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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 9-11, 15-16, 18 & 20 is/are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by US 2020/0222188 hereinafter Smith.
In Regards to Claim 1: An implantable device (Smith, Paragraph 86; Figure 7 Item 700) comprising:
a fluid reservoir configured to hold fluid (Smith, Paragraph 86; Figure 7 Item 702);
an inflatable member configured to be implanted in a body of a patient (Smith, Paragraph 86; Figure 7 Item 708); and
an electronic pump assembly including: a controller configured to actuate at least one of a pump or an active valve to inflate the inflatable member (Smith, Paragraph 86; Figure 7 Item 706); and
a pressure sensor configured to monitor a pressure of the inflatable member (Smith, Paragraph 47 Items 216 & 218),
the controller configured to detect a value of at least one fluid transfer parameter for the pressure of the inflatable member to reach a target pressure during an inflation cycle (Smith, Paragraphs 42 & 46-47; The processor within the electronic control unit is coupled with sensors that indicate the pressure within the inflatable member), the controller configured to generate size capability information of the inflatable member for the patient based on the detected value of the at least one fluid transfer parameter (Smith, Paragraphs 42; Figure 2 Item 118; Examiner interprets the size capability information as information generated in the processor acknowledging the patients input of inflation or deflation as reference for what size the inflatable member can be).
In Regards to Claim 2: The size capability information indicates whether a size of the inflatable member is compatible with the patient (Smith, Paragraph 47; “pressure differential”).
In regards to Claim 3: The size capability information indicates a sizing option for the inflatable member for the patient (Smith, Paragraph 47).
In regards to Claim 4: The controller is configured to transmit the size capability information to an external device (Smith, Paragraph 42).
In Regards to Claim 5: The controller includes a memory device storing sizing information, the sizing information defining at least one sizing option, the at least one sizing option being mapped to a range of values of the at least one fluid transfer parameter (Smith, Paragraph 42; “non-transitory computer readable medium”).
In regards to Claim 6: The controller is configured to determine the size capability information based on whether the detected value is included within the range of values of the at least one fluid transfer parameter (Smith, Paragraph 46-47; “pressure data” compared to “pressure threshold”).
In regards to Claim 9: The at least one fluid transfer parameter includes a pump rate required to achieve the target pressure in a predetermined amount of time (Smith, Paragraph 67; “First and second flow rate”).
In regards to Claim 10: An implantable device (Smith, Paragraph 86; Figure 7 Item 700) comprising:
a fluid reservoir configured to hold fluid (Smith, Paragraph 86; Figure 7 Item 708);
an inflatable member (Smith, Paragraph 86; Figure 7 Item 708); and
an electronic pump assembly (Smith, Paragraph 86; Figure 7 Item 706) including:
a controller configured to actuate at least one of a pump or an active valve to inflate the inflatable member, the controller including a memory device storing sizing information, the sizing information defining one or more of a plurality of sizing options, each sizing option being mapped to a range of values of at least one fluid transfer parameter (Smith, Paragraph 86-47; “Inflation and deflation target compared to target threshold”); and
a pressure sensor configured to monitor a pressure of the inflatable member (Smith, Paragraph 47; Figure 2 Items 216 & 218),
the controller configured to detect a value of the at least one fluid transfer parameter for the pressure of the inflatable member to reach a target pressure during an inflation cycle, the controller configured to select a sizing option from the plurality of sizing options based on the detected value of the at least one fluid transfer parameter (Smith, Paragraph 46-47; “Monitor pressure & Transmit Pressure Data).
In regards to Claim 11: wherein the plurality of sizing options include a first sizing option and a second sizing option, the first sizing option being mapped to a first range of values, the second sizing option being mapped to a second range of values, the controller configured to select the first sizing option in response to the detected value belonging to the first range of values (Smith, Paragraphs 46-47; Inflation and Deflation target thresholds).
In regards to Claim 15: The implantable device includes a urinary sphincter device (Smith, Paragraph 35; Figure 2 Item 200).
In regards to Claim 16: The implantable device includes an inflatable penile prosthesis (Smith, Paragraph 35; Figure 2 Item 200).
In regards to Claim 18: A method for determining size capability information of an implantable device, the method comprising:
actuating at least one of a pump or an active valve of an electronic pump assembly to transfer fluid from a fluid reservoir to an inflatable member during an inflation cycle, the inflatable member being implanted in a body of a patient (Smith, Paragraph 29);
monitoring, by a pressure sensor of the electronic pump assembly, a pressure of the inflatable member in the body of the patient (Smith, Paragraph 31);
detecting a value of at least one fluid transfer parameter for the pressure of the inflatable member to reach a target pressure during the inflation cycle (Smith Paragraph 31; “Pressure Differential”); and
generating size capability information of the inflatable member for the patient based on the detected value of the at least one fluid transfer parameter (Smith, Paragraph 83).
In regards to Claim 20: the size capability information indicates at least one of whether a size of the inflatable member is compatible with the patient or a sizing option for the inflatable member for the patient (Smith, Paragraph 83; If the surgeon is determining an appropriate size of the inflatable member to implant, examiner interprets determining if it's compatible with the patient or obviating a determining that the inflatable member is compatible with the patient in order to deliver an inflatable member that is an appropriate size/length for the patient.).
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) 7, 8, & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0222188 hereinafter Smith in view of US 2018/0110623 hereinafter Vaingast.
In regards to Claim 7: Smith teaches all of Claim 1, but does not teach the at least one fluid transfer parameter includes a time duration to achieve the target pressure.
Vaingast teaches the at least one fluid transfer parameter includes a time duration to achieve the target pressure (Vaingast, Paragraph 40, Figure 8 Items 254 & 256).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the time duration parameter taught in Vaingast to the urinary control device, the motivation being to better regulate and control the pressure the cuff applies to the urethra to reduce injury caused by the device’s use.
In regards to Claim 8: Smith teaches all of claim 1, but does not teach the at least one fluid transfer parameter includes a volume of the fluid transferred to the inflatable member to achieve the target pressure.
Vaingast teaches the at least one fluid transfer parameter includes a volume of the fluid transferred to the inflatable member to achieve the target pressure (Vaingast, Paragraph 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the parameter including the volume of the fluid to the urinary control device taught by Smith, the motivation being to better regulate and control the pressure the cuff applies to the urethra to reduce injury caused by the device’s use.
In regards to Claim 12: Smith teaches all of claim 10, but does not teach the at least one fluid transfer parameter includes a time duration to achieve the target pressure, a volume of the fluid transferred to the inflatable member to achieve the target pressure, or a pump rate required to achieve the target pressure in a predetermined amount of time.
Vaingast teaches the at least one fluid transfer parameter includes a time duration to achieve the target pressure, a volume of the fluid transferred to the inflatable member to achieve the target pressure, or a pump rate required to achieve the target pressure in a predetermined amount of time (Vaingast, Paragraph 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the time and volume parameters taught in Vaingast to the urinary control device of Smith, the motivation being to better regulate and control the pressure the cuff applies to the urethra to reduce injury caused by the device’s use.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2020/0222188 hereinafter Smith in view of 2011/0313240 hereinafter Phillips.
In regards to Claim 13: Smith teaches all of claim 10, but does not teach wherein the controller is configured to detect a performance issue event based on the value of the at least one fluid transfer parameter for the pressure of the inflatable member to reach the target pressure during the inflation cycle.
Phillips teaches wherein the controller is configured to detect a performance issue event based on the value of the at least one fluid transfer parameter for the pressure of the inflatable member to reach the target pressure during the inflation cycle (Phillips, Paragraph 152; “the sensor indicates that the intra-band pressure or the contact pressure between the band and the stoma is low (perhaps 5 mm Hg), this might be an indication that: (1) the bladder 198 has transferred all of its fluid to the balloon portion 200 of band 192 and needs to be refilled; or (2) there is a fluid leak in the system; or (3) the bladder is not working properly to continuously maintain the correct pressure at sensor 190.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the detection of performance issues taught in Phillips to the urinary control device taught in Smith, the motivation being to allow for early indication of the devices defect and prevent irreversible injury.
In regards to Claim 14: Smith teaches all of claim 10, but does not teach the controller is configured to detect a tissue atrophy event or tissue damage based on the value of the at least one fluid transfer parameter for the pressure of the inflatable member to reach the target pressure during the inflation cycle.
Phillips teaches the controller is configured to detect a tissue atrophy event or tissue damage based on the value of the at least one fluid transfer parameter for the pressure of the inflatable member to reach the target pressure during the inflation cycle (Phillips, Paragraph 152; “the bladder assemblies disclosed herein can incorporate one or more wireless sensors to measure parameters such as pressure, flow, temperature, tissue impedance to detect tissue erosion, slippage of the gastric band, stoma diameter (via ECHO or sonomicrometry) for erosion.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the detection of tissue erosion taught in Phillips to the urinary control device taught by Smith, the motivation being to provide detection method to prevent irreversible injury to the user.
Claim(s) 17 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2020/0222188 hereinafter Smith in view of US 2006/0142636 hereinafter Meretei.
In regards to Claim 17: Smith teaches all of claim 17, but does not teach the controller is configured to transmit the selected sizing option to an external device for display.
Meretei teaches the controller is configured to transmit the selected sizing option to an external device for display (Meretei, Paragraph 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the display screen taught in Meretei to the urinary control device taught in Smith, the motivation being to provide an interaction interface for the user to control the device and receive feedback from the device.
In regards to Claim 19: Smith teaches all of claim 18, but does not teach transmitting the size capability information to an external device.
Meretei teaches transmitting the size capability information to an external device (Meretei, Paragraph 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the display device taught in Meretei to the urinary control device of Smith, the motivation being to provide an interaction interface for the user to control the device and receive feedback from the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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/N.R.D./ Patent Examiner, Art Unit 3791
/ALEX M VALVIS/ Supervisory Patent Examiner, Art Unit 3791