DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 9, 2026 has been entered.
The Examiner acknowledges the amendments to claims 1-14 and 16-18. Claims 1-20 are pending.
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 .
Terminal Disclaimer
The terminal disclaimer filed on March 9, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,324,596 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 15 is objected to because of the following informalities: at line 1, --penile-- should be inserted prior to “implant” in order to maintain consistent terminology with Claims 1-14 . Appropriate correction is required.
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 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 16 of U.S. Patent No. 10,813,762. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate all of the limitations of claim 16 of the instant application.
Claims 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 16 of U.S. Patent No. 10,813,762 in view of Daniel et al. (EP 2,992,858). Claims 8 and 16 of the patent teach all of the claim limitations except for specifically teaching that the coating is a "molded coating". While it is considered to be obvious to one skilled in the art to apply the coating in any well known manner, Daniel et al. discloses a penile prosthesis with cylinders or inflatable members (22) and teaches it is well known to use a molded coating (paragraph [0035], Figure 7). It would have been obvious to one skilled in the art to modify claims 8 and 16 of the patent such that the coating is a "molded coating" since applying the coating in any well known manner, including a molded coating (as taught by Daniel et al), would merely be applying a known coating to a known penile prosthesis in a known manner with predictable results.
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 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lund et al (WO 2013/096615), cited by applicant in view of Poucher et al (US 2018/0214271).
Lund et al discloses a method of making an inflatable member for a "bodily" implant (inflatable penile prosthesis (100)) comprising providing an inflatable member (102,144,116) that includes a sidewall defining a lumen (inner chamber (132)), passing a structural member (116) through the inflatable member at a first and second locations (along the length of the lumen), and applying a coating to the member (paragraph [0046)). Lund et al. teaches all of the limitations of the claim except for disposing a dissolvable rod member within the lumen and dissolving the rod member.
Poucher et al disclose disposing a rigid rod made of salt within the inflatable member of a penile implant to provide column strength to the prosthetic when the surgeon delivers the distal end portion of the penile prosthetic into the glans penis that subsequently dissolves when the prosthetic is filled with liquid (see at least paragraph [0008]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to dispose a dissolvable salt rod in the inflatable member of Lund et al when manufacturing the bodily implant in view of the teachings of Poucher et al so as to provide the prosthetic with additional column strength to allow the surgeon to deliver the prosthetic to the desired location within the body.
Allowable Subject Matter
Claims 1-15 are allowed.
Response to Arguments
Applicant’s arguments, see page 5 of the Remarks filed March 9, 2026, with respect to the rejections of claims 1-20 under 35 USC 112(a), claims 1-2, 6-13 and 16 under 35 USC 102(a)(1), claims 3-5, 14-15 and 17-18 under 35 USC 103, and claims 1-20 under nonstatutory double patenting over US 11,324,596 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made hereinabove.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Charles A Marmor, II whose telephone number is (571)272-4730. The examiner can normally be reached Monday-Friday 9AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at (571) 272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner, Art Unit 3791
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