DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/22/26 has been entered.
Response to Arguments
Applicant's arguments filed 7/22/26 have been fully considered but they are not persuasive. Regarding the double patenting rejection, the applicant requests the rejections to be held in abeyance. However, with the minimal amendment of scope added to the independent claims, it is noted that the patents 10653512 and 11541154 there is not explicit overlap in scope with the pending claims and thus, the rejections over those patents are withdrawn. However, there is clear overlap in scope with US 10507268 and thus a double patenting rejection is being maintained.
Regarding the rejection over Hannes DE ‘501 for claim 19 and its dependent claims, it is argued that the prior art does not disclose the added limitation of “porosity between about 0% and about 50%” since not explicit in the reference. However the examiner must alert the applicant as to the breadth of scope of the claim, which first of all has a contradiction, reciting a porous mat but yet a claimed range includes a value of 0 that means it is not porous. Second the range is large in that it goes to values around 50% or slightly higher by using the term “about” in the claim. Now the examiner would like to inform applicant that claims are given their broadest reasonable interpretation and that prior art is applied with broadest reasonable standard of which must be noted that Hannes stated “at least partially porous” in paragraph 10 of which can be considered to fall within the scope of the upper limit in the claim reciting “about 50%” since that can be considered partially porous.
Regarding the argument against Dubson and alleging it suggests at a minimum 60 % porosity for an electrospun layer, the examiner disagrees because on page 30 lines 13-15 mentioned a layer of material could be provided with about 50%. Thus Applicant is incorrect in assessing the Dubson reference. However, it is also noteworthy the applicant had a dependent claim (10) that broadened the range beyond 50% porosity to 60% to then cover the alleged embodiments of Dubson. Thus, the reference still renders the claim obvious especially because what is the breadth of “about” for the limit of 50%, can it be ± 10% more? According to applicant’s claim 10, the answer is yes. In addition the examiner also notes and presented that even if applicant argues Dubson, the reference of Flanagan teaches ranges less than 50% and thus the claimed porosity is obvious over the prior art of record.
Claim Objections
Claims 1, 12, 19 are objected to because of the following informalities: claims 1,12 recite “at least one electrospun polymer layer having a percent porosity of between about 0%.....” to thus be contradictory as if there is 0 pores, then there is no porosity. Claim 19 recites “a porous PTFE mat having a percent porosity of between about 0%.....” to thus be contradictory as if there is 0 pores, then the mat is not porous. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 19,20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hannes et al. (DE 102011012501) in view of Puckett et al. (WO 2013/151778). Hannes et al. disclose a method of using a coated medical device or stent in which it inhibits an inflammatory response to the implantable medical appliance, due to the impermeable surface, paragraphs 13,17 of translated description. Hannes et al. disclose
(paragraph 33) implanting the medical appliance into a patient, such that the medical
appliance coated with a first electrospun polymer layer, paragraph 20 and can be a
porous (paragraphs 10,13) PTFE (paragraph 12) mat and a second polymer layer that
inhibits tissue ingrowth into or through the second polymer layer, paragraphs 16,38. Please note claims are given their broadest reasonable interpretation and prior art is applied accordingly with a broadest reasonable standard such that the broad limitation of “between about 0% and about 50%” covers a scope of some porous layer that is “partially” porous and thus since Hannes stated the porous mat is “partially” porous it clearly overlapping in scope of the range since partially would not be much higher than “about 50%” in giving a reasonable interpretation. It is noted that Hannes et al. disclose an adhesive material be used to bond layers of polymer, but did not disclose a layer with FEP. Puckett et al. teach (page 2, lines 26-28,31, page 12, lines 7-11,14) that a porous PTFE layer is joined with another polymer layer that can be a layer of FEP. It would have been obvious to one of ordinary skill in the art to utilize an impermeable bonding layer such as FEP taught by Puckett et al. with the stent of Hannes et al. such that it assures a strong bond between the polymer layers with allowing ingrowth in the outer porous layer. With respect to the limitation of "the at least one electrospun polymer layer has an average pore size between 2 microns to 8 microns", Hannes was silent as to pore size. However, Puckett et al. teach (page 9, lines 1-8) that a pore size of an electrospun polymer layer be of values within 2 microns to 8 microns. It would have been obvious to one of ordinary skill in the art to select a pore size within the range of 2 microns to 8 microns for an electrospun polymer layer as taught by Puckett et al. with the stent of Hannes et al. such that it provides the desired porosity to enable the material to perform its desired function of permitting endothelial cells to attach thereon. Regarding claim 20, since the combined teachings of Hannes with Puckett disclose the same material of electrospun PTFE with the second polymer material also, it is inherent that it provides the same properties of providing an H-score of less than 150, in vivo two weeks after implantation.
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hannes et al. (DE 102011012501) in view of Puckett et al. (WO 2013/151778) as applied to claim 19 above, and further in view of Anneaux et al. (2011/0031656). Hannes et al. in view of Puckett et al. is explained supra. However, Hannes et al. as modified by Puckett et al. did not disclose the first electrospun PTFE layer has been heated and stretched after sintering. It must be noted that this is a product by process claim. Since the coating on the stent of Hannes is electrospun it is fully capable of being heated and stretched after sintering. However, in the alternative, Anneaux et al. teach (paragraph 34-36) that electrospinning involves heating and stretching after sintering. It would have been obvious to one of ordinary skill in the art to utilize a process of heating
and stretching after sintering when applying an electrospun layer as taught by Anneaux et al. on the stent coated device of Hannes as modified by Puckett et al. such that the appropriate material properties are provided for the coating layer on the stent, paragraph 14 of Anneaux.
Claim 1-10,12-14,17,18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dubson et al. (WO 02/49536) in view of Puckett et al. (WO 2013/151778) and alternatively in view of Flanagan et al. (2012/0316633). Dubson et al. disclose a method for promoting endothelial cell growth on an implantable medical appliance, page 4, lines 26,27. Dubson et al. disclose the method (page 16, lines 9-11) includes implanting the medical appliance into a patient. Dubson et al. disclose (page 11, lines 4-6) the medical appliance comprising at least one electrospun polymer layer. Dubson et al. further disclose (page 30, lines 13,14) an embodiment having a percent porosity of between about 0% and about 50%, such that endothelial cells grow on or attach to the surface of the at least one electrospun polymer layer. Please note claims are given their broadest reasonable interpretation and prior art is applied accordingly with a broadest reasonable standard such that the broad limitation of “between about 0% and about 50%” covers a scope beyond 50% since it is noted the term “about” broadens a porosity of 50% and it could be ± 10% and clearly overlaps in scope of porosity for other embodiments of Dubson. However, it must be noted as best understood of the scope of Applicant’s upper limit of the claimed range is that in giving a broadest reasonable interpretation one could consider even 60% to be about 50% especially since claim 10 of current application includes a range 10% greater up to 60% and thus one can reasonably conclude this interpretation is a fair interpretation. Alternatively Flanagan et al. teach (paragraph 36) one can utilize various porosities that fall within the claimed range of about 0% to about 50%. Thus, it would have been obvious to one of ordinary skill in the art to alternatively find an optimal porosity within the range of about 0% to about 50% as taught by Flanagan et al. with the implantable device of Dubson as modified Puckett such that it provides the appropriate tissue surface properties sufficient for the environment in which it is placed. Such a modification only involves routine skill in the art. It is noted that Dubson et al. further disclose (page 10, lines 11,12,16) a second polymer layer coupled to the at least one electrospun polymer layer the second polymer layer impermeable to tissue growth into the second polymer layer. However, Dubson et al. was silent to the medical appliance being a stent. It is noted that Dubson et al. illustrate a structure analogous to a stent, see Figs. 1c 1d. Dubson further disclose page 16, the structure of the coil which is used with the polymer electrospun layers. Puckett et al. teach (page 8) that a stent is used with electrospun layers. It would have been obvious to one of ordinary skill in the art to select a stent for use with electrospun polymers as taught by Puckett et al. in the medical appliance of Dubson et al. such that the appropriate structural support device is provided for the patient when selecting the medical device based on the patient's needs. With respect to claims 2,12 Dubson et al. did not explicitly state the at least one electrospun polymer layer has an average pore size between 2 microns to 8 microns, but was silent as to pore size. However, Puckett et al. teach (page 9, lines 1-8) that a pore size of an electrospun polymer layer be of values within 2 microns to 8 microns. It would have been obvious to one of ordinary skill in the art to select a pore size within the range of 2 microns to 8 microns for an electrospun polymer layer as taught by Puckett et al. with the medical appliance of Dubson et al. such that it provides the desired porosity to enable the material to perform its desired function of permitting endothelial cells to attach thereon. Regarding claim 3, Dubson discloses (page 16, lines 9,10) the medical appliance can be a graft. With respect to claims 8,9 as best understood, since the combined teachings of Dubson with Puckett disclose the electrospun polymer layer with a porosity falling within the claimed recited range, it is inherent the resulting polymer layer possesses the same properties as claimed of permitting "at least 150% in vitro endothelial cell attachment, compared to an expanded PTFE material" or also permitting "between 30% and 170% in vitro endothelial cell attachment, compared to an expanded PTFE material" as properties cannot be separated from their material. Regarding claim 10, Dubson discloses (page 19, line 7) the percent porosity of the electrospun polymer layer is about 60%. Regarding claims 4,13, Puckett teaches (page 9, lines 21,22) the material for the electrospun polymer is PTFE. It would have been obvious to one of ordinary skill in the art to select a known, biocompatible material such as PTFE as taught by Puckett for the polymer electrospun in the medical appliance of Dubson since such a selection only involves routine skill in the art and is a well established biocompatible material used in vascular devices. With respect to claim 5, the intermediate layer is impervious as disclosed by Dubson (page 10, lines 15,16). With respect to claims 6,17 Dubson et al. did not disclose the impervious layer is formed of FEP. Puckett et al. teach (page 2, lines 26-28,31, page 12, lines 7-11,14) that a porous PTFE layer is joined with another polymer layer that can be an FEP layer. It would have been obvious to one of ordinary skill in the art to utilize to select a known impervious material and use as a layer made of FEP taught by Puckett et al. with the medical device of Dubson et al. such that it assures a strong bond between the polymer layers with allowing ingrowth in the outer porous layer. Regarding claim 7, Dubson shows (Fig. 2) a fiber mat of randomized microfibers or nanofibers, see page 31, line 12. Also note the PTFE material is suggested by Puckett. Regarding claim 14, since the combined teachings of Dubson with Puckett disclose the same material of electrospun PTFE with the claimed porosity, it is inherent that it provides the same properties of permitting at least 20% penetration, in vivo two weeks after implantation. With respect to claim 18, Dubson did disclose there can be multiple layers but did not disclose the specific polymers as recited with a third polymer layer comprising an electrospun PTFE layer, and wherein the FEP layer is disposed between a first and the third polymer layers. Puckett et al. teach (page 10, lines 27,28, page 11, lines 13-15, page 13, lines 20-29, col. 14, lines 4,5,9,10) there can be 3 polymer layers on the medical appliance. It would have been obvious to one of ordinary skill in the art to utilize a third polymer layer comprising an electrospun PTFE layer, and wherein the FEP layer is disposed between a first and the third polymer layers per the teaching of Puckett with the medical appliance of Dubson such that the polymer layers remain affixed on the medical appliance and provide a biocompatible device since a finite number of arrangements are within the field of options and only involves routine skill in the art.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dubson et al. (WO 02/49536) in view of Puckett et al. (WO 2013/151778) and Flanagan et al. (2012/0316633) as applied to claim 4 above, and further in view of Anneaux et al. (2011/0031656). Dubson et al. in view of Puckett et al. and Flanagan et al. is explained supra. However, Dubson et al. as modified by Puckett et al. and Flanagan et al. did not disclose the first electrospun PTFE layer has been heated and stretched after sintering. It must be noted that this is a product by process claim. Since the coating on the graft of Dubson is electrospun it is fully capable of being heated and stretched after sintering. However, in the alternative, Anneaux et al. teach (paragraph 34-36) that electrospinning involves heating and stretching after sintering. It would have been obvious to one of ordinary skill in the art to utilize a process of heating and stretching after sintering when applying an electrospun layer as taught by Anneaux et al. on the graft coated device of Dubson as modified by Puckett and Flanagan such that the appropriate material properties are provided for the coating layer on the stent, paragraph 14 of Anneaux.
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, 4-6, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11,13 of U.S. Patent No. 10,507,268. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader pending claims are anticipated by the narrower patented claims of US ‘268. Claim 11 recites a medical device (stent) capable of being implanted in a vessel, in which cellular growth would occur. Thus it would have been obvious to use the device of claim 11 and implant in a vessel to support a stenosed region and provide a device that can promote cellular ingrowth to stabilize the device and inhibit cell growth on another surface to prevent cell ingrowth. Regarding claim 1, the porosity between 0-50% for the first polymer layer of the pending claim overlaps in scope with the patented claimed range in claim 11 of US '268. Regarding claim 2, claim 11 recites the device is a stent. Regarding claim 4, claim 11 of US '268 recites the electrospun polymer is PTFE. Regarding claim 5, see claim 13 of US '268. With respect to claim 6, see claim 11 of US '268 reciting a tie layer of FEP with the second polymer layer to bond it. Regarding claim 10, the claimed range overlaps with the range recited in claim 11 of US '268 and only involves routine skill in the art to find an optimal porosity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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