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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,6,7,10,13-18,20 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.
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 6-12, 15-20 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 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the first and second positions of the locking head such that resistance of axial movement is achieved due to structure of protrusions 212 to slide over the shoulders 208 when the locking head 196 is pulled in a proximal direction P1 in a manner that causes the locking head 196 to rotate as explained in paragraph 107 of specification.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the retention of the locking head in the connector hub is accomplished by some rotation (see paragraph 108 of specification) thus the retained limitation in the claim does not appear to be accomplished until the rotation step, see for example claim 19.
Dependent claims carry ambiguity or indefinite issues of claims they depend thereon and are rejected for this reason.
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) 1,13 are rejected under 35 U.S.C. 103 as being unpatentable over Oktay (2003/0040791) in view of Hunt et al. (4589621). Please note that the preamble must give life and meaning to the body of the claim. It cannot be just a "convenient label for the invention as a whole" or just a statement of the intended use. IMS Tech. V. Haas Automation Inc., F3d 1422,1434 (2000) or Storage Technology Corp. V. Cisco Systems Inc. Thus, the preamble is just an intended use when the body of the claim provides no structure to support the preamble. For example claims 1,15 provides no support in the body of the claim for the preamble recitation to a prosthetic “heart valve” and further the claims fail to define what one considers a valve structure per the preamble. Additionally note the Examiner is entitled to give terms in a claim its plain meaning as interpreted by one of ordinary skill in the art. It is noted that the specification must clearly set forth the definition explicitly and with reasonable clarity, deliberateness, and precision. Exemplification is not an explicit definition. Even explicit definitions can be subject to varying interpretations. See Teleflex, Inc. v. Ficosa North America Corp., 63 USPQ2d 1374, 1381 (Fed. Cir. 2002), Rexnord Corp. v. Laitram Corp., 60 USPQ2d 1851,1854 (Fed. Cir. 2001) and MPEP 2111.01. Thus, according to the recited limitations, an expanding structure as claimed being an annular frame can thus be considered a “prosthetic heart valve” so long as it has the same recited structure in giving the broadest reasonable interpretation. Oktay shows (Fig. 1A,1B) a prosthetic implant support structure 100 (fully capable of being an intended heart valve prosthetic) comprising: an annular frame 102 comprising an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end and defining an axial direction, the annular frame movable between a radially expanded state (Fig. 1B) and a radially compressed state (Fig. 1A). Oktay further show (Fig. 8) at least one compliant actuator 802 coupled to the annular frame. Oktay further disclose (paragraph 67) the at least one compliant actuator configured to produce radial expansion of the annular frame and retain the annular frame in the radially expanded state and also configured to resiliently pull the first and second axially spaced locations toward each other to retain the annular frame in the radially expanded state against a radial compression force applied to the annular frame by tissue surrounding the prosthetic implant (heart valve is an intended use). However, Oktay did not disclose the at least one compliant actuator comprises an extension spring coupled to the annular frame at first and second axially spaced locations. Hunt et al. teach (Fig. 2) a support structure or frame defined as a diamond shaped, parallelogram device of trusses (20,22,30,32) with hinged linkages having a compliant actuator in the form of an extension spring 52 coupled to the support frame at first and second axially spaced locations. The substitution of one known element (actuator in form of extension spring as shown in Hunt) for another (actuator of extension structure as shown in Oktay) would have been obvious to one of ordinary skill ion the art at the time of the invention since the substitution of the actuator defined as an extension spring in Hunt et al. would have yielded predictable results, namely in providing the necessary force of keeping tension on hinged struts of the frame of Oktay to maintain the support structure in an expanded state. Thus, one skilled in the art would have readily recognized that providing Oktay with an extension spring as taught by Hunt et al. would provide a simple alternative by using simple mechanical structure and no need for electrical power that would be required for the actuator of Oktay being substituted. It is noted that Oktay does state (paragraph 73) that alternative approaches to using power is within ordinary skill in the art. Regarding claim 13, Oktay also disclose (Figs. 1A,B) what can be construed as at least one noncompliant actuator 103 coupled to the annular frame, the at least one noncompliant actuator configured to produce radial expansion and compression of the annular frame, see paragraph 59 as these assist in the expansion.
Claim(s) 14,21 are rejected under 35 U.S.C. 103 as being unpatentable over Oktay (2003/0040791) in view of Hunt et al. (4589621) and also in view of Cohen-Tzemach et al. (WO 2020/117887). Please note that the preamble must give life and meaning to the body of the claim. It cannot be just a "convenient label for the invention as a whole" or just a statement of the intended use. IMS Tech. V. Haas Automation Inc., F3d 1422,1434 (2000) or Storage Technology Corp. V. Cisco Systems Inc. Thus, the preamble is just an intended use when the body of the claim provides no structure to support the preamble. For example claim 14 provides no support in the body of the claim for the preamble recitation to a prosthetic “heart valve” and further the claims fail to define what one considers a valve structure per the preamble. Additionally note the Examiner is entitled to give terms in a claim its plain meaning as interpreted by one of ordinary skill in the art. It is noted that the specification must clearly set forth the definition explicitly and with reasonable clarity, deliberateness, and precision. Exemplification is not an explicit definition. Even explicit definitions can be subject to varying interpretations. See Teleflex, Inc. v. Ficosa North America Corp., 63 USPQ2d 1374, 1381 (Fed. Cir. 2002), Rexnord Corp. v. Laitram Corp., 60 USPQ2d 1851,1854 (Fed. Cir. 2001) and MPEP 2111.01. Thus, according to the recited limitations, an expanding structure as claimed being an annular frame can thus be considered a “prosthetic heart valve” so long as it has the same recited structure in giving the broadest reasonable interpretation. Oktay shows (Fig. 1A,1B) a prosthetic implant support structure 100 (fully capable of being an intended heart valve prosthetic) comprising: an annular frame 102 comprising an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end and defining an axial direction, the annular frame movable between a radially expanded state (Fig. 1B) and a radially compressed state (Fig. 1A). Oktay further show (Fig. 8) at least one compliant actuator 802 coupled to the annular frame. Oktay further disclose (paragraph 67) the at least one compliant actuator configured to produce radial expansion of the annular frame and retain the annular frame in the radially expanded state and also configured to resiliently pull the first and second axially spaced locations toward each other to retain the annular frame in the radially expanded state against a radial compression force applied to the annular frame by tissue surrounding the prosthetic implant (heart valve is an intended use). However, Oktay did not disclose the at least one compliant actuator comprises an extension spring coupled to the annular frame at first and second axially spaced locations. Hunt et al. teach (Fig. 2) a support structure or frame defined as a diamond shaped, parallelogram device of trusses (20,22,30,32) with hinged linkages having a compliant actuator in the form of an extension spring 52 coupled to the support frame at first and second axially spaced locations. The substitution of one known element (actuator in form of extension spring as shown in Hunt) for another (actuator of extension structure as shown in Oktay) would have been obvious to one of ordinary skill ion the art at the time of the invention since the substitution of the actuator defined as an extension spring in Hunt et al. would have yielded predictable results, namely in providing the necessary force of keeping tension on hinged struts of the frame of Oktay to maintain the support structure in an expanded state. Thus, one skilled in the art would have readily recognized that providing Oktay with an extension spring as taught by Hunt et al. would provide a simple alternative by using simple mechanical structure and no need for electrical power that would be required for the actuator of Oktay being substituted. It is noted that Oktay does state (paragraph 73) that alternative approaches to using power is within ordinary skill in the art. However, Oktay was silent as to delivery instrumentation which includes a handle, at least one shaft extending distally from the handle and the prosthetic implant coupled to the at least one shaft. Cohen-Tzemach et al. show (Fig. 13) a delivery assembly 600 comprising: a handle 604; at least one shaft 608 extending distally from the handle; and a prosthetic heart valve 100 coupled to the at least one shaft. Fig. 2 further shows the prosthetic heart valve 100 comprising: an annular frame movable between a radially expanded state and a radially compressed state; and at least one compliant actuator 108 coupled to the annular frame, the at least one compliant actuator configured to produce radial expansion of the annular frame and retain the annular frame in the radially expanded state, paragraph 64. Thus, it would have been obvious to one of ordinary skill in the art to utilize known delivery systems providing a handle, at least one shaft extending distally from the handle and the prosthetic implant coupled to the at least one shaft as taught by Cohen-Tzemach et al. with the expandable prosthetic of Oktay as modified with Hunt et al. such that it is able to deliver the prosthetic apparatus in a compressed state within the vessel and then release when at the site of implantation using the handle of the instrumentation. With respect to claim 21, Oktay in view of Hunt is explained as before. However, Oktay as modified with Hunt did not explicitly detail a connector hub and a connector base coupled to the annular frame at the first and second axially spaced locations, respectively, a locking head movable axially relative to the connector hub, and the extension spring has a first end attached to the connector base and a second end attached to the locking head, and wherein proximal movement of the locking head relative to the connector hub elongates the extension spring and radially expands the annular frame. Cohen-Tzemach et al. teach (Fig. 4) that an actuator having a spring can be utilized with connector hub 130 and a connector base 140 coupled to the annular frame at the first and second axially spaced locations. Cohen-Tzemach et al. further teach (Fig. 18) a spring 312 with a first end attached to the connector base and a second end attached to a locking head 304. It would have been obvious to one of ordinary skill in the art to incorporate a locking head along with a connector hub and a connector base attachable to the frame as taught by Cohen-Tzemach et al. to be attachable to the extension spring incorporated in the expandable frame of Oktay per the teaching of Hunt et al. such that the user/surgeon can proximally move the locking head relative to the connector hub for elongation of the extension spring and radially expands the annular frame and lock in the desired diameter.
Allowable Subject Matter
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Dependent claims 7-12 would also be allowable upon an amendment to claims 1 with claim 6 and correction of any amendments needed to address changes.
Claim 15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. Dependent claims 16-20 would also be allowable upon an amendment to claim 15 and correction of any amendments needed to address changes.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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