discuss nucleotides encoding the polypeptide.
The Sigma Aldrich guide discusses protein expression in E. coli (title). This uses a FLAG tag for affinity chromatography of FLAG fusion proteins (p1, 1st paragraph), with an enzyme cleavage site to remove the tag (fig 1, p1, middle of page) using a kit (p1, 2nd paragraph). The system places the appropriate DNA code of the protein of interest into a plasmid, which is expressed in E. coli, followed by isolation, purification, and optionally cleavage of the tag (fig 2, p2 all of page). This reference discusses expression of nucleotides in bacteria.
Therefore, it would be obvious to use the Sigma Aldrich system to express the protein of the competing claims, to provide the protein required for the method of the competing claims. As the document describes a kit; a generic system for expressing proteins using routine steps, an artisan in this field would attempt this process with a reasonable expectation of success.
response to applicant’s arguments
Applicants state that they will address this issue once the claims are otherwise found allowable. However, until the rejection is overcome, it will remain valid.
Examiner’s Note
Application 19/343,230 has a title suggestive of similar subject matter, but claims have not yet been filed for the application. Once a claim set is filed, it is possible that the application can be the basis of a new obvious type double patenting rejection.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone 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, Melissa Fisher can be reached at 571-270-7430. 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.
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658