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 without traverse of Species D: figs. 8a-f in the reply filed on 01/20/2026 is acknowledged.
Claims 6 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026.
Claim 2-5 and 11-13 are further withdrawn from further consideration by the examiner as being drawn to a nonelected species.
Claim 2 recites the first diameter of the catheter tubing being larger than the second diameter of the catheter tubing, which is not depicted in figs. 8a-f, and is instead depicted in at least non-elected species a: figs. 2a-c (see paras. [0041] and [0072] describing the proximal portion 220 having a proximal diameter 800 that is greater than a distal diameter 810 of distal portion 240).
Claims 3-5 recite wherein the reflux-occluder section is a bulge in the catheter tubing. Elected species d: figs. 8a-f does describe the expansile section 304 having a bulbous shape (para. [0065]), however, the species does not recite the expansile section being a bulge in the catheter tubing; instead, the expansile section is positioned on the catheter tubing in the form of a frame and membrane (figs. 8a-f).
Claims 11-13 recite a non-expansile section and a restrictor disposed within a lumen of the catheter tubing, which is drawn to nonelected species c: figs. 7a-c, because figs. 7a-c describe a delivery catheter 200 having a non-expansile section 212 and a restrictor 206.
Claim Objections
Claims 1 and 15 are objected to because of the following informalities:
In claim 1, line 2, the phrase “the catheter tubing having first diameter” should read “the catheter tubing having a first diameter”.
In claim 15, line 3, the phrase “the axial bars” should read “the plurality of axial bars”, to maintain consistency in referring to the plurality of axial bars.
Appropriate correction is required.
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 9 and 17 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 9, the claim recites “a proximal portion of the catheter tubing… a distal portion of the catheter tubing” in lines 13-14. It is unclear whether the phrase is referring to the proximal portion and the distal portion of the catheter tubing previously introduced, or introducing new, separate portions. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the proximal portion and the distal portion of the catheter tubing previously introduced.
Regarding claim 17, the claim recites “two adjacent axial bars” in line 1. It is unclear whether the phrase is referring to two adjacent axial bars of the plurality of axial bars previously introduced, or introducing new, separate bars. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to be two adjacent axial bars of the plurality of axial bars previously introduced.
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) 1, 9-10 and 14-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Markham (US 2024/0131301 A1).
Regarding claim 1, Markham discloses (see abstract; paras. [0020]-[0053]; figs. 2-4) a delivery catheter (102, para. [0021]) comprising:
a catheter tubing (tubing of catheter 102) extending a length (fig. 2), a proximal portion (includes proximal end 104) of the catheter tubing having first diameter and a distal portion (includes distal end 106) of the catheter tubing having a second diameter (fig. 2); and
a reflux-occluder section (110, para. [0021]) having a third diameter greater than the first diameter and the second diameter (fig. 2), the reflux-occluder section being disposed along the length of the catheter tubing between the proximal portion and the distal portion (fig. 2).
Regarding claim 9, Markham discloses a method of using the delivery catheter of claim 1, wherein the method comprises the steps of:
advancing a distal tip of the delivery catheter through a main vessel (advanced in the vessel, para. [0029]) to a position distal to a non-targeted site and proximal to a targeted site (proximal to targeted site by preventing reflux in a proximal direction, para. [0051]);
positioning the reflux-occluder section proximal to the targeted site such that the reflux- occluder section extends radially from the catheter tubing of the delivery catheter and contacts a vessel wall proximate the targeted site (paras. [0029] and [0035]);
delivering a fluid embolic agent through the catheter tubing (para. [0021]);
limiting, via the reflux-occluder section, the fluid embolic agent from refluxing proximal to the reflux-occluder section (paras. [0035] and [0051]); and
withdrawing the delivery catheter from the main vessel (para. [0048]),
wherein the reflux-occluder section comprises an occluder diameter greater than a proximal diameter of a proximal portion of the catheter tubing and also greater than a distal diameter of a distal portion of the catheter tubing (depicted in figs. 2-3).
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]); 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 14, Markham discloses the delivery catheter of claim 10. Markham further discloses wherein the expansile section comprises 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]).
Regarding claim 15, Markham discloses the delivery catheter of claim 14. 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 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 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).
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) 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Markham in view of Onozuka (US 2020/0171276 A1).
Regarding claim 7, Markham discloses the delivery catheter of claim 1.
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 8, Markham (as modified) teaches the delivery catheter of claim 7. Markham further discloses wherein the catheter tubing comprises an axial fiber (may be made of PET which is considered a fiber, para. [0023]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2012/0330348 A1 to Strauss, disclosing a device including an embolic implant.
US 2023/0310003 A1 to Chanduszko, disclosing a flow reduction catheter.
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