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 .
Status of Claims
In light of the amendment filed 11/26/2025, the status of claims is as follows: Claims 1-20 are pending, claims 1, 2 and 4 have been amended, and claims 8-20 are withdrawn.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant argues that neither Burbank nor Schwartz discloses a mitral repair device. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The limitation “mitral valve repair device” merely states the intended use of the device and provides no distinguishing structure over the prior art. The clip of Burbank is fully capable of being used in mitral valve repair. The implantable device being an electrode or occluder [0007] is fully capable of being used in mitral valve repair.
The arguments to claim 5 are moot in light of the above response to arguments of claim 1.
Note that a typo if the nonfinal indicated that claims 1-4 and 7 were anticipated by Schwartz. However, the body of the rejection addressed claims 1-4, 6. As such, claims 1-4 and 6 are rejected as being anticipated by Schwartz.
Regarding the 103 rejection as unpatentable over Shuey in view of Schwartz, applicant argues that Schwartz discloses position sensor 128 relies upon a fixed relationship of all relevant structural features and therefore would not apply to the system of Shuey where the implantable device is deployed and separated from the delivery/deployment device. Applicant’s argument are not persuasive as their own claimed invention is directed to a system with a delivery/deployment device having sensors for determining the relationship of the implantable device relative to the deployment site and an implantable device that is deployed/separated from the delivery/deployment device. The combination of Shuey and Shwartz provides the same structure as the claimed invention since the modification is to incorporate the sensor onto the delivery device 634 of Shuey. The sensors remain fixed on the delivery device and therefore would function in the same manner as taught by Schwartz. It is irrelevant that the implantable device is deployed/separated from the delivery device.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 1 positively recites an implantable mitral repair device. Claim 7 functionally claims a clip with respect to how it can be oriented and operated with respect to the clip spreader. It is examiner’s understanding in light of the spec that these two elements are in fact the same structure and the claims should be amended to indicate so. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1- 4 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Burbank et. al. (US 2003/0120286).
Burbank discloses:
Claim 1: A delivery/deployment system (12, Fig. 1), comprising:
an implantable mitral repair device (34) (it is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The prior art structure being a luminal clip is capable of performing the intended use, therefore it meets the claim.)
a delivery/deployment device configured to deliver and/or deploy the implantable mitral repair device (34, Fig . 3) and
one or more sensors (14) disposed along a portion of the delivery/deployment device (note sensor along distal end) and configured to engage the implantable device (Fig. 3, note the clip is capable of engaging the sensors at some point in time, for example after it has been released from the jaws), the one or more sensors being positioned and configured to generate a signal so that the delivery/deployment device and the implantable device need not be imaged to determine the relationship of the implantable device relative to the deployment site ([0011] and [0032]).
Claim 2: wherein the delivery/deployment device includes a seat (for example 32) in which the implantable device (34) is positionable (Fig. 3).
Claim 3: wherein the one or more sensors extend along at least one side of the seat (see Fig. 5).
Claim 4: further comprising an indicator (sensor controller, [0011]) coupled with the one or more sensors and configured to generate a signal indicating a condition of the delivery/deployment device and/or an implantable device associated therewith relative to the deployment site (may provide sensor signal output for interpretation by an operator [0011]).
Claim 7. wherein the delivery/deployment device is a clip spreader configured to operatively engage a clip (where the clip is not positively claimed) having a first clip arm (30) and a second clip arm (30) to shift the clip between an open configuration (Fig. 3) in which the first clip arm and the second clip arm are spaced apart from each other to allow tissue to be positioned therebetween, and a closed configuration (Fig. 4) in which the first clip arm and the second clip arm are adjacent to each other to clamp tissue therebetween.
Claim(s) 1- 4 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated Schwartz et. al. (US 2004/0220471)
Schwartz discloses:
Claim 1: A delivery/deployment system (120) comprising:
an implantable mitral valve repair device ([0007] recites an implantable device, for example, electrode or occlusion device. It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The prior art structure being is capable of performing the intended use, therefore it meets the claim.)
a delivery/deployment device configured to deliver and/or deploy the implantable device ([0007-0008]) and including one or more sensors (128, 124, 125) disposed along a portion of the delivery/deployment device and configured to engage the implantable device ([0054] sensor located on inner surface of 120 and therefore capable of engaging any device that is inserted through 120), the one or more sensors being positioned and configured to generate a signal so that the delivery/deployment device and the implantable device need not be imaged to determine the relationship of the implantable device relative to the deployment site ([0016], [0070]).
Claim 2: wherein the delivery/deployment device includes a seat (lumen of probe) in which an implantable device is positionable (implantable device is capable of being positioned within the lumen).
Claim 3: wherein the one or more sensors extend along at least one side of the seat (see for example 4a, 6a where sensor is attached to inner surface along the lumen).
Claim 4: further comprising an indicator coupled with the one or more sensors and configured to generate a signal indicating a condition of the delivery/deployment device and/or the implantable device associated therewith relative to the deployment site [0018], [0040], 0059).
Claim 6. wherein the one or more sensors are impedance sensors capable of distinguishing body tissue. (124,125 measures impedance and senses characteristics of tissue [0014],[0042])
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Burbank et. al. (US 2003/0120286).
Regarding claim 5, the limitation “formed by vapor deposition process” is being treated as a product-by-process limitation. It has been held that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698,227 USPQ 964,966 (Fed. Cir. 1985). In this case, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the process of vapor deposition since using a known technique to form a known device would yield predictable results.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Schwartz (US2004/0220471).
Regarding claim 5, the limitation “formed by vapor deposition process” is being treated as a product-by-process limitation. It has been held that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698,227 USPQ 964,966 (Fed. Cir. 1985). In this case, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the process of vapor deposition since using a known technique to form a known device would yield predictable results.
Claim(s) 1-4, 6 and 7 is/are rejected under 35 U.S.C. 103 as obvious over as applied to Shuey (US 2021/000599) in view of Schwartz (US2004/0220471)
Shuey discloses
Claim 1: A delivery/deployment system (Fig. 6) comprising:
an implantable mitral valve device (600),
the delivery/deployment system comprising: a delivery/deployment device (634) configured to deliver and/or deploy the implantable device (600);
Claim 7: wherein the delivery/deployment device is a clip spreader (620), configured to operatively engage a clip having a first clip arm (622) and a second clip arm (626) to shift the clip between an open configuration in which the first clip arm and the second clip arm are spaced apart from each other to allow tissue to be positioned therebetween, and a closed configuration in which the first clip arm and the second clip arm are adjacent to each other to clamp tissue therebetween ([0060]).
Claim 2, the delivery device includes a seat (see Fig. 6)
Shuey does not disclose one or more sensors as claimed.
However, Shwartz discloses a transluminal delivery catheter including one or more sensors (128, 124, 125) along a portion of the delivery/deployment device (for example Fig. 5), the one or more sensors being positioned and configured to generate a signal so that the delivery/deployment device and the implantable device need not be imaged to determine the relationship of the implantable device relative to the deployment site ([0016], [0070]).
As to claim 4, further comprising an indicator coupled with the one or more sensors and configured to generate a signal indicating a condition of the delivery/deployment device and/or an implantable device associated therewith relative to the deployment site [0018], [0040], 0059).
As to claim 6. wherein the one or more sensors are impedance sensors capable of distinguishing body tissue. (124,125 measures impedance and senses characteristics of tissue [0014],[0042])
It would have been obvious to one of ordinary skill in the art in the art before the effective filing date to incorporate the use of location sensors on the delivery/deployment device (623) of Shuey along the distal end of catheter 634 which extends along one side of the seat (where clip 600 is located) based on the teachings of Schwartz. Further, where the sensors are configured to engage the mitral repair device (note that the clamp is capable of engaging the sensors at some point in time, for example after it has been released from the jaws). Combining the sensors into the delivery device would provide the advantage of aiding the user in more accurately locating the delivery tool in the body resulting in a more efficiently carrying out the procedure.
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 ELIZABETH HOUSTON whose telephone number is (571)272-7134. The examiner can normally be reached generally M-F 8:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771
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