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 .
Election/Restrictions
Claims 4-9, 13, 14, 16, 17, and 23 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/03/2025.
Applicant’s election without traverse of Group I, drawn to a vascular flow modulator and Species A, drawn to a flow modulator with an adjustable ring and driven gear mechanism in the reply filed on 03/03/2025 is acknowledged.
Claims 4-9, 13, 14, 16, 17, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/03/2025.
Applicant's election with traverse of Group I, drawn to a vascular flow modulator and Species A, drawn to a flow modulator with an adjustable ring and driven gear mechanism in the reply filed on 03/03/2025 is acknowledged. The traversal is on the ground(s) that means forming an adjustable flow restriction is a special technical feature which is not shown in Good et al (US 20210290358 A1). The applicant further argues that Goodman does not include as part of the device any “means forming an adjustable flow restriction” which according to the present disclosure is a flow restriction that is adjustable in vivo after placement of the vascular flow modulator within a patient’s vasculature. This is not found persuasive because the element 204 is an element that restriction flow in vivo after placement of the vascular flow modulator within a patient’s vasculature (see [0046] of Goodman, as it restricts blood flow, furthermore, in [0047] of Goodman it is discussed that the device can be diametrically adjustable in vivo after placement via a balloon, “Either or both of the stent and the graft structure of the implantable medical device 200 may be configured to maintain a new diameter in response to the distensible force”, in this case, 204 is part of the stent and graft structure hence it is adjustable).
The requirement is still deemed proper and is therefore made FINAL.
Response to Amendment
This office action is responsive to the amendment filed on 03/03/2025. As directed by the amendment: claims 10 have been amended, claims 11, 15, 18-22, and 24-43 have been cancelled, claims 4-9, 13, 14, 16, 17, and 23 have been withdrawn and claims 44-49 have been added. Thus, claims 1-10, 12-14, 16-17, 23, and 44-49 are presently pending in this application.
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.
The claim limitation “means forming an adjustable flow restriction” in claims 1-3, and 49 will be interpreted as “an adjustable ring” per applicant’s patent application publication in [0005] and [0034].
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(s) 1-3, 10, 12, and 44-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben Muvhar et al (US 20050055082 A1), herein referenced to as “Ben Muvhar” in view of Fahey et al (US 20230165672 A1), herein referenced to as “Fahey”.
Claims 1-3, 12, 44, 45, 48, and 49 are rejected over Fig. 13 of Ben Muvhar in view of Fahey.
Claim 1
Ben Muvhar discloses: A vascular flow modulator 2400 (see Fig. 13, [0223]), comprising: an expandable tubular structure 2406 (see Fig. 13, [0223]-[0224], inflatable flow reducing implant) having first and second ends distal and proximal ends of 2400 (see Fig. 13) with a central portion 2404 (see Fig. 13, [0228]) therebetween; means forming an adjustable flow restriction 2420 (see Fig. 13, [0223]-[0224], meets the 112f definition of an adjustable ring) through said central portion 2404.
Ben Muvhar does not explicitly disclose: and a thrombosis-resistant surface within the flow restriction.
However, Fahey in a similar field of invention teaches a vascular flow modulator 200 (see Figs. 2A-2B) with a means forming an adjustable flow restriction 218 (see Figs. 2A-2B, [0038], meets the definition of an adjustable ring). Fahey further teaches: and a thrombosis-resistant surface 212 (see Figs. 2A-2B, [0034], the membrane which forms the inner and outer surface of the device is made of ePTFE, which is an example of a thrombosis-resistant surface material given by the applicant, see applicant’s patent application publication [0038]) within the flow restriction 218.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ben Muvhar to incorporate the teachings of Fahey and have an vascular flow modulator with a thrombosis-resistant surface within the flow restriction. This is due to using ePTFE for membrane of vascular flow modulators being common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 2
The combination of Ben Muvhar and Fahey teaches: The vascular flow modulator of claim 1, see 103 rejection above. Ben Muvhar further discloses: wherein said means forming an adjustable flow restriction 2420 comprises means forming an adjustable reduced diameter section of the central portion (see Fig. 13, the reduced diameter section is at the central portion, namely 2114).
Claim 3
The combination of Ben Muvhar and Fahey teaches: The vascular flow modulator of claim 2, see 103 rejection above. Ben Muvhar further discloses: wherein said means forming an adjustable reduced diameter section 2420 comprise means for adjusting the reduced diameter portion after the flow modulator is deployed within a vascular lumen of a patient (see Fig. 13, the flow modulator is deployed within a vascular lumen of a patient and can be adjusted in vivo, see also [0225], after implantation it may further expand to constrict the reduced diameter section).
Claim 12
The combination of Ben Muvhar and Fahey teaches: The vascular flow modulator of claim 1, see 103 rejection above. Ben Muvhar further discloses: wherein said means forming an adjustable flow restriction 2420 comprises an adjustable ring 2420 (see Fig. 13, [0223]-[0224], 2420 is an expandable, hence adjustable ring) surrounding the central portion 2404 of the expandable tubular structure 2406 and a flexible tether 2428 (see Fig. 13, [0224]) manipulable from outside the patient's vasculature (2428 is part of the delivery system and inflates 2420) cooperating with the adjustable ring 2420 to alter the adjustable ring diameter the inner diameter of the ring decreases as the ring inflates (see Fig. 13, [0223]-[0224]).
Claim 44
Ben Muvhar discloses: A vascular flow modulator 2400 (see Fig. 13. [0223]), comprising: an expandable tubular structure 2406 (see Fig. 13, [0223]-[0224], inflatable flow reducing implant) having first and second ends distal and proximal ends of 2400 (see Fig. 13) with a central portion 2404 (see Fig. 13, [0228]) therebetween; an adjustable ring 2420 (see Fig. 13, [0223]-[0224]) surrounding the central portion 2404 (see Fig. 13) of the expandable tubular structure 2406 configured to provide an adjustable flow restriction (see [0223]-[0226], the flow restriction is dependent on the expansion of 2420, and this can alter in vivo after the device has been implanted as well) through said central portion 2404.
Ben Muvhar does not explicitly disclose: and a thrombosis-resistant surface within the flow restriction.
However, Fahey in a similar field of invention teaches a vascular flow modulator 200 (see Figs. 2A-2B) with an adjustable ring 218 (see Figs. 2A-2B, [0038]). Fahey further teaches: and a thrombosis-resistant surface 212 (see Figs. 2A-2B, [0034], the membrane which forms the inner and outer surface of the device is made of ePTFE, which is an example of a thrombosis-resistant surface material given by the applicant, see applicant’s patent application publication [0038]) within the flow restriction 218.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ben Muvhar to incorporate the teachings of Fahey and have an vascular flow modulator with a thrombosis-resistant surface within the flow restriction. This is due to using ePTFE for membrane of vascular flow modulators being common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 45
The combination of Ben Muvhar and Fahey teaches: The vascular flow modulator of claim 44, see 103 rejection above. Ben Muvhar further discloses: wherein the adjustable ring 2420 is adjustable in vivo after implantation (see [0225], the flow modulator is deployed within a vascular lumen of a patient and can be adjusted in vivo, after implantation it may further expand to constrict the reduced diameter section) of the vascular flow modulator 2400 in a patient's vasculature.
Claim 48
The combination of Ben Muvhar and Fahey teaches: The vascular flow modulator of claim 44, see 103 rejection above. Ben Muvhar further discloses: further comprising a flexible tether 2428 (see Fig. 13, [0224]) manipulable from outside the patient's vasculature (2428 is part of the delivery system and inflates 2420) cooperating with the adjustable ring 2420 to alter the adjustable ring diameter the inner diameter of the ring decreases as the ring inflates (see Fig. 13, [0223]-[0224]).
Claim 49
Ben Muvhar discloses: A vascular flow modulator 2400 (see Fig. 13, [0223]), comprising: an expandable tubular structure 2406 (see Fig. 13, [0223]-[0224], inflatable flow reducing implant) having first and second ends distal and proximal ends of 2400 (see Fig. 13) with a central portion 2404 (see Fig. 13, [0228]) therebetween; means forming an adjustable flow restriction 2420 (see Fig. 13, [0223]-[0224], meets the 112f definition of an adjustable ring) through said central portion 2404, wherein said means forming an adjustable flow restriction 2420 comprises means forming an adjustable reduced diameter section of the central portion (see Fig. 13, the reduced diameter section is at the central portion, namely 2114), and said means forming an adjustable reduced diameter section 2420 comprise means for adjusting the reduced diameter portion after the flow modulator is deployed within a vascular lumen of a patient (see Fig. 13, the flow modulator is deployed within a vascular lumen of a patient and can be adjusted in vivo, see also [0225], after implantation it may further expand to constrict the reduced diameter section).
Ben Muvhar does not explicitly disclose: and a thrombosis-resistant surface within the flow restriction.
However, Fahey in a similar field of invention teaches a vascular flow modulator 200 (see Figs. 2A-2B) with a means forming an adjustable flow restriction 218 (see Figs. 2A-2B, [0038], meets the definition of an adjustable ring). Fahey further teaches: and a thrombosis-resistant surface 212 (see Figs. 2A-2B, [0034], the membrane which forms the inner and outer surface of the device is made of ePTFE, which is an example of a thrombosis-resistant surface material given by the applicant, see applicant’s patent application publication [0038]) within the flow restriction 218.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ben Muvhar to incorporate the teachings of Fahey and have an vascular flow modulator with a thrombosis-resistant surface within the flow restriction. This is due to using ePTFE for membrane of vascular flow modulators being common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claims 1, 10, 44, 46, and 47 are rejected over Fig. 14 of Ben Muvhar in view of Fahey.
Claim 1
Ben Muvhar discloses: A vascular flow modulator 2700 (see Fig. 14, [0230]), comprising: an expandable tubular structure 2102 (see Fig. 14, [0233]) having first and second ends proximal and distal ends of 2700 (see Fig. 14) with a central portion central portion of 2700 adjacent to 2730 (see Fig. 14) therebetween; means forming an adjustable flow restriction 2720 + 2722 (see Fig. 14, [0231]-[0234], they additionally are exterior to the implant and as the bend they narrow the lumen, meets 112f definition of an adjustable ring as the two portions create a ring-like shape to match and surround the tubular device of 2700) through said central portion central portion of 2700 adjacent to 2730.
Ben Muvhar does not explicitly disclose: and a thrombosis-resistant surface within the flow restriction.
However, Fahey in a similar field of invention teaches a vascular flow modulator 200 (see Figs. 2A-2B) with an adjustable ring 218 (see Figs. 2A-2B, [0038]). Fahey further teaches: and a thrombosis-resistant surface 212 (see Figs. 2A-2B, [0034], the membrane which forms the inner and outer surface of the device is made of ePTFE, which is an example of a thrombosis-resistant surface material given by the applicant, see applicant’s patent application publication [0038]) within the flow restriction 218.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ben Muvhar to incorporate the teachings of Fahey and have an vascular flow modulator with a thrombosis-resistant surface within the flow restriction. This is due to using ePTFE for membrane of vascular flow modulators being common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 10
The combination of Ben Muvhar and Fahey teaches: The vascular flow modulator of claim 1, see 103 rejection above. Ben Muvhar further discloses: wherein said means forming an adjustable flow restriction 2720 + 2722 comprises: an electronic package 2730 + 2732 (see Fig. 14, [0231] and [0236]) comprising a sensor controlled micro-motor 2730 + 2732 (see Fig. 14, [0236], motors powered or stimulated by such signals); in adjustable ring 2730 + 2732 extending around the central portion central portion of 2700 adjacent to 2730 (see Fig. 14) of said tubular structure 2102, the adjustable ring 2730 + 2732 having a variable diameter the diameter of the 2730 + 2732 (see [0234], around the central portion, controls the diameter of the lumen of 2700 via 2730 and 2732, see [0231]) driven by the micro-motor 2730 + 2732.
Ben Muvhar does not explicitly disclose: a pressure sensor communicating with the micro-motor whereby a diameter of the adjustable flow restriction of said tubular structure is varied in response to changes in vascular pressure.
However, Fahey in a similar field of invention teaches a vascular flow modulator 200 (see Figs. 2A-2B) with an adjustable ring 218 (see Figs. 2A-2B, [0038]) and a sensor controlled micro-motor 216 (see Figs. 2A-2B, [0043], motors, [0082], consistent adjustment to flow of blood based on blood pressure level, including pressure sensors, see [0145]). Fahey further teaches: a pressure sensor (see [0145], pressure sensor) communicating with the micro-motor 216 (see Figs. 2A-2B, [0043] and [0082]-[0083], adjustment of the geometry of the flow modulator is done via 216 and based on blood pressure) whereby a diameter (see [0083], diameter of the aperture) of the adjustable flow restriction of said tubular structure 200 is varied in response to changes in vascular pressure (see [0082]-[0083]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ben Muvhar to incorporate the teachings of Fahey and have a vascular flow modulator with pressure sensor communicating with the micro-motor whereby a diameter of the adjustable flow restriction of said tubular structure is varied in response to changes in vascular pressure. Motivation for such can be found in Fahey as this allows for consistent adjustments to be made to adjust the flow of blood based on a blood pressure level which changes frequently over the course of a day (see [0082]).
Claim 44
Ben Muvhar discloses: A vascular flow modulator 2700 (see Fig. 14, [0230]), comprising: an expandable tubular structure 2102 (see Fig. 14, [0233]) having first and second ends proximal and distal ends of 2700 (see Fig. 14) with a central portion central portion of 2700 adjacent to 2730 (see Fig. 14) therebetween; an adjustable ring 2720 + 2722 (see Fig. 14, [0231]-[0234], they additionally are exterior to the implant and as the bend they narrow the lumen, meets definition of an adjustable ring as the two portions create a ring-like shape to match and surround the tubular device of 2700) surrounding the central portion central portion of 2700 adjacent to 2730 (see Fig. 14) of the expandable tubular structure 2102 configured to provide an adjustable flow restriction (see [0231]-[0234], the flow restriction is dependent on the actuation of 2720 + 2722, and this can alter in vivo after the device has been implanted as well) through said central portion central portion of 2700 adjacent to 2730.
Ben Muvhar does not explicitly disclose: and a thrombosis-resistant surface within the flow restriction.
However, Fahey in a similar field of invention teaches a vascular flow modulator 200 (see Figs. 2A-2B) with an adjustable ring 218 (see Figs. 2A-2B, [0038]). Fahey further teaches: and a thrombosis-resistant surface 212 (see Figs. 2A-2B, [0034], the membrane which forms the inner and outer surface of the device is made of ePTFE, which is an example of a thrombosis-resistant surface material given by the applicant, see applicant’s patent application publication [0038]) within the flow restriction 218.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ben Muvhar to incorporate the teachings of Fahey and have an vascular flow modulator with a thrombosis-resistant surface within the flow restriction. This is due to using ePTFE for membrane of vascular flow modulators being common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 46
The combination of Ben Muvhar and Fahey teaches: The vascular flow modulator of claim 44, see 103 rejection above. Ben Muvhar further discloses: an electronic package 2730 + 2732 (see Fig. 14, [0231] and [0236]) comprising a sensor controlled micro-motor 2730 + 2732 (see Fig. 14, [0236], motors powered or stimulated by such signals), wherein the adjustable ring 2730 + 2732 has a variable diameter the diameter of the 2730 + 2732 (see [0234], around the central portion, controls the diameter of the lumen of 2700 via 2730 and 2732, see [0231]) driven by the micro-motor 2730 + 2732.
Claim 47
The combination of Ben Muvhar and Fahey teaches: The vascular flow modulator of claim 46, see 103 rejection above.
Ben Muvhar does not explicitly disclose: further comprising a pressure sensor communicating with the micro-motor whereby a diameter of the adjustable flow restriction of said tubular structure is varied in response to changes in vascular pressure.
However, Fahey in a similar field of invention teaches a vascular flow modulator 200 (see Figs. 2A-2B) with an adjustable ring 218 (see Figs. 2A-2B, [0038]) and a sensor controlled micro-motor 216 (see Figs. 2A-2B, [0043], motors, [0082], consistent adjustment to flow of blood based on blood pressure level, including pressure sensors, see [0145]). Fahey further teaches: a pressure sensor (see [0145], pressure sensor) communicating with the micro-motor 216 (see Figs. 2A-2B, [0043] and [0082]-[0083], adjustment of the geometry of the flow modulator is done via 216 and based on blood pressure) whereby a diameter (see [0083], diameter of the aperture) of the adjustable flow restriction of said tubular structure 200 is varied in response to changes in vascular pressure (see [0082]-[0083]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ben Muvhar to incorporate the teachings of Fahey and have a vascular flow modulator with pressure sensor communicating with the micro-motor whereby a diameter of the adjustable flow restriction of said tubular structure is varied in response to changes in vascular pressure. Motivation for such can be found in Fahey as this allows for consistent adjustments to be made to adjust the flow of blood based on a blood pressure level which changes frequently over the course of a day (see [0082]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771