DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 1/28/26 have been fully considered but they are not persuasive. Applicant argues the 112 2nd paragraph rejection is overcome since Applicant suggests the claims (8,9) are clear since a “comparison” is recited in the claims as opposed to the porosity of one polymer layer is not meant to be over 100% but only in comparing with “expanded PTFE control material” to establish the value. While the examiner understands this, it is not inherent what the standard porosity of “expanded PTFE material” is such that one knows that the porosity of the other polymer is the claimed range being greater since it is well known that manufacturing of electrospun layers can achieve different porosities, thus one does not know the base value.
Applicant’s arguments, see page 6 of response, filed 1/28/26, with respect to a 112 2nd paragraph rejection of claims 14,20 have been fully considered and are persuasive. The rejection of claims 14,20 under 112 second paragraph has been withdrawn per the amendment of 1/28/26.
Applicant’s arguments, see page 7 of response, filed 1/28/26, with respect to the rejection(s) of claim(s) 1,3,10,12 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Puckett et al. (WO 2013/151778) to address the limitation of a stent for the medical device because while Dubson was silent or just failed to use the word “stent” in the reference, it is noted that Dubson did teach and show a support structure, see Figs. 1c, 1d. Dubson further discuss a coil, page 16. Thus, it would have been obvious to use a “stent” per the teaching of Puckett as the coil with the polymer electrospun layers of Dubson.
Regarding arguments of Dubson and Hannes not disclosing pore size, please note the new limitation is addressed by Puckett and presented below in the rejection.
In response to the double patenting rejections to hold in abeyance, as to not filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a request should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03.Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995. Applicant argues claim 2 was not rejected by a reference which is incorrect, US 10507268 clearly stated in claim 11 a stent is the medical device and was used to reject claim 2 of the pending claims of the current application.
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 8, 9 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.
Regarding claim 8, it is not understood how one can assess "at least 150% in vitro endothelial cell attachment" to the medical appliance because while the claim compares to an “expanded PTFE control material” and its surface to permit endothelial cell attachment, how does one know what the porosity or cell attachment for the control as it is no inherent, that it is known or that all expanded PTFE has the same porosity or tissue cell attachment capabilities since expanding PTFE can be done at different rates. With respect to claim 9, it is also not understood how can assess values "between 30% and 170% in vitro endothelial cell attachment" to the medical appliance because while the claim compares to an “expanded PTFE control material” and its surface to permit endothelial cell attachment, how does one know what the porosity or cell attachment for the control as it is no inherent, that it is known or that all expanded PTFE has the same porosity or tissue cell attachment capabilities since expanding PTFE can be done at different rates.
Claim Rejections - 35 USC § 103
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.
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). 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 19, lines 2,7) having a percent porosity of between about 35% and about 70% or between recited range of 30-80% for claim 12, such that endothelial cells grow on or attach to the surface of the at least one electrospun polymer layer. 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 control material” or also permitting “between 30% and 170% in vitro endothelial cell attachment, compared to an expanded PTFE control 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 House et al. (5620763) 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 House et al. is explained supra. However, Dubson et al. as modified by Puckett et al. and House 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 House such that the appropriate material properties are provided for the coating layer on the stent, paragraph 14 of Anneaux.
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. 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 21 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 Flanagan et al. (2012/0316633). 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 percent porosity of the first electrospun polymer layer is between about 40% and about 60%. Flanagan et al. teach (paragraph 54) that porosities for a coating on a stent can play a role in release rates. Flanagan et al. also teach (paragraph 36) the percent porosity of the first electrospun polymer layer is between about 40% and about 60%. It would have been obvious to one of ordinary skill in the art to utilize a porosity between about 40% and about 60% for the porous polymer layer as taught by Flanagan et al. in the stent coated device of Hannes as modified by Puckett et al. such that the appropriate porosity is provided to establish the desired tissue integration time.
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.
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. 10507268. 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 for the first polymer layer falls within the claimed range of 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 falls within the range cited in claim 11 of US '268 and only involves routine skill in the art to find an optimal porosity.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11541154 in view of Puckett et al. (WO 2013/151778). Although the claims at issue are not identical, they are not patentably distinct from each other because the narrower claim (18 of US '154) renders the broader pending claim 19 as obvious. See In re Goodman. All claim limitations are recited in the patented claim except for “the at least one electrospun polymer layer has an average pore size between 2 microns to 8 microns”, such that one can select the optimal 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 implanted medical appliance of US ‘154 such that it provides the desired porosity to enable the material to perform its desired function of permitting endothelial cells to attach thereon.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10653512 in view of Puckett et al. (WO 2013/151778). Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 1 of US '512 recites a medical appliance (stent) capable of being implanted in a patient. The patented device or appliance has a coating of first electrospun polymer layer of porous PTFE that can be construed as a "mat" since it is of fibers. Also recited in the patent claim is a second polymer layer with an FEP layer that inhibits tissue ingrowth into the second polymer layer. It would have been obvious to implant the medical appliance or coated stent of US '512 in a patient to treat for a stenosis or a plaque region to hold open a narrowed vessel and have a device that inhibits an inflammatory response. Thus all steps are disclosed by the claim of US ‘512 except for “the at least one electrospun polymer layer has an average pore size between 2 microns to 8 microns”, such that one can select the optimal 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 implanted medical appliance of US ‘154 such that it provides the desired porosity to enable the material to perform its desired function of permitting endothelial cells to attach thereon.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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