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 Objections
Claims 2, 4, 7, 16, and 17 are objected to because of the following informalities:
“,” should be added after the preamble of claims 2, 4, 7, 16, and 17
Appropriate correction is required.
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: fastening element in claims 6 and 9.
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.
“Fastening element” is interpreted as an adhesive element or magnets as mentioned in [0109] of the PGPUB.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,575,788 in view of Kassab et al. ‘268 (US Pub No. 2019/0298268) further in view of Sarvazyan et al. ‘275 (US Pub No. 2002/0143275).
Regarding claim 1, the US Patent teaches a device for facilitating treatment for anorectal and pelvic floor disorders of users using biofeedback therapy (Claim 1), the device comprising:
a body extending between a top end and a bottom end, wherein the body comprises a top end portion, a middle portion, and a bottom end portion, wherein the body is configured to be placed in a rectum of a user by inserting the body into the rectum, wherein the top end portion is positioned adjacent to a first region of the rectum, the middle portion is positioned adjacent to a second region of the rectum, and the bottom end portion is positioned adjacent to a third region of the rectum based on the placing of the body in the rectum (Claim 1);
a balloon mounted on the top end portion of the body (Claim 1);
a plurality of sensors comprising at least one first sensor, at least one second sensor, and at least one third sensor (Claim 1), wherein the at least one first sensor is configured for:
generating at least one final first balloon data based on detecting at least one balloon characteristic associated with the balloon after the placing of the body in the rectum, wherein the at least one balloon characteristic corresponds to at least one maneuver performed by the user (Claim 1); and
generating at least one first sensor data based on detecting at least one region characteristic associated with the first region, wherein the at least one second sensor is configured for generating at least one second sensor data based on detecting the at least one region characteristic associated with the second region, wherein the at least one third sensor is configured for generating at least one third sensor data based on detecting the at least one region characteristic associated with the third region (Claim 1);
a processing device communicatively coupled with the plurality of sensors (Claim 1), wherein the processing device is configured for:
analyzing the at least one final first balloon data, the at least one first sensor data, the at least one second sensor data, and the at least one third sensor data (Claim 1);
determining at least one anorectal anatomical change associated with the rectum based on the analyzing (Claim 1); and
generating at least one dynamic visual representation of a human anatomy for stimulating the at least one anorectal anatomical change during the at least one maneuver in real-time based on the at least one anorectal anatomical change and a static visual representation of the human anatomy (Claim 1); and
a communication device communicatively coupled with the processing device, wherein the communication device is configured for transmitting the at least one dynamic visual representation to at least one output device, wherein the at least one output device comprises a biofeedback software configured for presenting the at least one dynamic visual representation (Claim 1).
The US Patent teaches all of the elements of the current invention as mentioned above except for wherein each of the plurality of sensors are operatively positioned circumferentially on the body.
Kassab et al. ‘268 teaches a plurality of circumferentially-positioned pressure sensors on a device for testing distal colonic and anorectal function to obtain a plurality of pressure measurements at one or more locations within the large bowel (Fig. 17 and [0123]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of sensors of the US Patent to include being operatively positioned circumferentially on the body as Kassab et al. ‘268 teaches that this will aid in obtaining a plurality of pressure measurements at one or more locations within the large bowel.
The US Patent in view of Kassab et al. ‘268 teaches all of the elements of the current invention as mentioned above except for wherein the at least one anorectal anatomical change comprises at least one of a topographical anorectal anatomical change and a configurational anorectal anatomical change.
Sarvazyan et al. ‘275 teaches a topographic picture to represent the different pressure levels at pressure transducers of a tactile sensor for improved differentiation between pressure levels (Fig. 4 and [0034]). Preferably, lines 44 have a predetermined color to represent the prostate shape and lines 45 corresponding to a higher pressure have a predetermined second color to represent color regions with increased hardness inside the prostate. Pressure gradient analysis of pressure data can be used to determine the prostate shape and its inner structure ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one anorectal anatomical change of the US Patent in view of Kassab et al. ‘268 to include at least one of a topographical anorectal anatomical change and a configurational anorectal anatomical change as Sarvazyan et al. ‘275 teaches that this will aid in determining organ hardness, organ shape, and its inner structure.
Regarding claim 2, the US Patent teaches a base attached to the bottom end, wherein the base is not placed inside the rectum, wherein the base facilitates the inserting of the body in the rectum, wherein the body is operatively coupled to the base using a u- shaped bend joint (Claim 1).
Regarding claim 3, the US Patent teaches wherein the balloon is fluidly coupled with at least one port comprised in the base through at least one tube, wherein the balloon deflatably inflatable by removably transferring at least one amount of at least one fluid to the balloon through the at least one port, wherein the at least one first sensor is further configured for generating at least one initial first balloon data based on detecting the at least one balloon characteristic associated with the balloon before the placing of the body in the rectum, wherein the at least one balloon characteristic corresponds to the at least one amount of the at least one fluid, wherein the processing device is further configured for analyzing the at least one initial first balloon data, wherein the determining of the at least one anorectal change is further based on the analyzing of the at least one initial first balloon data (Claim 2).
Regarding claim 4, the US Patent teaches a second balloon mounted on the middle portion of the body, wherein the at least one second sensor is further configured for detecting at least one balloon characteristic associated with the second balloon after the placing of the body in the rectum, wherein the processing device is further configured for analyzing the at least one second balloon data, wherein the determining of the at least one anorectal change is further based on the analyzing of the at least one second balloon data (Claim 1).
Regarding claim 5, the US Patent teaches wherein the second balloon is movably mounted on the middle portion, wherein the second balloon is configured to be moved between a plurality of positions along the middle portion (Claim 1).
Regarding claim 6, the US Patent teaches wherein the second balloon is further configured to be fastened to the middle portion in one of the plurality of positions using a fastening element (Claim 3).
Regarding claim 7, the US Patent teaches a third balloon mounted on the bottom end portion of the body, wherein the at least one third sensor is further configured for detecting at least one balloon characteristic associated with the third balloon after the placing of the body in the rectum, wherein the processing device is further configured for analyzing the at least one third balloon data, wherein the determining of the at least one anorectal change is further based on the analyzing of the at least one third balloon data (Claim 1).
Regarding claim 8, the US Patent teaches wherein the third balloon is movably mounted on the bottom end portion, wherein the third balloon is configured to be moved between a plurality of positions along the bottom end portion (Claim 4).
Regarding claim 9, the US Patent teaches wherein the third balloon is further configured to be fastened to the bottom end portion in one of the plurality of positions using a fastening element (Claim 4).
Regarding claim 10, the US Patent teaches, wherein the communication device is configured for:
receiving an indication associated with the user and one of a plurality of anorectal and pelvic floor disorders from at least one input device (Claim 6); and
transmitting at least one instruction to the at least one output device, wherein the device comprises a storage device communicatively coupled with the communication device, wherein the storage device is further configured for retrieving at least one treatment program associated with the user for one of the plurality of anorectal and pelvic floor disorders, wherein the processing device is communicatively coupled with the storage device, wherein the processing device is further configured for generating the at least one instruction for at least one therapy session based on the at least one treatment program, wherein the at least one instruction instructs the user for performing the at least one maneuver after the placing of the body in the rectum (Claim 6).
Regarding claim 11, the US Patent teaches wherein the processing device is further configured for:
determining a state of the user with regards to one of the plurality of anorectal md pelvic floor disorders based on the analyzing of the at least one final first balloon data, the at least one first sensor data, the at least one second sensor data, and the at least one third sensor data (Claim 7); and
generating a current status report corresponding to the state of the user based on the determining of the state, wherein the storage device is further configured for storing the current status report of the user (Claim 7).
Regarding claim 12, the US Patent teaches wherein the storage device is further configured for retrieving i historical status report associated with a historical state of the user with regards to one of the plurality of anorectal and pelvic floor disorders based on the indication, wherein the processing device is further configured for analyzing the historical status report, wherein the generating of the at least one instruction is further based on the analyzing of the historical status report (Claim 8).
Regarding claim 13, the US Patent teaches wherein the transmitting of the at least one dynamic visual representation to the at least one output device comprises transmitting the at least one dynamic visual representation to the at least one output device over at least one wireless communication channel (Claim 9).
Regarding claim 14, the US Patent teaches a device for facilitating treatment for anorectal and pelvic floor disorders of users using biofeedback therapy (Claim 1), the device comprising:
a body extending between a top end and a bottom end, wherein the body comprises a top end portion, a middle portion, and a bottom end portion, wherein the body is configured to be placed in a rectum of a user by inserting the body into the rectum, wherein the top end portion is positioned adjacent to a first region of the rectum, the middle portion is positioned adjacent to a second region of the rectum, and the bottom end portion is positioned adjacent to a third region of the rectum based on the placing of the body in the rectum (Claim 1);
a balloon mounted on the top end portion of the body (Claim 1);
a plurality of sensors comprising at least one first sensor, at least one second sensor, and at least one third sensor (Claim 1), wherein the at least one first sensor is configured for:
generating at least one final first balloon data based on detecting at least one balloon characteristic associated with the balloon after the placing of the body in the rectum, wherein the at least one balloon characteristic corresponds to at least one maneuver performed by the user (Claim 1); and
generating at least one first sensor data based on detecting at least one region characteristic associated with the first region, wherein the at least one second sensor is configured for generating at least one second sensor data based on detecting the at least one region characteristic associated with the second region, wherein the at least one third sensor is configured for generating at least one third sensor data based on detecting the at least one region characteristic associated with the third region (Claim 1);
a processing device communicatively coupled with the plurality of sensors (Claim 1), wherein the processing device is configured for:
analyzing the at least one final first balloon data, the at least one first sensor data, the at least one second sensor data, and the at least one third sensor data (Claim 1);
determining at least one anorectal anatomical change associated with the rectum based on the analyzing (Claim 1); and
generating at least one dynamic visual representation of a human anatomy for stimulating the at least one anorectal anatomical change during the at least one maneuver in real-time based on the at least one anorectal anatomical change and a static visual representation of the human anatomy (Claim 1); and
a communication device communicatively coupled with the processing device, wherein the communication device is configured for transmitting the at least one dynamic visual representation to at least one output device, wherein the at least one output device comprises a biofeedback software configured for presenting the at least one dynamic visual representation (Claim 1).
The US Patent teaches all of the elements of the current invention as mentioned above except for wherein each of the plurality of sensors are operatively positioned circumferentially on the body.
Kassab et al. ‘268 teaches a plurality of circumferentially-positioned pressure sensors on a device for testing distal colonic and anorectal function to obtain a plurality of pressure measurements at one or more locations within the large bowel (Fig. 17 and [0123]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of sensors of the US Patent to include being operatively positioned circumferentially on the body as Kassab et al. ‘268 teaches that this will aid in obtaining a plurality of pressure measurements at one or more locations within the large bowel.
The US Patent in view of Kassab et al. ‘268 teaches all of the elements of the current invention as mentioned above except for wherein the at least one anorectal anatomical change comprises at least one of a topographical anorectal anatomical change and a configurational anorectal anatomical change.
Sarvazyan et al. ‘275 teaches a topographic picture to represent the different pressure levels at pressure transducers of a tactile sensor for improved differentiation between pressure levels (Fig. 4 and [0034]). Preferably, lines 44 have a predetermined color to represent the prostate shape and lines 45 corresponding to a higher pressure have a predetermined second color to represent color regions with increased hardness inside the prostate. Pressure gradient analysis of pressure data can be used to determine the prostate shape and its inner structure ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one anorectal anatomical change of the US Patent in view of Kassab et al. ‘268 to include at least one of a topographical anorectal anatomical change and a configurational anorectal anatomical change as Sarvazyan et al. ‘275 teaches that this will aid in determining organ hardness, organ shape, and its inner structure.
Regarding claim 15, the US Patent teaches wherein the balloon is fluidly coupled with at least one port comprised in the base through at least one tube, wherein the balloon deflatably inflatable by removably transferring at least one amount of at least one fluid to the balloon through the at least one port, wherein the at least one first sensor is further configured for generating at least one initial first balloon data based on detecting the at least one balloon characteristic associated with the balloon before the placing of the body in the rectum, wherein the at least one balloon characteristic corresponds to the at least one amount of the at least one fluid, wherein the processing device is further configured for analyzing the at least one initial first balloon data, wherein the determining of the at least one anorectal change is further based on the analyzing of the at least one initial first balloon data (Claim 2).
Regarding claim 16, the US Patent teaches a second balloon mounted on the middle portion of the body, wherein the at least one second sensor is further configured for detecting at least one balloon characteristic associated with the second balloon after the placing of the body in the rectum, wherein the processing device is further configured for analyzing the at least one second balloon data, wherein the determining of the at least one anorectal change is further based on the analyzing of the at least one second balloon data (Claim 1).
Regarding claim 17, the US Patent teaches a third balloon mounted on the bottom end portion of the body, wherein the at least one third sensor is further configured for detecting at least one balloon characteristic associated with the third balloon after the placing of the body in the rectum, wherein the processing device is further configured for analyzing the at least one third balloon data, wherein the determining of the at least one anorectal change is further based on the analyzing of the at least one third balloon data (Claim 1).
Regarding claim 18, the US Patent teaches wherein the transmitting of the at least one dynamic visual representation to the at least one output device comprises transmitting the at least one dynamic visual representation to the at least one output device over at least one wireless communication channel (Claim 9).
Regarding claim 19, the US Patent teaches wherein the communication device is configured for:
receiving an indication associated with the user and one of a plurality of anorectal and pelvic floor disorders from at least one input device (Claim 6); and
transmitting at least one instruction to the at least one output device, wherein the device comprises a storage device communicatively coupled with the communication device, wherein the storage device is further configured for retrieving at least one treatment program associated with the user for one of the plurality of anorectal and pelvic floor disorders, wherein the processing device is communicatively coupled with the storage device, wherein the processing device is further configured for generating the at least one instruction for at least one therapy session based on the at least one treatment program, wherein the at least one instruction instructs the user for performing the at least one maneuver after the placing of the body in the rectum (Claim 6).
Regarding claim 20, the US Patent teaches a device for facilitating treatment for anorectal and pelvic floor disorders of users using biofeedback therapy (Claim 1), the device comprising:
a body extending between a top end and a bottom end, wherein the body comprises a top end portion, a middle portion, and a bottom end portion, wherein the body is configured to be placed in a rectum of a user by inserting the body into the rectum, wherein the top end portion is positioned adjacent to a first region of the rectum, the middle portion is positioned adjacent to a second region of the rectum, and the bottom end portion is positioned adjacent to a third region of the rectum based on the placing of the body in the rectum (Claim 1);
a balloon mounted on the top end portion of the body (Claim 1);
a plurality of sensors comprising at least one first sensor, at least one second sensor, and at least one third sensor (Claim 1), wherein the at least one first sensor is configured for:
generating at least one final first balloon data based on detecting at least one balloon characteristic associated with the balloon after the placing of the body in the rectum, wherein the at least one balloon characteristic corresponds to at least one maneuver performed by the user (Claim 1); and
generating at least one first sensor data based on detecting at least one region characteristic associated with the first region, wherein the at least one second sensor is configured for generating at least one second sensor data based on detecting the at least one region characteristic associated with the second region, wherein the at least one third sensor is configured for generating at least one third sensor data based on detecting the at least one region characteristic associated with the third region (Claim 1);
a processing device communicatively coupled with the plurality of sensors (Claim 1), wherein the processing device is configured for:
analyzing the at least one final first balloon data, the at least one first sensor data, the at least one second sensor data, and the at least one third sensor data (Claim 1);
determining at least one anorectal anatomical change associated with the rectum based on the analyzing (Claim 1); and
generating at least one dynamic visual representation of a human anatomy for stimulating the at least one anorectal anatomical change during the at least one maneuver in real-time based on the at least one anorectal anatomical change and a static visual representation of the human anatomy (Claim 1);
a communication device communicatively coupled with the processing device (Claim 1), wherein the communication device is configured for:
transmitting the at least one dynamic visual representation to at least one output device, wherein the at least one output device comprises a biofeedback software configured for presenting the at least one dynamic visual representation (Claim 1);
receiving an indication associated with the user and one of a plurality of anorectal and pelvic floor disorders from at least one input device (Claim 6); and
transmitting at least one instruction to the at least one output device (Claim 1); and
a storage device communicatively coupled with the communication device, wherein the storage device is further configured for retrieving at least one treatment program associated with the user for one of the plurality of anorectal and pelvic floor disorders, wherein the processing device is communicatively coupled with the storage device, wherein the processing device is further configured for generating the at least one instruction for at least one therapy session based on the at least one treatment program, wherein the at least one instruction instructs the user for performing the at least one maneuver after the placing of the body in the rectum (Claim 6).
The US Patent teaches all of the elements of the current invention as mentioned above except for wherein each of the plurality of sensors are operatively positioned circumferentially on the body.
Kassab et al. ‘268 teaches a plurality of circumferentially-positioned pressure sensors on a device for testing distal colonic and anorectal function to obtain a plurality of pressure measurements at one or more locations within the large bowel (Fig. 17 and [0123]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of sensors of the US Patent to include being operatively positioned circumferentially on the body as Kassab et al. ‘268 teaches that this will aid in obtaining a plurality of pressure measurements at one or more locations within the large bowel.
The US Patent in view of Kassab et al. ‘268 teaches all of the elements of the current invention as mentioned above except for wherein the at least one anorectal anatomical change comprises at least one of a topographical anorectal anatomical change and a configurational anorectal anatomical change.
Sarvazyan et al. ‘275 teaches a topographic picture to represent the different pressure levels at pressure transducers of a tactile sensor for improved differentiation between pressure levels (Fig. 4 and [0034]). Preferably, lines 44 have a predetermined color to represent the prostate shape and lines 45 corresponding to a higher pressure have a predetermined second color to represent color regions with increased hardness inside the prostate. Pressure gradient analysis of pressure data can be used to determine the prostate shape and its inner structure ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one anorectal anatomical change of the US Patent in view of Kassab et al. ‘268 to include at least one of a topographical anorectal anatomical change and a configurational anorectal anatomical change as Sarvazyan et al. ‘275 teaches that this will aid in determining organ hardness, organ shape, and its inner structure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee (“High Resolution and High Definition Anorectal Manometry and Pressure Topography: Diagnostic Advance or a New Kid on the Block?” – 2013) teaches a similar device as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
