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 § 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.
Claim 4 is 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. As claim 1 was amended to recite that the device comprises “a pressure-sensitive deformable tip”, the recitation of the pressure-sensitive tip comprising “a deformable tip” in claim 4 renders the claim indefinite. It is unclear if the “a deformable tip” of claim 4 is the same as or different than the “pressure-sensitive deformable tip” of claim 1. For this examination, claim 4 is being interpreted such that the “a deformable tip” is the same deformable tip recited in claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 7, 11, 13, 14, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn’281 (US Pub No. 2012/0130281 – previously cited) in view of Dijkman’392 (US Pub No. 2004/0054392 – previously cited) further in view of Wolkenstorfer’812 (US Pub No. 2010/0298812 – previously cited).
Regarding claims 1-4 and 11, Figure 15 of Ahn’281 discloses a rectal tonometer device for quantitatively detecting and measuring a rectal tone of a patient (see ABSTRACT), the device comprising: a body 15 made up of a forward end 40 and a second end 45 (section [0081]). The second end is a cylindrically shaped main body, and the first end is a tip, extending from a distal end of the main body, comprising a pressure sensor 20 (section [0080]). Section [0083] makes clear that the pressure sensor can be located anywhere on or in the body 15, including along the entire length of the body. This would include a pressure sensor that is partially within main body 45 and extends from the main body into tip 40. In order for the pressure sensor to be within main body 45, main body 45 would inherently require a cavity within which the pressure sensor is located. Ahn’281 further discloses that the device comprises a circuit board communicatively coupled to the tip, comprising a microprocessor configured to execute computer-readable instructions and a memory component operatively coupled to the circuit board, comprising a plurality of computer-readable instructions for: i. accepting a pressure signal from the pressure sensor; and ii. measuring, based on the pressure signal, the rectal tone of the patient (see ABSTRACT, and sections [0038], [0083-0085]: computer 46 inherently comprises a circuit board comprising a microprocessor configured to execute computer-readable instructions and a memory component operatively coupled to the circuit board, comprising a plurality of computer-readable instructions for performing the accepting and measuring steps).
Ahn’281 discloses all of the elements of the current invention, as discussed above, except for explicitly reciting that the tip is a pressure-sensitive, deformable tip configured to actuate the pressure sensor when deformed. As noted in paragraph [0030] of Ahn’281, Dijkman’392 teaches a pressure-sensitive deformable tip configured to actuate a pressure sensor when deformed (see section [0007] of Dijkman’392). A pressure sensor within a cavity of the tip detects pressure signals when flexible walls of the tip deform due to pressure exerted against the flexible walls. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the tip of Ahn’281 to be a pressure-sensitive, deformable tip configured to actuate the pressure sensor when deformed, as it would merely be combining prior art elements according to known methods to yield predictable results. Ahn’281 requires its pressure sensor to detect pressure signals related to pressure exerted by rectal surfaces of the patient onto the rectal tonometer device, but fails to provide details of how the pressure sensor detects the pressure signals. Dijkman’392 provides details as to how a pressure sensor within a tip would detect pressure signals related to pressure exerted by rectal surfaces of the patient onto a rectal tonometer device.
Ahn’281 in view of Dijkman’392 discloses all of the elements of the current invention, as discussed above, except for the circuit board being disposed within the cavity. It is noted that Applicant has failed to provide details of criticality or unexpected results in their specification with regard to the placement of the circuit board. As such, it would have been an obvious matter of design choice as to the arrangement of the circuit board within the rectal tonometer device of Ahn’281 in view of Dijkman’392 (see MPEP 2144.04 VI. C.).
Ahn’281 in view of Dijkman’392 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the tip further comprising longitudinally aligned ribs such that stiffness in an axial direction is greater than stiffness in a radial direction. Wolkenstorfer’812 teaches providing longitudinally aligned ribs on an insertable probe in order to increase the stiffness of the probe and assist in preventing undesirable kinking of the probe when inserted into a patient (section [0031]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the tip of Ahn’281 in view of Dijkman’392 to include longitudinally aligned ribs that increase the stiffness of the device in an axial direction with respect to a stiffness of the device in a radial direction, as Wolkenstorfer’812 teaches that this would help prevent kinking of the probe when inserted into the patient.
Regarding claims 6 and 13, Ahn’281 discloses a display component 25 disposed on the rectal tonometer device (Figure 15, display component 25, section [0080]). It is noted that Applicant has failed to provide details of criticality or unexpected results in their specification with regard to the placement of the display component on the main body. As such, it would have been an obvious matter of design choice to dispose the display component on the main body of Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812 (see MPEP 2144.04 VI. C.). Furthermore, Figure 3 of Ahn’281 shows an embodiment wherein the display component 25 is disposed on the main body.
Regarding claims 7 and 14, Ahn’281 discloses that the circuit board (processing device) is further configured to display the pressure signal on the display component in units of mmHg (sections [0080], [0106]). While section [0080] specifically teaches displaying the pressure in units of pounds per square inch, section [0106] teaches determining a diagnosis of a complication (cauda equina syndrome or a risk of having it) based on pressure measurements in units of mmHg. One of ordinary skill in the art would have found it obvious to display the obtained pressure measurements in units of mmHg in order to allow for an easier determination of whether or not the patient has cauda equina syndrome or is at risk of having it.
Regarding claim 18, Figure 15 of Ahn’281 discloses a system for diagnosing a complication affecting an anorectal region of a patient (see ABSTRACT), the system comprising: a rectal tonometer device comprising: a body 15 made up of a forward end 40 and a second end 45 (section [0081]). The second end is a cylindrically shaped main body, and the first end is a tip, extending from a distal end of the main body, comprising a pressure sensor 20 (section [0080]). Section [0083] makes clear that the pressure sensor can be located anywhere on or in the body 15, including along the entire length of the body. This would include a pressure sensor that is partially within main body 45 and extends from the main body into tip 40. In order for the pressure sensor to be within main body 45, main body 45 would inherently require a cavity within which the pressure sensor is located. Ahn’281 further discloses that the device comprises a circuit board communicatively coupled to the tip, comprising a microprocessor configured to execute computer-readable instructions and a memory component operatively coupled to the microprocessor, comprising a plurality of computer-readable instructions for: i. accepting a pressure signal from the pressure sensor; ii. transmitting the pressure signal through a communication component (communication component 50 of Figure 5), the communication component coupling the rectal tonometer device to a computing device (computing device 46 of Figure 5); and the computing device comprising a processor configured to execute computer-readable instructions and a memory component operatively coupled to the processor, comprising computer-readable instructions for: i. accepting the pressure signal from the rectal tonometer device by the communication component (sections [0083-0085]), ii. generating, based on the pressure signal, a data log (sections [0083-0085]); and iii. determining, based on the data log, a diagnosis of the complication (sections [0080], [0083-0085], [0106]).
Ahn’281 discloses all of the elements of the current invention, as discussed above, except for explicitly reciting that the tip is a pressure-sensitive, deformable tip configured to actuate the pressure sensor when deformed. As noted in paragraph [0030] of Ahn’281, Dijkman’392 teaches a pressure-sensitive deformable tip configured to actuate a pressure sensor when deformed (see section [0007] of Dijkman’392). A pressure sensor within a cavity of the tip detects pressure signals when flexible walls of the tip deform due to pressure exerted against the flexible walls. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the tip of Ahn’281 to be a pressure-sensitive, deformable tip configured to actuate the pressure sensor when deformed, as it would merely be combining prior art elements according to known methods to yield predictable results. Ahn’281 requires its pressure sensor to detect pressure signals related to pressure exerted by rectal surfaces of the patient onto the rectal tonometer device, but fails to provide details of how the pressure sensor detects the pressure signals. Dijkman’392 provides details as to how a pressure sensor within a tip would detect pressure signals related to pressure exerted by rectal surfaces of the patient onto a rectal tonometer device.
Ahn’281 in view of Dijkman’392 discloses all of the elements of the current invention, as discussed above, except for the circuit board being disposed within the cavity. It is noted that Applicant has failed to provide details of criticality or unexpected results in their specification with regard to the placement of the circuit board. As such, it would have been an obvious matter of design choice as to the arrangement of the circuit board within the rectal tonometer device of Ahn’281 in view of Dijkman’392 (see MPEP 2144.04 VI. C.).
Ahn’281 in view of Dijkman’392 discloses all of the elements of the current invention, as discussed above, except for the tip further comprising longitudinally aligned ribs such that stiffness in an axial direction is greater than stiffness in a radial direction. Wolkenstorfer’812 teaches providing longitudinally aligned ribs on an insertable probe in order to increase the stiffness of the probe and assist in preventing undesirable kinking of the probe when inserted into a patient (section [0031]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the tip of Ahn’281 in view of Dijkman’392 to include longitudinally aligned ribs that increase the stiffness of the device in an axial direction with respect to a stiffness of the device in a radial direction, as Wolkenstorfer’812 teaches that this would help prevent kinking of the probe when inserted into the patient.
Regarding claim 19, Ahn’281 discloses that determining the diagnosis comprises determining whether the pressure signal falls above or below a predetermined threshold on the data log (sections [0080], [0083-0084], [0106]).
Claims 5, 8, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812, as applied to claims 1, 6, 11, and 13, further in view of Zeller’800 (US Pub No. 2019/0239800 – previously cited).
Regarding claims 5 and 12, Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the rectal tonometer device further comprising a tip stopper connecting the tip to the main body. Figure 8 of Zeller’800 shows an insertion probe that comprises a tip stopper 820 connecting a tip to a main body. The tip stopper ensures correct entry depth and internal alignment of the insertion probe (section [0125]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the rectal tonometer device of Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812 to include a tip stopper connecting the tip to the main body, as Zeller’800 teaches that this would ensure correct entry depth and internal alignment of the rectal tonometer device.
Regarding claims 8 and 15, Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812 discloses all of the elements of the current invention, as discussed in paragraph 5 above except for the display component comprising an LED display. While Ahn’281 discloses a display component (Figures 5, 11, and 15, display component 25; sections [0080], [0084]), it fails to provide details of the display component. Zeller’800 teaches that a display component may be an LED display (section [0060]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have used an LED display as the display component of Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812. The modification to Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812 would merely be combining prior art elements according to known methods to yield predictable results.
Claims 9, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812, as applied to claims 1, 11, and 18, further in view of Walsh et al.’341 (US Pub No. 2004/0122341 – previously cited).
Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the rectal tonometer device further comprising a fastening ring operatively coupled to a base of the tip, configured to fasten a finger cot disposed over the tip in place. It is noted that Ahn’281 discloses a finger cot disposed over the tip (section [0082]: protective sheath/condom). Walsh et al.’341 teaches securing a sheath to a probe with a fastening ring (section [0052]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the rectal tonometer device of Ahn’281 in view of Dijkman’392 further in view of Wolkenstorfer’812 to include a fastening ring operatively coupled to a base of the tip, as Walsh et al.’341 teaches that the fastening ring can be used to rigidly secure the finger cot (sheath) to the tip.
Response to Arguments
Applicant's arguments filed 10 June 2026 have been fully considered.
Regarding the rejection of the claims under 35 U.S.C. 101, Applicant’s arguments are persuasive. The rejection has been withdrawn.
Regarding the rejections of claims 18-20 under 35 U.S.C. 112(b), the amendments to claim 18 have overcome the previous rejections.
Regarding the rejections of the claims in view of the cited prior art, Applicant’s arguments are not persuasive. Applicant argues that Wolkenstorfer does not teach a “saguaro-design for a deformable rectal tonometer”. This argument is not persuasive as Wolkenstorfer was not relied upon to teach a saguaro-design for a deformable rectal tonometer. Ahn in view of Dijkman teaches a deformable rectal tonometer. Wolkenstorfer was relied upon to modify Ahn in view of Dijkman so that the tip of the rectal tonometer of Ahn in view of Dijkman comprises longitudinally aligned ribs such that stiffness in an axial direction is greater than stiffness in a radial direction. Applicant is arguing the Wolkenstorfer reference individually instead of the combination of references used to reject the claims. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argues that the purpose of the longitudinally aligned ribs of Wolkenstorfer is incompatible with a rectal tonometer. Applicant relies on paragraph [0014] of Wolkenstorfer for this argument. While paragraph [0014] teaches an embodiment wherein longitudinally aligned ribs are used to maintain fluid communication throughout tubes, this is not the embodiment of Wolkenstorfer that was relied upon to reject the claims. The Examiner relied on the embodiment discussed in paragraph [0031]. This section of Wolkenstorfer’812 clearly teaches an embodiment wherein providing longitudinally aligned ribs on an insertable probe increases the stiffness of the probe and assists in preventing undesirable kinking of the probe when inserted into a patient. This teaching is directly applicable to the rectal tonometer of Ahn in view of Dijkman.
Applicant next argues that Wolkenstorfer “teaches away from the inventive technical feature of the present invention”. This argument is not persuasive as a secondary reference must not teach away from the primary reference that it is modifying. Applicant further argues against implementing a saguaro-design into the device of Wolkenstorfer. This argument is not persuasive as no rejection was made by modifying Wolkenstorfer to include the claimed “saguaro-design”.
Applicant’s argument that implementing the longitudinally aligned ribs into a rectal tonometer device with pressure sensing capabilities would cause the device to axially bend, causing kinks in the system and prevent it from being efficiently inserted into the rectal cavity is not persuasive as Wolkenstorfer explicitly recites that its longitudinally aligned ribs prevent undesirable kinking of a probe when inserted into a patient. Applicant’s argument that “the radial rigidity would prevent the pressure sensor from being efficiently actuated, reducing the efficacy of the rectal tone measurement device” is not persuasive as it is merely speculation. Applicant provides no rationale as to why modifying the rectal tonometer device of Ahn in view of Dijkman to include longitudinally aligned ribs, which is what is claimed, would prevent the pressure sensor from being efficiently actuated.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mondry et al.’482 (US Pub No. 2008/0221482) discloses using longitudinally aligned ribs to help guide steerable tips through various body configurations (section [0040]).
Schultz et al.’138 (US Pub No. 2019/0184138) teaches a catheter comprising longitudinally aligned ribs. Schultz et al.’138 further teaches adjusting lengths of the ribs to achieve desired stiffness and deflection characteristics along the length of the catheter (section [0045]).
Slattery et al.’054 (US Pub No. 2019/0344054) teaches a cylindrical device configured to be guided through blood vessels, the device comprising longitudinally aligned ribs. Slattery et al.’054 further teaches that the ribs allow for longitudinal flexibility to facilitate ease of navigation of the device through the vessels, and provide stiffness for optimum pushability for advancement of the device (section [0131]).
Broens’044 (US Pub No. 2012/0265044 – previously cited) teaches providing elongated ribs on a probe configured to be inserted within an orifice (section [0059]).
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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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