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 .
Claims 1-33 are under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: The full meaning of the abbreviation “irAE” should be recited on first use in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5 and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 recites: “The method of claim 4, wherein the subject has at least an 85% chance of complete resolution of irAE symptoms following treatment”, which indicates that the subject has up to a 15% chance of not having complete resolution of irAE symptoms following treatment. Claim 4 requires that the subject has complete resolution of irAE symptoms following treatment, which does not encompass any possibility that subject does not have complete resolution of irAE symptoms following treatment. Therefore, claim 5 is broader than claim 4. Claims 6 and 7 are related in the same way.
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 6-9 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.
The term “immunosuppression” is ambiguous in claims 6-9. The term can refer to the result of a treatment, rather than the treatment itself. For example, the expression “subject has immunosuppression discontinued” in claim 6, could be referring to a point when the subject becomes refractory to an ongoing immunosuppressive treatment. It may be guessed that Applicant intends to refer to the discontinuation of immunosuppressive therapy or drugs, but this is not clear.
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 1-5, 10-19, and 22-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 9, 17-24 and 28 of copending Application No. 17787836 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
A Notice of Allowability was sent on 08/21/2025 in copending Application No. 17787836. The reference claim numbers cited herein are the original numbers prior to renumbering of the claims at allowance.
The pending and copending claims are drawn to methods wherein a blood sample from a subject is contacted with a photosensitizing agent, specifically 8-methoxypsoralen, and subjected to UVA radiation (pending claim 1; copending claims 3 and 17-23), after which the treated sample is administered to the subject. In both sets of claims, the subject suffers from cancer (pending claim 15; copending claim 1), specifically including melanoma (pending claim 16; copending claims 8 and 24). In both sets of claims, the subject is receiving checkpoint-inhibitor therapy (pending claim 10; copending claim 1); the recited checkpoint-inhibitors overlap (pending claim 22; copending claim 10). Pending claim 6 is interpreted as indicating that immunosuppressive drug treatment is discontinued following treatment, which indicates that immunosuppressive drug treatment must have been ongoing at the time of treatment, as in copending claims 9 and 28. Therefore, the pending and copending claims encompass overlapping subject matter such that a single embodiment could meet the limitations of both sets of claims. As the treatment is the same, outcomes recited in pending claims 4, 5, 12, 14, 17-19, and 24-30 are inherent in the methods of the copending claims.
Furthermore, as the method of copending claim 1 increases immunoregulatory NK cells in the sample that is administered to the subject, it would be obvious monitor efficacy by immune cell phenotyping by common methods, as in pending claims 11-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20, 21, and 31-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17-23 of copending Application No. 17787836 in view of US 5985914 (Zeldis; of record).
As noted above, the pending and copending independent claims encompass the same method of extracorporeal photopheresis. The copending claims do not recite repeated and continued treatment, as in pending claims 20, 21, and 31-33. One of skill in the art would approach the optimization of an effective treatment protocol in view of prior art directed to similar goals. Zeldis teaches (whole document) treatment of inflammatory bowel diseases by extracorporeal photopheresis. In particular, Zeldis teaches treatment on two consecutive days for four weeks (8 photopheresis treatments) and then on two consecutive days every other week for the next eight weeks (8 additional treatments) for a total of 16 photopheresis procedures over 12 weeks (col. 9, lines 47-50). Therefore, the methods of pending claims 20, 21, and 31-33 are obvious embodiments of the generic methods of the copending claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. 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, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL C GAMETT/Primary Examiner
Art Unit 1647