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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 06/08/2026. Claims 10, 15 and 17 are amended. Claims 1-9, 11-14 and 19-20 are cancelled. Claims 21-23 are new. Claims 10, 15-18 and 21-23 are currently pending.
The objection of claims 1 and 15 has been withdrawn due to applicant’s amendment.
The rejection of claims 9 and 17 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/08/2026, with respect to the rejection(s) of claim(s) 1, 9-10 and 14-18 under 35 U.S.C. 102(a)(2) as being anticipated by Markham; and claims 7-8 under 35 U.S.C. 103 as being unpatentable over Markham in view of Onozuka, have been fully considered but are not persuasive. The rejection has been modified, necessitated by applicant’s amendments to the claims.
Applicant argues Markham does not disclose moving the collar causing the transition between the collapsed and expanded configurations (Remarks, pgs. 4-6).
In response to applicant’s argument, it is respectfully submitted the movable collar is considered to be capable of transitioning the occluder between a collapsed configuration and an expanded configuration when moved proximally or distally. Based on fig. 3 of Markham, proximal and distal movement of the collar would cause the occluder to assume a more bulbous-shape and a less bulbous-shape, which are considered to be collapsed and expanded relative to each other. Markham does teach use of a sleeve during deployment and dynamic movement of the filaments of the occluder as discussed in the remarks, however, Markham also teaches the system tracked to the target location without the sleeve (para. [0027]), such that Markham discloses deployment of the system without necessarily needing the sleeve. Further, Markham discloses multiple configurations of the occluder that could be considered a collapsed configuration or an expanded configuration. For example, Markham describes a deployed configuration of the occluder which is closed (para. [0029]), such that the occluder can assume multiple stages of expansion. Additionally, as evidenced by Chanduszko (US 2023/0310003 A1), proximal/distal movement of a distal collar transitions a device between extended and collapsed configurations (para. [0062]; figs. 3a and 3c). Therefore, the claim limitation is considered to be met, because Markham discloses a sliding distal collar that would move the occluder upon proximal and distal movement between collapsed and expanded configurations as claimed.
Applicant’s arguments with respect to claims 21-23 have been fully considered, and new claims 21-23 are rejected as discussed below.
Claim Objections
Applicant is advised that should claim 17 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 15-18 and 21-23 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 recites “the collapsed configuration and the expanded configuration” in line 7. There is insufficient antecedent basis for this limitation in the claim, since a collapsed configuration and an expanded configuration have not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a collapsed configuration and an expanded configuration.
Further, the claim recites “a collapsed configuration… an expanded configuration” in lines 9-10. It is unclear whether the phrase is referring to the collapsed configuration and the expanded configuration previously recited, or introducing new, separate configurations. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the collapsed configuration and the expanded configuration previously recited.
Claims 15-18 and 21-23 are indefinite due to their dependency on indefinite base claim 10.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 10, 15-18 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Markham (US 2024/0131301 A1) (all references previously of record).
Regarding claim 10, Markham discloses (see abstract; paras. [0020]-[0053]; figs. 2-4) a delivery catheter (102, para. [0021]) comprising:
a length of catheter tubing (length of tubing of catheter 102, fig. 2); and
an expansile section (110) positioned along the length, the expansile section comprising:
a fixed proximal collar (130, para. [0026]);
a frame (includes strands 120, para. [0024]) extending from the fixed proximal collar (fig. 3), the frame comprising a sliding distal collar (attachment 128 which may be a movable collar, para. [0026]), the sliding distal collar movable to transition the expansile section between the collapsed configuration and the expanded configuration (considered to be movably coupled such that 110 transitions between the collapsed and expanded configurations, para. [0026]); and
a membrane (132, para. [0026]) having an open end (depicted in fig. 3),
wherein the expansile section has a collapsed configuration with a first diameter and an expanded configuration with a second diameter (paras. [0024], [0027] and [0029]), the second diameter sized to limit reflux of fluid embolic agent within a vessel proximal to the expansile section (paras. [0002] and [0035]).
Regarding claim 15, Markham discloses the delivery catheter of claim 10. Markham further discloses wherein the frame comprises a plurality of axial bars (strands 120) extending between the fixed proximal collar and the sliding distal collar (fig. 3), and wherein the membrane is affixed to the plurality of axial bars (para. [0026]).
Regarding claim 16, Markham discloses the delivery catheter of claim 15. Markham further discloses wherein the open end is positioned mid-way between the fixed proximal collar and the sliding distal collar (considered to at least be positioned mid-way when valve 110 is in the collapsed condition, see also fig. 3 depicting open end of 132 distal of proximalmost end of attachment location 130).
Regarding claim 17, Markham discloses the delivery catheter of claim 15. Markham further discloses wherein two adjacent axial bars of the plurality of axial bars are integrated distally via looped ends (see fig. 3, at least proximal end of 110 considered to be looped).
Regarding claim 18, Markham discloses the delivery catheter of claim 10. Markham further discloses wherein the open end has an open diameter less than the second diameter (see open end of 132 within tapered section of 110 as 110 tapers distally, fig. 3).
Regarding claim 21, Markham discloses the delivery catheter of claim 10. Markham further discloses wherein the frame comprises a plurality of axial bars (strands 120) extending between the fixed proximal collar and the sliding distal collar (fig. 3), and wherein the membrane is affixed to the plurality of axial bars (para. [0026]), and wherein two adjacent axial bars of the plurality of axial bars are integrated distally via looped ends (see fig. 3, at least proximal end of 110 considered to be looped).
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.
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(s) 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Markham in view of Onozuka (US 2020/0171276 A1).
Regarding claim 22, Markham discloses the delivery catheter of claim 10.
Markham further discloses wherein the catheter tubing comprises an inner liner (para. [0023]) and an outer jacket (outer coating, para. [0023]), wherein the inner liner comprises highly oriented polytetrafluoroethylene (PTFE) (see para. [0052] of the published application describing a wrapped PTFE material as an example of the liner material, para. [0023] of Markham).
However, Markham fails to explicitly disclose wherein a modulus of elasticity of the outer jacket is less than 10% of that of the inner liner.
Onozuka teaches (para. [0043]), in the same field of endeavor, a delivery catheter comprising an inner tube (40) and an outer tube (50), wherein the modulus of elasticity of the outer tube is less than the modulus of elasticity of the inner tube (para. [0043]), for the purpose of providing higher bending rigidity and tensile elastic modulus to the inner tube (para. [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer jacket of Markham to have a lower modulus elasticity than the inner liner, in order to provide higher bending rigidity and tensile elastic modulus to the inner tube, increasing the flexibility of the device, based on the teachings of Onozuka (para. [0043]).
Markham (as modified) still fails to teach wherein a modulus of elasticity of the outer jacket is less than 10% of that of the inner liner.
Markham (as modified) teaches (paras. [0014]-[0015], [0031]-[0032], [0043] and [0083] of Onozuka) that the rigidity/modulus of elasticity of the catheter needs to be optimized to “prevent the occurrence of kink and have small variation in function such as blood vessel selectivity, runnability in a blood vessel or torque properties.” As described in Markham and Onozuka, the rigidity of the catheter is important in traversing a blood vessel, reducing kink and providing manufacturing stability, and as such the rigidity/modulus of elasticity of the catheter and therefore the outer jacket relative to the liner is disclosed to be a result effective variable in that changing the rigidity of the outer jacket changes the occurrence of kink in the catheter which affects how the catheter is inserted into a blood vessel. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the catheter of Markham (as modified) to have a modulus of elasticity within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment (para. [0052] of the published application). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Markham (as modified) by making the modulus of elasticity of the outer jacket less than 10% of that of the inner liner as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 23, Markham (as modified) teaches the delivery catheter of claim 22. Markham further discloses wherein the catheter tubing comprises an axial fiber (may be made of PET which is considered a fiber, para. [0023]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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, Darwin Erezo can be reached at (571)-272-4695. 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.
/BRIGID K BYRD/Examiner, Art Unit 3771
Prosecution Insights