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 Arguments
Applicant’s amendments and arguments, filed 7/23/2026, with respect to the rejection(s) of claims 1 – 8, 10 – 22 and 25 – 28 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lee et al. (US 2020/0028198 A1), 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 Therefore, the rejection has been withdrawn.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 further in view of Gumennik et al. (US 2014/0212084 A1), Coppede et al. (US 2018/0279930 A1) and Dong et al. (US 2015/0087731 A1; hereinafter “Dong”).
The rejection of claims 8, 18, 21 and 24 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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, 26, 27 and 28 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gumennik et al. (US 2014/0212084 A1; hereinafter “Gumennik”).
Regarding claims 1 and 26, Gumennik teaches throughout the publication a method of fabricating a chemically active fiber sensing device (sensor fiber 10; paragraph 22; figure 1A) by thermal drawing (paragraph 31), the method comprising the steps of:
providing a preform (paragraph 31), the preform comprising a support element at least partially made of a first polymeric material (e.g., amorphous thermoplastic polymeric materials; paragraphs 60 and 61), the preform comprising one or more chemically active agents (e.g., transduction element sensing materials can be co-drawn with other fiber elements from a fiber preform into the sensor fiber; paragraph 68) configured to react with a fluid sample to perform chemical sensing when the one or more chemically active agents are in contact with the fluid sample; and
carrying out a thermal drawing process of the preform to produce a thermally drawn fiber (the fiber is produced by a thermal fiber drawing process like that employed for producing optical fibers; paragraph 31),
wherein the thermally drawn fiber comprises one or more capillaries (e.g., microcapillaries 12; paragraphs 24 – 27 and 32 - 34; figure 1B) for receiving the fluid sample, the one or more capillaries extending longitudinally between a first end and a second, opposite end of the thermally drawn fiber, the thermally drawn fiber comprising one or more agent carriers (e.g., various material layers, such as conductive polymer layers and pads can be included in the preform arrangement; paragraph 67) placed within the respective capillary, and/or forming a coating (the one or more microcapillaries in the drawn fiber can be coated with one or more sensing materials; paragraph 98) for the respective capillary, the one or more agent carriers being at least partially made of a second polymeric material (e.g., paragraphs 67 and 80) and comprising the one or more chemically active agents (e.g., a peroxide sensing material is disposed in the fiber after fiber drawing; paragraph 99), and wherein the one or more chemically active agents remain active after the thermal drawing process.
Regarding claim 27, Gumennik teaches wherein the support element is made of transparent or translucent polymeric material (paragraphs 46 and 60; claim 23).
Regarding claim 28, Gumennik teaches wherein the support element comprises one or more channels extending through the support element along a longitudinal axis of the support element (Gumennik does teach the incorporation of channels (e.g., a microcapillary of the fiber or species intake microcapillaries; paragraphs 43 and 32 – 34) for receiving the fluid sample. Gumennik teaches that the fiber can be configured with ports, inlets, apertures, hollow cores, or other features to provide a physical site for species entry into the fiber (paragraph 33)).
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) 1, 15 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Gumennik et al. (US 2014/0212084 A1; hereinafter “Gumennik”) in view of Coppede et al. (US 2018/0279930 A1).
Regarding claims 1, 15 and 26, Gumennik teaches throughout the publication a method of fabricating a chemically active fiber sensing device (sensor fiber 10; paragraph 22; figure 1A) by thermal drawing (paragraph 31), the method comprising the steps of:
providing a preform (paragraph 31), the preform comprising a support element at least partially made of a first polymeric material (e.g., amorphous thermoplastic polymeric materials; paragraphs 60 and 61), the preform comprising one or more chemically active agents (e.g., transduction element sensing materials can be co-drawn with other fiber elements from a fiber preform into the sensor fiber; paragraph 68) configured to react with a fluid sample to perform chemical sensing when the one or more chemically active agents are in contact with the fluid sample; and
carrying out a thermal drawing process of the preform to produce a thermally drawn fiber (the fiber is produced by a thermal fiber drawing process like that employed for producing optical fibers; paragraph 31),
wherein the thermally drawn fiber comprises one or more capillaries (microcapillaries 12; paragraphs 24 – 27 and 32 – 34; figure 1B) for receiving the fluid sample, the one or more capillaries extending longitudinally between a first end and a second, opposite end of the thermally drawn fiber, the thermally drawn fiber comprising one or more agent carriers (e.g., various material layers, such as conductive polymer layers and pads can be included in the preform arrangement; paragraph 67) placed within the respective capillary, and/or forming a coating (the one or more microcapillaries in the drawn fiber can be coated with one or more sensing materials; paragraph 98) for the respective capillary, the one or more agent carriers being at least partially made of a second polymeric material (e.g., paragraphs 67 and 80) and comprising the one or more chemically active agents (e.g., a peroxide sensing material is disposed in the fiber after fiber drawing; paragraph 99), and wherein the one or more chemically active agents remain active after the thermal drawing process.
Gumennick does not specifically teach the incorporation of biological materials configured to react with a fluid sample to perform chemical sensing when one or more chemically active biological materials are in contact with the fluid sample.
Coppede teach sensors comprising an enzyme bonded to a functionalized polymer fiber for facilitating the detection of a specific molecule, such as glucose oxidase enzyme for the detection of glucose (paragraphs 46 and 52 – 60). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, Gumennick in paragraph 68 states that other sensing materials can be included in a fiber preform for co-drawing as desired for a given application (see also paragraphs 103, 105 and 123). Consequently, as evidenced by Gumennik, it would have been obvious to try to incorporate the use of an enzyme as a biological sensing material in a method of making the sensing device as claimed. The Supreme Court decided that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art (see MPEP § 2143, E.). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a biological material comprising an enzyme configured to react with a fluid sample to perform chemical sensing when one or more chemically active biological materials are in contact with the fluid sample with the sensing device as claimed.
Claim(s) 4 – 8, 10, 11, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gumennik et al. (US 2014/0212084 A1; hereinafter “Gumennik”) and Coppede et al. (US 2018/0279930 A1), and further in view of Dong et al. (US 2015/0087731 A1; hereinafter “Dong”).
Regarding claim 4, modified Gumennik does not specifically teach the method according to claim 1, 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 channels for receiving the fluid sample.
Gumennik does teach the incorporation of channels (e.g., a microcapillary of the fiber or species intake microcapillaries; paragraphs 43 and 32 – 34) for receiving the fluid sample. Gumennik teaches that the fiber can be configured with ports, inlets, apertures, hollow cores, or other features to provide a physical site for species entry into the fiber (paragraph 33).
Dong further teaches gels comprising polyethylene glycol for sensor applications having pores with diameters of between 2 nm and 50 nm (paragraphs 6, 136 and 149). 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 are made of a porous material having pore diameters between 2 nm and 500 nm, and/or the one or more channels for receiving the fluid sample.
Regarding claim 5, Dong teaches 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., an aerogel or wet gel; paragraphs 6, 136 and 149).
Regarding claim 6, Dong teaches wherein the one or more agent carriers are at least partially made of a gel-like material (e.g., an aerogel or wet gel; paragraphs 6, 136 and 149).
Regarding claim 7, Dong teaches wherein the gel-like material is a polymerized gel, a physical hydrogel (paragraph 149).
Regarding claim 8, Dong teaches wherein the gel-like comprises poly(ethylene glycol) (paragraph 149).
Regarding claims 10 and 11, Dong teaches wherein the one or more agent carriers comprise a plasticizer and/or an excipient is polyethylene glycol (PEG) (paragraph 149).
Regarding claim 13, Dong teaches the use of a gel comprising polyethylene glycol (PEG) (paragraph 149). It is implicit that the thermally drawn fiber can further comprises one or more hydrophilic layers at least partially encompassing the one or more capillaries, and having a static contact angle comprised between 5° and 80°. Since the chemical compound or composition is the same, absent any other further evidence to the contrary, it must have the same chemical properties. 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.). The Courts have held that with regard to chemical homologs that the greater the physical and chemical similarities between the claimed species disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner (see Dillon, 99 F.2d at 696, 16 USPQ2d at 1904).
Regarding claim 14, Dong teaches wherein the one or more hydrophilic layers are at least partially made of a poly(ethylene glycol) (paragraph 149).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gumennik et al. (US 2014/0212084 A1; hereinafter “Gumennik”), Coppede et al. (US 2018/0279930 A1), and Dong et al. (US 2015/0087731 A1; hereinafter “Dong”), and further in view of Rangavajla (US 2011/0070334 A1; hereinafter “Rangavajla”).
Regarding claim 9, modified Gumennik 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) 16 – 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gumennik et al. (US 2014/0212084 A1; hereinafter “Gumennik”) and Coppede et al. (US 2018/0279930 A1), and further in view of Lee et al. (US 2020/0028198 A1; hereinafter “Lee”).
Regarding claims 16 and 17, modified Gumennick does not specifically teach the method according to claim 1, wherein the first polymeric material and/or the second polymeric material has/have a glass transition temperature comprised between -60°C and 60°C, and wherein the first polymeric material comprises polyvinyl chloride.
Lee teaches a pertinent thermally drawn fiber sensing device (paragraphs 51, 68 and 134). Lee teaches 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 polyvinyl chloride; paragraph 53, 85, 103) has/have a glass transition temperature comprised between -60°C and 60°C. Since the chemical compound or composition is the same, absent any other further evidence to the contrary, it must have the same chemical properties. 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.). As indicated by Lee, it would have been obvious to a person of ordinary skill in the art to select an appropriate polymer material, such as polyvinyl chloride for the fabrication of the disclosed device depending on the desired specific properties. 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 first polymeric material and/or the second polymeric material, such as for example, comprising polyvinyl chloride, that has/have a glass transition temperature comprised between -60°C and 60°C.
Regarding claim 18, Lee teaches wherein the drawing process is carried out at a temperature comprised between 50°C and 70°C (e.g., a bottom-zone temperature of 60°C; paragraph 115).
Regarding claim 19, Lee teaches 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 polyvinyl chloride; paragraph 53, 85, 103). It is implicit that the first polymeric material has a density comprised between 0.85 g/cm³ and 1.4 g/cm³ (e.g., polyvinylchloride; paragraph 53). Since the chemical compound or composition is the same, absent any other further evidence to the contrary, it must have the same chemical properties. 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 wherein the fiber can have a cross-sectional area orthogonally to its longitudinal axis (A) comprised between 1 mm² and 20 mm² (paragraph 43).
Regarding claim 21, Lee teaches 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 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 fiber and/or within one or more channels comprised in the preform (paragraphs 54 and 55).
Regarding claim 25, Lee teaches wherein the method can comprise the further step of 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).
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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
Prosecution Insights