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 .
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fogarty et al (2007/0142700) in view of Kuyava et al(7,637,861, hereinafter Kuy; cited by applicant in the IDS of 3/25/2022) and Henkel et al(8,276,591, hereinafter Hen; cited by applicant in the ids of 3/25/2022).
Claim 1 - Fogarty et al discloses an inflatable penile prosthesis (IPP) comprising: a fluid reservoir (1) configured to hold fluid; an inflatable member (5a,5b); and
a pump assembly (3, fig.3) configured to transfer the fluid between the fluid reservoir and the inflatable member, the pump assembly including a pump bulb (8), a valve body (9,fig.8), a push valve (4) movably coupled to the valve body, a first fluid port (6) configured to be fluidly coupled to the fluid reservoir, and a second fluid port (7)
configured to be fluidly coupled to the inflation member, the push valve (4) including a movable valve element (301 of fig.8) configured to move between an inflation position and a deflation position within a bore of the valve body (compare fig.8a,8b), the movable valve element in the inflation position defining a fluid passageway through the bore to transfer fluid from the pump bulb to the second fluid port (see inflation position fig.8a), the movable valve element, when moved to the deflation position, configured to change the fluid passageway through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump bulb is bypassed (see deflation position fig.8b). Fogarty does not set forth an unbiased valve member.
Kuy and Hen teach an implantable penile prosthesis and pump wherein both Kuy and Hen teach the use of biased and unbiased valve members, see elements -78- and -34- and elements -22- and -20- of Hen.
In the absence of showing any criticality in the use of biased, unbiased or a combination of both type valves, in a pump for a penile implant, the selection of at least one unbiased valve portion as taught by both Kuy and Hen would have been an ordinary design expedient of one of ordinary skill in the medical arts at the time the invention was effectively filed to use any combination of biased and unbiased valve elements as taught by Kuy and Hen. Such a modification would produce a valve taught by Fogarty including a combination of biased and unbiased members and have a high expectation of success because the combined use of biased and unbiased members are old and well known.
Claims 2-7, Fogarty et al discloses a biasing member (spring 303), ring member (340, paragraph [0094]), single push system (one touch release paragraphs [0006] and [0072]), feedback component (interaction of rings 341 and 317) , position of movable element with respect to valve body (fig.8a,8b).
Claims 8-9 and 11, Fogarty et al discloses the configuration of the ports, refill and inflation valves are discloses in Figures 3-10.
Claim 12, Fogarty et al discloses a pump assembly (3, fig.3) configured to transfer the fluid between the fluid reservoir and the inflatable member, the pump assembly including a pump bulb (8), a valve body (9,fig.8), a push valve (4) movably coupled to the valve body, a first fluid port (6) configured to be fluidly coupled to the fluid reservoir, and a second fluid port (7) configured to be fluidly coupled to the inflation member, the push valve (4) including a movable valve element (301 of fig.8) configured to move between an inflation position and a deflation position within a bore of the valve body (compare fig.8a,8b), the movable valve element in the inflation position defining a fluid passageway through the bore to transfer fluid from the pump bulb to the second fluid port (see inflation position fig.8a), the movable valve element, when moved to the deflation position, configured to change the fluid passageway through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump bulb is bypassed (see deflation position fig.8b).
Fogarty does not set forth an unbiased valve member.
Kuy and Hen teach an implantable penile prosthesis and pump wherein both Kuy and Hen teach the use of biased and unbiased valve members, see elements -78- and -34- and elements -22- and -20- of Hen.
In the absence of showing any criticality in the use of biased, unbiased or a combination of both type valves, in a pump for a penile implant, the selection of at least one unbiased valve portion as taught by both Kuy and Hen would have been an ordinary design expedient of one of ordinary skill in the medical arts at the time the invention was effectively filed to use any combination of biased and unbiased valve elements as taught by Kuy and Hen. Such a modification would produce a valve taught by Fogarty including a combination of biased and unbiased members and have a high expectation of success because the combined use of biased and unbiased members are old and well known.
Claims 13-18, the movable valve element according to Fogarty et al has obviously several different diameters (fig.8d), two cylinder members are coupled to the ports by tubular members (fig. 1), the configuration of the ports, refill and inflation valves are disclosed in figures 3 and 4-10, the anti-auto inflation is described in paragraph [0073], a tactile feedback is provided by the interaction of rings 341 and 317.
Claim 19 – Fogarty teaches a method for controlling a direction of fluid through a pump assembly of an inflatable penile prosthesis, the method comprising: transferring, by a pump assembly, shown in figure 3, fluid from a fluid reservoir -1- to an inflatable member, 5a and 5b, including: transferring the fluid from the fluid reservoir -1- to a pump bulb -8- via a refill valve -11-; transferring the fluid from the pump bulb -8- to the inflatable member -5- via an inflation valve -12- and a push valve -302- having a movable valve element and a biasing member -303-; pushing the movable valve element along an axis to a deflation position to change a fluid passageway through a valve body of the pump assembly; and transferring the fluid from the inflatable member to the fluid reservoir via the push valve such that the fluid is not transferred through the pump bulb, see paragraph [0158] through [0180]. Anti-auto inflation is described in paragraph [0073].
Claim 20 – Fogarty teaches the refill valve -11- and the inflation valve -12- are not used to transfer the fluid from the inflation member -5a- to the fluid reservoir -1- when the movable valve element -302- is in the deflation position.
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 1-20 of U.S. Patent No. 11,311,382. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the pending claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL G GILBERT whose telephone number is (571)272-4725. The examiner can normally be reached MaxiFlex; M-F 8-5.
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/SAMUEL G GILBERT/Primary Examiner, Art Unit 3791