DETAILED ACTION
The following Office Action is in response to the Response to Restriction filed on April 13, 2026. Claims 1-12 are currently pending, wherein of the pending claims, claims 1-4 and 11-12 are withdrawn from further consideration.
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 Group II in the reply filed on April 13, 2026 is acknowledged.
Claims 1-4 and 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 April 13, 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 Objections
Claim 5 is objected to because of the following informalities: Line 19 of the claim recites the phrase “the monitored and pressure data”, wherein the word “volume” appears to be mistakenly omitted between “monitored” and “and pressure data”. 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) 5-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Michaels et al. (US 5,342,298, hereinafter Michaels).
Concerning claim 5, the Michaels et al. prior art reference teaches a method for automated adaptive treatment of a blood vessel with an inflatable balloon catheter, comprising: providing the inflatable balloon catheter (Figure 2; 42); a pressure controller (Figure 1; 18) in operative and fluid communication with a fluid reservoir (Figure 1; 14) and the inflatable balloon catheter (Figure 1; 12); a volume sensor in operative communication with the inflatable balloon catheter and/or the pressure controller and configured to monitor volume data in real time (Figure 1; 26); a pressure sensor (Figure 1; 20) in operative communication with the inflatable balloon catheter and/or the pressure controller and configured to monitor pressure data in real time; a processor (Figure 1; 22) having programmed instructions, the processor in operative communication with the volume sensor, the pressure sensor, and the pressure controller, wherein the programmed instructions comprise at least one reaction window having predetermined boundaries (Column 6, Line 54 – Column 7, Line 27; minimum pressure limit, maximum pressure limit, and the time limit define the predetermined boundaries of the at least one reaction window), inserting the inflatable balloon catheter within the blood vessel to a location of interest (Column 5, Lines 38-47); using the pressure controller to execute a series of inflations (Column 5, Lines 48-68); receiving at the processor the monitored volume and pressure data (Figure 1; 22, 20, 26); determining if the monitored volume and pressure data are compliant within the predetermined boundaries of the at least one reaction window (Figures 5AB); automatically adapting when at least one of the monitored volume and pressure data are non-compliant outside of the predetermined boundaries of the at least one reaction window (Figure 5B; 124); and determining if the monitored volume and pressure data after the automatic adapting are compliant within the predetermined boundaries of the at least one reaction window (Figure 5B; 120).
Concerning claim 6, the Michaels reference teaches the method of claim 5, wherein the automatic adapting comprises reducing pressure applied within the balloon (Figure 5B; 124).
Concerning claims 7 and 8, the Michaels reference teaches the method of claim 6, further comprising providing relaxation periods between each inflation, wherein said relaxation periods may be interpreted as the periods when the target pressure is reached and no increase or decrease in pressure is necessitated, which would result in a balloon pressure magnitude greater than zero given the balloon pressure would be at the target balloon pressure.
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) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michaels et al. (US 5,342,298, hereinafter Michaels) in view of Schoenle (US 2019/0000491).
Concerning claims 9 and 10, the Michaels reference teaches the method of claims 5 and 8, but does not specifically teach each of the series of inflations comprising a pressure magnitude that increases with each successive inflation.
However, the Schoenle reference teaches a method for automated adaptive treatment of a blood vessel with an inflatable balloon catheter similar to that of the Michaels reference, wherein the Schoenle reference further teaches a pressure controller that may execute a series of inflations, wherein the series of inflations comprise a pressure magnitude that increases with each success inflation ([¶ 0050]).
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 method of Michaels reference have the series of inflations comprise a pressure magnitude that increases with each successive inflation as in the Schoelnle reference to allow a vessel wall being treated by the balloon be allowed to adapt to the increasing load from the balloon without deformation while the balloon breaks up calcified material (Schoenle; [¶ 0050]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Chisena et al. reference (US 2020/0046949) teaches a method for automated adaptive treatment of a blood vessel with an inflatable balloon catheter including executing a series of inflations with relaxation periods between each inflation; the Donovan et al. reference (US 2010/0274180) teaches a method for inflating a balloon catheter including a pressure sensor, a volume sensor, and a compensation circuit with a threshold pressure and volume; and the Baido et al. reference (US 2021/0369394) teaches an intelligent ecosystem that may be used with an angioplasty balloon that includes a volume sensor and a pressure sensor that provides a feedback system.
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.
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/MARTIN T TON/Examiner, Art Unit 3771 5/15/2026
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