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/JP2022/008737 which claims the benefit of JP 2022-020271 and JP 2021-033583 having the effective filing date of 03 March 2021 as reflected in the filing receipt mailed on 06 June 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 depends from claim 1. Claim 7 recites in the preamble “A protein solubilizing agent”, “[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 “a protein solubilizing agent” is regarded as an intended use of the claimed active ingredient; therefore, the preamble statement is not considered a claim limitation and is not given patentable weight. As a result, claim 7 fails to further limit the “active ingredient” recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 2, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoogerhout (US6361777, published 26 March 2002).
Hoogerhout is in the known prior art field of coupling polysaccharides or other hapten to an immunogenic protein or peptide or other bio-organic molecule using an amino-thiol linker in order to prepare effective vaccines, see Abstract; Col. 1, Lns. 4-62.
Regarding instant application claims 1, 2, and 7, Hoogerhout discloses an active ingredient comprising an amino-thiol linker of compound 1, such as 2-[(2-aminoethyl)amino]ethanethiol
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, where instantly claimed X1 and Y1 are independently C1 alkylene, see Col. 3, Lns. 27-40, meeting compound 1 in instant application claim 1, in instant application claim 2, and in instant application claim 7.
In regard to the preamble statements of “a protein folding agent” and “a protein solubilizing agent”, “[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 statements of “a protein folding agent” and “a protein solubilizing agent” are regarded as an intended use of the claimed active ingredient; therefore, the preamble statements are not considered a claim limitation and are not given patentable weight.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (“IR spectroscopic characterization of SAMs made from a homologous series of pyridine disulfides”, published 2009, Journal of Electron Spectroscopy and Related Phenomena, Vol. 172, Pgs. 120-127, hereinafter Liu).
Liu is in the known prior art field of organothiols, such as pyridine-terminated organic disulfide linkers, to prepare self-assembled monolayers (SAMs) of the corresponding thiolates, see Abstract; Figs. 1-2; Pg. 121, Col. 1, First Full Para.; Pg. 126, Col. 2, 5. Conclusions.
Regarding instant application claims 1 and 3, Liu discloses an active ingredient comprising an amino-thiol linker of compound 11, such as 4,4’-(dithiodimethylene)dipyridine
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, where instantly claimed Z2 are each independently C1 alkylene, see Abstract; Figs. 1-2; Pg. 121, Col. 1, First Full Para., meeting compound 11 in instant application claim 1 and in instant application claim 3.
In regard to the preamble statement of “a protein folding agent”, “[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 “a protein folding agent” is regarded as an intended use of the claimed active ingredient; therefore, the preamble statement is not considered a claim limitation and is not given patentable weight.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hoogerhout (US6361777, published 26 March 2002), as applied to claims 1, 2, and 7 in the 35 USC 102 rejection above, in view of Liu et al. (“IR spectroscopic characterization of SAMs made from a homologous series of pyridine disulfides”, published 2009, Journal of Electron Spectroscopy and Related Phenomena, Vol. 172, Pgs. 120-127, hereinafter Liu).
Regarding instant application claim 4, Hoogerhout teaches an active ingredient comprising disulphides and an amino-thiol linker of compound 1, such as 2-[(2-aminoethyl)amino]ethanethiol
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, where instantly claimed X1 and Y1 are independently C1 alkylene, see Col. 3, Lns. 27-50, meeting compound 1 in instant application claim 4.
Hoogerhout does not teach the instant application claim 4 limitations of formulas (8) to (14).
Liu teaches an active ingredient comprising an amino-thiol linker of compound 11, such as 4,4’-(dithiodimethylene)dipyridine
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, where instantly claimed Z2 are each independently C1 alkylene, see Abstract; Figs. 1-2; Pg. 121, Col. 1, First Full Para., meeting compound 11 in instant application claim 4.
In regard to the preamble statement of “a protein folding agent”, “[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 “a protein folding agent” is regarded as an intended use of the claimed active ingredient; therefore, the preamble statement is not considered a claim limitation and is not given patentable weight.
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 Hoogerhout to use the amino-thiol linker of Hoogerhout in combination with the amino-thiol disulfide linker of Liu with a reasonable predictability of success for the purpose of efficiently covalently linking and non-covenant linking organic surfaces with organothiols in order to create the optimal pre-defined chemical functionalities of the organic surfaces, see Liu, Pg. 120, Col. 2, First Two Paras.; Pg. 126, Col. 2, 5. Conclusions.
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 both Hoogerhout and Liu teach the use of organothiol/amino-thiol linkers, a person of ordinary skill in the art has good reason to modify Hoogerhout by relying upon the compound of Liu before the effective filing date of the claimed invention for knowledge generally available within the amino-thiol disulfide bond formation art regarding thiol linkage, see MPEP 2143 B & G and 2141, for the benefit of efficiently covalently linking and non-covenant linking organic surfaces with organothiols in order to create the optimal pre-defined chemical functionalities of the organic surfaces, see Liu, Pg. 120, Col. 2, First Two Paras.; Pg. 126, Col. 2, 5. Conclusions and MPEP 2141.
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 organothiol/amino-thiol linkers, 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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hoogerhout (US6361777, published 26 March 2002), as applied to claims 1, 2, and 7 in the 35 USC 102 rejection above, in view of Clark (“Protein refolding for industrial processes”, 2001, Current Opinion on Biotechnology, Vol. 12, Pgs. 202-207).
Regarding instant application claims 5 and 6, Hoogerhout teaches an active ingredient comprising an amino-thiol linker of compound 1, such as 2-[(2-aminoethyl)amino]ethanethiol
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, where instantly claimed X1 and Y1 are independently C1 alkylene, see Col. 3, Lns. 27-40, meeting compound 1 in instant application claim 5 and in instant application claim 6.
Hoogerhout does not specifically teach the methods of instant application claims 5 and 6.
Clark is in the known prior art field of methods of folding and renaturing proteins by treating unfolded, denatured, and misfolded proteins, see Abstract; Pg. 202, Introduction, with compositions comprising active agents for oxidative protein refolding, that is, refolding with concomitant disulfide-bond formation, see Pg. 202, Introduction.
Regarding instant application claims 5 and 6, Clark teaches in step 1 the protein is destroyed/unfolded and denatured by solubilizing, see Pg. 202, Inclusion body isolation, purification and solubilization – Pg. 203, Col. 1, First Full Para. and Fig. 1, then in step 2 the protein is folded, built, and renatured in the presence of renaturation buffers that promote disulfide-bond formation/oxidation, such as a cysteamine aka HSCH2CH2NH2 and cystamine aka C4H12N2S2 thiol/disulfide mixture, see Pg. 204, Renaturation of solubilized protein – Pg. 205, Disulfide-bond formation during folding and Fig. 1, meeting the methods in instant application claim 5 and in instant application claim 6.
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 Hoogerhout to use the Hoogerhout amino-thiol cysteamine linker compound in the protein solubilizing, folding, building, and renaturing methods of Clark with a reasonable predictability of success for the purpose of efficiently reducing the cost of folding proteins by an oxido-shuffling system, which consists of mixtures of reduced and oxidized low molecular weight thiol reagents, such as cysteamine/cystamine compounds, to induce interchain disulfide formation in order to result in a greater extent of the correct disulfide bond formation, see Clark, Pg. 205, Disulfide-bond formation during folding -Improving renaturation yields, First Full Para.; Pg. 206, Conclusions and Fig. 1.
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 both Hoogerhout and Clark teach the use of cysteamine compounds as amino-thiol and thiol/disulfide linkers, a person of ordinary skill in the art has good reason to modify Hoogerhout by relying upon Clark before the effective filing date of the claimed invention for knowledge generally available within the amino-thiol disulfide bond formation art regarding protein folding, see MPEP 2143 B & G and 2141, for the benefit of efficiently reducing the cost of folding proteins by an oxido-shuffling system, which consists of mixtures of reduced and oxidized low molecular weight thiol reagents, such as cysteamine/cystamine compounds, to induce interchain disulfide formation in order to result in a greater extent of the correct disulfide bond formation, see Clark, Pg. 205, Disulfide-bond formation during folding -Improving renaturation yields, First Full Para.; Pg. 206, Conclusions; Fig. 1 and MPEP 2141.
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.
Conclusion
No claims are allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Yen-Ye Goon can be reached at (571) 270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YO/Examiner, Art Unit 1692
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699