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.
Claims 1-12 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 pre-AIA the applicant regards as the invention. Claim 1 is also rejected because the scope of the term “operationally coupleable” is unclear and indefinite. Claim 2 is rejected because “the forward systolic peak” lacks proper antecedent basis. Claims 5 is rejected because “the maximum reverse flow peak” lacks proper antecedent basis.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2010/0234731 to Lu et al. “Lu”.
As for Claim 1, Lu discloses an ultrasound diagnostic imaging system configured to produce a spectral Doppler display on which automated measurements are made (Abstract) wherein the system comprises a transceiver for capturing a representation of blood flow through a blood vessel of interest (Paragraph [0018] noting transducer array transmits and receives ultrasonic signals); a waveform converter and processor configured to analyze the representation (Paragraphs [0018]-[0019], ; Doppler processor) and a display coupled to the processor for providing at least one visual indicia for a user (Fig. 4 and corresponding descriptions).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of U.S. Publication No. 2013/0281862 to Yoon et al. “Yoon”.
As for Claims 2-6, Lu discloses processing steps of identifying peaks in the spectral waveform and determining the maximum peak within each heart cycle (Paragraph [0026]). However, it is not clear if the non-maximum (e.g. secondary) peaks are filtered.
Yoon teaches from within a similar field of endeavor with respect to analyzing Doppler data where first, second and third peaks bay be identified in a spectrum with filtering (Paragraphs [0017]-[0019] and [0105]). Examiner notes that the secondary peaks (e.g. second and third peaks) would fall within the claimed range in its broadest reasonable interpretation.
Accordingly, one skilled in the art would have been motivated to have filtered the detection of second or third peaks as described by Yoon in order to automatically identify features in Lu’s Doppler spectrum. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu and Yoon as applied to claims 1-2 above, and further in view of U.S. Publication No. 2014/0358000 to Gupta et al. “Gupta”.
As for Claims 7-9, Lu and Yoon disclose a Doppler processing device as described above but do not appear to generate a monotonicy indicator as claimed.
Gupta teaches from within a similar field of endeavor with respect ultrasound Doppler systems and methods (Abstract) where a processor is configured to analyze Doppler signal characteristics to reach a diagnosis (Paragraph [0051]). Gupta discloses where a display is configured to display a selected cycle or cycles (Paragraph [0018]) and for displaying the clinical parameter, responsive to the computing (Paragraphs [0019]-[0020]). Gupta teaches that the cycles are selected based on at least one of a group of conditions such as, for example, existence of at least one of more than one peak and more than one valley, frequency response in a spectral band of the cycle not exceeding a predetermined threshold, cycles not reaching its peak systolic value within a predetermined duration and/or cycles having less than a predetermined length (Paragraph [0036]). In one embodiment, Gupta’s Fig. 4 depicts a process for selecting “good” pulse cycles (Fig. 4 and corresponding descriptions). Gupta explains that the automatic operation tends to reduce examination time, thereby relieving workload and making examination more convenient (Paragraph [0051]). Examiner notes that if no “good” cycle is detected then the waveform is considered to be monotonic in its broadest reasonable interpretation. Likewise, a waveform with a peak to peak time of less than 400 or 600 milliseconds would be not be selected as a good cycle based on Gupta’s criteria above.
Accordingly, one skilled in the art to would have been motivated to have modified the ultrasound system and method described by Lu and Yoon to incorporate Gupta’s automatic Doppler signal analyzing and displaying of clinical parameters techniques in order to determine the presence of peripheral artery disease based on the Doppler data. Examiner notes that such a modification would appear to reduce examination time, relieve workload and to enhance the convenience of the examination (Gupta-Paragraph [0051]).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of U.S. Patent No. 5,409,010 to Beach et al. “Beach”.
As for Claim 10, Lu discloses a Doppler processing system and method as described above. However, Lu does not specify the Doppler data is audio.
Beach teaches from within a similar field of endeavor with respect to Doppler systems and method where audible sounds are detected with Doppler systems (Column 22, Lines 10-60, Column 23, Lines 20-67).
Accordingly, one skilled in the art would have been motivated to have used Lu’s Doppler system and method to analyze audio Doppler signals from the body as described by Beach in order to diagnose internal conditions.
Regarding Claims 10-11, the spectrum displayed in the modified system of Lu and Beach is considered to be a directional sinogram in its broadest reasonable interpretation with maximum frequency outlines for forward and reverse blood flow (See Beach Fig. 3 and also Column 7, Lines 1-15).
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No. 11,660,063. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward a system to determine peripheral artery disease comprising a transceiver, waveform converter and processor and display. Examiner notes that the presently pending claims are considered an obvious broadening of the patented system.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,660,063. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward a system to determine peripheral artery disease comprising a transceiver, waveform converter and processor and display. Examiner notes that the presently pending claims are considered an obvious broadening of the patented system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797