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 .
A preliminary amendment was filed on 05/02/2024.
Information Disclosure Statement
An information disclosure statement was filed on 05/20/2024.
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.
Claims 1-15, 17, 21, 22 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zizovic et al (Supercritical Fluid Applications in the Design of Antimicrobial Materials, Molecules, May 2020.
Zizovic et al teach placing a material that has a surface and interior portion. This is inherent to all the materials used because Zizovic et al discuss impregnating the material (see Abstract). Zizovic et al further discuss the use of supercritical CO2 to push the bioactive into the material which is to be loaded. This is pushed into a vessel into which the material and bioactive/Supercritical CO2 have been pushed into, followed by decompression (see page 3, 2. Supercritical Solvent Impregnation (SSI). A generalized schematic of the process is found at Figure 2. Bioactive substances are set out at the bottom of page 2. At the bottom of page 3, a study by Milanovic is cited for its impregnation by the combination of thymol is SSI. Figure 1 shows that the mixture can be added separately to the substrate since the process can be done batch wise or semi-batch wise. The reference sets out pressure in Mpa. However, with conversion of the data for Milanovic et al (bottom of page 3), and Markovic et al (top of page 4) studies, conversion of the pressures falls within the claimed psi units of the claims for these examples. Temperatures as high as 120 C are disclosed at the bottom of page 6 in the study by Ma et al. Polypropylene is specifically recited for use in the process at the second paragraph of page 4. Impregnation can occur for varying amounts of time as shown at the last paragraph of page 3 and can last as long as 24 hrs. The use of SSI as an antisolvent for ethanol is described at the top of page 18, in a study by Cuadra et al. The SSI is added to ethanol, then combined with the base material and bioprotectant. The studies cited in Zizovic et al use polypropylene, polyamide, polyester (see page 3 for these first three). Polysiloxanes are set out at page 6. Other polymers such as cellulose acetate and PLA are described for use in the method through page 9. Bioactives may also include quaternary ammonium compounds as shown at bottom of page 21, Table 1. Also see the incorporated study by Xu et al (reference 76 in the citations). The amount of impregnation of the material is taught as factor dependent upon the length of the process, temperature , pressure, and decompression (see page 4, paragraphs 2 and 3). As such, those of ordinary skill would have expected similar results from the instantly claimed method given the teachings of Zizovic et al. The instantly claimed method would have been obvious to one of ordinary skill in the art at the time of filing given the teachings of the paper by Zizovic et al.
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.
Claims 1-15, 17, 21, 22 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,497,834 (US’834). Although the claims at issue are not identical, they are not patentably distinct from each other because US’834 claims :
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Claim 2 sets out that the bioprotectant is combined with SCF-CO2 to form a mixture before the mixture contacts the base material in the enclosure. Claims 4 and 5 set out an elevated pressure from about 500 psi to about 6000 psi (claim 4), and 500 psi to about 2500 psi. Claim 6 sets out the temperature in the enclosure from 15 C to about 60 C during the contact. In Claim 7 , the base material comprises decellularized tissue. The temperature of the enclosure may have a temperature of from about 60 C to about 160 C in claims 9. Claim 10 sets out a base material comprising polypropylene. Contacting the base material and bioprotectant with SCF-CO2 occurs for a period of from about 1 minute to about 24 hours(claim 11), or 5 minutes to about 8 hours (claim 12). Claim 14 sets out that the solvent is combined with SCF-CO2 prior to contact of the SCF-Co2 with the base material, and additionally in the presence of the bioprotectant (claim 15). Surgical mesh is the base material of claim 16, and can additionally be decellularized bone tissue (claim 17). Claim 18 sets out the bioprotectant comprising an immunosuppressant agent or anti-infective agent. The anti-infective agent can be anti-microbial agent, anti-biofilm agent, or combination thereof in claim 19, or a quaternary ammonium salt in claim 20. This quaternary ammonium salt is further defined in claims 21-22. The immunosuppressant agents is set out in claims 23-25. The bioprotectant is impregnated throughout the medical implant material in claim 26. The percentage of impregnation comprises 50% - 70% in claims 28-30. As such, the ordinary practitioner would have expected similar results from the instantly claimed method given the claims of US’834. The instantly claimed method would have been obvious to one of ordinary skill in the art at the time of filing given the claims of US’834.
Conclusion
No claims are allowed.
Correspondence
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz