CTNF 18/241,965 CTNF 86077 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Specification 06-31 AIA 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 07-29-01 AIA Claim 7 is objected to because of the following informalities: “a wireless transmitter;” should read --a wireless transmitter .--. Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 3 and 4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 3 recites “obtaining measurements to compute frictional force” and claim 4 recites “generating a visual representation of frictional force using the obtained measurements”. Applicant’s original specification fails to provide any disclosure of how frictional force is computed based on obtained measurements, and how a visual representation thereof is produced. While there is a presumption an original claim is adequately supported by the written description, in this instance claims 3 and 4 describe a desired result ( i.e. , compute frictional force, generate a visual representation of frictional force) but the specification fails to describe in any manner how those results are achieved. See MPEP 2163.03(V). 07-30-02 AIA 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. 07-34-01 Claims 1-8 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 1 recites “the obtained size data” in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “the anorectal angle” and “the puborectalis muscle”. There is insufficient antecedent basis for these limitations in the claim. Claim 7 recites “gyroscope-accelerometer-magnetometer sensor”. It is unclear whether applicant intends to require the sensor includes a gyroscope, accelerometer, and a magnetometer, or whether applicant intends to require the sensor in one of a gyroscope, accelerometer, or a magnetometer. For the purposes of examination, this limitation is interpreted as requiring an gyroscope, accelerometer, or magnetometer. Claim 8 recites “the patient” and “the desired goal”. There is insufficient antecedent basis for these limitations in the claim. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-6 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim 1 recites a method of obtaining measurements within a mammalian gastrointestinal tract and generating a model colon based on the measurements. Claim 8 recites a method of obtaining measurements within a mammalian gastrointestinal tract and generating auditory or tactile indication(s) to a patient regarding the measurements. In claim 1, the limitations “generating a visual representation…” and “displaying the visual representation…” as drafted, are a process that, under its broadest reasonable interpretation, covers performance of the limitations on paper by a practitioner. For example, a practitioner may hand-draw a visual model of a patient’s colon using collected size data. In claim 8, the limitations “generating auditory or tactile messages…” and “alerting the patient…” as drafted, are a process that, under its broadest reasonable interpretation, covers performance of the limitations by hand by a practitioner. For example, a practitioner may verbally convey information regarding the measurements to a patient and verbally “alert” the patient whether the measurements are deemed beneficial or detrimental. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application. Claims 1 and 8 each additionally recite the step of “obtaining measurements using a device configured to fit within the mammalian gastrointestinal tract”. The “device” is recited at a high level of generality ( i.e. , a generic data collection device performing its generic function of measuring) such that it amounts to mere data gathering using a generic device, which has been found by the courts to be insignificant extra-solution activity. See MPEP 2106.04(d) and 2106.05(g). This additional element when considered alone and in combination does not integrate the abstract idea into a practical application because they do not impose any meaningful limit on practicing the abstract idea. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The original specification and present claim language provide no indication that the step of acquiring measurements via a general “device” is anything other than mere data gathering, as is well-known in the art, especially when claimed at a high level of generality, as is recognized by the courts. “Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis)”, see MPEP 2106.05(g). Accordingly, this additional element when considered alone and in combination does not amount to significantly more than the judicial exception, thus does not provide an inventive concept. Claims 2-4 and 6 include all the limitations of claim 1, thus is directed to the same abstract idea. These claims further limit the steps of the abstract idea performable by hand, thus do not impose any meaningful limit on practicing the abstract idea. Claim 5 includes all the limitations of claim 1, thus is directed to the same abstract idea. Claim 5 includes additional elements including “console or computer”, “processor”, “storage medium”, “display”, and “output device”. Each of these additional elements are generic computer components recited at a high level of generality ( i.e. , as generic computer elements performing their generic functions of data collection, processing, storage, and display) such that they amount to no more than mere instructions to apply the exception using the generic computer components. Thus these additional elements do not impose any meaningful limit on practicing the abstract idea. The examiner notes the limitations of claim 7, introduce additional elements that when considered alone and in combination amount to significantly more than the judicial exception. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-3, 5, and 6 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by U.S. Patent Application Publication No. 2008/0027358 (Gregersen et al.) . Regarding claim 1 , Gregersen teaches a method to treat functional anorectal disorders using biofeedback (abstract; feedback, [0040]; thermal stimulation, [0043]; [0049]-[0052]; stimulations, [0103]), comprising the steps of: obtaining measurements within a mammalian gastrointestinal tract using a device configured to fit within the mammalian gastrointestinal tract (probe, [0046]; [0103]); and generating a visual representation using the obtained measurements ([0052]; [0055]); displaying the visual representation modifying a model colon using the obtained size data to generate a patient-specific colon model (patient-specific colon model generated based on measurements and images: [0054]-[0056]; [0103]). Regarding claim 2 , Gregersen teaches the step of generating a visual representation using the obtained measurements comprises the steps of generating an image of the anorectal angle caused by the puborectalis muscle (entire rectum modeled: “size of the bag chosen…where distention of the entire length of rectum by a 14 cm long bag was confirmed”, [0046]; [0050]; [0055]-[0056]). Regarding claim 3 , Gregersen teaches the step of obtaining measurements comprises the steps of: obtaining measurements to compute frictional force (The limitation “to compute frictional force” is intended use, thus is not positively required. The measurements obtained as taught by Gregersen may contribute to a computation of some otherwise undefined frictional force:[0041]; [0043]; [0103].). Regarding claim 5 , Gregersen teaches the step of generating a visual representation using the obtained measurements is performed using a console or computer having a processor connected or otherwise in communication with a storage medium, whereby computer instructions stored within the storage medium are accessible by the processor to operate the console or computer to obtain the measurements from the device and to process the same to generate and display the visual representation on an output device operably connected to or formed as part of the console or computer (displayed model: [0054]-[0056]; software, data processing unit, hardware: [0043]; software, display, processing: [0103]; see discussion for claim 1). Regarding claim 6 , Gregersen teaches the measurements are obtained from the device wirelessly ([0038]) . 07-15 AIA Claim 8 is rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by U.S. Patent Application Publication No. 2012/0035642 (O’dea et al.) . Regarding claim 8 , O’dea teaches a method to treat functional anorectal disorders using biofeedback (abstract; [0011]), comprising the steps of: obtaining measurements within a mammalian gastrointestinal tract using a device configured to fit within the mammalian gastrointestinal tract (stomach is part of a mammalian GI tract, [0001]; measuring volume of stomach pouch, [0228]; Figures 22-24 ); and generating auditory or tactile messages using the obtained measurements; alerting the patient of changes in the obtained measurements related to either beneficial or detrimental progress towards achieving the desired therapeutic goal (alert signal based on measurements indicated via visual flash or audible warning, [0231]). When reading the preamble in the context of the entire claim, the recitation “to treat functional anorectal disorders using biofeedback” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co. , 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2008/0027358 (Gregersen et al.) in view of U.S. Patent Application Publication No. 2002/0107444 (Adler) . Regarding claim 7 , Gregersen teaches all the limitations of claim 1. Gregersen teaches the step of obtaining measurements is performed using the device comprising: a central stabilizing core at least partially surrounded by a balloon or bag ([0046]; [0076]; Figure 12 ); a front-positioned pressure sensor; a rear-positioned pressure sensor; a plurality of electrodes for measurement of electrical impedances; and a wireless transmitter (electrodes, [0014], [0037]; wireless, [0038]; “4-5 pressure channels/transducers”, [0103]). Gregersen does not expressly teach the probe includes front and rear positioned gyroscope-accelerometer-magnetometer sensors. However, Adler teaches a method for calculating a size of a gastrointestinal tract (abstract), comprising: obtaining measurements within a mammalian gastrointestinal tract using a device configured to fit within the mammalian gastrointestinal tract; wherein the device includes an accelerometer ([0018]-[0020]; [0022]; [0030]). 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 method of Gregersen such that the probe additionally includes an accelerometer as taught by Adler to collect additional data regarding movement of the gastrointestinal tract to improve characterization of the patient’s gastrointestinal tract (Adler, [0030]) . Double Patenting 08-33 AIA 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. 08-34 AIA Claim s 1 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 and 3 of U.S. Patent No. 11,844,622 . Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is merely broader in scope than all that is recited in claim 1 of the ‘622 patent. That is, claim 1 is anticipated by claim 1 of the ‘622 patent. Once applicant has received a patent for a species or a more specific embodiment, applicant is not entitled to a patent for the generic or broader invention (see In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)). Claims 5-7 of the instant application are anticipated by claims 1 and 3 of the ‘622 patent, by the same reasoning . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20100265251 (Vining et al.) teaches a system and method for measuring characteristics of a body lumen and generating a model thereof (abstract) Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CARRIE R DORNA/Primary Examiner, Art Unit 3791 Application/Control Number: 18/241,965 Page 2 Art Unit: 3791 Application/Control Number: 18/241,965 Page 3 Art Unit: 3791 Application/Control Number: 18/241,965 Page 4 Art Unit: 3791 Application/Control Number: 18/241,965 Page 5 Art Unit: 3791 Application/Control Number: 18/241,965 Page 6 Art Unit: 3791 Application/Control Number: 18/241,965 Page 7 Art Unit: 3791 Application/Control Number: 18/241,965 Page 8 Art Unit: 3791 Application/Control Number: 18/241,965 Page 9 Art Unit: 3791 Application/Control Number: 18/241,965 Page 10 Art Unit: 3791 Application/Control Number: 18/241,965 Page 11 Art Unit: 3791 Application/Control Number: 18/241,965 Page 12 Art Unit: 3791 Application/Control Number: 18/241,965 Page 13 Art Unit: 3791