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 .
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-4, 6-7, 9-15, 17-18, and 20-26 have an effective filing date of 12 AUG 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/14/2024 & 1/23/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 11/19/2025, Applicant elected without traverse:
Species
sPD-L1 as a species of marker measured in a biological sample
anti-PD-1 antibody as a species of immunotherapy
melanoma as a species of cancer; and
sPD-L1 as a species of one or more immunosuppressive components
Status of Claims
Claims 1-4, 6-7, 9-15, 17-18, and 20-26 are currently pending and presented for examination on the merits.
Claims 2-4, 7, 9-11, 13-15, 18, 20-22, and 26 are amended.
Claims 5, 8, 16, and 19 are canceled.
Claims 6 and 17 are withdrawn from further consideration by examiner under 37 CFR 1.142(b) as being drawn to a non-elected species.
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 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “sPD-L1” in claims 2-4, 13-15, and 25 is used by the claim to mean “soluble PD-L1,” while the accepted meaning is “secreted splice variant PD-L1 (sPD-L1).”[Specifications, pg. 2]. The term is indefinite because the specification does not clearly redefine the term. Furthermore, Applicant lists two different definitions for “sPD-L1”, both soluble PD-L1 (see [0008] of the specification) and secreted splice variant PD-L1 (see [0006] of the specification). Clarification is required.
Claim 25 recites the limitation "one or more immunosuppressive components" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7, 10-15, 18, and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Dronca et al (Bim and soluble PD-L1 (sPD-L1) as predictive biomarkers of response to anti-PD-1 therapy in patients with melanoma and lung carcinoma, ASCO Annual Meeting, Abstract 11534, J Clin Oncol 35, 2017, IDS 1/23/2024), and further in view of Eliaz et al (WO 2015099826 A1).
In regards to claims 1, 12, and 23-24, Dronca et al teaches measuring the level of sPD-L1 in melanoma patients [Methods]. Dronca et al further teaches treating melanoma patients with anti-PD-1 [Methods]. Dronca et al further teaches high sPD-L1 is associated with progression on anti-PD-1 therapy [Results]. Dronca et al further teaches high baseline was 2.8 ng/ml vs. 0.7 ng/ml and the levels increased by the first tumor assessment are likely resistant to anti-PD-1 [Results]. Dronca et al further teaches detecting sPD-L1 in peripheral blood [Background].
Dronca et al does not specifically teach performing therapeutic plasma exchange on a mammal. However, this deficiency is made up in the teachings of Eliaz et al.
Applicant states, on page 14 of the Specifications, “TPE (therapeutic plasma exchange) also is referred to as plasmapheresis or apheresis”.
Eliaz et al teaches methods of performing plasmapheresis [0015]. Eliaz et al further teaches selective remove of a protein from the blood [0019]. Eliaz et al further teaches the administration of a treatment, medication, or pharmaceutical back to the plasma [0019].
One of ordinary skill, before the effective filing date, would have been motivated to use Dronca’s methods of measuring of sPD-L1 serially in peripheral blood from melanoma patients and treating with an immunotherapy, with Eliaz’s method of performing plasmapheresis on patients to measure, remove, and administrate a treatment. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143.It would have been prima facie obvious to use Dronca’s and Eliaz’s method for performing TPE on a mammal having cancer, measuring the level of a marker in a biological sample and having measured a marker that is equal to or higher than a threshold level, and administering an immunotherapy, because there would have been a reasonable expectation that said method would be effective in treating cancer. The method of Dronca et al and Eliaz et al meets the limitations of claims 1, 12, and 23.
In regards to claims 2, 13, and 25, Dronca et al teaches the marker is sPD-L1 [Methods].
In regards to claims 3-4 and 14-15, Dronca et al teaches that a high baseline for sPD-L1 is 2.8 ng/ml and a normal baseline of 0.7 ng/ml [Results]. Furthermore one of ordinary skill in the art would have been motivated, based upon the cited references, to determine a threshold that correlates with resistance to anti-PD-1 therapy.
In regards to claims 7 and 18, Dronca et al teaches measuring sPD-L1 with ELISA [Methods].
In regards to claims 10, 21, and 26, Dronca et al teaches the subject is 60 patients with melanoma [Methods].
In regards to claims 11 and 22, Dronca et al teaches treating melanoma [Background, Methods].
Claims 1-4, 7, 9-15, 18, and 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over Dronca et al (Bim and soluble PD-L1 (sPD-L1) as predictive biomarkers of response to anti-PD-1 therapy in patients with melanoma and lung carcinoma, ASCO Annual Meeting, Abstract 11534, J Clin Oncol 35, 2017, IDS 1/23/2024), Eliaz et al (WO 2015099826 A1), and further in view of Abstract #4 (Association of soluble PD-L1 (sPD-L1) with decreased survival in metastatic melanoma, Abstract #4, ASCO-SITC Clinical Immuno-oncology Symposium, J Clin Oncol 35, 2017).
The teachings of Dronca et al and Eliaz et al are taught above.
However, Dronca et al does not specifically teach administering an anti-PD-1 antibody. However, this deficiency is made up in the teachings of Abstract #4.
In regards to claims 9 and 20, Abstract #4 teaches a method of measuring the level of sPD-L1 with an ELISA in melanoma patients then treating with an anti-PD-1 antibody pembrolizumab [Background, Methods, & Results]. Abstract #4 further teaches the samples are from blood donations and plasma samples from melanoma patients [Methods]. Abstract #4 further teaches a normal mean value for sPD-L1 is 0.77 ng/mL vs melanoma patients 1.73 ng/mL [Results]. Abstract #4 further teaches that melanoma patients with a high sPD-L1 at baseline (2.1 vs. 1.1 ng/mL) had clinical benefit (OR/PR/SD) after 4 cycles of pembrolizumab treatment [Results].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine Dronca’s method of measuring of sPD-L1 serially in peripheral blood from melanoma patients and treating with an immunotherapy, with Abstract #4 method of measuring the level of sPD-L1 with an ELISA in melanoma patients then treating with an anti-PD-1 antibody pembrolizumab. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Dronca’s, Eliaz’s, and Abstract #4’s methods for a method for performing TPE on a mammal having cancer, measure the level of a marker in a biological sample and having measured a marker that is equal to or higher than a threshold level, and administer an anti-PD-1 antibody, such as pembrolizumab.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642