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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 December 2025 has been entered.
Response to Amendment
Applicant’s amendment, filed 16 December 2025, is acknowledged. Claims 1, 7, 12, and 18 are amended.
Claims 1-20 are pending in the instant application.
Response to Arguments
Regarding the 35 USC 102(a)(1) rejection of claims 1-7, 10-14, and 17 and the 35 USC 103 rejections of claims 8, 9, 15, 16, and 18-20, applicant states the cited references do not disclose the device of amended claims 1, 12 and 18. Examiner disagrees as the amendments can be broadly interpreted with respect to Henkel (US20020082471A1). With regard to claim 1, “second end portion” can be interpreted as any portion that touches the second end of the protrusion previously identified in Henkel, the second end portion can be interpreted as being “disposed within the fluid passageway at a location between the first end portion of the fluid passageway and a second end portion of the fluid passageway”. See annotated figure below. The same general interpretation can be applied to the 102 and 103 rejections of claims 12 and 18. For this reason, the previous rejection stands. The amended structure is set forth above in the labelled figure and rejections.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 10-14 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henkel (US 20020082471 A1).
Regarding claims 1, 7, and 12, Henkel discloses an inflatable penile prosthesis (paragraph [0005]) comprising: a reservoir configured to hold fluid (paragraph [0005)]); an inflatable member (paragraph [0005]); and a pump assembly (figure 2) configured to facilitate a transfer of a fluid from the reservoir to the inflatable member, the pump assembly including a pump bulb (figures 2, feature 36), and a valve body (figure 2) defining a fluid passageway (feature 33, 34), the valve body including a refill valve (feature 20) disposed in the fluid passageway, a protrusion having a first end portion disposed at a first end portion of the fluid passageway and a second end portion disposed within the fluid passageway at a location between the first end portion of the fluid passageway and a second end portion of the fluid passageway (Annotated in the figure below), the valve body including a seat disposed in the second end portion, (Annotated in the figure below), the refill valve including a valve member (Figure 2 “20”), in response to the pump bulb being compressed, the valve member configured to move within the fluid passageway in a first direction (to the right) to a closed position in which the valve member blocks the fluid from being transferred around the refill valve, in response to the pump bulb being uncompressed, the valve member configured to move within the fluid passageway in a second direction to an open position in which the valve member allows the fluid to transfer around the refill valve (paragraphs [0006] and [0007)).
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Claims 2-3 and 10 – Henkel teaches a valve seat (24) is used with the valve member to move back and forth to block and open the valve member against the valve seat (paragraphs [0006] and [0007]). The valve seat is also tapered (Figure 4).
Claims 4-6 and 11 – Henkel teaches the valve member having a guide member that extends in a first and second direction with one end of the guide member including grooves (145, Figures 18 and 18A).
Claim 13 – Henkel teaches a biasing member (28) to bias the valve member closed.
Claims 14 and 17 – Henkel teaches (Figures 1-2) a central section (the section that includes spring 28) between a first second (passageway 33) and a second section (part of the passageway on the opposite side in which part of the valve member 20 extends), where the central section is larger than the second.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henkel as applied to claim 1 above and in view of Fogarty (US 20130072751 A1).
Claims 8 and 9 - Henkel et al discloses a pump assembly of a penile prosthesis and teaches the claimed device except for the valve specifically being void of a biasing member.
Fogarty discloses another penile prosthesis and teaches that is well known to use a valve member void of a biasing member (paragraph [0065)).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to substitute a biased valve member, Henkel, with a valve member without a biasing member as a mere substitution of one well known type of valve member used in penile prosthetics for another.
Claim(s) 15, 16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henkel as applied to claim 12 above, and further in view of Hemmeter (US 4699128 A).
Henkel discloses a pump assembly of a penile prosthesis and teaches the claimed device (see claim 1 and annotated figure above) except for the valve specifically being a flapper valve.
Hemmeter discloses another penile prosthesis and teaches that is well known to use a valve member that is a flapper valve (element 12, column 3, lines 24-53). Therefore, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify Henkel by substituting a flapper valve for the biased valve member as a substitution of functionally equivalent valve types from other penile prosthesis.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,285,006. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor II can be reached at (571) 272-4730. 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
/M.D.H./Examiner, Art Unit 3791