DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
New claims 53-74, (12/1/2023), are pending and under consideration by the Examiner.
Claims 1-52 have been canceled in the amendment filed on 12/1/2023.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 4/10/2024, 12/1/2023, and 5/10/2023, are in compliance with the provisions of 37 CFR 1.97 and have been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
Claim Rejections - 35 U.S.C. § 112 second paragraph
4. 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.
4a. Claim 71 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 pre-AIA the applicant regards as the invention.
Claim 71, line 1, is improper because it recites the limitation “wherein the” is recited twice.
Claim rejections-Double Patenting
Non-statutory double patenting rejection (obviousness-type)
5. The non-statutory 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 non-statutory double patenting rejection is appropriate where the claims at issue 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); and 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 non-statutory 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 non-statutory 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
5a. Claims 53-74 are rejected on the ground of non-statutory double patenting as being unpatentable over claim 17 of US Patent No. 11,072,652 (‘652).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 17 in ‘652 (having the same four inventors as the instant application) recites a method for detecting ILT7 expression in a sample comprising (a) contacting said sample with an anti-Immunoglobulin-like transcript-7 (ILT7) antibody comprising Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs:203, 204, 205, 208, 209, and 210, respectively, and (b) detecting binding of said antibody in said sample.
Instant claim 53 recites a method for detecting ILT7 expression in a sample, comprising detecting binding of an ILT7 binding molecule in a sample of a subject in need thereof, wherein the ILT7 binding molecule comprises: Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDRI, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDRI, LCDRZ, and LCDR3 comprise the amino acid sequences of SEQ ID NOs: 203, 204, 205, 208, 209, and 210, respectively.
Claims 53-74, in the instant application overlap in scope with claim 17 in the ‘652 patent because both sets of claims are drawn to a method for detecting ILT7 in a sample with the same antibody. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method of for detecting ILT7 expression in a sample with an ILT7 binding molecule, wherein the ILT7 binding molecule comprises: Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDRI, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDRI, LCDRZ, and LCDR3 comprise the amino acid sequences of SEQ ID NOs: 203, 204, 205, 208, 209, and 210, respectively, as recited in the instant claims, is included in the method as recited in the patented claims. The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
5b. Claims 53-74 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 12, of US Patent No. 11,673,950 (‘950).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 12 in ‘950 (having the same four inventors as the instant application) recites a method comprising detecting the reduced level of plasmacytoid dendritic cells (pDCs), wherein the level is reduced by at least about 1-fold as compared to an otherwise comparable method lacking the administering of an anti-Immunoglobulin-like transcript-7 (ILT7) antibody to a subject having a disease associated with ILT7 expressing cells, wherein the ILT7 antibody comprises Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs: 203, 204, 205, 208, 209, and 210, respectively, and wherein the administering is effective in treating a disease as determined by detecting a reduced level of plasmacytoid dendritic cells (pDCs) in the subject, wherein the detecting is performed using the same ILT7 antibody.
Instant claim 53 recites a method for detecting ILT7 expression in a sample, comprising detecting binding of an ILT7 binding molecule in a sample of a subject in need thereof, wherein the ILT7 binding molecule comprises: Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDRI, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3, LCDRI, LCDRZ, and LCDR3 comprise the amino acid sequences of SEQ ID NOs: 203, 204, 205, 208, 209, and 210, respectively. Dependent claim 68 recites “wherein the subject has a disease associated with ILT7-expressing cells”.
Instant claim 70 recites a method for detecting plasmacytoid dendritic cells in a sample, comprising detecting binding of an ILT7 binding molecule in a sample of a subject in need thereof, wherein the ILT7 binding molecule comprises: Complementarity-Determining Regions (CDRs) HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, wherein the HCDR1, HCDR2, HCDR3,LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of SEQ ID NOs: 203, 204, 205, 208, 209, and 210, respectively. Dependent claim 73 recites “wherein the subject in need thereof has a disease associated with ILT7-expressing cells.”
Therefore, claims 53-74 in the instant application overlap in scope with the claims in the ‘950 patent because a method as recited in instant claims 53-74 encompasses the method of claims 1, and 12 of the ‘950 patent. The method in the instant claims and in the ‘950 patent are practiced using the same antibody, and the method claims in the ‘950 patent could not be performed without overlapping the method claims in the instant application. However, the instant claims are obvious from the patented claims because the instant claims are directed to a specific embodiment encompassed by the patented claims. Therefore, the instant method is included in the patented claims. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method as recited in the instant claims, was included in the method as recited in the patented claims. The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
Conclusion
No claim is allowed.
Claims 53-74 are rejected.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1646