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 .
This Office action is responsive to an amendment filed October 21, 2024. Claims 1-4, 10-18, 21-22 & 25-29 are pending. Claims 1, 4, 10-18 & 22 have been amended. New claims 25-29 have been added. Claims 5-9, 19-20 & 23-24 have been canceled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 14, 2024 and May 12, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-4, 10-18 & 21-22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 & 19-22 of U.S. Patent No. 11,642,075.
In regards to claim 1, all the elements of the claim can clearly be found in Claim 1 of the patent. The difference between claim 1 of the application and claim 1 of the patent lies in the fact that the patent claim includes many more elements (e.g., such as “[the first tissue assessment area]…having a first radial distance,” “[the second tissue assessment area]…having a second inner radial distance and a third inner radial distance,” “wherein the SEM scanner comprises one or more bipolar sensors configured to measure tissue biocapacitance indicative of SEM”) and is thus much more specific. Thus the invention of claim 1 of the patent is in effect a "species" of the "generic" invention of claim 1 of the application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct therefrom.
In regards to claim 2, all the elements of the claim can clearly be found in Claim 2 of the patent.
In regards to claim 3, all the elements of the claim can clearly be found in Claim 3 of the patent.
In regards to claim 4, all the elements of the claim can clearly be found in Claims 4-7 of the patent.
In regards to claim 10, all the elements of the claim can clearly be found in Claim 8 of the patent.
In regards to claim 11, all the elements of the claim can clearly be found in Claim 9 of the patent.
In regards to claim 12, all the elements of the claim can clearly be found in Claim 10 of the patent.
In regards to claim 13, all the elements of the claim can clearly be found in Claim 11 of the patent.
In regards to claim 14, all the elements of the claim can clearly be found in Claim 12 of the patent.
In regards to claim 15, all the elements of the claim can clearly be found in Claim 13 of the patent.
In regards to claim 16, all the elements of the claim can clearly be found in Claim 14 of the patent.
In regards to claim 17, all the elements of the claim can clearly be found in Claim 15 of the patent.
In regards to claim 18, all the elements of the claim can clearly be found in Claim 16 of the patent.
In regards to claim 21, all the elements of the claim can clearly be found in Claim 19 of the patent.
In regards to claim 22, all the elements of the claim can clearly be found in Claims 20-22 of the patent.
Claims 25-29 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,642,075 in view of Burns et al. (US 2018/0220924) (“Burns” hereinafter).
In regards to claim 25, all the elements of the claim can clearly be found in Claim 1 of the patent. However, the claim of the patent fails to explicitly teach a method wherein steps (a) through (f) are repeated in two or more measurement sets, wherein the measurement sets are separated by a measurement time interval. However, Burns teaches that it is known to provide a method wherein steps (a) through (f) are repeated in two or more measurement sets, wherein the measurement sets are separated by a measurement time interval (see par 0063, 0068 & 0091). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of patent wherein steps (a) through (f) are repeated in two or more measurement sets, wherein the measurement sets are separated by a measurement time interval as taught by Burns since such a modification would amount to applying a known technique (i.e., as taught by Burns) to a known device (i.e., as taught by the patent) ready for improvement to achieve a predictable result such as enabling measurements to be taken at the same location, which may be defined as a set of two or more specific points relative to anatomical features, at time intervals over a period of time in the general range of hours to weeks (see at least par 0091 of Burns)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 26, all the elements of the claim can clearly be found in Claim 25 of the patent. The patent fails to explicitly teach a method wherein the measurement time interval is selected from the group consisting of 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, and 2 weeks. However, Burns teaches that it is known to provide a method wherein the measurement time interval is selected from the group consisting of 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, and 7 days (see at least par 0068 & 0091). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of patent wherein the measurement time interval is selected from the group consisting of 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, and 7 days as taught by Burns since such a modification would amount to applying a known technique (i.e., as taught by Burns) to a known device (i.e., as taught by the patent) ready for improvement to achieve a predictable result such as enabling measurements to be taken at the same location, which may be defined as a set of two or more specific points relative to anatomical features, at time intervals over a period of time in the general range of hours to weeks (see at least par 0091 of Burns)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 27, all the elements of the claim can clearly be found in Claim 25 of the patent. The patent fails to explicitly teach a method wherein the tissue is flagged as damaged tissue when the differences calculated from step (f) of at least X measurement sets out of Y consecutive measurement sets are greater than or equal to a predetermined threshold, wherein X and Y are integers, and wherein X is smaller than Y. However, Burns teaches that it is known to provide a method wherein the tissue is flagged as damaged tissue when the differences calculated from step (f) of at least X measurement sets out of Y consecutive measurement sets are greater than or equal to a predetermined threshold, wherein X and Y are integers, and wherein X is smaller than Y (see par 0068 & 0091). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of patent when the differences calculated from step (f) of at least X measurement sets out of Y consecutive measurement sets are greater than or equal to a predetermined threshold, wherein X and Y are integers, and wherein X is smaller than Y as taught by Burns since such a modification would amount to applying a known technique (i.e., as taught by Burns) to a known device (i.e., as taught by the patent) ready for improvement to achieve a predictable result such as enabling measurements to be taken at the same location, which may be defined as a set of two or more specific points relative to anatomical features, at time intervals over a period of time in the general range of hours to weeks (see at least par 0091 of Burns)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 28, all the elements of the claim can clearly be found in Claim 1 of the patent. The patent fails to explicitly teach a method wherein the SEM scanner is further configured to communicate with a remote device. However, Burns teaches that it is known to provide a method wherein the SEM scanner 180 is further configured to communicate with a remote device (620, 630, 685) (see at least fig. 13 and par 0075 & 0092). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of patent wherein the SEM scanner is further configured to communicate with a remote device as taught by Burns since such a modification would amount to applying a known technique (i.e., as taught by Burns) to a known device (i.e., as taught by the patent) ready for improvement to achieve a predictable result such as providing an integrated system for measurement, evaluation, storage, and transfer of SEM values (see at least par 0092 of Burns)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 29, all the elements of the claim can clearly be found in Claim 28 of the patent. The patent fails to explicitly teach a method wherein the remote device is selected from the group consisting of a computer, a laptop computer, a smart phone, a tablet, a Wi-Fi access point, and a mobile or wearable device. However, Burns teaches that it is known to provide a method wherein the remote device is selected from the group consisting of a computer 685, a laptop computer 620, a smart phone 630, a tablet, a Wi-Fi access point 610, and a mobile or wearable device 630 see at least fig. 13 and par 0075 & 0092). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of patent wherein the remote device is selected from the group consisting of a computer, a laptop computer, a smart phone, a tablet, a Wi-Fi access point, and a mobile or wearable device as taught by Burns since such a modification would amount to applying a known technique (i.e., as taught by Burns) to a known device (i.e., as taught by the patent) ready for improvement to achieve a predictable result such as providing an integrated system for measurement, evaluation, storage, and transfer of SEM values (see at least par 0092 of Burns)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Conclusion
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/RENE T TOWA/ Primary Examiner, Art Unit 3791
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