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 § 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 1-10, 12, 14-15, 19, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Von Segesser 2015/0065999.
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Noting for example figures 1B-3A, Von Segesser discloses an implantable artificial bronchus (see [0098]), comprising: a body (6) having a proximal upper opening (1) and a distal lower (area 10) opening in fluid communication with the proximal upper opening, the body at least partially tapering along a length of the body toward the distal lower opening and having a plurality of side openings (these are the openings in the lattice structure) configured to allow air to enter into and exit the implantable artificial bronchus through the body, and wherein a diameter of the proximal upper opening is larger than a diameter of the distal lower opening.
However, Von Segesser does not disclose wherein a length of the body is greater than 4 times a largest diameter of the body. It would have been obvious to one
having ordinary skill in the art at the time the invention was made to modify the invention
of Von Segesser and provide an implant that is selected that has a length of the body is
greater than 4 times the size of a largest diameter of the body in order to optimize the
device for fitting within a bronchia passageway.
Regarding claim 2, Von Segesser teaches the implantable artificial bronchus of
claim 1, wherein the body includes a proximal portion a first middle portion a second
middle the proximal portion being tapered towards a central axis of the body (see mark-
up supra).
Regarding claim 3, Von Segesser teaches “wherein the first middle portion
and the second middle portion are disposed between the proximal portion and the distal portion, the first middle portion being proximate the proximal portion and the second middle portion being proximate the distal portion, the first middle portion having a first taper and the second middle portion having a second taper, the second taper being larger than the first taper.”
Regarding claim 4, Von Segesser teaches the implantable artificial bronchus of claim 2, wherein a diameter of the first middle portion is greater than a diameter of the proximal portion, a diameter of the second middle portion, and a diameter of the distal portion.
Regarding claim 5, Von Segesser teaches the implantable artificial bronchus of
claim 4, wherein the diameter of the distal portion is less than the diameter of the
proximal portion, the diameter of the first middle portion, and the diameter of the second
middle portion.
8. As pertaining to claim 6, Von Segesser teaches the implantable artificial
bronchus of claim 4, wherein the diameter of the first middle portion is equal to or less
than the largest diameter of the body.
As pertaining to claim 7, Von Segesser teaches the implantable artificial
bronchus of claim 4, wherein the diameter of the second middle portion constantly
decreases along the length of the body from the first middle portion to the distal portion.
As pertaining to claim 8, Von Segesser teaches the implantable artificial bronchus of claim 4, wherein the diameter of the distal portion is substantially the same proximate the second middle portion and proximate distal lower opening (roughly similar diameter throughout as seen in the mark-up).
As pertaining to claim 9, Von Segesser teaches the implantable artificial bronchus of claim 2, wherein the proximal portion flares out from the proximal upper opening to the first middle portion).
As pertaining to claim 10, Von Segesser teaches the implantable artificial bronchus of claim 1, wherein a maximum diameter of the body is greater than the diameter of the proximal upper opening (diameter of 4 less than diameter of 3; Fig. 8).
As pertaining to claim 12, Von Segesser teaches the implantable artificial bronchus of claim 1, wherein the diameter of the proximal upper opening is greater than the diameter of the distal lower opening, but is silent to: “wherein the diameter of the proximal upper opening is greater than twice the diameter of the distal lower opening.”
Selecting a diameter of a taught element by routine experimentation is within the ordinary skill of one in the art. Accordingly, it would have been obvious to a person having ordinary skill in the art to have selected a diameter of the proximal upper opening greater than twice the diameter of the distal lower opening, in order to optimize device fitting within a narrow bronchial passage.
Regarding the limitations of claim 14, this is considered to be functional language. The intended use recitation language “…wherein in an implanted state the body is configured to curve in a first radial direction along a first length of the body and a second radial direction opposite the first radial direction along a second length of the body” carries no weight in the absence of any distinguishing structure. Von Segesser discloses the structure as claimed and states in [0115] that the implant is elastic, bendable and moldable, and flexible is thus capable of performing the functions.
As pertaining to claim 15, Von Segesser teaches the implantable artificial bronchus of claim 1, but is silent wherein the plurality of side openings include an angle ranging between approximately 130 degrees proximate the proximal upper opening and 20 degrees proximate the distal lower opening. Selection of an angle of a taught element by routine experimentation is within the ordinary skill of one in the art. Accordingly, it would have been obvious to a person having ordinary skill in the art to have selected an angle ranging between approximately 130 degrees proximate the proximal upper opening and 20 degrees proximate the distal lower opening, in order to optimize device curving around tortuous bronchial passages and avoid pulmonary damage.
As pertaining to claim 19, Von Segesser teaches the implantable artificial bronchus of claim 1, but is silent wherein the body has a maximum diameter of approximately 6 mm to approximately 12 mm. selecting a size for a device by routine experimentation is within the ordinary skill of one in the art. Accordingly, it would have been obvious to a person having ordinary skill in the art to have selected a maximum diameter of approximately 6 mm to approximately 12 mm, in order to in order to optimize device fitting within a narrow bronchial passage.
As pertaining to claim 21, Von Segesser teaches the implantable artificial bronchus of claim 1, wherein the body is comprised of Nitinol (para [0022).
Regarding claim 22, Von Segesser discloses that the implant may have a plurality of flexible filaments may include one or more materials selected from metals, shape-memory metals, alloys, plastics, textile fibers, synthetic fibers, and/or combinations thereof (see [0096]) and that the plurality of flexible filaments can be braided together, knitted together or interwoven. Alternatively, the plurality of flexible filaments are interlaced ([0097]). However Von Segesser et al. does not specify a single fiber arrangement. It would have been obvious to modify the device of Von Segesser et al. and utilize a single fiber arrangement in order to provide various sizes and dimension of the implant thus still resulting in a cross woven pattern.
Regarding claim 23 Von Segesser does not disclose that ta valve or nozzle is coupled to the body.
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 24-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,510,771 hereafter (‘771) in view of U.S. Patent 11, 654,010 hereafter (‘010) claims 1-20.
Regarding current claim 24 which recites:
“24. (Original) An implantable artificial bronchus, comprising: a body having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the proximal upper opening tapering towards a central axis of the body, and the body constantly tapering from a portion proximate the proximal upper opening toward a portion proximate the distal lower opening, and having a plurality of side openings configured to allow air to enter into and exit the implantable artificial bronchus through the body, the body comprising: a proximal portion being tapered toward a central axis of the body; a first middle portion having a first middle taper; a second middle portion having a second middle taper larger than the first middle taper; and a distal portion having a constant distal diameter, wherein the first middle portion and the second middle portion are disposed between the proximal portion and the distal portion; wherein a diameter of the proximal upper opening is at least twice as large as a diameter of distal lower opening, and the diameter of the proximal upper opening is less than a maximum diameter of the body, the maximum diameter of the body being proximate the proximal upper opening, and wherein in an implanted state the body is configured to curve in a first radial direction along a first length of the body and a second radial direction opposite the first radial direction along a second length of the body.
Patent ‘771 claims 1 and 2 recite the subject matter in a varied manner. In particular ‘771 claim 1 states that “…wherein the proximal upper opening includes a woven portion defining the proximal upper opening, the woven portion tapering radially inwards..” It is obvious that this meets the limitation of “the diameter of the proximal upper opening is less than a maximum diameter of the body, the maximum diameter of the body being proximate the proximal upper opening” because the woven portion tapers inwardly thus giving it a diameter less than a maximum diameter of the body.
Current claim 25 recites:
25. (Original) A method of promoting lung disinsufflation, the method comprising: inserting a catheter distally into a respiratory passageway of a patient’s lung, the catheter containing the implantable artificial bronchus of claim 1 compressed within the catheter; and withdrawing the catheter proximally relative to the implantable artificial bronchus, unsheathing the implantable artificial bronchus, causing the implantable artificial bronchus to naturally expand and remain in the respiratory passageway, the implantable artificial bronchus configured to promote enlargement of the respiratory passageway.“
Patent ‘771 claim 1 states:
“1. An implantable artificial bronchus comprising: a body comprised of one or more fibers woven together forming a lattice structure, the body having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the body at least partially tapering along a length of the body toward the distal lower opening and having a plurality of side openings configured to allow air to enter into and exit the implantable artificial bronchus through the body, wherein the proximal upper opening includes a woven portion defining the proximal upper opening, the woven portion tapering radially inwards; wherein a length of the body is greater than 4 times a largest diameter of the body, wherein a diameter of the proximal upper opening is larger than a diameter of the distal lower opening, and wherein the plurality of side openings include a first side opening proximate the proximal upper opening and a second side opening proximate the distal lower opening, the first side opening having a first angle and the second side opening having a second angle less than the first angle.”
The limitations of current claim 1 are recited within the limitations of patent ‘771 claim 1 and are narrower in scope (providing more structural limitations) than the current claim. However, patent ‘771 does not recite the methods of using a catheter for delivery of the artificial bronchus implant.
Patent ‘010 claim 1 recites the methods stating:
“1. A method of promoting lung disinsufflation, the method comprising: inserting a catheter distally into a respiratory passageway of a patient's lung, the catheter containing an implantable artificial bronchus disposed within the catheter in a compressed state, the implantable artificial bronchus comprising: a body including a proximal portion having a proximal upper opening, a distal portion having a distal lower opening in fluid communication with the proximal upper opening, a middle portion disposed between the proximal upper opening and the distal lower opening, and a central axis extending from the proximal upper opening to the distal lower opening, the body at least partially tapering along a length of the body towards the distal lower opening, and the proximal portion being tapered radially inward towards the central axis relative to the middle portion; and withdrawing the catheter proximally relative to the implantable artificial bronchus causing the implantable artificial bronchus to unsheathe and naturally expand into an expanded state such that the implantable artificial bronchus remains disposed within the respiratory passageway, wherein the implantable artificial bronchus being in the expanded state and disposed within the respiratory passageway results in at least a portion of the middle portion abutting an inner wall of the respiratory passageway and prevents the proximal upper opening from contacting the inner wall of the respiratory passageway.”
It would be obvious to one having ordinary skill in the art to utilize the implantable artificial bronchus as claimed in patent ‘771 by the methods as recited in patent ‘010 because ‘’771 claims envisions methods to delivering the device in an air passage way utilizing a delivery device (see claim 28) and catheters are well known in the art as means for percutaneous delivery minimally invasive procedures.
Regarding claim 26, Pat. ‘771 nor ‘’010 recite the use of a guide catheter. It would have been obvious to modify the patents and utilize a guide catheter as they are well known in the art for proper placement of implants (see for example as evidenced by Bramfitt et al. 5,935,135 which states “The stents are placed at a desired location within a body lumen through a guide catheter or similar device and are expanded, by various known methods..”.
Regarding claim 27, see pat. 010 claim 2.
Regarding claim 28, see the limitations of patent ‘771 claims 28-29 which recites equivalent method steps. The only difference is in that the current claim 28 depends from claim 1”. It would be obvious to one having ordinary skill in the art to utilize the implantable artificial bronchus as claimed in patent ‘771, claim 1 by the methods as recited in patent ‘’771 (claim 28) because ‘’771 claims envisions methods to delivering the device in an air passage way utilizing a delivery device (see claim 28) and catheters are well known in the art as means for percutaneous delivery minimally invasive procedures.
Regarding claim 29, see patent ‘771 claims 28 and 29.
Conclusion
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 December 19, 2025