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 .
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.
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: “actuator” in claim 20.
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.
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 § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-7, 14-16, 18 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kapur et al. (WO 2021/102203).
Regarding claim 1, Kapur et al. disclose a system, comprising: an intravascular reperfusion therapy device (Figures 4B and 6) configured to be positioned within a coronary vein of a patient (¶[0029] - the system is deliverable through the subclavian vein and/or implantable in the superior vena cava, therefore it could be used to occlude at least a coronary sinus of at least some patients) to deliver reperfusion therapy to a myocardium of a heart of the patient associated with the coronary vein, wherein the intravascular reperfusion therapy device comprises- a catheter (57) comprising a lumen (60) and a distal end; a sensor (42; ¶[0123], [0129], [0137]) configured to obtain physiological data associated with blood flow through the coronary vein (¶[0034], [0042], [0123]-[0126]); a flexible elongate member (54) extending within the lumen of the catheter (¶[0137]); an expandable structure (50) coupled to the flexible elongate member such that the flexible elongate member and the expandable structure are movable relative to the catheter (¶[0135]), wherein the expandable structure is configured to expand into the coronary vein to deliver the reperfusion therapy by obstructing blood flow in a first direction in the coronary vein to generate back pressure in an opposite, second direction within the coronary vein (the device of Figure 6 could occlude at least a coronary sinus to create a backflow to cause reperfusion therapy to heart tissue; e.g. as evidentiary support see US 2015/0157326 - Figure 2 and elsewhere)y wherein the expandable structure is configured to be transitioned between a first state and a second state, wherein, in the first state, the expandable structure is not expanded and a portion of the flexible elongate member coupled to the expandable structure (any portion of 54 that is within the distal end of lumen 60) is within the lumen of the catheter (¶[0137]), wherein, in the second state, the expandable structure is expanded and the portion of the flexible elongate member coupled to the expandable structure has moved in the second direction within the coronary vein such that the expandable structure is outside of the lumen of the catheter and distal of the distal end of the catheter (at least the entire device, 50/54/57, can be moved in the second direction while the expandable structure is distal to the distal end of the catheter).
Regarding claim 21, a processor circuit (within 37) is in communication with the intravascular reperfusion therapy device and configured to: receive, from the sensor, physiological data associated with blood flow through the coronary vein; determine, based on the physiological data, a progression of the reperfusion therapy delivered to the myocardium of the heart; and control, based on the progression of the reperfusion therapy, expansion of the plurality of arms while the intravascular reperfusion therapy device is positioned within the coronary vein such that the back pressure within the coronary vein is controlled (¶[0034], [0042], [0123]-[0126] - the sensor can be distal of the arms; therefore, the processor can measure blood flow rate and/or pressure distal of the catheter and based thereon control expansion of the catheter which could be used to regulate a backflow within a coronary sinus and reperfusion of coronary tissue).
Regarding claim 22, the sensor is coupled to the distal end of the catheter (¶[0126]).
Regarding claim 23, to control the expansion of the expandable structure, the processor circuit is configured to control a degree of expansion of the expandable structure (¶[0139]).
Regarding claim 3, the expandable structure comprises a plurality of arms (51), wherein the degree of expansion corresponds to at least one of a quantity of expanded arms of the plurality of arms or a diameter to which the expanded arms are expanded (¶[0139]).
Regarding claim 4, to control the expansion of the expandable structure, the processor circuit is configured to control an oscillation of the degree of expansion between a first degree of expansion and a different, second degree of expansion (¶[0139], [0214]).
Regarding claim 5, the processor circuit is configured to control a frequency of the oscillation (¶[0139], [0214]).
Regarding claim 6, the processor circuit is configured to control a duty cycle of the oscillation (¶[0139], [0214]).
Regarding claim 7, the expandable structure comprises a plurality of arms (51), wherein, in the second state of the expandable structure, the plurality of arms are configured to be spaced from one another such that a gap is positioned between a first and second arm of the plurality of arms (there would be gap between the arms and covered by the membrane - ¶[0135]).
Regarding claim 14, the processor circuit is further configured to: output, to display in communication with the processor circuit, a visual representation of the progression of the reperfusion therapy (¶[0128]).
Regarding claim 15, the sensor comprises a flow sensor, wherein the physiological data comprises a blood flow rate (¶[0125]-[0127]).
Regarding claim 16, the sensor comprises a pressure sensor, wherein the physiological data comprises pressure data (¶[0125]-[0127]).
Regarding claim 18, the sensor is positioned at a distal portion of the flexible elongate member (¶[0034], [0042], [0126]).
Regarding claim 20, an actuator (36; Figure 4B; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s actuator - ¶[0065] of Applicant’s published application) is coupled to a proximal portion the catheter, wherein the actuator is configured to control the expandable structure to be transitioned between the first state and the second state (¶[0123]-[0126]).
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kapur et al. (WO 2021/102203) in view of Mohl et al. (US 2020/0268391).
Regarding claim 2, Kapur et al. fail to disclose that when determining the progression of the reperfusion therapy, the processor circuit is configured to: determine a derivative of the physiological data with respect to time.
Mohl et al. (Kapur et al. and Mohl et al. being in Applicant’s field of partial occlusion of coronary vessels to improve cardiac function) disclose determining the progression of reperfusion therapy by determining a derivative of a physiological data with respect to time in order to reduce the stress on heart vessels caused by occluding blood flow (¶[0012]-[0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the determination method of Mohl et al. on the physiological data of Kapur et al. in order to reduce the stress on heart vessels caused by occluding blood flow.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kapur et al. (WO 2021/102203) in view of Eidenschink et al. (US 2008/0086081).
Regarding claims 8 and 10, Kapur et al. disclose that the expansion of the plurality of arms or expandable structure to the second state can result in expansion of a material (“membrane” - ¶[0135]) into the coronary vein but fail to disclose that the material is coupled between the plurality of arms. Kapur et al. also fail to disclose that the expandable structure comprises an electroactive polymer configured to deform responsive to an electrical signal as claimed.
Eidenschink et al. disclose an expandable medical device (the expandable angioplasty and stent delivery devices of Eidenschink et al. being reasonably pertinent to Applicant’s problem of reestablishing blood flow following angioplasty or stent delivery) having a plurality of arms (10; Figure 26) comprising an electroactive polymer (¶[0158]) configured to deform responsive to an electrical signal (¶[0111]) which allows controlled, incremental expansion and contraction of the expandable member (¶[0153). Eidenschink et al. further teach a collapsed configuration for the device where a material is disposed between expandable arms (Figure 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the electroactive polymer of Eidenschink et al. to form the arms of Kapur et al. and to have configured the processor circuit as claimed in order to allow better control of the incremental expansion and contraction required by Kapur et al. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the collapsed configuration of Eidenschink et al. when collapsing the device of Kapur et al. in order to allow a more compact delivery profile.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kapur et al. (WO 2021/102203) in view of Desai et al. (US 2009/0287193).
Regarding claim 11, Kapur et al. fail to disclose that the plurality of arms or expandable structure comprises a material configured to deform responsive to application of thermal energy as claimed.
Desai et al. disclose a minimally invasive expandable medical device (such devices being reasonably pertinent to Applicant’s problem of using a minimally invasive expandable device for occluding a lumen) having a plurality of expandable arms (66; Figure 4B) comprising a material configured to deform responsive to application of thermal energy (¶[0015], [0017]) and further teach that this is a functionally equivalent expansion means as compared to mechanically foreshortening the arms (¶[0015], [0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Desai et al. to have configured the processor circuit to control delivery of thermal energy to deform the arms of Kapur et al. to transition the device from the first expansion state to the second expansion state (¶[0015], [0017]) as a simple substitution of one known expansion means for another to obtain predictable results (MPEP 2143 (I)(B)).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kapur et al. (WO 2021/102203) in view of Mohl et al. (US 4,934,996).
Regarding claim 17, Kapur et al. fail to disclose that the sensor comprises an ultrasound transducer.
Mohl et al. (in Applicant’s field of coronary occlusion devices) disclose an ultrasound transducer (40) at a distal portion of an occlusion catheter (Figure 2A) for sensing blood flow rate (col. 4, lines 14-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the ultrasound transducer of Mohl et al. as the flow rate sensor of Kapur et al. as a suitable prior art, low profile, blood flow rate sensor that can easily be provided at the end of an occlusion catheter; where Kapur et al. are silent as to the structural details of their flow rate sensor.
Response to Arguments
Applicant's arguments filed February 3rd 2026 have been fully considered but they are not persuasive. Applicant has argued that the flexible elongate member and expandable structure of Kapur et al. are not movable relative to the catheter. The elongate member (54) is moved relative to the catheter (57) to expand the arms (51; thereby moving the arms relative to the catheter) as described in paragraph 0135. The remaining limitations indicated by Applicant as missing from Kapur et al. (apparently indicated in bold and/or underlined) are described above. It is not understood from Applicant’s remarks specifically why it is believed that Kapur et al. fail to disclose these limitations. Accordingly, the previous grounds of rejection are respectfully maintained.
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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