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 .
Drawings
The drawings are objected to as failing to properly use shading to aid in understanding the
invention. 37 CFR 1.84(m) encourages the use of shading to indicate certain shapes or to show parts in
perspective views. However, in the instant case, the use of shading in at least Figs. 16 and 17 reduces legibility by detracting from understanding the invention. The current use of shading in Figs. 16 and 17 is not legible, does not facilitate understanding of the invention, and the details would be lost in a printed patent. Correction is required.
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 1-6, 8-10, 19-22, 24, 25, 34, 36, 42, and 87-90 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 1 recites the limitation "the affected segment" in lines 8-9, 12, and 13. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if “the affected segment” is referring the segment “affected by” or “previously affected by.” Assuming “the affected segment” refers to both affected and previously affected segments, it is noted that all recitations of “the affected segment” should be changed to “the affected segment or previously affected segment” or something similar for clarification.
Claim 5 recites “the plurality of affected segments in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites “the affected vein” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 22 and 24 are rejected for similar reasons as set forth above regarding claim 1.
The remaining claims are rejected by virtue of being dependent on a rejected base claim.
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.
Claims 1-6, 8-10, 19-21, 24, 34, 42, and 87-90 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2022/0016397 to Wilson et al. (“Wilson”) in view of U.S. Patent Publication No. 2015/0141959 to Seward and U.S. Patent No. 5,645,815 to Dean et al. (“Dean”).
Regarding claim 1, Wilson teaches a method of reducing progression to post-thrombotic syndrome (PTS) in a subject ([0093]), the method comprising (b) advancing a therapeutic delivering catheter within a lumen of the vein to or near a segment of the vein, the segment affected by or previously affected by DVT ([0154]-[0155]) and (c) delivering a therapeutic composition into a perivascular tissue at or near the affected segment using the therapeutic delivering catheter ([0157]), wherein the therapeutic composition comprises an anti-inflammatory agent ([0165]) but does not teach the dosage.
Seward teaches a therapeutic dosage of an anti-inflammatory agent ([0104], dexamethasone) ranges from about 0.1 mg per cm of the thrombosed segment to about 10 mg per cm of the thrombosed segment ([0104], 1.6±1.1 mg per cm of the lesion).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a 0.1-10 mg per cm dosage in the method of Wilson as taught by Seward because the use of such a dosage yielded 100% procedural safety with a lack of drug-related serious adverse events or major adverse limb events ([0104]).
Regarding method step (a) identifying a vein in the subject affected by or previously affected by deep vein thrombosis (DVT), Examiner submits that since Wilson is being used to treat an area affected by DVT as shown above, that given the broadest reasonable interpretation, Wilson teaches the identification of the vein affected by DVT as an inherent part of treating a vein affected by DVT. In other words, one cannot treat a vein affected by DVT without identifying the affected vein, especially since no specifics regarding the “identifying” step have been claimed. Additionally, Wilson contemplates treating areas previously affected by DVT ([0093]) in order to reduce the potential risk of post-thrombotic syndrome (PTS). Examiner further submits that drug delivery to areas previously affected by DVT cannot occur without knowing where the previous DVT occurred. Previous treatment for DVT indicates inherent knowledge of that treatment location in order for subsequent treatment to be performed to prevent potential PTS.
In any case, Dean has been cited to teach common methods of identifying a vein in the subject affected by deep vein thrombosis (column 1, lines 43-45). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of identifying a vein affected by DVT with the method of treating a vein affected of Wilson to yield the predictable result of treating a vein affected by DVT, since the treatment method of Wilson would inherently need a means of identifying a target area in order to be performed, and Dean shows art-recognized examples of identifying DVT target areas.
Regarding claim 2, Wilson, Seward, and Dean teach the method of claim 1 as shown above, Wilson further teaching the anti-inflammatory agent comprising a glucocorticoid ([0093], dexamethasone).
Regarding claim 3, Wilson, Seward, and Dean teach the method of claim 2 as shown above, Wilson further teaching dexamethasone ([0093]).
Regarding claim 4, Wilson, Seward, and Dean teach the method of claim 3 as shown above, Wilson further teaching the vein affected by DVT comprising a plurality of thrombotic segments ([0058]).
Regarding claim 5, Wilson, Seward, and Dean teach the method of claim 4 as shown above, Wilson further teaching the therapeutic composition being delivered to the plurality of affected segments ([0058]).
Regarding claim 6, Wilson, Seward, and Dean teach the method of claim 1 as shown above, Wilson further teaching the vein affected by DVT has undergone a catheter-directed thrombolysis or thrombectomy (CDT) previously ([0093]).
Regarding claim 8, Wilson, Seward, and Dean teach the method of claim 1 as shown above, Seward further teaching a total dosage of the anti-inflammatory agent delivered into the vein affected by DVT ranges between about 1 mg and about 100 mg ([0104], Seward teaches 3.2 mg to 24 mg).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a 1 mg to about 100 mg dosage of anti-inflammatory agent in the method of Wilson, Seward, and Dean, as taught by Seward, because procedural safety was seen in 100% of patients, with a lack of drug-related or device-related serious adverse events or major adverse limb events (amputation or major vascular re-intervention in the index limb) within 30 days of the procedure with such a dosage ([0104]).
Regarding claim 9, Wilson, Seward, and Dean teach the method of claim 1 as shown above, Seward further teaching a therapeutic concentration of the anti-inflammatory agent delivered into the vein affected by DVT ranges between about 0.1 mg/ml to about 10 mg/ml ([0118], 4 mg/ml).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a 0.1-10 mg/ml concentration in the method of Wilson, Seward, and Dean, as taught by Seward, because such a concentration is approved for reducing soft tissue inflammation (Seward [0118]).
Regarding claim 10, Wilson, Seward, and Dean teach the method of claim 9 as shown above, Seward further teaching a volume of the anti-inflammatory agent delivered into the vein affected by DVT ranges between about 0.01 ml per cm of the thrombosed vein to about 100 ml per cm of the thrombosed vein ([0118], 0.5 ml per cm).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a 0.01-100 ml per cm volume in the method of Wilson, Seward, and Dean, as taught by Seward, because such a target volume is approved for reducing soft tissue inflammation ([0118]).
Regarding claim 19, Wilson, Seward, and Dean teach the method of claim 1 as shown above, but the above rejection has not explicitly addressed biomarker levels. However, it is known that the level of one or more inflammatory biomarkers would decrease after the delivery of the therapeutic (anti-inflammatory) composition of Wilson, Seward, and Dean into a perivascular tissue at or near the thrombosed segment, as evidenced by Seward. Seward states that reduction of biomarker levels is indicative of the ability to combat localized inflammation ([0035]), therefore the reduction of inflammation caused by the anti-inflammatory agent would result in reduced biomarker levels.
Regarding claims 20 and 21, Wilson, Seward, and Dean, as evidenced by Seward teach the method of claim 19, but the above rejection has not specified examples of the biomarker or where the biomarker is measured. Seward further teaches an inflammatory biomarker comprising MCP-1 (claim 8) that is taken from whole blood ([0035], circulating blood).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used MCP-1 measured from the blood as the specific biomarker used in the method of Wilson, Seward, and Dean, as taught by Seward, because MCP-1 is a known example of a biomarker that is useful as an indicator of inflammation reduction (Seward, [0035]).
Regarding claim 24, Wilson, Seward, and Dean teach the method of claim 1 as shown above, but the above rejection has not addressed patency. However, it is known that the reduction in progression to PTS (i.e., the presence of DVT as previously defined) is assessed by maintenance or an increase in patency of the affected segment, as evidenced by Seward. Seward states that improved patency accompanies the reduction of inflammation by dexamethasone, which is the same therapeutic agent used by Applicant ([0057]).
Regarding claim 34, Wilson, Seward, and Dean teach the method of claim 1 as shown above, but the above rejection does not specifically address PTS symptoms. However, the reduction in progression to PTS being assessed by a decrease or a lack of increase in a symptom of PTS, wherein Wilson further teaches the symptoms of PTS comprises one or more of pain or edema ([0093]). Wilson shows that at least pain or edema are common signs of PTS, and that infusate delivery of anti-inflammatory drugs can reduce the incidence of PTS, thereby reducing symptoms of PTS such as pain or edema ([0093]).
Regarding claim 42, Wilson, Seward, and Dean teach the method of claim 1 as shown above, Wilson further teaching the therapeutic composition comprising one or more components for extended release, sustained release, or controlled release ([0092], microspheres for controlled release).
Regarding claim 87, Wilson, Seward, and Dean teach the method of claim 1, Wilson further teaching the delivering of the therapeutic composition into the perivascular tissue comprises one or more injections of the therapeutic composition into the perivascular tissue ([0086]).
Regarding claim 88, Wilson, Seward, and Dean teach the method of claim 87, Wilson further teaching the method further comprises repeating steps (b) and (c) at an additional segment of the vein ([0058], successive infusion).
Regarding claim 89, Wilson, Seward, and Dean teach the method of claim 2, Wilson previously teaching the glucocorticoid comprises dexamethasone, but does not explicitly mention dexamethasone sodium phosphate, although dexamethasone sodium phosphate is merely the form of dexamethasone commonly used for injections.
Seward teaches dexamethasone sodium phosphate ([0118]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted dexamethasone sodium phosphate for dexamethasone to yield the predictable result of providing an anti-inflammatory agent infusion.
Regarding claim 90, Wilson, Seward, and Dean teach the method of claim 89, but the previous rejection does not include an iodinated contrast agent.
Seward teaches the therapeutic composition further comprises an iodinated contrast agent ([0118]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an iodinated contrast agent with the therapeutic composition of Wilson, Seward, and Dean, in order to allow for X-ray fluoroscopic visualization required to positively assess infusion success ([0119]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson, Seward, and Dean as applied to claim 1 above, and as further evidenced by “High dose dexamethasone increases circulating P-selectin and von Willebrand factor levels in healthy men,” Throm Haemost to Jilma et al. (“Jilma”).
Regarding claim 22, Wilson, Seward, and Dean teach the method of claim 1 as shown above, however the above rejection has not specifically addressed the biomarkers. However, it is known that a level of one or more anti- inflammatory biomarkers increases after the delivery of a therapeutic composition into a perivascular tissue at or near the affected segment, as evidenced by Jilma. Jilma shows that, for example, certain biomarkers such as P-selectin increase as a result of dexamethasone delivery (title and summary).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson, Seward, and Dean as applied to claim 1 above, and as further evidenced by “Adventitial Drug Delivery of Dexamethasone to Improve Primary Patency in the Treatment of Superficial Femoral and Popliteal Artery Disease,” JACC: Cardiovascular Interventions to Ravazi et al. (“Ravazi”).
Regarding claim 25, Wilson, Seward, and Dean, as evidenced by Seward, teach the method of claim 24 as shown above, but the above rejection does not specifically address the length of patency. However, it is known that the maintenance or the increase in patency can last for at least 3 months, as evidenced by Ravazi. Ravazi shows that the administration of dexamethasone is known to be effective in maintaining high patency over time (Fig. 5).
Claims 1 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2022/0016397 to Wilson et al. (“Wilson”) in view of U.S. Patent Publication No. 2015/0141959 to Seward and “F-FDG PET in the Evaluation of Acuity of Deep Vein Thrombosis,” Clinical Nuclear Medicine to Rodina et al., herein referred to as Rodina.
Regarding claim 1, Wilson teaches a method of reducing progression to post-thrombotic syndrome (PTS) in a subject ([0093]), the method comprising (b) advancing a therapeutic delivering catheter within a lumen of the vein to or near a segment of the vein, the segment affected by or previously affected by DVT ([0154]-[0155]) and (c) delivering a therapeutic composition into a perivascular tissue at or near the affected segment using the therapeutic delivering catheter ([0157]), wherein the therapeutic composition comprises an anti-inflammatory agent ([0165]) but does not teach the dosage.
Seward teaches a therapeutic dosage of an anti-inflammatory agent ([0104], dexamethasone) ranges from about 0.1 mg per cm of the thrombosed segment to about 10 mg per cm of the thrombosed segment ([0104], 1.6±1.1 mg per cm of the lesion).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a 0.1-10 mg per cm dosage in the method of Wilson as taught by Seward because the use of such a dosage yielded 100% procedural safety with a lack of drug-related serious adverse events or major adverse limb events ([0104]).
Regarding method step (a) identifying a vein in the subject affected by or previously affected by deep vein thrombosis (DVT), Examiner submits that since Wilson is being used to treat an area affected by DVT as shown above, that given the broadest reasonable interpretation, Wilson teaches the identification of the vein affected by DVT as an inherent part of treating a vein affected by DVT. In other words, one cannot treat a vein affected by DVT without identifying the affected vein, especially since no specifics regarding the “identifying” step have been claimed. Additionally, Wilson contemplates treating areas previously affected by DVT ([0093]) in order to reduce the potential risk of post-thrombotic syndrome (PTS). Examiner further submits that drug delivery to areas previously affected by DVT cannot occur without knowing where the previous DVT occurred. Previous treatment for DVT indicates inherent knowledge of that treatment location in order for subsequent treatment to be performed to prevent potential PTS.
In any case, Rodina has been cited to teach a method of identifying a vein in the subject affected by deep vein thrombosis (CONCLUSIONS, FDG-PET can be useful for detecting DVT). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of identifying a vein affected by DVT as taught by Rodina, with the method of treating a vein affected of Wilson to yield the predictable result of treating a vein affected by DVT, since the treatment method of Wilson would inherently need a means of identifying a target area in order to be performed, and Dean shows one example of identifying DVT target areas.
Regarding claim 36, Wilson, Seward, and Rodina teach the method of claim 1 as shown above, Rodina further teaching the vein affected by DVT currently is identified by positron emission tomography (FDG-PET) (CONCLUSIONS, FDG-PET can be useful for detecting DVT).
Response to Arguments
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn in-part, certain drawing objections remain as shown above.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn. However, a new 112 rejection in response to the new claim amendments has been made as shown above.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on the King reference applied in the prior rejection of record.
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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