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 disclosure is objected to because of the following informalities: Applicant is requested to amend the first paragraph of the specification to indicate that parent application 16/939,441 is now U.S. Patent No. 11,660,193.
Appropriate correction is required.
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
Claim 13 is objected to because of the following informalities: in line 2, “configured couple” should apparently read --configured to couple--. 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 2-10 and 15-20 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 2 recites the limitation "the middle third" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “a resilient ellipse” in line 1. It is not clear what is meant by this limitation. An ellipse is a shape, not a structural component. Further, an ellipse is a two-dimensional shape, yet the specification appears to refer to such as a three-dimensional structure that is used as an artificial testicle.
Claims 7 and 10 each recite that “the plate includes silicon.” It is unclear if this is actually intended to recite silicon (i.e., the semiconductor element) or silicone. Silicon is a hard and brittle element that is not generally implanted in the human body and would not likely be able to be bent as recited in claim 1. Silicone, by contrast, is a well-known biocompatible material that is flexible and elastic and thus easily bendable.
Claim 8 recites the limitation “is to couple” in line 2. It is not clear if this is reciting an intended use (i.e., that the additional inflatable tube is to be coupled to the pump) or an actual structural limitation of the claimed prosthetic (i.e., the limitation should read something like --wherein the additional inflatable tube is coupled to the pump via…--).
Claims 3-10 are rejected by virtue of their dependence upon at least one rejected base claim.
Claim 15 recites the limitation “a resilient ellipse” in line 1. It is not clear what is meant by this limitation. An ellipse is a shape, not a structural component. Further, an ellipse is a two-dimensional shape, yet the specification appears to refer to such as a three-dimensional structure that is used as an artificial testicle.
Claim 17 recites the limitation “[t]he prosthetic of claim 15 comprising at least one of collagen, fibrin, or combinations thereof.” It is not clear if this is intended to recite that the entire prosthetic comprises at least one of these materials, or rather that the prosthetic additionally comprises at least one of these materials (e.g., as a coating), or if merely a sub-component of the prosthetic comprises at least one of these materials.
Claim 18 recites the limitation “[t]he prosthetic of claim 15 comprising at least one of a foam, a hydrogel, or combinations thereof.” It is not clear if this is intended to recite that the entire prosthetic comprises at least one of these materials, or rather that the prosthetic additionally comprises at least one of these materials (e.g., as a coating), or if merely a sub-component of the prosthetic comprises at least one of these materials.
Claim 19 recites that “the plate includes silicon.” It is unclear if this is actually intended to recite silicon (i.e., the semiconductor element) or silicone. Silicon is a hard and brittle element that is not generally implanted in the human body and would not likely be able to be flexed as recited in claim 11. Silicone, by contrast, is a well-known biocompatible material that is flexible and elastic and thus easily bendable.
Claims 16-20 are rejected by virtue of their dependence upon claim 15.
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, 2, 11, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 14, and 16 of U.S. Patent No. 10,722,367. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. The expandable/inflatable conduit of the issued patent is taken to correspond to the inflatable tube recited by the present claims; the second axis of the issued patent is taken to correspond to the first axis of the present claims, and vice versa.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,660,193. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claims 1 and 8 of the issued patent map to present claims 1 and 2; claim 9 of the issued patent maps to present claim 3; claim 10 of the issued patent maps to present claim 4; claim 3 of the issued patent maps to present claim 5; claim 2 of the issued patent maps to present claim 6; claim 7 of the issued patent maps to present claims 7 and 10; claim 5 of the issued patent maps to present claim 8; and claim 6 of the issued patent maps to present claim 9. Claims 11 and 18 of the issued patent map to present claims 11 and 12; claim 19 of the issued patent maps to present claim 13; claim 20 of the issued patent maps to present claim 14; claim 12 of the issued patent maps to present claim 15; claim 13 of the issued patent maps to present claim 16; claim 14 of the issued patent maps to present claim 17; claim 15 of the issued patent maps to present claim 18; claim 16 of the issued patent maps to present claim 19; and claim 17 of the issued patent maps to present claim 20.
Claims 1, 2, 11, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-9, and 16 of copending Application No. 18/862,058 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. The inflatable conduit of the reference application is taken to correspond to the inflatable tube recited by the present claims; the flexible portion of the plate system of the reference application is taken to thus be able to bend/flex about the central/first axis, as recited in the present claims; a maximum width of at least 3 cm is taken to correspond to a maximum width of no greater than 6 cm as recited in present claim 11 (e.g., 3 cm, 4 cm, 5 cm, and 6 cm maximum widths meet both criteria).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 1 and 11-14 would be allowable if the double patenting rejections set forth in this Office action are overcome.
Claims 2-10 and 15-20 would be allowable if the double patenting rejections set forth in this Office action are overcome and if rewritten or amended 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.
The following is a statement of reasons for the indication of allowable subject matter: while similar penile prosthetics are known in the prior art (see IDS filed 24 May 2023), none of the references cited in the IDS nor any other prior art of record teaches or reasonably suggests the recited dimensions of the device, in conjunction with the limitations regarding the plate.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THADDEUS B COX/Primary Examiner, Art Unit 3791
Prosecution Insights