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 .
Response to Amendment
The amendment filed 12/12/2025 has been entered. Claims 1-2, 4-18 have been amended. Claim 3 has been cancelled. Claims 1-2, 4-18 remain pending in this application.
Response to Arguments
The amendment filed 12/12/2025 overcomes the claim objections and rejections under 35 USC §112(b) and such objections and rejections are therefore withdrawn.
Applicant's arguments filed 12/12/2025 with respect to claim 1 have been fully considered but they are not persuasive.
Regarding claim 1, such limitation of “3D-printing at least one layer of the scaffold” is being treated as product-by-process. Accordingly, claim 1 remains anticipated by Parikh.
Applicant’s arguments with respect to claim(s) 12 and 18 have been considered but are moot because the new ground of rejection does not rely on Parikh for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made over Parikh in view of Bornemann.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, ln. 5-6 should read ---formed from [[a]] the polymer or copolymer;---
Appropriate correction is required.
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.
Claim(s) 1, 4-5, and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parikh et al. (Pub. No.: US 2019/0046696 A1).
Regarding claim 1, Parikh discloses (fig. 2) a device (stent) comprising:
A scaffold (outer wall 200, ¶ 0133) formed from a polymer or co-polymer (the stent contains one or more non-biodegradable polymer ¶ 0093);
A matrix (inner wall 210) formed from hyaluronic acid (the stent contains one or more bio-degradable polymers such as hyaluronic acid ¶ 0087-¶ 0088); and
At least one active agent (¶ 0107);
Wherein the scaffold comprises at least one layer (¶ 0055).
The claim limitation, “wherein the scaffold comprises at least one 3D printed layer” is being treated as product-by-process.
When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP § 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “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. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Parikh discloses the invention substantially as claimed by Applicant but is silent to the scaffold comprising at least one 3D-printed layer. This claim is interpreted as a product-by-process claim, since it claims an apparatus and describes the process used to make or construct the apparatus. In spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established (MPEP 2113).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding “interbonded by interfusion” to limit structure of the claimed composite and noting that terms such as “welded,” “intermixed,” “ground in place,” “press fitted,” and “etched” are capable of construction as structural limitations.)
Regarding claim 4, Parikh discloses wherein the scaffold comprises a plurality of layers (the scaffold is formed by electrospinning polymer solutions, thus forming a plurality of layers, ¶ 0012, ¶ 0055, ¶ 0074). As discussed in claim 1 above, such limitation of the layer(s) being 3D-printed is being treated as product-by-process.
Regarding claim 5, Parikh discloses wherein the scaffold comprises a plurality of sequentially additively deposited layers, wherein the diameter or circumference of each layer is greater than the diameter or circumference of each previous layer (the scaffold is formed by electrospinning polymer solutions, thus forming a plurality of layers, ¶ 0012, ¶ 0074). As discussed in claim 1 above, such limitation of the layer(s) being 3D-printed is being treated as product-by-process.
Regarding claim 10, Parikh discloses wherein the scaffold comprises 0.1% to about 30% w/w of the active agent which encompasses the claimed range of at least 0.001% w/w (the active agent can be encapsulated in the non-degrading layer, ¶ 0107, ¶ 0118).
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 11, Parikh discloses wherein the matrix 0.1% to 30% w/w of the active agent which encompasses the claimed range of at least 0.001% w/w (the active agent can be encapsulated in the biodegradable inner core ¶ 0107, ¶ 0118).
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parikh, as applied to claim 1 above, and further in view of Horvath et al. (Pub. No.: US 2017/0348150 A1).
Regarding claim 2, Parikh fails to disclose wherein the scaffold has a substantially frustoconical shape.
Horvath teaches (fig. 4) a device (intraocular implant 100) and thus in the same field of endeavor, comprising a scaffold having a substantially frustoconical shape in order to reduce and/or prevent movement or migration of the device when implanted (fig. 4, ¶ 0061-0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold of Parikh such that it has a substantially frustoconical shape, as taught by Horvath, as such shape can reduce and/or prevent movement or migration of the device when implanted (Horvath ¶ 0062).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parikh, as applied to claim 1 above, and further in view of Sanchez, JR. et al. (Pub. No.: US 2012/0055490 A1), hereinafter Sanchez.
Regarding claim 6, Parikh discloses wherein the at least one layer comprises a peripheral member which is substantially annular in shape and defines at least one aperture (fig. 2, ¶ 0012, ¶ 0074).
Parikh fails to disclose at least one cross-bar extending diametrically across the aperture.
Sanchez teaches (fig. 1-2) a device (punctal plug 10) comprising a scaffold comprising at least one layer (body portion 12), wherein the at least one layer comprises a peripheral member which is substantially annular in shape (fig. 2) and defines at least one aperture (fig. 2), and at least one cross-bar (cross-member 24) extending diametrically across the aperture in order to aid in retaining the shape of the scaffold (fig. 2, ¶ 0017, 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one layer of Parikh such that it comprises at least one cross-bar extending diametrically across the aperture, as taught by Sanchez, in order to aid in retaining the shape of the scaffold (Sanchez ¶ 0022).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parikh, as applied to claim 1 above, and further in view of Nelms et al. (Pub. No.: US 2020/0093852 A1).
Regarding claim 7, Parikh fails to disclose wherein the matrix is formed from a 0.1 to 5 % w/v hyaluronic acid solution.
Nelms teaches a device (¶ 0299) comprising a matrix (pharmaceutical composition), wherein the matrix is formed from a 0.5% to 5% w/v hyaluronic acid solution (¶ 0295) which overlaps with the claimed range of 0.1-5% w/v, in order to obtain a desired viscosity of the matrix.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the matrix of Parikh such that it is formed from a 0.1 to 5 % w/v hyaluronic acid solution, as taught by Nelms, in order to obtain a desired viscosity of the matrix (Nelms ¶ 0295).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parikh, as applied to claim 1 above, and further in view of Park et al. (Pub. No.: US 2022/0257585 A1).
Regarding claim 8, Parikh fails to disclose wherein the matrix is a cross-linked matrix.
Park teaches a device (¶ 0001) and thus in the same field of endeavor, comprising a matrix formed from hyaluronic acid, wherein the matrix is a cross-linked matrix in order to provide a matrix that retains its shape (¶ 0021).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the matrix of Parikh such that it is a cross-linked matrix, as taught by Park, in order to provide a matrix that retains its shape (Park ¶ 0036).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parikh, as applied to claim 1 above, and further in view of Liou et al. (Pub. No.: US 2021/0196626 A1).
Regarding claim 9, Parikh fails to disclose wherein the matrix has a pH of less than 7.0.
Liou teaches (fig. 1) a device (ophthalmic drug delivery device 100) and thus in the same field of endeavor, comprising a matrix formed from hyaluronic acid (drug release element 20 comprising a drug which can be hyaluronic acid ¶ 0026), wherein the matrix has a pH of between 6.5 to 7.5 (¶ 0028) which overlaps with the claimed range of less than 7.0 in order achieve the effect of long-term drug delivery with a constant rate release.
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the matrix of Parikh such that it has a pH of less than 7.0, as taught by Liou in order achieve the effect of long-term drug delivery with a constant rate release (Liou ¶ 0028).
Claim(s) 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parikh in view of Bornemann et al. (Pub. No.: US 2020/0069466 A1).
Regarding claims 12-14, Parikh discloses a method of manufacturing a device (stent) comprising a scaffold (outer wall 200, ¶ 0133) formed from a polymer or co-polymer (the stent contains one or more non-biodegradable polymer ¶ 0093), a matrix (inner wall 210) formed from hyaluronic acid (the stent contains one or more bio-degradable polymers such as hyaluronic acid ¶ 0087-¶ 0088), and at least one active agent (¶ 0107), the method comprising the steps of:
Providing at least one layer of the scaffold formed from the polymer or co-polymer (¶ 0070, ¶ 0133);
Providing the matrix (inner wall 210) formed from hyaluronic acid (the stent contains one or more bio-degradable polymers such as hyaluronic acid ¶ 0087-¶ 0088);
Providing the at least one active agent (¶ 0107); and
Combining the scaffold, matrix and the at least one active agent (¶ 0012).
Parikh fails to disclose 3D-printing at least one layer of the scaffold.
Bornemann teaches (fig. 1) a method of manufacturing a device comprising a scaffold (implant 12) (abstract) and thus in the same field of endeavor, comprising the step of: 3D-printing at least one layer as well as multiple layers in sequence of the scaffold in order to yield a scaffold of a specific shape and size (¶ 0024).
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 method of Parikh such that it comprises the step of: 3D-printing at least one layer of the scaffold, as taught by Bornemann, as 3D-printing is suitable for yielding a scaffold of a specific shape and size (Bornemann ¶ 0024).
Parikh in view of Bornemann fail to explicitly disclose wherein the diameter or circumference of each layer is greater than the diameter or circumference of each previous layer.
However, Bornemann teaches (fig. 1) wherein the deposition of successive layers yields a specific shape and size (¶ 0024).
Thus, 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 method of Parikh in view of Bornemann such that each layer is greater than the diameter or circumference of each previous layer, in order to yield a scaffold of a specific shape and size (Bornemann ¶ 0024).
Regarding claim 15, Parikh discloses wherein the providing at least one active agent step comprises incorporating the active agent into the matrix (the active agent can be encapsulated in the biodegradable inner core ¶ 0107, ¶ 0118).
Regarding claim 16, Parikh discloses wherein the method further comprises adding the at least one active agent and a co-polymer to a vinyl polymer to form nanoparticles (the stent may include the at least one active agent encapsulated in, blended/conjugated to sustained release nanoparticle formulations entrapped in between or conjugated with the fibers of the stents ¶ 0107, fibers of the stents including a co-polymer ¶ 0087 and a vinyl polymer ¶ 0093).
Regarding claim 17, Parikh discloses wherein the providing the at least one active agent step comprises incorporating the at least one active agent into the scaffold (the active agent can be encapsulated in the non-degrading layer, ¶ 0107, ¶ 0118).
Regarding claim 18, Parikh discloses a method of controlled delivery at least one active agent (¶ 0009, ¶ 0107), the method comprising the steps of:
Providing at least one layer of a scaffold (outer wall 200, ¶ 0133) formed from a polymer or co-polymer (the stent contains one or more non-biodegradable polymer ¶ 0093);
Incorporating the at least one active agent into the scaffold (the active agent can be encapsulated in the non-degrading layer, ¶ 0107, ¶ 0118);
Providing a matrix (inner wall 210) formed from hyaluronic acid (the stent contains one or more bio-degradable polymers such as hyaluronic acid ¶ 0087-¶ 0088);
Combining the scaffold and matrix and optionally the at least one active agent (¶ 0012).
Parikh fails to disclose 3D-printing at least one layer of the scaffold.
Bornemann teaches (fig. 1) a method of manufacturing a device comprising a scaffold (implant 12) (abstract) and thus in the same field of endeavor, comprising the step of: 3D-printing at least one layer of the scaffold in order to yield a scaffold of a specific shape and size (¶ 0024).
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 method of Parikh such that it comprises the step of: 3D-printing at least one layer of the scaffold, as taught by Bornemann, as 3D-printing is suitable for yielding a scaffold of a specific shape and size (Bornemann ¶ 0024).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Csaky (Pub. No.: US 2016/0081920 A1) discloses a method comprising 3D printing. Peyman (Pat. No.: US 10,314,690 B1) discloses a method comprising 3D printing.
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.
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/MEAGAN NGO/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 20 January 2026