DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Pre-Appeal Conference Request and Remarks, filed 9 January 2025, in the matter of Application N° 17/169,195. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application is being examined under the pre-AIA first to invent provisions.
Claims 62-81 are pending, where claims 79-81 remain withdrawn from consideration.
No claims have been added, amended, or canceled. No new matter has been added.
Prosecution Reopened
Applicants’ filed Pre-Appeal Conference Request has resulted in the withdrawal of both of the obviousness rejections of record over Lovett et al. (WO 2009/023615 A1) and Zhang et al. (WO 2011/008842 A2).
Applicants’ remarks filed in the Pre-Appeal Brief Request were deemed persuasive and therefore effective in overcoming the rejections. Therefore, finality of the previously mailed rejection is presently withdrawn in order to consider the remaining ground(s) of rejection.
Thus, claims 62-78 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 9 October 2024 since the art that was previously cited continues to read on the amended and previously recited limitations.
Nonstatutory 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 62-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 20 of Mauney et al. (USPN 10,912,862 B2; of record). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the reference ‘862 patent discloses:
A multilayer biomaterial composition, comprising:
a first and second layer;
the first layer comprising a porous biomaterial matrix, wherein the porous biomaterial matrix comprises silk fibroin, and
the second layer comprising an impermeable biomaterial layer, wherein the impermeable biomaterial layer is characterized in that it prevents passage of liquid water across it,
wherein a bottom surface of the second layer contacts and/or covers a top surface of the first layer,
wherein the multilayer biomaterial composition has a shape selected from the group consisting of approximately a contoured sheet, a plane, a cuboid a sheet, and a tube, so that the multilayer biomaterial composition, when positioned at a site of a wound or defect, a bottom surface of the first layer is oriented such that the porous biomaterial matrix of the first layer is in contact with the wound or defect and provides a scaffold for tissue regeneration and the impermeable biomaterial layer provides a seal that prevents passage of cellular material, fluids, hollow organ contents, and/or particles into the site.
The foregoing reads on the recitations of instant claims 62, 63, 65, 66, 68, 69, and 78, with the limitations of claims 65 being further defined by the reference ‘862 patent (see e.g., col. 3, lines 28-44).
Reference claim 2 discloses the limitations of instant claim 67.
Reference claim 3 discloses the limitations of instant claim 68.
Reference claim 4 discloses the limitations of instant claim 69.
Reference claim 5 discloses the limitations of instant claim 70.
Reference claim 6 discloses the limitations of instant claim 71.
Reference claims 7 and 8 disclose the limitations of instant claim 72.
Reference claim 9 discloses the limitations of instant claim 73.
Reference claim 10 discloses the limitations of instant claim 74.
Reference claim 11 contributes to and discloses limitations of instant claim 62.
Reference claim 12 discloses the limitations of instant claim 63 and 64.
Reference claim 13 discloses the limitations of instant claim 64.
Reference claim 14 discloses the limitations of instant claim 77.
Reference claim 15 discloses the limitations of instant claim 75.
Reference claim 16 discloses the limitations of instant claim 76.
Reference claims 17 and 18 disclose the limitations of instant claim 78.
Reference claim 20 discloses the limitations of instant claim 69.
The Examiner respectfully submits that a person of ordinary skill in the art practicing the invention of Mauney (‘862) would have had a reasonable expectation of successfully achieving and practicing the instantly claimed method of treating wounds and defects.
Therefore, were the reference available as prior art, the instant invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ filed response to the rejection of claims 62-78 on the grounds of nonstatutory double patenting over the patented teachings of Mauney et al. has been fully considered, but is not persuasive.
The following remarks are re-presented from the Final Rejection mailed 9 October 2024:
Regarding the filed amendment to claim 62, as discussed above, the claimed composition has simply been amended to recite a functional limitation of the already rejected second layer that is comprised of impermeable biomaterial. Notably, since the defining material is later recited as being formed of silk fibroin and the reference continues to teach this compositional limitation, Applicants’ amendment fails to overcome the rejection.
Though the above rejection was listed in the Pre-Appeal Brief Request filed on 9 January 2025, Applicants provided no remarks traversing the rejection. As such, the rejection is considered to have been conceded by Applicants.
Thus, the double patenting rejection of record is maintained.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
Prosecution Insights