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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2-6, 8, 10, 12-15, 20, 22, and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 15, the claim recites a pressure sensing system which is directed towards a machine/apparatus which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed toward any judicial exception.
(underline= additional elements, italicized = judicial exception)
a pressure sensing system, comprising:
an artificial pressure sensing device comprising
an elongate housing configured to be at least partially inserted into a user, the elongate housing defining an external surface and having a proximal end and a distal end defining a longitudinal axis therebetween, the distal end being the leading end of the elongate housing in a direction of insertion of the elongate housing into the user;
a first pressure sensor configured to sense first pressure applied to a first portion of the external surface and to convert the sensed first pressure to first pressure data and
a second pressure sensor configured to sense second pressure applied to a second portion of the external surface and to convert the sensed second pressure to second pressure data, the second pressure sensor spaced, along the longitudinal axis, toward the distal end from the first pressure sensor
a computer configured to receive and process the first pressure data and the second pressure data from the pressure sensing device;
wherein the processing of the pressure data by the computer comprises processing to assess the magnitude of pressure applied to the first and second pressure sensors and the timing of pressure applied to the first and second pressure sensors, and wherein the processing of the pressure data by the computer comprises processing to determine whether the magnitude and timing of pressure applied to the first and second pressure sensors meets predetermined criteria, the predetermined criteria at least comprising whether pressure data obtained simultaneously by the first pressure sensor and the second pressure sensor indicates that the magnitude of the first pressure applied to the first pressure sensor is within a first pressure range and that the magnitude of the second pressure applied simultaneously to the second pressure sensor is within a second pressure range; and
a user interface associated with the computer and configured to present, to the user, information associated with the first pressure data and the second pressure data received from the pressure sensing device, wherein the information associated with the first pressure data and the second pressure data received from the pressure sensing device comprises information on whether, based on the processing of the pressure data by the computer, the first pressure data and the second pressure data indicates that the magnitude and timing of pressure applied to the first and second sensors meets the predetermined criteria.
These limitations describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. The Examiner also notes that nothing from the claims suggests that the limitations cannot be practically performed by a human or using simple pen/paper.
This judicial exception is not integrated into a practical application because the limitations of the additional elements are mere insignificant extra-solution activity, i.e. mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into practical application. See MPEP 2106.05(g)
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are deemed to not be well understood, routine, and conventional by the prior art of record and particularly the Rao reference which discloses the sensor configuration. It is notable that the previously cited references provide the same configuration. Further, simply using a general purpose computer or computer components after the fact to an abstract idea does not provide significantly more.
Dependent claims 2-6, 8, 10, 12-14, 20, 22, and 23 fail to add something more to the abstract independent claim and merely further limit the abstract idea, recite limitations that do not integrate the claims into practical application for substantially similar reasons as set forth above, and/or do not significantly more than the abstract idea for substantially similar reasons as set forth above.
Therefore, claims 2-6, 8, 10, 12-15, 20, 22, and 23 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 102
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.
Claim(s) 15, 2-6, 10, 12-14, 20, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rao (8,758,387).
Regarding claim 15, Rao discloses a pressure sensing system, comprising:
an artificial pressure sensing device comprising
an elongate housing (item 102) configured to be at least partially inserted into a user, the elongate housing defining an external surface and having a proximal end and a distal end defining a longitudinal axis therebetween, the distal end being the leading end of the elongate housing in a direction of insertion of the elongate housing into the user (see figure 2, proximal, distal ends define a longitudinal axis);
a first pressure sensor (items 210, 222) configured to sense first pressure applied to a first portion of the external surface and to convert the sensed first pressure to first pressure data and
a second pressure sensor (item 206, 220) configured to sense second pressure applied to a second portion of the external surface and to convert the sensed second pressure to second pressure data, the second pressure sensor spaced, along the longitudinal axis, toward the distal end from the first pressure sensor (see figure 2)
a computer (items 114, 106, etc.) configured to receive and process the first pressure data and the second pressure data from the pressure sensing device;
wherein the processing of the pressure data by the computer comprises processing to assess the magnitude of pressure applied to the first and second pressure sensors and the timing of pressure applied to the first and second pressure sensors, and wherein the processing of the pressure data by the computer comprises processing to determine whether the magnitude and timing of pressure applied to the first and second pressure sensors meets predetermined criteria, the predetermined criteria at least comprising whether pressure data obtained simultaneously by the first pressure sensor and the second pressure sensor indicates that the magnitude of the first pressure applied to the first pressure sensor is within a first pressure range and that the magnitude of the second pressure applied simultaneously to the second pressure sensor is within a second pressure range (col. 7, lines 29-59, simultaneous taught in lines 33-35, “dynamic pressures” define magnitude, timing taught in lines 41-44); and
a user interface (items 108 and 118) associated with the computer and configured to present, to the user, information associated with the first pressure data and the second pressure data received from the pressure sensing device, wherein the information associated with the first pressure data and the second pressure data received from the pressure sensing device comprises information on whether, based on the processing of the pressure data by the computer, the first pressure data and the second pressure data indicates that the magnitude and timing of pressure applied to the first and second sensors meets the predetermined criteria (col. 5, lines 7-24 and col. 7, lines 40-44).
Regarding claim 2, Rao further discloses wherein the first pressure sensor is configured to sense anal sphincter pressure applied to the first portion of the external surface (item 210, col. 3, lines 60-62), and the second pressure sensor is configured to sense rectal pressure applied to the second portion of the external surface (item 206, col. 3, lines 60-62).
Regarding claim 3, Rao further discloses wherein the first portion has a length, measured along the longitudinal axis of between 1-6cm (col. 4, lines 4-15).
Regarding claims 4 and 23, Rao further discloses wherein the length of the first portion is defined by a first pressure pad (item 210 is defined as a pad, item 240 is length thereof) associated therewith, the first pressure pad being configured to transfer the first pressure applied thereto to the first pressure sensor (wiring to 222).
Regarding claim 5, Rao further discloses wherein the spacing, along the longitudinal axis, between a center of the first portion and a center of a second portion is between 3 and 8 cm (col. 4, lines 4-15, radius or half lengths of 240 and 236 combine to 1.5cm, remainder of lengths of 230 is equal to 9.5cm for each of the three sections of 200 which would fall between 3 to 8).
Regarding claim 6, Rao further discloses a system comprising a transmitter carried by the elongate housing, the transmitter being configured to transmit the first and second pressure data (items 208, 212, wiring to sensors).
Regarding claim 10, Rao further discloses wherein the external surface of the elongate housing has a shape that causes the first pressure sensor to automatically align with the user’s anal sphincter upon insertion of the elongate housing into the user (item 216 and previous citations).
Regarding claim 12, Rao further discloses a system comprising a flange (item 216) extending outwardly in a direction transverse to the longitudinal axis, the flange being configured to abut a portion of the user upon insertion of the elongate housing into the user and thereby to limit the extent of the insertion of the elongate housing into the user (see figure 2).
Regarding claim 13, Rao further discloses wherein the position along the longitudinal axis, of the flange relative to the first pressure sensor is such that, in use, the abutment of the flange with the portion of the user facilities alignment of the first pressure sensor with the user’s anal sphincter (see figure 2 and previous citations).
Regarding claim 14, Rao further discloses a system further comprising an inflatable element carried by the distal end of the elongate housing (item 202).
Regarding claim 20, Rao further discloses wherein the computer is further configured to receive data inputs from the user and to process the received data inputs, wherein the received data inputs comprise at least one of: food intake of the user, water intake of the user, physical exercise performed by the user, and properties of stools produced by the user (col. 7, lines 45-65, input modes based on properties of the stool).
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rao in view of JP2019528103 (previously known as ‘103).
Regarding claim 8, Rao fails to disclose wherein the transmitter is configured to wirelessly transmit the first pressure data and the second pressure data. It is noted that Rao does teach wireless technology but not within the housing.
‘130 teaches a transmitter carried by the housing (Figure 1 depicts transmitter/receiver 100 on a circuit board on a ring-shaped body 110 of the device).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize wireless technology as taught by ‘103 to the system of Rao, the motivation being that it would allow for wireless communication and a single electrical power source to power and disseminate information in the device. Additionally, the examiner takes official notice that wireless technology is widely known and available at the time of filing of the invention.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rao.
Regarding claim 22, Rao discloses determining pressure values simultaneously which are sent to a display to present the results to the user but fails to specify the ranges of pressure.
However, it would have been obvious to one of ordinary skill in the art at the filing date of the invention to display or control the pressure components to appropriate ranges as disclosed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is pressure values of the anal and sphincter which achieves the recognized result of an appropriate pressure to perform the function of stopping incontinence or providing therapy, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Response to Arguments
Regarding the objections and previous 112B rejections, they are withdrawn in view of the amendment received on 10/15/25.
Applicant’s arguments with respect to claim(s) 2-6, 8, 10, 12-15, 20, 22, and 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments against the 35USC101 rejection filed 10/15/25 have been fully considered but they are not persuasive. Firstly, it is noted that the amendment was helpful and in the right direction. The review of the prior art however showed that the additional elements added were well known at the time of filing in view of the Rao reference. The previously used reference Broens also substantially taught the structure claimed. It is noted that technological improvements must not be solely within the judicial exception. In response to the memo, applicant should point to the examples cited in the memo and how the claims of the current application are analogous. It would appear that these claims are more similar to example 47, claim 2. It would also appear that specific machine learning training is not particularly claimed in this application.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX M VALVIS whose telephone number is (571)272-4233. The examiner can normally be reached 9:00-5:00 M-F.
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ALEX M. VALVIS
Supervisory Patent Examiner
Art Unit 3791
/ALEX M VALVIS/ Supervisory Patent Examiner, Art Unit 3791