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 .
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.
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.
Claim(s) 2, 4, 14 and 15 is/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 4 recites the limitation "the venous plantar pump" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the capillaries" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the capillaries" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The term “improves” in claim 2 and claim 14 is a relative term which renders the claim indefinite. The term “improves” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The size and shape of expansion of the venous reducer that improves arterial blood flow to the foot or hand is rendered indefinite by the use of the term “improves”.
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) 1-12, 24-26 and 28 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 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]. 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.
Regarding claim 2, Ben Muvhar discloses expanding the venous reducer [0149, 0260].
Regarding claim 3, Ben Muvhar discloses delivering the venous reducer to one of the foot or calf of the patient to regulate a patient’s venous plantar pump [0258].
Regarding claim 4, Ben Muvhar discloses that expansion of the venous reducer causes higher pressure in a proximal portion [0260] 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, Ben Muvhar discloses maintaining the venous reducer in the vasculature of the foot or ankle for a desired treatment period after expansion and removing the venous reducer from the vein after the desired treatment [0178-180].
Regarding claim 6, Ben Muvhar discloses that the narrowed connection portion increases fluid pressure to the upstream pressure due to veins taking blood upstream to the heart (Fig. 4D).
Regarding claim 7, Ben Muvhar discloses delivering the venous reducer to the posterior tibial vein [0257].
Regarding claim 8, Ben Muvhar 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].
Regarding claim 9, Ben Muvhar discloses that the venous reducer expands both the upstream and downstream portions simultaneously [0141].
Regarding claim 10, Ben Muvhar discloses allowing self-expansion of the venous reducer from a compressed state within a catheter [0016].
Regarding claim 11, Ben Muvhar discloses that the expanded upstream portion includes a diameter that is different from an expanded diameter of the downstream portion [0200, 0204].
Regarding claim 12, Ben Muvhar discloses that the expanded upstream portion includes a diameter that is the same as an expanded diameter of the downstream portion (Fig. 4D).
Regarding claims 24 and 28, Ben Muvhar discloses a venous reducer (1100; Fig. 4D) including 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 [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).
Regarding claim 25, Ben Muvhar discloses that the upstream and downstream portions are expandable within the vasculature of at least one of a patient’s hand or foot [0149, 0257, 0276] via balloon or self-expansion [0016, 0018, 0019].
Regarding claim 26, Ben Muvhar discloses that the narrowed connection portion is not expandable [0015].
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.
Claim(s) 13-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben Muvhar.
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. 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 used the method of Ben Muvhar in a cephalic or basilic vein within wrist or hand of the patient since in the instant case, the device of Ben Muvhar would not operate differently within the claimed location, a cephalic or basilic vein within the wrist or hand. The Applicant places no criticality of the location claimed, indicating simply that the method may be used within the foot, hand and/or other areas of the body (instant specification [0058]). 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 with a vein within the wrist or hand, as this modification involves the simple substitution of one location with another for the predictable result of treating ischemia.
Regarding claim 14, the combination of Ben Muvhar and Brandeis discloses expanding the venous reducer [0149, 0260;Ben Muvhar].
Regarding claim 15, the combination of Ben Muvhar and Brandeis 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 Brandeis discloses maintaining the venous reducer in the vasculature of the foot or ankle for a desired treatment period after expansion and removing the venous reducer from the vein after the desired treatment [0178-180;Ben Muvhar].
Regarding claim 17, the combination of Ben Muvhar and Brandeis 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 Brandeis 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 Brandeis 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 Brandeis 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 Brandeis 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 Brandeis 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) 27 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 27, 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.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ruiz (US 6,120,534) discloses a method of delivering a venous reducer and Jackson et al. (US 2020/0229956A1) discloses a flow modifying apparatus.
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