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 .
Status of Claims
Claims 1-5, 7-16, 18-19, 21-22 and 27 are pending and have been examined.
Priority
This application 18/027,587 (PGPub: US2023/0349893) was filed 03/21/2023. This application is a 371 of PCT/CA2021/051320 filed 09/22/2021, which claims benefit of US Provisional Application 63/081,622 filed 09/22/2020.
Information Disclosure Statement
The Information Disclosure Statement filed 06/20/2023 has been considered by the Examiner.
Claim Objections
Claims 11 and 21 are objected to because of the following informalities:
Claim 11 should be corrected to spell “organaosilane” correctly.
Claim 21 is dependent on cancelled claim 20.
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.
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 11-12 and 21-22 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.
Claim 11 recites “the organaosilane” and while claim 1 has recited “organosilane groups”, it is unclear if the limitation in claim 11 is referring to the organosilane groups of claim 1 or an additionally organosilane.
Claim 21 recites “the polymer” however this limitation lacks antecedent basis.
Regarding claim 12, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 22, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-5, 10-12, 15-16, 18-19, 22 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Badv et al. (ACS Nano 2018, 12, pages 10890-10902, published 10/24/2018, hereinafter “Badv”).
Regarding claim 1, Badv teaches throughout the publication a method for fabricating a biofunctionalized surface on a substrate, wherein the substrate comprises hydroxyl groups on the surface to be biofunctionalized, the method comprising: (a) covalently attaching organosilane groups to hydroxyl groups on the surface of the substrate; (b) covalently attaching one or more biospecies to the surface of the substrate; and (c) applying a lubricant to the substrate, wherein the biospecies comprises a biorecognition element that detects a target analyte in a sample (pages 10891-10892: Design and Fabrication of Biofunctional Lubricant-Infused Surfaces section; Page 10898-10899: Materials and Methods section).
While Badv does not explicitly teach that the organosilane is covalently attached to less than all of the hydroxyl groups on the surface of the substrate, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 1 are for any particular purpose or solve any stated problem, and the prior art teaches that varying the ratio of covalent attachment components allows for further control over the degree of antibody and target binding (Badz, page 10891, right column, first full paragraph). Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the surface functionalization art.
Regarding claim 2, Badv teaches the method wherein the silane solutions containing the glass samples were stirred for 1 h at room temperature, and then the glass samples were removed from the solution, washed with 100% anhydrous ethanol and deionized water, and ultimately 70% ethanol was used to complete the washing step. After drying the samples at room temperature, they were placed in the oven at 60 °C overnight for at least 12 h. Similar to CVD-treated samples, after removing the LPD-treated glass slides from the oven, they were sonicated for 10 min, and placed under vacuum for 30 min in order to remove the noncovalently attached silane molecules (page 10899, left column, first paragraph). While Badv does not specifically teach contacting the substrate with an organosilanating reagent for about 5 minutes to about 30 minutes at a temperature of about 20 0C to about 90 0C, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 2 are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the surface functionalization art.
Regarding claim 3, Badv teaches the method wherein the organosilane groups are attached to less than all of the hydroxyl groups on the surface of the substrate in (a) by first treating the substrate with CO2 plasma under conditions to convert only a portion of the hydroxyl groups to carboxyl groups and covalently attaching organosilane groups to the unconverted hydroxyl groups , and the biospecies is covalently attached in (b) to the carboxyl groups (page 10891-10892: Design and Fabrication of Biofunctional Lubricant-Infused surfaces section; page 10898: Initial Activation of the Surfaces Using Oxygen Plasma Treatment section).
Regarding claim 4, Badz teaches the method wherein covalently attaching organosilane groups comprises chemical vapor deposition or liquid phase deposition (page 10899, left column, first two paragraphs).
Regarding claim 5, Badz teaches the method wherein covalently attaching the biospecies comprises applying a covalent crosslinking agent to the substrate before applying the biospecies to the substrate, or combining a covalent crosslinking agent with the biospecies into a mixture then applying the mixture to the substrate (page 10891-10892: Design and Fabrication of Biofunctional Lubricant-Infused surfaces section).
Regarding claim 10, Badz teaches the method wherein the substrate comprises a glass material (page 10898: Initial Activation of the Surfaces Using Oxygen Plasma Treatment section).
Regarding claims 11-12, Badz teaches the method wherein the organosilane is a fluorosilane and more specifically wherein the fluorosilane comprises trichloro(1 H,1 H,2H,2H-perfluorooctyl)silane (page 10891-10892: Design and Fabrication of Biofunctional Lubricant-Infused surfaces section).
Regarding claim 15, Badz teaches the method wherein the lubricant comprises perfluoroperhydrophenanthrene (PFPP) (page 10891-10892: Design and Fabrication of Biofunctional Lubricant-Infused surfaces section).
Regarding claims 16 and 18, Badz teaches the method wherein the covalent crosslinking agent comprises a silane coupling agent comprising a mono-, di- or tri-functional silane and more specifically, wherein the silane coupling agent is (3-aminopropyl)triethoxysilane (APTES) (page 10891-10892: Design and Fabrication of Biofunctional Lubricant-Infused surfaces section).
Regarding claim 19, Badz teaches the method wherein the covalent crosslinking agent comprises a carbodiimide crosslinker (page 10891-10892: Design and Fabrication of Biofunctional Lubricant-Infused surfaces section).
Regarding claim 22, Badz teaches the method wherein the biospecies comprises a biomolecule, wherein the biomolecule is an antibody (page 10891-10892: Design and Fabrication of Biofunctional Lubricant-Infused surfaces section).
Regarding claim 27, Badz teaches a biosensor comprising a biofunctionalized surface prepared using a method of claim1, wherein the biofunctionalized surface is capable of preventing non-specific adsorption (abstract and conclusion).
Claim(s) 1, 3-5, 7-12, 14-16, 18-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Didar et al. (CA3087896, Pub Date: 07/18/2019, hereinafter “Didar”, IDS).
Regarding claim 1, Didar teaches throughout the publication a method for fabricating a biofunctionalized surface on a substrate, wherein the substrate comprises hydroxyl groups on the surface to be biofunctionalized, the method comprising: (a) covalently attaching organosilane groups to hydroxyl groups on the surface of the substrate; (b) covalently attaching one or more biospecies to the surface of the substrate; and (c) applying a lubricant to the substrate, wherein the biospecies comprises a biorecognition element that detects a target analyte in a sample (paragraph 0025).
Although Didar does not explicitly teach the method wherein less than all of the hydroxyl groups are covalently attached to organosilane groups, the references teaches that creating uniform silane monolayers is challenging (paragraph 0006) and therefore it would be obvious to one skilled in the art that not all the hydroxyl groups would have organosilane attached based on the general limitations of techniques in the art.
Regarding claim 3, Didar teaches the method wherein the organosilane groups are attached to less than all of the hydroxyl groups on the surface of the substrate in (a) by first treating the substrate with CO2 plasma under conditions to convert only a portion of the hydroxyl groups to carboxyl groups and covalently attaching organosilane groups to the unconverted hydroxyl groups, and the biospecies is covalently attached in (b) to the carboxyl groups (paragraph 0010).
Regarding claim 4, Didar teaches the method wherein covalently attaching organosilane groups comprises chemical vapor deposition (paragraph 0032).
Regarding claim 5, Didar teaches the method wherein covalently attaching the biospecies comprises applying a covalent crosslinking agent to the substrate before applying the biospecies to the substrate (paragraph 0160)
Regarding claim 7, Didar teaches the method wherein covalently attaching the biospecies comprises positioning the biospecies in a distinct pattern on the surface (paragraph 0126).
Regarding claim 8, Didar teaches the method wherein covalently attaching the biospecies comprises non-contact printing (paragraph 0126).
Regarding claim 9, Didar teaches the method wherein covalently attaching the biospecies comprises contact printing (paragraph 0126).
Regarding claim 10, Didar teaches the method wherein the substrate comprises a glass material (paragraph 0103).
Regarding claims 11-12, Didar teaches the method wherein the organosilane is a fluorosilane and more specifically, trichloro(1 H,1 H,2H,2H-perfluorooctyl)silane (paragraph 0103).
Regarding claim 14, Didar teaches the method further comprising micro-sized structures on the surface (paragraph 0035 and Figure 11, ePTFE).
Regarding claim 15, Didar teaches the method wherein the lubricant comprises a perfluoroperhydrophenanthrene (PFPP) (paragraph 0041).
Regarding claims 16 and 18, Didar teaches the method wherein the covalent crosslinking agent comprises a silane coupling agent comprising a mono-, di- or tri-functional silane and more specifically, wherein the silane coupling agent is (3-aminopropyl)triethoxysilane (APTES) (paragraph 0019).
Regarding claim 19, Didar teaches the method wherein the covalent crosslinking agent comprises a carbodiimide crosslinker (paragraph 0019).
Regarding claim 22, Didar teaches the method wherein the biospecies comprises a biomolecule such as a protein or antibody (paragraph 0017).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Didar et al. (CA3087896, Pub Date: 07/18/2019, hereinafter “Didar”, IDS), as applied to claim 1 above, further in view of Liang et al. (US2017/0306491, IDS).
Regarding claim 13, while Didar teaches the presence of organosilane groups such as fluorosilane (paragraph 0025), the reference fails to explicitly teach the method wherein organosilane groups comprises n-propyltrichlorosilane, and/or methyltrichlorosilane.
Liang teaches throughout the publication apparatuses and methods for self-assembled monolayer deposition (abstract). More specifically Liang teaches that the SAM precursors can include fluorosilanes (paragraph 0043) or alternatively chlorosilane materials such as methyltrichlorosilane or propyltrichlorosilane (paragraph 0041).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute for the fluorosilane of Didar, alternative organosilanes such as methyltrichlorosilane or propyltrichlorosilane as taught by Liang. One having ordinary skill in the art would have been motivated to make such a change as a mere alternative and functionally equivalent organosilane groups and since the same expected covalent attachment would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired surface functionalization.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Didar et al. (CA3087896, Pub Date: 07/18/2019, hereinafter “Didar”, IDS), as applied to claim 1 above, further in view of Ingber et al. (US 2015/0173883, Pub Date: 06/25/2015, hereinafter “Ingber”).
Regarding claim 21, Didar teaches the method as described above wherein crosslinking agents can be used (paragraph 0019). However, the reference fails to teach wherein a polymer can be used comprising cyclophane-containing polymers, poly(allylamine hydrochloride), poly(ethyleneimine), poly(acrylic acid), functional polyethylene glycol (PEG) (e.g. NHS-PEG), amine functional polyacrylamide, poly(ethyleneimine) (PEI), poly(allylamine hydrochloride) (PAH), and, polyallylamine, amine functional parylenes, and/or hyperbranched polyglycerol.
Ingber teaches throughout the publication method and uses for modifying surfaces for simultaneously providing repellency and selective binding (abstract). More specifically, Ingber teaches that cross-linking agents can be used such as amines or polar polymers such as PEG (paragraph 0093).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute for the crosslinking agents of Didar, alternative crosslinkers such as PEG as taught by Ingber. One having ordinary skill in the art would have been motivated to make such a change as a mere alternative and functionally equivalent crosslinking agents and since the same expected attachment would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired surface functionalization.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Peck (US2017/0151546) teaches throughout the publication methods for producing fluorosilanated substrates to which a biomolecule is attached (paragraphs 0003,0056, 0096) .
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677