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 .
Election/Restrictions
Applicant’s election without traverse of invention I and species I, claims 1-12, in the reply filed on 13 March 2026 is acknowledged. The previous office action included claim 13 in both invention I and invention II, but the method of invention II starts with claim 13, with the penile sleeve device limited to claims 1-12 and 16-23, therefore the invention I and species I is limited to claims 1-12.
Claims 1-23 are pending in the instant application, but claims 13-23 are withdrawn from consideration.
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 2 and 3 are objected to because of the following informalities:
Claim 2, 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 3, line 2 states “a second plurality plurality of V-cuts” but should read -- a second plurality of V-cuts--.
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 1-12 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 2-12 inherit the same deficiencies.
Claim 12, line 1, recites the limitation “said indicia”, There is insufficient antecedent basis for this limitation in the claim. Claim 12 is dependent on claim 9 but should be dependent on claim 11.
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, and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cornell (US20200022812A1) and further in view of Loria (US9877835B1).
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 and a proximal end at a 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 (Paragraph [0032]), 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 Cornel, 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).
Regarding claim 2, 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 5, Cornell, as modified by Loria, discloses said elongated member comprises a
durometer of Shore A (40-50) (Cornell, Paragraph [0034]).
Regrading claims 6-8, 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 9, 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]).
Allowable Subject Matter
Claims 3, 4, an 10-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, 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 claims 3 and 4, Loria is the closest prior art for teaching the use of V-cuts in a penile implant, but Loria does not disclose the V-cuts may vary in size, wherein the V-cuts vary in size along the longitudinal axis of the elongate member.
Regarding claim 10, Cornell is the closest prior art for teaching a penile implant with a vary thickness along the longitudinal axis, but Cornell does not teach a thickness of said elongated member in a portion of said proximal portion decreases towards a proximal end of said elongated member.
Regarding claims 11 and 12, the prior art does not teach a penile implant that comprises the limitations of claim 1, wherein indicia is provided at a distal end on a dorsal side of said elongated member, and wherein the indicia is a notch.
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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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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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
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