DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This action is in response to the non-provisional application filed on 05/23/2025. Claims 1-30 are pending. Claims 1, 11, and 21 are independent.
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 and 35 U.S.C. 119(e)as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 18/544,266, Application No. 16/178,537, Application No. 14/215,399, Application No. 61/794,889, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 18/544,266, Application No. 16/178,537, Application No. 14/215,399, and Application No. 61/794,889 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the limitations “a valvuloplasty balloon and includes a distal tapered tip that tapers, along 10 mm-40 mm, from (i) a proximal maximum outside diameter substantially equal to a valve-delivery diameter to (ii) a distal minimum outside diameter of 2 mm or less, the tip being formed of a polymer whose flexibility increases toward the distal end,” “a second catheter that carries the prosthetic heart valve in a radially crimped state and has a distal tapered tip formed within the same taper-length, maximum-diameter, minimum-diameter, and flexibility ranges as the first catheter,” and “deflating and longitudinally elongating the delivery balloon” in claim 1. Although the prior-filed applications disclose that “[t]he dilatation balloon catheter tip 36 may be formed in a similar fashion to the delivery catheter tips discussed below and depicted with respect to FIGS. 6-10 (see element 84 therein),” however, the specifications of the prior-filed applications do not disclose that the dilatation balloon catheter tip 36 has the exact same structure/shape and material to the deliver catheter tips 84. That’s the same for all the limitations in claims 2-4. Furthermore, the prior-filed applications do not disclose deflating and longitudinally elongating the delivery balloon. Application No. 18/544,266, Application No. 16/178,537, Application No. 14/215,399, and Application No. 61/794,889 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the limitation “a distal outside diameter not greater than 1 mm” in claim 2, “a guide-wire lumen sized to accept a 0.035-inch guide wire” in claim 4, “injecting radiographic contrast medium through a lumen of the second catheter to verify absence of perivalvular leak” in claim 8, “wherein the pre-dilatation balloon catheter has a tapered distal tip formed in a substantially same fashion, and within a same taper-length range, as a distal tip of the valve-delivery catheter” in claim 11, ” inflating the valvuloplasty balloon comprises introducing saline optionally mixed with radiopaque contrast to a pressure sufficient to enlarge the aortic annulus without bursting the balloon” in claim 17, “the delivery balloon is formed of nylon to increase rated burst pressure” in claim 19, “confirming, under fluoroscopy with contrast injection, that both coronary ostia remain unobstructed after prosthetic-valve deployment” in claim 20, “a first catheter whose distal tapered tip tapers, along 10 mm-40 mm, from a proximal maximum outside diameter substantially equal to a valve-delivery diameter to a distal minimum outside diameter of 2 mm or less, the tip being progressively more flexible toward its distal end” “a second catheter that carries a balloon-expandable prosthetic heart valve and whose distal tapered tip conforms to the same taper-length, maximum-diameter, and minimum-diameter ranges of the first catheter” in claim 21, “during expansion of the balloon-expandable prosthetic heart valve, a physician maintains real-time fluoroscopic visualization to verify valve position relative to the aortic annulus” in claim 24, “each catheter's distal tapered tip includes a self-biased curved portion that straightens when advanced over a guide wire” in claim 25, “advancing a 0.035-inch guide wire through the sheath and across the valve annulus” in claim 26, “injecting contrast medium through a lumen of the second catheter and visualizing flow to assess valve seating” in claim 27.
Claim Objections
Claims 1, 17, 21, 24, and 30 are objected to because of the following informalities:
Claim 1, line 19-20, “the aortic annulus” should be amended to “the aortic-valve annulus” to be consistent with the limitation in line 12 of the claim.
Claim 17, line 3, “the aortic annulus” should be amended to “the aortic-valve annulus” to be consistent with the limitation in claim 11.
Claim 21, line 18, “the annulus” should be amended to “the valve annulus” to be consistent with the claim language of the claim.
Claim 24, line 3, “the aortic annulus” should be amended to “the valve annulus” to be consistent with the limitation in claim 21.
Claim 30, line 2, “the annulus” should be amended to “the valve annulus” to be consistent with the claim language of claim 21.
Appropriate correction is required.
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 1-30 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 limitation "a distal tapered tip that tapers, along 10 mm-40 mm, from" in line 6 of the claim. It is unclear whether the limitation “along 10 mm-40 mm” means that the distal tapered tip has a length of 10 mm-40 mm, the tapered tip tapers from its widest diameter to its tip along a length of 10 mm-40 mm, or something else.
Claim 1 recites the limitation "the same taper-length” in line 17. The limitation is indefinite because claim 1 does not disclose a tapered length. There is insufficient antecedent basis for this limitation in the claim. Claims 2-10 are rejected because they depend on claim 1.
Claim 7 recites the limitation "the balloon" in line 1 of the claim. Claim 1 recites two different balloons. It is unclear which balloon that “the balloon’ in line 1 of claim 7 is referring to.
Claim 11 recites the limitation "the native aortic valve annulus" in line 8 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "within a same taper-length range" in line 17 of the claim. First, it is unclear whether the limitation “taper-length range” means a range of the length of the distal tapered tip or a range of the length of the tapered tip that tapers from its widest diameter to its tip. Secondly, it is unclear whether the limitation "within a same taper-length range" means the tapered distal tip of the predilalation balloon catheter has the same taper-length range or within the range of the tapered length of the distal tip of the valve-delivery catheter. Claims 12-20 are rejected because they depend on claim 11
Claim 12 recites the limitation "the thoracic access incision" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the single puncture" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "a first catheter whose distal tapered tip tapers, along 10 mm-40 mm" in lines 5-6 of the claim. It is unclear whether the limitation “along 10 mm-40 mm” means that the distal tapered tip has a length of 10 mm-40 mm, the tapered tip tapers from its widest diameter to its tip along a length of 10 mm-40 mm, or something else.
Claim 21 recites the limitation "the same taper-length” in line 13-14 of the claim. The limitation is indefinite because claim 21 does not disclose a tapered length. There is insufficient antecedent basis for this limitation in the claim. Claims 22-30 are rejected because they depend on claim 21.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20060074484 A1 Huber; Christoph Hans discloses a heart valve prosthesis delivery method.
US 20070112422 A1 Dehdashtian; Mark discloses a method of delivery a prosthetic heart valve.
US 20070282367 A1 Jeffrey; Andrew et al. discloses a catheter having a soft distal tip.
US 6908481 B2 Cribier; Alain discloses a method for delivering a prosthetic heart valve.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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