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 .
DETAILED ACTION
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites a related application that has now matured into a patent. The paragraph should be updated to include the issued patent number.
Appropriate correction is required.
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 9-12 and 18-20 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 9 recites “the third sensing member is configured to sense a third parameter”, however a first and second sensing parameter have not been previously recited, clarification is required. Claim 18 recites the limitation "the first sensing member" in line 14 and “the second sensing member” in line 15. There is insufficient antecedent basis for this limitation in the claim. Claims 10-12 and 19-20 directly or indirectly depend from claims 9 or 18 and are also rejected to for the reasons stated above regarding claims 9 and 18.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-9 and 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-9 and 18 of U.S. Patent No. 12,220,569. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims 1-9 and 11-20 in the instant application and claims 3-9 and 18 in U.S. Patent No. 12,220,569 recite almost identical systems that are tracked through the vasculature and methods that include advancing a first and second medical device within a superior and inferior vena cava with a first, second and third sensing member extending therethrough with the claims in the instant application being more generic than the claims within U.S. Patent No. 12,220,569, see claim chart below for further analysis. The entire scope of claims 1-9 and 11-20 in the instant application falls within the scope of claims 3-9 and 18 of U.S. Patent No. 12,220,569, therefore a patent to the generic claims within the instant application would improperly extend the right to exclude granted by U.S. Patent No. 12,220,569, see MPEP 804.
Instant Application
US Patent No. 12,220,569
Analysis
Claim 1. A method for treating the heart, the method comprising: advancing a first medical device into the superior vena cava, the first medical device including a first expandable member coupled to a distal end of a first elongate shaft, wherein the first elongate shaft includes a first aperture positioned proximal to the first expandable member; and advancing a second medical device into the inferior vena cava, the second medical device including a second expandable member coupled to a distal end of a second elongate shaft, wherein the second elongate shaft includes a second aperture positioned proximal to the second expandable member; extending a first sensing member within a portion of the first elongate shaft and through the first aperture, wherein the first sensing member includes a first end positioned proximal the first expandable member; extending a second sensing member within a portion of the second elongate shaft and through the second aperture, wherein the second sensing member includes a first end positioned proximal the second expandable member; extending a third sensing member distally out of the distal end of the first elongate shaft, wherein the third sensing member has a first end configured to be positioned distal to the first expandable member.
Claim 18. A method for treating the heart, the method comprising: advancing a first medical device into the superior vena cava through the jugular vein, the first medical device including a first elongate shaft having a first aperture and a proximal end coupled to a control system and a distal end, wherein a first expandable member is coupled to the first elongate shaft adjacent to the distal end of the first elongate shaft, and wherein the first medical device further includes a first sensing member extending through the first aperture and coupled to the control system; advancing a second medical device into the inferior vena cava through the femoral vein, the second medical device including a second elongate shaft having a second aperture and a proximal end coupled to a control system and a distal end, wherein a second expandable member is coupled to the second elongate shaft adjacent to the distal end of the second elongate shaft, and wherein the second medical device further include a second sensing member extending through the second aperture and coupled to the control system; advancing a third sensing member within the first elongate shaft to a position adjacent the right atrium, wherein the third sensing member extends distally out of the distal end of the first elongate shaft….
Claim 1 of the instant application is fully anticipated by claim 18 of U.S. Patent No. 12,220,569. The only difference being that U.S. Patent No. 12,220,569 recites the medical devices being coupled to a control system and analyzing a blood flow and expanding the expandable member based on the changes in blood flow. Therefore the scope of claim 1 within the instant application falls within the scope of claim 18 of U.S. Patent No. 12,220,569 and is fully anticipated by claim 18 of U.S. Patent No. 12,220,569.
Claim 2…wherein advancing a first medical device into the superior vena cava further includes tracking the first medical device through the jugular vein.
18. A method for treating the heart, the method comprising: advancing a first medical device into the superior vena cava through the jugular vein,….
See analysis above regarding claim 1 of the instant application. The limitations within claim 2 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
Claim 3…wherein advancing a second medical device into the inferior vena cava further includes tracking the second medical device through the femoral vein.
18. A method for treating the heart, the method comprising:…advancing a second medical device into the inferior vena cava through the femoral vein,…
See analysis above regarding claim 1 of the instant application. The limitations within claim 3 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
Claim 4…wherein extending a third sensing member distally out of the distal end of the first elongate shaft further includes positioning the third sensing member adjacent the right atrium.
18. A method for treating the heart, the method comprising:…advancing a third sensing member within the first elongate shaft to a position adjacent the right atrium,…
See analysis above regarding claim 1 of the instant application. The limitations within claim 4 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
Claim 5… sensing a first parameter with the first sensing member; sensing a second parameter with the second sensing member; and expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the first parameter, a change in the second parameter, or a change in both the first and the second parameters.
18. A method for treating the heart, the method comprising:… sensing a first parameter with the first sensing member; sensing a second parameter with the second sensing member;… analyzing a blood flow based on the first parameter, the second parameter or both the first and the second parameter; and expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the blood flow.
See analysis above regarding claim 1 of the instant application. The limitations within claim 5 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
Claim 6… wherein the first sensing member, the second sensing member or both the first sensing member and the second sensing member includes a microelectrical mechanical (MEMS) sensor.
3…. wherein the first sensing member, the second sensing member or both the first sensing member and the second sensing member includes a microelectrical mechanical (MEMS) sensor.
Claim 1 of U.S. Patent No. 12,220,569 discloses all of the structural elements of the structure disclosed within claim 4 of the instant application as being advanced into the body and further discloses that the structure is tracked through vasculature of the body, i.e. advanced into the body. Claim 6 of the instant application provides additional structural limitations regarding that structure in particular with regards to the first and second sensing members. The structural elements of claim 6 of the instant application are fully disclosed within claim 3 of U.S. Patent No. 12,220,569.
Claim 7… wherein the first sensing member, the second sensing member or both the first sensing member and the second sensing member includes a fiber optic sensor.
4…. wherein the first sensing member, the second sensing member or both the first sensing member and the second sensing member includes a fiber optic sensor.
Claim 1 of U.S. Patent No. 12,220,569 discloses all of the structural elements of the structure disclosed within claim 4 of the instant application as being advanced into the body and further discloses that the structure is tracked through vasculature of the body, i.e. advanced into the body. Claim 7 of the instant application provides additional structural limitations regarding that structure in particular with regards to the first and second sensing members. The structural elements of claim 7 of the instant application are fully disclosed within claim 4 of U.S. Patent No. 12,220,569.
Claim 8… wherein the first sensing member, the second sensing member or both the first sensing member and the second sensing member includes a fluid-filled pressure sensing catheter.
5…. wherein the first sensing member, the second sensing member or both the first sensing member and the second sensing member includes a fluid-filled pressure sensing catheter.
Claim 1 of U.S. Patent No. 12,220,569 discloses all of the structural elements of the structure disclosed within claim 4 of the instant application as being advanced into the body and further discloses that the structure is tracked through vasculature of the body, i.e. advanced into the body. Claim 8 of the instant application provides additional structural limitations regarding that structure in particular with regards to the first and second sensing members. The structural elements of claim 7 of the instant application are fully disclosed within claim 5 of U.S. Patent No. 12,220,569.
Claim 9… wherein the third sensing member is configured to sense a third parameter.
18. A method for treating the heart, the method comprising:… sensing a third parameter with the third sensing member;…
See analysis above regarding claim 1 of the instant application. The limitations within claim 9 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
Claim 11… further comprising a fourth sensing member having a first end positioned adjacent the second expandable member, and wherein the fourth sensing member is configured to sense a fourth parameter.
6… further comprising a fourth sensing member having a first end positioned adjacent the second expandable member and a second end coupled to the control system, the fourth sensing member designed to sense a fourth parameter.
Claim 1 of U.S. Patent No. 12,220,569 discloses all of the structural elements of the structure disclosed within claim 9 of the instant application as being advanced into the body and further discloses that the structure is tracked through vasculature of the body, i.e. advanced into the body. Claim 11 of the instant application provides additional structural limitations regarding that structure in particular with regards to a fourth sensing member. The structural elements of claim 11 of the instant application are fully disclosed within claim 6 of U.S. Patent No. 12,220,569.
Claim 12…wherein the first expandable member is positioned between a distal end of the first sensing member and a distal end of the third sensing member.
7… wherein the first expandable member is positioned between a distal end of the first sensing member and a distal end of the third sensing member.
Claim 6 of U.S. Patent No. 12,220,569 discloses all of the structural elements of the structure disclosed within claim 11 of the instant application as being advanced into the body and further discloses that the structure is tracked through vasculature of the body, i.e. advanced into the body. Claim 12 of the instant application provides additional structural limitations regarding that structure in particular with regards to the positioning of the first expandable member. The structural elements of claim 12 of the instant application are fully disclosed within claim 7 of U.S. Patent No. 12,220,569.
Claim 13… wherein the first elongate shaft has a plurality of lumens extending therein, and wherein at least a portion of the first sensing member extends within at least a portion of a first lumen of the plurality of lumens.
8… wherein the first elongate shaft has a plurality of lumens extending therein, and wherein at least a portion of the first sensing member extends within at least a portion of a first lumen of the plurality of lumens.
Claim 1 of U.S. Patent No. 12,220,569 discloses all of the structural elements of the structure disclosed within claim 1 of the instant application as being advanced into the body and further discloses that the structure is tracked through vasculature of the body, i.e. advanced into the body. Claim 13 of the instant application provides additional structural limitations regarding that structure in particular that the elongated shaft has a plurality of lumens. The structural elements of claim 13 of the instant application are fully disclosed within claim 8 of U.S. Patent No. 12,220,569.
Claim 14.. wherein at least a portion of the third sensing member extends within at least a portion of a second lumen of the plurality of lumens of the first elongate shaft.
9…. wherein at least a portion of the third sensing member extends within at least a portion of a second lumen of the plurality of lumens of the first elongate shaft.
Claim 8 of U.S. Patent No. 12,220,569 discloses all of the structural elements of the structure disclosed within claim 13 of the instant application as being advanced into the body and further discloses that the structure is tracked through vasculature of the body, i.e. advanced into the body. Claim 14 of the instant application provides additional structural limitations regarding that structure in particular with regards to the third sensing member being located in a second lumen. The structural elements of claim 14 of the instant application are fully disclosed within claim 9 of U.S. Patent No. 12,220,569.
Claim 15. A method for treating the heart, the method comprising: advancing a first medical device into the superior vena cava, the first medical device including a first expandable member coupled to a distal end of a first elongate shaft, wherein a proximal end of the first elongate shaft is coupled to a control system having a processor and a pump, wherein the first elongate shaft includes a first aperture positioned proximal to the first expandable member; and advancing a second medical device into the inferior vena cava, the second medical device including a second expandable member coupled to a distal end of a second elongate shaft, wherein a proximal end of the second elongate shaft is coupled to the control system, wherein the second elongate shaft includes a second aperture positioned proximal to the second expandable member; extending a first sensing member within a portion of the first elongate shaft and through the first aperture, wherein the first sensing member includes a first end positioned proximal the first expandable member; extending a second sensing member within a portion of the second elongate shaft and through the second aperture, wherein the second sensing member includes a first end positioned proximal the second expandable member; extending a third sensing member distally out of the distal end of the first elongate shaft, wherein the third sensing member has a first end configured to be positioned distal to the first expandable member.
Claim 18. A method for treating the heart, the method comprising: advancing a first medical device into the superior vena cava through the jugular vein, the first medical device including a first elongate shaft having a first aperture and a proximal end coupled to a control system and a distal end, wherein a first expandable member is coupled to the first elongate shaft adjacent to the distal end of the first elongate shaft, and wherein the first medical device further includes a first sensing member extending through the first aperture and coupled to the control system; advancing a second medical device into the inferior vena cava through the femoral vein, the second medical device including a second elongate shaft having a second aperture and a proximal end coupled to a control system and a distal end, wherein a second expandable member is coupled to the second elongate shaft adjacent to the distal end of the second elongate shaft, and wherein the second medical device further include a second sensing member extending through the second aperture and coupled to the control system; advancing a third sensing member within the first elongate shaft to a position adjacent the right atrium, wherein the third sensing member extends distally out of the distal end of the first elongate shaft;…
Claim 15 of the instant application is fully anticipated by claim 18 of U.S. Patent No. 12,220,569. The only difference being that U.S. Patent No. 12,220,569 recites analyzing a blood flow and expanding the expandable member based on the changes in blood flow. Therefore the scope of claim 15 within the instant application fall within the scope of claim 18 of U.S. Patent No. 12,220,569 and is fully anticipated by claim 18 of U.S. Patent No. 12,220,569.
Claim 16… sensing a first parameter with the first sensing member; sensing a second parameter with the second sensing member; and expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the first parameter, a change in the second parameter, or a change in both the first and the second parameters.
18. A method for treating the heart, the method comprising:… sensing a first parameter with the first sensing member; sensing a second parameter with the second sensing member;… analyzing a blood flow based on the first parameter, the second parameter or both the first and the second parameter; and expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the blood flow.
See analysis above regarding claim 15 of the instant application. The limitations within claim 16 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
Claim 17.. wherein the processor is configured to assess a blood flow based on the first parameter, the second parameter or both the first parameter and the second parameter, and wherein the processor communicates with the pump to expand or contract the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the blood flow.
18. A method for treating the heart, the method comprising:… sensing a first parameter with the first sensing member; sensing a second parameter with the second sensing member;… analyzing a blood flow based on the first parameter, the second parameter or both the first and the second parameter; and expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the blood flow.
See analysis above regarding claim 15 of the instant application. The limitations within claim 17 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
Claim 18. A method for treating the heart, the method comprising: advancing a first medical device into the superior vena cava, the first medical device including a first expandable member coupled to a distal end of a first elongate shaft, wherein a proximal end of the first elongate shaft is coupled to a control system having a processor and a pump, wherein the first elongate shaft includes a first aperture positioned proximal to the first expandable member; and advancing a second medical device into the inferior vena cava, the second medical device including a second expandable member coupled to a distal end of a second elongate shaft, wherein a proximal end of the second elongate shaft is coupled to the control system, wherein the second elongate shaft includes a second aperture positioned proximal to the second expandable member; advancing a third sensing member distally out of the distal end of the first elongate shaft, wherein the third sensing member has a first end configured to be positioned distal to the first expandable member; sensing a first parameter with the first sensing member; sensing a second parameter with the second sensing member; sensing a third parameter with the third sensing member; analyzing a blood flow based on the first parameter, the second parameter or both the first and the second parameters.
Claim 18. A method for treating the heart, the method comprising: advancing a first medical device into the superior vena cava through the jugular vein, the first medical device including a first elongate shaft having a first aperture and a proximal end coupled to a control system and a distal end, wherein a first expandable member is coupled to the first elongate shaft adjacent to the distal end of the first elongate shaft, and wherein the first medical device further includes a first sensing member extending through the first aperture and coupled to the control system; advancing a second medical device into the inferior vena cava through the femoral vein, the second medical device including a second elongate shaft having a second aperture and a proximal end coupled to a control system and a distal end, wherein a second expandable member is coupled to the second elongate shaft adjacent to the distal end of the second elongate shaft, and wherein the second medical device further include a second sensing member extending through the second aperture and coupled to the control system; advancing a third sensing member within the first elongate shaft to a position adjacent the right atrium, wherein the third sensing member extends distally out of the distal end of the first elongate shaft; sensing a first parameter with the first sensing member; sensing a second parameter with the second sensing member; sensing a third parameter with the third sensing member; analyzing a blood flow based on the first parameter, the second parameter or both the first and the second parameter;…
Claim 18 of the instant application is fully anticipated by claim 18 of U.S. Patent No. 12,220,569. The only difference being that U.S. Patent No. 12,220,569 recites the medical device having first and second sensing members and expanding the expandable member based on the changes in blood flow. Therefore the scope of claim 18 within the instant application fall within the scope of claim 18 of U.S. Patent No. 12,220,569 and is fully anticipated by claim 18 of U.S. Patent No. 12,220,569.
Claim 19… expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the blood flow.
18. A method for treating the heart, the method comprising:… expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the blood flow.
See analysis above regarding claim 18 of the instant application. The limitations within claim 19 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
Claim 20… expand or contract the first expandable member, the second expandable member or both the first and the second expandable members to regulate blood flow in the superior vena cava, the inferior vena cava or both the superior vena cava and the inferior vena cava.
18. A method for treating the heart, the method comprising:… expanding the first expandable member, the second expandable member or both the first and the second expandable members based on a change in the blood flow.
See analysis above regarding claim 18 of the instant application. The limitations within claim 20 are fully disclosed within claim 18 of U.S. Patent No. 12,220,569.
U
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 12,220,569 in view of US 2006/0064059 to Gelfand et al. (Gelfand). Claim 18 of U.S. Patent No. 12,220,569 recites a method that includes sensing a third parameter but does not explicitly teach the third parameter being blood pressure. Gelfand, in the same field of endeavor, discloses a method of advancing a medical device with expandable elements within the vena cava (e.g. Figs. 1-2) which discloses sensing blood pressure (e.g. monitoring blood pressure, para. [0032], [0045], [0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 18 of U.S. Patent No. 12,220,569 to include the third parameter being blood pressure, as taught by Gelfand, in order to provide accurate measurements of pressure in the RA of the heart to control inflation and deflation of the expandable members to maintain adequate cardiac output (‘059, para. [0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2010/0318114 to Pranevicius et al. which discloses venous modulation that includes a catheter with multiple expandable occluders. US 2017/0049946 to Kapur et al. which teaches systems and methods for treating acute and chronic heart failure which discloses the use of pressure sensors located along the length of the catheter. US 2020/0038566 to Johnson et al. which discloses endovascular perfusion which include a catheter with multiple expandable balloons for occlusion. US Patent No. 5,433,700 to Peters which discloses an intraluminal catheter with multiple balloons.
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