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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/05/2026 has been entered.
Status of the Claims
This action is in response to papers filed 06/05/2026 in which claims 5, 6, and 8 were canceled; claims 11-15 were withdrawn; and claim 1 was amended. Please note that claim 7 was not amended, yet indicated as “currently amended” in the claims set filed 06/05/2026. Thus, the status identifier of “currently amended” for claim 7 is incorrect. In response to this office action, Applicant is requested to file compliant claim amendments. All the amendments have been thoroughly reviewed and entered.
Claims 1-4, 7, 9 and 10 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Maintained Objection
Claim Objections
Claim 1 is objected to because of the following informalities: for language clarity, please amend “further wherein” (2nd to last line of claim 1) to “and wherein”. Appropriate correction is required.
Response to Arguments
Applicant’s in the response filed 06/05/2026 did not address this objection in claim 1. Thus, the objection to claim 1 is maintained for the reason of record.
New Rejection
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7, 9 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 introduces new matter as the claims recite the limitation: a single layer porous surface covering. There is no support in the specification for this limitation.
Nowhere in the specification does it describe or disclose that the porous surface covering is a single layer. The only disclosure in the specification pertaining to layer is to “two layers of porous electrospray PTFE film” (Specification, page 6, bottom paragraph), which is clearly not support for the claimed “a single layer porous surface covering.”
Claims 2-4, 7, 9 and 10 are also rejected as they depend directly or indirectly from claim 1, thereby also containing the new matter material.
MPEP §2163.06 states: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of amended claim 1 at the time of filing of the instant application.
Maintained Rejections
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.
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, 7 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Betts et al (US 2015/0297662 A1; hereafter as Betts ‘662) in view of Landy et al (US 2011/0054595 A1) and Hall et al (US 2014/0086971 A1).
Regarding claim 1, Betts ‘662 teaches a drug eluting stent comprising (a) a stent capable of radial expansion; and a coating composed of a porous surface covering and at least one therapeutic agent such as a macrocyclic triene immunocompromise compound, wherein the stent is encapsulated by the coating (Abstract; [0005]-[0018], [0045]-[0053]; claims 1-14).
However, Betts ‘662 does not teach the porosity and thickness of the porous surface covering; the concentration of the therapeutic agent; and the porous surface covering is a nonwoven fabric; the nonwoven fabric is composed of electrospun fibers; and the mesh pore diameter of claim 1.
Regarding the porosity of the porous surface covering of claim 1, Landy teaches stents comprising at least one coating covering at least a portion of the device, the at least one coating comprising a porous substrate, wherein the porous substrate is impregnated a composition containing at least one pharmaceutical active agent (Abstract; [0008]-[0024], [0044]-[0045], [0067]-[0074], [0105]-[0111]; claims 1-4, 9, 29, and 33). Landy teaches the porosity volume of the porous substrate can be designed to have porosity volume ranging from 30-70%, wherein only the abluminal side of the stent has the porous substrate ([0109]-[0111]).
It would have been obvious to one of ordinary skill in the art to design the stent of Betts ‘662 such that the porous surface covering is present only on the abluminal side of the stent, wherein the porosity of the porous surface covering is the range of 20% to 40%, and the therapeutic agent is present in the porous surface covering, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Landy provided the guidance for designing the stent of Betts ‘662 such that the therapeutic agent is impregnated in pores of the porous surface covering, and such porous surface covering is present only on the abluminal side of the stent ([0109]-[0111]). Furthermore, Landy further guides the ordinary artisan to optimize the porosity of the porous surface covering that is present only on the abluminal side of the stent to be in the range of 30-70%, and such porous surface covering design provides high loading of the therapeutic agent ([0055], [0086], and [0109]-[0111]). It is noted that the porosity range of 30-70% as taught by Landy, overlaps the claimed porosity range of “20% to 40%,” and thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of porosity of the porous surface covering impregnated therein a therapeutic agent to provide a resultant stent with high loading of the therapeutic agent would have been obvious before the effective filing date of applicant's invention. “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). See MPEP §2144.05 (I)-(II).
Regarding the concentration of the therapeutic agent and the porous surface covering is a nonwoven fabric, the nonwoven fabric is composed of electrospun fibers, thickness of the porous surface covering, and mesh pore diameter of claim 1, Hall teaches a drug-eluting stent containing a porous surface coating nonwoven mat (fabric) composed of electrospun fibers of a polymer selected from fibrin, collagen, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polypropylene , polycarbonate, and polyurethane, wherein the porous surface coating impregnates a therapeutic agent such as a rapamycin derivative (analog), and wherein the porosity of the porous surface coating is from about 30% to about 80% (Abstract; [0002]-[0159], [0233]-[0300]; claims 1-33). Hall teaches the therapeutic agent is impregnated in the porous surface coating at concentration from about 2 to about 6 µg/mm2 ([0088]). Hall teaches the mat (fabric) has an average pore size of about 3 microns to about 5 microns, and a thickness of about 20 micrometers to about 100 micrometer ([0139]).
It would have been obvious to one of ordinary skill in the art to routinely optimize the concentration of the rapamycin derivative (analog) of Betts ‘662 in the porous surface coating (covering) to a concentration between 3.0 and 5.0 µg/mm2, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Hall teaches that the concentration of a rapamycin derivative (analog) in a porous surface coated stent can be optimize to a concentration of from about 2 to about 6 µg/mm2, which is a concentration range that overlaps the claimed range of between 3.0 and 5.0 µg/mm2. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of concentration of the therapeutic agent in the porous surface covering would have been obvious before the effective filing date of applicant's invention. “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). See MPEP §2144.05 (I)-(II).
It would also have been obvious to one of ordinary skill in the art to optimize the mesh pore diameter and thickness of the porous surface coating (covering) of Betts ‘662 to a mesh pore diameter and thickness as claimed in claim 1, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Hall teaches that the porous surface coating (covering) of Betts ‘662 can be optimize to have an average pore size of about 3 microns to about 5 microns, and a thickness of about 20 micrometers to about 100 micrometer, which are pore size and thickness that reads on the mesh pore diameter and thickness of the claimed porous surface covering. Thus, an ordinary artisan would looked to optimizing the mesh pore diameter and thickness of the porous surface coating (covering) of Betts ‘662 to an average pore size of about 3 microns to about 5 microns, and a thickness of about 20 micrometers to about 100 micrometer so as to provide porous surface covering that has desirable healing, biocompatibility, prevention of thrombosis, or reducing turbulent blood flow within the stent, per Hall ([0139]), and achieve Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to one of ordinary skill in the art to modify the porous surface coating (covering) of Betts ‘662 such that the coating on the stent containing the rapamycin derivative is a non-woven fabric composed of electrospun fibers that is a polymer selected from fibrin, collagen, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polypropylene , polycarbonate, and polyurethane, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Hall provided the guidance to do so by teaching that the coating covering the stent of Betts ‘662 can be made of a non-woven fabric composed of electrospun fibers, wherein the electrospun fibers is a polymer selected from fibrin, collagen, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polypropylene , polycarbonate, and polyurethane, and such use of the electrospun fabric with the rapamycin impregnated therein, provide controlled release of the drug over an extended period. One of ordinary skill in the art would have reasonable expectation of success of the making said modification because Betts ‘662 also indicated that the objective of the coating is to provide controlled release of the rapamycin derivative (Betts ‘662: [0005], [0033], and [0045]). Thus, it is a prima facie obvious to look to other known coating materials that provide controlled release of drug including the non-woven electrospun fabric (mat) of Hall to be used as the coating (covering) on the stent of Betts ‘662, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 2, as discussed above, Betts ‘662 teaches the therapeutic agent is a macrocyclic triene immunocompromise compound.
Regarding claim 3, Betts ‘662 teaches the macrocyclic triene immunocompromise compound is a rapamycin derivative (analog) having the following structure:
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, wherein R is C(O)—(CH2)n—X, n is 0, 1 or 2, X is a cyclic hydrocarbon having 3-8 carbons, optionally one or more unsaturated bonds ([0006], [0015]-[0016]; claim 1).
Regarding claim 4, Betts ‘662 teaches the C(O)—(CH2)n—X has one of the following the following structures:
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([0007], [0016][-[0017]; claim 2).
Regarding claim 7, as discussed above, Hall teaches a drug-eluting stent containing a porous surface coating nonwoven mat (fabric) composed of electrospun fibers of a polymer selected from fibrin, collagen, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polypropylene, polycarbonate, and polyurethane, wherein the coating impregnates a drug such as a rapamycin derivative (analog). Thus, Hall provided the guidance to do so by teaching that the coating covering the stent of Betts ‘662 can be made of a non-woven fabric composed of electrospun fibers, wherein the electrospun fibers is a polymer selected from fibrin, collagen, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polypropylene , polycarbonate, and polyurethane, and such use of the electrospun fabric with the rapamycin impregnated therein, provide controlled release of the drug over an extended period.
Regarding claim 9, as discussed above, Landy provided the guidance for designing the stent of Betts ‘662 such that the therapeutic agent is impregnated in pores of the porous surface covering, and such porous surface covering is present only on the abluminal side of the stent ([0109]-[0111]), thereby meeting and rendering obvious the claimed “the porous surface covering has a porosity of 0% of the surface area at the stent system’s luminal surface” as recited in claim 9.
Regarding claim 10, as discussed above, Hall provided the guidance for optimizing the concentration of a rapamycin derivative (analog) in a porous surface coated stent to a concentration of from about 2 to about 6 µg/mm2, which is a concentration range that overlaps the claimed range of between about 4.0 and 5.0 µg/mm2. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of concentration of the therapeutic agent in the porous surface covering would have been obvious before the effective filing date of applicant's invention. “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). See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 06/05/2026 have been fully considered but they are not persuasive.
Applicant argues:
“the disclosure of Landy is expressly devoted to a porous substrate having an average pore diameter of less than 1 µm (see Landy at paragraphs [0009], [0012], [0017], [0022], [0027], [0045], [0050], [0071], [0081], [0089], [0095], [0106] and [0109]), with preferred average pore diameters all ranging less than 0.6 µm (Id. at paragraph [0109]). This stands in stark contrast to, and indeed teaches away from, Applicant's instant invention, where in order to provide a coating suitable for carrying a very large drug load (ie. drug concentration between 3.0 - 5.0 µg/mm2), the pore diameter is preferably within the range of 1 µm to 5 µm (see Applicant's application as filed, at pgs. 8 and 11). In fact, based on Applicant's SEM images, the porous mesh has a preferred pore diameter of 2 µm to 5 µm (Id. at Fig. 6) as recited in claim 1. One having ordinary skill in the art would not look to the teachings of Landy when developing a drug eluting stent used to carry such an extraordinarily large drug load concentration range of between 3.0 - 5.0 µg/mm2, since Landy's disclosure is restricted to coatings having pore sizes much too small to accommodate those heavy drug loads as described in the instant application.” (Remarks, page 7, middle paragraph).
In response, the Examiner disagrees. The standing 103 rejection is based on the combined teachings of Betts ‘662, Landy, and Hall. Landy was not used for teaching the pore diameter, but rather the porosity of the porous surface coating. As discussed in the standing 103 rejection, Landy provided the guidance for designing the stent of Betts ‘662 such that the therapeutic agent is impregnated in pores of the porous surface covering, and such porous surface covering is present only on the abluminal side of the stent ([0109]-[0111]). Furthermore, Landy further guides the ordinary artisan to optimize the porosity of the porous surface covering that is present only on the abluminal side of the stent to be in the range of 30-70%, and such porous surface covering design provides high loading of the therapeutic agent ([0055], [0086], and [0109]-[0111]). It is noted that the porosity range of 30-70% as taught by Landy, overlaps the claimed porosity range of “20% to 40%,” and thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See MPEP §2144.05 (I)-(II).
As to the mesh pore diameter of the porous surface covering of claim 1, the pore diameter was taught and render obvious by the teachings from Hall. It is noted that the prior art of Hall is used for all that they teach including alternative embodiments. As discussed in the standing 103 rejection, Hall at paragraph [00139] teaches that it is desirable for the pore size of the inner layer that is coated around the stent be as low as 1 microns, which is also the lower limit of the claimed average pore size (1 micron to 5 micron). Particularly, Hall also teaches 3 microns to 5 microns as a desirable pore size parameter. Thus, Hall teaches towards Applicant's claimed invention by providing direct guidance for optimizing pore size from 3 microns to 5 microns to provide porous surface covering that has desirable healing, biocompatibility, prevention of thrombosis, or reducing turbulent blood flow within the stent.
Applicant argues:
“the porous substrate disclosed in Landy has insufficient thickness to be applicable to the instant invention. Landy teaches the porous substrate having a preferred thickness of up to 10 um. The only exception described in Landy is an orthopedic implant embodiment, where the thickness can be greater than 10 um (Landy, paragraph [0116]). Again, one having ordinary skill in the art, when developing a drug eluting stent specifically designed to carry a very large drug load between 3.0 - 5.0 ug/mm2, would not have looked to a reference such as Landy, which is largely restricted to coatings having low porous surface thicknesses.” (Remarks, page 7, last paragraph).
In response, the Examiner disagrees. As discussed in the standing 103 rejection, the claimed concentration of the therapeutic agent, thickness of the porous surface covering, and mesh pore diameter was taught and render obvious by Hall. See 103 rejection, pages 8-11, said pages being incorporated herein in its entirety.
Applicant argues:
“since Landy fails to teach the amended claims, one having ordinary skill in the art would certainly not utilize Hall for a suitable combination. Hall is quite clear in its disclosure that a relatively porous layer on the luminal side (Hall, inner layer 325) used in conjunction with a substantially impermeable layer on the abluminal side (Id., outer layer 330) is most desired, since this may permit tissue ingrowth and/or endothelial attachment or growth on the inside diameter of the stent (Id. at paragraph [0139]). Examiner asserts that Hall teaches a covering having an average pore size of about 3 microns to about 5 microns which overlaps the claimed mesh pore diameter ranging from 1 pm to 5 pm. However, this is not the case since Hall teaches that an optional inner layer may have an average pore size of about 3 microns to about 5 microns. The claims as amended recite a single layer porous covering. According to Hall, the inner layer that may be a mat having an average pore size from 3 microns to 5 microns may or may not be used in conjunction with the impermeable outer layer (para. 139). Therefore, Hall does not teach that the porous surface covering has a mesh pore size diameter ranging from 3 micron to 5 microns as argued by the Examiner; Hall teaches that the optional inner, i.e. secondary layer, may have an average pore size of about 3 microns to about 5 microns. In contrast to the claimed invention, Hall teaches that the outer or primary layer is substantially impermeable, having an average pore size of about 0 microns to about 1.5 microns (para. 136). This small pore size makes sense for Hall given that Hall teaches a spun coating (i.e. mat) that effectively increases the surface area of the stent covering (para. 91). It is a goal of Hall to teach a stent with an increased surface area. This is clearly different from the claimed invention and teaches away from the claimed invention given the pore size being bigger than the pore size taught by Hall. As such, one of skill in the art would not find it obvious from the teaching of Hall to reach the claimed invention which has a larger pore size for the single layer surface covering thereby reducing the surface area of the mats.” (Remarks, page 8).
In response, the Examiner disagrees. As discussed above, Landy provided the guidance for designing the stent of Betts ‘662 such that the therapeutic agent is impregnated in pores of the porous surface covering, and such porous surface covering is present only on the abluminal side of the stent ([0109]-[0111]). Furthermore, Landy further guides the ordinary artisan to optimize the porosity of the porous surface covering that is present only on the abluminal side of the stent to be in the range of 30-70%, and such porous surface covering design provides high loading of the therapeutic agent ([0055], [0086], and [0109]-[0111]). It is noted that the porosity range of 30-70% as taught by Landy, overlaps the claimed porosity range of “20% to 40%,” thereby render obvious the claimed porosity by routine optimization.
As discussed in the 103 rejection, the claimed concentration of the therapeutic agent, thickness of the porous surface covering, and mesh pore diameter was taught and render obvious by Hall. As discussed in the 103 rejection, Hall teaches such as a rapamycin derivative (analog) is impregnated in the porous surface coating at concentration from about 2 to about 6 µg/mm2 ([0088]). Hall teaches the mat (fabric) has an average pore size of about 3 microns to about 5 microns, and a thickness of about 20 micrometers to about 100 micrometer ([0139]). Also see 103 rejection, pages 8-11 of this office action. Thus, Hall teaches toward Applicant's claimed invention by providing direct guidance for optimizing pore size from 3 microns to 5 microns so as to provide porous surface covering that has desirable healing, biocompatibility, prevention of thrombosis, or reducing turbulent blood flow within the stent. It is also noted that like Landy, Hall also teaches the porosity of the porous surface coating is optimizable from about 30% to about 80% for desired controlled release of the active ingredient. See Hall, paragraphs [0129]-[0131]. Thus, the combined teachings of Landy and Hall with Betts ‘662 do not teach away from the claimed invention, but rather teach towards Applicant’s claimed invention based on routine optimization to achieve the desired controlled release of the active ingredient as well as desirable healing, biocompatibility, prevention of thrombosis, or reducing turbulent blood flow within the stent.
With respect to Applicant’s argument focusing on the single layer porous covering, it is noted that the porous surface coating of the mat (fabric) of Hall is a one layer, as well as, the porous surface covering of Betts ‘662 is also one layer. Thus, Applicant is reminded that Hall was used for teaching the pore diameter of the porous surface covering and that the inner layer that is coated around the surface of the stent of Hall reads on the claimed porous surface coating. While Hall teaches the stent system can contain additional coating layers such as impermeable outer layer, the drug eluting stent system of instant claim 1 does not exclude multilayer coating or presence of additional coating layers.
Accordingly, the combined teachings of Betts ‘662, Landy, and Hall as provided in the standing 103 rejection are proper to render obvious Applicant’s claimed invention.
As a result, for at least the reasons discussed above and of record, claims 1-4, 7, 9 and 10 remain rejected as being obvious and unpatentable over the combined teachings of Betts ‘662, Landy, and Hall in the standing 103 rejection as set forth in this office action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 7, 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9408884 in view of Landy et al (US 2011/0054595 A1) and Hall et al (US 2014/0086971 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘884 significant overlap with the subject matter of the instant claims i.e., drug eluting stents comprising a coating covering the stent, the coating contains a drug eluting polymer and a rapamycin compound having the following structure:
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, wherein R is C(O)—(CH2)n—X, n is 0, 1 or 2, X is a cyclic hydrocarbon having 3-8 carbons, optionally one or more unsaturated bonds.
While the instant claims recites the coating as being a porous surface covering having “a porosity of within a range of 20% to 40% of the surface area at the stent system's abluminal surface and of less than 5% of the surface area at the stent system's luminal surface and the at least one therapeutic agent is present in the porous surface covering in a concentration between 3.0 and 5.0 pg/mm2 and is applied only to the stent system's abluminal side,” it would have been obvious to modify the coating in the claims of Patent ‘884 to have the porosity and therapeutic agent’s concentration as claimed in the instant claims in view of the guidance from Landy and Hall, in which Landy guides the ordinary artisan to optimize the porosity of the porous surface covering that is present only on the abluminal side of the stent to be in the range of 30-70%, and such porous surface covering design provides high loading of the therapeutic agent (Landy: Abstract; [0008]-[0024], [0044]-[0045], [0067]-[0074], [0105]-[0111]; claims 1-4, 9, 29, and 33); and Hall provided the guidance for optimizing the concentration of a rapamycin derivative (analog) in a porous surface coated stent to a concentration of from about 2 to about 6 µg/mm2 (Hall: Abstract; [0002]-[0159], [0233]-[0300]; claims 1-33). It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of porosity of the porous surface covering, as well as, the concentration of the therapeutic agent in the porous surface covering would have been obvious before the effective filing date of applicant's invention. “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). See MPEP §2144.05 (I)-(II).
While the instant claims also recite the porous surface covering has a mesh pore diameter ranging from 1 µm to 5 µm and a thickness ranging from 20 µm to 100 µm, it would have been obvious to optimize the coating in the claims of Patent ‘884 to have a mesh pore diameter ranging from 1 µm to 5 µm and a thickness ranging from 20 µm to 100 µm in view of the guidance from Hall, in which Hall teaches that the porous surface coating (covering) of Patent ‘884 can be optimize to have an average pore size of about 3 microns to about 5 microns, and a thickness of about 20 micrometers to about 100 micrometer (Hall: [0139]), which are pore size and thickness that reads on the mesh pore diameter and thickness of the claimed porous surface covering.
While the drug eluting polymers are different between the claims of Patent ‘884 and the claims of the instant application, it would have been obvious that the drug eluting polymers of the instant claims can be substitute with the drug eluting polymers of the Patent ‘884, and vice versa, in view of the guidance from Hall (Abstract; [0002]-[0159], [0233]-[0300]; claims 1-33).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 9408884 in view of Landy and Hall.
Claims 1-4, 7, 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9867911 in view of Landy et al (US 2011/0054595 A1), Hall et al (US 2014/0086971 A1), and Betts et al (US 2015/0297662 A1; hereafter as Betts ‘662).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘911 significant overlap with the subject matter of the instant claims i.e., while the instant claims are drawn to drug eluting stents and the claims in the Patent ‘911 are drawn to drug coated balloon, the coating material used is the same drawn to a coating comprising a coating covering the stent, the coating contains a rapamycin compound having the following structure:
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, wherein R is C(O)—(CH2)n—X, n is 0, 1 or 2, X is a cyclic hydrocarbon having 3-8 carbons, optionally one or more unsaturated bonds.
While the instant claims recites the coating as being a porous surface covering having “a porosity of within a range of 20% to 40% of the surface area at the stent system's abluminal surface and of less than 5% of the surface area at the stent system's luminal surface and the at least one therapeutic agent is present in the porous surface covering in a concentration between 3.0 and 5.0 p g/mm2 and is applied only to the stent system's abluminal side,” it would have been obvious to modify the coating in the claims of Patent ‘884 to have the porosity and therapeutic agent’s concentration as claimed in the instant claims in view of the guidance from Landy and Hall, in which Landy guides the ordinary artisan to optimize the porosity of the porous surface covering that is present only on the abluminal side of the stent to be in the range of 30-70%, and such porous surface covering design provides high loading of the therapeutic agent (Landy: Abstract; [0008]-[0024], [0044]-[0045], [0067]-[0074], [0105]-[0111]; claims 1-4, 9, 29, and 33); and Hall provided the guidance for optimizing the concentration of a rapamycin derivative (analog) in a porous surface coated stent to a concentration of from about 2 to about 6 µg/mm2 (Hall: Abstract; [0002]-[0159], [0233]-[0300]; claims 1-33). It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of porosity of the porous surface covering, as well as, the concentration of the therapeutic agent in the porous surface covering would have been obvious before the effective filing date of applicant's invention. “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). See MPEP §2144.05 (I)-(II).
While the instant claims also recite the porous surface covering has a mesh pore diameter ranging from 1 µm to 5 µm and a thickness ranging from 20 µm to 100 µm, it would have been obvious to optimize the coating in the claims of Patent ‘884 to have a mesh pore diameter ranging from 1 µm to 5 µm and a thickness ranging from 20 µm to 100 µm in view of the guidance from Hall, in which Hall teaches that the porous surface coating (covering) of Patent ‘911 can be optimize to have an average pore size of about 3 microns to about 5 microns, and a thickness of about 20 micrometers to about 100 micrometer (Hall: [0139]), which are pore size and thickness that reads on the mesh pore diameter and thickness of the claimed porous surface covering.
While claim 3 of the Patent ‘911 is further drawn to a pharmaceutical composition containing microparticles of the rapamycin compound, it would have been obvious to formulate the rapamycin compound of the instant claims into microparticles in view of the guidance from Betts ‘662 (Abstract; [0006]-[0018], [0045]-[0053]; claims 1-14).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 9867911 in view of Landy, Hall, and Betts ‘662.
Claims 1-4, 7, 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10751450 in view of Betts et al (US 2015/0297662 A1; hereafter as Betts ‘662), Landy et al (US 2011/0054595 A1), and Hall et al (US 2014/0086971 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘450 significant overlap with the subject matter of the instant claims i.e., while the claims in the Patent ‘450 are drawn to method of using, said claims from Patent ‘450 use the substantially the same drug eluting stent containing a rapamycin compound having the following structure:
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, wherein R is C(O)—(CH2)n—X, n is 0, 1 or 2, X is a cyclic hydrocarbon having 3-8 carbons, optionally one or more unsaturated bonds. Thus, the "Nonstatutory Double Patenting Rejection Based on Equitable Principles" discussed in paragraph II.B.6 below should be considered. Cf. Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003) (rejecting claims to methods of use over claims to compound based on unjustified timewise extension rationale). See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
While the claims in the instant application recites the stent contains a coating, it would have been obvious to produce the stent of the claims from the Patent ‘450 to contain coating having the rapamycin compound in view of the guidance from Betts ‘662 (Abstract; [0006]-[0018], [0045]-[0053]; claims 1-14).
While the instant claims recites the coating as being a porous surface covering having “a porosity of within a range of 20% to 40% of the surface area at the stent system's abluminal surface and of less than 5% of the surface area at the stent system's luminal surface and the at least one therapeutic agent is present in the porous surface covering in a concentration between 3.0 and 5.0 p g/mm2 and is applied only to the stent system's abluminal side,” it would have been obvious to modify the coating in the claims of Patent ‘884 to have the porosity and therapeutic agent’s concentration as claimed in the instant claims in view of the guidance from Landy and Hall, in which Landy guides the ordinary artisan to optimize the porosity of the porous surface covering that is present only on the abluminal side of the stent to be in the range of 30-70%, and such porous surface covering design provides high loading of the therapeutic agent (Landy: Abstract; [0008]-[0024], [0044]-[0045], [0067]-[0074], [0105]-[0111]; claims 1-4, 9, 29, and 33); and Hall provided the guidance for optimizing the concentration of a rapamycin derivative (analog) in a porous surface coated stent to a concentration of from about 2 to about 6 µg/mm2 (Hall: Abstract; [0002]-[0159], [0233]-[0300]; claims 1-33). It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of porosity of the porous surface covering, as well as, the concentration of the therapeutic agent in the porous surface covering would have been obvious before the effective filing date of applicant's invention. “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). See MPEP §2144.05 (I)-(II).
While the instant claims also recite the porous surface covering has a mesh pore diameter ranging from 1 µm to 5 µm and a thickness ranging from 20 µm to 100 µm, it would have been obvious to optimize the coating in the claims of Patent ‘884 to have a mesh pore diameter ranging from 1 µm to 5 µm and a thickness ranging from 20 µm to 100 µm in view of the guidance from Hall, in which Hall teaches that the porous surface coating (covering) of Patent ‘450 can be optimize to have an average pore size of about 3 microns to about 5 microns, and a thickness of about 20 micrometers to about 100 micrometer (Hall: [0139]), which are pore size and thickness that reads on the mesh pore diameter and thickness of the claimed porous surface covering.
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 10751450 in view of Betts ‘662, Landy, and Hall.
Claims 1-4, 7, 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11383009 in view of Betts et al (US 2015/0297662 A1; hereafter as Betts ‘662), Landy et al (US 2011/0054595 A1), and Hall et al (US 2014/0086971 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘009 significant overlap with the subject matter of the instant claims i.e., a rapamycin compound having the following structure:
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, wherein R is C(O)—(CH2)n—X, n is 0, 1 or 2, X is a cyclic hydrocarbon having 3-8 carbons, optionally one or more unsaturated bonds.
While the claims in the Patent ‘009 is drawn to a pharmaceutical formulation that further contains ethanol, it would have been obvious that the rapamycin compound in the instant claim can be formulated in a pharmaceutical formulation containing ethanol and such formulation can be used as coating on stents in view of the guidance from Betts ‘662 (Abstract; [0006]-[0018], [0045]-[0053]; claims 1-14).
While the instant claims recites the coating as being a porous surface covering having “a porosity of within a range of 20% to 40% of the surface area at the stent system's abluminal surface and of less than 5% of the surface area at the stent system's luminal surface and the at least one therapeutic agent is present in the porous surface covering in a concentration between 3.0 and 5.0 p g/mm2 and is applied only to the stent system's abluminal side,” it would have been obvious to design the formulation in the claims of Patent ‘884 to a porous surface covering formulation for stents having the porosity and therapeutic agent’s concentration as claimed in the instant claims in view of the guidance from Landy and Hall, in which Landy guides the ordinary artisan to optimize the porosity of the porous surface covering that is present only on the abluminal side of the stent to be in the range of 30-70%, and such porous surface covering design provides high loading of the therapeutic agent (Landy: Abstract; [0008]-[0024], [0044]-[0045], [0067]-[0074], [0105]-[0111]; claims 1-4, 9, 29, and 33); and Hall provided the guidance for optimizing the concentration of a rapamycin derivative (analog) in a porous surface coated stent to a concentration of from about 2 to about 6 µg/mm2 (Hall: Abstract; [0002]-[0159], [0233]-[0300]; claims 1-33). It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of porosity of the porous surface covering, as well as, the concentration of the therapeutic agent in the porous surface covering would have been obvious before the effective filing date of applicant's invention. “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). See MPEP §2144.05 (I)-(II).
While the instant claims also recite the porous surface covering has a mesh pore diameter ranging from 1 µm to 5 µm and a thickness ranging from 20 µm to 100 µm, it would have been obvious to optimize the coating in the claims of Patent ‘884 to have a mesh pore diameter ranging from 1 µm to 5 µm and a thickness ranging from 20 µm to 100 µm in view of the guidance from Hall, in which Hall teaches that the porous surface coating (covering) of Patent ‘009 can be optimize to have an average pore size of about 3 microns to about 5 microns, and a thickness of about 20 micrometers to about 100 micrometer (Hall: [0139]), which are pore size and thickness that reads on the mesh pore diameter and thickness of the claimed porous surface covering.
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11383009 in view of Betts ‘662, Landy and Hall.
Response to Arguments
Applicant's arguments filed 06/05/2026 have been fully considered but they are not persuasive.
Applicant argues by requesting the Examiner reconsider the double patenting rejections, as the current amendments to the claims now patentably distinct over the patents as cited. (Remarks, page 8).
In response, the Examiner disagrees, the instant claims remain not patentably distinct over the cited patents for the reasons discussed in the standing double patenting rejections, and for the reasons discussed on pages 13-18 of this office action, said discussion being incorporated herein in its entirety.
Accordingly, the double patenting rejections are maintained for the reasons discussed above, and pending the filing of a terminal disclaimer.
Conclusion
No claim is allowed.
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/DOAN T PHAN/Primary Examiner, Art Unit 1613
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