Prosecution Insights
Last updated: July 17, 2026
Application No. 18/428,831

DEVICE, METHOD, AND SYSTEM FOR PELVIC FLOOR REHABILITATION

Non-Final OA §103§112
Filed
Jan 31, 2024
Priority
Dec 11, 2020 — provisional 63/124,595 +1 more
Examiner
HOWELL, GWYNNETH LINNEA
Art Unit
Tech Center
Assignee
Hyivy Health Inc.
OA Round
1 (Non-Final)
43%
Grant Probability
Moderate
1-2
OA Rounds
1y 4m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 43% of resolved cases
43%
Career Allowance Rate
29 granted / 67 resolved
-16.7% vs TC avg
Strong +80% interview lift
Without
With
+80.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
35 currently pending
Career history
97
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
82.4%
+42.4% vs TC avg
§102
12.1%
-27.9% vs TC avg
§112
3.4%
-36.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 67 resolved cases

Office Action

§103 §112
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 . This office action is in response to preliminary amendment filed on 04/15/2024. As directed by the amendment, claims 1-70 were canceled, no claims were amended, and claims 71-90 were newly added. Thus, claims 71-90 are presently pending in this application. Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “an identification system” of claim 78 line 2, and “a barcode scanner” and “a barcode” of claim 79 line 2, and “a puncturing mechanism”, “a puncture hole”, and “the needle” of claim 80 lines 2-4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The drawings are objected to because of the unlabeled rectangular box(es) shown in Figures 12 and 13. The drawings should be provided with suitable descriptive legends. See: 37 CFR 1.84 (n) and (o). The drawings are objected to because the drawings contain blank boxes and other shapes, which are not widely, recognized engineering symbols. Applicant must supply a suitable legend. A proposed drawing correction or corrected drawings are required in reply to the Office action to avoid abandonment of the application. The objection to the drawings will not be held in abeyance. 37 CFR 1.84(n) and (o) permit use of symbols which are not universally recognized, subject to approval by the Office, if they are not likely to be confused with existing conventional symbols, and if they are readily identifiable. In addition, suitable descriptive legends may be used subject to approval by the Office, or may be required by the examiner where necessary for understanding of the drawing. (Emphasis added). Thus the examiner may require, on a case-by-case basis, the use of descriptive legends where it is believed that such will facilitate a clear understanding of the drawings without undue reliance on the specification for understanding of the subject matter depicted therein. "When possible, a drawing should be so complete that the purpose and operation of the invention may be readily understood by one skilled in the art by means of a mere inspection of said drawing. The necessity of reading the specification in connection with the drawing should be avoided, if possible." See Ex Parte Hartley, 1901 C.D. 247 (Comm'r Pat. 1901). In the instant case, Figs. 12 and 13 have boxes and other shapes with lines connecting the shapes together and the use of descriptive legends is necessary because it is believed that such will facilitate a clear understanding of the drawings without undue reliance on the specification for understanding of the subject matter depicted therein. It is clear that Figs. 12-13 are not “so complete that the purpose and operation of the invention may be readily understood by one skilled in the art by means of a mere inspection of said drawing” and that undue reliance on the specification is required for understanding of the subject matter depicted therein. The drawings are objected to because specification paragraph [0192] lists “surface 557” as part of Fig. 8, but Fig. 8 appears to have “857” that is incorrectly labeled in either the drawing or specification for the “surface” part. Reference number “857” is not used in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 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. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a lubrication system” of claim 71 line 9 Corresponding structure is [0130] “Various components of the lubrication system, for example the lubricant pump, may be disposed in the handle 305”; [0135] “ The lubrication system 330 of the pelvic floor rehabilitation device 300 is configured to accept a lubrication cartridge” “an identification system” of claim 78 line 2 Corresponding structure is [0141] “The identification system may include a barcode scanner… The lubrication system may include a needle” “a puncturing mechanism” of claim 80 line 2 Corresponding structure is [0141] “Needle… The puncture may be made with any puncturing mechanism and is not limited to a needle.” “a temperature adjusting system” of claim 84 line 1-2 Corresponding structure is [0025-27] “ The at least one temperature adjusting element may comprise at least one thermoelectric module…” “an electromyography (EMG) system” of claim 89 line 1-2 “an ultrasound system” of claim 90 line 1-2 Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 79-80 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 79 lines 1-3, the claim reads on “the identification system includes a barcode scanner to scan a barcode on the lubrication cartridge to identify the lubrication cartridge”. However, the specification fails to provide adequate written description of where the identification system is located within the device, and subsequently where a barcode scanner could be located within the device. Furthermore, there is no description as to the specifics of the barcode on the lubrication cartridge and the description of that structure. Specification paragraphs [0014] and [0141] mention the “barcode scanner” and “barcode” but do not provide further detail than the claim limitations as written. As indicated in the drawing objections above, neither specification paragraph points to a specific figure regarding what the claimed structures are. Thus, the specification fails to provide adequate written description of the structures. Regarding claim 80 lines 1-5, the claim reads on “the lubrication system may include a puncturing mechanism for puncturing the lubrication cartridge… wherein a puncture hole produced by the needle allows for drawing the contents from the lubrication cartridge by the lubrication system”. However, the specification fails to provide adequate written description of where and what the puncturing mechanism is. Where is there a puncturing mechanism or needle located in the device and where is the puncture hole for drawing contents from the lubrication cartridge made? Specification paragraphs [0015] and [0141] mention the “puncturing mechanism”, “puncture hole”, and “needle” but do not provide further detail than the claim limitation as written. As indicated in the drawing objections above, neither specification paragraph points to a specific figure regarding what the claimed structures are. Thus, the specification fails to provide adequate written description of the structures. 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 71-90 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. Regarding claim 71 line 9, the term “the vagina” is indefinite because it lacks proper antecedent basis. Regarding claim 75 line 1-2, the term “a pharmaceutical” is unclear as to if the term is the same or different than “a pharmaceutical” of claim 72 line 2. Regarding claim 80 line 2, the term “may include” is unclear as to whether the claim is included as part of the invention as a whole. Is the structure following “may include” an optional structure in the invention? In line 4, the term “the needle” is indefinite because it lacks proper antecedent basis. In line 4, the term “the contents” is indefinite because it lacks proper antecedent basis. Regarding claim 86 line 2, the term “the force” is indefinite because it lacks proper antecedent basis. Regarding claim 87 line 2, the term “the temperature” is indefinite because it lacks proper antecedent basis. Regarding claims 84-88 line 2, the term “a vagina” is unclear as to if the term is the same or different than “the vagina” in claim 71 line 9. Claim limitations “an electromyography (EMG) system” of claim 89 line 1-2 and “an ultrasound system” of claim 90 line 1-2 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Regarding “an electromyography (EMG) system” of claim 89 line 1-2, the specification states [0053] “an electromyography (EMG) system for tracking and measuring pelvic floor dysfunction using surface electrodes on a surface of the shaft.” However, no structure is assigned to the electromyography system that is able to perform the functions. The specification [0133] states “the at least one sensor may include at least one electromyography (EMG) sensor…”. Is this a components of “an electromyography (EMG) system”? Therefore, there is no clear and obvious link to structure for the function described. Regarding “an ultrasound system” of claim 90 line 1-2, the specification states [0137] the ultrasound system can be used for elastography, imagine, and monitoring changes to muscle, other tissues, and nerves. However, no structure is assigned to the ultrasound system that is able to perform the functions. The specification [0272] states “The sensors at the tip may include… ultrasound.” Is this a component of “an ultrasound system”? Therefore, there is no clear and obvious link to structure for the function described. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Any remaining claims are rejected as being dependent upon a rejected base claim. 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. 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 71-77, 81-82, 84-88, and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz et al. (US 2018/0345012; hereinafter “Schwarz”) in view of Beer et al. (US 2019/0160332; hereinafter “Beer”). Regarding claim 71, Schwarz discloses a pelvic floor rehabilitation device (see Schwarz internal applicator 301; title “Device for pelvic floor tissue treatment”) comprising: a handle for holding and manipulating the pelvic floor rehabilitation device (see Schwarz Fig. 3D handle attachable on distal end with nozzle 312; and Abstract “an internal applicator has an insertable part… and non-insertable part which may be detachable from a handle”); a controller to receive instructions and to control operation of the pelvic floor rehabilitation device (see Schwarz control unit 103); a shaft extending from the handle (see Schwarz Fig. 3D expandable elements 310), wherein at least part of the shaft dilates based on input from the controller (see Schwarz [0154] “The expandable element may be partially or totally filled at specific times during the treatment”); at least one sensor for collecting data during operation of the pelvic floor rehabilitation device (see Schwarz [0122] device may include one or more sensors 112; specifically Fig. 3D has sensor 313; either proximity or pressure sensor [0154]). Schwarz is silent as to a lubrication system operable to introduce a substance into the vagina. However, Beer teaches a lubrication system operable to introduce a substance into the vagina (see Beer Intravaginal device 100 comprising main body 110 with reservoirs 103, where intravaginal device 100 is inserted into the vagina on insertion tool 600; [0145] reservoir can hold a pharmaceutical agent and/or lubricating agent). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the insertable device of Schwarz with the addition of the intravaginal device lubrication system as taught by Beer so as to use both dilation treatment, as taught by Schwarz, and deliver pharmaceutical treatment as taught by Beer for pelvic floor disorder conditions (see Beer [0068]). Regarding claim 72, modified Schwarz discloses the substance introduced by the lubrication system includes at least a pharmaceutical (see Beer [0068] reservoir 103 may contain one or more pharmaceutical agents). Regarding claim 73, modified Schwarz discloses the pharmaceutical is contained within a lubrication cartridge (see Beer [0068] reservoir 103 is single or double chambered containing the pharmaceutical agent). Regarding claim 74, modified Schwarz discloses the lubrication cartridge contains at least one of a lubricant and a fluid (see Beer [0044] pharmaceutical composition can refer to the medicinal/pharmaceutical formulation containing an active ingredient and carrier). Regarding claim 75, modified Schwarz discloses the at least a pharmaceutical is personalized for a patient (see Beer [0045] pharmaceutical composition and its effectiveness based in desire of the patient and intended treatment). Regarding claim 76, modified Schwarz discloses the pharmaceutical is used for at least one of desensitization, pain relief, and hormone replacement (see Beer [0015] treat pelvic pain and nonrelaxing floor dysfunction; [0014] pharmaceutical agent can be a hormone). Regarding claim 77, modified Schwarz discloses the pharmaceutical is at least one of an estrogen, a progesterone, lidocaine, morphine, valium, a muscle relaxant (see Beer [0014] pharmaceutical agent may be a hormone, a muscle relaxant). Regarding claim 81, modified Schwarz discloses a transmitter for transmitting data collected by the at least one sensor to at least a first computing device (see Schwarz [0109] “Connection of the central control unit 103 to the user interface 104 may be wireless”). Regarding claim 82, modified Schwarz discloses the controller is communicatively coupled to a computing device which transmits instructions for operation of the pelvic floor rehabilitation device (see Schwarz [0109] control unit 103 wirelessly connected to user interface 104; [0110] user interface 104 may be a PC). Regarding claim 84, modified Schwarz discloses a temperature adjusting system operable to alter a temperature in a vagina (see Schwarz cooling and/or heating system 110; Fig 3D [0153] expandable elements 310 may be filled with warm or cold fluid). Regarding claim 85, modified Schwarz discloses the at least one sensor comprises a pressure sensor to detect a resistance from a vagina (see Schwarz sensor 313; can be a pressure sensor [0154]). Regarding claim 86, modified Schwarz discloses the at least one sensor comprises a force sensor to measure the force of dilation on a vagina (see Schwarz [0123] sensor 112 may be force sensor). Regarding claim 87, modified Schwarz discloses the at least one sensor comprises a temperature sensor to measure the temperature inside a vagina (see Schwarz [0123] sensor 112 may be temperature sensor; [0149] internal applicator may include temperature sensor 320). Regarding claim 88, modified Schwarz discloses the at least one sensor comprises a moisture sensor to measure a level of moisture inside a vagina (see Schwarz [0200] the sensor may determine humidity of the tissue). Regarding claim 90, modified Schwarz discloses an ultrasound system for elastography and imaging (see Schwarz [0125] imaging sensor may be an ultrasound transducer). Claims 78-79 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz in view of Beer as applied to claim 73 above, and further in view of Ignon et al. (US 2014/0343574; hereinafter “Ignon”). Regarding claim 78, modified Schwarz is silent as to the lubrication system includes an identification system for identifying the type of lubrication cartridge inserted into the lubrication system. However, Ignon teaches includes an identification system for identifying the type of lubrication cartridge inserted into the lubrication system (see Ignon [0120] vials or cartridges 1300 inserted in handheld assembly [Fig. 12] may have identification ages 1350a,b such as a barcode; [0121] The barcode identifier per vial can be reads by a reader/detector on the handheld assembly). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lubrication system of modified Schwarz with the addition of a barcode on the lubrication cartridge and barcode reader for identification as taught by Ignon so as to ensure the proper, safe, approved, etc. cartridge is used by the user (see Ignon [0122]). Regarding claim 79, modified Schwarz discloses the identification system includes a barcode scanner to scan a barcode on the lubrication cartridge to identify the lubrication cartridge (see modified Schwarz above to include Ignon barcode and barcode scanner in Claim 78 [0120-0121]). Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz in view of Beer as applied to claim 71 above, and further in view Peddicord (US 2012/0215141). Regarding claim 83, modified Schwarz discloses the handle includes at least one input control engageable by a user and communicatively coupled to the controller to control operation of the pelvic floor rehabilitation device. However, Peddicord teaches the handle includes at least one input control engageable by a user and communicatively coupled to the controller to control operation of the pelvic floor rehabilitation device (see Peddicord pelvic floor muscle device 101 including a handle 111 including buttons 174a-c communicating with control unit [0028]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of modified Schwarz with the user input controls on the handle as taught by Peddicord so as to have ergonomic control of the device from the handle as opposed to an outside user interface. Claim 89 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz in view of Beer as applied to claim 71 above, and further in view of Egorov (US 2017/0065222). Regarding claim 89, modified Schwarz is silent as to an electromyography (EMG) system for tracking and measuring pelvic floor dysfunction using surface electrodes on a surface of the shaft. However, Egorov teaches an electromyography (EMG) system for tracking and measuring pelvic floor dysfunction using surface electrodes on a surface of the shaft (see Egorov vaginal probe 106; [0041] electromyographic sensor arrays 105, 110 as stimulating electrodes, acquiring signals from vaginal canal). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft of the device of modified Schwarz with the addition of electromyography system sensors as taught by Egorov so as to measure specifically pelvic muscle activation patterns relating to pelvic floor dysfunction (see Egorov [0009]), and as this would have been an obvious substitution for one known type of sensor measuring pelvic floor dysfunction for another and would yield predictable results, i.e. measure the desired condition regarding pelvic floor dysfunction. Conclusion The prior art made of record and not relied upon is considered pertinent to the applicant' s disclosure. Nady (US 2005/0148447), Foltz et al. (US 2005/0055043), Borkon (US 2010/0082057), and Alexander et al. (US 2016/0022400) are cited to show a dilating pelvic muscle exerciser. Siegel (US 2016/0008664) is cited to show a pelvic exerciser with sensors. Elman et al. (US 2013/0138134) is cited to show a vaginal dilator with porous membrane to release drugs. Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F. 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, Tim Stanis can be reached at (571) 272-5139. 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. /GWYNNETH L HOWELL/Examiner, Art Unit 3785 /RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
Read full office action

Prosecution Timeline

Jan 31, 2024
Application Filed
Jun 29, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
43%
Grant Probability
99%
With Interview (+80.1%)
3y 9m (~1y 4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 67 resolved cases by this examiner. Grant probability derived from career allowance rate.

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