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 .
Election/Restrictions
Applicant's election with traverse of Group I and Species C in the reply filed on 8/26/2026 is acknowledged. The traversal is on the ground(s) that claims 103-105 recite that the elongate member is while claim 113 simply states that the elongate member comprises a proximity sensor. This is found persuasive and as such dependent claim 113 shall be rejoined, yet it is noted that applicant’s traversal argument was limited exclusively to dependent claim 113, thus it is understood that applicant has withdrawn the remainder of the claims in response to the restriction requirement without traverse. The remainder of the requirement is therefore made FINAL.
Claims 97-102 and 105-113 remain pending in the current application.
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.
Claim 112 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.
The term “about” in claim 112 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of this office action, any durometer within a reasonable order of magnitude will be considered applicable to the limitation in question.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 97-102 and 105-112 are rejected under 35 U.S.C. 103 as being unpatentable over Eller (US 20180303594 A1) in view of Bales (US 20170020698 A1).
Regarding claim 97, Eller teaches a system for selecting a length of an endobronchial implant to be placed in a patient ([0031] The stent scaffold 110 may have a plurality of annular rows 112 arranged along the longitudinal direction of the stent scaffold 110. Each annular row 112 may include interconnected strut arms 114; [0035] Each strut arm 114 may define a length along the strut arm 114. Again, as shown in FIG. 3, each strut arm 114 is coupled to two other strut arms 114, thereby forming apexes 115 on both ends of the strut arm 114. The length of a single strut arm 114 is the length of the strut arm 114 from a first end to a second end, or the distance between each apex 115 at which the strut arm 114 is coupled to an adjacent strut arm 114; [0024] a portion of the respiratory tract, such as a portion of the respiratory tract within the bronchi or the lungs)
a flexible elongate member configured to be inserted through a lumen of a device ([0084] The tubular shaft 520 may be at least partially disposed within the outer sheath 510; [0078] In some embodiments, the outer sheath 510 includes a proximal portion 513, a distal portion 515, and an intermediate portion 514. The proximal portion 513 may be considered a “shaft portion,” the intermediate portion 514 may be a “flex portion” and the distal portion 515 may be a “deployment pod” that is configured for crimping, contracting, or otherwise holding a stent 50 in a compressed state)
Eller fails to teach a plurality of markers arranged along a longitudinal axis of the elongate member, wherein at least a portion of the plurality of markers are evenly distributed along the longitudinal axis, or at least a portion of the plurality of markers correspond to predetermined available lengths of the endobronchial implant, or both.
However, Bales teaches a plurality of markers arranged along a longitudinal axis of the elongate member ([0015] At least two paddle-shaped markers extend away from a respective one of the strut ends. The markers have respective marker extreme ends and different overall longitudinal lengths substantially aligning the marker extreme ends approximately along a single circumference of the stent body)
wherein at least a portion of the plurality of markers are evenly distributed along the longitudinal axis, or at least a portion of the plurality of markers correspond to predetermined available lengths of the endobronchial implant, or both ([0019] the stent body has a longitudinal axis and the markers extend away from a respective one of the strut ends substantially parallel to the longitudinal axis).
Eller and Bales are considered analogous because both disclose internal stents. Therefore, it would have been obvious to one of ordinary skill in the art to equip the bronchial implant of Eller with the markers of Bales which run parallel to a longitudinal axis in order to help a medical practitioner in determining an ideal number of struts to strut length ratio for a patient requiring a stent (Bales [0012]).
Regarding claim 98, Eller fails to teach the plurality of markers are arranged on a distal portion of the elongate member.
However, Bales teaches the plurality of markers are arranged on a distal portion of the elongate member ([0023] the struts are disposed in a single helix having one strut … at a distal end of the helix).
Eller and Bales are considered analogous because both disclose internal stents. Therefore, it would have been obvious to one of ordinary skill in the art to place at least one marker at the distal end of the device in order to help a medical practitioner in determining an ideal number of struts to strut length ratio for a patient requiring a stent (Bales [0012]).
Regarding claim 99, Eller fails to teach the plurality of markers are arranged on a proximal portion of the elongate member.
However, Bales teaches the plurality of markers are arranged on a proximal portion of the elongate member ([0023] the struts are disposed in a single helix having one strut at a proximal end of the helix).
Eller and Bales are considered analogous because both disclose internal stents. Therefore, it would have been obvious to one of ordinary skill in the art to place at least one marker at the proximal end of the device in order to help a medical practitioner in determining an ideal number of struts to strut length ratio for a patient requiring a stent (Bales [0012]).
Regarding claim 100, Eller fails to teach at least a portion of the plurality of markers comprise a radiopaque material.
However, Bales teaches at least a portion of the plurality of markers comprise a radiopaque material ([0029] the markers are combinations of radiopaque, ultrasound, and magnetic resonance imaging markers. The radiopaque markers can be tungsten, tantalum, molybdenum, platinum, gold, zirconium oxide, barium salt, bismuth salt, hafnium, and/or bismuth subcarbonate).
Eller and Bales are considered analogous because both disclose internal stents. Therefore, it would have been obvious to one of ordinary skill in the art to manufacture at least some of the markers to be radiopaque in order to help a medical practitioner in determining an ideal number of struts to strut length ratio for a patient requiring a stent (Bales [0012]).
Regarding claim 101, Eller fails to teach at least a portion of the plurality of markers are evenly distributed along a longitudinal axis of the elongate member.
However, Bales teaches at least a portion of the plurality of markers are evenly distributed along a longitudinal axis of the elongate member ([0019] the stent body has a longitudinal axis and the markers extend away from a respective one of the strut ends substantially parallel to the longitudinal axis).
Eller and Bales are considered analogous because both disclose internal stents. Therefore, it would have been obvious to one of ordinary skill in the art to equip the bronchial implant of Eller with the markers of Bales which run parallel to a longitudinal axis in order to help a medical practitioner in determining an ideal number of struts to strut length ratio for a patient requiring a stent (Bales [0012]).
Regarding claim 102, Eller fails to teach at least a portion of the plurality of markers correspond to predetermined available lengths of the endobronchial implant.
However, Bales teaches at least a portion of the plurality of markers correspond to predetermined available lengths of the endobronchial implant ([0015] At least two paddle-shaped markers extend away from a respective one of the strut ends. The markers have respective marker extreme ends and different overall longitudinal lengths substantially aligning the marker extreme ends approximately along a single circumference of the stent body).
Eller and Bales are considered analogous because both disclose internal stents. Therefore, it would have been obvious to one of ordinary skill in the art to design the markers in such a way that they correspond to predetermined lengths of struts used as subsections in the stent in order to help a medical practitioner in determining an ideal number of struts to strut length ratio for a patient requiring a stent (Bales [0012]).
Regarding claim 105, Eller teaches the elongate member is a sheath defining a lumen ([0073] the stent delivery device 500 includes a handle 502, an actuator 504, a lock 506, a support shaft 508, a tapered segment 509, an outer sheath 510, and a tubular shaft 520)
Regarding claim 106, Eller teaches the elongate member is a first elongate member (520) and the sheath is a first sheath (510), wherein the first sheath is coupleable to an implant delivery system (500) ([0084] The tubular shaft 520 may be at least partially disposed within the outer sheath 510 and coupled (e.g., attached) to the handle 502 of the stent delivery device 500)
a second flexible elongate member (521) having an implant mounting surface ([0086] The tubular shaft 520 may include a relatively low-friction inner (i.e., luminal) surface 521 (see FIG. 12). The low-friction inner surface 521 may facilitate displacement of the stent delivery device 500 along a guide wire over a relatively tortuous pathway, such as a pathway leading to a relatively distal region of a lung).
and a second sheath (530) at least partially covering the second elongate member, wherein the second sheath is movable relative to the second elongate member to at least partially expose the implant mounting surface ([0093] an intermediate sheath 530 is disposed between the tubular shaft 520 and the outer sheath 510. For instance, in the depicted embodiment, the intermediate sheath 530 is disposed around the tubular shaft 520 and extends distally from the distal tip of the elongate shaft 503 of the handle 502).
Regarding claim 107, Eller teaches the first sheath is removably coupleable to a handle of the implant delivery system ([0084] The tubular shaft 520 may be at least partially disposed within the outer sheath 510 and coupled (e.g., attached) to the handle 502 of the stent delivery device 500).
Regarding claim 108, Eller teaches the implant comprises a tubular region with one or more interstitial regions ([0093] an intermediate sheath 530 is disposed between the tubular shaft 520 and the outer sheath 510. For instance, in the depicted embodiment, the intermediate sheath 530 is disposed around the tubular shaft 520 and extends distally from the distal tip of the elongate shaft 503 of the handle 502)
wherein the implant mounting surface comprises a conformable material configured to adapt to the one or more interstitial regions of the implant when the implant is radially collapsed on the implant mounting surface, thereby engaging the implant ([0079] the distal portion 515 is less flexible than the intermediate portion 514. In some embodiments, the distal portion 515 of the outer sheath 510 may include or be formed from a relatively hard and/or inflexible material, such as nylon (e.g., nylon 12). In contrast, the intermediate portion 514 of the outer sheath 510 may be formed from a more flexible material, such as PEBAX 7233. The relatively hard and/or inflexible distal portion 515 may be less prone to breakage or deformation arising from the expansive force provided by the stent 50 within the deployment pod. As the relatively hard and/or inflexible distal portion 515 does not expand to a significant extent as a result of the expansive force provided by the stent 50, the distal portion 515 may reduce the amount of friction between the distal portion 515 of the outer sheath 510 and a channel (e.g., a channel of a bronchoscope) into which the stent delivery device 500 is inserted; [0081] the intermediate portion 514 of the outer sheath 510 may be more flexible than the distal portion 515 of the outer sheath 510. The relative flexibility of the intermediate portion 514 may improve trackability of the stent delivery device 500 over a guidewire. The relative flexibility of the intermediate portion 515 may also render the stent delivery device 500 less traumatic upon insertion into a patient).
Regarding claim 109, Eller teaches the conformable material extends fully circumferentially around a longitudinal axis of the second flexible elongate member (observe configuration of features surrounding second flexible elongate member 521 in fig. 12)
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Regarding claim 110, Eller teaches the conformable material extends fully circumferentially around a longitudinal axis of the second flexible elongate member ([0050] the coating 130 is disposed on an inner (i.e., luminal) surface of the stent scaffold 110. The coating 130 may provide a smooth luminal surface).
Regarding claim 111, Eller teaches the conformable material comprises a thermoplastic ([0092] thermoplastic elastomers (e.g., CHRONOPRENE™)).
Regarding claim 112, Eller teaches the conformable material has a durometer between about 5A and about 75A ([0083] proximal portion 513 of the outer sheath 510 has a durometer of between 72 and 100 (or greater) on the Shore A scale. The intermediate portion 514 of the outer sheath 510 may have a durometer of between 60 and 70 on the Shore A scale, and the distal portion 515 may have a durometer of between 40 and 55 on the Shore A scale. In some embodiments, the durometer for these sections may differ somewhat from the ranges disclosed above).
Claim(s) 113 is rejected under 35 U.S.C. 103 as being unpatentable over Eller in view of Bales as applied to claim 97 above, and further in view of Abdelmoaty (US 20200368007 A1).
Regarding claim 113, Eller as modified fails to teach a proximity sensor.
However, Abdelmoaty teaches a proximity sensor ([0125] the tubular member 202 and/or the control device 300 can comprise a plurality of proximity sensors, such as Hall-effect sensors, arrayed along the tubular member 202 and/or circumferentially around the tubular member 202)
Eller as modified and Abdelmoaty are considered analogous because both disclose tubular medical implant devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to equip the tubular portion of the device with proximity sensors in order to interact with the magnets 234 to produce signals indicative of the angular and/or axial position of the actuator member 206 relative to the tubular member 202 (Abdelmoaty [0125]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 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, 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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/GABRIEL VICTOR POPESCU/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
Prosecution Insights