DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicants filed a Preliminary Amendment on August 28, 2023, in which Applicants canceled claims 1-18 and added new claims 19-26. Thus, claims 19-26 are pending in this application, and are under examination.
Information Disclosure Statement
The Information Disclosure Statements filed June 14, 2023 (3); October 23, 2023; September 16, 2024; December 9, 2024; April 2, 2025; April 14, 2025; June 3, 2025; and September 11, 2025 have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informalities:
All genus and species names should be italicized.
The use of the terms VITRASE® at paragraph [00143]; AMPHADASE® at paragraph [00143]; HYLENEX® at paragraph [00143]; REMICADE® at paragraph [00148]; ACTEMRA® at paragraph [00149]; STELARA® at paragraph [00151]; 431A® at paragraph [00199]; TRITO®N at paragraph [00270]; and SNARF® at paragraph [00271]; which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
Claims 19-26 are 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 19 recites the limitation "the DNA" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is suggested that “the” be changed to “a.”
Claims 20-26 depend from claim 19, and are therefore included in this rejection.
Claim 23 recites the limitation "the DNA" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the DNA" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the DNA" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 19-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,709,755.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘755 patent and the instant application claim a method of preparing a conditionally active antibody.
Regarding claim 19, the ‘755 patent claims selecting a wild-type antibody against an antigen; evolving the DNA encoding the wild-type antibody using one or more evolutionary techniques to obtain at least one mutant antibody; expressing the mutant DNAs to obtain at least one mutant antibody; subjecting the mutant and wild-type antibodies to an assay under a normal physiological condition, which included pH; and selecting the conditionally active antibody which exhibits a decrease in binding activity to the antigen at normal physiological condition compared to the wild-type antibody and an increase in binding activity to the antigen under aberrant conditions compared to the wild-type antibody (claim 1).
Regarding claims 20 and 22, the ‘755 patent claims that the physiological condition is pH (claim 1).
Claims 19-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 26, and 31 of U.S. Patent No. 9,464,284.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘284 patent and the instant application claim a method of preparing a conditionally active antibody.
Regarding claim 19, the ‘284 patent claims selecting an inflammatory response mediator; identifying a wild-type antibody to the selected mediator; evolving the antibody to obtain mutant antibodies; screening the mutant and wild-type antibodies to an assay under a normal physiological condition, which included pH; and selecting the conditionally active protein which exhibits a decrease in activity at normal physiological condition compared to the wild-type protein and an increase in activity under aberrant conditions compared to the wild-type protein (claim 3). The ‘284 patent claims that the condition is pH (claim 26). The ‘284 patent claims that the activity is binding activity to an antigen (claim 31).
Regarding claims 20 and 22, the ‘284 patent claims that the condition is pH (claim 26).
Claims 19-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 9,982,252.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘252 patent and the instant application claim a method of preparing a conditionally active anti-tumor antibody.
Regarding claim 19, the ‘252 patent claims selecting a wild-type antibody against an tumor; expressing the mutant DNAs to obtain at least one mutant antibody; subjecting the mutant and wild-type antibodies to an assay under a normal pH physiological condition; and selecting the conditionally active antibody which exhibits a decrease in binding activity to the tumor at normal physiological condition compared to the wild-type antibody and an increase in binding activity to the tumor under aberrant conditions compared to the wild-type antibody (claim 1).
Regarding claims 20 and 22, the ‘252 patent claims that the physiological condition is pH (claim 1).
Regarding claim 21, the ‘252 patent claims a tumor environment (claim 1)
Claims 19-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, and 20 of U.S. Patent No. 11,254,932.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘932 patent and the instant application claim a method of preparing a conditionally active antibody.
Regarding claim 19, the ‘932 patent claims selecting an conditionally active biologic protein which exhibits a decrease in activity at normal physiological condition compared to the wild-type protein and an increase in activity under aberrant conditions compared to the wild-type protein (claim 1). The ‘932 patent claims that the protein is an antibody (claim 3). The ‘932 patent evolving the antibody to obtain mutant antibodies; screening the mutant and wild-type antibodies to an assay under a normal physiological condition; and selecting the conditionally active protein which exhibits a decrease in activity at normal physiological condition compared to the wild-type protein and an increase in activity under aberrant conditions compared to the wild-type protein (claim 7). The ‘932 patent claims that the condition is pH (claim 20).
Regarding claims 20 and 22, the ‘932 patent claims that the condition is pH (claim 20).
Claims 19-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,472,876.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘876 patent and the instant application claim a method of preparing a conditionally active antibody.
Regarding claim 19, the ‘876 patent claims selecting a wild-type antibody against an antigen; evolving the DNA encoding the wild-type antibody using one or more evolutionary techniques to obtain at least one mutant antibody; expressing the mutant DNAs to obtain at least one mutant antibody; subjecting the mutant and wild-type antibodies to an assay under a normal physiological condition, which included pH; and selecting the conditionally active antibody which exhibits a decrease in binding activity to the antigen at normal physiological condition compared to the wild-type antibody and an increase in binding activity to the antigen under aberrant conditions compared to the wild-type antibody (claim 1).
Regarding claims 20 and 22, the ‘876 patent claims that the physiological condition is pH (claim 1).
Claims 19-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11,718,844.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘844 patent and the instant application claim a method of preparing a conditionally active antibody.
Regarding claim 19, the ‘844 patent claims selecting a wild-type antibody against an antigen; evolving the DNA encoding the wild-type antibody using one or more evolutionary techniques to obtain at least one mutant antibody; expressing the mutant DNAs to obtain at least one mutant antibody; subjecting the mutant and wild-type antibodies to an assay under a normal physiological condition, which included pH; and selecting the conditionally active antibody which exhibits a decrease in binding activity to the antigen at normal physiological condition compared to the wild-type antibody and an increase in binding activity to the antigen under aberrant conditions compared to the wild-type antibody (claim 1).
Regarding claims 20 and 22, the ‘844 patent claims that the physiological condition is pH (claim 1).
Claims 19-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,773,509.
Regarding claim 19, the ‘509 patent claims selecting a wild-type antibody against an antigen; evolving the DNA encoding the wild-type antibody using one or more evolutionary techniques to obtain at least one mutant antibody; expressing the mutant DNAs to obtain at least one mutant antibody; subjecting the mutant and wild-type antibodies to an assay under a normal physiological condition, which included pH at a first pH of 7.4 and a second pH of 6.0; and selecting the conditionally active antibody which exhibits a decrease in binding activity to the antigen at normal physiological condition compared to the wild-type antibody and an increase in binding activity to the antigen under aberrant conditions compared to the wild-type antibody (claim 1).
Regarding claims 20 and 22, the ‘509 patent claims that the physiological condition is pH at 7.4 and 6.0 (claim 1).
Claims 19-20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,110,611.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘611 patent and the instant application claim a method of preparing a conditionally active antibody.
Regarding claim 19, the ‘611 patent claims selecting a wild-type antibody against an antigen; evolving the DNA encoding the wild-type antibody using one or more evolutionary techniques to obtain at least one mutant antibody; expressing the mutant DNAs to obtain at least one mutant antibody; subjecting the mutant and wild-type antibodies to an assay under a normal physiological condition, which included pH; and selecting the conditionally active antibody which exhibits a decrease in binding activity to the antigen at normal physiological condition compared to the wild-type antibody and an increase in binding activity to the antigen under aberrant conditions compared to the wild-type antibody (claim 1).
Regarding claims 20 and 22, the ‘611 patent claims that the physiological condition is pH (claim 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
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