DETAILED ACTION
Claims 1-20 are currently pending. Claims 1-12 are currently under examination.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/13/2025 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/13/2025.
Priority
The instant application is a continuation of PCT/CN2021/089448, filed 04/23/2021, which claims priority of CN2020331255.1, filed 04/24/2020.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 10/24/2022 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
A copy of Guo, Gaoyang reference has not been provided and thus has been line through.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guo (Guo, Gaoyang et al., “Radical polymerization-crosslinking method for improving extracellular matrix stability in bioprosthetic heart valves, with reduced potential for calcification and inflammatory response,” Acta Biomaterial, Vol 82, 14 October 2018 44-55, 12 pages) in view of US 2016/0263278.
Regarding claim 1, the limitation of a method for preparing a biological material, comprising following steps: introducing, on a biological tissue, a polymerization reactive group and undergoing free radical copolymerization is met by Guo teaching bioprosthetic heart valves (BHVs) with radical polymerization-crosslinking method to improve extracellular matrix stability. Porcine pericardium (PP) tissue was decellularized, functionalized with methacryloyl groups and subsequently crosslinked by radical polymerization. Improved the stability is taught (abstract). Porcine pericardium methacryloyl was obtained by decellularized PP was blotted dry and then immersed in deionized water. MA was added dropwise into the tissue at 4 degrees C with a vigorous stirring and washed (page 45, second column, 2.3). Crosslinking is taught.
Regarding claims 2, 7 and 11, Guo teaches APS (ammonium persulfate) is present in a solution at 50 mM for 24 hours at 37 degrees C, the resulting crosslinked PPs were rinsed and treated with Glut (50 mM) at room temperature for 7 days (page 45, second column, 2.4).
Regarding claim 3, the limitation of wherein the biological tissue introduced with the reactive group is added to solution and soaked at 35 to 40 degrees C, an initiator is added to initiate the polymerization to obtain the biological material is met by Guo teaches APS (ammonium persulfate) is present in a solution at 50 mM for 24 hours at 37 degrees C, the resulting crosslinked PPs were rinsed and treated with Glut (50 mM) at room temperature for 7 days (page 45, second column, 2.4).
Regarding claim 4-6, the limitation of wherein the biological tissue is soaked in deionized water, and then the reactive group is added to provide a concentration of the reactive group is 3 to 10% by volume is met by porcine pericardium methacryloyl was obtained by decellularized PP was blotted dry and then immersed in deionized water. MA was added dropwise into the tissue at 4 degrees C with a vigorous stirring where the reaction is continued to 24 hours at 20-25 degrees C and washed (page 45, second column, 2.3). Concentrations of Ma:PP is taught to be 0.04, 0.2, 1.0 and 5.0 (page 45, second column, 2.3). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding claim 8, the limitation of wherein the biological tissue is pericardium is met by the Guo teaches porcine pericardium (abstract).
Regarding clam 9, the limitation of wherein the reactive group is methacrylic anhydride is met by Guo teaching methacryloyl (page 45, second column, 2.3).
Regarding claim 12, the limitation of wherein the initiator is a thermal initiator or a photo initiator is met by Guo teaching ammonium persulfate (page 45, second column, 2.4).
Guo does not specifically teach the claims zwitterion structures (claim 1).
Guo does not specifically teach the zwitterion solution having a final concentration of 20 to 500 mM (claim 2), specifically 500 mM (claim 7) wherein the zwitterion accounts for 1 to 30% by weight based on a total weight of biological material (claim 10).
The ‘278 publication teaches polymers which can be used as tissue supplements which can be used for prevention of adhesion formation (abstract). Figure 14 teaches a zwitterion which provides lubrication and compressive strength (Figure 14). A monomer incorporated into the polymer comprises chemical functionality selected from the group consisting of carboxylic acid, phosphate, phosphonate, ammonium and combinations thereof. Without limitations the monomers can be charge (i.e., a negative or positive charge). A solution of monomers and photo-initiators are first allowed to permeate into the tissue followed by in situ photopolymerization with light trough minimally invasive flexible fiberoptic cable. The monomers polymerize upon exposure to visible light into a hydrogel or polymer that is entangled [0015]. The IPN can change mechanical properties to any parameter so desired by the medical practitioners such a compressive modulus, lubrication, prevention of wear [0016]. The IPN is taught to contain polymerized 2-methacryloyloxyethyle phosphorylcholine (pMPC) (Figure 3). Use of a photo initiator is taught ([0133], [0135]). Explants were incubated for 24 hours in the dark in an aqueous solution containing MPC (20 w/v%), ethylene glycol dimethacrylate, eosin (0.1mM). Explants were removed from solution ad irradiated with 514 nm ion laser and rinsed for 2 days [0284].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to react MPC with the methacryloyl porcine pericardium as Guo teaches the desire for extracellular matrix stability though functionalization of porcine tissue and the ‘278 publication teaches improvement of compressive modulus and prevention of wear and improved lubrication and compressive strength. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘278 publication teaches polymerization through photopolymerization to tissue and Guo teaches polymerization using photo initiator through radical crosslinking onto tissue. It would have been prima facie obvious to one of ordinary skill in the art to use MPC on the methacryloyl porcine treated tissue of Guo as Guo teaches the desire for further treatment for matrix stability and the ‘278 publication teaches specific MPC to be used to treat tissue to obtain the desired functionality such as compressive strength and lubriciously. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the concentration of methacryloyl and MPC to obtain the desired porcine pericardium tissue as the ‘278 publication teaches changing the properties to obtain the desired mechanical properties and Guo teaches multiple concentrations thus teaching an optimizable parameter. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/666,839 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘839 application are directed to preparation of biological material by treating with methacrylate followed by treatment with 2-methacryloyloxyethyl phosphorylcholine.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,097,113. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘113 patent are directed to preparation of a bioprosthetic valve and functional biologic tissue material treated with methacrylamide and MPC by soaking the tissue in water to obtain a first mixture, adding an active group then performing polymerization with a second mixture containing the MPC, wherein overlapping times and concentrations are taught.
Conclusion
No claims are allowed.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613