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 .
DETAILED ACTION
Status of Claims
This office action is responsive to the amendment filed on 12/17/2025. As directed by the amendment: claim 2 has been withdrawn, claim 116 has been cancelled, and new claims 121-122 have been added. Thus, claims 3, 25-26, 36, 40-41, 65-66, 73-74, 94-96, 112-115 and 117-122 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 3, 25-26, 36, 40-41, 65-66, 73-74 and 94 rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Dietz et al. (2020/0093960) “Dietz”; claims 40, 112-113, 116-117 and 119 rejected under 35 U.S.C. 102 (a)(1) 35 U.S.C. 102 (a)(2) as being anticipated by Blum et al. (2015/0257763) “Blum”; claims 95-96 rejected under 35 U.S.C. 103 as being unpatentable over Dietz et al. (2020/0093960) “Dietz” and claims 114-115, 118 and 120 rejected under 35 U.S.C. 103 as being unpatentable over Blum et al. (2015/0257763) “Blum” in view of Kim et al. (2012/0256355) “Kim” have been fully considered but they are not found persuasive.
Applicants argue on page 7 of the remarks regarding the rejection of claim 116 as anticipated by Blum et al. (2015/0257763) “Blum” that “the cited passages merely disclose that the orifice from which the material is ejected and/or that the mandrel onto which the material is deposited may be positively or negatively charged, which is the standard electrospinning process and does not necessarily result in a material with a net charge, positive or negative. Generally, the electrostatic properties of the orifice (and collector) cause the formation of electrospun fibers and, while in some cases there may be a residual charge on the fibers, it does not occur in every case due to the equipment and operating conditions in use, or in some cases, any residual charge dissipates over time. As such, the electrospun nanofibrous polymer produced in Blum does not necessarily have a net charge is imparted throughout, within, or on a surface of the electrospun nanofibrous polymer.”
This is not found to be persuasive because amended claim 40 and newly added claims 121-122 are directed to a device which broadly requires a net charge is imparted throughout, within, or on a surface of the electrospun nanofibrous polymer. Pars. 0049-0052 and Fig. 3 of Blum disclose “an electric potential may be applied across the spinneret 320 and the mandrel 360…the fibers may contract the mandrel 360 to form the coating of nonwoven fibers” (par. 0049). Furthermore, par. 0050 discloses “By attaching the support structure 110 to the mandrel 360, the coating applied by the apparatus 300 will form the covering 111 on the support structure 110 to create the occlusion device 100”. As a result, the electrospun fibers which are in contact with and attached to the charged spinneret and mandrel would also be charged via the voltage sources 340a and 340b.
The limitation “via a post-treatment process applied thereto” is a product by process limitation which does not impart any structure to the device of claim 40 (see rejection of claims 40 and 121-122 below). Therefore, Blum discloses all of the limitations of amended claim 40 including “a net charge is imparted throughout, within, or on a surface of the electrospun nanofibrous polymer via a post-treatment process applied thereto”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 40, 112-113, 117 and 119 are rejected under 35 U.S.C. 102 (a)(1) 35 U.S.C. 102 (a)(2) as being anticipated by Blum et al. (2015/0257763) “Blum”.
Regarding claim 40, Blum discloses a device 100 (Figs. 1A-1C) for implantation into a fistula tract (par. 0084 discloses the device is used for fistula, furthermore, device 100 is fully capable of performing this intended use) within a subject (abstracta), wherein the fistula tract has a primary opening in a wall of a bodily structure and a tract extending from the primary opening (device 100 is fully capable of being implanted in a fistula tract; par. 0084), the device 100 comprising: a body 111 configured to fill at least a portion of the fistula tract (Fig. 1A) and at least partially formed from an electrospun nanofibrous polymer (pars. 0012, 0078 and abstract disclose the device is made of electrospun polymeric nanofibers), wherein a net charge is imparted throughout, within, or on a surface of the electrospun nanofibrous polymer via a post-treatment process applied thereto (Pars. 0049-0052 and Fig. 3 disclose “an electric potential may be applied across the spinneret 320 and the mandrel 360…the fibers may contract the mandrel 360 to form the coating of nonwoven fibers,” par. 0050 discloses “By attaching the support structure 110 to the mandrel 360, the coating applied by the apparatus 300 will form the covering 111 on the support structure 110 to create the occlusion device 100”; as a result, the electrospun fibers which are in contact with and attached to the charged spinneret and mandrel would also be charged via the voltage sources 340a and 340b) and the body comprises: an enlarged portion (Fig. 1A discloses larger diameter portion 111 located at the left end) located at a first end of the body; and a tube-like structure extending from the enlarged portion and terminating at a second end of the body (Fig. 1A discloses hub 118 which is tube shaped as disclosed in par. 0026 and Fig. 1C discloses the lengthened state of the support structure on the right which terminates to the second end of the device) wherein the enlarged portion has a cross-sectional dimension equal to or greater than a cross-sectional dimension of the tube-like structure relative to a longitudinal axis of the body (Figs. 1A-1C disclose the intermediate product of an enlarged disk shape 111 on the left end which has a cross-section that is larger than the hub 118 and lengthened portion of the mesh 114 located on the right end; when being deployed, the left end would have a larger cross section than the hub and the right end in its lengthened state).
Furthermore, the claimed phrase “via a post-treatment process applied thereto” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Regarding claims 112-113, Blum discloses wherein the nanofibrous polymer comprises a polyester, a polyurethane, or a combination of polyester and polyurethane and wherein the nanofibrous polymer comprises a polyester selected from polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PTT), and combinations thereof, and/or a polyurethane selected from polycarbonate, polyether, and combinations thereof (abstract discloses PET).
Regarding claims 117 and 119, Blum discloses wherein the net charge imparted to the nanofibrous polymer is negative and positive (pars. 0049 and 0052 discloses the polymer having a positive and negative charge where the electrospun nanofibrous polymer is positively and negatively charged, orifice 324).
Regarding claims 121-122, Blum discloses wherein the net negative charge is imparted via exposing the nanofibrous polymer to a sodium hydroxide solution and wherein the net positive charge is imparted via exposing the nanofibrous polymer to a diamine solution (pars. 0049 and 0052 discloses the polymer having a positive and negative charge where the electrospun nanofibrous polymer is positively and negatively charged, orifice 324).
Furthermore, the claimed phrases “via exposing the nanofibrous polymer to a sodium hydroxide solution” and “via exposing the nanofibrous polymer to a diamine solution” are being treated as a product-by-process limitations and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3, 25-26, 36, 40-41, 65-66, 73-74, 94-96 and 121-122 are rejected under 35 U.S.C. 103 as being unpatentable over Dietz et al. (2020/0093960) “Dietz” in view of Blum et al. (2015/0257763) “Blum”.
Regarding claim 40, Dietz discloses a device 200 (Fig. 2) for implantation into a fistula tract 80 (Fig. 1) within a subject (abstracta and Fig. 1), wherein the fistula tract 80 has a primary opening 60 in a wall of a bodily structure and a tract extending from the primary opening (Fig. 1), the device 200 comprising: a body configured to fill at least a portion of the fistula tract (par. 0041) and at least partially formed from an electrospun nanofibrous polymer (par. 0054 discloses the device is a plug made from electrospun polymeric fibers, electrospun fibers are known in the art to be nanofibrous), wherein the body comprises: an enlarged portion 210 (Fig. 2) located at a first end of the body; and a tube-like structure extending from the enlarged portion 220 (Fig. 2 discloses legs 220 arranged in a tubular shape and par. 0030 discloses a tubular shape) and terminating at a second end of the body 230, wherein the enlarged portion 210 has a cross-sectional dimension equal to or greater than a cross-sectional dimension of the tube-like structure relative to a longitudinal axis of the body ( the enlarged portion 210 has a cross section that is greater that the legs 230 when measured along the longitudinal direction, as shown in Fig. 2).
Dietz is silent regarding a net charge is imparted throughout, within, or on a surface of the electrospun nanofibrous polymer via a post-treatment process applied thereto. However, Blum teaches a similar device comprising electrospun nanofibrous polymer, wherein a net charge is imparted throughout, within, or on a surface of the electrospun nanofibrous polymer via a post-treatment process applied thereto (Pars. 0049-0052 and Fig. 3 disclose “an electric potential may be applied across the spinneret 320 and the mandrel 360…the fibers may contract the mandrel 360 to form the coating of nonwoven fibers,” par. 0050 discloses “By attaching the support structure 110 to the mandrel 360, the coating applied by the apparatus 300 will form the covering 111 on the support structure 110 to create the occlusion device 100”; as a result, the electrospun fibers which are in contact with and attached to the charged spinneret and mandrel would also be charged via the voltage sources 340a and 340b).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Dietz to include a net charge is imparted throughout, within, or on a surface of the electrospun nanofibrous polymer via a post-treatment process applied thereto, as taught and suggested by Blum, for providing electrospun nanofibrous polymer material with increased strain capabilities (abstract).
Furthermore, the claimed phrase “via a post-treatment process applied thereto” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Regarding claim 3, Dietz discloses wherein at least a portion of the tube-like structure is split into a plurality of elongate members (par. 0041 discloses multiple legs 220; Fig. 15C discloses the split legs).
Regarding claims 25-26 and 36, Dietz discloses wherein the device comprises an electrospun material that has a therapeutic agent incorporated into the nanofibers (par. 0054 and par. 0040 disclose electrospun fibrous scaffold having therapeutic agents); wherein the therapeutic agent is selected from the group consisting of a small molecule, an antimicrobial agent, an anti-inflammatory agent, immunosuppressive agent, or an analgesic agent (par. 0040 discloses therapeutic agents including small molecule growth factors) and wherein the device further comprises cells selected from the group consisting of allogeneic stem cells, autologous stem cells, mesenchymal stem cells, allogenic adipose tissue-derived stromal stem cells, or a combination thereof (abstract and par. 0008 disclose the scaffold comprising mesenchymal stem cells).
Regarding claim 41, Dietz discloses wherein the fistula tract is a perianal fistula, an enterocutaneous fistula or a rectovaginal fistula (par. 0004).
Regarding claim 65, Dietz discloses wherein the body is a unitary structure (the portions 210 and 230 are attached and function as a unit when implanted (par. 0041).
Regarding claim 66, Dietz discloses wherein the body further comprises a neck located between the enlarged portion and the tube-like structure, the neck comprising a reduced cross-sectional dimension relative to the cross-sectional dimensions of the enlarged portion and the tube-like structure (the portion of the legs 220 that attaches to the disk would have a smaller cross-section than the enlarged portion and the legs when the legs are split apart as shown in Fig. 15C).
Regarding claims 73-74, Dietz discloses wherein the second end 230 is configured for insertion into the primary opening and the first end is configured to fill all or a portion of the fistula tract (par. 0043 discloses the ends 230 are pulled into opening 60 and the first end having the enlarged portion 210 fills a portion of the tract 80) and wherein the first end is configured to fill the primary opening (par. 0043 discloses the first end having disk 210 is flush with the opening 60).
Regarding claim 94, Dietz discloses a kit comprising a device for implantation in a fistula in accordance with claim 1; (par. 0043 discloses using a suture to pull the plug into the opening 60).
Regarding claims 95-96, Dietz in view of Blum discloses the claimed invention of claims 40 and 94 including a suture (par. 0043 of Dietz discloses using a suture to pull the plug into the opening 60); except for further comprising a non-biodegradable suture and the non-biodegradable suture comprises an electrospun material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the suture in Dietz to be biodegradable and comprising electrospun material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, since Dietz is directed to devices made of electrospun materials. MPEP 2144.07
Claims 114-115, 118 and 120 are rejected under 35 U.S.C. 103 as being unpatentable over Blum et al. (2015/0257763) “Blum” in view of Kim et al. (2012/0256355) “Kim”.
Blum discloses the claimed invention of claim 40 including positively and negatively charged polymers; except for wherein the nanofibrous polymer comprises nPET-PBT; wherein the nanofibrous polymer is nanofibrous polyurethane (nPU); wherein the nanofibrous polymer is negatively charged nPET-PBT and; wherein the nanofibrous polymer is positively charged nPET-PBT. However, Kim teaches a similar electrospun nanofibers polymeric device (abstract) comprising the nanofibrous polymer comprises nPET-PBT; wherein the nanofibrous polymer is nanofibrous polyurethane (nPU); wherein the nanofibrous polymer is charged nPET-PBT (abstract and par. 0020 disclose PET and PBT nanofibers that are charged). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Blum to include wherein the nanofibrous polymer comprises nPET-PBT; wherein the nanofibrous polymer is nanofibrous polyurethane (nPU); wherein the nanofibrous polymer is negatively charged nPET-PBT and; wherein the nanofibrous polymer is positively charged nPET-PBT, as taught and suggested by Kim, for providing a nanofiber web preparing method in which both of thermoplastic and thermosetting resins are applicable, such that a polymer solution does not need to be heated and electrical insulation is readily realized.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/YASHITA SHARMA/
Primary Examiner, Art Unit 3774