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 .
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.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,257,102. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim 1 is directed to
“a blood vessel patency measurement system for assessing peripheral arterial disease (PAD) of a subject, the system including: an inflatable cuff, wearable on a limb of the subject; (similar to claim 21 of present application)
a pump, in fluid communication with the inflatable cuff to inflate the inflatable cuff; (similar to claim 21 of present application)
a pressure sensor, in fluid communication with the inflatable cuff to measure an inflation pressure of the inflatable cuff; (similar to claim 21 of present application)
a wearable acoustic Doppler blood flowmeter, wearable on the limb of the subject, the flowmeter including: a wearable carrier, configured to be wearably affixed to a target location on the limb of the subject, (similar to claim 21 of present application)
the wearable carrier carrying a set of more than two transducers, the set of more than two transducers including: a first transducer, carried by the carrier, the first transducer configured as an acoustic transmitter having a first location and a first orientation; and a second transducer, carried by the carrier, the second transducer configured as an acoustic receiver having a second location and a second orientation; (similar to claim 21 of present application)
controller circuitry, configured to be located with at least one of the carrier or the inflatable cuff, the controller circuitry configured to: select the acoustic transmitter and the acoustic receiver from the set of more than two transducers; (similar to claim 21 of present application)
control the acoustic transmitter for insonating the subject with an insonation signal at an insonation frequency; control the acoustic receiver for transducing an acoustic response signal received from the subject in response to the insonation signal; and control the pump for inflating the inflatable cuff; (similar to claim 21 of present application)
and signal processing circuitry, configured to translate the transduced acoustic response signal from the insonation frequency to an audio response signal in an audio frequency range, such that the audio response signal includes Doppler-shift information corresponding to detected blood flow when blood flow is detected by the Doppler blood flowmeter” (similar to claim 21 of present application).
Claim 1 of ‘102 also includes elements of the “audio response enhancement signal injection circuit” that are more specific than claim 21 of present application and therefore anticipates present application.
Claim Rejections - 35 USC § 112
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 8-10 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 8 is directed to a first transducer “having a first location and having a first orientation in the Z direction, forming a first angle that is orthogonal to the first surface”, a second transducer “having a second location that is offset from the first transducer in the X direction and having a second orientation that forms a second angle that is oblique to the Z direction and intersects the first orientation to define a first depth region of interest”, and a third transducer “having a third location that is further offset from the first transducer in the X direction than the second transducer and having a third orientation that forms a third angle that is oblique to the Z direction, wherein the third angle is larger than the second angle and intersects the first orientation to form a second depth region of interest that is closer to the first surface than the first depth region of interest”.
Upon reviewing the specification, “a transducer arrangement 900, such as shown in FIG. 9A, can help increase or maximize these differences, such as by orienting the transducers 402A-I parallel to each other, and orienting the end transducers 402J-K perpendicular thereto. By contrast, a transducer arrangement, such as shown in FIGS. 9D-9E, in which the end transducers 402J-K are arranged at an oblique angle (e.g., between 30 degrees and 60 degrees, such as 45 degrees, or between 120 degrees and 150 degrees, such as 135 degrees) can obtain some benefit of a higher echo response frequency associated with an elongate transducer 402 having its long axis perpendicular to the direction of blood flow, and can also obtain some benefit of the higher signal strength associated with an elongate transducer 402 having its long axis parallel to the direction of blood flow” [0129].
It is not clear from the above paragraph from the specification, the support for all the elements of claim 8 with respect to the orientation of the first transducer, second transducer, and the third transducer and the first/second/third angles and depths. It is suggested the claim language be modified in view of the disclosure and provide support for the three transducers/location, angles/depths. It is also not clear from the claim language the location of the first/second/third transducer relative to the embodiments as disclosed in figure 14 with the multiple acoustic transducer carriers 1408 with an array or other arrangement of transducers 402.
Claims 11-18 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 11 is directed to a first transducer “having a first location and having a first orientation in the Z direction, forming a first angle that is orthogonal to the first surface”, a second transducer “having a second location that is offset from the first transducer in the X direction and having a second orientation that forms a second angle that is oblique to the Z direction and intersects the first orientation to define a first depth region of interest”, and a third transducer “having a third location that is further offset from the first transducer in the X direction than the second transducer and having a third orientation that forms a third angle that is oblique to the Z direction, wherein the third angle is larger than the second angle and intersects the first orientation to form a second depth region of interest that is closer to the first surface than the first depth region of interest”. Claim 14 further recites a fourth/fifth transducers oriented as claimed at a certain third depth.
Upon reviewing the specification, “a transducer arrangement 900, such as shown in FIG. 9A, can help increase or maximize these differences, such as by orienting the transducers 402A-I parallel to each other, and orienting the end transducers 402J-K perpendicular thereto. By contrast, a transducer arrangement, such as shown in FIGS. 9D-9E, in which the end transducers 402J-K are arranged at an oblique angle (e.g., between 30 degrees and 60 degrees, such as 45 degrees, or between 120 degrees and 150 degrees, such as 135 degrees) can obtain some benefit of a higher echo response frequency associated with an elongate transducer 402 having its long axis perpendicular to the direction of blood flow, and can also obtain some benefit of the higher signal strength associated with an elongate transducer 402 having its long axis parallel to the direction of blood flow” [0129].
It is not clear from the above paragraph from the specification, the support for all the elements of claims 11 and 14 with respect to the orientation of the first transducer, second transducer, third, fourth, and the fifth transducer and the first/second/third/fourth angles and depths. It is also not clear from the claim language, support for the claimed subject matter with respect to the location of the first/second/third/fourth/fifth transducer relative to the embodiments as disclosed in figure 14 and others with the multiple acoustic transducer carriers 1408 with an array or other arrangement of transducers 402. It is suggested the claim language be modified in view of the disclosure and provide support for each of the transducers/location, angles/depths.
Claim 22 is 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 22 is directed to a first transducer “having a first location and having a first orientation in the Z direction, forming a first angle that is orthogonal to the first surface”, a second transducer “having a second location that is offset from the first transducer in the X direction and having a second orientation that forms a second angle that is oblique to the Z direction and intersects the first orientation to define a first depth region of interest”, and a third transducer “having a third location that is further offset from the first transducer in the X direction than the second transducer and having a third orientation that forms a third angle that is oblique to the Z direction, wherein the third angle is larger than the second angle and intersects the first orientation to form a second depth region of interest that is closer to the first surface than the first depth region of interest”.
Upon reviewing the specification, “a transducer arrangement 900, such as shown in FIG. 9A, can help increase or maximize these differences, such as by orienting the transducers 402A-I parallel to each other, and orienting the end transducers 402J-K perpendicular thereto. By contrast, a transducer arrangement, such as shown in FIGS. 9D-9E, in which the end transducers 402J-K are arranged at an oblique angle (e.g., between 30 degrees and 60 degrees, such as 45 degrees, or between 120 degrees and 150 degrees, such as 135 degrees) can obtain some benefit of a higher echo response frequency associated with an elongate transducer 402 having its long axis perpendicular to the direction of blood flow, and can also obtain some benefit of the higher signal strength associated with an elongate transducer 402 having its long axis parallel to the direction of blood flow” [0129].
It is not clear from the above paragraph from the specification, the support for all the elements of claim 22 with respect to the orientation of the first transducer, second transducer, and the third transducer and the first/second/third angles and depths. It is also not clear from the claim language the location of the first/second/third transducer relative to the embodiments as disclosed in figure 14 with the multiple acoustic transducer carriers 1408 with an array or other arrangement of transducers 402. It is suggested the claim language be modified in view of the disclosure and provide support for the three transducers/location, angles/depths.
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) 2-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nazer et al. (2023/0093814).
With respect to claim 2, Nazer et al. teach of an ultrasound transducer assembly 100 for treating peripheral arterial disease that includes a housing or sleeve 102 or the transducer carrier with a proximal end 103, distal end 107, and sidewall 105 with a transducer array 106 attached to the inner and/or outer surface of the sleeve [0061, 0062]. As shown in figure 4E, the transducer arrays can conform to the foot and the ankle or calf [0069, fig. 4E]. Nazer et al. teach in figure 4B, a multi-transducer array 116 including a plurality of transducers 106 positioned over the posterior calf [0063]. As shown below transducer array 252 is positioned on a portion of the limb to represent to one surface configured to face toward the leg of the living subject to which the transducer carrier or housing is affixed to insonify the subject [0064]. Nazer et al. also teach of transducer array 208 on top of the foot to represent the alternate surface [0068]. Under broadest reasonable interpretation, the carrier includes a first surface defining a first X-Y plane defining an X/Y direction that is orthogonal to the X direction and defining a Z direction that orthogonal to the X-Y plane and a second surface opposing and offset in the Z direction from the first surface.
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Nazer et al. further teach of the carrier or sleeve to include a plurality of transducer receptacles or transducer dock 710 to carry the respective ultrasound transducers where the transducer dock is incorporated into the sleeve or carrier to secure the transducer along the sleeve [(fig. 7A, 0088, 0089].
With respect to claims 3 and 7, Nazer et al. teach of the receptacles or dock sites to be sized and shaped to accommodate corresponding individual ones of the transducer and including a partial perimeter surface sized and shaped to be seated against a sidewalk of the transducer to provide a specified positioning alignment feature or positioning line 730 between an individual of the docks and corresponding individual one of the transducers [(as shown in figure 7A, 0088, 0090]. The docks are sized and shaped to receive a subject facing side of the ultrasound transducer such as the front of the shin/knee (for a calf sleeve), and back of ankle (ankle sleeve)where the docks can be positioned at an appropriate distance from the positioning line based on average human leg circumferences such that the transducer is aimed at the appropriate lower extremity surface or other target location [0088]. Nazer et al. teach of each of each transducer element in an array to be “spaced sufficiently apart so as to avoid acoustic interaction of side lobe artifacts emanating from one transducer with adjacent transducers and the width of the side lobes may be measured prior to array fabrication and elements can thus be spaced accordingly”[0121]. Under broadest reasonable interpretation, if the docks or receptacles may be elongate in size and shape and it is configured in size and shape to receive a transducer, then the transducer would also be of the same size and shape as the dock or receptacle to ensure proper positioning with respect to the limb of the patient.
With respect to claims 4, Nazer et al. teach of the individual one of the receptacles or docks including a corresponding recess in the transducer carrier or sleeve sized and shaped to receive a subject facing side of the ultrasound transducer such as the front of the shin/knee (for a calf sleeve), and back of ankle (ankle sleeve)where the docks can be positioned at an appropriate distance from the positioning line based on average human leg circumferences such that the transducer is aimed at the appropriate lower extremity surface or other target location [0088].
With respect to claim 5, Nazer et al. teach of receptacles with the recess that that is shaped to provide an adjacent cutout [0120-0122] to allow electrical lead access to a subject-facing electrode on a corresponding one of the ultrasound transducers that is located in the corresponding recess or where each strip of the device can connect via a conduit to a multi-channel generator which is configured to independently drive each transducer with its required power necessary to produce the desired acoustic output and the generator can also be configured to provide all the necessary isolation to meet safety requirements [0123]. Nazer et al. also teach of continuous electronic monitoring of the power being delivered to each of the transducers to assure desired acoustic dosage is delivered and includes other design features such as connection ports or one port for each strip of transducers [0123].
With respect to claim 6, Nazer et al. teach of the transducer assembly to include a recess or channel located between adjacent individual ones of the plurality of receptacles to provide an acoustic barrier between the adjacent individual ones of the plurality of receptacles (as shown in fig. 10G) with vertically-oriented strips of 3 transducers each and 2 medially generally vertically-oriented strips of 5 transducers each with clear recess or channel located between adjacent individual ones of the plurality of transducers.
Nazer et al. do not explicitly teach of all the claimed elements in a single embodiment. It would have therefore been obvious to one of ordinary skill in the art to combine the elements from the different embodiments to provide a non-invasive, non-surgical treatment for peripheral vascular disease [0005] with the placement of array of ultrasound transducers conforming to a limp to cause a therapeutically effective amount of ultrasonic energy over a set time period to be directed toward the target site and promoting angiogenesis within the tissue [0012].
Conclusion
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797
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