DETAILED ACTION
Claims 1, 3, and 5 are amended. Claims 8-20 remain withdrawn. A complete action on the merits of pending claims 1-7 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to Applicant’s amendments filed on 12/18/2025 which are entered. With regards to the drawing objection, specification objections, claim objection, and 35 USC 112(b) rejection documented in the Non-Final Office Action sent on 10/31/2025, all are overcome through Applicant’s amendments/arguments and are withdrawn. With regards to the 35 USC 112(f) interpretation documented in the Non-Final Office Action sent on 10/31/2025, it is maintained.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “cutting mechanism” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“cutting mechanism” – the corresponding structure is found in paragraph [0044], which states, “… a blade 740 is affixed to the upper jaw 730a, the blade 740 having a sharp cutting edge 742. Some alternatives are possible as shown in Figs. 7B-F. For example, a blade 740 may be affixed only to the upper jaw (Fig. 7B) or only the lower jaw (Fig. 7C). Two opposing blades 740a-b may be affixed to both jaws and oppose one another (Fig. 7D). The blade(s) may oppose a flat inner surface of the jaw, or a receiving slot 745 cut into the opposing lower jaw (Fig. 7E) or upper jaw (Fig. 7F). The blade 740 may also be recessed into the jaw and actuated using an independent control wire to allow leaflet grasping and laceration to be performed independently. The jaw assembly 700 and/or blade 740 actuation may be controlled at the handle, together or independently, and may be performed with or without proximal tension on the device to cut a tissue 750.”
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Feld (WO 2022/013857 A1 (See attached document)), in view of Brock (US 2002/0087049 A1).
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Regarding claim 1, Feld teaches, a medical instrument (Figure 1A and 5, valve-splitting device (20); Page 7, line 8-11), comprising:
a flexible sheath (Figure 1A and 5, cover sheath (22)) configured and sized to pass through a femoral artery (Page 7, line 13-23);
an inner catheter (Figure 1E-1F, cutting sleeve (44)) at least partially disposed within the flexible sheath (Page 8, line 25-27), the inner catheter (cutting sleeve (44)) being rotatable and translatable relative to the flexible sheath (Page 8, line 23-27, disclosure, describing the movement of cutting sleeve (44) relative to cover sheath (22) is a clear indication that cutting sleeve (44) is capable of translation and rotation relative to cover sheath (22)), and the inner catheter having a deflectable section (See annotated Figure 5 above, (Deflectable section); As seen in Figures 1A-1B and 5, the cover sheath (22) is clearly flexible and bending, given that cutting sleeve (44) is situated within sheath (22) it is also reasonable to assume that sleeve (44) is also flexible and capable of bending, thus resulting in a deflectable section);
a pair of opposing jaws (Figures 1B and 1D, cutters (30 & 32); Page 7, line 24-28) coupled to the inner catheter (Figures 1E-1F; Page 8, line 23-25), the pair of opposing jaws having an open condition and a closed condition (Figures 1B and 1D; Page 8, line 13-25); and
a cutting mechanism (Figures 1B and 1D, protrusions (34); Page 7, line 25-28) disposed adjacent to at least one of the pair of opposing jaws (Page 7, line 30-Page 8, line 5).
Feld fails to teach, a hinge point configured for annular plane deflection to allow a bend between the inner catheter and the pair of opposing jaws, the hinge point being distal to the deflectable section and positioned adjacent the pair of opposing jaws.
Brock discloses, a remote-controlled flexible instrument system (catheter/shaft) for minimally invasive procedures, including cardiac valve interventions (Paragraphs [0095]-[0096]). Brock teaches, coaxial outer guide shaft (Figures 6-12, (O1/32)) and inner working shaft (Figures 7-13, (O2/34)), where the inner shaft supports a tool (Figures 12-13, grasper with opposing jaws (18)) at its distal end (Figures 12-13; Paragraph [0183]); the inner shaft is controllable for rotation about the co-axis and translation (Paragraphs [0172]-[0173] and [0184]); the system includes a controlled flexible/operative segment (Figures 6-8 and 12, (O/42)) on the shaft for bending (deflectable section); and at the distal end of the inner working shaft there is a hinge point that provides a degree of freedom (ψ) for bending motion (Figure 13; Paragraph [0185]; Where this hinge point will enable the bend/orientation between the shaft and too/jaws).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Feld’s cutting sleeve (inner catheter) by incorporating Brock’s distal hinge point (as shown in Figure 13 and described in Paragraph [0185] with the (ψ) degree of freedom to enable the motion/orientation/bending), where this hinge point is distal to the deflectable section and positioned adjacent the opposing jaws for annular plane deflection, allowing the desired bend between the inner catheter and the jaws, as both references and the claimed invention are directed to steerable catheters for cardiac valve procedures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Feld’s cutting sleeve (inner catheter) by incorporating Brock’s distal hinge point (as shown in Figure 13 and described in Paragraph [0185] with the (ψ) degree of freedom to enable the motion/orientation/bending), where this hinge point is distal to the deflectable section and positioned adjacent the opposing jaws for annular plane deflection, allowing the desired bend between the inner catheter and the jaws, as such a modification would have been predictable, namely, enables the exact type of controlled bend needed for proper tool orientation at the valve site (Paragraph [0012] of Brock). The combination yields only predictable results with a reasonable expectation of success (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Regarding claim 2, Feld further teaches, wherein the deflectable section (Deflectable section) of the inner catheter (cutting sleeve (44)) is disposed proximal to the pair of opposing jaws (As seen in Figure 5, the (Deflectable section) is indeed proximal of cutters (30 & 32)).
Regarding claim 3, Feld in view of Brock discloses the claimed invention except for, “wherein the hinge point is configured to allow a bend of 90 degrees between the inner catheter and the pair of opposing jaws.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the bend to approximately 90 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. As shown in Figure 13 and described in paragraph [0185] of Brock, a hinge point at degree of freedom (ψ) on inner working shaft (O2/34) is fully capable of performing a 90 degree bend. In re Aller.
Regarding claim 4, Feld further teaches, wherein the cutting mechanism (protrusions (34)) comprises at least one sharp blade (protrusions (34); Page 7, line 27-28) coupled to at least one of the pair of opposing jaws (Figures 1B and 1D, second opposing cutter (32); Page 7, line 25-28).
Regarding claim 5, Feld further teaches, wherein the cutting mechanism (protrusions (34)) comprises a single blade (protrusion (34); Page 7, line 27-28) affixed to the at least one of the pair of opposing jaws (Figures 1B and 1D, second opposing cutter (32); Page 7, line 25-28).
Regarding claim 6, Feld further teaches, wherein the at least one sharp blade (protrusions (34)) includes two opposing blades affixed to respective ones of the pair of opposing jaws (Figures 1B and 1D, first over-the-wire cutter (30) and second opposing cutter (32); Page 7, line 30-Page 8, line 2).
Regarding claim 7, Feld further teaches, wherein the at least one sharp blade (protrusions (34)) is independently actuatable via a dedicated control wire that passes through the inner catheter (Page 8, line 13-18, disclose, “As shown in Fig. 1D, after confirmation of proper positioning, splitter 26 is opened by separating first over-the-wire cutter 30 and second opposing cutter 32 from each other. For some applications, splitter 26 comprises a spring 42 that is configured to separate the cutters 30 an d32 from each other (as shown, for example, in Fig. 1D); alternatively, splitter 26 is opened using other techniques, such as using one or more control wires (configuration not shown).” For the control wire mechanism to be operative, it must follow the only functional and enabled pathway illustrated by the overall device architecture described in Feld. Since the control wire must connect the proximal control (Figure 5, operating handle (212); Page 10, line 17-26) to the distal cutters (30 & 32) which include protrusions (34), and the sleeve (44) is situated between these two points, the wire necessarily passes through the lumen of the inner catheter (cutting sleeve (44)). A person of ordinary skill in the art would recognize this inherent structural necessity. Further, the dedicated control wire, which is meant as a distinct alternative to the spring mechanism, enables the independent actuation of the sharp blade (protrusion (34)) on the cutter (32) by providing a separate, user-controlled input of splitter (26) which includes cutters (30 & 32). This functionality is consistent with the broadest reasonable interpretation (BRI) of the claim).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
See updated rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/ Supervisory Patent Examiner, Art Unit 3771
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