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 Objections
Claims 3, 11, 24, 25, and 28 are objected to because of the following informalities:
Claim 3, line 3, states “provided a desired thickness” but should read --provides a desired thickness--.
Claim 11, line 1 states “wherein each V-cuts” but should read --wherein each V-cut of the plurality of V-cuts-- for grammar and antecedent basis.
Claim 24, lines 3-4, states “provided a desired thickness” but should read --provides a desired thickness--.
Claims 25 and 28, line 1, state “The penile sleeve” but should read --The penile sleeve device--.
Appropriate correction is required.
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 1-21 and 23-26 and 28 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, line 8, recites the limitation "a shorter arcuate shaped configuration" which renders the claim indefinite because it is not clear what the arcuate shaped configuration is being compared to.
Claim 1, line 16, recites the limitation " the silicone material" but line 7 recites “a bio-implantable reinforced silicon rubber” which renders the claim indefinite because it is not clear if the silicone material is referencing the silicon rubber of line 7.
Claims 2-21 inherit the same deficiencies.
Claims 2 and 23, line 2 recite “a non-dissolvable/absorbable bio-implantable netting/mesh material” which renders the claim indefinite because it is unclear if the “/” is intended to be “and” or “or”.
Claims 3, 4, 24 and 25 inherit the same deficiencies.
Claims 26 and 28 recite the limitation "said mesh layer" in line 1. There is insufficient antecedent basis for this limitation in the claims.
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) 1, 2, 5-11, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cornell (US20200022812A1) in view of Loria (US9877835B1) and further in view of Elist (US20210361433A1).
Regarding claim 1, Cornell discloses a penile sleeve device configured for implantation in the subcutaneous space of a patient's penis for enhancing or correcting penis shape and size (Abstract), the penis having a glans, a penile shaft, penile dermis and an associated pubic area of the patient (Figure 14B), said penile sleeve device comprising an elongated member having a longitudinal axis (Figure 1) and formed of a bio-implantable reinforced silicon rubber (Paragraphs [0032], [0044])), said elongated member having a distal portion comprising a C-shaped configuration (Figure 1 and Figure 4) and having a proximal portion having a shorter arcuate shaped configuration (Figure 1 and Figure 3, the interior circumference of the proximal portion is smaller than the interior circumference of the distal portion (Figure 4)) and wherein said elongated member further comprises a transitional portion formed between said distal portion and said proximal portion (Figure 2, this could be interpreted as the straight portion of the device), said distal portion configured for implantation on the patient's penile shaft adjacent the glans of the patient's penis and said proximal portion configured for implantation on the patient's penile shaft adjacent the pubic area of the patient (Paragraph [0048]), said elongated member having a pair of longitudinal edges from said distal portion, through said transitional portion and through said proximal portion (Figure 2).
Cornell does not disclose said longitudinal edges each comprise a plurality of V-cuts transversely oriented with regard to said longitudinal axis (the limitation “to avoid or minimize any buckling of the silicone material in said penile sleeve device if the penis is ever rotated or twisted with said penile sleeve device implanted therein.” Is written as intended use). Loria discloses a penile insert device effective to prevent retraction of the penis and to increase the length of a penis in its flaccid or erect state. Loria further discloses the insert device comprises a plurality of alternating lateral plateaus and lateral valleys (Abstract) which serve to provide for a bendable device that can move with the movement of the penis without causing discomfort to the user (Col 2, lines 14-15). 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 Cornell, with the longitudinal edges each comprising a plurality of V-cuts transversely oriented with regard to said longitudinal axis as taught by Loria, since such a modification would provide the predictable results of a bendable device that can move with the movement of the penis without causing discomfort to the user (Loria, Col 2, lines 14-15).
Cornell, as modified by Loria, discloses mesh tabs located at the proximal and distal ends of the elongate body for the purpose of suturing the implant and promoting tissue ingrowth (Cornell, Paragraph [0049]). Modified Cornell does not disclose a mesh cover surrounding said elongated member for enhancing anchoring of said elongated member in the penile dermis. Elist discloses a genital implant enhancement device wherein the genital implant device comprises an elongated cylindrical sleeve that is configured to encircle a shaft of a penis (Abstract). Elist further discloses using a mesh layer as the external layer to the device in order to enable tissue ingrowth (Paragraph [0021]) wherein the mesh is configured to cover the sleeve (Paragraph [0062]). 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 modified Cornell, with a mesh cover surrounding said elongated member for enhancing anchoring of said elongated member in the penile dermis as taught by Elist, since such a modification would provide the predictable results of better allowing the patient to acclimate to the device through tissue ingrowth (Elist, Paragraph [0021]).
Regarding claim 2, Cornell, as modified by Elist, further discloses said mesh cover includes a mesh layer comprising a non-dissolvable/absorbable bio-implantable netting/mesh material (Elist, Paragraph [0021]).
Regarding claims 5 and 6, Cornell, as modified by Elist, further discloses said mesh layer is coupled to said elongated member with dissolvable sutures (Elist, Paragraphs [0032], [0033]).
Regarding claim 7, Cornell, as modified by Elist further discloses said mesh layer is formed into a shape similar to a shape of said elongated member to form a snug fit around said elongated member (Paragraph [0062]).
Regarding claims 8-10, modified Cornell did not previously disclose said penile sleeve device comprises a length in the range of 1.5-9 inches. Loria discloses the penile insert may be manufactured to have an initial length of about 9-12 inches and then cut down to size to fit each recipient individually and to a desired flaccid penile length (Col 6, lines 6-13). 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 modified Cornell, with said penile sleeve device comprising a length to fit each recipient individually and to a desired flaccid penile length as taught by Loria, and since the length disclosed by Loria is greater than 9 inches, it would have been obvious to modified the device to a length in a range of 1.5-9 inches in order to fit individual patients.
Regarding claim 11, Cornell, as modified by Loria, discloses each V-cut is oriented such that a wider opening of said V-cut is along a longitudinal edge, with said V -cut tapering down in a direction towards a dorsal region of said penile sleeve device (Loria, Figure 1).
Regarding claim 14, Cornell, as modified by Loria, discloses said elongated member comprises a
durometer of Shore A (40-50) (Cornell, Paragraph [0034]).
Regrading claims 15-17, Cornell, as modified by Loria, discloses the elongate edges to include distal and proximal portions have pillowed or rounded edges (Cornell, Paragraph [0048]).
Regarding claim 18, Cornell, as modified by Loria, discloses thickness of said elongated member in a portion of said distal portion increases towards a thickness of said elongated member in said transitional portion (Paragraph [0048]).
Claim(s) 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Cornell (US20200022812A1) in view of Loria (US9877835B1) and Elist (US20210361433A1) and further in view of Yachia (US4602625A).
Regarding claim 3, modified Cornell does not disclose said mesh cover further comprises at least one silicone sheet coupled to said mesh layer, said at least one silicone sheet comprising silicone sheeting material that is non-reinforced, said at least one silicone sheet provided a desired thickness to said mesh cover. Yachia discloses a penile erectile system for treating male impotency comprising a sleeve of biocompatible material (Abstract) wherein the sleeve is encased in a smooth outer cover of silicone coated mesh (Col 3, lines 61-64, Figure 1, “27”). The coating of silicone can be interpreted as layer or sheet of silicone and the coating would be non-reinforced before it is coupled to the mesh. The coupled mesh and silicone would provide a desired thickness by design. 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 modified Cornell, with a mesh cover that further comprises at least one silicone sheet coupled to said mesh layer, said at least one silicone sheet comprising silicone sheeting material that is non-reinforced, said at least one silicone sheet provided a desired thickness to said mesh cover as taught by Yachia, since such a modification would provide the predictable results of controlled elasticity (Col 3, lines 61-64).
Regarding claim 4, Cornell, as modified by Loria and Elist, disclosed the mesh cover is coupled to the elongate member with sutures in claim 5 supra. As Cornell, modified in claim 3 by Yachia, discloses the silicone coats the mesh, as the mesh is sutured to the elongated member, the silicone would also be coupled to the mesh via suture.
Claim(s) 22, 23, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Cornell (US20200022812A1) in view of Elist (US20210361433A1).
Regarding claim 22, Cornell discloses a penile sleeve device configured for implantation in the subcutaneous space of a patient’s penis for enhancing or correcting penis shape and size (Abstract), the penis having a glans, a penile shaft, penile dermis and an associated pubic area of the patient (Figure 14B), said penile sleeve device comprising: an elongated tubular section (Figure 1) comprising a flexible elastomer for maintaining the penis outstretched in a flaccid or erect state (Paragraph [0044]) and a high durometer silicone rubber material providing hardness and structural support features (Paragraph [0033], the hardness of the material varies based on design need), said elongated tubular section having a proximal end flange (Figure 1, “116”), configured for positioning near the pubic bone (Paragraph [0048]), and having a tapered distal end (Figure 1), configured for positioning adjacent the glans of the penis (Paragraph [0048]), said elongated tubular section being configured to be positioned around the penile shaft in the subcutaneous space of the patient’s penis )Figures 14B and 14C)
Cornell discloses mesh tabs located at the proximal and distal ends of the elongate body for the purpose of suturing the implant and promoting tissue ingrowth (Cornell, Paragraph [0049]). Cornell does not disclose said elongated tubular section further comprises a mesh cover surrounding said elongated member for enhancing anchoring of said elongated member in the penile dermis. Elist discloses a genital implant enhancement device wherein the genital implant device comprises an elongated cylindrical sleeve that is configured to encircle a shaft of a penis (Abstract). Elist further discloses using a mesh layer as the external layer to the device in order to enable tissue ingrowth (Paragraph [0021]) wherein the mesh is configured to cover the sleeve (Paragraph [0062]). 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 Cornell, with a mesh cover surrounding said elongated member for enhancing anchoring of said elongated member in the penile dermis as taught by Elist, since such a modification would provide the predictable results of better allowing the patient to acclimate to the device through tissue ingrowth (Elist, Paragraph [0021]).
Regarding claim 23, Cornell, as modified by Elist, further discloses said mesh cover includes a mesh layer comprising a non-dissolvable/absorbable bio-implantable netting/mesh material (Elist, Paragraph [0021]).
Regarding claims 26 and 27, Cornell, as modified by Elist, further discloses said mesh layer is coupled to said elongated member with dissolvable sutures (Elist, Paragraphs [0032], [0033]).
Regarding claim 28, Cornell, as modified by Elist, further discloses said mesh layer is formed into a shape similar to a shape of said elongated member to form a snug fit around said elongated member (Elist, Paragraph [0062]).
Claim(s) 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Cornell (US20200022812A1) in view of Elist (US20210361433A1) and further in view of Yachia (US4602625A).
Regarding claim 24, modified Cornell does not disclose said mesh cover further comprises at least one silicone sheet coupled to said mesh layer, said at least one silicone sheet comprising silicone sheeting material that is non-reinforced, said at least one silicone sheet provided a desired thickness to said mesh cover. Yachia discloses a penile erectile system for treating male impotency comprising a sleeve of biocompatible material (Abstract) wherein the sleeve is encased in a smooth outer cover of silicone coated mesh (Col 3, lines 61-64, Figure 1, “27”). The coating of silicone can be interpreted as layer or sheet of silicone and the coating would be non-reinforced before it is coupled to the mesh. The coupled mesh and silicone would provide a desired thickness by design. 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 modified Cornell, with a mesh cover further comprises at least one silicone sheet coupled to said mesh layer, said at least one silicone sheet comprising silicone sheeting material that is non-reinforced, said at least one silicone sheet provided a desired thickness to said mesh cover as taught by Yachia, since such a modification would provide the predictable results of controlled elasticity (Col 3, lines 61-64).
Regarding claim 25, Cornell, as modified by Loria and Elist, disclosed the mesh cover is coupled to the elongate member with sutures in claim 26 5 supra. As Cornell, modified in claim 24 by Yachia, discloses the silicone coats the mesh, as the mesh is sutured to the elongated member, the silicone would also be coupled to the mesh via suture.
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 and 11-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12 of copending Application No. 17/994,874 in view of Elist (US20210361433A1). Claims 1 and 11-21 of the instant application are identical to claims 1-12 of copending Application No. 17/994,874, except for claim 1 of the instant application recites “mesh cover surrounding said elongated member for enhancing anchoring of said elongated member in the penile dermis.” Elist discloses a genital implant enhancement device wherein the genital implant device comprises an elongated cylindrical sleeve that is configured to encircle a shaft of a penis (Abstract). Elist further discloses using a mesh layer as the external layer to the device in order to enable tissue ingrowth (Paragraph [0021]) wherein the mesh is configured to cover the sleeve (Paragraph [0062]). 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 claims of the copending application, with a mesh cover surrounding said elongated member for enhancing anchoring of said elongated member in the penile dermis as taught by Elist, since such a modification would provide the predictable results of better allowing the patient to acclimate to the device through tissue ingrowth (Elist, Paragraph [0021]).
This is a provisional nonstatutory double patenting rejection.
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.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
Prosecution Insights