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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: [a] figures 8-11 do not include the following reference sign(s) “442” mentioned in the description [0058-0059]; [b] figure 19 does not include the following reference sign(s) “941” mentioned in the description [0067].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“…the pressure relief mechanism includes a valve member 140 that has a secondary valve or secondary valve or secondary valve member…” para.[0035] needs to be corrected. A suggested correction is -- the pressure relief mechanism includes a valve member 140 that has a secondary valve or secondary valve member--.
“The contact surface 642 of the includes or defines cutouts or recesses 643” para.[0061] needs to be corrected. A suggested correction is -- The contact surface 642
“The contact surface 742 of the includes or defines cutouts or recesses 743” needs to be corrected. A suggested correction is -- The contact surface 742 ses 743--.
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 1 lines 10-11 “wherein the valve body includes a sealing surface configured to engage the valve to form seal” needs to be corrected. A suggested correction is -- wherein the valve body includes a sealing surface configured to engage the valve to form a seal--.
Claim 11 “wherein valve includes a surface configured to engage the sealing surface” needs to be corrected. A suggested correction is -- wherein the valve includes a surface configured to engage the sealing surface—in light of its antecedent “a valve” in claim 1 line 5.
Claim 19 lines 10-11 “wherein the valve body includes a sealing surface configured to engage the valve to form seal” needs to be corrected. A suggested correction is -- wherein the valve body includes a sealing surface configured to engage the valve to form a seal --.
Appropriate correction is required.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed at least para. [0025-0027], [0069].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 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.
Claims 1-5, 7-13, 15-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Daly et al. (Pat. No.: US 4898158 A, hereinafter referred to as “Daly”).
As per independent Claim 1, Daly discloses an inflatable penile prosthesis (Daly in at least abstract, fig. 1-11, col. 1 lines 9-13, lines 60-65, col. 2 lines 5-44, col. 3 line 4-68, col. 4 line 1-68, col. 5 line 1-68, col. 6 lines 1-42, col. 7 lines 1-6 for example discloses relevant subject-matter. More pertinently, Daly in at least abstract, fig. 1, col. 1 lines 9-13, col. 3 lines 4-18 for example discloses inflatable penile prosthesis. See at least col. 1 lines 10-11, lines 62-65 “a inflatable penile implant”), comprising:
a fluid reservoir (21) configured to hold fluid (Daly in at least col. 3 lines 38-40 “chamber 21 is substantially filled with a non-compressible hydraulic fluid 22 which may be a biocompatible fluid such as saline or a free flowing silicone gel”);
an inflatable member (20); and
a pump assembly (18) configured to transfer the fluid between the fluid reservoir and the inflatable member (Daly in at least col. 5 line col. 6 lines 1-3 “outer chamber 21 serves primarily as a reservoir of pressurizing fluid for the inner chamber”), the pump assembly including a pump bulb (28), a valve body (27), a valve (30, see col. 4 lines 28-41“valve 17 is seen … inlet valve 30 … outlet valve 32”; col. 5 lines 13-14 “pressure relief valve 23 ”) disposed within the valve body (27), a first fluid port (29) configured to be fluidly coupled to the fluid reservoir, and a second fluid port (31) configured to be fluidly coupled to the inflatable member, the valve being configured to move between an inflation position (fig. 6) and a deflation position (fig. 5, 7), wherein the valve body includes a sealing surface of 27 under valve 30 configured to engage the valve to form seal (col. 4 lines 28-65 “When the pump 18 is not in use both the valves 30 and 32 are closed as seen in FIG. 5… the lip of the cap 30a of the inlet valve 30 is lifted off its seat permitting fluid to enter the pumping chamber 28 via the inlet passage 29… outlet valve 32 of the pump 18 normally closes the passage 31. The valve 32 forms a seal about the exit 31a of passage 31… The passageways 33 seen best in FIGS. 6 and 8) form part of the passage 31 which also includes the exit of passageway 34 (seen best in FIG. 9) which is closed by the back of the cap 32a of the valve 32”), the valve body includes a slot formed at 29 (see fig. 5-6, col. 4 lines 42-50 “the passage 29 is closed by the inlet valve 30. When the squeezing is stopped and the walls of the pump 18 flex … the lip of the cap 30a of the inlet valve 30 is lifted off its seat … via the inlet passage 29”) disposed adjacent the sealing surface.
As per dependent Claim 2, Daly further discloses inflatable penile prosthesis wherein the sealing surface is disposed between the slot (29) and the valve 30 (fig. 5-6, col. 4 lines 55-62).
As per dependent Claim 3, Daly further discloses inflatable penile prosthesis wherein the slot is a first slot formed by 29, the valve body includes a second slot 29 (fig. 8) formed in valve body 27 (fig. 8, shows multiple slots in valve).
As per dependent Claim 4, Daly further discloses inflatable penile prosthesis wherein the slot is a first slot formed by 29, the valve body includes a second slot 29 (fig. 8) disposed adjacent the sealing surface, the sealing surface being disposed between the second slot (29) and the valve 30 cap .
As per dependent Claim 5, Daly further discloses inflatable penile prosthesis wherein the valve (30) includes an elongate portion extending into valve body 27 and an engagement portion, the engagement portion having a surface configured to engage the sealing surface of the valve body between seal formed by valve 30 and valve body 27.
As per dependent Claim 7, Daly further discloses inflatable penile prosthesis of claim 1, wherein the slot 29 includes a linear portion formed by base or sidewall of slot 29.
As per dependent Claim 8, Daly further discloses inflatable penile prosthesis wherein the pump assembly (18) includes a biasing member (valve 30 cap which is biased to the closed position at rest as in fig. 6), the biasing member being configured to bias the valve towards the sealing surface as seen in fig. 6.
As per dependent Claim 9, Daly further discloses inflatable penile prosthesis wherein the pump assembly includes a biasing member (43), the biasing member being configured to engage the valve (23, 39) and bias the valve towards the sealing surface (42 col. 5 lines 15-26 “pressure relief valve 23 …the seal 41 is seated against an internal annular flange 42 in the housing … seal 41 is maintained seated by a precalibrated spring 43.”).
As per dependent Claim 10, Daly further discloses inflatable penile prosthesis wherein the pump assembly (18) includes a spring member represented by cap of valve 30 which is spring biased to the closed position while at rest as seen in fig. 5.
As per dependent Claim 11, Daly further discloses inflatable penile prosthesis wherein valve (30) includes a surface configured to engage the sealing surface formed by underside of the valve 30 cap, the surface of the valve including a projection portion represented by tapered portion of cap of the valve 30 (fig. 5-7).
As per dependent Claim 12, Daly further discloses inflatable penile prosthesis wherein the valve (30) includes a projection portion represented by tapered portion of cap of the valve 30, the projection portion being configured to engage the sealing surface of the valve body (fig. 5-7).
As per dependent Claim 13, Daly further discloses inflatable penile prosthesis wherein the valve (30) includes a first member (30a) and a second member represented by stem of valve 30 inside passageway 33 (fig. 5-7), the first member being configured to move with respect to the second member as in fig. 7.
As per dependent Claim 15, Daly further discloses inflatable penile prosthesis wherein the valve 23 defines a groove (fig. 10) configured to receive at least a portion of a biasing member/spring 43 (fig. 1, 10-11, spring within groove-like structure).
As per independent Claim 16, Daly discloses an inflatable penile prosthesis (Daly in at least abstract, fig. 1-11, col. 1 lines 9-13, lines 60-65, col. 2 lines 5-44, col. 3 line 4-68, col. 4 line 1-68, col. 5 line 1-68, col. 6 lines 1-42, col. 7 lines 1-6 for example discloses relevant subject-matter. More pertinently, Daly in at least abstract, fig. 1, col. 1 lines 9-13, col. 3 lines 4-18 for example discloses inflatable penile prosthesis. See at least col. 1 lines 10-11, lines 62-65 “a inflatable penile implant”), comprising:
a fluid reservoir (21) configured to hold fluid (Daly in at least col. 3 lines 38-40 “chamber 21 is substantially filled with a non-compressible hydraulic fluid 22 which may be a biocompatible fluid such as saline or a free flowing silicone gel”);
an inflatable member (20);
a pump assembly configured to transfer the fluid between the fluid reservoir and the inflatable member, the pump assembly (18, 23) including a pump bulb (28), a valve body (35), a valve (23, 39) disposed within the valve body, a first fluid port (44) configured to be fluidly coupled to the fluid reservoir, and a second fluid port (at 42) configured to be fluidly coupled to the inflatable member, the valve being configured to move between an inflation position (fig. 10) and a deflation position (col. 5 lines 55-60 “implant 11 can be quickly and more totally deflated by bending and the valve 23 will not close until the pressure has dropped substantially thereby giving the implant better flaccidity”); and a pressure relief valve (23, 39), wherein the valve defines a cavity (fig. 10), the pressure relieve valve is disposed within the cavity and is configured to move within the cavity (fig. 1, 10).
As per dependent Claim 17, Daly further discloses inflatable penile prosthesis wherein the valve defines a groove (fig. 10) configured to receive a biasing member/spring 43 (spring within groove-like structure).
As per dependent Claim 18, Daly further discloses inflatable penile prosthesis wherein the valve defines a groove (fig. 10) configured to receive a portion of a spring 43 (fig. 1, 10, spring within groove-like structure).
As per independent Claim 19, Daly discloses an inflatable penile prosthesis (Daly in at least abstract, fig. 1-11, col. 1 lines 9-13, lines 60-65, col. 2 lines 5-44, col. 3 line 4-68, col. 4 line 1-68, col. 5 line 1-68, col. 6 lines 1-42, col. 7 lines 1-6 for example discloses relevant subject-matter. More pertinently, Daly in at least abstract, fig. 1, col. 1 lines 9-13, col. 3 lines 4-18 for example discloses inflatable penile prosthesis. See at least col. 1 lines 10-11, lines 62-65 “a inflatable penile implant”), comprising:
a fluid reservoir (21) configured to hold fluid (Daly in at least col. 3 lines 38-40 “chamber 21 is substantially filled with a non-compressible hydraulic fluid 22 which may be a biocompatible fluid such as saline or a free flowing silicone gel”);
an inflatable member (20); and
a pump assembly (18) configured to transfer the fluid between the fluid reservoir and the inflatable member (Daly in at least col. 5 line col. 6 lines 1-3 “outer chamber 21 serves primarily as a reservoir of pressurizing fluid for the inner chamber”), the pump assembly including a pump bulb (28), a valve body (27), a valve (32, see col. 4 lines 28-41“valve 17 is seen … inlet valve 30 … outlet valve 32”; col. 5 lines 13-14 “pressure relief valve 23 ”) disposed within the valve body, a first fluid port (29) configured to be fluidly coupled to the fluid reservoir, and a second fluid port (29) configured to be fluidly coupled to the inflatable member, the valve being configured to move between an inflation position (fig. 6) and a deflation position (fig. 5, 7), wherein the valve body includes a sealing surface formed between 27 and 32 (fig. 5-7) configured to engage the valve to form seal (fig. 5), the valve body includes a first slot formed by 31a disposed adjacent the sealing surface, the valve body includes a second slot shown in fig. 9 which shows two slots in the stem portion of the valve 32 disposed adjacent the sealing surface, the sealing surface being disposed between the first slot and the valve (fig. 5), the sealing surface being dispose between the second slot and the valve (fig. 5, fig. 9).
As per dependent Claim 20, Daly further discloses inflatable penile prosthesis wherein the pump assembly 18 includes a biasing member (valve 32 cap which is biased to the closed position at rest as in fig. 5), the biasing member being configured to bias the valve towards the sealing surface formed between 27 and 32 as in fig. 5.
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 of this title, 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.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Daly.
As per dependent Claim 6, Daly discloses inflatable penile prosthesis of claim 1 (see Claim 1 analysis above),
Daly does not necessarily require or explicitly disclose slot is triangular shaped feature.
However, Daly disclosure makes obvious the slot is triangular shaped (Examiner notes that the specification is silent as to the criticality of the recited triangular shape as evidenced in instant application specification as-filed [0054]. Consequently, the shape of the slot 31a disclosed by Daly in fig. 5-6 reads on the subject-matter as now explicitly, positively and specifically recited by the Applicant as a matter of design choice (MPEP 2144.04) to order obtain functionally equivalent fluid movement result).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve body slot as taught by Daly, such that the valve body slot is triangular shaped, as made obvious by Daly. A person of ordinary skill would have been motivated to do so as a matter of design choice (MPEP 2144.04), with a reasonable expectation of success, to obtain the desired functionally equivalent fluid movement result (Daly, col. 6 lines 5-6).
Contingently Allowable Subject-Matter
As per dependent claim 14, dependent claim 14 is being objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per dependent Claim 14, none of the prior art discloses inflatable penile prosthesis wherein the valve body includes a projection, the valve defines a cavity, the valve cavity being configured to receive at least a portion of the projection of the valve body including all of the limitations, features, combination and arrangement of features of their respective base claim and any intervening claims.
Prior art US 4898158 A to Daly discloses inflatable penile implant that includes a tapered pumping chamber, pump valve, a pressure relief valve and a compensator which absorbs any increased pressure to protect the components of the hydraulic system from pressure damage. However, Daly does not disclose wherein the valve body includes a projection, the valve defines a cavity, the valve cavity being configured to receive at least a portion of the projection of the valve body as recited in claim 14.
Prior art US 20190307567 A1 to Mujwid et al. discloses an inflatable penile prosthesis that includes a reservoir configured to hold fluid, an inflatable member, and a pump assembly configured to facilitate a transfer of a fluid from the reservoir to the inflatable member. The pump assembly includes a pump bulb, and a valve body defining a fluid passageway. The valve body includes a refill valve disposed in the fluid passageway. The refill valve includes a valve member. In response to the pump bulb being compressed, the valve member moves within the fluid passageway in a first direction 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 moves 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. However, Mujwid does not disclose wherein the valve body includes a projection, the valve defines a cavity, the valve cavity being configured to receive at least a portion of the projection of the valve body as recited in claim 14.
Prior art US 20070142700 A1 to Fogarty et al. discloses pump that comprises a fluid reservoir, a pump bulb, a plurality of tubing, and at least one inflatable penile cylinder. The pump comprises a pump body, an inlet valve within the pump body, an exhaust valve within the pump body and in fluid communication with the inlet valve, and a deflate valve within the pump body and in fluid communication with the inlet valve and the exhaust valve. The deflate valve enables one-touch release by (i) providing a voluntarily-activated fluid bypass so that fluid from the at least one inflatable penile cylinder can return to the fluid reservoir through at least one of the plurality of tubing without sustained activation of the deflate valve, and (ii) closing upon subsequent inflation of the at least one inflatable penile cylinder when such inflation is initiated by squeezing the pump bulb so that fluid does not flow back to the fluid reservoir. However, Fogarty does not disclose wherein the valve body includes a projection, the valve defines a cavity, the valve cavity being configured to receive at least a portion of the projection of the valve body as recited in claim 14.
However, none of the subject-matter discloses subject-matter of dependent claim 14 i.e. inflatable penile prosthesis wherein the valve body includes a projection, the valve defines a cavity, the valve cavity being configured to receive at least a portion of the projection of the valve body including all of the limitations, features, combination and arrangement of features of their respective base claim and any intervening claims as in claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims. US 4407275 (abstract, fig. 1, 5); US 20160015519 (abstract, fig. 1-3); US 20200129295 (abstract, fig. 1-2); US 5263981 (abstract, fig. 1-7); US 20130324793 (abstract, fig. 1-3); US 20050113638 (abstract, fig. 1-6); US 20160008162 (abstract, fig. 1-11); US 20030135089 (abstract, figures 1-19); US 20180318085 (abstract, fig. 1-13); US 20180214271(abstract, fig. 1-14); US 4224934(abstract, fig. 1-7); US 20190350712(abstract, fig. 1-6 ); US 20120022323(abstract, fig. 1-4); US 20180071101(abstract, fig. 1-5) for disclosing implantable penile prosthesis with features similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (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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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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