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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The limitation of claim 30, which recites a low-temperature phase and a high-temperature phase, is disclosed at least in the disclosure of PCT/IB2023/000161 (WO 2023/170478 A1) dated 03/10/2023 and the instant application. However, said limitation is not supported in the originally foreign-filed application CH000265/2022 dated 03/11/2022. Accordingly, claim 30 will have an effective filing date of 03/10/2023.
Election/Restrictions
Applicant’s election without traverse of Group I: claims 21-30 and Species C: claims 29-30 in the reply filed on 09/01/2026 is acknowledged.
Claims 27-28, and 31-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II-III, and species A-B there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/01/2026.
Accordingly, claims 21-40 are pending and under consideration; claims 21-26 and 29-30 are currently under examination.
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 26 and 29-30 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.
Claim 26 recites the limitation "the first or second shaft component" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, Examiner currently interprets the limitation as “a first or a second shaft component”. Claims 29-30 are also rejected based on their dependency on Claim 26.
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.
Claims 21 and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levine et al. US 2007/0027548 A1 (hereinafter Levine), as cited in the IDS.
Regarding claim 21, Levine discloses a delivery device 4250 (Fig. 42A – catheter system 4250) for introducing and/or deploying an implant (Par. 189) within the gastro-intestinal tract 102+104+108 (Fig. 43 – stomach 102, duodenum 104, and pylorus 108; Par. 77 – “FIG. 43 is a sectional view of a portion of the digestive tract in a body”, and Par. 189 – “a low profile catheter system 4250 for delivery of a gastrointestinal implant device”), comprising
a shaft assembly 4200 (Fig. 42A-45 – inner shaft 4200) with a longitudinal axis (Fig. 42A – the length of inner shaft 4200), and
having an atraumatic tip component 4218 (Fig. 42A-45 – spherical shaped element 4218, and Par. 195 – “a spherical shaped element 4218 that is either solid, or inflatable to form an atraumatic tip”) arranged at a distal end of the shaft 4200 (Fig. 42A-45, and Par. 195 – “The ball 4218 at the end of the catheter shaft is held onto the shaft 4200”).
Regarding claim 23, Levine discloses the invention of claim 21. Levine further discloses wherein the atraumatic tip component 4218 (Fig. 42A-45) is carried at the distal end (Fig. 42A-45, and Par. 195 – “The ball 4218 at the end of the catheter shaft is held onto the shaft 4200”), further wherein the atraumatic tip component 4218 (Fig. 42A-45) defines a clamp for clamping an end of a sleeve structure 202 (Fig. 42A, Fig. 44 – sleeve 202, wherein element 4218 caps off sleeve 202 at its distal end, and Par. 205 – “the sleeve retention wire 4208 in the catheter 4302 which holds the sleeve 202 in place and also holds the ball 4218 to the distal tip of the catheter).
Regarding claim 24, Levine discloses the invention of claim 21. Levine further discloses wherein the atraumatic tip component 4218 (Fig. 42A-45) is coupled to the distal end (Fig. 42A-45, and Par. 195 – “The ball 4218 at the end of the catheter shaft is held onto the shaft 4200”) by a releasable connection 4208+4600 (Fig. 46 – retention wire 4208 and wire 4600, and Par. 209 – “The ends of wire 4600 are attached to the ball 4218 and the wire 4600 is looped through sleeve retention wire 4208 to hold the ball 4218 at the distal end of the inner shaft 4200 of the catheter. The ball 4218 is released by pulling back on sleeve retention wire 4208 with fitting 4200 (FIG. 42A) until wire 4600 is no longer held by sleeve retention wire 4208. The ball 4218 then falls off the distal end of the inner shaft of the catheter 4200”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 22 is rejected under 35 U.S.C. 103 as being unpatentable over Levine in view of Vargas US 9,173,734 B2 (hereinafter Vargas).
Regarding claim 22, Levine discloses the invention of claim 21. Levine further discloses wherein the atraumatic tip component 4218 (Fig. 42A-45) is carried at the distal end (Fig. 42A-45, and Par. 195 – “The ball 4218 at the end of the catheter shaft is held onto the shaft 4200”).
However, Levine does not disclose wherein the atraumatic tip component is at least partly rotatable about the longitudinal axis.
Vargas, in the same field of endeavor of intragastric implant device (Title), teaches wherein the atraumatic tip component 204 (Fig. 2 – distal balloon 204) is at least partly rotatable about the longitudinal axis (Fig. 2, Col. 12, line 27-29 – “The flexible section 205 may be constructed of flexible material… this flexible configuration allows the distal balloon 204 of an intragastric anchor implant 200 to rotate”, wherein the section 205 shows a longitudinal length/axis of the device).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the atraumatic tip component of Levine to have it at least partly rotatable about the longitudinal axis as taught by Vargas, in order to accommodate the curvature of the stomach (Col. 12, line 29-30 of Vargas).
Claims 25, 26, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Levine in view of Ken US 6,293,960 B1 (hereinafter Ken), as cited in the IDS.
Regarding claim 25, Levine discloses the invention of claim 21. However, Levine does not disclose wherein the shaft assembly includes first and second elongate shaft components.
Ken, in the same field of endeavor of catheter for releasing an implant (Col. 2, line 18-22), teaches wherein the shaft assembly 20 (Fig. 2 – catheter 20) includes first 26 (Fig. 2 – mounting means/shape memory collar 26) and second 36 elongate shaft components (Fig. 2 – elongated stem portion 36).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft assembly of Levine to have two elongate shaft components as taught by Ken, in order to provide an attachment between the balloon and the catheter body/shaft assembly (Col. 4, line 36-50 of Ken).
Regarding claim 26, Levine discloses the invention of claim 24. However, Levine does not disclose wherein the releasable connection is releasable by relative movement of the first or second shaft component with respect to the respective other shaft component.
Ken, in the same field of endeavor of catheter for releasing an implant (Col. 2, line 18-22), teaches wherein the releasable connection 26+36 (Fig. 2-3, and Col. 3, line 38-44 – “FIG. 2 is an exploded side sectional view… showing the shape memory collar in a first, open configuration; FIG. 3 is a side sectional view… showing the shape memory collar in a second, closed or narrowed configuration) is releasable by relative movement of the first shaft component 26 (Fig. 2) with respect to the respective other shaft component 36 (Fig. 2, and Col. 4, line 40-44 – “the shape memory collar is preferably heat treated in a opened releasing configuration illustrated in FIG. 2, and can be heated to a temperature that allows the collar to be worked and crimped into a narrowed gripping configuration shown in FIG. 3 gripping over an elongated stem portion 36”, and Col. 4, line 59-63 – “The shape memory collar can then be heated to be induced to shrink and pull back to assume the enlarged configuration shown in FIG. 2, disconnecting the valve of the balloon from the catheter shaft”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the releasable connection of Levine to be relative movement between two shaft components as taught by Ken, in order to provide a precise method of detaching balloons or other therapeutic interventional devices with0out comprising the position of the implant, without presenting broken or jagged ends that can potentially injure the vasculature, and without releasing undesirable particles of materials into the bloodstream (Col. 2, line 5-10 of Ken). It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the wires of Levine that allows for a releasable attachment of the atraumatic tip to the shaft assembly, for the relative movement of shaft components of Ken since these mechanisms perform the same function of providing temporary connection between the balloon and delivery shaft. Simply substituting one releasable attachment means for another would yield the predicable result of allowing the atraumatic tip to be attached and released when desired. See MPEP 2143.
Regarding claim 29, Levine in view of Ken discloses the invention of claim 26. The combination further discloses wherein the releasable connection 26+36 (Fig. 2-3 of Ken) comprises a phase transition element 26 (Fig. 2-3 of Ken, and Col. 4, line 40-42 of Ken – “The shape memory collar is preferably heat treated in a opened releasing configuration illustrated in FIG. 2”) having two distinct phases (Col. 3, line 38-44 of Ken – “FIG. 2 is an exploded side sectional view… showing the shape memory collar in a first, open configuration; FIG. 3 is a side sectional view… showing the shape memory collar in a second, closed or narrowed configuration”), said phase transition element 26 (Fig. 2-3 of Ken) being adapted to provide a fixed connection between the shaft assembly 4200/20 (Fig. 44 of Levine modified by Fig. 2-3 of Ken) and the atraumatic tip 4218 (Fig. 2-3 of Levine and Fig. 5) in a first phase (Col. 3, line 38-44 of Ken – “FIG. 2 is an exploded side sectional view… showing the shape memory collar in a first, open configuration”, and Col. 4, line 40-47 of Ken – “The shape memory collar… can be heated to a temperature that allows the collar to be worked and crimped into a narrowed gripping configuration shown in FIG. 3 gripping over an elongated stem portion 36 of the valve of the occlusion balloon to connect the occlusion balloon to the catheter body”), and release the atraumatic tip component 4218 (Fig. 45 of Levine) from the shaft assembly 4200/20 (Fig. 44 of Levine modified by Fig. 2-3 of Ken) in a second phase (Col. 4, line 59-64 of Ken – “The shape memory collar can then be heated to be induced to shrink and pull back to assume the enlarged configuration shown in FIG. 2, disconnecting the valve of the balloon from the catheter shaft”).
Examiner notes that once the modification is made as discussed in claim 26, the releasable connection of Levine will be substituted with the releasable connection via shape memory collar of Ken, including the collar’s two phases of connecting and releasing the atraumatic tip.
Regarding claim 30, Levine in view of Ken discloses the invention of claim 29. The combination further discloses wherein the phase transition element 26 (Fig. 2-3 of Ken) is formed by a shape memory alloy (Col. 4, line 40-42 of Ken – “The shape memory collar is preferably heat treated in a opened releasing configuration illustrated in FIG. 2” and Col. 5, line 24-25 of Ken – “In a presently preferred embodiment, the shape memory collar is formed from a shape memory material such as nickel titanium alloy,… that can be heat treated to have shape memory behavior, such that the alloy has a desired closed configuration at a temperature appropriate for introduction into the body via a catheter, and after placement, the collar will take on a more open shape for detaching the valve of the occlusion balloon from the catheter shaft”), wherein
the first phase is a low-temperature phase (Col. 5, line 24-25 of Ken – “In a presently preferred embodiment, the shape memory collar is formed from a shape memory material such as nickel titanium alloy,… that can be heat treated to have shape memory behavior, such that the alloy has a desired closed configuration at a temperature appropriate for introduction into the body via a catheter…”), and
the second phase is a high-temperature phase (Col. 4, line 59-63 of Ken – “The shape memory collar can then be heated to be induced to shrink and pull back to assume the enlarged configuration shown in FIG. 2, disconnecting the valve of the balloon from the catheter shaft”, Col. 5, line 24-25 of Ken – “The shape memory collar is preferably heat treated in a opened releasing configuration illustrated in FIG. 2”, and Col. 5, line 24-25 of Ken – “In a presently preferred embodiment, the shape memory collar is formed from a shape memory material such as nickel titanium alloy, that can be heat treated to have shape memory behavior, such that the alloy has a desired closed configuration at a temperature appropriate for introduction into the body via a catheter, and after placement, the collar will take on a more open shape for detaching the valve of the occlusion balloon from the catheter shaft”; thus indicating that when the shape memory collar is exposed to a temperature higher than the closed configuration, the collar transitions into its pre-configured shape to facilitate detachment of the tip).
Examiner notes that once the modification is made as discussed in claim 26, the releasable connection of Levine will be substituted with the releasable connection via shape memory collar of Ken, including the collar’s shape memory alloy material that holds different shapes/configurations at different temperatures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Henkes et al. US 2021/0307944 A1 teaches a device for introducing implants using heat applied to the shaft such that the connection points become detached and the implant is released.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
