DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on September 23, 2024. Claims 1-20 are currently pending.
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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 6, 7, 13, and 14 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.
Concerning claims 6 and 13, lines 2-3 of both claims recite the limitation of “the one or more filaments”. There is a lack of antecedent basis for this limitation in the claims. For the purposes of compact prosecution, the limitation will be interpreted as “one or more filaments”.
Concerning claim 6, line 3 of the claim recites the limitation of “the braided member”. There is a lack of antecedent basis for this limitation in the claim, therein making it indefinite as to whether “the braided member” refers to the funnel braid or the braided inner and braided outer layer. For the purposes of compact prosecution, the limitation of “the braided member will be interpreted as “the braided inner layer and the braided outer layer”.
Claims 7 and 14 are further rejected for being dependent on indefinite claims.
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) 1-6, 8-13, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2021/0068854, hereinafter Wallace) in view of Kelly et al. (US 2020/0281611, hereinafter Kelly).
Concerning claim 1, the Wallace et al. prior art reference teaches a thrombectomy apparatus for removing a clot from a vessel (Figure 1-18; 100), the thrombectomy apparatus comprising: a catheter (Figure 3A; 307) having a distal region including a distal end, the catheter defining a lumen extending proximally from the distal end, the catheter having an outer surface; a funnel secured to the distal end and extending distally therefrom (Figure 3B; 308), the funnel including: a braided inner layer (Figure 11A; 1118, inside layer), a braided outer layer (Figure 11A; 1118, outside layer), and a reinforcing structure disposed between the braided inner layer and the braided outer layer (Figure 11A; 1111); a tractor (Figure 2A; 305) adapted to extend over the outer surface of the catheter and the funnel in an uninverted configuration (Figure 3B; portion of 305 outside of catheter and funnel) and to extend in an inverted configuration through the funnel and into the lumen (Figure 3B; portion of 305 extending into tunnel and lumen), the tractor adapted to invert by rolling over the distal end of the funnel when the tractor moves proximally within the lumen ([¶ 0113]); and an elongate member extending through the lumen and secured to an end of the tractor disposed within the lumen (Figure 3A; 303), but it does not specifically teach the reinforcing structure comprising one or more arched wires extending between the braided inner layer and the braided outer layer, wherein a first end and a second end of each wire are each secured from movement.
However, the Kelly reference also teaches a thrombectomy apparatus for removing a clot from a vessel (Figure 1A; 100) comprising a catheter (Figure 1A; 102) having a distal region including a distal end and a funnel secured to the distal end and extending distally therefrom (Figure 1A; 110), the funnel including a membrane (Figure 1A; 130) which may define inner and outer layers surrounding ([¶ 0050]) a reinforcing structure (Figure 1A; 124), wherein the reference teaches a number of reinforcing structures, some of which may be interpreted as comprising arched wires extending between the inner layer and outer layer, wherein the first end and second end of each arched wire are each secured from movement (Figure 3A, 4A-F, 7, 10, 11, 14B, 16, 18; 124).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the reinforcing structure of the Wallace reference with the reinforcing structure of the Kelly reference to include arched wires extending between the inner layer and outer layer, wherein the first end and second end of each arched wire are each secured from movement to promote even expansion of the reinforcing structure, the braided inner layer, and the braided outer layer (Kelly; [¶ 0072]).
Concerning claim 2, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claim 1, wherein the Wallace reference further teaches the tractor being adapted to engage the clot and pull the clot into the funnel as the tractor inverts over the distal end of the funnel (Figure 1C; 109 | [¶ 113]).
Concerning claim 3, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claim 2, wherein the Wallace reference further teaches the tractor comprising a flexible tube comprising a plurality of loops that lie flat before teaching the distal end of the catheter and after passing the distal end of the catheter, but temporarily extend radially outwardly as the tractor inverts over the distal end of the catheter, the plurality of loop temporarily extending radially outward as the tractor inverts over the distal end of the catheter engage the clot and pull the clot proximally (Figure 5A; [¶ 0134]).
Concerning claim 4, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claim 1, wherein the Kelly reference further teaches that the one or more arched wires may form a closed loop funnel braid ([¶ 0090]).
Concerning claim 5, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claim 4, wherein the limitation of the first end and the second end of each one of the one or more arched wires being welded to another arched wire is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. Thus, even though the Wallace and Kelly combination may not specifically teach the first end and the second end of each one of the one or more arched wires being welded to another arched wire, the reinforcing structure of the Wallace and Kelly combination still reads on the claimed reinforcing structure because the structure is the same despite a difference in the method by which said structure is achieved.
Concerning claim 6, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claim 4, wherein the Wallace reference teaches the thickness of the reinforcing structure being greater than a diameter of a filament diameter for one or more filaments forming the braided inner layer and braided outer layer, wherein it would further be obvious to have the diameter of the plurality of wires forming the closed loop funnel braid of the combination have a wire diameter greater than the filament diameter of the one or more filaments forming the braided inner layer and braided outer layer to provide proper reinforcement to the funnel.
Concerning claim 8, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claim 1, wherein the Kelly reference further teaches the reinforcing structure further comprising: a tubular base member (Figure 4C; 408); and a plurality of fingers extending distally from the tubular base, wherein the first ends and the second ends of each one of the one or more arched wires are secured to corresponding fingers of the plurality of fingers (Figure 4C; struts extending from 408 define fingers, where further struts extending from said struts may be defined as the arched wires).
Concerning claims 9, 10, 16, and 17, the Wallace et al. prior art reference teaches a thrombectomy apparatus for removing a clot from a vessel (Figure 1-18; 100), the thrombectomy apparatus comprising: a catheter (Figure 3A; 307) having a distal region including a distal end, the catheter defining a lumen extending proximally from the distal end, the catheter having an outer surface; a funnel secured to the distal end and extending distally therefrom (Figure 3B; 308), the funnel including: a braided member (Figure 11A; 1118) including a braided inner layer (Figure 11A; 1118, inside layer), a braided outer layer (Figure 11A; 1118, outside layer), and a reinforcing structure disposed between the braided inner layer and the braided outer layer (Figure 11A; 1111); a tractor (Figure 2A; 305) adapted to extend over the outer surface of the catheter and the funnel in an uninverted configuration (Figure 3B; portion of 305 outside of catheter and funnel) and to extend in an inverted configuration through the funnel and into the lumen (Figure 3B; portion of 305 extending into tunnel and lumen), the tractor adapted to invert by rolling over the distal end of the funnel when the tractor moves proximally within the lumen ([¶ 0113]); wherein the reinforcing structure is adapted to engage the braided member when the braided member is subject to axial compression as a result of the tractor being pulled proximally over a distal end of the funnel (the reinforcing structure is always engaged with the braided member given it is encapsulated inside it, including when the braided member is subject to axial compression), but it does not specifically teach the reinforcing structure comprising one or more arched wires extending between the braided inner layer and the braided outer layer, wherein a first end and a second end of each wire are each secured from movement.
However, the Kelly reference also teaches a thrombectomy apparatus for removing a clot from a vessel (Figure 1A; 100) comprising a catheter (Figure 1A; 102) having a distal region including a distal end and a funnel secured to the distal end and extending distally therefrom (Figure 1A; 110), the funnel including a membrane (Figure 1A; 130) which may define inner and outer layers surrounding ([¶ 0050]) a reinforcing structure (Figure 1A; 124), wherein the reference teaches a number of reinforcing structures, some of which may be interpreted as comprising arched wires extending between the inner layer and outer layer, wherein the first end and second end of each arched wire are each secured from movement (Figure 3A, 4A-F, 7, 10, 11, 14B, 16, 18; 124).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the reinforcing structure of the Wallace reference with the reinforcing structure of the Kelly reference to include arched wires extending between the inner layer and outer layer, wherein the first end and second end of each arched wire are each secured from movement to promote even expansion of the reinforcing structures, the braided inner layer, and the braided outer layer (Kelly; [¶ 0072]).
Concerning claims 11 and 18, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claims 9 and 16, wherein the Kelly reference further teaches that the one or more arched wires may form a closed loop funnel braid ([¶ 0090]).
Concerning claims 12 and 19, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claims 11 and 18, wherein the limitation of the first end and the second end of each one of the one or more arched wires being welded to another arched wire is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. Thus, even though the Wallace and Kelly combination may not specifically teach the first end and the second end of each one of the one or more arched wires being welded to another arched wire, the reinforcing structure of the Wallace and Kelly combination still reads on the claimed reinforcing structure because the structure is the same despite a difference in the method by which said structure is achieved.
Concerning claim 13, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claim 11, wherein the Wallace reference teaches the thickness of the reinforcing structure being greater than a diameter of a filament diameter for one or more filaments forming the braided member, wherein it would further be obvious to have the diameter of the plurality of wires forming the closed loop funnel braid of the combination have a wire diameter greater than the filament diameter of the one or more filaments forming the braided inner layer and braided outer layer to provide proper reinforcement to the funnel.
Concerning claims 15 and 20, the combination of the Wallace and Kelly references as discussed above teaches the apparatus of claims 9 and 16, wherein the Kelly reference further teaches the reinforcing structure further comprising: a tubular base member (Figure 4C; 408); and a plurality of fingers extending distally from the tubular base, wherein the first ends and the second ends of each one of the one or more arched wires are secured to corresponding fingers of the plurality of fingers (Figure 4C; struts extending from 408 define fingers, where further struts extending from said struts may be defined as the arched wires).
Claim(s) 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2021/0068854, hereinafter Wallace) in view of Kelly et al. (US 2020/0281611, hereinafter Kelly) as applied to claims 1-6, 8-13, and 15-20 above, and further in view of Martin (US 2014/0005712).
Concerning claims 7 and 14, the combination of the Wallace and Kelly references as discussed above teaches the thrombectomy apparatus of claim 4, but does not a specifically teach the wire diameter of the plurality of wires forming the closed loop funnel braid.
However, the Martin reference teaches a thrombectomy device including a braided structure formed form a plurality of wires to form a closed loop funnel braid (Figure 5E; 260), wherein the reference teaches that the wires may include a diameter of 0.003 inches or may include a larger diameter to increase the overall strength of the device ([¶ 0110]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the diameter of the plurality of wires forming the closed loop funnel braid of the Wallace and Kelly combination have a wire diameter in the range of 0.007 inches to 0.0011 inches to provide the proper strength for the closed loop funnel braid structure (Martin; [¶ 0110]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Murray, III et al. reference (US 2011/0251682) teaches a funnel including a reinforcing structure disposed within inner and outer layers; the Vale et al. reference (US 2017/0105743) teaches a funnel including a reinforcing structure including arched wires which may be embedded in inner and outer layers (Figure 66e); and the Culhane et al. reference (US 2017/0136158) teaches a thrombectomy device including a funnel including a reinforcing structure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 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.
/MARTIN T TON/Examiner, Art Unit 3771 12/18/2025