DETAILED ACTION
Election/Restrictions
Applicant’s election of Group 1, claims 1-7,9,12,15,16,21-26,28 in the reply filed on 5/8/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 29 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 5/8/2026.
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 § 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) 1-6,9,12,15,16,22,26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macoviak et al U.S Pat 6,585,689.
Claim 1: Macoviak et al disclose a catheter as best seen in figures 1-2, comprising: an expandable occlusion element 120 coupled to an external surface of a tubular body 102 at a proximal end of the expandable occlusion element and a distal end of the expandable occlusion element, where an inner surface (it is noted that an interior area of 110, fig. 2) of the expandable occlusion element defines a volume of space between the inner surface of the expandable occlusion element and an external surface of the tubular body; and a plurality of lumens (108/110/112/114/116/118, fig. 2), wherein each of the plurality of lumen extends from a proximal end of the tubular body to an external surface of the tubular body at one or more defined exit points between the proximal end of the expandable occlusion element and the distal end of the expandable occlusion element; wherein the plurality of lumen include: a first lumen 116 configured to allow a first fluid to be introduced and/or removed from the volume of space defined by the inner surface of the expandable occlusion element; a second lumen 114 configured to receive a pressure sensor or define a fluid- filled pressure transducer; and a third lumen 118 configured to allow a second fluid to be removed from the volume of space.
Claims 2-3: Macoviak et al disclose wherein the first fluid comprises a liquid; wherein the first fluid comprises a saline fluid (see col. 11, lines 59-62).
Claims 4-6: Macoviak et al disclose wherein the first lumen 116 is operably coupled to a plurality of defined fluid exit points, each defined fluid exit point being disposed an axial distance from an adjacent defined fluid exit point (see col. 11, line 59-col. 12, line 23)., wherein the plurality of defined fluid exit points includes three exit points (fig. 25 at area 326); wherein all defined fluid exit points are circumferentially aligned (see fig. 25, note the area at 326 are circumferentially).
Claims 9, 12: Macoviak et al disclose wherein a defined exit point at area 326, fig. 25 of the second lumen is centered axially within the volume of space defined by the inner surface of the expandable occlusion element; wherein a defined exit point of the third lumen is disposed axially between the defined exit point of the second lumen and the proximal end of the expandable occlusion element 120.
Claims 15, 16: Macoviak et al disclose wherein the expandable occlusion element is a balloon (see col. 2, lines 25-45); wherein the expandable occlusion element comprises a conical distal end, a conical proximal end, and a cylindrical intermediate portion between the distal end and the proximal end as best seen in fig. 1.
Claims 22, 26: Macoviak et al disclose wherein an axial length of conical proximal end is no longer than an axial length of the cylindrical intermediate portion as best seen in fig. 1; further comprising a vacuum pump (at perfusion pump, fig. 14, see col. 11, lines 8-31) operably coupled to third lumen 118.
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) 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak et al in view of Wainwright et al U.S 2023/0149021.
Claim 25: Macoviak et al disclose the invention substantially as claimed, but is silent regarding a controller operably coupled to the catheter. However, Wainwright et al teach the treatment system 10 includes a suction source 25 (e.g., a syringe, a pump, etc.) configured to be fluidly coupled (e.g., via a connector 23) to a proximal portion of one or more of the first catheter 200, the second catheter 210, and/or the third catheter 220 to apply negative pressure therethrough. In some embodiments, the treatment system 10 includes a fluid source 27 (e.g., a fluid reservoir, a syringe, pump, etc.) configured to be fluidly coupled (e.g., via the connector 23) to a proximal portion of one or more of the first catheter 200, the second catheter 210, and/or the third catheter 220 to supply fluid (e.g., saline, contrast agents, a drug such as a thrombolytic agent, etc.) to the treatment site.
[0040] According to some embodiments, for example as shown in FIG. 1, each of the first, second, and third catheters 200, 210, and 220 can be formed as a generally tubular member extending along and about a central axis and terminating in a respective distal end. The first catheter 200 can be sized and configured to slidably receive both the second catheter 210 and the third catheter 220 therethrough. In some embodiments, the first catheter 200 is a balloon-guide catheter having an inflatable balloon or other expandable member that can be used to anchor the first catheter 200 with respect to a surrounding vessel, and/or arrest the flow of blood at the location of the balloon, and further teach a controller 1928 operably coupled to the catheter 200, figures 19a,b. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Macoviak with a controller operably coupled to the catheter as taught by Wainwright et al in order to store instructions that is executed by the processor or the controller (see paragraph 94).
Claim 23-24: Wainwright et al teach wherein the second fluid is a gas/air (see paragraphs 39, 172).
Allowable Subject Matter
Claims 7,21,28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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