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 .
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, 18, 21 and 24 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, the phrase “preferably” which is considered equivalent to the phrases: “such as,” “for example,” “in particular,” “specifically,” “or more specifically,” and “or the like,” is considered indefinite. The metes and bounds of the claim scope are not clear. It is not clear if the claim limitation is optional or not. Furthermore, without knowing this information, one of ordinary skill in the art would not know whether they are infringing on the claims or not.
Regarding claims 18 and 24, the phrase “more specifically” which is considered equivalent to the phrases: “such as,” “for example,” “in particular,” “specifically,” and “or the like,” is considered indefinite. The metes and bounds of the claim scope are not clear. It is not clear if the claim limitation is optional or not. Furthermore, without knowing this information, one of ordinary skill in the art would not know whether they are infringing on the claims or not.
Regarding claim 21, the phrase “for example” which is considered equivalent to the phrases: “such as,” “in particular,” “specifically,” and “or the like,” is considered indefinite. The metes and bounds of the claim scope are not clear. It is not clear if the claim limitation is optional or not. Furthermore, without knowing this information, one of ordinary skill in the art would not know whether they are infringing on the claims or not.
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.
Claim(s) 1 – 8, 10 – 22 and 25 – 28 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lee et al. (US 2020/0028198 A1; hereinafter “Lee”).
Regarding claim 1, Lee teaches throughout the publication a method of fabricating a chemically active fibre device (fiber 10; paragraphs 42 – 45; figure 1A) by thermal drawing (Abstract; paragraph 3; claims 29 and 30), the method comprising the steps of:
providing a preform, the preform comprising a support element at least partially made of a first polymeric material (e.g., a preform including a fiber body material (12) and a plurality of gel domains (14, 16) including a porous polymer matrix material and includes an ionically conducting liquid gel component that is entrapped in the molecular structure of the host matrix material and that is disposed in in interstices of the host material matrix; paragraphs 11, 53, 54, 56, 60, 110; fiber body materials can be various polymeric materials; paragraph 53); and
carrying out a thermal drawing process of the preform to produce a thermally drawn fibre (paragraphs 3, 7, 11, 52 – 57, 60, 62 – 71, 78, 79, 83, 86 – 92, 96, 101, 105 – 118, 127, 129 – 131 and 135; figures 7, 8A, 8B, 9 and 10A- 10C), wherein the preform comprises one or more chemically active agents and/or biological materials (each gel can include one or more additional components or additives that provide selected functionality to the gel; paragraphs 51, 67, 68, 71, 78, 93) configured to react with a fluid sample when the one or more chemically active agents and/or biological materials are in contact with the fluid sample, and wherein the one or more chemically active agents and/or biological materials remain active after the thermal drawing process (e.g., paragraph 111).
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Regarding claim 2, Lee teaches the method according to claim 1, wherein the preform comprises one or more agent carriers (e.g., polyethylene glycol; paragraph 57) comprising the one or more chemically active agents and/or biological materials.
Regarding claim 3, Lee teaches the method according to claim 2, wherein the one or more agent carriers are at least partially made of a second polymeric material (e.g., polyethylene glycol; paragraph 57).
Regarding claim 4, Lee teaches the method according to claim 2, wherein the one or more agent carriers are made of a porous material having pore diameters between 2 nm and 500 nm, and/or the one or more agent carriers comprise one or more channels for receiving the fluid sample (gels can comprise pores, a porous morphology or interconnected porous network, or channel structures; Abstract; paragraphs 8, 9, 11, 45, 47 , 50, 59, 76, 79, 86, 96, 114, 116, 123 and 130).
Regarding claim 5, Lee teaches the method according to claim 2, wherein the one or more agent carriers are made of a material dissolvable in the fluid sample, and wherein the fluid sample is a liquid sample (e.g., to obtain a viscous liquid gel state at thermal drawing temperatures, the host polymer component of the fiber gels is provided by polyethylene glycol (PEG); paragraph 57; the solvent component or liquid sample component of the fiber gels can be provided other suitable solvents; paragraphs 11 and 57).
Regarding claim 6, Lee teaches the method according to claim 2, wherein the one or more agent carriers are at least partially made of a gel-like material (e.g., polyethylene glycol (PEG); paragraph 57).
Regarding claim 7, Lee teaches the method according to claim 6, wherein the gel-like material is a polymerised gel (e.g., polyethylene glycol (PEG); paragraph 57), a physical hydrogel or an excipient formulation.
Regarding claim 8, Lee teaches the method according to claim 6, wherein the gel-like material is poly(ethylene glycol) (e.g., polyethylene glycol (PEG); paragraph 57).
Regarding claim 10, Lee teaches the method according to claim 2 wherein the one or more agent carriers comprise a plasticiser and/or an excipient (e.g., polyethylene glycol (PEG); paragraph 57).
Regarding claim 11, Lee teaches the method according to claim 10, wherein the plasticiser or excipient is polyethylene glycol (e.g., polyethylene glycol (PEG); paragraph 57).
Regarding claim 12, Lee teaches the method according to claim 1, wherein the support element comprises one or more channels for receiving the fluid sample, and wherein the one or more agent carriers is/are placed within the respective channel, and/or the one or more agent carriers form a coating for the respective channel (gels can comprise pores, a porous morphology or interconnected porous network, or channel structures; Abstract; paragraphs 8, 9, 11, 45, 47 , 50, 55, 59, 76, 79, 86, 96, 114, 116, 123 and 130).
Regarding claim 13, Lee teaches the method according to claim 12, wherein the preform further comprises one or more hydrophilic layers at least partially encompassing the one or more channels, and having a static contact angle comprised between 5° and 80° (e.g., gels can comprise pores, a porous morphology or interconnected porous network, or channel structures; Abstract; paragraphs 8, 9, 11, 45, 47 , 50, 55, 57, 59, 76, 79, 86, 96, 114, 116, 123 and 130; figure 1).
Regarding claim 14, Lee teaches the method according to claim 13, wherein the one or more hydrophilic layers are at least partially made of a material selected from a non-limiting list selected from poly(ethylene glycol) and polyvinyl alcohol (paragraph 57).
Regarding claim 15, Lee teaches the method according to claim 1, wherein the active agent (paragraphs 51, 71, 78) is a pharmacologically active organic molecules including drugs (e.g., for drug delivery; paragraph 71).
Regarding claim 16, Lee teaches the method according to claim 1, wherein the first polymeric material (fiber body materials can be various polymeric materials; paragraph 53) and/or the second polymeric material (e.g., various polymer materials including polyethylene glycol; paragraph 57) has/have a glass transition temperature comprised between -60°C and 60°C. Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). Furthermore, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.).
Regarding claim 17, Lee teaches the method according to claim 1, wherein the first polymeric material is polyvinyl chloride (polyvinylchloride; paragraph 53).
Regarding claim 18, Lee teaches the method according to claim 1, wherein the drawing process is carried out at a temperature comprised between 50°C and 70°C, or more specifically between most 55°C and 65°C (paragraphs 89, 108 and 115).
Regarding claim 19, Lee teaches the method according to claim 1, wherein the first polymeric material has a density comprised between 0.85 g/cm³ and 1.4 g/cm³ (e.g., polyvinylchloride; paragraph 53). Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). Furthermore, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.).
Regarding claim 20, Lee teaches the method according to claim 1, wherein the fibre has a cross-sectional area orthogonally to its longitudinal axis (A) comprised between 1 mm² and 20 mm² (paragraph 43).
Regarding claim 21, Lee teaches the method according to claim 1, wherein the preform comprises one or more additional materials, wherein the one or more additional materials comprise electrically conductive materials, stretchable polymers and/or semiconductors (paragraphs 51, 71, 78, 82 and 85).
Regarding claim 22, Lee teaches the method according to claim 1, wherein the method further comprises adding one or more coatings comprising one or more active materials after the thermal drawing process on the thermally drawn fibre and/or within one or more channels comprised in the preform (paragraphs 54 and 55).
Regarding claim 25, Lee teaches the method according to claim 1, wherein the method further comprises drying an active agent carrier comprised in the support element before the thermal drawing process to make the thermomechanical properties of the plurality of materials of the preform compatible with that of the support element material during the thermal drawing process (the host matrix and the gel can be dried; paragraph 47).
Regarding claim 26, Lee teaches a thermally drawn chemically active fibre device for sensing a fluid sample, the chemically active fibre device comprising:
a thermally drawable support element (fiber 10; paragraphs 42 – 45; figure 1A) at least partially made of a first polymeric material (e.g., a preform including a fiber body material (12) and a plurality of gel domains (14, 16) including a porous polymer matrix material and includes an ionically conducting liquid gel component that is entrapped in the molecular structure of the host matrix material and that is disposed in in interstices of the host material matrix; paragraphs 11, 53, 54, 56, 60, 110; fiber body materials can be various polymeric materials; paragraph 53); and
one or more chemically active agents and/or biological materials (each gel can include one or more additional components or additives that provide selected functionality to the gel; paragraphs 51, 67, 68, 71, 78, 93) configured to react with the fluid sample when the one or more biochemically active agents and/or biological materials are in contact with the fluid sample at least after the support element and the one or more chemically active agents and/or biological materials have undergone a thermal drawing process.
Regarding claim 27, Lee teaches the chemically active fibre device according to claim 26, wherein the support element is made of transparent or translucent polymeric material (fiber body materials can be various polymeric materials; paragraph 53).
Regarding claim 28, Lee teaches the chemically active fibre device according to claim 26, wherein the support element comprises one or more channels extending through the support element along a longitudinal axis of the support element (the volume occupied by gel domains 14 and 16 in the fiber body 12; paragraph 42; figure 1).
Claim Rejections - 35 USC § 103
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 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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2020/0028198 A1; hereinafter “Lee”) in view of Rangavajla (US 2011/0070334 A1; hereinafter “Rangavajla”).
Regarding claim 9, Lee does not specifically teach the method according to claim 2, wherein the one or more agent carriers comprise trehalose.
However, Rangavajla teaches that trehalose can form a gel phase and is useful in forming a protective matrix around fragile molecules, such as a probiotic or other type of molecules (paragraph 41). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the one or more agent carriers comprise trehalose.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2020/0028198 A1; hereinafter “Lee”).
Regarding claim 23, Lee does not specifically teach the method according to claim 1, wherein the method further comprises cutting the thermally drawn fibre into a plurality of chemically active fibre devices.
Regarding claim 24, Lee does not specifically teach the method according to claim 23, wherein the chemically active fibre devices have a length between 0.5 cm and 10 cm, or between 1 cm and 5 cm.
However, Lee does indicate that the disclosed fiber devices can be produced in any arbitrary length (paragraph 90). It would have been within the ambit of a person of ordinary skill in the art to cut the fibre devices as claimed into a desired length as needed. The mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.04). The Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04). The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). Furthermore, the prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide wherein the method further comprises cutting the thermally drawn fibre into a plurality of chemically active fibre devices in the lengths as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796