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 .
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanche et al. (US 2018/0296383) in view of Sheffy (US 2015/0257921).
Regarding claim 1, Blanche et al. teaches a tissue treatment device (Fig. 1, male stimulatory device 100) comprising:
an elongate tubular assembly (Fig. 3; para. 0040, wherein the male stimulatory device 100 comprises an outer body tube 120 and an inner body tube 150) extending along an axis (see Annotated Figure 6) with an interior chamber (Fig. 3, inner body tube 150) having a proximal opening therein adapted for receiving a shaft of a penis of a patient (para. 0041; see Figs. 1 and 6, wherein the proximal end of the male stimulatory device 100, differentiated by the sealing ring 186, comprises an opening); and
a first acoustic energy emitter (see Annotated Figure 5) and a second acoustic energy emitter (see Annotated Figure 5), each on opposing sides of the interior chamber for delivering acoustic energy to opposing sides of said shaft (paras. 0042-0043; Figs. 3 and 5-6, ultrasonic transducers 156);
Blanche et al. fails to teach a sensor in the interior chamber for sensing a physiological parameter of the patient.
Sheffy teaches an analogous tissue treatment device comprising a sensor in the interior chamber for sensing a physiological parameter of the patient (paras. 0021, 0030, 0047-0048, 0080, and 0098; Fig. 1, pulse measuring elements 110).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the tissue treatment device of Blanche et al. with the physiological sensor of Sheffy. The data obtained from the pulse measuring components reflect the peripheral pulse of the penis, which is specific to the blood vessels. Consequently, the stimulation application may be adjusted based on these readings to optimize blood flow in the subject, thereby potentially improving erectile dysfunction (Sheffy, paras. 0014, 0021, 0030, 0047-0048, 0080, and 0098).
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Annotated Figure 6
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Annotated Figure 5
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,992,451. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim is anticipated by the patent claim.
See table below for corresponding teachings of reference U.S. Patent No. 11,992,451.
Instant Application
11,992,451
Claim 1. A tissue treatment device comprising:
Claim 1, line 38
an elongate tubular assembly extending along an axis with an interior chamber having a proximal opening therein adapted for receiving a shaft of a penis of a patient; and
Claim 1, lines 39-41
a first acoustic energy emitter and a second acoustic energy emitter, each on opposing sides of the interior chamber for delivering acoustic energy to opposing sides of said shaft;
Claim 1, lines 42-46
a sensor in the interior chamber for sensing a physiological parameter of the patient.
Claim 1, lines 47-48
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Squicciarini (US 2009/0171144) teaches a therapeutic prosthetic device for women or men configured to transmit tactile sensations to the surface of a sex organ. The sensations are delivered through the controlled release of electrical energy. Chen et al. (CN 106726418) teaches a shock wave generating device configured to treat male erectile dysfunction wherein electromagnetic coils are incorporated into the interior space of the elongated cylindrical shock wave generating device. Alarcon (WO 2010042884) teaches an apparatus for generating sensations, the apparatus comprises an opening for a user’s body to be inserted and an actuator adapted to output a force. Furthermore, the apparatus comprises multiple sensors configured to collected biometric data.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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