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 10 and 20 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.
Regarding claim 10, the claim limitation “a cylindrical ultrasound transducer” is indefinite because it is unclear if this cylindrical ultrasound transducer is same as the ultrasound transducer that is already recited in claim 9. For examining purpose, it is assumed they are the same transducer.
Regarding claim 20, the claim limitation “an imaging core” in lines 2-3 is indefinite because it is unclear if this imaging core is additional imaging core or same as the imaging core that is already recited in line 2 of claim 20 and in claim 16.
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.
Claims 1-9, 11, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2016/0157880; hereinafter Aklog), in view of Morley et al. (US 2021/0068778; hereinafter Morley).
Regarding claim 1, Aklog discloses a system and method for percutaneous division of fibrous structures. Aklog shows a device for dividing a fibrous structure (see abstract), the device comprising: a handle having a proximal end (see par. [0034], [0035], [0079]; the examiner notes that probe device 200 will have handle with proximal end for the physician to perform the fibrous treatment), (a distal end see par. [0034], [0035], [0079]; the examiner notes that probe device 200 will have handle with distal end for the physician to perform the fibrous treatment), and an imaging core configured to image tissue including the fibrous structure (see par. [0066], [0071], [0078], [0079]; claim 45); an expandable member positioned near the distal end of the handle (see 400 fig. 3A; par. [0035], [0037]), the expandable member being transitionable between an inflated state and a deflated state (see par. [0035-[0037]; see 400 in fig. 3A and 3B), and the expandable member includes a cutting element arranged on a surface of the expandable member for weakening or cutting the fibrous structure resulting in its division (see 500 in fig. 3A and 4A and abstract, par. [0041]).
But, Aklog fails to explicitly state that the imaging module extending therebetween the proximal and distal end of handle, a probe cover coupled to the handle, the probe cover including a covering extending in a proximal direction for draping over the handle to create a sterile barrier between the handle and the expandable member.
Morley discloses biopsy device and method of use thereof. Morley teaches imaging module extending therebetween the proximal and distal end of handle (see ultrasound transducers 108 and 110 which are placed between the distal end and proximal end of the handle 102 in fig. 2; see par. [0045]), a probe cover coupled to the handle (see par. [0047]), the probe cover including a covering extending in a proximal direction for draping over the handle to create a sterile barrier between the handle and treatment element (see par. [0047]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the imaging module extending therebetween the proximal and distal end of handle, a probe cover coupled to the handle, the probe cover including a covering extending in a proximal direction for draping over the handle to create a sterile barrier between the handle and treatment element in the invention of Aklog, as taught by Morley, to provide a single imaging and treatment device to have a integral diagnostic device, and provide a sterile barrier between the handle body and treatment element. The examiner notes that upon modification of prior art Aklog to incorporate the teaching of the cover as taught by Morley will provide a sterile barrier between the handle and expandable member.
Regarding claim 2, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows wherein the expandable member is a balloon (see par. [0039]).
Regarding claim 3, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows wherein the expandable member has an elongated cross-sectional shape (see 400 in fig. 3A and 3B; par. [0042]).
Regarding claim 4, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows wherein the expandable member is configured to contact the fibrous structure and expand outwards to tension the fibrous structure across the cutting element.
Regarding claim 5, where in the cutting element is situated along a longitudinal dimension of the expandable member (see 500 in fig. 3A and par. [0041]).
Regarding claim 6, wherein the expandable member expands radially so as to tension the fibrous structure in a direction substantially transverse to the cutting element (see 500 in fig. 3A and 4A; also see fig. 5A-B, 6A-C; par. [0041], [0045]).
Regarding claim 7, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows wherein the cutting element is configured to emit electrical or thermal energy to weaken or cut the fibrous structure (see par. [0046], [0052]).
Regarding claim 8, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Morley shows wherein the imaging core is translatable relative to the treatment member (see fig. 3, 6A and 6B). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of imaging core is translatable relative to the treatment member in the invention of Aklog, as taught by Morley, to be able to image and monitor the treatment and advancing of treatment element into the patient. The examiner notes that upon modification of prior art Aklog to incorporate the teaching of Morley will provide the imaging core is translatable relative to the expandable member.
Regarding claim 9, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows wherein the imaging core is an ultrasound transducer (see par. [0013], [0079], and Morley also teaches ultrasound transducer (see par. [0045]).
Regarding claim 11, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows a series of dilators (see par. [0079]). The claim limitation “...capable of being coupled to the probe cover” is directed to directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Aklog and Morley is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 13, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, wherein the treatment element is coupled to the probe cover (see par. [0047]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the treatment element is coupled to the probe cover in the invention of Aklog, as taught by Morley, to provide a single imaging and treatment device to have a integral diagnostic device, and provide a sterile barrier between the handle body and treatment element. The examiner notes that upon modification of prior art Aklog to incorporate the teaching of Morley will provide the expandable member is coupled to the probe cover.
Regarding claim 15, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Morley wherein the imaging core is translatable relative to the handle (fig. 2 shows that the imaging core housing 102b is translatable relative to the handle 102a). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the imaging core is translatable relative to the handle in the invention of Aklog, as taught by Morley, to be able to remove and change the imaging transducer for different imaging requirement with different transducer parameters.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2016/0157880; hereinafter Aklog), in view of Morley et al. (US 2021/0068778; hereinafter Morley) as applied to claim 1 above, and further in view of Hingston et al. (US 2016/0287223; hereinafter Hingston).
Regarding claim 10, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state wherein the imaging core is a cylindrical ultrasound transducer configured to circumferentially image tissue.
Hingston discloses an ultrasound imaging catheter with cylindrical ultrasound transducer (see par. [0165]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of using cylindrical ultrasound transducer in the invention of Aklog and Morley, as taught by Hingston, to provide a wide-angle imaging focusing. The claim limitation “...circumferentially image tissue” is directed to directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Aklog, Morley and Hingston is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2016/0157880; hereinafter Aklog), in view of Morley et al. (US 2021/0068778; hereinafter Morley) as applied to claims 1 and 11 above, and further in view of Dharan et al. (US 2020/0222078; hereinafter Dharan).
Regarding claim 12, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows a tear-away sheath into the tissue compartment (see par. [0045], [0063]) and dilators (see par. [0079]), and inserting the expandable member through the tear-away sheath (see par. [0045], [0063]), but Aklog fails to explicitly state that the tear-away sheath is introduced over at least one of the series of dilators.
Dharan teaches sheath is introduced over at least one of the series of dilators (see par. [0258]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of introduced over at least one of the series of dilators in the invention of Akalog and Morley, as taught by Dharan, to be able to properly guide treatment device properly without causing any injury to tissue.
The claim limitation “...removably coupled to the at least one of the series of dilators” is directed to directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Aklog, Morley and Dharan is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2016/0157880; hereinafter Aklog), in view of Morley et al. (US 2021/0068778; hereinafter Morley) as applied to claim 1 above, and further in view of Barnes et al. (US 2019/0262024; hereinafter Barnes).
Regarding claim 14, Aklog and Morley disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows a tear-away sheath (see par. [0045], [0063]), and Morley teaches the probe cover (see par. [0047]), but Aklog and Morley fails to explicitly state a secondary expandable member disposed withing the tear-away sheath and being capable of being coupled to the probe cover.
Barnes discloses a soft tissue cutting device. Barnes teaches plurality of expandable members (see 34a and 34b). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of second expandable member in the invention of Aklog and Morley, as taught by Barnes, to be able to anchor the soft tissue cutting device in stationary position during the treatment. The examiner notes that upon modification of combined invention of Aklog and Morley to incorporate the teaching of Barnes will provided the second expandable member being withing the tear away sheath and coupled to the probe cover.
The claim limitation “...dilate tissue” is directed to directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Aklog, Morley and Barnes is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2016/0157880; hereinafter Aklog), in view of Dharan et al. (US 2020/0222078; hereinafter Dharan).
Regarding claim 16, Aklog discloses a system and method for percutaneous division of fibrous structures. Aklog shows a method for dividing a fibrous structure (see abstract), the method comprising: successively introducing a series of dilators with increasing diameters through an incision into a tissue compartment that includes the fibrous structure (see par. [0079]); positioning, proximate the fibrous structure, a division device including an expandable member having a cutting element situated thereon (see 500 in fig. 3A and 4A; abstract; par. ]0041]); expanding the expandable member outwards to tension the fibrous structure across the cutting element (see fig. 3B and par. [0037], [0042]); providing an imaging core ((see par. [0066], [0071], [0078], [0079]; claim 45); imaging the tissue compartment with the imagining core ((see par. [0066], [0071], [0078], [0079]; claim 45); and activating the cutting element to weaken or cut the fibrous structure (abstract, par. [0041]).
But, Aklog fails to explicitly state activating the cutting element to weaken or cut the fibrous structure while displaying an image from the imaging core in real-time, and providing the imaging core into the tissue compartment.
Dharan discloses a surgery device. Dharan also teaches series of dilators (see par. [0175], [0212]), and further teaches providing imaging core into tissue compartment (see par. [0249]); activating cutting element to perform surgery while displaying an image from the imaging core in real-time (see par. [0313]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of providing imaging core into tissue compartment, and activating cutting element to perform surgery while displaying an image from the imaging core in real-time in the invention of Aklog, as taught by Dharan, provide a single imaging and treatment device to have a integral diagnostic device to monitor the treatment. The examiner notes that upon modification of prior art Aklog to incorporate the teaching of Dharan will provide displaying real time image of the weakening or cutting of the fibrous structure.
Regarding claim 17, Aklog and Dharan disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows a tear-away sheath into the tissue compartment (see par. [0045], [0063]) and dilators (see par. [0079]), and inserting the expandable member through the tear-away sheath (see par. [0045], [0063]), but Aklog fails to explicitly state that the tear-away sheath is introduced over at least one of the series of dilators.
Dharan teaches sheath is introduced over at least one of the series of dilators (see par. [0258]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of introduced over at least one of the series of dilators in the invention of Akalog, as taught by Dharan, to be able to properly guide treatment device properly without causing any injury to tissue.
Regarding claim 18, Aklog and Dharan disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows removing the tear-away sheath from the tissue compartment prior to expanding the expandable member (see par. [0063]).
Regarding claim 19, Aklog and Dharan disclose the invention substantially as described in the 103 rejection above, furthermore, Aklog shows wherein the cutting element includes an electrocautery lead (see par. [0007]), and wherein the step of activating the cutting element includes delivering radiofrequency energy to the electrocautery lead (see par. [0046]).
Regarding claim 20, Aklog and Dharan disclose the invention substantially as described in the 103 rejection above, furthermore, Dharan teaches that the imaging core at least partly through division device (see par. [0194], [0249]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of having the imaging core at least partly through division device in the invention of Aklog, as taught by Dharan, to provide a single imaging and treatment device to have an integral diagnostic device to monitor the treatment
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M 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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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797