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 .
CLAIM INTERPRETATION
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘expandable balloon,’ ‘embolic filter’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Claim Objections
Claim 18 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 17. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 16-21 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.
Claims 16-19 recites the limitation "the distal collar" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 16-19 recites the limitation "the proximal collar" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 20 and 21 recites the limitation "the cage" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell et al. (US 2013/0178891A1, “Russell”) in view of Martin (US 2020/0054432A1).
Regarding claim 15, Russell discloses a prosthetic heart valve delivery catheter including a balloon catheter shaft (105; [0019, 0045]; Fig. 2) having a distal portion. An expandable balloon (145) is disposed on the distal portion of the catheter shaft. An embolic filter (110; [0043, 0047, 0049]) is disposed on the distal portion of the shaft at a location proximal of the balloon (Fig. 2D; [0064]). The embolic filter has a collapsed configuration and a deployed configuration wherein an outer periphery of the filter is capable of contacting a blood vessel wall [0045]. The embolic filter includes a filter membrane (195) and a support structure (185; [0058]), wherein the support structure includes a cage having a distal collar connected to the filter membrane and a proximal collar attached to the distal portion of the catheter shaft via a sliding mechanism (190). However, Russell does not expressly disclose a prosthetic valve disposed on the expandable balloon on the distal portion of the catheter shaft.
In the same field of endeavor, valve delivery, Martin teaches a prosthetic heart valve delivery catheter having integrated embolic protection including a shaft (guidewire; [0091]) having a distal portion. A prosthetic valve (132; [0089]) is disposed on the distal portion of the shaft and an embolic filter (100) is disposed on the distal portion of the shaft at a location proximal of the prosthetic valve (Fig. 8). An expandable balloon is on the distal portion of the catheter upon which the prosthetic valve is disposed [0091; Figs. 8B,C]. The embolic filter has a collapsed configuration and a deployed configuration [0091]. An outer periphery of the filter is capable of contacting a blood vessel wall (Fig. 8). The filter includes a filter membrane (102; [0063]; Fig. 8B) and a support structure (185), wherein the support structure includes a cage having a distal collar and a proximal collar attached to the distal portion of the catheter shaft. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have disposed the prosthetic valve of Russell over the expandable balloon, as taught by Martin, for the predictable result of expanding a prosthetic heart valve and maneuvering the filter to capture debris while treating a heart valve.
Allowable Subject Matter
Claims 2-14 and 22-27 allowed.
Regarding claim 2, the prior art of record does not disclose or suggest a prosthetic heart valve delivery catheter including a catheter shaft, an expandable balloon fixedly mounted on a balloon catheter located at a distal portion of the catheter shaft, a prosthetic valve disposed on the expandable balloon, an embolic filter disposed on a filter deployment catheter located at the distal portion of the shaft proximal of the prosthetic valve, the embolic filter including a narrow end that is slidably mounted on the filter deployment catheter and an open end located distally of the narrow end, in combination with the other claimed limitations.
Regarding claim 22, the prior art of record does not disclose or suggest a prosthetic heart valve delivery catheter including a catheter shaft, an expandable balloon fixedly mounted on a balloon catheter located at a distal portion of the catheter shaft, a prosthetic valve disposed on the expandable balloon, an embolic filter disposed on a filter deployment catheter located at the distal portion of the shaft proximal of the prosthetic valve, the embolic filter including a conical wall portion proximal a cylindrical wall portion, the conical wall portion having a proximal tip slidably attached to the filter deployment catheter, in combination with the other claimed limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Groh (US 2016/0317276A1) discloses a catheter shaft, prosthetic valve, a balloon and an embolic filter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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