DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: in lines 2-3, “configured to a disposed” should apparently read --configured to be disposed--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation “at least some of the plurality of sensors comprise flexible strain gauges” in lines 1-2. The metes and bounds of “some” are not clear; e.g., does this mean at least one or more than one? Based upon the use of the term “gauges” this will be taken herein to mean more than one.
Claim 3 recites the limitation “wherein the flexible strain gauges comprise a capacitive strain gauge” in lines 1-2. It is not clear how multiple gauges can comprise a single gauge. Is this intended to recite that each of the flexible strain gauges comprises a capacitive strain gauge, or is this actually an indication that “some” from claim 2 can mean only one?
Claim 4 recites the limitation “wherein the flexible strain gauges comprise an optical strain gauge” in lines 1-2. It is not clear how multiple gauges can comprise a single gauge. Is this intended to recite that each of the flexible strain gauges comprises an optical strain gauge, or is this actually an indication that “some” from claim 2 can mean only one?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 recites limitations regarding software installed on the external computer. However, none of these components have been recited as part of the claimed system. Indeed, claim 1 merely recites that the transceiver is configured to transmit data to an external computer or smartphone. The external computer (or smartphone) is not recited as part of the claimed system. Thus, the software limitations do not actually further limit the claimed system. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claims 1, 2, 5, 15, 16, 20, 21, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (CN 212996394 U; hereinafter known as “Zhang”), in view of Hovland et al. (U.S. No. 6,015,393; cited in the IDS filed 30 March 2023; hereinafter known as “Hovland”).
Regarding claim 1, Zhang discloses a system for monitoring penile tumescence of a subject (Abstract; Fig. 1), the system comprising: a wearable comprising a tube of biocompatible flexible and elastic material configured to a disposed on a penis of the subject (flexible wrap knitting body; flexible sleeve capable of being sleeved on the penis; film cylinder-shaped structure; flexible carrier sleeved on the penis, flexible carrier is a cylindrical structure made of flexible material), the tube having a plurality of sensors configured to generate data indicative of circumferential and axial dimensional changes of the penis (peripheral/circumferential diameter change sensors and length measuring device that comprises length change sensors); and a controller operatively coupled to the plurality of sensors to retrieve and store the data from the plurality of sensors (data processing device for receiving the data obtained by the sensors, in a wired or wireless way). Zhang fails to specifically disclose that the controller is configured to be disposed at a location spaced apart from the penis, as well as to disclose that the controller comprises a transceiver configured to transmit the data to an external computer or smartphone for analysis and display. Hovland discloses a similar system (Abstract; Fig. 1) that comprises a controller 50 operatively coupled to a plurality of sensors 30 to retrieve and store data from the sensors, wherein the controller is configured to be disposed at a location spaced apart from the penis 20, and the controller comprises a transceiver configured to transmit the data to an external computer 62/64 or smartphone for analysis and display, in order to allow the controller to be easily worn and allow for display and evaluation of the data (col. 9, lines 27-33; col. 10, lines 40-65; col. 12, lines 1-11; col. 12, lines 55-59). 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 invention of Zhang so that the controller is configured to be disposed at a location spaced apart from the penis and comprises a transceiver configured to transmit the data to an external computer or smartphone for analysis and display, as taught by Hovland, in order to allow the controller to be easily worn and allow for display and evaluation of the data.
Regarding claim 2, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, and Zhang further discloses that at least some of the plurality of sensors comprise flexible strain gauges (flexible tensile strain sensors).
Regarding claim 5, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, and Zhang further discloses that the wearable further comprises one or more sensors configured to apply a contractile force on the penis during a tumescence event, and wherein the controller is configured to measure penile rigidity based on the contractile force applied to the penis during the tumescence event (hardness measuring device; can change the corresponding deformation along with the penis shape in the penis erection process).
Regarding claim 15, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, and Hovland further discloses that the controller further comprises a housing 55 configured to removably secure the controller to a groin area, a lower abdomen, or an upper thigh of the subject (col. 12, lines 55-59). The combination of Zhang and Hovland fails to expressly disclose an adhesive pad coupled to the housing to removably secures the controller to the subject. However, Hovland teaches that the housing may be “otherwise mounted on or carried by the body” (col. 12, lines 55-59), as well as an adhesive pad configured to removably secure the sensors to the subject (col. 10, lines 17-27). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Zhang and Hovland with such an adhesive pad, as taught elsewhere by Hovland, as this is a known alternative for temporarily mounting a wearable component to the subject.
Regarding claim 16, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, and further discloses that the plurality of sensors is coupled to the controller via a flexible lead (Zhang: wired connection between data processing device and sensors; Hovland: col. 10, lines 53-55).
Regarding claim 20, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, and Hovland further discloses that the transceiver is configured for bi-directional communication with the external computer or the smartphone (col. 10, lines 56-63).
Regarding claim 21, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, and further discloses that software installed on the external computer is configured to provide real-time feedback to physician controller software for selecting electrode configuration or selection of electrostimulation parameters for an implantable array of penile electrostimulation electrodes (as detailed supra, these limitations do not further limit the claimed system; the external computer of the proposed combination is capable of having such software installed).
Regarding claim 24, Zhang discloses a method of monitoring penile tumescence of a subject (Abstract; Fig. 1), the method comprising: applying a wearable comprising a tube of biocompatible flexible and elastic material on a penis of the subject (flexible wrap knitting body; flexible sleeve capable of being sleeved on the penis; film cylinder-shaped structure; flexible carrier sleeved on the penis, flexible carrier is a cylindrical structure made of flexible material), the tube having a plurality of sensors configured to generate data indicative of circumferential and axial dimensional changes of the penis (peripheral/circumferential diameter change sensors and length measuring device that comprises length change sensors); as well as using a controller operatively coupled to the plurality of sensors and operating the controller to retrieve and store data from the plurality of sensors (data processing device for receiving the data obtained by the sensors, in a wired or wireless way). Zhang fails to disclose removably securing the controller to the subject at a location spaced apart from the penis and transmitting the data to an external computer or smartphone for analysis and display. Hovland discloses a similar method (Abstract; Fig. 1) that utilizes a controller 50 operatively coupled to a plurality of sensors 30 to retrieve and store data from the sensors, wherein the controller is removably secured to the subject at a location spaced apart from the penis 20, and the controller transmits the data to an external computer 62/64 or smartphone for analysis and display, in order to allow the controller to be easily worn and allow for display and evaluation of the data (col. 9, lines 27-33; col. 10, lines 40-65; col. 12, lines 1-11; col. 12, lines 55-59). 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 invention of Zhang so that the controller is removably secured at a location spaced apart from the penis and transmits the data to an external computer or smartphone for analysis and display, as taught by Hovland, in order to allow the controller to be easily worn and allow for display and evaluation of the data.
Regarding claim 25, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, and Zhang further discloses applying a contractile force on the penis during a tumescence event to generate data indicative of penile rigidity (hardness measuring device; can change the corresponding deformation along with the penis shape in the penis erection process).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Hovland as applied to claim 2 above, and further in view of Souri et al., “Wearable and Stretchable Strain Sensors: Materials, Sensing Mechanisms, and Applications,” Advanced Intelligent Systems (2020) 2000039, https://doi.org/10.1002/aisy.202000039 (cited by Applicant in paragraph 0046 of the published application; hereinafter known as “Souri”). The combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, but fails to disclose that the flexible strain gauges comprise a capacitive strain gauge comprising an insulated flexible membrane encapsulated by a pair of conductive materials, a thickness of the insulated flexible membrane configured to vary responsive to circumferential and axial dimensional changes of the penis, and wherein the controller is configured to measure capacity of the capacitive strain gauge as the thickness of the insulated flexible membrane varies. The present application teaches that the recited capacitive strain gauges, as taught by Souri, are a known effective type of strain gauge that provides the necessary functionality. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Zhang and Hovland with such capacitive strain gauges, as taught by Souri, as this is a known effective alternative for generating the recited data.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Hovland as applied to claim 2 above, and further in view of Guo et al., “Highly Flexible and Stretchable Optical Strain Sensing for Human Motion Detection,” Optica 4, 1285-1288 (2017), https://doi.org/10.1364/OPTICA.4.001285, or Jeong et al., “Highly Stretchable Polymer-based Optical Strain Sensor for Integration with Soft Actuator,” 2019 IEEE International Conference on Consumer Electronics (ICCE), Las Vegas, NV, USA, 2019. pp. 1-3, doi: 10.1109/ICCE.2019.8661937, https://iecexplore.ieec.org/document/8661937 (cited by Applicant in paragraph 0047 of the published application; hereinafter known as “Guo” and “Jeong”). The combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, but fails to disclose that the flexible strain gauges comprise an optical strain gauge comprising an optical fiber operatively coupled to a light source and a photodetector configured to measure light intensity, and wherein the controller is configured to: cause the light source to emit a beam of light having a predetermined light intensity through the optical fiber, the beam of light configured to undergo interference as it travels through the optical fiber, the interference configured to vary responsive to strain of the optical fiber due to circumferential and axial dimensional changes of the penis; receive data from the photodetector indicative of a final light intensity of the beam of light measured by the photodetector; and calculate a difference between the predetermined light intensity and the final light intensity of the beam of light, the difference proportional to the strain of the optical fiber. The present application teaches that the recited optical strain gauges, as taught by Guo or Jeong, are a known effective type of strain gauge that provides the necessary functionality. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Zhang and Hovland with such optical strain gauges, as taught by Guo or Jeong, as this is a known effective alternative for generating the recited data.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Hovland as applied to claim 5 above, and further in view of Perrin, “A Tiny Pump Comes to the Aid of Weakened Hearts,” available at: https://actu.epfl.ch/news/a-tiny-pump-comes-to-the-aid-of-weakened-hearts/, or Martinez, “A Novel Soft Cardiac Assist Device based on a Dielectric Elastomer Augmented Aorta: An In Vivo Study” (2022), https://doi.org/10.1002/btm2.10396 (cited by Applicant in paragraph 0055 of the published application). The combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, but fails to disclose that the one or more sensors comprise an electroactive polymer structure configured to apply the contractile force on the penis during the tumescence event, wherein the electroactive polymer structure comprises a dielectric elastomer actuator comprising alternating layers of an elastomer and one or more electrodes, a size and shape of the elastomer configured to vary when stimulated by an electric field of the one or more electrodes to thereby apply the contractile force on the penis. The present application teaches that the EAP sensors, as taught by Perrin or Martinez, are a known effective type of sensor that provides the necessary contractile force. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Zhang and Hovland with such EAP sensors, as taught by Perrin or Martinez, as this is a known effective alternative for providing the necessary contractile force.
Claims 17-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Hovland as applied to claim 1 above, and further in view of Cho et al. (KR 20200095839 A; hereinafter known as “Cho”).
Regarding claim 17, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, but fails to disclose that the wearable further comprises at least one RFID tag. Cho discloses a similar system (Abstract; Fig. 1) comprising a wearable 100 that comprises at least one RFID tag 300 in order to provide wireless recognition for the transmission of measured data. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Zhang and Hovland with an RFID tag, as taught by Cho, in order to provide wireless recognition for the transmission of measured data.
Regarding claim 18, the combination of Zhang, Hovland, and Cho discloses the invention as claimed, see rejection supra, and Cho further discloses that the controller 400 further comprises an RFID reader circuit for interrogating the RFID tag.
Regarding claim 19, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, but fails to disclose that the controller further comprises a rechargeable battery. Cho discloses a similar system (Abstract; Fig. 1) comprising a rechargeable battery in order to provide rechargeable power when used multiple times. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Zhang and Hovland with a rechargeable battery for the controller, as taught by Cho, in order to provide rechargeable power when used multiple times.
Regarding claim 22, the combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the tube comprises a latex or silicone rubber. Cho discloses a similar system (Abstract; Fig. 1) comprising a tube 100 configured to be disposed on a penis, wherein the tube comprises a latex or silicone rubber, in order to provide elasticity that can be expanded by erection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Zhang and Hovland so that the tube comprises a latex or silicone rubber, as taught by Cho, in order to provide elasticity that can be expanded by erection.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Hovland as applied to claim 1 above, and further in view of Xu (CN 110710959 A). The combination of Zhang and Hovland discloses the invention as claimed, see rejection supra, but fails to disclose that the tube further comprises a bacteriostatic coating. Xu discloses a similar system (Abstract; Figs. 1-3) comprising a wearable that comprises a bacteriostatic coating in order to ensure a sanitary environment (outer layer of silver ion antibacterial). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Zhang and Hovland with a bacteriostatic coating, as taught by Xu, in order to ensure a sanitary environment.
Allowable Subject Matter
Claims 8-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: regarding claim 8, none of the prior art of record teaches or reasonably suggests such a sensor for applying a contractile force during a tumescence event so that the controller can measure penile rigidity based on the contractile force, wherein the sensor comprises such a wire with a looped end and free end, a spool coupled to the free end, and a micromotor configured to rotate the spool, in combination with such a system. Regarding claims 9-11, none of the prior art of record teaches or reasonably suggests such a sensor for applying a contractile force during a tumescence event so that the controller can measure penile rigidity based on the contractile force, wherein the sensor comprises such a wire with a looped end and free end, a magnet coupled to the free end, and an electromagnetic assembly configured to generate an electromagnetic field to move the magnet, in combination with such a system. Regarding claims 12-14, none of the prior art of record teaches or reasonably suggests such a sensor for applying a contractile force during a tumescence event so that the controller can measure penile rigidity based on the contractile force, wherein the sensor comprises such a wire comprising a SMA, wherein the size and shape of the wire varies when heated or stimulated by an electric field, in combination with such a system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Barnea (U.S. No. 6,162,188) teaches a penile tumescence and rigidity monitoring device wherein data signals are fed to an RF transceiver unit via a cable and then sent to a computer processor. Leang et al. (U.S. No. 4,913,162) teaches a penile tumescence and rigidity monitoring device with a controller that can be worn around a patient’s waist or thigh. Lai et al. (CN 105011939 A) and Oh (KR 2019/0115833 A) also teach similar wearable tumescence monitoring devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791