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 has amended independent claims 16 and 25 to recite the cardiac stimulator is configured to be removably inserted (claim 16), or adapted to be inserted (claim 25) “minimally invasively via a catheter.”
Examiner has added a Section 112 rejection to address the newly added claim limitations.
Applicant argues neither Heilman nor Bar disclose or suggest a minimally invasively inserted cardiac stimulator via a catheter. Examiner disagrees. Applicant is reminded 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114, see also Bar, para. 301).
Bar paragraph 301 states “[0301] The DEMS device is adapted to be implanted using either (a) a surgical (e.g. epicardial) open-chest and/or thoracoscopic approach, or, alternatively, (b) using a percutaneous approach using either an anterograde transeptal or retrograde trans-aortic approach for endocardial implantation. For some applications, a delivery apparatus is used to deliver the myocardial stent, pre-mounted on its distal end to the target zones to facilitate proper implantation.” Therefore, it would have been obvious to use a percutaneous catheter-based implantation as taught by Bar as an obvious expedient.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-18, 20, 22, 24-25, 31-32, 36-38, 40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Applicant has amended independent claims 16 and 25 to recite the cardiac stimulator is configured to be removably inserted (claim 16), or adapted to be inserted (claim 25) “minimally invasively via a catheter.”
Specification page 14 lines 32-36 state “In an example, the device 1 is also translumenally deliverable to the heart. A sheath or a catheter encompassing the gripper 1 is brought through the left arteria brachialis and advanced further to the target site. The target site may be a site, where the device 1 is in contact with, but exterior to the pericardial sack.” This paragraph provides the written description for the claim amendment. This description is insufficient to enable one skilled in the art to make and use the claimed invention.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
Here, the claims provide no further details other than “minimally invasively via a catheter.” Details of how the device may be compressed, folded, or reduced in diameter such that the device would fit within a catheter for minimally invasive delivery are absent in the claim and in the specification. Regarding the nature of the invention, catheter-based medical devices are inserted into the body’s vasculature in a reduced diameter configuration, advanced through the anatomy to an implantation site, and released from the catheter to expand to an implanted configuration. Here, there are no details on how the device is intended to be collapsed to fit within the vasculature. The specification is notably silent as to any mechanism for folding, compressing, or reducing the diameter of the device. The prior art includes several examples of catheter-based delivery, including acknowledgement of the tubular nature of the body’s vasculature and explaining how catheter-based devices are compressed or reduced into a small tubular catheter. In contrast, the specification does not provide any indication how the device described in figures 1-4 would fit within a tubular delivery catheter. The level of ordinary skill in the art is high, however, one of ordinary skill would not readily appreciate how to convert the claimed invention into a minimally invasive catheter-based implantation. The predictability in the art is also fairly high, however, here, there is no indication on how the device would fit within a tubular delivery catheter. With no direction provided by the inventor and no working examples, there is no enabling disclosure. Finally, the quantity of experimentation to create a catheter-based device would be high, including redesigning the device such that it may be collapsed into a tubular catheter for minimally invasive delivery.
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 22 is 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 22 states “wherein the cardiac stimulator is configured to be deployed intercostally.” This contradicts the independent claim requiring catheter-based delivery.
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.
Claims 16-18, 20, 22, 24-25, 31-32, 36-38, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Heilman et al. (U.S. Pat. No.: 5,383,840) in view of Bar et al. (Pub. No.: US 2008/0064917).
Heilman et al. (hereinafter, Heilman) discloses a radially compressible cardiac stimulator for at least direct mechanical stimulation of a heart having ventricles (e.g., abstract), comprising: a contractible body 38 configured to be removably (abstract) inserted minimally invasively via a catheter (not disclosed) around an outside of said heart around the ventricles of said heart (e.g., abstract) in a single plane (e.g., fig. 5) and to apply a force directly mechanically and selectively to contract the heart ventricles in said plane (e.g., col. 10 lines 41-68), wherein the contractible body is configured for movement in said plane, said movement being a direct movement on the heart ventricle for directly stimulating the heart at at least systole (e.g., fig. 5, 6, col. 10 lines 41+); wherein said contractible body is configured to provide said direct movement in said plane as a pressing movement on the heart muscle from its exterior during a systolic heart cycle phase (e.g., fig. 5, 6, col. 10 lines 41+); wherein the contractile body is configured to be pressurized by a fluid (not disclosed).
As provided in italicized text, Heilman does not specify the contractible body is inserted minimally invasively via a catheter. Applicant is reminded 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114; see also Bar, para. 301). Bar paragraph 301 states “[0301] The DEMS device is adapted to be implanted using either (a) a surgical (e.g. epicardial) open-chest and/or thoracoscopic approach, or, alternatively, (b) using a percutaneous approach using either an anterograde transeptal or retrograde trans-aortic approach for endocardial implantation. For some applications, a delivery apparatus is used to deliver the myocardial stent, pre-mounted on its distal end to the target zones to facilitate proper implantation.” Therefore, it would have been obvious to use a percutaneous catheter-based implantation as taught by Bar as an obvious expedient.
As provided in italicized text, Heilman lacks a contractile body which is configured to be pressurized by a fluid. Instead, Heilman’s contractile body is contracted and relaxed with a motorized winding action (abstract). Bar et al. (hereinafter, Bar) teaches a ventricular compression device in the form of a contractile body 32 which extends around an outside of the heart in as ingle plane (e.g., fig. 1). The contractile body is pressurized by fluid (abstract) to provide the contractile motion. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified Heilman to include a contractile body which is pressurized by fluid as taught by Bar as an obvious alternate mechanism for providing a compression force on the ventricles of the heart. This modification would have occurred using known methods and would have yielded predictable results.
For claim 17, Heilman discloses the cardiac stimulator according to claim 16, wherein at least a portion of the contractible body comprises a corrugated section 130 (e.g., fig. 5).
For claim 18, Heilman discloses the cardiac stimulator according to claim 16, wherein at least a portion of the contractible body comprises a sinusoidal surface, and wherein the sinusoidal surface is angled towards a center point of the cardiac stimulator (e.g., fig. 5).
For claim 20, Bar teaches the cardiac stimulator according to claim 16, wherein the cardiac stimulator comprises a fluid channel 30 having an inlet and wherein the inlet is arranged at the contractible body (e.g., fig. 1, para. 178).
For claim 22, Heilman’s cardiac stimulator is fully capable of being deployed intercostally (Applicant is reminded 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114; see also Bar, para. 301).
For claim 24, Heilman discloses the cardiac stimulator according to claim 16, wherein said contractible body is configured to squeeze the heart ventricles during the systolic heart cycle phase (e.g., fig. 5, col. 10 lines 41+).
For claim 25, Heilman discloses a cardiac augmenting system comprising: a removably inserted (abstract) radially compressible cardiac stimulator for at least a direct mechanical stimulation of a heart having ventricles (e.g., abstract), said cardiac stimulator adapted to be inserted minimally invasively via a catheter around an exterior of the heart and to provide a direct contraction force around the exterior of the heart in a single plane for directly stimulating the heart at systole (e.g., fig. 5, col. 10 lines 41+); wherein: said cardiac stimulator is adapted to provide said contraction as a direct pressing movement on the heart ventricles from the exterior and squeeze the heart ventricles during a systolic heart cycle phase and to expand during a diastolic heart cycle phase(e.g., 12 lines 42-51); and said cardiac stimulator is configured to have a relaxed state in which no force is introduced on the heart muscle when the cardiac stimulator is not in operation (e.g., fig. 7A, solid line position refers to the initial condition state); and said cardiac stimulator is configured to be pressurized by a fluid (not disclosed).
As provided in italicized text, Heilman does not specify the cardiac stimulator is inserted minimally invasively via a catheter. Applicant is reminded 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114; see also Bar, para. 301). Bar paragraph 301 states “[0301] The DEMS device is adapted to be implanted using either (a) a surgical (e.g. epicardial) open-chest and/or thoracoscopic approach, or, alternatively, (b) using a percutaneous approach using either an anterograde transeptal or retrograde trans-aortic approach for endocardial implantation. For some applications, a delivery apparatus is used to deliver the myocardial stent, pre-mounted on its distal end to the target zones to facilitate proper implantation.” Therefore, it would have been obvious to use a percutaneous catheter-based implantation as taught by Bar as an obvious expedient.
As provided in italicized text, Heilman lacks a contractile body which is configured to be pressurized by a fluid. Instead, Heilman’s contractile body is contracted and relaxed with a motorized winding action (abstract). Bar et al. (hereinafter, Bar) teaches a ventricular compression device in the form of a contractile body 32 which extends around an outside of the heart in as ingle plane (e.g., fig. 1). The contractile body is pressurized by fluid (abstract) to provide the contractile motion. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified Heilman to include a contractile body which is pressurized by fluid as taught by Bar as an obvious alternate mechanism for providing a compression force on the ventricles of the heart. This modification would have occurred using known methods and would have yielded predictable results.
For claim 31, Heilman discloses the cardiac augmenting system according to claim 25, wherein the augmenting system comprises a processing unit configured to stimulate the heart electrically if sensing that the heart is moving too slowly, and, in absence of a response of the electrical stimulation, mechanically stimulate said heart with said compressible cardiac stimulator (e.g., abstract, embedded defibrillator electrodes).
For claim 32, Heilman discloses the cardiac augmenting system of claim 31, wherein said system includes at least one pressure sensor configured to respond to pressure of the heart and/or said stimulator is configured to sense a force from motion of the heart and/or sense a counterforce when augmenting the heart mechanically (e.g., col. 6 lines 62-col. 7 line 24).
For claim 36, Heilman discloses the cardiac stimulator according to claim 31, wherein the radially compressible cardiac stimulator is configured to be transluminally delivered through the left arteria brachialis and advanced to the target site (Applicant is reminded 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114, see also Bar, para. 301).
For claim 37, Heilman and Bar lack disclosure of the cardiac stimulator according to claim 31, further comprising an ultrasound transmitter, receiver, sensor, or transducer. However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have utilized ultrasound technology including a transmitter, receiver, sensor, or transducer as an obvious expedient to visualize the operation of the device within the surgical theater. This modification would have occurred using known methods and would have yielded predictable results.
For claim 38, Heilman discloses the cardiac stimulator according to claim 31 further comprising a mesh comprising a sensor (e.g., col. 6 lines 62-col. 7 line 24).
For claim 40, Heilman discloses the cardiac stimulator of claim 16, wherein the cardiac stimulator is configured to be deployed in a minimally invasive surgical procedure (Applicant is reminded 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. Here, the device is fully capable of being implanted minimally invasively, for example with a mini-sternotomy. See also, Bar para. 301).
Conclusion
THIS ACTION IS MADE FINAL. 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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/SUBA GANESAN/Primary Examiner, Art Unit 3774