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 .
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “an erection” in line 4. It is not clear if this is intended to refer to the erection recited in line 1 of the claim or to a separate erection.
Claim 3 recites the limitation “a second distal end to a second proximal end” in lines 1-2. It is not clear if this is intended to implicitly recite a first distal end and a first proximal end, or if “second” is merely arbitrary and is so-called because these ends are part of the second receptacle. Having this claim depend upon claim 2 would obviate this rejection.
Claim 4 recites the limitation “cup-shaped” in two separate instances. The metes and bounds of this limitation are not clear; cups may have numerous different shapes.
Claims 2-15 are rejected by virtue of their dependence upon claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 11-14 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Each claim recites the limitation “wherein the base of the implantable support is attached to the pelvis of the trans-male person with [an attachment component].” This positively recites the human body. Suggested language would be --wherein the base of the implantable support is configured to be attached to the pelvis of the trans-male person with-- or --wherein the base of the implantable support is attachable to the pelvis of the trans-male person with--.
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.
Claims 1, 4, 5, 7, 8, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elist (U.S. No. 5,899,849).
Regarding claim 1, Elist discloses a device 5 adapted to support an erection for a trans-male person identified as female at birth (Abstract; Figs. 1-3; device is capable of such intended use), the device comprising: a penile prosthesis 6 implantable into a neophallus of the trans-male person and adapted to provide the neophallus with an erection (col. 5, lines 56-67; capable of such intended use) and an implantable support comprising a base 40 attachable to a pelvis of the trans-male person, the implantable support comprising a first body attached to the base and forming a first recess on a first side of the base and a second body attached to the base and forming a second recess adjacent to the first recess of the first body and located on a second side of the base; wherein the first recess of the first body forms a first receptacle that is shaped and sized to receive a first proximal end portion of the penile prosthesis; wherein the second recess of the second body forms a second receptacle that is shaped and sized to receive a second proximal end portion of the penile prosthesis (Figs. 1-3; col. 6, lines 52-62; e.g., the cylinders extending from base 40 are taken to be the first and second bodies with first and second recesses; proximal end portions of inflatable tubular sack means 20 are received within these recesses); wherein, when the base of the implantable support is attached to the pelvis of the trans-male person with the first proximal end portion of the penile prosthesis inserted into the first receptacle and the second proximal end portion of the penile prosthesis inserted into the second receptacle, the neophallus of the trans-male person, when erect, will be adapted for penetrative intercourse (col. 4, lines 37-52; capable of such intended use).
Regarding claim 4, Elist discloses that the first recess of the first body has a first closed base and is cup-shaped, and the second recess of the second body has a second closed base and is cup-shaped (Figs. 2, 3; such cylindrical structures are taken to meet the broadest reasonable interpretation of “cup-shaped”).
Regarding claim 5, Elist discloses a first connecting structure connected between the first body and the base and a second connecting structure connected between the second body and the base (Figs. 2, 3; e.g., the connections between the first and second bodies and the base may be taken to comprise connecting structures).
Regarding claim 7, Elist discloses that the penile prosthesis comprises a dual cylinder inflatable penile prosthesis, with a first cylinder of the dual cylinder inflatable penile prosthesis insertable into the first recess of the first body and a second cylinder of the dual cylinder inflatable penile prosthesis insertable into the second recess of the second body (col. 5, lines 64-67).
Regarding claim 8, Elist discloses that the penile prosthesis comprises a dual cylinder malleable penile prosthesis, with a first cylinder of the dual cylinder malleable penile prosthesis insertable into the first recess of the first body and a second cylinder of the dual cylinder malleable penile prosthesis insertable into the second recess of the second body (col. 6, lines 15-26).
Regarding claim 12, Elist discloses that the base of the implantable support is attached to the pelvis of the trans-male person with a suture 46 (col. 6, lines 55-57).
Regarding claim 15, Elist discloses that a longitudinal axis vertically separates and spaces the first body apart from the second body to locate the first recess on a patient right hand side of the base and the second recess adjacent to the first recess and located on a patient left hand side of the base (Fig. 3; e.g., longitudinal axis along suture hole 42).
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.
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.
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.
Claims 1-3, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel (U.S. Pub. No. 2012/0184806 A1), in view of Choi et al. (U.S. Pub. No. 2008/0139880 A1; cited in the IDS filed 11 November 2024; hereinafter known as “Choi”).
Regarding claim 1, Daniel discloses a device 20 adapted to support an erection for a trans-male person identified as female at birth (Abstract; Fig. 1; device is capable of such intended use), the device comprising: a penile prosthesis 26 implantable into a neophallus of the trans-male person and adapted to provide the neophallus with an erection ([0027]; capable of such intended use), wherein the penile prosthesis includes first and second proximal end portions 36 ([0031]). Daniel fails to disclose an implantable support comprising a base attachable to a pelvis of the trans-male person, the implantable support comprising a first body attached to the base and forming a first recess on a first side of the base and a second body attached to the base and forming a second recess adjacent to the first recess of the first body and located on a second side of the base; wherein the first recess of the first body forms a first receptacle that is shaped and sized to receive the first proximal end portion of the penile prosthesis; wherein the second recess of the second body forms a second receptacle that is shaped and sized to receive the second proximal end portion of the penile prosthesis; wherein, when the base of the implantable support is attached to the pelvis of the trans-male person with the first proximal end portion of the penile prosthesis inserted into the first receptacle and the second proximal end portion of the penile prosthesis inserted into the second receptacle, the neophallus of the trans-male person, when erect, will be adapted for penetrative intercourse. Choi discloses a similar device adapted to support an erection (Abstract; Figs. 1, 2, 11, 14) comprising an implantable penile prosthesis 10 for providing an erection ([0001]) and an implantable support comprising a base 33 attachable to a pelvis 34 of a trans-male person, the implantable support comprising a first body 31 forming a first recess 32 on a first side of the base, wherein the first recess of the first body forms a first receptacle that is shaped and sized to receive a first proximal end portion of the penile prosthesis, in order to prevent shaking or dislocation of the prosthesis ([0022]; [0056]-[0057]); wherein, when the base of the implantable support is attached to the pelvis of the trans-male person with the first proximal end portion of the penile prosthesis inserted into the first receptacle, the neophallus of the trans-male person, when erect, will be adapted for penetrative intercourse ([0010]; [0022]; capable of such intended use). 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 invention of Daniel with such an implantable support, as taught by Choi, in order to prevent shaking or dislocation of the penile prosthesis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Daniel and Choi so that the implantable support additionally comprises a second body attached to the base and forming a second recess adjacent to the first recess and located on a second side of the base, wherein the second recess of the first body forms a second receptacle that is shaped and sized to receive the second proximal end portion of the penile prosthesis, in order to properly support both cylinders of Daniel’s penile prosthesis.
Regarding claims 2 and 3, the combination of Daniel and Choi discloses the invention as claimed, see rejection supra, and Choi further discloses that the first and second receptacles are conical in shape tapering from first and second distal ends to first and second proximal ends, and so sized to receive the first and second proximal end portions of the penile prosthesis, respectively (Fig. 11).
Regarding claims 9 and 10, the combination of Daniel and Choi discloses the invention as claimed, see rejection supra, but fails to expressly disclose that a depth of the first recess of the first body or the second recess of the second body is in a range from 1-4 cm. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Daniel and Choi with the recited dimensions via routine experimentation/optimization. Choi teaches general dimensions of the prosthesis ([0021]), while Daniel teaches selecting a proper length of the penile implant ([0043]; [0048]). Thus, it would not have been inventive to determine the optimum or workable depth of the recesses via routine experimentation, as the general conditions are disclosed in the prior art; the possible values are constrained by the requisite size of the penis/neophallus and the base being able to sufficiently support the penile prosthesis.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel and Choi as applied to claim 1 above, and further in view of Gomez-Llorens (U.S. Pub. No. 2018/0200060 A1; cited in the IDS filed 11 November 2024).
Regarding claim 11, the combination of Daniel and Choi discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the base of the implantable support is attached to the pelvis of the trans-male person with a screw; Choi teaches that the attachment may be made by “adhesive or other relevant means” ([0057]). Gomez-Llorens teaches a similar device (Abstract; Fig. 1) comprising a base 3 that is attached to a pelvis with a screw ([0048]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Daniel and Choi so that the base is attached to the pelvis with a screw, as taught by Gomez-Llorens, as this is a known effective and appropriate attachment means.
Regarding claim 13, the combination of Daniel and Choi discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the base of the implantable support is attached to the pelvis of the trans-male person with a textile wrap; Choi teaches that the attachment may be made by “adhesive or other relevant means” ([0057]). Gomez-Llorens teaches a similar device (Abstract; Fig. 1) comprising a base 3 that is attached to a pelvis with a textile wrap ([0049]; embedded mesh is taken to be such a textile wrap). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Daniel and Choi so that the base is attached to the pelvis with a textile wrap, as taught by Gomez-Llorens, as this is a known effective and appropriate attachment means.
Allowable Subject Matter
Claims 6 and 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) and 35 U.S.C. 101 set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: regarding claim 6, none of the prior art of record teaches or reasonably suggests such first and second connecting structures that respectively orient the first and second recesses at an angle in a range from 5-30 degrees relative to the base, in combination with the other recited features. Regarding claim 14, none of the prior art of record teaches or reasonably suggests using a bone graft material to attach such a base to a pelvis, in combination with the other recited features.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
