L52 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 .
Response to Amendment
Applicant’s amendment, filed 23 June 2026, is acknowledged. Claims 1, 5, and 16 are amended. Claims 17 and 18 are cancelled.
Claims 1-16, 19 and 20 are pending in the instant application.
Response to Arguments
Applicant’s arguments, filed 31 July 2026, with respect to the objection to the drawings, have been fully considered and are persuasive in light of the amendment. The objection to the drawings has been withdrawn.
Applicant’s arguments, with respect to the 35 USC 102 rejections of claims 1-5, 10, 11 and 13-17, and 19 have been fully considered and are persuasive in light of the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Derus (US A1).
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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) 1-3, 10, 11, 13-14 and 16 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Derus (US 20130324793 A1).
Regarding claim 1, Derus discloses an implantable inflatable device (Abstract), comprising an elongate member having a storage portion and an inflatable portion (Abstract) and a pump assembly operatively coupled to the elongate member (Figure 2) such that the storage portion of the elongate member is fluidically disposed between the inflatable portion of the elongate member and the pump assembly (Figure 2, the fluid flow goes from the inflation volume to the reservoir to the pump), the pump assembly being configured to transfer fluid from the storage portion of the elongate member to the inflatable portion of the elongate member (Figures 1 and 2).
Regarding claim 2, Derus discloses the storage portion is fluidically coupled to the inflatable portion (Figure 2), the elongate member includes a flow control member disposed between the storage portion and the inflatable portion (Figure 2, valve).
Regarding claim 3, Derus discloses the storage portion is fluidically coupled to the inflatable portion (Figure 2), the elongate member includes a flow restrictor or a valve disposed between the storage portion and the inflatable portion (Figure 2, valve).
Regarding claim 10, Derus discloses the pump assembly is operatively coupled to the elongate member via a tubular member.
Regarding claim 11, Derus discloses the pump assembly is operatively coupled to the elongate member via a tubular member (Figures 1 and 2).
Regarding claim 13, Derus discloses the elongate member is configured to be disposed within a penis of a patient (Abstract)).
Regarding claim 14, Derus discloses the elongate member and the pump assembly are configured to be disposed within a pelvic region of a patient (Figure 3, in order for the elongate member to function it has to be in the pelvic region. The design is common in the art, wherein the pump is implanted in the scrotum).
Regarding claim 16, Derus discloses an implantable inflatable device (Abstract), comprising an elongate member (Abstract, Figure 2) having an inflatable portion (Abstract, Figure 2), a storage portion (Abstract, Figure 2), and a flow control member fluidically disposed between the inflatable portion and the storage portion (Figure 2, valve); a pump assembly operatively coupled to the elongate member via a tubular member (Figure 2) such that the storage portion of the elongate member is fluidically disposed between the pump assembly and the inflatable portion of the elongate member (Figure 2, the fluid flow goes from the inflation volume to the reservoir to the pump), the pump assembly being configured to transfer fluid to the inflatable portion of the elongate member (Figures 1 and 2).
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.
Claim(s) 4, 5, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Derus (US 20130324793 A1) in view of Buuck (US 3954102 A).
Regarding claims 4 and 5, which are identical, Derus does not disclose the elongate member is a first elongate member, the device further comprising: a second elongate member having a storage portion and an inflatable portion, the pump assembly being operatively coupled to the second elongate member and configured to transfer fluid from the storage portion of the second elongate member to the inflatable portion of the second elongate member. Buuck discloses a prosthesis that comprises a pair of expandable cylinders which are implanted in the penis, replacing the function and space of the two corpora cavernosa for physiologically compatibility (Abstract, Col 1, lines 35-37, Figures 4 and 5). Buuck further discloses a pump assembly (Figure 6 “96”) being operatively coupled to the second elongate member (Figure 6) and configured to transfer fluid from a storage portion to the inflatable portion of the second elongate member (Figure 6). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Derus, to have a second elongate member of the same design connected to a singular pump as taught by Buuck, since such a modification would provide replacing the function and space of the two corpora cavernosa for physiologically compatibility (Abstract, Col 1, lines 35-37, Figures 4 and 5).
Regarding claim 12, Derus does not disclose the elongate member is a first elongate member, the device further comprising: a second elongate member, the pump assembly being operatively coupled to the first elongate member and the second elongate member via a Y shaped tubular member. Buuck discloses a prosthesis that comprises a pair of expandable cylinders which are implanted in the penis, replacing the function and space of the two corpora cavernosa for physiologically compatibility (Abstract, Col 1, lines 35-37, Figures 4 and 5). Buuck further discloses a pump assembly (Figure 6 “96”) being operatively coupled to the first elongate member and the second elongate member via a Y shaped tubular member (Figure 6). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Derus, to have a second elongate member of the same design connected to a singular pump via a Y shaped tubular member as taught by Buuck, since such a modification would provide replacing the function and space of the two corpora cavernosa for physiologically compatibility (Abstract, Col 1, lines 35-37, Figures 4 and 5).
Regarding claim 19, Derus does not disclose the elongate member is a first elongate member, the device further comprising: a second elongate member. Buuck discloses a prosthesis that comprises a pair of expandable cylinders which are implanted in the penis, replacing the function and space of the two corpora cavernosa for physiologically compatibility (Abstract, Col 1, lines 35-37, Figures 4 and 5). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Derus, to have a second elongate member of the same design as taught by Buuck, since such a modification would provide replacing the function and space of the two corpora cavernosa for physiologically compatibility (Abstract, Col 1, lines 35-37, Figures 4 and 5).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Derus (US 20130324793 A1) in view of Borgaonkar (US 20120157764 A1).
Regarding claim 9, Derus does not disclose the elongate member includes an adjustable portion, the adjustable portion including a plurality of pieces configured to be removably coupled to each other. Borgaonkar discloses an implantable penile prosthesis having an adjustable length rear tip extender (Abstract) wherein the adjustable extender comprises a plurality of pieces configured to be removably coupled to each other (Paragraph [0026] Figures 5-6). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Derus, with the adjustable length rear tip extender as taught by Borgaonkar, since such a modification would provide the predictable results of “insuring the implantable penile prosthesis is properly fitted and positioned within the penis according to the specific anatomy of the male patient” (Paragraph [0003]).
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Derus (US 20130324793 A1) in view of Marconi Toro (WO 2021203212 A1).
Regarding claims 6-8, Derus does not disclose an adjustable portion. Marconi Toro discloses a prosthetic device for implantation within the corpora cavernosa of a penis (Abstract), wherein the distal end of the prosthetic comprises a shortenable anchoring rod (Abstract), wherein the storage portion is disposed between the adjustable portion and the inflatable portion (Figure 2, adjustable portion “600”, storage portion “700”, inflatable portion “10”), with the adjustable portion being configured to be cut to adjust a size of the adjustable portion (Page 10, last paragraph) and the adjustable portion including visual indicia (Page 10, last paragraph). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Derus with the adjustable distal end as taught by Marconi Toro, since such a modification would provide the predictable results of allowing the device to be trimmed to fit the needs of the patient (Page 11).
Claims 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Derus (US 20130324793 A1) in view of Forsell (US 20120022324 A1).
Regarding claims 15 and 20, Derus does not disclose the pump assembly is configured to be wirelessly coupled to a controller. Forsell discloses a penile implant (Abstract) wherein the pump is wirelessly controlled via a wireless remote (Paragraph [0355]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Derus, with the pump assembly being configured to be wirelessly coupled to a controller as taught by Forsell, since such a modification would provide the predictable results of reducing the user’s need to manipulate the implanted device.
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 Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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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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/M.D.H./Examiner, Art Unit 3791
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
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