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 .
Information Disclosure Statement
Information Disclosure Statement (IDS) submitted on 12/23/2025 has been entered and fully considered by the examiner.
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 1-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-12 of U.S. Patent No. 12533287. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Patent ‘287 are directed towards a method of treating the Peyronie’s disease while claims 1-16 of instant application are directed towards an apparatus capable of performing the same method with similar requirement and limitations.
In particular, claim 1 of instant application is an obvious modification of the method of claim 1 as the apparatus includes all the limitations required in claim 1 of patent ‘287. Similarly, dependent claims 2-16 are obvious over claims 2-7 and 9-12 of Patent ‘287 as they include all the limitations and requirements of the claims of the patent ‘287.
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 7 and 8 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.
The term “remote” in claim 7 is a relative term which renders the claim indefinite. The term “remote” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular, it is not clear at what distance from the tubular member, a pressure source would be considered to be remote? Is it enough that the source is not attached to the tubular member? Is there a certain distance required? Or the source has to be in a separate room? As a result, the claim is considered to be indefinite as the metes and bounds of the claim are not clear and the claim is open to the subjective interpretation of the reader.
Regarding claim 8, claim recites: “the negative pressure source comprises to be disposed in a distal portion”. It is unclear and indefinite as to what the claim intends to recite and whether the pressure source comprises another element or the pressure source is configured to be disposed in a certain position. As a result, the claim is considered to be indefinite as the metes and bounds of the claim are not clear and the claim is open to the subjective interpretation of the reader.
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.
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.
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.
Claims 1, 2, 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Publication No. 2002/0042635) hereinafter “Zhang” in view of Zhu (U.S. Patent No. 10,441,498) hereinafter “Zhu”.
Regarding claim 1, Zhang discloses a system for treating Peyronie's disease [see abstract of Zhang disclosing a system for treatment of various erectile dysfunctions (which includes Peyronie disease)], the system comprising:
a sheath [Sheath 104] configured to receive a penile shaft, [see [0035] and FIG. 1] wherein the sheath comprises at least one emitter positioned on a surface of the sheath; [see [0035] and FIGs. 1-2; electrodes 106 are placed on the sheath 104]
a tubular member comprising an open proximal end, a closed distal end, and an interior chamber therebetween, [cuff 102 of Zhang is the equivalent of the claimed tubular member; see FIG. 1 and [0035] and [0045] disclosing that the distal end of the device can be closed in the shape of a “closed condom” or “cone” shaped apparatus which can be manufactured such that inserting the penile shaft to the end of the tube would ensure proper positioning within the apparatus] wherein the interior chamber is configured to receive the elastomeric sheath and the at least one acoustic emitter; [see FIG. 1 and [0035]]
a negative pressure source coupled to the interior chamber, [see [0070]; vacuum treatment may be used as well] wherein the negative pressure source is configured to evacuate air from the interior chamber to increase blood flow into the penile shaft; and [the negative pressure inside such a chamber would inherently remove air and causes an increase of blood flow to the limb which is positioned in the negative pressured area]
wherein the at least one emitter is configured to apply shock waves to plaque in the penile shaft. [see [0051]; various pulse waves can be applied using the electrode emitter 106]
Even though Zhang discloses that ultrasound emission for the treatment can also be used [see [0035] of Zhang], Zhang does not expressly disclose that the electrode emitters are acoustic emitters. Zhang further fails to expressly disclose that the sheath is an elastomeric sheath.
Zhu, directed towards acoustic treatment of penile shaft for erectile disfunction [see abstract of Zhu] further discloses that the emitters which are used are acoustic emitters [see column 5, lines 30-40 of Zhu disclosing using acoustic shock-wave generators to treat the penile shaft]. Zhu further discloses using a sheath that could be elastomeric [see column 11, lines 30-40 of Zhu]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the electrodes of Zhang and use acoustic emitters of Zhu instead in order to provide an alternative energy source which has been proven to be effective in treating erectile disfunction [see column 1, lines 34-60 of Zhu]. Doing so would have been substituting a method of tissue excitation with another resulting in equivalent and improved results and would have been obvious to try by an ordinarily skilled in the art [KSR rationale B] Further, It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the sheath of Zhang and make it an elastomeric sheath in order to make it flexible and durable. Doing so would be substituting one material of sheath with another resulting in equivalent and improved results and would have been obvious to try by an ordinarily skilled in the art [KSR rationale B]
Regarding claim 2, Zhang in view of Zhu discloses all the limitations of claim 1 [see rejection of claim 1 above].
Zhu further discloses a cuff around the proximal end of the tubular member. [see FIGS. 2A-2B and column 4, lines 30-45 of Zhu]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the electrodes of Zhang further such that it includes a cuff around the proximal end of the tubular member according to the teachings of Zhu since doing so would have been a design choice and would have been obvious to try by an ordinarily skilled in the art since it has been held that design choices would have been obvious to try by an oridinarily skilled in the art absent any persuasive evidence that a particular configuration was significant. In re Daily, 357, F. 2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 4, Zhang further discloses that the tubular member comprises a flexible polymer layer configured for bending of the tubular member in any direction. [see [0045] a polymer such as polycarbonate can be used. See FIG. 14; the structure allows for bending]
Regarding claim 5, Zhang further discloses that the tubular member comprises a plastic structure. [see [0035] disclosing that the tubular member can be made of a thin film such as a plastic]
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Publication No. 2002/0042635) hereinafter “Zhang” in view of Zhu (U.S. Patent No. 10,441,498) hereinafter “Zhu” as applied to claim 1 above and further in view of Holt (U.S. Publication No. 2017/0354532) hereinafter “Holt”.
Regarding claim 3, Zhang as modified by Zhu, discloses all the limitations of claim 2 [see rejection of claim 2 above]
Zhang as modified by Zhu does not disclose that the cuff is sponge-like.
Holt, directed towards a tubular device for the penile shaft [see abstract of Holt] further discloses that the cuff is sponge-like [see [0021] and FIG. 1 of Holt]
It would have been obvious to one of ordinary skill in the art of at the time the invention was effectively filed to modify Zhang as modified by Zhu further such that the cuff is sponge-like according to the teachings of Holt in order to provide a soft grip at the end of the shaft for securing the device.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Publication No. 2002/0042635) hereinafter “Zhang” in view of Zhu (U.S. Patent No. 10,441,498) hereinafter “Zhu” as applied to claim 1 and further in view Rosenblum (U.S. Publication No.) hereinafter “Rosenblum”.
Regarding claim 6, Zhang in view of Zhu discloses all the limitations of claim 1 [see rejection of claim 1 above].
Zhang in view of Zhu does not disclose the tubular member comprises a helical structure.
Rosenblum directed towards a male securing device [see abstract of Rosenblum] further discloses that the tubular member comprises a helical structure. [see [0006] and claim 6 of Rosenblum]
It would have been obvious to one of ordinary skill in the art of at the time the invention was effectively filed to modify Zhang as modified by Zhu such that the tubular member comprises a helical structure according to the teachings of Rosenblum in order to provide resilient support for the penile shaft. [see [0006] of Rosenblum]
Claims 7, 8, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Publication No. 2002/0042635) hereinafter “Zhang” in view of Zhu (U.S. Patent No. 10,441,498) hereinafter “Zhu” as applied to claim 1 above and further in view of Spector (U.S. Publication No. 2012/0215142) hereinafter “Spector”.
Regarding claim 7, Zhang as modified by Zhu, discloses all the limitations of claim 1 [see rejection of claim 1 above]
Zhang as modified by Zhu does not disclose that the negative pressure source is remote from the tubular member.
Spector further discloses that the negative pressure source is remote from the tubular member. [see FIG. 2 and [0012] disclosing inlet and outlet 130 for vacuum indicating that the vacuum source is away from the tubular member]
It would have been obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhang as modified by Zhu further such that the negative pressure source is remote from the tubular member according to the teachings of Spector since doing so would have been a design choice and would have been obvious to try by an ordinarily skilled in the art since it has been held that design choices would have been obvious to try by an ordinarily skilled in the art absent any persuasive evidence that a particular configuration was significant. In re Daily, 357, F. 2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 8, Zhang as modified by Zhu, discloses all the limitations of claim 1 [see rejection of claim 1 above]
Spector further discloses that the negative pressure source comprises a be disposed in a distal portion of the tubular member. [see FIG. 2 and [0012] disclosing inlet and outlet 130 for vacuum indicating that the vacuum source is away from the tubular member]
It would have been obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhang as modified by Zhu further such that the negative pressure source comprises a be disposed in a distal portion of the tubular member according to the teachings of Spector since doing so would have been a design choice and would have been obvious to try by an ordinarily skilled in the art since it has been held that design choices would have been obvious to try by an ordinarily skilled in the art absent any persuasive evidence that a particular configuration was significant. In re Daily, 357, F. 2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 13, Zhang as modified by Zhu, discloses all the limitations of claim 1 [see rejection of claim 1 above]
Spector further discloses the at least one acoustic emitter is configured to apply shock waves over a selected interval at a frequency of 1 to 5 Hz [see [0011] lines 1-8 of spector, teaches treating Peyronie's by applying shock wave therapy to the plaque with an emission frequency of 120 waves/min * 1 min/60 s = 2 waves/s = 2 Hz- Thereby, the disclosed frequency interval of 2 Hz anticipates the claimed interval range of 1 to 5 Hz] with an energy intensity of 0.10 mJ/mmz2 to 0.30 mJ/mm2 [see (0011] lines 1-9, teaches treating Peyronie's by applying shock wave therapy to the plaque with an energy intensity of 0.11 mJ/mm2 to 0.17 mJ/mm2- Therefore, the energy intensity of 0.11 mJ/mm2 to 0.17 muJ/mm_2 anticipates the claimed energy intensity of 0.10 mJ/mm2 to 0.30 mJ/mm2z2.]
It would have been obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhang as modified by Zhu, further so as to incorporate the teachings of Spector with applying shock waves over a selected interval at a frequency of 1 to 5 Hz and with an energy intensity of 0.10 muJ/mm_2 to 0.30 mJ/mm2 in order to allow the device to properly soften the plaque causing penile deformation and angulation, as well as to increase the vascularity in the area of the plaque.
Regarding claim 14, Zhang as modified by Zhu, and Spector teach the claim limitations of claim 13 [see rejection of claim 13 above]
Spector further teaches wherein the selected interval is from 1 minute to 30 minutes by disclosing [see [0011] where each treatment session provides 3000 shockwaves at the frequency of 120 waves/min, such that 3000 shockwaves x (1 min/ 120 shockwaves) = 25 minutes- the disclosed interval of treatment of 25 minutes anticipates the claimed interval of treatment of 1 minute to 30 minutes].
It would have been obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhang as modified by Zhu and Spector to incorporate the teachings of Spector to have a session from 1 minute to 30 minutes in order to allow the device to properly soften the plaque causing penile deformation and angulation, as well as to increase the vascularity in the area of the plaque.
Regarding claim 15, Zhang as modified by Zhu, Spector, teach the claim limitations of claim 13 [see rejection of claim 13 above]
Spector further teaches the selected interval, frequency and energy are delivered in a series of treatments over time [see [0011] disclosing applying shock wave therapy to the plaque over 5 sessions]
It would have been obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhang as modified by Zhu, Spector, to incorporate the teachings of Spector such that the selected interval, frequency and energy are delivered in a series of treatments over time in order to allow the device to properly soften the plaque causing penile deformation and angulation, as well as to increase the vascularity.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Publication No. 2002/0042635) hereinafter “Zhang” in view of Zhu (U.S. Patent No. 10,441,498) hereinafter “Zhu” as applied to claim 1 and further in view of Hibri (U.S. Publication No. 2018/0228639) hereinafter “Hibri” and Rosenblum (U.S. Publication No. 2003/0018321) hereinafter “Rosenblum”.
Regarding claim 9, Zhang in view of Zhu discloses all the limitations of claim 1 [see rejection of claim 1 above].
Zhang in view of Zhu does not disclose a braided structure configured to receive the elastomeric sheath, wherein the braided structure expands in diameter when axially compressed and contracts in diameter when axially stretched such that the penile shaft stretches axially when the braided structure is axially stretched.
Hibri, directed towards penile erection correction apparatus [see abstract of Hibri] further discloses inserting the elastomeric sheath into a braided structure [see [0134]-[01378] of Hibri]
Rosenblum, directed towards a male securing device [see abstract od Rosenblum] further discloses a braided structure configured to receive the elastomeric sheath wherein the braided structure expands in diameter when axially compressed and contracts in diameter when axially stretched such that the penile shaft stretches axially when the braided structure is axially stretched [see [0008] of Rosenblum disclosing: “if the catheter is traumatically pulled, the device's diameter decreases, clamping down (constricting) on the penis, securing the catheter in position. Fundamentally, the strands which form the cylindrical body invention are constricted when pulled. This keeps the catheter relatively immobilized, fixing it in position with regard to the urethra. Greater force to remove the invention further tightens the invention in position. Additionally, the device surrounds the penis, providing a cage effect, which protects the penis and tends to resist a patient from grasping the penis.”]
It would have been obvious to one of ordinary skill in the art of at the time the invention was effectively filed to modify Blanche in view of Spector and Zhu such that it includes inserting the elastomeric sheath into a braided structure according to the teachings of Hibri in order to reinforce the curved portions of the arcuate sections of the structure [see [0134] of Hibri]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the position of the emitters of Zhang further such that the braided structure expands in diameter when axially compressed and contracts in diameter when axially stretched such that the penile shaft stretches axially when the braided structure is axially stretched according to the teachings of Rosenblum in order to keep the device in place and provide a cage effect protecting the penile shaft [see [0008] of Rosenblum]
Regarding claim 10, Zhang in view of Zhu, Hibri and Rosenblum discloses all the limitations of claim 9 [see rejection of claim 9 above].
Rosenblum further discloses a tether coupled to the braided structure at the distal end of the braided structure, [strands 14; see FIG. 3 and [0017]] wherein the tether is configured to be pulled distally to stretch the braided structure axially. [see [0017]; the tether is pulled in direction 101]
It would have been obvious to one of ordinary skill in the art of at the time the invention was effectively filed to modify Zhang as modified by Zhu, Hibri and Rosenblum such that discloses a tether coupled to the braided structure wherein the tether is configured to be pulled distally to stretch the braided structure axially according to the teachings of Rosenblum in order to locking the penile shaft in place and secure it and maintain it in position [see [0017] of Rosenblum]
Regarding claim 11, Zhang in view of Zhu, Hibri and Rosenblum discloses all the limitations of claim 9 [see rejection of claim 1 above].
Hibri further discloses that the braided structure and the elastomeric sheath are inserted into the interior chamber. [see [0134]-[01378] of Hibri]
It would have been obvious to one of ordinary skill in the art of at the time the invention was effectively filed to modify Zhang as modified by Zhu, Spector, Hibri and Rosenblum such that it includes inserting the elastomeric sheath and the braided structure into the interior chamber of the device according to the teachings of Hibri in order to reinforce the curved portions of the arcuate sections of the structure [see [0134] of Hibri]
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Publication No. 2002/0042635) hereinafter “Zhang” in view of Zhu (U.S. Patent No. 10,441,498) hereinafter “Zhu” as applied to claim 1 above, and further in view of Wessells (“Vacuum Erection Devices”. In: Male Sexual Function. 2006, Current Clinical Urology. Humana Press., Reference U on PTO-892) hereinafter “Wessells”.
Regarding claim 12, Zhang as modified by Zhu teach the claim limitations of claim 1 [see rejection of claim 1 above]
Zhang as modified by Zhu does not expressly disclose wherein the negative pressure is from 50 mm Hg to 250 mm Hg.
Wessells, directed towards applying vacuum treatment to penile shaft [see abstract of Wessells] further discloses that the negative pressure is from 50 mm Hg to 250 mm Hg ([Summary] lines 2-3, that using vacuum negative pressure more than 100 mm Hg- The disclosed range of more than 100 mm Hg anticipates the claimed range of 50 mm Hg to 250 mm Hg.)
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use the vacuum from Zhang as modified by Zhu such that the negative pressure is from 50 mm Hg to 250 mm as indicated by Wessells to have an effective way to cause blood to fill the corpora cavernosum, thereby causing an erection and distending the penile shaft.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. Publication No. 2002/0042635) hereinafter “Zhang” in view of Zhu (U.S. Patent No. 10,441,498) hereinafter “Zhu” and Spector (U.S. Publication No. 2012/0215142) hereinafter “Spector” as applied to claim 13 above, and further in view of Ichim (U.S. Patent Publication No. 2023/0218757) hereinafter “Ichim”.
Regarding claim 16, Zhang as modified by Zhu, Spector, teach the claim limitations of claim 13 [see rejection of claim 13 above]
Zhang as modified by Zhu, Spector, does not expressly disclose that the shock waves modify the plaque.
However, Ichim, directed towards shock therapy of Peyronie’s disease [see abstract of Ichim] discloses shock waves modify the plaque [[0004] lines 1-4, that shockwaves were studied and shown to contribute to degradation of penile plaques, thereby teaching the method of treating Peyronie's disease of claim 1 wherein the shock waves modify the plaque.).
It would have been obvious to one of ordinary skill in the art of at the time the invention was effectively filed to modify Zhang as modified by Zhu, Spector, by incorporating the method of Ichim to have shockwaves to modify the plaque in order to allow the device to properly soften the plaque causing penile deformation and angulation, as well as to increase the vascularity in the area of the plaque.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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