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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/15/2025 has been entered.
Response to Arguments
In the arguments filed 12/15/2025, Applicant asserts that the amendments have overcome the previously presented 35 USC 102a1 rejections over Janardhan. The examiner respectfully disagrees. Janardhan discloses that the heat set scraping member may be biased to a non-expanded configuration by controlling the temperature of the environment around the heat set scraping member. When the temperature is held at a first temperature, such as ambient room temperature according to Janardhan (e.g., about 25 degree C; see [0805]), the heat set scraping member is maintained in the non-expanded configuration (cylindrical shape). Because the temperature is controlling the shape of the scraping member, the scraping member will remain in the collapsed configuration at this first temperature even if it is unconstrained (i.e., when not held in a sheath or other enclosure that exerts a constraining force on the scraping member) as long as this first temperature is maintained. According to Janardhan, when the scraping member is at a second temperature, which can be achieved on contact with blood at body temperature (e.g., about 37 degree C; see [0805]), the scraping member expands from the collapsed cylindrical configuration to the configuration having a plurality of bulbs as shown in fig. 27H. As long as the scraping member is held at the first temperature and not exposed to the second temperature, it is biased to a non-expanded configuration even when unconstrained due to its shape memory properties. It is noted that the collapsed configuration has a diameter less than that of the inner diameter of the sheath such that there is clearance between the collapsed scraping member and the sheath (see [0389]).
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13: in lines 8, 9, 11, and line 13, “plurality of wires” should read “plurality of braided wires” for consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 7-11, and 13-17 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Janardhan et al. (US 2014/0261977). 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 heat set scraping member of Janardhan is biased to a non-expanded configuration when unconstrained. In particular, Janardhan discloses that the heat set scraping member may be biased to the non-expanded configuration (tubular/cylindrical shape without bulbs and necks) when exposed to ambient room temperature (e.g., about 25 degree C; see [0805]). Because the temperature is controlling the shape of the scraping member, the scraping member will remain in the collapsed configuration at this first temperature even when unconstrained (i.e., when not held in a sheath or other enclosure that exerts a constraining force on the scraping member) as long as this temperature is maintained (noting scraping member expands when exposed to a higher temperature of about 37 degrees C; see [0805]).The scraping member of Janardhan is configured to shift between the non-expanded configuration (fig. 27F) and an expanded configuration (figs. 27G, 27H: upon release from the sheath and exposure to higher temperature; [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) when exposed to a particular temperature (see [0805]), and initiates collapse at the location of the medial region (e.g., if forced into a sheath, medial region collapses).
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Regarding claims 2 and 14, constraining the proximal end region of the scraping member/plurality of braided members includes constraining the proximal end region with a first constraining wire (180; fig. 10G).
Regarding claims 3 and 15, constraining the distal end region of the scraping member/plurality of braided members 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]).
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]).
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]; 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 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) 12 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janardhan in view of Diamant et al. (US 2011/0082483). Janardhan discloses the invention substantially as stated above including first and second constraining wires, the wires being metal ([0529]), 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
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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KSH 1/30/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771