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 Invention I, claims 1-11 and 15-20 in the reply filed on August 26, 2025 is acknowledged.
Claims 12-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 26, 2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The claimed invention is only disclosed in the current application and therefore has a priority date as of its filing date, which is August 23, 2023.
Drawings
The drawings are objected to because there are two figures titled “Fig. 9.”
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
reference character “140” has been used to designate both the “guidewire” in Fig. 1 and “MRI-based tracking system” in Fig. 1I.
reference character “150” has been used to designate both the “the retraction catheter” in Fig. 1 and “a fluoroscopic image” in Fig. 1I.
reference character “160” has been used to designate both the “retraction wire” in Fig. 1 and “a fluoroscopic image” in Fig. 1I.
reference character “1508” has been used to designate both the “expander” in Fig. 15 and “a greatest distance” in Figs. 15A & B.
reference character “1504” has been used to designate both the “struts with elastic memory” in Fig. 15 and “clot” in Figs. 15A & B.
reference character “1502” has been used to designate both the “the distal mesh element” in Fig. 15 and “blood vessel” in Figs. 15A & B.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 68, 97, 250, 260, 262, 264, 272, 274, 276, 278, 280, 290, 320, 464, 481, 800a, 804a, 822, 824, 826, 828, 830, 904d, 912, 916, 926, 928, and 934.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 182 and 188.
The drawings are objected to because Figures 1-15B do not have uniformly thick, well-defined, sufficiently dark lines. See CFR 1.84(l) which states “All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction (in the present application Figures 1-15B, it is difficult to clearly read the reference numbers, since the weight of the lines are not sufficiently thick). This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning”.
The drawings are objected to because Figures 2 and 3 use shading, however, this shading reduces legibility. See CFR 1.84(m) which states “Shading. The use of shading in views is encouraged if it aids in understanding the invention and if it does not reduce legibility. Shading is used to indicate the surface or shape of spherical, cylindrical, and conical elements of an object. Flat parts may also be lightly shaded. Such shading is preferred in the case of parts shown in perspective, but not for cross sections. See paragraph (h)(3) of this section. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. As a substitute for shading, heavy lines on the shade side of objects can be used except where they superimpose on each other or obscure reference characters. Light should come from the upper left corner at an angle of 45°. Surface delineations should preferably be shown by proper shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color”.
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.
Specification
The disclosure is objected to because of the following informalities:
Page 23 recites “FIGs. 9A & 9B” when only Fig. 9 is shown in the drawings.
Page 45 recites “FIGs. 11A, 11B and 11C” when only Fig. 11 is shown in the drawings.
Page 34 recites reference character “1514” has been used to designate both the “clot” in Fig. 15 and “struts with elastic memory” in Figs. 15A & B.
Page 34 recites reference character “140” as both the “guidewire” and “retracting wire” and page 41 recites reference character “140” as the “MRI-based tracking system.”
Page 34 recites reference character “150” as the “retraction catheter,” page 35 recites reference character “150” as “guiding catheter,” and page 41 recites reference character “150” as “fluoroscopic image.”
Page 34 recites reference character “160” as both the “guidewire” and “retracting wire,” and page 41 recites reference character “160” as the “fluoroscopic image.”
Page 46 recites reference character “1502” as both “a blood vessel” and “the wall” and page 47 recites reference character “1502” as the “the distal mesh element” and pages 48 reference character “1502” as “the distal mesh element collecting basket,” “the collecting basket,” and “the holding basket.”
Page 47 recites reference character “1504” as the “clot” and page 48 recites reference character “1504” as the “struts with elastic memory.”
Page 46 recites reference character “1508” as “a greatest distance” and page 47 recites reference character “1508” as the “the intermediate mesh element” and pages 48 and 49 recite reference character “1508” as the “the expander.”
Appropriate correction is required.
Claim Objections
Claims 4, 17, and 19 are objected to because of the following informalities:
Claim 4 recites “a surface of the middle mesh element conformed against a surface” but should recite “a surface of the middle mesh element is conformed against a surface.”
Claim 17 recites “without passing the position of the blood” but should recite “without passing the position of the blood clot.”
Claim 20 recites “the mechanical thrombectomy catheter combined with an aspiration device” but should recite “the mechanical thrombectomy catheter is combined with an aspiration device.”
Appropriate correction is required.
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 1-11 and 14-20 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.
“To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.” (MPEP § 2163).
There is a presumption that an adequate written description of the claimed invention is present when the application is filed. In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976) ("[W]e are of the opinion that the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims."). However, as discussed in subsection I, supra, issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. (MPEP § 2106(I)(A)).
Claim 1 recites “bringing the most distal mesh element and the middle one of the mesh elements together, with the blood clot stabilized between the most distal mesh element and the middle mesh element; bringing the stabilized blood clot and the most distal mesh element and the middle one of the mesh elements towards the most proximal of the three separate and distinct compressed and expandable mesh elements.”
There is no explicit, implicit, or inherent support anywhere in the Specification or Drawings as to how the distal mesh element and the middle mesh elements are brought together and then how both mesh elements are brought towards the proximal mesh element. The Specification is silent as to how the device with three separate and distinct compressed and expandable mesh elements supported by at least two struts, as claimed in claim 1, shown in Figs. 14A-14D moves the mesh elements independently of one another such that the distal mesh element can be withdrawn while the middle and proximal mesh elements remain stationary and then the distal and middle mesh elements can be withdrawn while the proximal mesh element remains stationary. Further, while Fig. 14D shows reference numbers 928 and 926 which appear to be used in the withdrawing process, these reference numbers are not discussed in the Specification, as noted in the drawing objections above. Therefore, the process of how the mesh elements are withdrawn as claimed has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing.
Claims 2-11 and 14-20 are rejected based upon their dependency from claim 1.
Claim 15 recites “a relative distance between the most distal mesh element and the middle one of the mesh elements is repeatedly altered to assist in positioning the stabilized blood clot against the most distal mesh element, and the most distal mesh element is rotated within the blood vessel.”
There is no explicit, implicit, or inherent support anywhere in the Specification or Drawings as to how the distance between the distal and middle mesh elements is repeatedly altered to assist in positioning the stabilized blood clot, nor how the most distal mesh element is rotated within the blood vessel. The Specification is silent as to how the distal and middle mesh elements are moved relative to one another as claimed in claim 15 and shown in Figs. 14A-14D. Further, while Fig. 14D shows reference numbers 928 and 926 which appear to be used in the manipulation of the distal and middle mesh elements, these reference numbers are not discussed in the Specification, as noted in the drawing objections above. Therefore, the process of how the distance between the distal and middle mesh elements is repeatedly altered and how the distal mesh element is rotated as claimed has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing.
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 1-11 and 14-20 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.
Claim 1 recites “the interior catheter with a second lumen” in line 8 It is unclear if the interior catheter has two lumens within itself or if the interior catheter is a second lumen of the delivery catheter system. Therefore, this limitation is indefinite.
Claim 1 recites “wherein bringing the stabilized blood clot and the most distal mesh element and the middle one of the mesh elements towards the most proximal of the three separate and distinct compressed and expandable mesh elements,” in lines 18-20. This is an incomplete sentence and is grammatically confusing as there is no action step for what happens after the blood clot, middle mesh element, and distal mesh element are brought towards the proximal mesh element. Therefore, this limitation is indefinite.
Claim 1 recites “a most proximal one of the three separate and distinct compressed and expandable mesh elements having an opening which faces away from the interior catheter and towards the middle one of the three separate and distinct compressed and expandable mesh elements after the most proximal one of the compressed and expandable mesh elements is deployed and expands,” in lines 21-26. This is grammatically confusing as “having” indicates the proximal mesh element continuously has the opening, yet later the claim indicates the proximal mesh element only has the opening after it has been deployed and expanded. Therefore, this limitation is indefinite. Examiner suggests changing “having” to recite “which has.”
Claims 2-11 and 14-20 are rejected based upon their dependency form claim 1.
Claims 2-3 each recite “wherein bringing the stabilized blood clot and the most distal mesh element and the middle one of the mesh elements towards the most proximal of the three separate and distinct compressed and expandable mesh elements,” in lines 1-4. This is an incomplete sentence as no resulting action is given for once the middle and distal of the three separate and distinct compressed and expandable mesh elements are brought toward the proximal mesh element. Therefore, this limitation is indefinite.
Claim 5 recites the limitation "wherein there are at least three struts" in line 1. It is unclear if there are 3 more additional struts in addition to the at least two struts recited in claim 1 or if the at least two struts further comprise at least three struts.
Claim 7 recites the limitation "the front face" in line 6. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution, Examiner interprets claim 7 to recite “a front face.”
Claim 20 does not properly recite the previous claim from which it depends and therefore is indefinite. In the interest of compact prosecution, Examiner interprets claim 20 to depend from claim 19.
Claim 20 recites the limitation "the mechanical thrombectomy catheter" in line 1. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution, Examiner interprets claim 7 to recite “the delivery catheter.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US-20150250497-A1, US-20150265299-A1, US-20170086960-A1, US-20220087694-A1, US-20210007760-A1, US-20110125181-A1, US-20070185501-A1, US-20020072764-A1, US-20220023025-A1, US-20190142445-A1, US-20110288572-A1, US-20100268265-A1, US-20060155305-A1, US-20180193043-A1, US-20140100597-A1, US-20110282379-A1, US-20070088383-A1, US-20030100919-A1, US-20200297364-A1, US-20130046330-A1, US-9724112-B2, US-10070878-B2, US-9999493-B2, US-11284913-B2, US-11259824-B2, US-11246612-B2, US-11202646-B2, US-12239523-B2, and US-20170119408-A1 all teach thrombectomy devices similar to applicant’s disclosure; however, none of which explicitly disclose three distinct and expandable mesh elements supported by at least two struts in addition to all the limitations as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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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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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771