The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Interpretation
It is noted that the claims 8 and 9 utilize the term “approximately” with respect to end points of a range. In the specification (i.e., paragraph 136 of the PGPUB 2025/0269180 representative of the instant application) the examples using the term approximately are seen to state for a lower limit that the value is equivalent to or greater than the lower limit up to the halfway point of the entire range. Similarly, the use of the term approximately with the upper limit is equivalent to or less than the upper limit down to the halfway point of the entire range. Therefore, the use of “approximately” in claims 8 and 9 limits the claim to specifically being greater than or equal to 0 Hz and less than or equal to 150 Hz (or a higher limit of 50 Hz in claim 9).
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
The following claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (note: all citations come from PGPUB 20258/0269180, representative of the specification of the instant application):
Claim 1
“An electrical energy source” (see line 2) … “delivering electrical energy” (see line 4)
This term utilizes generic placeholder “source”, does not utilize a transition word, and is not modified by sufficient structure for performing the claimed function of “delivering electrical energy”.
Paragraph 141 states “Externally coupling the electrical energy source using the device 10 of FIGS. 1 and 2, for example, includes attaching one or more electrical contacts 18, 26 to the subject 48.” And paragraph 142 states “In one example, externally coupling an electrical energy source includes engaging an electrode with a skin surface of the subject 48.”
Therefore, “an electrical energy source” is an electrode.
“A vibration mechanism” (see line 3) … “applying vibrations” (see line 5)
This term utilizes generic placeholder “mechanism”, does not utilize a transition word, and is not modified by sufficient structure for performing the claimed function of “applying vibrations”.
In paragraph 126 states “The vibration mechanism 28 includes a housing 40, a vibratory element 44 disposed in the housing 40, the wire 34, and the plug 38. The vibration mechanism 28 is configured to apply a massage-like input to a target nerve, muscle, or tissue. The vibratory element 44 is a DC motor that generates vibrations, such as an Eccentric Rotating Mass (“ERM”) vibration motor, which uses an unbalanced load to generate vibrations. However, in other examples, the vibratory element 44 may be a pancake or shaftless motor, a piezoelectric vibration generator, or other suitable means for producing vibrations.”
Therefore, “a vibration mechanism” is any of these motors piezoelectric generators, “or other suitable means for producing vibrations”.
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, 4-8 and 10-20 provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-7, 9-13, 15-16 and 19-20 of co-pending Application No. 18/589,921 in view of John et al. (US Patent Pub. No. 2022/0016413).
Although the claims at issue are not identical, they are not patentably distinct from each other because, although the instant application’s claims add a vibration mechanism, these claims fully encompass the subject matter in the co-pending application, which only claims the electrical energy stimulation aspects. John teaches a wearable neurostimulation system with curated therapy (see Title). In paragraph 262, John discusses the use of “an ‘adjunct signal’ is designed to serve as a ‘sensory mask’ that masks the sensations produced by the signals supplied by the primary stimulation channels… In embodiments, the sensory mask is provided by non-electrical modalities such as, vibration … The sensory mask may be constant or modulated at a selected rate.” As discussed in paragraph 53, the primary stimulation channel “is a set of 3 or more conductive stimulation pads that serve as an “electrode array” for providing transcutaneous electrical stimulation.” Specifically, John teaches the use of vibration transducers in paragraph 450 - “Treatment may include short (e.g., 10-sec) bursts of vibration at a selected frequency (e.g., 20-50 Hz) and amplitude (e.g., 1-2 mm) followed by a pause (e.g., 5 to 10 sec) to increase skin blood flow. In an embodiment, the wrap is provided with a vibration transducer and the control module is provided with stimulation protocols for adjunctive therapy, or the system includes an accessory device to provide the adjunctive therapy”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize vibratory stimulus along with electrical stimulus as a means of masking the electrical stimulation, as taught by John, and to incorporate this into the system of the instant application “to alter the user perception of the treatment stimulation signal” (see paragraph 262), which would improve the overall experience for the patient.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The specific claim correspondences are as follows:
Instant Application [Wingdings font/0xE0] co-pending Application 18/589,921
Claim 1 [Wingdings font/0xE0] Claim 1
Claim 2 [Wingdings font/0xE0] Claim 2
Claim 4 [Wingdings font/0xE0] Claim 3
Claim 5 [Wingdings font/0xE0] Claim 4
Claim 6 [Wingdings font/0xE0] Claim 5
Claim 7 [Wingdings font/0xE0] Claim 6
Claim 8 [Wingdings font/0xE0] Claim 7
Claim 10 [Wingdings font/0xE0] Claim 9
Claim 11 [Wingdings font/0xE0] Claim 10
Claim 12 [Wingdings font/0xE0] Claim 10
Claim 13 [Wingdings font/0xE0] Claim 11
Claim 14 [Wingdings font/0xE0] Claim 12
Claim 15 [Wingdings font/0xE0] Claim 13
Claim 16 [Wingdings font/0xE0] Claim 15
Claim 17 [Wingdings font/0xE0] Claim 15
Claim 18 [Wingdings font/0xE0] Claim 16
Claim 19 [Wingdings font/0xE0] Claim 19
Claim 20 [Wingdings font/0xE0] Claim 20
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over John et al. (US Patent Pub. No. 2022/0016413) in view of Boutos (US Patent No. 5,782,902)
Regarding claims 1, 11 and 18, John discloses a wearable neurostimulation system with curated therapy (see Title). “In embodiments, system may be applied to treat, prevent, or improve many unwanted conditions, symptoms, and disorders using stimulation of the SAFN or other nerve. These include… Orchialgia (persistent pain in the scrotum)” (see paragraph 409 – thereby reading on the preamble). John teaches that “Stimulation pad is a conductive substrate that is applied to the patient's skin and is used to provide an electrical stimulation signal (also termed “conductive pad” or “electrode”) and states the following in paragraph 67:
FIG. 1a shows an embodiment of a neurostimulation system 10 including a neurostimulation device 12 that connects electrically and physically to a stimulation matrix 14 with stimulation pads 16 that are removably attached to, and deliver electrical stimulation signals through, a user's skin. The device 12 and matrix 14 can be secured to a location on a user's limb (e.g., lower leg) using a garment such as a wrap 18.
Therefore, this teaches coupling an electrical energy source to the subject and delivering electrical energy to the region on which the pad or wrap is applied. In paragraph 262, John discusses that “an ‘adjunct signal’ is designed to serve as a ‘sensory mask’ that masks the sensations produced by the signals supplied by the primary stimulation channels… In embodiments, the sensory mask is provided by non-electrical modalities such as, vibration … The sensory mask may be constant or modulated at a selected rate.” As discussed in paragraph 53, the primary stimulation channel “is a set of 3 or more conductive stimulation pads that serve as an “electrode array” for providing transcutaneous electrical stimulation.” Specifically, John teaches the use of vibration transducers in paragraph 450 - “Treatment may include short (e.g., 10-sec) bursts of vibration at a selected frequency (e.g., 20-50 Hz) and amplitude (e.g., 1-2 mm) followed by a pause (e.g., 5 to 10 sec) to increase skin blood flow. In an embodiment, the wrap is provided with a vibration transducer and the control module is provided with stimulation protocols for adjunctive therapy, or the system includes an accessory device to provide the adjunctive therapy”. This teaches that a vibration mechanism would be applied to the same location as the electrical energy source, and would be used to apply vibrations to that same location.
While John discusses that its system may be used for treating many disorders and conditions, including “urinary or fecal incontinence, … chronic pelvic pain (CPP) syndrome such as Orchialgia (persistent pain in the scrotum)” (see paragraph 409), or “to provide treatment of a disorder (e.g., pelvic floor disorder)” (see paragraph 450(a) and note that paragraph 452 also mentions treatment of pelvic floor disorder), John does not explicitly state that the stimulators would be attached to the pelvic region.
Boutos teaches “Electrodes for stimulating living tissue such as … scrotal… Electrical stimulation to such areas is intended to control incontinence” (see Abstract). Therefore, it is clear from Boutos that electrical stimulation of the scrotum can achieve the desired effect of controlling incontinence, similarly to the desired effect in John.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide the electrical stimulation in John, and therefore also the adjunct signal (i.e., vibratory stimulation), to the scrotum as is taught by Boutos, because both John and Boutos teach electrical stimulation for controlling incontinence and while John does not specify the scrotum as the location, Boutos does teach this location. This would have been an obvious location to use because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Regarding claims 2-4, 12, it is re-iterated that by the combination of John with Boutos as described above in the rejection of claim 1, the location of electrical stimulation and vibratory stimulation would be the scrotum.
Regarding claim 5, it is noted that John teaches a wearable “wrap” (see paragraph 67), which at least partially wraps around a location to which it is applied. By the description of the combination of John and Boutos, that location would be the scrotum and the teachings of John would result in the electrical stimulation and vibratory energy to be applied to that location. It is additionally noted that Boutos explicitly illustrates and teaches a “cuff” by teaching a tube electrode, illustrated in Figure 6 to as being entirely around a scrotum of a subject.
Regarding claim 6, Figure 6 of Boutos illustrates a first electrode 700 placed around the scrotum and a second ring electrode 100 placed around the penis. As such, both locations (based on the combination as described in the rejection of claim 1) would include vibratory energy being applied.
Regarding claim 7, John contemplates that “The matrix 14 is realized with each pad comprising silver-electrodes on a flexible PET substrate, covered by an adhesive hydrogel layer that reduces electrode-skin impedance and typically includes adhesive to promote connection to the user's leg” (see paragraph 119), thereby teaching “adhering an electrode to the subject”.
Regarding claim 8, John teaches “an “effective” stimulation frequency such as 20 Hz is supplied by the combination of a first diagonal channel C1-A3 providing a 10 Hz pulse train signal, and a second diagonal channel C3-A1 providing a second 10 Hz pulse train signal” (see paragraph 216; also see paragraphs 88,174, 268 and 291 where different frequencies are also discussed).
Regarding claim 9, John teaches that adjunctive therapies “may include short (e.g., 10-sec) bursts of vibration at a selected frequency (e.g., 20-50 Hz)” (see paragraph 449 and 450(c)). It is noted that 20-50 Hz is within the claimed 0-50 Hz.
Regarding claim 10, it is noted that by the combination of John with Boutos, it would be obvious to one of skill in the art that the location of the tube electrode around the scrotum as illustrated by Figure 6 of Boutos would provide the therapy to a portion of the genital branch of the genitofemoral nerve.
Regarding claim 13, Figure 6 of Boutos illustrates a first electrode 700 placed around the scrotum and a second ring electrode 100 placed around the penis.
Regarding claim 14, it is noted that John teaches a wearable “wrap” (see paragraph 67), which at least partially wraps around a location to which it is applied. By the description of the combination of John and Boutos, that location would be the scrotum and the teachings of John would result in the electrical stimulation and vibratory energy to be applied to that location. It is additionally noted that Boutos explicitly illustrates and teaches a “cuff” by teaching a tube electrode, illustrated in Figure 6 to as being entirely around a scrotum of a subject. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to a single attachment means (the wrap of John or the cuff of Boutos) to hold the means for the applying electrical and vibratory energy to the tissue, since both energies are taught by John as being applied to the same location.
Regarding claim 15, John teaches “an “effective” stimulation frequency such as 20 Hz is supplied by the combination of a first diagonal channel C1-A3 providing a 10 Hz pulse train signal, and a second diagonal channel C3-A1 providing a second 10 Hz pulse train signal” (see paragraph 216, emphasis added).
Regarding claims 16-17, John teaches “FIG. 1b shows an embodiment of a neurostimulator device 12 having a housing formed as a durable plastic enclosure containing electronics and power. The top housing portion 24a has a power button 22 and stimulation field controls that allow user adjustment of the stimulation amplitude 26a,26b” (see paragraph 71). Additionally, “the neurostimulator 12 can receive input from user devices 20 such as a smartphone 20a (or tablet running Android or iOS, and an “App” 21 that supports all features of digital ecosystem), smartwatch 20b, laptop or tablet computer 20c (of the user or a doctor), a remote laptop or computer of a telemedicine service 20c′, a specialized “remote control” 20d device (e.g., only having controls for therapy regimen parameter values to be controlled and communicated to the stimulation device 12, or also having a display of therapy parameters), an virtual assistant AI technology (e.g., Alexa—type) device 20e, a remote computer 20f that provides data storage and other functionality” (see paragraph 112). Also see Figure 3b.
Regarding claim 19, John explicitly teaches that “FIG. 1c shows an embodiment with a garment such as a leg wrap 18 realized as a flexible/fabric wrap that secures the neurostimulator 12 and stimulation matrix to a user's upper calf area during treatment” (see paragraph 73).
Regarding claim 20, John teaches “the neurostimulator 12 can receive input from user devices 20 such as a smartphone 20a (or tablet running Android or iOS, and an “App” 21 that supports all features of digital ecosystem), smartwatch 20b, laptop or tablet computer 20c (of the user or a doctor), a remote laptop or computer of a telemedicine service 20c′, a specialized “remote control” 20d device (e.g., only having controls for therapy regimen parameter values to be controlled and communicated to the stimulation device 12, or also having a display of therapy parameters), an virtual assistant AI technology (e.g., Alexa—type) device 20e, a remote computer 20f that provides data storage and other functionality” (see paragraph 112). Also see Figures 3b-3f and Figures 5a-5f. It is additionally noted that in paragraph 450(c), John states “Treatment may include short (e.g., 10-sec) bursts of vibration at a selected frequency (e.g., 20-50 Hz) and amplitude (e.g., 1-2 mm) followed by a pause (e.g., 5 to 10 sec) to increase skin blood flow. In an embodiment, the wrap is provided with a vibration transducer and the control module is provided with stimulation protocols for adjunctive therapy, or the system includes an accessory device to provide the adjunctive therapy” (emphasis added).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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, Unsu Jung can be reached at (571) 272-8506. 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.
/JAMES KISH/ Primary Examiner, Art Unit 3792