DETAILED ACTION
This Office Action is in response to the Amendment filed 23 April 2026 Claim(s) 1-6, 8-17, 19-26, and 28 are currently pending. The Examiner acknowledges the amendments to claim(s) 1-5, 13-16, 24-25 and 28, cancelled claim(s) 7, 18, and 27.
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 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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘expandable structure’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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) 24-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben Muvhar et al. (US 2005/0055082A1, Ben Muvhar”).
Regarding claims 24 and 25, the combination of Ben Muvhar and Shook discloses a venous reducer (1100; Fig. 4D; Ben Muvhar) including an upstream portion and a downstream portion (1160; Ben Muvhar) that are capable of being sized and shaped for placement within the vasculature of at least one of a patient’s hand or foot [0257, 0276; Ben Muvhar] via a delivery system (catheter; [0016, 0149, 0208] ; Ben Muvhar). A narrowed connection portion (1168) extends between the upstream and downstream portions. The narrowed connection portion includes a diameter that is smaller than a diameter of the upstream and downstream portions (Fig. 4D; Ben Muvhar). It is noted that a deep limb vein includes a plantar veinous arch, lateral plantar vein and a medial plantar vein and Ben Muvhar discloses that the placement may be used in other veins [0255]. Further noted, the venous reducer must only be capable of being delivered to one of a cephalic vein and a basilic vein or a plantar veinous arch, lateral plantar vein and a medial plantar vein of a patient’s foot. It has been held that the recitation that an element is "capable of" performing a function in a system or device claim is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138. The upstream and downstream portions are expandable within the vasculature of at least one of a patient’s hand or foot [0149, 0257, 0276; Ben Muvhar] via balloon or self-expansion [0016, 0018, 0019; Ben Muvhar].
Regarding claim 26, the combination of Ben Muvhar and Shook discloses that the narrowed connection portion is not expandable [0015; Ben Muvhar].
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.
Claim(s) 1-6 and 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben Muvhar et al. (US 2005/0055082A1, Ben Muvhar”) in view of Shook et al. (US 5,823,195, “Shook”).
Regarding claim 1, Ben Muvhar discloses a method of treatment including delivering a venous reducer(1100; Fig. 4D) by way of the patient’s vasculature to a first delivery location within a vein of the foot [0149, 0257 notes that the method may be performed in the ankle and that the size of the reducer may adapted to fit the particular vein being treated]. The venous reducer includes an expandable structure that when expanded includes upstream and downstream portions (1160) that are connected to a narrowed connection portion (1168). The venous reducer is expanded within the vasculature of the of the ankle [0257, 0141] of the patient and thus creating an hourglass shaped structure (Fig. 4D) within the vasculature where the narrowed connection portion acts as a restriction (flow reducing; [0259-0263, 0277]) for blood flow. The vasculature in which the reducer may be expanded includes a limb deep vein. In the same field of endeavor, treating a limb deep vein, and as evidenced by Shook et al., Shook teaches that deep veins of the foot include deep plantar venous arch and the medial and lateral plantar veins (C1:L60-63). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the placement of the venous reducer of Ben Muvhar, with placement within a deep plantar venous arch, medial plantar vein or lateral plantar vein, as this modification involves the simple substitution of one deep vein with another for the predictable result of treating a lower limb vein.
Regarding claim 2, the combination of Ben Muvhar and Shook discloses expanding the venous reducer to a size and shape that increases arterial blood flow to the foot [0149, 0257, 0260; Ben Muvhar].
Regarding claim 3, the combination of Ben Muvhar and Shook discloses delivering the venous reducer to the foot of the patient to regulate a patient’s venous plantar pump [0258; Ben Muvhar].
Regarding claim 4, the combination of Ben Muvhar and Shook discloses that expansion of the venous reducer causes higher pressure in a proximal portion [0260; Ben Muvhar] wherein increasing blood flow to the foot via capillaries and increases oxygen to the foot in response to a venous plantar pump which is a natural mechanism in the foot that pumps blood upwards toward the heart.
Regarding claim 5, the combination of Ben Muvhar and Shook discloses maintaining the venous reducer in the vasculature at the first delivery location for a desired treatment period after expansion and removing the venous reducer from first delivery location after the desired treatment [0178-180; Ben Muvhar].
Regarding claim 6, the combination of Ben Muvhar and Shook discloses that the narrowed connection portion increases fluid pressure to the upstream pressure due to veins taking blood upstream to the heart (Fig. 4D; Ben Muvhar).
Regarding claim 8, the combination of Ben Muvhar and Shook discloses delivering at least one additional venous reducer to a second delivery location within a vein of the foot by way of the vasculature [0255, 0257, 0258; Ben Muvhar].
Regarding claim 9, Ben the combination of Ben Muvhar and Shook discloses that the venous reducer expands both the upstream and downstream portions simultaneously [0141; Ben Muvhar].
Regarding claim 10, the combination of Ben Muvhar and Shook discloses allowing self-expansion of the venous reducer from a compressed state within a catheter [0016; Ben Muvhar].
Regarding claim 11, the combination of Ben Muvhar and Shook discloses that the expanded upstream portion includes a diameter that is different from an expanded diameter of the downstream portion [0200, 0204; Ben Muvhar].
Regarding claim 12, the combination of Ben Muvhar and Shook discloses that the expanded upstream portion includes a diameter that is the same as an expanded diameter of the downstream portion (Fig. 4D; Ben Muvhar).
Claim(s) 13-17 and 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben Muvhar in view of Schwartz (US 2023/0039005A1).
Regarding claims 13 and 18, Ben Muvhar discloses a method of treatment including delivering a venous reducer(1100; Fig. 4D) by way of the patient’s vasculature to a first delivery location within a vein of the foot [0149, 0257, 0276 notes that the venous reducer may be adapted to match other ducts or conduits other than the foot]. The venous reducer includes an expandable structure that when expanded includes upstream and downstream portions (1160) that are connected to a narrowed connection portion (1168). The venous reducer is expanded within the vasculature of the of the ankle [0257] of the patient and thus creating an hourglass shaped structure (Fig. 4D) within the vasculature where the narrowed connection portion acts as a restriction (flow reducing; [0259-0263, 0277]) for blood flow. However, Ben Muvhar does not expressly disclose performing the method in the cephalic or basilic veins of the hand or wrist of the patient but does disclose the use of the method in other ducts or conduits other than the foot [0255].
In the same field of endeavor, treating veins, Schwartz teaches a venous stent that is implanted within a cephalic or basilic vein [0086]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the vein within the foot or ankle of Ben Muvhar with the cephalic or basilic vein, as taught by Schwartz, as this modification involves the simple substitution of one location with another for the predictable result of treating a vein to maintain a flow channel.
Regarding claim 14, the combination of Ben Muvhar and Schwartz discloses expanding the venous reducer [0149, 0260;Ben Muvhar].
Regarding claim 15, the combination of Ben Muvhar and Schwartz discloses that expansion of the venous reducer causes higher pressure in a proximal portion [0260;Ben Muvhar] wherein increasing blood flow to the foot via capillaries and increases oxygen to the foot in response to a venous plantar pump which is a natural mechanism in the foot that pumps blood upwards toward the heart.
Regarding claim 16, the combination of Ben Muvhar and Schwartz discloses maintaining the venous reducer in the vasculature at the first delivery location for a desired treatment period after expansion and removing the venous reducer from the first delivery location after the desired treatment [0178-180;Ben Muvhar].
Regarding claim 17, the combination of Ben Muvhar and Schwartz discloses that the narrowed connection portion increases fluid pressure to the upstream pressure due to veins taking blood upstream to the heart (Fig. 4D;Ben Muvhar).
Regarding claim 19, the combination of Ben Muvhar and Schwartz discloses delivering at least one additional venous reducer to a second delivery location within a vein of the foot by way of the vasculature [0255, 0257, 0258;Ben Muvhar].
Regarding claim 20, the combination of Ben Muvhar and Schwartz discloses that the venous reducer expands both the upstream and downstream portions simultaneously [0141;Ben Muvhar].
Regarding claim 21, the combination of Ben Muvhar and Schwartz discloses allowing self-expansion of the venous reducer from a compressed state within a catheter [0016;Ben Muvhar].
Regarding claim 22, the combination of Ben Muvhar and Schwartz discloses that the expanded upstream portion includes a diameter that is different from an expanded diameter of the downstream portion [0200, 0204;Ben Muvhar].
Regarding claim 23, the combination of Ben Muvhar and Schwartz discloses that the expanded upstream portion includes a diameter that is the same as an expanded diameter of the downstream portion (Fig. 4D;Ben Muvhar).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben Muvhar in view of Brandeis et al. (US 2009/0216261A1, “Brandeis”).
Regarding claim 28, Ben Muvhar discloses system including a venous reducer (1100; Fig. 4D) having an upstream portion and a downstream portion (1160) that are capable of being sized and shaped for placement within the vasculature of at least one of a patient’s hand or foot (cephalic vein, basilic vein, plantar venous arch, lateral plantar vein or medial plantar vein; [0255, 0257,0276]) via a delivery system (catheter; [0016, 0149, 0208]). A narrowed connection portion (1168) extends between the upstream and downstream portions. The narrowed connection portion includes a diameter that is smaller than a diameter of the upstream and downstream portions (Fig. 4D). It is noted that the venous reducer must only be capable of being delivered to one of a cephalic vein and a basilic vein or a plantar veinous arch, lateral plantar vein and a medial plantar vein of a patient’s foot. It has been held that the recitation that an element is "capable of" performing a function in a system or device claim is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138. Ben Muvhar does not disclose that the venous reducer includes bioabsorbable material that is absorbable into the vasculature of a patient at a desired time period after its placement within the vasculature.
Ben Muvhar discloses that the reducer may be formed of nitinol [0226]. In the same field of endeavor, venous reducers, Brandeis teaches a venous reducer that may be formed of nitinol or biodegradable polypropylene or other suitable materials [0059], wherein the reducer constructed from absorbable and/or dissolvable materials may dissolve in the body after a certain period of time. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the venous reducer of Ben Muvhar with the bioabsorbable material, as taught by Brandeis, as this modification involves the simple substitution of one biocompatible material for another for the predictable result of avoiding the need to re-enter the vein for removal. Furthermore, a person of ordinary skill has good reason to pursue their known options within their technical grasp with the reasonable expectation that at least one would be successful.
Response to Arguments
Applicant's arguments filed 23 April 2026 have been fully considered but they are not persuasive. The Applicant contends that Ben Muvhar does not disclose placement of its implant in any locations that are distal to the ankle (below-the-ankle (BTA)), such as the plantar venous arch, the lateral plantar vein, and the medial plantar vein. The Applicant contends that Ben Muvhar does not disclose placement of its implant in areas of the hand or wrist including the cephalic vein and the basilic vein. Respectfully, Ben Muvhar discloses that the flow reducing implants may be delivered to blood vessels including a limb deep vein. A limb deep vein includes medial and lateral plantar veins as evidenced by Shook et al. (US 5,823,195) which teaches that deep veins of the foot include deep plantar venous arch and medial and lateral plantar veins (C1:L60-63). Schwartz (US 2023/0039005A1) teaches a venous stent that may be used in cephalic and basilic veins to maintain a flow channel by providing temporary support.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mackiewicz (US 2009/0187210A1) discloses a filter having a narrow portion disposed between proximal and distal expandable portions.
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 JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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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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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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