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 Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-5 and 7-18 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.
Independent claims 1 and 13 each include the limitation “wherein the heat set scraping member is biased to a non-expanded configuration when unconstrained and at body temperature” (emphasis added), which is not supported in the application as originally filed since the application is silent on the temperature(s) at which the heat set scraping member is biased to the non-expanded configuration. Claims 2-5, 7-12 and 14-18 depend from claim 1 or claim 13 and are therefore also rejected under 35 USC 112a as failing to comply with the written description requirement.
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.
Claim(s) 1-5, 7-11, and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janardhan et al. (US 2014/0261977) in view of Sachar et al. (US 2019/0133616).
Regarding claims 1 and 13, Janardhan discloses a method of forming an expandable thrombectomy device, the method comprising disposing a scraping member comprising a plurality of braided members ([0062]-[0063], [0463]) along a mandrel (170; see fig. 10E, 10F, 10G), the scraping member including a proximal end region, a distal end region, and a medial region positioned between the proximal end region and the distal end region (see examiner-annotated reproduction of figure 10G below; some reference numbers and lines have been removed in order to facilitate examiner’s labelling), constraining the proximal end region of the scraping member (with wire 180; fig. 10G), constraining the distal end region of the scraping member (with wire 182; fig. 10G), and heat setting the scraping member ([0529]-[0536]). The scraping member of Janardhan is configured to shift between the non-expanded configuration (fig. 27F) and an expanded configuration (figs. 27G, 27H: [0805]). The medial region (see annotated figure provided below) of Janardhan is predisposed to initiate shifting of the scraping member from the non-expanded configuration and the expanded configuration. In particular, the medial region is heat treated such that it initiates expansion at the location of the medial region (i.e., a bulb) and initiates collapse at the location of the medial region.
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Janardhan fails to expressly disclose that the heat set scraping member of Janardhan is biased to a non-expanded configuration when unconstrained and at body temperature, though it is noted that Janardhan contemplates a mechanically controlled expansion of the scraping member (last sentence of [0029]).
Sachar discloses another thrombectomy device used for removal of a thrombus from a blood vessel, the thrombectomy device comprising a scraping member (102) made of a plurality of braided wires (figs. 1a, 1b; [0049]). Sachar discloses that the scraping member/braided members are made of a shape memory material that is biased in the non-expanded configuration when unconstrained and in a patient’s body ([0052]; see fig. 6c and par. [0074], noting the device is unexpanded while in the vessel until the practitioner places tension in the activation wire). According to Sacher, such an arrangement enables deployment of the braided device to a range of diameters via tensioning of an activation wire to precisely custom fit the size of the vessel ([0067], [0069], [0071]). Sacher further discloses that using a shape memory device biased to the collapsed position reduces the risk of overexpansion and injury during self-expansion ([0067]). Although Sacher does not expressly disclose that the scraping member is biased to the non-expanded configuration at body temperature, Sacher does illustrate the scraping member biased to the non-expanded configuration when unconstrained and within the body (specifically, in patient’s vasculature; see fig. 6c; [0074],[0075]), and discloses expansion of the device only upon manual manipulation of the activation wire. Thus, one skilled in the art would have found it obvious to use a shape memory material for the device of Sacher that is biased to the non-expanded configuration when at body temperature in order to ensure the reduced risk of overexpansion and injury while the device is being used within the vasculature of the patient, as is intended by Sacher, without the need to modify the temperature at the treatment site to achieve these advantages.
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Janardhan to bias the heat set scraping member of Janaradhan to a non-expanded configuration when unconstrained and at body temperature, wherein expansion is controlled by tensioning of an activation wire, in view of the teachings of Sachar in order to enable deployment of the braided device to a range of diameters to precisely custom fit the size of the vessel, and to reduce the risk of overexpansion or injury within the vessel.
Regarding claims 2 and 14, constraining the proximal end region of the scraping member/plurality of braided wires includes constraining the proximal end region with a first constraining wire (180; fig. 10G of Janaradhan).
Regarding claims 3 and 15, constraining the distal end region of the scraping member/plurality of braided wires includes constraining the distal end region with a second constraining wire (182; fig. 10G).
Regarding claims 4, 5, and 16, Janardhan discloses removing the first constraining wire (180) and the second constraining wire (182) after heat setting the scraping member (see [0544] of Janaradhan).
Regarding claim 7, heat setting the scraping member defines an expansion point in the medial region (noting largest diameter at center of medial region; [0531] of Janaradhan).
Regarding claim 8, the medial region is free of the first and second constraining wires during the heat setting (see annotated fig. 10G above).
Regarding claims 9 and 10, the first and second constraining wires are configured to maintain the proximal and distal end regions at a first and second diameter, respectively, during the heat setting (as understood in view of par. [0531] of Janaradhan; wires wrapped around necks “during a second heat treatment”).
Regarding claim 11, the medial region includes a third diameter (at its center) during the heat setting, wherein the third diameter is larger than the constrained first and second diameters (see annotated figure above, noting constrained first and second diameters directly under constraining wires).
Regarding claim 17, heat setting the scraping member defines an expansion point in the medial region (noting largest diameter at center of medial region; see annotated figure above and par. [0531] of Janardhan).
Claim(s) 12 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janardhan in view of Sachar as applied to claims 3 and 15 above, and further in view of Diamant et al. (US 2011/0082483). Janardhan in view of Sachar discloses the invention substantially as stated above including first and second constraining wires, the wires being metal ([0529] of Janaradhan), but fails to disclose that one or both of the wires are copper.
Diamant discloses that a plurality of wires (131) forming a tubular mesh portion of a medical device (see fig. 2) may be secured to a mandrel using copper constraining wires ([0108], [0109])). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Janardhan to use copper constraining wires in view of Diamant’s disclosure that copper is suitable for the construction of constraining wires, and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KSH 6/9/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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