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 .
Priority
This application is a 371 of PCT/JP/2022/011135 which claims the benefit of US Provisional Application No. 63/160,269 with an effective filing date of 12 March 2021 as reflected in the filing receipt mailed on 29 January 2024.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Status of the Claims
Claims 1-11, 13-17, 19-21, 23-24, 26, and 27 are pending.
Claims 5, 11, 13, 16, 19, 20, 23, 26, and 27 are currently amended.
Claims 12, 18, 22, 25, 28, and 29 are currently cancelled.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms Milli-Q, Triton, Atago, AAT Bioquest, Invitrogen, Hobart, Ulvac, ImageQuant, Canon, Fiji, Olympus, DeepSee, OriginLab, Leica, Microsoft, etc., which are trade name or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-7, 9-11, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He (EP3456848, published 20 March 2019).
He is in the known prior art field of “a deliming process by using the deliming agent, and use of the phenolic compound as the deliming agent” to delime leather pelts “from common mammals used in the leather manufacturing field, such as cattle, sheep, pig, deer, or from common birds”, see Abstract; Paras. [0017]-[0035].
Regarding the limitations of instant application claims 1 and 27, He discloses benzenecarboxylic acid compounds of Formulas I, I-a to I-f and I-m to I-o, hydroxybenzene compounds of Formula I, and benzene sulfonic acid compounds of Formulas I-g to I-l and I-p to I-r are used as deliming agents in order to delime leather, see Paras. [0017]-[0035]. Specifically see, the multiple single embodiments of claims 1-5 and 14 of clearing of lime/deliming an animal pelt, meeting:
The reagent for clearing a carbohydrate or protein tissue comprising a benzenecarboxylic acid compound, a hydroxybenzene compound, and/or a benzene sulfonic acid compound in instant application claim 1; and,
The cleared material in instant application claim 27.
In regard to the preamble statement in instant application claim 1 of “for optically clearing a carbohydrate- or protein-containing material”, “[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”, see MPEP 2111.02 II. The preamble statement of “for optically clearing a carbohydrate- or protein-containing material” is regarded as an intended use of the claimed reagent; therefore, the preamble statement is not considered a claim limitation and is not given patentable weight.
In addition, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations is of no significance to claim construction, see MPEP 2111.02 II. Therefore, the intended use is not considered a claim limitation.
Regarding the limitations of instant application claims 2-5, He teaches benzenecarboxylic acid compounds of Formulas I-a to I-f and I-m to I-o, see Paras. [0017]-[0035]. Specifically, for example, m-hydroxybenzoic acid sodium salt aka 3- hydroxybenzoic acid sodium salt,
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, see Paras. [0020]-[0022], corresponding to instant application claim 2 chemical formula 1, where M is a hydrogen atom or is forming a salt with Na+, R1, R2, R3, and R5 are each independently a hydrogen atom, and R4 is a hydroxy group, meeting:
The chemical formula 1 in instant application claim 2;
R4 is a hydroxy group in instant application claim 3;
The salt of a 3-hydroxybenzoic acid with sodium in instant application claim 4; and,
M forms a salt with sodium in instant application claim 5.
Regarding the limitations of instant application claims 6 and 7, He teaches the phenolic compound is “sodium 4-hydroxybenzoate, potassium 4-hydroxybenzoate, barium 4-hydroxybenzoate”, see Para. [0022], and the hydroxybenzene compounds of Formula I, see Paras. [0017]-[0035]. Specifically, for example, Formulas I-g to I-I,
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, “wherein M is Li, Na, K or Ba”, see Paras. [0019]-[0022], corresponding to instant application claim 6 chemical formula 2, where R1-R5 are each independently a hydrogen atom, a hydroxyl group, or a sulfonic acid group, meeting:
Chemical formula 2 in instant application claim 6; and,
At least one addition -OH within R1-R5 in instant application claim 7.
Regarding the limitations of instant application claims 9-11, He teaches benzene sulfonic acid compounds of Formulas I-g to I-l and I-p to I-r, see Paras. [0017]-[0035]. Specifically, for example, p-hydroxybenzenesulfonic acid sodium salt aka 4-hydroxybenzenesulfonic acid sodium salt,
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, see Paras. [0019]-[0021], corresponding to instant application claim 9 chemical formula 3, where M is a hydrogen atom or is forming a salt with Na+, R1, R2, R4, and R5 are each independently a hydrogen atom, and R3 is a hydroxyl group, meeting:
The chemical formula 3 in instant application claim 9;
R3 is a hydroxyl group in instant application claim 10; and,
M forms a salt with sodium in instant application claim 11.
Claims 1, 13, 16, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yohei et al. (JP2015049101, published 16 March 2015, see Original and Machine Translation, hereinafter Yohei).
Yohei is in the known prior art field of “[b]iological body transparentizing agent which uses as an active ingredient the compound represented by general formula (A-1), the compound represented by general formula (B-1), the compound represented by general formula (C-1), and 1 or more types of compounds selected from the group which consists of disaccharides”, see Abstract.
Regarding the limitations of instant application claims 1, 13, 16, and 27, Yohei discloses “there is a great deal of activity in developing so-called optical clearing agents that suppress light scattering in living organisms and improve light transmittance “, see Translation, Para. [0002], and “the biological clearing agents according to the present invention are as follows [1] to [5]”, see Translation and Original, Paras. [0008]-[0018], where “the biological clearing agent according to the present invention contains as an active ingredient one or more compounds selected from the group consisting of compounds represented by the following general formula (A-1), compounds represented by general formula (B-1), compounds represented by general formula (C-1), and disaccharides”, see Translation Para. [0024]. “The biological clearing agent according to the present invention is a compound having a specific structure, which can make biological tissue transparent by infiltrating it”, see Para. [0022]. Specifically, in Example 1 “solutions of diatrizoic acid, metrizoic acid, iodipamide, and iopanoic acid to clear adipose tissue [were] investigated … which have been reported to be able to clear skin tissue”, where by visualization in a stereomicroscope “it was confirmed that diatrizoic acid, iodipamide, metrizoic acid, and iopanoic acid all provide a greater clearing effect in a shorter time compared to glycerol and the like”, see Paras. [0077]-[0082], i.e., diatrizoic acid, metrizoic acid, and iodipamide are all benzenecarboxylic acids, meeting:
The reagent for optically clearing a carbohydrate or protein tissue comprising a benzenecarboxylic acid compound in instant application claim 1;
The method of treating a carbohydrate or protein tissue to obtain visual clarity by contacting the tissue with the reagent in instant application claim 13 and in instant application claim 16; and,
The cleared material in instant application claim 27.
In regard to the preamble statement in instant application claim 1 of “for optically clearing a carbohydrate- or protein-containing material”, “[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”, see MPEP 2111.02 II. The preamble statement of “for optically clearing a carbohydrate- or protein-containing material” is regarded as an intended use of the claimed reagent; therefore, the preamble statement is not considered a claim limitation and is not given patentable weight.
In addition, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations is of no significance to claim construction, see MPEP 2111.02 II. Therefore, the intended use is not considered a claim limitation.
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.
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.
Claims 1, 2, 6-8, 13, 16, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Yohei et al. (JP2015049101, published 16 March 2015, see Original and Machine Translation, hereinafter Yohei).
Yohei is in the known prior art field of “[b]iological body transparentizing agent which uses as an active ingredient the compound represented by general formula (A-1), the compound represented by general formula (B-1), the compound represented by general formula (C-1), and 1 or more types of compounds selected from the group which consists of disaccharides”, see Abstract.
Regarding the limitations of instant application claims 1, 13, 16, and 27, Yohei teaches “there is a great deal of activity in developing so-called optical clearing agents that suppress light scattering in living organisms and improve light transmittance “, see Translation, Para. [0002], and “the biological clearing agents according to the present invention are as follows [1] to [5]”, see Translation and Original, Paras. [0008]-[0018], where “the biological clearing agent according to the present invention contains as an active ingredient one or more compounds selected from the group consisting of compounds represented by the following general formula (A-1), compounds represented by general formula (B-1), compounds represented by general formula (C-1), and disaccharides”, see Translation Para. [0024]. “The biological clearing agent according to the present invention is a compound having a specific structure, which can make biological tissue transparent by infiltrating it.”, see Para. [0022]. Specifically, in Example 1 “solutions of diatrizoic acid, metrizoic acid, iodipamide, and iopanoic acid to clear adipose tissue [were] investigated … which have been reported to be able to clear skin tissue”, where by visualization in a stereomicroscope “it was confirmed that diatrizoic acid, iodipamide, metrizoic acid, and iopanoic acid all provide a greater clearing effect in a shorter time compared to glycerol and the like”, see Paras. [0077]-[0082], i.e., diatrizoic acid, metrizoic acid, and iodipamide are all benzenecarboxylic acids, meeting:
The reagent for optically clearing a carbohydrate or protein tissue comprising a benzenecarboxylic acid compound in instant application claim 1;
The method of treating a carbohydrate or protein tissue to obtain visual clarity by contacting the tissue with the reagent in instant application claim 13 and in instant application claim 16; and,
The cleared material in instant application claim 27.
In regard to the preamble statement in instant application claim 1 of “for optically clearing a carbohydrate- or protein-containing material”, “[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”, see MPEP 2111.02 II. The preamble statement of “for optically clearing a carbohydrate- or protein-containing material” is regarded as an intended use of the claimed reagent; therefore, the preamble statement is not considered a claim limitation and is not given patentable weight.
In addition, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations is of no significance to claim construction, see MPEP 2111.02 II. Therefore, the intended use is not considered a claim limitation.
Regarding the limitations of instant application claim 2, Yohei teaches Formula A-8
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, see Original, Para. [0040], where Z12 is a single bond, see Translation, Para. [0041], corresponding to instant application claim 2 chemical formula 1, where M is a hydrogen atom, R1, R3, and R5 are a halogen atom, R2 is a hydrogen atom, and R4 is an amino group, meeting chemical formula 1 in instant application claim 2.
Regarding the limitations of instant application claims 6-8, Yohei teaches Formulas C-2 and C-3
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, see Original, Para. [0064], where Z61 is a single bond, where hydroxybenzenes of “the general formula (C-1), hydroquinone (CAS registration number: 123-31-9) or resorcinol (CAS registration number: 108-46-3) are preferred”,
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see Translation, Paras. [0063]-[0065], resorcinol corresponding to instant application claim 6 chemical formula 2, where R2 is -OH, and R1, R3, R4, and R5 are each independently a hydrogen atom, meeting:
Chemical formula 2 in instant application claim 6;
R2 is -OH in instant application claim 7; and,
Resorcinol in instant application claim 8.
Yohei does not specifically teach the use of formula A-8 and/or resorcinol in one single express embodiment or Example.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified Yohei to choose formula A-8 with Z12 as a single bond and to choose resorcinol as transparentizing agents with a reasonable predictability of success for the purpose of efficiently suppressing “light scattering in living organisms and improve light transmittance” through use of “a compound having a specific structure” that “can effectively and rapidly suppress light scattering in adipose tissue” thus making “biological tissue transparent by infiltrating it” so that the tissue may be observed, see Yohei, Paras. [0002];[0007];[0022];[0080].
A rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. Another rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. One of ordinary skill in the art would have been capable of modifying Yohei to select the optimal transparentizing agents by applying the differing known transparentizing agents as taught by Yohei with a reasonable predictability of success for the purpose of efficiently suppressing “light scattering in living organisms and improve light transmittance” through use of “a compound having a specific structure” that “can effectively and rapidly suppress light scattering in adipose tissue” thus making “biological tissue transparent by infiltrating it” so that the tissue may be observed, see Yohei, Paras. [0002];[0007];[0022];[0080]; and MPEP 2143 I. B-D.
Furthermore, an “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, see MPEP 2145 X.B. Since Yohei teaches transparentizing agents, such as formula A-8 with Z12 as a single bond and resorcinol, the prior art contains “detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful”, see MPEP 2145 X.B.; therefore, it would have been obvious for one of ordinary skill in the art at the time the invention was made to try the transparentizing agents of formula A-8 with Z12 as a single bond and resorcinol in order to clarify a specimen for visualization.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
Selection of a known material, such as any of the transparentizing agents of Yohei, based on their suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
Claims 1-3, 6, 13, 14, 16, 17, 20, 21, 23, 24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Crider et al. (US20180021285, published 25 January 2018, hereinafter Crider), as evidenced by Haynes, (“CRC Handbook of Chemistry and Physics”, 2017, 97th Edition, CRC Press, Pgs. 4-7, 4-8).
Crider is in the known prior art field of “compositions and methods for visualizing the skeletal tissues of a biological specimen, comprising treating the specimen with a calcium chelating agent, a staining solution, and a clearing solution”, see Abstract.
Regarding the limitations of instant application claims 1, 13, 16, and 27, Crider teaches “a method of visualizing skeletal components in a tissue specimen … the method comprises contacting a specimen with a calcium chelating agent. The specimen is then stained with a dye, and then contacted with a clearing agent to cause the tissue to become transparent”, see Paras. [0008]-[0009], where the specimen includes “plants, vertebrates and/or portions thereof”, see Paras. [0010];[0039]. For “a good visualization effect”, see Para. [0045], the clearing agent includes “benzyl benzoate (neat)”, “methyl salicylate (neat)”, and/or “mono or dichloro-salicylate (neat)”, see Paras. [0051];[0056], meeting:
The reagent for optically clearing a carbohydrate or protein tissue comprising a benzenecarboxylic acid compound in instant application claim 1;
The method of treating a carbohydrate or protein tissue to obtain visual clarity by contacting the tissue with the reagent in instant application claim 13 and in instant application claim 16; and,
The cleared material in instant application claim 27.
Regarding the limitations of instant application claim 2, Crider teaches the clearing agent is “mono or dichloro-salicylate (neat)”, see Paras. [0051];[0056],
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, where R1, R3, and R4 are independently hydrogen atoms, R2 is a halogen atom, R5 is hydroxy group or O-, and M is a hydrogen atom. As stated in the instant specification Paras. [0032]-[0033], salicylic acids are also referred to as salicylates, meeting chemical formula 1 in instant application claim 2.
Regarding the limitations of instant application claim 3, Crider teaches the clearing agent is “mono or dichloro-salicylate (neat)”, see Paras. [0051];[0056], 5-Chlorosalicyclic acid where R5 is a hydroxy group, see above, meeting the limitations in instant application claim 3.
Regarding the limitations of instant application claim 6, Crider teaches the clearing agent includes “methyl salicylate (neat)”, see Paras. [0051];[0056],
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, where R2, R3, R4, and R5 are each independently a hydrogen atom and R1 is a methoxycarbonyl group, meeting chemical formula 2 in instant application claim 6.
Regarding the limitations of instant application claim 14, Crider teaches before treating with the clearing reagent, the specimen is “submerged in a calcium chelating agent. To remove most of the calcium-containing components out of the soft tissue, while leaving the bone components intact”, see Paras. [0009];[0043]. As evidenced by Haynes, calcium “has a silvery color”, see Haynes, Pg. 4-7; therefore, Crider teaches pretreating the specimen by decolorizing the specimen by the removal of calcium in the soft tissue. Crider also teaches the fat pads surrounding the specimen vertebrate are removed, see Para. [0040], meeting the decolorization and defatting pretreatment in instant application claim 14.
Regarding the limitations of instant application claim 17, Crider teaches “a method of visualizing skeletal components in a tissue specimen … the method comprises contacting a specimen with a calcium chelating agent. The specimen is then stained with a dye, and then contacted with a clearing agent to cause the tissue to become transparent”, see Paras. [0008]-[0009], where the stain/dye is fluorescent, see Paras. [0046]-[0047], meeting the treating with a fluorescent dye in instant application claim 17.
Regarding the limitations of instant application claims 20, Crider teaches “a kit for visualizing a calcified component in a tissue specimen, the kit comprising a chelating agent, calcium binding dye, and a clearing solution”, see Paras. [0015]-[0021], meeting the kit in instant application claim 20.
Regarding the limitations of instant application claims 21 and 24, Crider teaches, as stated above, pretreating the specimen with the chelating agent to decolorize the specimen by the removal of silvery calcium in the soft tissue, see Paras. [0009];[0043], and the kit includes a chelating agent and a bacteriostatic, a surfactant, instructions, or combinations thereof, the bacteriostatic comprises azide, i.e., a fixative to prevent spoilage by bacteria, see Paras. [0015]-[0017];[0021];[0042], meeting the kit including a decolorizing agent and a fixative in instant application claim 21 and in instant application claim 24.
Regarding the limitations of instant application claim 23, Crider teaches “a kit for visualizing a calcified component in a tissue specimen, the kit comprising a chelating agent, calcium binding dye, and a clearing solution”, see Paras. [0015]-[0021], where the stain/dye is fluorescent, see Paras. [0046]-[0047], meeting the kit with a fluorescent dye in instant application claim 23.
Crider does not specifically teach the instant application claim 1 limitations of the clearing agent includes “benzyl benzoate (neat)” and/or “mono or dichloro-salicylate (neat)” in one single express embodiment or Example.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified Crider to choose the clearing agents “benzyl benzoate (neat)” and/or “mono or dichloro-salicylate (neat)” with a reasonable predictability of success for the purpose of efficiently clarifying the tissue under “the optimal conditions to obtain a good visualization effect within an acceptable time limit”, see Crider, Paras. [0045];[0051]-[0052].
A rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. Another rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. One of ordinary skill in the art would have been capable of modifying Crider to select the optimal clearing agents by applying the differing known clearing agents as taught by Crider with a reasonable predictability of success for the purpose of efficiently clarifying the tissue under “the optimal conditions to obtain a good visualization effect within an acceptable time limit”, see Crider, Paras. [0045];[0051]-[0052]; and MPEP 2143 I. B-D.
Furthermore, an “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, see MPEP 2145 X.B. Since Crider teaches clearing agents, such as “benzyl benzoate (neat)” and/or “mono or dichloro-salicylate (neat)”, the prior art contains “detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful”, see MPEP 2145 X.B.; therefore, it would have been obvious for one of ordinary skill in the art at the time the invention was made to try the “benzyl benzoate (neat)” and/or “mono or dichloro-salicylate (neat)” clearing agents in order to clarify a specimen for visualization.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
Selection of a known material, such as any of the clearing agents of Crider, based on their suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Crider et al. (US20180021285, published 25 January 2018, hereinafter Crider), as evidenced by Haynes, (“CRC Handbook of Chemistry and Physics”, 2017, 97th Edition, CRC Press, Pgs. 4-7, 4-8), as applied in the 35 USC 103 rejection of claims 1-3, 6, 13, 14, 16, 17, 20, 21, 23, 24, and 27 above, in further view of Hanssen et al. (US20070066733, published 22 March 2007, hereinafter Hanssen).
Crider is in the known prior art field of “compositions and methods for visualizing the skeletal tissues of a biological specimen, comprising treating the specimen with a calcium chelating agent, a staining solution, and a clearing solution”, see Abstract, where the clearing agents include benzyl benzoate, see Paras. [0014];[0020];[0051].
Crider does not teach:
The limitations of instant application claims 4 and 5.
Hanssen is in the known prior art field of clarifiers useful in the clarification of compositions in order “to change the measured optical properties” of the composition, see Paras. [0016];[0031];[0044], and is applied to teach the same.
Regarding the limitations of instant application claims 4 and 5, Hanssen teaches the clarifying agents in the composition “include, but are not limited to, benzoic acid salts, substituted benzoic acid salts, … hexahydrophthalic acid metal salts, … . Benzoic acid salts suitable for use as the … clarifying agent include, but are not limited to sodium benzoate, lithium benzoate, aluminum para-tertiary butyl benzoate, and combinations thereof”, see Paras. [0016];[0044], meeting the general benzoic acid salt and the specific sodium or lithium benzoate in instant application claim 4 and in instant application claim 5.
In reference to the above claims, it would have been obvious to one of ordinary
skill in the art, before the effective filing date of the claimed invention, to have modified the benzoate clearing agent of Crider to choose a benzoate salt clearing agent as taught by Hanssen with a reasonable predictability of success for the purpose of efficiently providing “certain desired optical properties such as reduced haze or increased clarity” in a product by including a compound that will suppress light scattering, Hanssen, Paras. [0003];[0007];[0031].
The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of modifying the benzoate clearing agent of Crider by applying the known technique of benzoate salt clarifying agents as taught by Hanssen with a reasonable predictability of success for the purpose of efficiently providing “certain desired optical properties such as reduced haze or increased clarity” in a product by including a compound that will suppress light scattering, Hanssen, Paras. [0003];[0007];[0031]; and MPEP 2143 I. B-D.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Crider and Hanssen both teach the use of clearing agents to obtain optical clarity, a person of ordinary skill in the art has good reason to modify Crider by relying upon Hanssen before the effective filing date of the claimed invention for knowledge generally available within the clearing agent optical clarity art, see MPEP 2143 B & G and 2141, for the benefit of efficiently providing “certain desired optical properties such as reduced haze or increased clarity” in a product by including a compound that will suppress light scattering, Hanssen, Paras. [0003];[0007];[0031]; and, MPEP 2141 and 2143 I. B-D.
Furthermore, an “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, see MPEP 2145 X.B. Since Crider teaches a benzoate clearing agent and Hanssen teaches benzoate salt clarifying agents, the prior art contains “detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful”, see MPEP 2145 X.B.; therefore, it would have been obvious for one of ordinary skill in the art at the time the invention was made to try the benzoate salt clarifying agents of Hanssen as benzoate clearing agents in Crider in order to clarify a specimen for visualization.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
Selection of a known material, such as a benzoate salt clearing agent, based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
In addition, “[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form”, such as salts of benzoate, “proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Crider et al. (US20180021285, published 25 January 2018, hereinafter Crider), as evidenced by Haynes, (“CRC Handbook of Chemistry and Physics”, 2017, 97th Edition, CRC Press, Pgs. 4-7, 4-8), as applied in the 35 USC 103 rejection of claims 1-3, 6, 13, 14, 16, 17, 20, 21, 23, 24, and 27 above, in further view of Liu et al. (“Quality Comparison of Rice Bran Oil Extracted with d-Limonene and Hexane”, published 2005, Cereal Chemistry, Vol. 82, No. 2, Pgs. 209-215, hereinafter Liu).
Crider is in the known prior art field of “compositions and methods for visualizing the skeletal tissues of a biological specimen, comprising treating the specimen with a calcium chelating agent, a staining solution, and a clearing solution”, see Abstract, where fat is manually removed from the specimen, see Para. [0040], and the specimen is a plant, see Paras. [0010];[0039];[0071]
Crider does not teach:
The limitations of instant application claim 15.
Liu is in the known prior art field of removing fat from cereal grain plant specimens, such as rice bran, see Abstract, and is applied to teach the same.
Regarding the limitations of instant application claim 15, Liu teaches d-limonene is a defatting agent for rice bran, see Abstract; Pg. 211, Results and Discussion-Pg. 212, Effect of Time on the Amount of Oil Extracted; Table II; Pg. 214, Conclusions, meeting the defatting agent is limonene in instant application claim 15.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the manual defatting of Crider to choose a chemical limonene defatting as taught by Liu with a reasonable predictability of success for the purpose of efficiently and safely removing fat from the plant specimen in an environmentally friendly green chemical manner eliminating a surgical fat removal procedure, see Liu, Abstract; and, MPEP 2144.06.
The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of modifying the surgical fat removal of Crider by applying the known technique of chemical fat removal as taught by Liu with a reasonable predictability of success for the purpose of efficiently and safely removing fat from the plant specimen in an environmentally friendly green chemical manner eliminating a surgical fat removal procedure, see Liu, Abstract; and MPEP 2143 I. B-D.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Crider and Liu both teach the removal of fat, a person of ordinary skill in the art has good reason to modify Crider by relying upon Liu before the effective filing date of the claimed invention for knowledge generally available within the fat removal art, see MPEP 2143 B & G and 2141, for the benefit of efficiently and safely removing fat from the plant specimen in an environmentally friendly green chemical manner eliminating a surgical fat removal procedure, see Liu, Abstract; and, MPEP 2141 and 2143 I. B-D.
Furthermore, an “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, see MPEP 2145 X.B. Since Crider teaches manual fat removal and Hanssen teaches chemical fat removal, the prior art contains “detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful”, see MPEP 2145 X.B.; therefore, it would have been obvious for one of ordinary skill in the art at the time the invention was made to try the chemical fat removal of Liu in the manual fat removal of Crider in order to clarify a specimen for visualization.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
Selection of a known material, such as a chemical fat remover, based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Crider et al. (US20180021285, published 25 January 2018, hereinafter Crider), as evidenced by Haynes, (“CRC Handbook of Chemistry and Physics”, 2017, 97th Edition, CRC Press, Pgs. 4-7, 4-8), as applied in the 35 USC 103 rejection of claims 1-3, 6, 13, 14, 16, 17, 20, 21, 23, 24, and 27 above, in further view of Bernklau et al. (“Protein network analysis — A new approach for quantifying wheat dough microstructure”, published online 12 October 2016, Food Research International, Vol. 89, Pgs. 812-819, hereinafter Bernklau).
Crider is in the known prior art field of “compositions and methods for visualizing the skeletal tissues of a biological specimen, comprising treating the specimen with a calcium chelating agent, a staining solution, and a clearing solution”, see Abstract, where the specimen is a plant, see Paras. [0010];[0039];[0071].
Crider does not teach:
The limitations of instant application claim 19.
Bernklau is in the known prior art field of microscopically “visualizing the protein microstructure” of wheat dough in food systems, see Abstract; Pgs. 812-813, Introduction, and is applied to teach the same.
Regarding the limitations of instant application claim 19, Bernklau teaches food wheat flour dough is “stained by addition of dye in bulk water with Rhodamine B to visualize proteins”, see Pg. 812, Introduction-Pg. 813, 2.3. Microstructure analysis by confocal laser scanning microscopy; Fig. 3, where the visualized protein is gluten, see Pg. 815, 3.1. Evaluation and development of image analysis on gluten networks, meeting the wheat flour-based food and the gluten visualization in instant application claim 19.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the plant of Crider to choose a wheat plant as taught by Bernklau with a reasonable predictability of success for the purpose of efficiently microscopically “visualizing the protein microstructure” of wheat dough in food systems, see Bernklau, Abstract; Pgs. 812-813, Introduction.
The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of modifying the plant to be visualized of Crider by applying the known technique of visualization of wheat as taught by Bernklau with a reasonable predictability of success for the purpose of efficiently microscopically “visualizing the protein microstructure” of wheat dough in food systems, see Bernklau, Abstract; Pgs. 812-813, Introduction; and MPEP 2143 I. B-D.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Crider and Bernklau both teach the visualization of plants, a person of ordinary skill in the art has good reason to modify Crider by relying upon Bernklau before the effective filing date of the claimed invention for knowledge generally available within the plant visualization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently microscopically “visualizing the protein microstructure” of wheat dough in food systems, see Bernklau, Abstract; Pgs. 812-813, Introduction; and, MPEP 2141 and 2143 I. B-D.
Furthermore, an “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, see MPEP 2145 X.B. Since Crider teaches visualization of plants and Bernklau teaches visualization of wheat, the prior art contains “detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful”, see MPEP 2145 X.B.; therefore, it would have been obvious for one of ordinary skill in the art at the time the invention was made to try to visualize wheat as taught by Liu in the clarification plant visualization of Crider.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
Selection of a known material, such as a wheat plant, based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Crider et al. (US20180021285, published 25 January 2018, hereinafter Crider), as evidenced by Haynes, (“CRC Handbook of Chemistry and Physics”, 2017, 97th Edition, CRC Press, Pgs. 4-7, 4-8), as applied in the 35 USC 103 rejection of claims 1-3, 6, 13, 14, 16, 17, 20, 21, 23, 24, and 27 above, in further view of Yohei et al. (JP2015049101, published 16 March 2015, see Original and Machine Translation, hereinafter Yohei).
Crider is in the known prior art field of “compositions and methods for visualizing the skeletal tissues of a biological specimen, comprising treating the specimen with a calcium chelating agent, a staining solution, and a clearing solution”, see Abstract.
Regarding the limitations of instant application claim 26, Crider teaches “compositions and methods for visualizing the skeletal tissues of a biological specimen, comprising treating the specimen with a calcium chelating agent, a staining solution, and a clearing solution”, see Abstract; Paras. [0008]-[0010], where the visualization results in photograph of the visible skeletal tissue, see Figs. 2, 5A, 7B; Paras. [0024];[0029];[0034], and the stain/dye is fluorescent, see Paras. [0046]-[0047], meeting the visualization of carbohydrates or proteins in a material comprising reagents and a fluorescent dye in instant application claim 26.
Crider does not teach:
The instant application claim 26 limitations of visualization with a device that is an optical microscope.
Yohei is in the known prior art field of “[b]iological body transparentizing agent which uses as an active ingredient the compound represented by general formula (A-1), the compound represented by general formula (B-1), the compound represented by general formula (C-1), and 1 or more types of compounds selected from the group which consists of disaccharides”, see Abstract.
Regarding the limitations of instant application claim 26, Yohei teaches after treatment with one or more reagents of Formulas “tubes filled with adipose tissue were removed from the solution. The tubes were then placed in a stereomicroscope so that the direction of the tube's height aligned with the optical axis of the stereomicroscope, and the transmitted image was observed.”, see Translation, Paras. [0002];[0022];[0080]; and, Translation and Original, Paras. [0008]-[0018], meeting the visualization with a device that is an optical microscope in instant application claim 26.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the photographic visualization of Crider to choose an optical microscope visualization as taught by Yohei with a reasonable predictability of success for the purpose of efficiently suppressing “light scattering in living organisms and improve light transmittance” through use of “a compound having a specific structure” that “can effectively and rapidly suppress light scattering in adipose tissue” thus making “biological tissue transparent by infiltrating it” so that the tissue may be observed by an optical microscope, see Yohei, Paras. [0002];[0007];[0022];[0080].
The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of modifying the photographic visualization of Crider by applying the known technique of optical microscope visualization as taught by Yohei with a reasonable predictability of success for the purpose of efficiently suppressing “light scattering in living organisms and improve light transmittance” through use of “a compound having a specific structure” that “can effectively and rapidly suppress light scattering in adipose tissue” thus making “biological tissue transparent by infiltrating it” so that the tissue may be observed by an optical microscope, see Yohei, Paras. [0002];[0007];[0022];[0080]; and MPEP 2143 I. B-D.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and Crider and Yohei both teach the visualization of tissue by optically clearing the tissue with clearing agents, a person of ordinary skill in the art has good reason to modify Crider by relying upon Yohei before the effective filing date of the claimed invention for knowledge generally available within the tissue visualization art, see MPEP 2143 B & G and 2141, for the benefit of efficiently suppressing “light scattering in living organisms and improve light transmittance” through use of “a compound having a specific structure” that “can effectively and rapidly suppress light scattering in adipose tissue” thus making “biological tissue transparent by infiltrating it” so that the tissue may be observed by an optical microscope, see Yohei, Paras. [0002];[0007];[0022];[0080]; and, MPEP 2141 and 2143 I. B-D.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
Selection of a known material, such as an optical microscope to visualize cleared tissue, based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), see MPEP 2144.07.
Conclusion
No claims are allowed.
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/YO/Examiner, Art Unit 1692
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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