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 responsive to the amendment filed on 03/11/2026. As directed by the amendment: claim 1 has been amended and claims 2 and 5 have been cancelled. Thus, claims 1, 3-4, and 6 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 4-7, filed 03/11/2026 with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(2) as being anticipated by Arthur et al (US 20230346382 A1), herein referenced to as “Arthur” have been fully considered but they are not fully persuasive.
The applicant amended claim 1 to further recite: “an outer edge of the turbulent flow mesh disc has a height less than or equal to a height of the bulge in the center of the turbulent flow mesh disc, the metal wires are fixed within the developing mark by way of glue curing or riveting, the double-layer metal wire braided structure is formed by folding the braided tube braided by the metal wires inwards, the metal wires have a number of 36, 48, 64, 72, 96, 128, or 144, and the metal wires can slide relative to each other without a fixed point”. The applicant asserts that Arthur does not disclose the amended claim language.
The examiner respectfully disagrees. While, Arthur (Figs. 40A-40C) does not explicitly disclose: wherein an outer edge of the turbulent flow mesh disc has a height less than or equal to a height of the bulge in the center of the turbulent flow mesh disc, a variant embodiment of Arthur does teach the claimed language.
Furthermore, Arthur teaches the additional amended claim language, see 103 rejection below. As such the rejection will be maintained under USC 103 instead of USC 102(a)(2).
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “and before the release portion is broken, a position for recovering the turbulent flow mesh disc is located by the developing mark, and the pushing guide wire pulls back the turbulent flow mesh disc” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim limitation “and the pushing guide wire pulls back the turbulent flow mesh disc” does not have adequate support in neither the specification nor the drawings. There is no mention of using the pushing guide wire to pull back the flow mesh disc. Appropriate correction is required.
Claims 3-4 and 6 are rejected as being dependent on claim 1.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim #
Line #
Current
Suggested change
1
21-22
a release position
the release portion
Appropriate correction is required.
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) 1, 3-4, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arthur.
Claim 1
Arthur discloses: An intratumor turbulent flow device 4002 (see Figs. 40A-40C, [0751]), comprising: a turbulent flow mesh disc 4008 + 4040 (see Figs. 40A-40C, [0759]), wherein the turbulent flow mesh disc 4008 + 4040 is of a double-layer metal wire braided structure (see Figs. 40A-40C, [0012], double layer), a developing mark 4066 (see Figs. 40A-40C, [0762], a radiopaque marker, hence a developing mark that is viewable under x-ray) is provided at a bottom the proximal portion of 4008 + 4040 (see Fig. 40A) of the turbulent flow mesh disc 4008 + 4040 and in a center the center of 4008 + 4040 (see Fig. 40A) of the turbulent flow mesh disc 4008 + 4040, metal wires 4009 (see Figs. 40A-40C, [0476]) in the center of the turbulent flow mesh disc 4008 + 4040 are fixed within the developing mark 4066 (see Fig. 40B), the center the center of 4008 + 4040 (see Fig. 40A, the center around 4006 + 4051 bulges upwards) of the turbulent flow mesh disc 4008 + 4040 bulges upwards, and a bottom end the bottom end of 4006 (see Fig. 40A, does not go past the lowest end of 4008 + 4040) of the developing mark 4006 does not exceed a lowest end 4016 (see Fig. 40A, [0757]) of the turbulent flow mesh disc 4008 + 4040; a release portion 4006 (see Figs. 40A-40B, [0761]-[0763]), the metal wires (see [0575]) are fixed within (see Figs. 40A-40C, the wires of 4002 are fixed within 4051 which is within 4066, see Fig. 40B) the developing mark 4066 by way of glue curing (see [0761], bonding material 5051, [0772], includes adhesive e.g. expoy e.g. UV cured epoxy, hence glue curing) or riveting (will not be examined here due to being an optional claim limitation), the double-layer metal wire braided structure is formed by folding the braided tube braided by the metal wires inwards, the metal wires (see [0575]) have a number of 36, 48, 64, 72, 96, 128, or 144 (see [0575], 96 wire device, the other numbers are not examined here due to being optional claim limitations in the alternative); and the metal wires can slide relative to each other without a fixed point (see [0378], the filaments are connected by interconnecting allowing them to change shape to expand and compress), wherein a distal end a distal end portion of 4006 attached to 4066 via 4051 (see Fig. 40B) of the release portion 4006 is fixedly connected (see Fig. 40B, [0764]) to the developing mark 4066; a pushing guide wire 4022 (see Fig. 40B, [0762]), wherein the pushing guide wire 4022 is connected to the turbulent flow mesh disc 4008 + 4040 by way of the release portion 4006, and is configured to push (see [0766]) the turbulent flow mesh disc 4008 + 4040; and a microcatheter (see [0293], delivery catheter, devices shown use a delivery catheter) for delivering the turbulent flow mesh disc 4008 + 4040, wherein the pushing guide wire 4022 is configured to push (see [0766]) the turbulent flow mesh disc 4008 + 4040, which is compressed into a bundle shape (see [0314], the device is delivered through vasculature in a collapsed state), into a cavity of an aneurysm along the microcatheter (see [0262] and [0314]), a release position 4006 (see claim objection above, interpreted as “the release portion”) for the turbulent flow mesh disc 4008 + 4040 is located by the developing mark 4066 (see Fig. 40B, 4006 is by 4066), the turbulent flow mesh disc 4008 + 4040 is configured to expand in the cavity (see [0022] and [0027]) and to be closely fitted to an inner wall of the cavity (see [0022] and [0027]), and the release portion 4006 is configured to be broken by electrolysis or electric heating (see [0322], electrolytic weakening of a connection between the push-wire/delivery device and the expandable device), such that the center of the turbulent flow mesh disc 4008 + 4040 is restored to a bulge 4040 bulges within the aneurysm for pulling the developing mark 4006 into the cavity (see Fig. 40A, expanded configuration, the developing mark is within 4008 which is seated within the cavity over the neck of the aneurysm, as shown in Fig. 42E); and before the release portion 4006 is broken (see Fig. 42C, before 4006 is broken), a position for recovering the turbulent flow mesh disc 4008 + 4040 (see Figs. 40A-40C, [0762], a radiopaque marker, hence a developing mark that is viewable under x-ray, hence this is also a viewable position for the recovery the mesh disc) is located by the developing mark 4066, and the pushing guide wire pulls back the turbulent flow mesh disc.
The language, " the pushing guide wire pulls back the turbulent flow mesh disc," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Arthur meets the structural limitations of the claim, and is capable of the pushing guide wire while attached to the flow mesh disc to pull and reposition the implant.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Arthur (Figs. 40A-40C) does not explicitly disclose: wherein an outer edge of the turbulent flow mesh disc has a height less than or equal to a height of the bulge in the center of the turbulent flow mesh disc.
However, a variant embodiment (see Figs. 12A-12D) of Arthur teaches in the same field of invention an intratumor turbulent flow device 1202 (see Figs. 12A-12D) with a turbulent flow mesh disc 1208 + 1240 (see Figs. 12A-12B) with a bulge the center portion of 1240 (see Figs. 12A-12D) in the center of the turbulent flow mesh disc 1208 + 1240. The variant embodiment (see Figs. 12A-12D) of Arthur further teaches: wherein an outer edge outer edge of 1208 (see Fig. 12B) of the turbulent flow mesh disc 1208 + 1240 has a height 1209 (see Fig. 12B, [0470]) less than or equal to a height 1258 (see Fig. 12B, [0470], 1260 in the paragraph) of the bulge 1240 in the center of the turbulent flow mesh disc 1208 + 1240.
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 Arthur to incorporate the teachings of a variant embodiment (Figs. 12A-12D) of Arthur and teach an intratumor turbulent flow device with an outer edge of the turbulent flow mesh disc has a height less than or equal to a height of the bulge in the center of the turbulent flow mesh disc. Motivation for such can be found in Arthur as a larger support/bulge helps prevent the collapse of the device within the aneurysm and provide strong blockage of flow of fluid into or out of the aneurysm (see [0473]).
Claim 3
Arthur teaches: The intratumor turbulent flow device of claim 1, see 103 rejection above. Arthur further discloses: wherein the metal wires are made of a material of nitinol (see [0309], nitinol wires, the other limitations are not examined here due to being optional claim limitations in the alternative), platinum-core nickel-titanium, or 35NLT alloy; and the metal wires may be developable metal wires (see [0325], the mesh is radiopaque, a developable wire is one that is viewable under x-ray).
Claim 4
Arthur teaches: The intratumor turbulent flow device of claim 1, see 103 rejection above. Arthur further discloses: wherein the developing mark 4066 is a solid ring (see Figs. 40A-40C, 4066 is a solid ring) made of gold, tantalum (see [0578]), platinum-iridium alloy (see [0578], platinum/iridium alloy, the connector is made of this material, and 4066 is a connector, the other limitations are not examined here due to being optional claim limitations in the alternative), or platinum-tungsten alloy.
Claim 6
Arthur teaches: The intratumor turbulent flow device of claim 1, see 103 rejection above. Arthur further discloses: wherein the turbulent flow mesh disc 4008 + 4040 has a height ranging from 5% to 40% of a width (see Figs. 40A-40C, the device has a height (which correlates to length) and a width, see [0431], the range of these measurements can be from 1-20 mm, hence in a selected embodiment the height can be 4 mm while the width can be 10 mm, hence the height would be 40% of the width) of the turbulent flow mesh disc 4008 + 4040.
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 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, 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.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771