DETAILED ACTION
Examiner’s Note
The Examiner’s position is clarified with this, the present, secondary Non Final Rejection.
Previous Rejections
Applicant’s arguments, filed 12/10/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1, 3-6, 11-12, 20-21, 25-26, 68, 70-73, 78-79 and 83-88 are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al (US 2013/0195792 A1), in view of Kellum et al (US 2016/0187349 A1).
Chan taught a method of treating systemic, regional, or local inflammation, from a patient suffering or at risk of inflammation, comprising administration of a therapeutically effective dose of a sorbent for an inflammatory mediator in said patient, wherein said sorbent was a porous biocompatible polymer [claims 1, 8 and 24-27]. At ¶ [0041], Chan taught treating systemic inflammatory response syndrome (SIRS), or sepsis.
Although Chen taught treating SIRS or sepsis, Chen did not specifically teach treating immunoparalysis, as instantly recited.
Keller taught that sepsis is characterized by immunoparalysis [0181,0187].
Since Chen taught treating sepsis, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Chen, treating immunoparalysis. The ordinarily skilled artisan would have been so motivated, because sepsis is characterized by immunoparalysis, as taught by Keller [0181,0187].
Claims 3, 6, 70 and 73 are rendered prima facie obvious because Chan taught a pore diameter of 50 Å to 3000 Å, and a pore volume between 0.5 cc/g and 3.0 cc/g dry powder; ratio of pore volume between a pore diameter of 50 Å to a pore volume between a pore diameter of 3000 Å was smaller than 200:1 [0027].
The instant claims 3 and 70 recite diameters between 50-4000 Å, and volumes between 0.5-5 cc/g. The instant claims 6 and 73 recite that a ratio of pore volume between 50-4000 Å to pore volume between 1,000-10,000 Å is smaller than 2:1.
Chan taught a pore diameter of 50 Å to 3000 Å and a pore volume between 0.5 cc/g and 3.0 cc/g dry powder; a ratio of pore volume between a pore diameter of 50 Å to a pore volume between a pore diameter of 3000 Å was smaller than 200:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claims 4-5 and 71-72 are rendered prima facie obvious because Chan taught extracorporeal and intravenous administrations [0044].
Claims 11 and 78 are rendered prima facie obvious because Chan taught biocompatible and hemocompatible exterior surface coatings, covalently bound by free-radical grafting [0053].
Claims 12 and 79 rendered prima facie obvious because Chan taught administration at the same time as supportive care measures [0075].
Regarding claims 16-17, 19, 22 and 24, Chan was not explicit wherein the administration of the sorbent reduces the severity or risk of immunoparalysis; increases HLA-DR expression or function; reduces T-cell or other immune cell exhaustion; removal of checkpoint inhibitors; or, removal of soluble ligands, as instantly recited.
However, Chan taught a therapeutically effective dose of the sorbent, at the abstract. And, the originally filed disclosure [0106] states that the sorbent may reduce the severity of immunoparalysis; increase HLA-DR function [0106]; reduce T-cell or other immune cell exhaustion; remove one or more checkpoint inhibitor proteins and/or their soluble counterparts [0215]; and, remove soluble ligands (e.g., sPD-L1) [0165], in methods of treating [0115], wherein treating comprised therapeutically effective amounts of the porous biocompatible polymer [0194].
Therefore, it appears that the methods and compositions of the instant claims (porous biocompatible polymer sorbent) and those of the prior art (porous biocompatible polymer sorbent) would reasonably be expected to have substantially the same physical and chemical properties (reducing the severity or risk of immunoparalysis; increasing HLA-DR expression or function; reducing T-cell or other immune cell exhaustion; removal of checkpoint inhibitor proteins and/or their soluble counterparts; removal of soluble ligands).
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition and its properties are inseparable. If the prior art teaches the identical chemical compounds, then the properties that the Applicant discloses and/or claims are necessarily present (see MPEP 2112).
Claims 20-21, 25 and 85-88 are rendered prima facie obvious because Chan taught that the sorbent binds, sequesters and removes locally produced inflammatory mediators, including cytokines, that are being produced enterally, and facilitates elimination of these mediators through excretion of the sorbent [0074]; administration includes removal of inflammatory mediators from blood or physiologic fluids [0040, 0044]; Botulinum Toxin A (e.g., reads on a soluble ligand) removal by porous polymer [0035].
Claims 26 and 83 are rendered prima facie obvious because Chan taught styrene and ethylstyrene monomers [0059].
Claim 68 is rendered prima facie obvious because Chen taught a method of treating sepsis [claim 6, ¶ 0041].
Claim 84 is rendered prima facie obvious because Chen taught that administration of the sorbent promoted healing [0074].
Response to Arguments
Applicant’s arguments with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim(s) 15 and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al (US 2013/0195792 A1), in view of Kellum et al (US 2016/0187349 A1) and further in view of Andreakos et al (Current Opinion in Biotechnology, 2002, 13, 615-620).
The 35 U.S.C. 103 rejection over Chan and Kellum was previously discussed.
Although Chan taught treating inflammation, as was discussed, Chan did not teach administration of monoclonal antibodies, as recited in claims 15 and 18.
Andreakos taught that monoclonal antibodies (mAbs) are of high quality, targeting almost any antigen can be engineered and manufactured in large quantities. In the clinic, monoclonal antibodies are proving to be safe and effective for the treatment of a wide range of immune and inflammatory diseases [abstract and title]. The combination of mAbs or their use in parallel with standard therapies provides a unique opportunity for the treatment of painful and incurable diseases [conclusion]. The administration of monoclonal antibodies was taught throughout.
Since Chan generally taught treating inflammation, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Chan, the administration of monoclonal antibodies, as taught by Andreakos. The ordinarily skilled artisan would have been so motivated, because the administration of mAbs in parallel with standard therapies provides a unique opportunity for the treatment of painful and incurable diseases, wherein mAbs are of high quality, target almost any antigen, and can be engineered and manufactured in large quantities, as taught by Andreakos et al [abstract, conclusion and title].
Response to Arguments
Applicant’s arguments with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Nonstatutory Double Patenting
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 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-103 of copending Application No. 18/713,370.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 19-20, 25-26, 28-30, 46-53, and 61-62 of copending Application No. 17/917,322.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of copending Application No. 18/022,018.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent Application No. 10,064,406.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent Application No. 9,717,755.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent Application No. 10,426,158.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent Application No. 11,602,585.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent Application No. 10,034,894.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent Application No. 10,967,001.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent Application No. 10,946,040.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent Application No. 12,280,196.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent Application No. 11,058,715.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent Application No. 11,020,521.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent Application No. 11,826,724.
Claims 1, 3-6, 11-12, 15-17, 19-22 24-26, 68, 70-73, 78-79 and 82-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent Application No. 11,752,250.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (porous biocompatible polymer sorbent) recited in the claims of the copending and issued applications fall within the genus (porous biocompatible polymer sorbent) recited in the claims of the instant application, and thus read on the instant claims.
Response to Arguments
Applicant's arguments filed 12/10/25 have been fully considered but they are not persuasive.
Applicant requested that double patenting rejections be held in abeyance until an indication of allowable subject matter is realized.
The Examiner responds that allowable subject matter has not been identified. The rejections are maintained; terminal disclaimers are required.
Conclusion
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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612