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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Specification
Applicant’s specification, at para [0079], discloses that “the anti-contractile agent and the second agent may be present in the endovascular device at a ratio of from about 50:20 to about 20:50,… such as from about 20:5 to about 5:20, or any range therebetween.”
The phrase “such as” is interpreted to introduce an example or narrower range of the immediately preceding broader range, such that the ratios following “such as” would ordinarily be understood as being encompassed by the preceding range.
However, the disclosed ratio of “from about 20:5 to about 5:20” extends beyond the endpoints of the preceding range of “about 20:50 to about 50:20.” Specifically, 20:5 corresponds to a ratio of 4:1, which is substantially greater than 50:20 (2.5:1), while 5:20 corresponds to a ratio of 1:4, which is substantially less than 20:50 (0.4:1). Thus, the range of “from about 20:5 to about 5:20” is not an example of the preceding range, calling into question the ranges that Applicant intended to disclose at the time of filing.
Appropriate correction and/or explanation is required to address this inconsistency.
Election/Restrictions
Claims 7, 13, 14, 21, 27, 28, 30 and 31 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/30/2026.
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 11 and 25 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.
Claims 11 and 25 recite that the anti-contractile agent and the second agent are present in the endovascular device “at a ratio of from about 50:20 to about 20:50.” This ratio is indefinite because it does not clearly set forth the units of the ratio (weight, volume, concentration, etc.).
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.
Claims 1-3, 6, 8, 9, 12, 15-17, 20, 22, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers et al (U.S. Pat. 8,870,816 B2, hereinafter “Chambers”).
Regarding claims 1 and 15, Chambers discloses an endovascular device, the device comprising:
an outer body comprising a biocompatible polymeric material (the device is coated with an outer (i.e., barrier) layer of a biocompatible polymeric material; see col. 10, lines 7-34, disclosing a barrier layer of poly(lactic acid) or poly(ethylene glycol); and see col. 6, lines 1-12, disclosing that the barrier layer can be the outer-most layer of the device); and
a core comprising a first layer and a second layer (see col. 10, lines 24-33, disclosing multiple layers of a balloon where different bioactives are present in the different layers).
It is noted that Chambers does not appear to explicitly disclose, in a single embodiment, the first layer comprising an anti-contractile agent and the second layer comprising a second agent.
However, Chambers teaches that various bioactives can be used in its, including anti-contractile agents (see col. 14, lines 30-31, disclosing angiotensin receptor blockers or nitric oxide and nitric oxide donors) and anti-proliferative agents (see col. 14, line 50 to col. 15, line 47, specifically lines 53-54, disclosing paclitaxel).
A skilled artisan would have found it obvious at the time of the invention to choose an anti-contractile agent for one of the layers of the core, and a second agent for the other layer of the core, with a reasonable expectation of success. Chambers discloses that at the time of the invention, angioplasty patients suffered acute closure of a blood vessel immediately after the angioplasty procedure (abrupt closure) as well as chronic restenosis within months after angioplasty (see col. 2, line 46 to col. 3, line 6). Chambers discloses that it is desirable to treat both conditions (see col. 3, lines 10-12).
As discussed above, Chambers identifies a finite number of predictable potential bioactive agents to solve these problems. For instance, angiotensin receptor blockers or nitric oxide and nitric oxide donors were known to address acute vasoconstrictive response to angioplasty1, while the antiproliferative agent paclitaxel were known to address restenosis by inhibiting smooth-muscle-cell proliferation.2 In light of the teaching in Chambers of using multiple layers of different bioactive agents, it would have been within the level of ordinary creativity to choose the first layer comprising an anti-contractile agent and the second layer comprising a second agent, with a reasonable expectation of success in addressing, treating and/or preventing both abrupt closure and restenosis post-angioplasty.
Regarding claim 2, Chambers discloses the endovascular device of claim 1, wherein the biocompatible polymeric material comprises poly(lactic acid) or poly(ethylene glycol); see col. 10, lines 7-34).
Regarding claim 3, Chambers discloses the endovascular device of claim 1, wherein the anti-contractile agent comprises a nitric oxide donor molecule, an angiotensin receptor blocker, or a combination thereof (see col. 14, lines 30-31, disclosing angiotensin receptor blockers or nitric oxide and nitric oxide donors).
Regarding claims 6, 8 and 9, Chambers discloses the endovascular device of claim 1, wherein the second agent is an anti-inflammatory agent, an anti-proliferative agent, or a combination thereof, and in particular, as per claims 8 and 9, is paclitaxel (anti-proliferative agents, as disclosed in col. 14, line 50 to col. 15, line 47; see specifically lines 53-54, disclosing paclitaxel).
Regarding claim 12, Chambers discloses the endovascular device of claim 1, wherein the device is in the form of a cylinder (see cylindrical balloon 101 in Fig. 1).
Regarding claims 16 and 29, Chambers discloses a method of treating peripheral artery disease in a subject in need thereof, the method comprises:
implanting an endovascular device within a vessel of the subject (see col. 16, lines 9-42), wherein the endovascular device comprises an outer body comprising a biocompatible polymeric material (the device is coated with an outer (i.e., barrier) layer of a biocompatible polymeric material; see col. 10, lines 7-34, disclosing a barrier layer of poly(lactic acid) or poly(ethylene glycol); and see col. 6, lines 1-12, disclosing that the barrier layer can be the outer-most layer of the device); and a core comprising a first layer and a second layer (see col. 10, lines 24-33, disclosing a multiple layers of a balloon where different bioactives are present in the different layers); and
releasing from the endovascular device a therapeutically effective amount of the bioactive(s) (see col. 16, lines 43-45).
It is noted that Chambers does not explicitly disclose that the implanting occurs within a peripheral vessel of the subject.
However, Chambers teaches that embodiments of the invention are implanted in peripheral arteries or veins (see col. 15, line 64 to col. 16, line 18). When implanted therein, the balloon device is intended to be compressed and then inflated (see col. 16, lines 19-28).
A skilled artisan would have found it obvious at the time of the invention to perform its method in the peripheral artery, based on the teaching that peripheral arteries may also suffer from thrombus formation, and that various embodiments of its invention are used specifically to treat the narrowing of the peripheral artery or vein. Therefore, the skilled artisan would have had a reasonable expectation of success in using a balloon with a core layer, two bioactive layers and a biocompatible polymer layer to treat a peripheral artery.
Further, Chambers does not appear to explicitly disclose, in a single embodiment, the first layer comprising an anti-contractile agent and the second layer comprising a second drug, such that release of the anti-contractile agent in combination with the second drug preserves the lumen upon maladaptive inward remodeling completion in the subject.
However, Chambers teaches that various bioactives can be used in its, including anti-contractile agents (see col. 14, lines 30-31, disclosing angiotensin receptor blockers or nitric oxide and nitric oxide donors) and anti-proliferative agents (see col. 14, line 50 to col. 15, line 47, specifically lines 53-54, disclosing paclitaxel).
A skilled artisan would have found it obvious at the time of the invention to choose an anti-contractile agent for one of the layers of the core, and a second agent for the other layer of the core, with a reasonable expectation of success. Chambers discloses that at the time of the invention, angioplasty patients suffered acute closure of a blood vessel immediately after the angioplasty procedure (abrupt closure) as well as chronic restenosis within months after angioplasty (see col. 2, line 46 to col. 3, line 6). Chambers discloses that it is desirable to treat both conditions (see col. 3, lines 10-12).
As discussed above, Chambers identifies a finite number of predictable potential bioactive agents to solve these problems. For instance, angiotensin receptor blockers or nitric oxide and nitric oxide donors were known to address acute vasoconstrictive response to angioplasty3, while the antiproliferative agent paclitaxel were known to address restenosis by inhibiting smooth-muscle-cell proliferation.4 In light of the teaching in Chambers of using multiple layers of different bioactive agents, it would have been within the level of ordinary creativity to choose the first layer comprising an anti-contractile agent and the second layer comprising a second agent, with a reasonable expectation of success in addressing, treating and/or preventing both abrupt closure and restenosis post-angioplasty.
The limitation “wherein the release of the anti-contractile agent in combination with the second drug preserves the lumen upon maladaptive inward remodeling completion in the subject” expresses the intended result of the previously recited process step of releasing the therapeutically effective amount of the first and second drugs from the endovascular device, and does not appear to hold patentable weight. See MPEP 2111.04, citing Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Applicant may present evidence that the “wherein” clause states a condition that is material to patentability.
Regarding claim 17, Chambers discloses the method of claim 16, wherein the anti-contractile agent comprises a nitric oxide donor molecule, an angiotensin receptor blocker, or a combination thereof (see col. 14, lines 30-31, disclosing angiotensin receptor blockers or nitric oxide and nitric oxide donors).
Regarding claims 20, 22 and 23, Chambers discloses the method of claim 16, wherein the second agent is an anti-inflammatory agent, an anti-proliferative agent, or a combination thereof, and in particular, as per claims 22 and 23, is paclitaxel (anti-proliferative agents, as disclosed in col. 14, line 50 to col. 15, line 47; see specifically lines 53-54, disclosing paclitaxel).
Regarding claim 26, Chambers discloses the method of claim 16, wherein the device is in the form of a cylinder (see cylindrical balloon 101 in Fig. 1).
Claims 4, 5, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers in view of Sugimoto et al (U.S. Pub. 2002/0168393 A1, hereinafter “Sugimoto”).
Regarding claims 4, 5, 18 and 19, it is noted that Chambers does not appear to disclose that the anti-contractile agent comprises eprosartan, olmesartan, telmisartan, losartan, valsartan, irbesartan, candesartan, or a combination thereof, and as per claims 5 and 19, is valsartan.
Sugimoto discloses an implantable medical material composed of an angiotensin II receptor antagonist in order to “reliably suppress the proliferation of smooth muscle cells and prevent restenosis of the blood vessel” (see Abstract) and where the angiotensin II receptor can be valsartan (see para [0030]; Sugimoto also discloses additional bioactive agents in the same paragraph that are coincident with those recited in claim 5, i.e., eprosartan, olmesartan, telmisartan, telmisartan, irbesartan, and candesartan).
A skilled artisan would have found it obvious at the time of the invention to choose valsartan as the specific anti-contractile agent for one of the layers of the core, based on the teaching in Sugimoto that valsartan was associated with a reduced risk of restenosis (see Sugimoto at para [0013]). Since Chambers identifies a restenosis to be a problem solvable by its invention, it would have been within the level of ordinary creativity to choose valsartan to include in the first layer as the anti-contractile agent, with a reasonable expectation of success in addressing, treating and/or preventing restenosis post-angioplasty.
Claims 10 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers in view of Speck et al (U.S. Pub. 2010/0233228 A1, hereinafter “Speck”).
Regarding claims 10 and 24, it is noted that Chambers does not appear to disclose the endovascular device of claim 1, or the method of claim 16 respectively, wherein the first layer and second layer further comprise urea.
Speck discloses a drug eluting medical device including a catheter balloon, comprising a coating layer of paclitaxel (see para [0037]). Speck teaches that the presence of urea in the coating layer promotes the release of the drug from the surface (see para [0038]).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the first and second layers in Chambers to comprise urea, in order to promote the release of the drug from the surface, as taught in Speck, with a reasonable expectation of success.
Claims 11 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers in view of Hunter (U.S. Pub. 2010/0074934 A1, hereinafter “Hunter”).
Regarding claims 11 and 25, it is noted that Chambers does not appear to disclose that the anti-contractile agent and the second agent are present in the endovascular device at a ratio of from about 50:20 to about 20:50.
Hunter discloses an implantable medical device for inhibiting vessel comprising a combination of an anti-contractile agent (e.g., dipyridamole or analogues) and an anti-proliferative agent (e.g., paclitaxel) (see Abstract). Hunter teaches that these compounds can be delivered by a balloon (see para [0013]) and are present in the implant at a variety of ratios (anti-contractile agent : anti-proliferative agent) exceeding about 0.06 to about 1.0 “to provide a superior biological effect”, or greater than 0.06 up to about 1.6 (see para [0118]). Applicant’s disclosed ratio range of 50/20 (2.5) to 20/50 (0.4) overlap the ratios contemplated in Hunter.
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the ratio of the anti-contractile agent to the second agent, i.e., the anti-proliferative agent, which Chambers already discloses as paclitaxel, as a matter of routine experimentation. It has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In this case, the only difference between the claimed invention and the prior art is the particular ratio of the anti-contractile agent to paclitaxel. Hunter expressly recognizes that this ratio is a result-effective variable, stating at para [0215] that the weight ratio of the anti-contractile agent to the anti-proliferative agent “may be adjusted to provide a superior biological effect (e.g., to minimize formation of neointimal hyperplasia).” Thus, a skilled artisan would have had reason to vary the ratio and would have reasonably expected that routine experimentation with different ratios, including ratios falling within the claimed range, could produce an improved biological effect, such as minimizing neointimal hyperplasia.
Such optimization would have required no more than routine experimentation within the teaching of the prior art and would not have required innovation or extraordinary creativity. Moreover, Applicant has not identified any evidence demonstrating that the claimed ratio is critical to achieving a particular result or solving a problem. To the contrary, Applicant acknowledges that ratios ranging from as low as 5:20 to as high as 20:5 are “sufficient to mediate adverse arterial remodeling” (see specification, para [0079]). Applicant further characterizes these ratios as being based on “experimental observations of maladaptive arterial remodeling outcomes” (see para [0004]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 10/06/2026
1 See Lablanche et al. Effect of the direct nitric oxide donors linsidomine and molsidomine on angiographic restenosis after coronary balloon angioplasty - The ACCORD Study. 1997. Attached.
2 See Wiskirchen et al. The effects of paclitaxel on the three phases of restenosis: smooth muscle cell proliferation, migration, and matrix formation: an in vitro study. Invest Radiol. 2004 Sep;39(9):565-71. Attached.
3 See Lablanche et al. Effect of the direct nitric oxide donors linsidomine and molsidomine on angiographic restenosis after coronary balloon angioplasty - The ACCORD Study. 1997. Attached.
4 See Wiskirchen et al. The effects of paclitaxel on the three phases of restenosis: smooth muscle cell proliferation, migration, and matrix formation: an in vitro study. Invest Radiol. 2004 Sep;39(9):565-71. Attached.
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