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 .
Election/Restrictions
Applicants’ election of Group 1, with traverse, in the reply filed on 3/04/2026 is acknowledged. The traversal is on the ground(s) that the product disclosed by Hevey (EP 0992283 A2) is allegedly not the same as the claimed biocompatible composite membrane. Applicant argues that the disclosed product comprises a crosslinking agent that permanently bonds the polymer layer with the water insoluble porous substrate. As a result, the final product does not have a layer that is water soluble.
The traversal has been considered and is found persuasive. Upon re-evaluation of the cited prior art, it is conceded that the polymer layer is not water soluble due to being crosslinked. However, an updated prior art search was found that reads on the claimed product (as discussed in more detail below). Since the technical feature is not a special technical feature, there is no unity of invention. The restriction requirement is therefore deemed proper.
Power of Attorney
There is no Power of Attorney on file and it is recommended that applicant submits one to facilitate prosecution.
Priority
The instant application is a national stage entry of PCT/EP2021/082887 (filed on 11/24/2021), which claims foreign priority under 35 U.S.C. 119(a)-(d) based on application LU102222 (filed on 11/24/2020). Certified copy of the foreign priority document is on file.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/23/2023 is in compliance with the provisions of 37 C.F.R. 1.97. Accordingly, all references cited in the IDS have been fully considered.
Claim Objections
Claim 1 is objected to since a Latin term is not written in italics. To resolve this issue, “in vitro” should be italicized.
Claim 2 is objected to because of the following informality: space is missing after the comma in line 1. Appropriate correction is required.
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.
Claims 2, 7-9 and 18-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2, 7-9 and 18 recite “preferably”, “more preferably, “even more preferably”, and/or “most preferably”, which render the claims indefinite because it is unclear whether the limitations following any of these terms are part of the claimed invention. Thus, these claims are indefinite. See MPEP § 2173.05(d). In the interest of compact prosecution, they are interpreted to be optional (i.e., not required).
Claim 19 is also considered indefinite for depending on claim 18.
Claim 8 recites the limitation “the fibrous scaffold” in line 2. There is insufficient antecedent basis for this limitation since the parent claim does not recite any fibrous scaffold. For the purpose of applying prior art, this limitation is examined as if it refers to the “porous scaffold”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 5-6, and 8 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Jancar et al. (Pub. No. CZ 2017256 A3; English translation).
Jancar et al. discloses a cell culturing carrier comprising a multi-well plate, wherein porous substrates are placed in the wells of said multi-well plate (Abstract, page 1). The porous substrates are three-dimensional and have a thickness of at least 10 µm (last par. page 2). They consist of one or more layers. Preferably at least two layers with different porosity, pore size, material composition (fifth par., page 3).
The porous substrates are preferably selected from the group comprising collagen, crosslinked EDC/NHS collagen, polymers and copolymers of polylactic acid, polyglycolic acid and/or polyethylene glycol, polycaprolactone, polysaccharides like gelatin, gum karaya, and fibrous silk (last par., page 3).
In Example 14 (page 13), porous substrates for wells of a 24-well plate are prepared layer by layer with the non-toxic materials in the following order: ultrapure water, collagen, gelatin nanofibers modified with halloysite, and ultrapure water. The resulting plate contains laminated porous scaffold comprising a lower layer and an upper layer, both having equal thickness but different sizes of pores.
Jancar et al.’s porous substrates read on the instant application’s biocompatible composite membrane as follows:
Regarding claim 1: Example 14’s porous substrates, each comprising a lower layer that has pores and is made of collagen, which is water insoluble, is equivalent to “a non-water soluble, first material” and meets “wherein the composite membrane comprises a porous scaffold… the scaffold comprising the first material”.
The upper layer being made of gelatin nanofibers modified with halloysite, which are water soluble, satisfies the requirement that the claimed composite membrane comprises “a water soluble second material” and “a filling layer… the filling layer comprising the second material”.
Regarding claims 2 and 5-6: the instant claims recite product-by-process limitations. A product-by-process limitation is considered only inasfar as the method of production imparts distinct structural properties to the product. MPEP § 2113 states “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)”. In this case, the lower collagen layer is coated with a gelatin-based upper layer.
Regarding claim 8: the lower and upper layers having the same thickness fulfills “wherein the thickness of the filling layer is equal to or smaller than that of the fibrous scaffold”.
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.
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.
Claims 1-2 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Jancar et al. (Pub. No. CZ 2017256 A3; English translation).
The teachings of Jancar et al. are set forth above and applied herein. Jancar et al. is found to anticipate claims 1-2, 5-6, and 8.
The disclosed porous substrates are comparable to the claims below:
Regarding claim 7: the porous scaffold is further required to have “a thickness of less than 10 µm”, which is rendered obvious by Jancar et al.’s teaching that the porous substrates have a thickness of at least 10 µm.
According to MPEP § 2144.05(I), a prima facie case of obviousness exists when the claimed ranges "overlap or lie inside ranges disclosed by the prior art". 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that suitable protection’ is provided if the protective layer is about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Regarding claim 9: the first material is further required to comprise “a hydrophobic material, preferably polycaprolactone”, while second material is optionally “wettable” and “comprises gelatin”.
Example 14’s upper layer comprises gelatin, but the lower layer is not hydrophobic. However, the prior art teaches that the porous substrates’ can be made of hydrophobic materials such as polycaprolactone. A person with ordinary skill in the art would have replaced the collagen with polycaprolactone and predict that the lower layer would be hydrophobic. Obviousness is based on the rationale that substitution of one known element for another known element, both elements having equivalent effect, is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v. Teleflex Inc. 550 US 398, 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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