DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements filed 2/13/23 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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 2-14 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.
In Claim 2, the claim includes depositing layers on the surface of a stent then implantation of the layers on the coronary stent. It seems that in the claim, “stent” and “coronary stent” are two separate entities but it is not clear due to claim language. However, the instant specification does not distinguish a stent from a coronary stent. There is a stent framework that is coated to become the coronary stent. This assumed to be what is meant in claim 1 by stent and coronary stent, but the language is indefinite and does not reflect this. Appropriate correction is required.
Claim 2 recites the limitation "the morphology of the limus drug particles". There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this is referred to shape, crystallinity, etc.
Claim 5 is confusing because it claims the stent has a thickness of about 50% or less of the coronary stent. The claim language seems to distinguish a stent and coronary stent as two separate objects, when the stent framework becomes the coronary stent. It is further unclear if the thickness is referring to the stent wall, diameter of the stent or coating thickness. Appropriate correction is required.
In claim 6 it is unclear if the thickness is referring to the stent wall, diameter of the stent or coating thickness. Appropriate correction is required.
In claim 14, e-SEDS is not defined. RESS can be supplemented with the definition in the instant specification, e-SEDS cannot. It is unclear to which process the applicant is referring.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Campbell (US 2007/0078513 A1) in view of Burgermeister et al. (US 2007/0154554 A1) and further in view of Davis (US 2007/0250159 A1) and Wang et al. (US 2005/0191491 A1)
As to claim 2, Campbell teaches a method of preparing a coronary stent (para 0002) comprising: depositing a plurality of layers on an outer surface of a stent (Fig. 2), wherein an initial one of the plurality of layers comprises a bioabsorbable polymer layer (para 0024, PLGA layer) and at least one of the layers comprises a layer of one or more limus drug particles (para 0044, rapamycin in any of layers 2-4, for example).
Campbell does not teach where at least part of the drug particles are in crystalline form. Burgermeister teaches the use of at least partially crystalline rapamycin in a drug eluting stent and thus is in the same field of endeavor of Campbell due to teaches rapamycin on a stent (paras 0010, 0025-0026, for example). Burgermeister desires the crystalline phase because it is more stable in para 0024. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Campbell such that the rapamycin is at least 50% crystalline as taught by Burgermeister in order to stabilize the drug molecule.
Campbell and Burgermeister do not teach wherein at least part of the limus drug particles is uncovered by polymer on an exterior surface of the plurality of layers and at least part of the limus drug particles is covered by polymer on the exterior surface of the plurality of layers prior to implantation on the coronary stent, and the part of the drug particles uncovered by the polymer is positioned to contact a medium surrounding the plurality of layers. Davis teaches a stent having an abluminal layer with a limus drug (para 0007, stent, Figures 3, 4B, 5B-D, 6-7; para 0031, drug #42; para 0056, rapamycin (limus drug)) that is both uncovered and covered by the polymer on an exterior surface of the stent (uncovered at portion protruding from the surface of polymer (#44) and the covered portion of the drug being that within the polymer) and positioned to contact a medium surrounding the stent and its layers (e.g. Figures 3, 4B, 5B-D, 6-7, the portion of #42 protruding from the surface contacts the medium surrounding the stent). Davis and the combination of Campbell and Burgermeister are concerned with the same field of endeavor as the claimed invention, namely stents having layers of material, at least some of which contain drugs.
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 combination of Campbell and Burgermeister such that at least part of the limus drug particles is uncovered by the polymer on an exterior surface of said plurality of layers and at least part of the limus drug particles is covered by the polymer on the exterior surface of the plurality of layers prior to implantation of said laminate coronary stent and the part of the limus drug particles uncovered by the polymer is positioned to contact a medium surrounding the plurality of layers as taught by Davis as it is combining prior art elements according to known methods (per Davis as noted supra) to yield predictable results (MPEP 2143).
Campbell does not explicitly teach sintering the layers under conditions that do not substantially modify the morphology of the limus drug particles. The instant specification defines the sintering process as polymer nanoparticles being fused via supercritical fluid using no solvents or high temperatures (para 0101). Burgermeister teaches the preservation of crystal morphology using supercritical fluids in para 0041. However, this is used in the context of forming the particles themselves and not coating. Wang et al. uses supercritical fluids for coating these same types of particles on a medical device (abstract) in order to control agglomeration levels (para 0024; also controlled agglomeration via sintering in instant specification). Therefore, 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 combination of Campbell and Burgermeister to include the sintering process using supercritical fluids as taught by Wang et al. in order to control agglomeration levels of coating.
As to claim 3, Campbell teaches wherein the bioabsorbable polymer layer is free of the one or more limus drug particles and separates the layer of one or more limus drug particles from the outer surface of the stent. (para 0036 states "providing blank layers in between gradient layers provided with pharmaceutical compounds"; this language indicates an embodiment where layers #s 2/4 are drug containing and layers #1/3 are blank, or drug free as claimed) and separates said layer of one or more limus drug particles from said outer surface of said stent framework (e.g. Figure 2, layer #1 separates layers #s 2-4 from the surface of the stent).
As to claim 4, Campbell teaches the stent materials in para 0046.
As to claims 5-6, the thickness claimed is indefinite (see above). Campbell shows relative thicknesses in Fig. 2, for example. Wang et al. adjusts thickness as a result effective variable in para 0110 to control agglomeration. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 105 USPQ 223 (CCPA 1955).
As to claim 7, Campbell teaches the bioabsorbable polymers in para 0024.
As to claim 8, Campbell teaches 4 or more layers in Fig. 2.
As to claim 9-10, Campbell teaches varying the composition of the layers in para 0033 to provide variation in drug releasing profiles. Therefore, it would have been obvious to one of ordinary skill in the art to alternate layers as desired by routine experimentation depending on the variation in drug releasing profile that is desired.
As to claim 11, Burgermeister teaches the claimed crystallinity in paras 0024-0026.
As to claims 12-13, Wang teaches that an RESS process for depositing powders on medical devices is well known in paras 0011-0012 and includes depositing powders on a medical device in dry powder form .
Claims 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Campbell (US 2007/0078513 A1) in view of Burgermeister et al. (US 2007/0154554 A1) and further in view of Davis (US 2007/0250159 A1) , Wang et al. (US 2005/0191491 A1) and Lye et al. (US 2006/0121080 A1)
Wang teaches that an RESS process for depositing powders on medical devices is well known in paras 0011-0012 and includes depositing powders on a medical device in dry powder form. As far as SEDS as a process is defined in the instant specification, Wang teaches several different ways to utilize supercritical fluids as might meet the definition of a SEDS process. Wang does not necessarily teach applying an electric potential to the stent.
Lye et al. teaches applying a potential to a stent or medical device surface during coating with a therapeutic agent to enhance attraction of the agent to the surface (para 0127). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the references above to include potential being applied to the stent as taught by Lye et al. to enhance the surface adhesion of the coating material.
Claims 15-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Campbell (US 2007/0078513 A1) in view of Burgermeister et al. (US 2007/0154554 A1) and in further view of Wang et al. (US 2005/0191491 A1) and Lye et al. (US 2006/0121080 A1)
As to claims 15-16, Campbell and Burgermeister teach a crystalline or semi crystalline powder and bioabsorbable polymer layer as discussed above where the that the first polymer layer is free of the pharmaceutical agent and separates the pharmaceutical agent from an outer surface of the stent. Burgermeister teaches the use of supercritical fluids, but does not specifically teach the orifices.
Wang et al. teaches deposition of such powders onto a stent surface as discussed above, including a supercritical fluid process that sinters the materials as broadly claimed. Wang et al. further teaches orifices used to aerosolize the particles and deposit the material (Fig. 2, paras 0011, 0120-0121, 0146-0147). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the coating nozzles of Wang et al. as Wang et al. teaches they are well known in their use and the Wang process controls agglomeration as discussed above.
Wang does not necessarily teach applying an electric potential to the stent. Lye et al. teaches applying a potential to a stent or medical device surface during coating with a therapeutic agent to enhance attraction of the agent to the surface (para 0127). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the references above to include potential being applied to the stent as taught by Lye et al. to enhance the surface adhesion of the coating material.
As to claims 17-21, these limitations are taught by the references as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELLY M GAMBETTA whose telephone number is (571)272-2668. The examiner can normally be reached M-F 9-5:30.
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KELLY M. GAMBETTA
Primary Examiner
Art Unit 1718
/KELLY M GAMBETTA/Primary Examiner, Art Unit 1718