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 .
This action is in response to the amendment filed on 06/09/2026. Claims 1-14, 20-26, 28-37, 52-59 are pending. Claims 1, 14, 20, 29, and 37 are independent. Claims 8, 13, 14, 20-26, 28-37, and 52-59 are withdrawn. Claims 15-19, 27, 38-51 are canceled.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
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)(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.
Claim(s) 1-6, 9, 11, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maguire et al. (US Pub. No.: 2004/0059277).
Regarding claims 1-6, 9, 11, and 12, Maguire discloses [claim 1] indwelling medical device for acute alteration of blood flow in a vessel of a patient, the device comprising: a catheter (11, Fig. 10); a vessel opposing member portion (14, Fig. 10 and Paras. [0200] and [0201]) arranged at or extending from a distal end of the catheter and configured to oppose against a vessel wall of the vessel (Paras. [0200] and [0201]), the vessel opposing member including an outer inflatable member configured to maintain contact with a wall of the vessel (Para. [0192], “the balloon 14 is expanded to an outer diameter that does not completely occlude the patient's aorta 31. However, in an alternative embodiment, the balloon expands into contact with the wall of the aorta 21, to an outer diameter that completely occludes the aorta 31.” Even in the embodiment that the balloon does not completely occlude the patient’s aorta, the balloon is still fully capable of maintaining contact with the wall of the vessel by shifting it to contacting the vessel wall on one side) ; and a flow altering element (13, Fig. 10 and Paras. [0200] and [0201]), arranged within the vessel opposing member portion and including a lumen (18, Fig. 11) for the blood flow through the vessel therethrough, configured to alter the blood flow through the lumen to restrict blood flow in the vessel and induce a physiologically mediated therapeutic response in the patient (Paras. [0200] and [0201], the flow altering element 13 is configured to alter the blood flow through the lumen to restrict blood flow in the vessel and induce a physiologically mediated therapeutic response in the patient by restricting blood flow in the vessel);
[claim 2] wherein the vessel is an aorta and the vessel opposing member portion is configured to oppose against the vessel wall in the aorta and create a narrowed flow lumen in a conduit located in the aorta distal of one or both renal arteries of between about 40% and about 80% of a starting diameter of the aorta to alter blood flow into the at least one branch vessel of the aorta to alter blood flow into one or both kidneys (Paras. [0194], [0200], and [0201],);
[claim 3] wherein the vessel is a vena cava and the vessel opposing member portion is configured to oppose against the vessel wall in the vena cava create a narrowed flow lumen in the conduit located in the vena cava distal of one or both renal veins of between about 40% and about 90% of a starting diameter of the vena cava to and alter blood flow through one or both of the renal veins to alter blood flow into one or both kidneys (Paras. [0194], [0200], and [0201], the flow altering element is fully capable to oppose against the vessel which is an vena cava and the vessel opposing member portion is configured to oppose against the vessel wall in the vena cava create a narrowed flow lumen in the conduit located in the vena cava distal of one or both renal veins of between about 40% and about 90% of a starting diameter of the vena cava to and alter blood flow through one or both of the renal veins to alter blood flow into one or both kidneys because the diameter of the lumen of flow altering element is about 4% to about 64% of a blood vessel);
[claim 4] wherein the vessel opposing member portion is configured to be arranged upstream from one or both of the renal veins and the flow altering element is configured to drop blood pressure out of one or both of the renal veins to promote blood flow through the kidneys (the vessel opposing member portion is fully capable to be arranged upstream from one or both of the renal veins and the flow altering element is fully capable to drop blood pressure out of one or both of the renal veins to promote blood flow through the kidneys because the vessel opposing member is configured to be placed within blood vessel and the flow altering element is configured to restrict blood flow);
[claim 5] wherein the flow altering element is at least one of a balloon (Paras. [0200] and [0201]), and vessel opposing member portion is comprised of an outer balloon (Paras. [0200] and [0201]);
[claim 6] wherein the flow altering element is an inner balloon (Paras. [0200] and [0201]), and the vessel opposing member portion is the outer balloon (Paras. [0200] and [0201]) and further including a plurality of inflation ports (Fig. 12 and Para. [0201], e.g. a port through lumen 21 for inflating/deflating 14 and a port through lumen 57 for inflating/deflating 13) configured to inflate and deflate the outer balloon and the flow altering element;
[claim 9] wherein one of the plurality of ports is configured to provide flow to restrict an internal diameter of at least a portion of the outer balloon to alter the lumen (Fig. 12 and Para. [0201], e.g. a port through lumen 21 for inflating/deflating 14 and a port through lumen 57 for inflating/deflating 13);
[claim 11] wherein the lumen of the flow altering element includes at least one of a cylindrical shape (Fig. 10 and 11);
[claim 12] wherein the flow altering element is a balloon (Paras. [0200] and [0201]).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US Pub. No.: 2004/0059277) as applied to claim 6 above, and further in view of Carrison (US Pub. No.: 2014/0039537).
Regarding claim 7, Maguire discloses all the limitation of claim 6 as taught above but fails to disclose the outer balloon and the flow altering element are of substantially similar lengths.
Carrison teaches, in the same field of endeavor (blood flow alteration device), an indwelling medical device comprising: a vessel opposing member (1402, Fig. 13) and a flow altering element (1412, Fig. 3); wherein the vessel opposing member and the flow altering element are of substantially similar lengths (Fig. 13).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art modify device of Maguire to include that the vessel opposing member and the flow altering element are of substantially similar lengths as taught by Carrison in order to obtain the advantage of having the vessel opposing member to evenly supporting the flow altering element along the whole flow altering element. In the modified invention, the opposing member which is the outer balloon as taught by Maguire and the flow altering element are of substantially similar lengths.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US Pub. No.: 2004/0059277) as applied to claim 6 above, and further in view of Walsh et al. (US Pub. No.: 2011/0137331).
Regarding claim 10, Maguire discloses all the limitation of claim 6 as taught above but fails to disclose a plurality of struts coupled to the catheter and arranged within the inner or outer balloon, the plurality of struts being configured to support the inner or outer balloon.
Walsh teaches, in the same field of endeavor (blood flow alteration device), a device comprising a plurality of struts (struts 22, Fig. 4) coupled to the catheter (23, Fig. 4) and arranged within a balloon, the plurality of struts being configured to support the balloon (Fig. 4).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art modify device of Maguire to include a plurality of struts coupled to the catheter and arranged within the balloon, the plurality of struts being configured to support the balloon as taught by Walsh in order to obtain the advantage of supporting the balloon (Walsh, Para. [0064]), such as the inner balloon and/or outer balloon.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 and 9-12 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument(s) on pages 10-11 of the remarks, Maguire discloses indwelling medical device for acute alteration of blood flow in a vessel of a patient, the device comprising: a catheter (11, Fig. 10); a vessel opposing member portion (14, Fig. 10 and Paras. [0200] and [0201]) arranged at or extending from a distal end of the catheter and configured to oppose against a vessel wall of the vessel (Paras. [0200] and [0201]), the vessel opposing member including an outer inflatable member configured to maintain contact with a wall of the vessel (Para. [0192], “the balloon 14 is expanded to an outer diameter that does not completely occlude the patient's aorta 31. However, in an alternative embodiment, the balloon expands into contact with the wall of the aorta 21, to an outer diameter that completely occludes the aorta 31.” Even in the embodiment that the balloon does not completely occlude the patient’s aorta, the balloon is still fully capable of maintaining contact with the wall of the vessel by shifting it to contacting the vessel wall on one side) ; and a flow altering element (13, Fig. 10 and Paras. [0200] and [0201]), arranged within the vessel opposing member portion and including a lumen (18, Fig. 11) for the blood flow through the vessel therethrough, configured to alter the blood flow through the lumen to restrict blood flow in the vessel and induce a physiologically mediated therapeutic response in the patient (Paras. [0200] and [0201], the flow altering element 13 is configured to alter the blood flow through the lumen to restrict blood flow in the vessel and induce a physiologically mediated therapeutic response in the patient by restricting blood flow in the vessel).
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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