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 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 15-17, 20, 23, 24, 31, 32 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 15 calls for a medical system comprising “a delivery component comprising a reservoir of the embolic material of claim 1”. Claim 1 recites a method of embolizing a hypervascular vessel including the step of releasing an embolic material. The scope of “the embolic material of claim 1” cannot be determined because claim 1 includes many limitations in addition to the embolic material. A recitation of a prior claim necessarily includes the entirety of the claim and cannot reference merely a portion of the claim.
Claims 16, 17, 20, 23, 24 inherit the deficiencies of claim 15.
Claim 31 calls for a medical system comprising “a delivery component comprising a reservoir of the embolic material of claim 25”. Claim 25 recites a method of embolizing a vessel including the step of releasing an embolic material. The scope of “the embolic material of claim 25” cannot be determined because claim 25 includes many limitations in addition to the embolic material. A recitation of a prior claim necessarily includes the entirety of the claim and cannot reference merely a portion of the claim.
Claim 32 inherits the deficiencies of claim 31.
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.
Claim(s) 1-4, 9, 10, 12, 13, 21, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothman et al (US 4,124,705) in view of Okuno et al (“Short-term results of transcatheter arterial embolization for abnormal neovessels in patients with adhesive capsulitis: a pilot study” Okuno et al, J Shoulder Elbow Surg (2014) 23, e199-e206).
Regarding claim 1, Rothman discloses method of embolizing a vessel comprising the steps of: advancing a catheter through a vasculature to a parent artery (col. 18, line 32); and releasing an embolic material from a distal end of the catheter into the vessel (col. 1, lines 58-62), with the embolic material blocking blood flow in the vessel without blocking blood flow to a parent vessel (col. 2, lines 1-3), wherein the embolic comprises particles that comprise starch (col. 2, lines 25-26) and are biodegradable within a period of time from 15 minutes to 48 hours (col. 18, lines 51-56).
Claim 1 calls for the method to be a method of embolizing a hypervascular vessel formed in response to chronic inflammation in a musculoskeletal vasculature, and the particles to be delivered to a hypervascular vessel. Rothman teaches a generic method of embolizing fine vessels, but does not specifically disclose embolizing hypervascular vessels formed in response to chronic inflammation in a musculoskeletal vasculature. Okuno teaches a method of performing transcatheter arterial embolization wherein a hypervascular vessel is embolized, and further that angiogenesis and inflammation are often closely related and that angiogenesis could facilitate inflammation, and further that a method of embolization can suppress inflammation that was otherwise enhanced by angiogenesis (page e204, bottom left column). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rothman to be performed on a hypervascular vessel formed in response to chronic inflammation in a musculoskeletal vasculature as taught by Okuno because Okuno discloses that transcatheter arterial embolization of hypervascular vessels caused by inflammation can reduce pain and inflammation in the joint.
Regarding claims 2 and 3, Rothman discloses that the particles have a size of 5-150 microns (col. 5, lines 22-24). This range is substantially similar to claimed range and therefore anticipates the claimed range.
Regarding claim 4, Rothman discloses that the particles are spherical (col. 5, lines 18-19).
Regarding claim 9, Rothman discloses that the particles are biodegradable by enzymatic action (col. 2, lines 10-16).
Regarding claim 10, Rothman discloses that the particles are biodegradable by amylase (col. 2, lines 26-29).
Regarding claim 12, Rothman discloses that the embolic material further comprises a contrast agent (col. 8, lines 49-54).
Regarding claim 13, Rothman discloses that the prior of time is within the range of 15 minutes to 8 hours (col. 18, lines 51-56).
Regarding claim 21, Rothman discloses that the starch is crosslinked (col. 2, lines 8-9).
Regarding claim 22, Rothman discloses that the particles consist essentially of starch (col. 2, lines 25-26).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothman in view of Okuno as applied to claim 1 above, and further in view of Zhiljakov et al (RU 2 604 949 C1). For ease of discussion, please refer to machine translation provided herewith.
Claim 14 calls for treatment of the heel, spine or knee. Okuno teaches that the treated joint is a shoulder. Zhiljakov teaches that pain in the knee can be treated by coagulation of new pathological vessels in the knee joint which results in reduced pain and limited damage to surrounding tissue (abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rothman in view of Okuno to include embolization of pathological vessels in the knee as taught by Zhiljakov to provide lasting reduction in knee pain without damaging surrounding tissue.
Claim(s) 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothman in view of Arepally et al (US 9,889,031).
Regarding claim 25, Rothman discloses a method for embolizing a vessel, the method comprising; advancing a catheter through a vasculature to a parent artery (col. 18, line 32); and releasing an embolic material from a distal end of the catheter into a vessel (col. 1, lines 58-62), with the embolic material blocking blood flow in the vessel without blocking blood flow to a parent vessel (col. 2, lines 1-3), wherein the embolic material is biodegradable within a predetermined period of time (col. 18, lines 51-56).
Claim 25 differs from Rothman in calling or the method to include embolization of a vessel related to production of ghrelin wherein the material is delivered to a vessel related to production of ghrelin. Arepally teaches a method of embolizing a vessel related to the production of ghrelin by delivering an embolizing agent to a vessel associated with the production of ghrelin to non-invasively induce weight loss (abstract; col. 1, lines 64-65; col. 2, lines 8-21). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rothman to include embolization of a vessel related to the production of ghrelin as taught by Arepally to provide non-invasive treatment for weight loss.
Regarding claim 26, Arepally further teaches that the vessel related to production of ghrelin is a vasculature feeding a fundus portion of a stomach (col. 2, lines 8-21). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rothman to include the step of embolizing a vessel feeding a fundus portion of the stomach as taught by Arepally to provide reduction is ghrelin and induce weight loss.
Regarding claim 27, Rothman discloses that the period of time from 15 minutes to 48 hours (col. 18, lines 51-56).
Regarding claim 28, Rothman discloses that the embolic material is starch (col. 2, lines 25-26).
Regarding claim 29, Rothman discloses that the starch is crosslinked (col. 2, lines 8-9).
Regarding claim 30, Rothman discloses that the particles consist essentially of starch (col. 2, lines 25-26).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: claims 15, 31, and claims depending therefrom have been rejected under 112(b) as the scope of the claims cannot be determined. However, it is noted that the prior art cited above appears to disclose as the limitations of these claims as they substantially correspond to the rejected claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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