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 11 and 12 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. It is unclear for what EDTA and DMSO stands for. Please, clarify in the claim if they are: ethylenediaminetetraacetic acid and dimethyl sulfoxide.
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)(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, and 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhu CN 108106909A.
As to claim 1, Zhu discloses a method for rendering biological tissue sufficiently optically transparent for three-dimensional light microscopy imaging (see abstract), the method comprising incubating biological tissue with an optical clearing solution for sufficient time for the optical clearing solution to impregnate the biological tissue and make the biological tissue sufficiently optically transparent for three-dimensional light microscopy imaging [Embryos were stained with three-dimensional immunohistochemistry, and nerve fibers were labeled after blocking, incubation with primary antibody, and incubation with secondary antibody. The embryonic tissue was soaked in the light-transparency agent of Example 5 to make it transparent] (see par. 0062), wherein said optical clearing solution comprises (i) formamide in an amount of 20-50 wt% [the third mixed solution is composed of 30%-40% formamide] (see par. 0036), (ii) glycerol in an amount of 10-90 wt%, and (iii) water as remainder [glycerol or sorbitol are mainly used for refractive index matching; the dosage is more than 70%, the reagent is too viscous and not conducive to penetration, less than 30 %The refractive index of the reagent is low, which affects the final degree of transparency. Water as a solvent is beneficial to maintain the fluorescent signal of fluorescent proteins, because most fluorescent proteins need to be in a water environment for their luminescence.] (see par. 0039).
As to claim 2, Zhu discloses the method of claim 1, further comprising performing three-dimensional light microscopy imaging on the biological tissue that has been rendered sufficiently optically transparent by the optical clearing solution [The continuous development of optical imaging technology and labeling technology provides an important research tool for obtaining the three-dimensional microstructure of biological tissues with high resolution][ The object of the present invention is to provide a biological tissue light-transparency agent, a light-transparency method and its application. The light-transparency agent can make the biological tissue transparent in a short time and retain the fluorescent signal of the sample.] (see par. 0003-004).
As to claim 4, Zhu discloses the method of claim 1, wherein said biological tissue is internal organ tissue [brain] (see fig. 2; par. 0062).
As to claim 8, Zhu discloses the method of claim 1, wherein the biological tissue is pre-treated with a blood decolorizing pre-treatment solution to make the biological tissue amenable for optical clearing, before the biological tissue is contacted with the optical clearing solution [This method can make different types of tissues transparent within a few hours to 2 days, the transparent time is short and the fluorescent signal of the sample is preserved, which provides a new method for obtaining information on neurons, blood vessels and other structures inside the tissue.] (see par. 0021).
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.
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 5 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu.
As to claim 3, Zhu discloses the method of claim 1, wherein said optical clearing solution consists of components (i)-(iii) [the light-transparent agent is a mixed solution of formamide, water and alcohols] (see par. 0034). Zhu fails to disclose only. However, since only 3 components are mentioned one of the ordinary skills in the art would know that can consisted of only those components and Glycerol is type of alcohol. Therefore, it would have been obvious to one of the ordinary skills in the art before the effective filing date of the present invention to use those components for the simple purpose of getting the desired refractive index and improving the imaging.
As to claim 5, Zhu fails to disclose wherein said internal organ tissue is heart tissue. However, it would have been obvious to one of the ordinary skills in the art that since Zhu discloses internal organ tissue is the brain (see fig. 2; par. 0062), the heart would bring the same predictable result of light-transparency to other tissues such as a heart. Therefore, it would have been obvious to one of the ordinary skills in the art before the effective filing date of the present invention to apply the same technique to other tissues such as a heart to bring the same predictable result modifying the light-transparency for the tissue and improving the imaging.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Jensen 8465988.
As to claims 9, Zhu wherein said blood decolorizing pre-treatment solution comprises an aqueous solution (see abstract). Zhu fails to disclose hydrogen peroxide. In an analogous art, Jensen discloses hydrogen peroxide (see col. 6, lines 5-12). Therefore, it would have been obvious to one of the ordinary skills in the art before the effective filing date of the present invention to combine the teachings for the simple purpose of improving the transparency of the tissue.
Allowable Subject Matter
Claims 6-7 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 11-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: wherein said biological tissue is impregnated with the optical clearing solution by impregnating the biological solution in successive steps comprising: a first impregnating step employing an optical clearing solution consisting only of 20-50 wt% formamide in water; an intermediate impregnating step employing an optical clearing solution comprising 20-50 wt% formamide, 30-60 wt% glycerol, and water; and a final impregnating step employing an optical clearing solution consisting only of 20-40 wt% formamide and 60-80 wt% glycerol, wherein the glycerol content increases from the intermediate impregnating step to the final impregnating step, wherein said blood decolorizing pre-treatment solution further comprises a catalase inhibitor to decrease the ability of catalase in the blood to convert the hydrogen peroxide to water and oxygen, wherein said catalase inhibitor is ascorbic acid, EDTA or wherein said blood decolorizing pre-treatment solution further comprises sodium azide and DMSO in combination with all previous limitations have not been found nor have been fairly suggested in the prior art search.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L TORRES whose telephone number is (571)272-7926. The examiner can normally be reached 10:00 AM - 6:00 PM M-F.
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MARCOS L. TORRES
Primary Examiner
Art Unit 2647
/MARCOS L TORRES/Primary Examiner, Art Unit 2647