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 Objections
Claims 3 and 9 are objected to because of the following informalities: 1-butyl-3-methylimidasolium chloride appears to be a misspelling. The correct term is 1-butyl-3-methylimidazolium chloride. Appropriate correction is required.
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, 2, 4 – 8 and 10 – 12 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ibrahim et al. (US 2020/0061214 A1; hereinafter “Ibrahim”).
Regarding claim 1, Ibrahim teaches throughout the publication an implantable (e.g., paragraphs 27 – 29) oxygen sensing composition comprising:
a) a transparent hydrogel (an oxygen-sensing compound is embedded within a hydrogel carrier, e.g., transparent collagen or gelatin; paragraphs 48, 53, 60 and 62); and
b) an oxygen sensing composition which fluoresces in the presence of oxygen embedded in the transparent hydrogel (paragraphs 46 and 63).
Regarding claim 2, Ibrahim teaches the implantable oxygen sensing composition according to claim 1, wherein the hydrogel is a HEMA hydrogel (polymer of 2-hydroxyethyl methacrylate) treated to be transparent (e.g., poly(hydroxyethyl methacrylate) (PHEMA); paragraph 60).
Regarding claim 4, Ibrahim teaches the implantable oxygen sensing composition according to claim 1, wherein the fluorescence of the oxygen sensing composition can be connected to a fiber optic cable to deliver fluorescence to a fluorescence reader (paragraphs 71 and 103).
Regarding claim 5, Ibrahim teaches the implantable oxygen sensing composition according to claim 1, wherein the oxygen sensing composition can be subcutaneously implanted and read through the skin by a fluorescence reader (paragraphs 28, 71 and 103).
Regarding claim 6, Ibrahim teaches the implantable oxygen sensing composition according to claim 1, wherein the oxygen sensing composition is comprising (a) palladium tetraphenyl-tetrabenzoporphyrin (PdTPTBP) (paragraph 52).
Regarding claim 7, Ibrahim teaches a method of measuring tissue oxygen tension in a mammal (paragraphs 42 and 44) comprising:
a) selecting an implantable oxygen sensing composition comprising a transparent hydrogel and an oxygen sensing composition which fluoresces in the presence of oxygen embedded in the transparent hydrogel (an oxygen-sensing compound is embedded within a hydrogel carrier, e.g., transparent collagen or gelatin; paragraphs 48, 53, 60 and 62);
b) implanting the implantable oxygen sensing composition in the mammal (paragraphs 28, 71 and 103); and
c) measuring the degree of fluorescence by measuring with a fluorescence reader (paragraphs 46 and 63, 71 and 103).
Regarding claim 8, Ibrahim teaches the method of measuring tissue oxygen tension in a mammal according to claim 7, wherein the hydrogel is a HEMA hydrogel treated to be transparent (e.g., poly(hydroxyethyl methacrylate) (PHEMA); paragraph 60).
Regarding claim 10, Ibrahim teaches the method of measuring tissue oxygen tension in a mammal according to claim 7, wherein the oxygen sensing composition is comprising (a) palladium tetraphenyl-tetrabenzoporphyrin (PdTPTBP) (paragraph 52).
Regarding claim 11, Ibrahim teaches the method of measuring tissue oxygen tension in a mammal according to claim 7, wherein the oxygen sensing composition is implanted subcutaneously (paragraphs 28, 71 and 103).
Regarding claim 12, Ibrahim teaches the method of measuring tissue oxygen tension in a mammal according to claim 7, wherein the oxygen sensing composition is implanted on an internal organ and delivers fluorescence to the fluorescence reader via a fiber optic cable (paragraphs 44, 71 and 72).
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.
Claim(s) 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ibrahim et al. (US 2020/0061214 A1; hereinafter “Ibrahim”) in view of Liu et al. (Cite No. 1 on the IDS filed 10/14/2024 by Applicant; hereinafter “Liu”).
Regarding claim 3, Ibrahim does not specifically teach the implantable oxygen sensing composition according to claim 2, wherein the HEMA hydrogel is a combination of 1-butyl-3-methylimidasolium chloride and 2-hydroxyethyl methacrylate that is degassed.
Regarding claim 9, Ibrahim does not specifically teach the method of measuring tissue oxygen tension in a mammal according to claim 8, wherein the HEMA hydrogel is a combination of 1-Butyl-3-methylimidasolium Chloride and 2-hydroxyethyl methacrylate that is degassed.
However, Liu teaches a hydrogel composition comprising poly(2-hydroxyethyl methacrylate) (PHEMA) and 1-butyl-3-methylimidazolium chloride (Abstract; Introduction and Experimental sections). These hydrogels have high transparence and mechanical properties, and can be used in biomedical applications such as tissue engineering scaffolds and drug delivery carriers (Abstract; Introduction and Conclusions sections). Consequently, as evidenced by Liu, this hydrogel composition would have been considered to be suitable and predictable to a person of ordinary skill in the art for use in a biomedical application such as for an implantable sensing composition. Degassing solutions is a well known laboratory technique to remove dissolved air and oxygen in liquid solutions. 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). Furthermore, 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 wherein the HEMA hydrogel is a combination of 1-butyl-3-methylimidasolium chloride and 2-hydroxyethyl methacrylate that is degassed.
Conclusion
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796