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 .
DETAILED ACTION
Applicant’s response filed on 01/20/2026 is duly acknowledged.
Claims 1-23 as currently presented are pending in this application.
Election/Restrictions
Applicant’s election of Group I (Claims 1-12, directed to “A mesoporous silica binding peptide…”; with species A1: peptide of SEQ ID NO: 12 from instant claim 12) in the reply filed on 01/20/2026 (see REM, p.1) is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, and did not specifically state if the election was made with or without traverse, the election has been treated as an election without traverse (MPEP § 818.01(a)).
However, upon further considerations of the claimed subject matter, the requirement for the species election for group I, as previously made by the examiner (paper dated 11/20/2025, p. 4), has been withdrawn. All species (from claim 12) have been re-joined for this office action.
Claims 13-23 (nonelected inventions of Groups II-III) have been withdrawn from further considerations.
Claims 1-12 (elected invention of Group I, taken as without traverse; directed to “A mesoporous silica binding peptide…”), as currently presented have been examined on their merits in this action hereinafter.
Priority
This application gets the effective filing date of 06/21/2023.
Claim Objections
Claim 7 (as recited) is objected to because of the following informalities: claim 7 recites the limitations “wherein the mesoporous silica to which the peptide is binds consists essentially of silicon and oxygen”, which should be amended to recite “wherein the mesoporous silica to which the peptide [[is]] binds consists essentially of silicon and oxygen”. 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 1-12 (as presented) 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.
It is to be noted that instant claim 1 recites the limitations “excluding such peptides as linked in a naturally occurring protein sequence”, which has been interpreted herein to exclude the peptides that are found in (or part of) “naturally occurring proteins” (see discussion below, and instant specification guidance, paragraph [0013]). Claim 1 is directed to “A mesoporous silica binding peptide comprising an amino acid sequence selected from the group consisting of SEQ ID NOS: 1 - 16, excluding such peptides as linked in a naturally occurring protein sequence.” As recited, the limitations of “such peptides as linked in a naturally occurring protein sequence” is ambiguous and confusing because it is not clear if this negative proviso excludes only peptides that are “linked” (i.e. physically connected/interconnected, or joined), i.e. associated (covalently or non-covalently) via a linker of some short, or linked to a naturally occurring protein sequence, or refers to a part of naturally occurring protein sequence (i.e. present in the form of naturally occurring protein sequence)? The disclosure of record in paragraph (instant specification, [0013]) states the following:
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From the above disclosure, it appears that applicants intend to exclude peptides that “occur in naturally occurring proteins”, in other words that are found as part of naturally occurring proteins. However, there is no disclosure, examples, and/or clarification as to what exactly is encompassed by the “peptides linked in a naturally occurring protein sequence”, and as to what it would structurally entail and/or mean for the scope of the peptide product as currently claimed in instant claim 1 (and claims dependent therefrom). The metes and bounds of the claimed peptide product does not appear to be properly defined. Also, since none of the dependent claims 2-12 clarify this point, they are also rejected as being indefinite, for the same reasons of record, as discussed above. Appropriate correction and/or explanation is required.
Claims 5 and 6 (as recited) 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 5 directly depends from instant claim 4 (that depends from instant claim 2 that requires that “the mesoporous silica binding peptide is fused to a termini of a heterologous protein”), as reproduced below:
“4. (original) The mesoporous silica binding peptide of claim 2, further comprising a linker peptide sequence fused at least partially between the mesoporous silica binding peptide and the protein.”
“5. (original) The mesoporous silica binding peptide of claim 4 wherein the linker peptide sequence is SGGGCGPXGPC (SEQ ID NO: 17) where X is a place holder for a peptide sequence of 8 to 18 residues”
First, it is noted that instant claim 5 does not end with a period. The recitation is therefore ambiguous (metes and bounds are not properly defined) because it is unclear as to what other limitations, if any, were supposed to be after limitations “8 to 18 residues”. Appropriate correction is required.
Second, it is to be noted that instant disclosure of record ([0042]; see below) states the following regarding the “place holder”:
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It is to be noted that the disclosure for the “place holder” in SEQ ID NO: 17 (designated as “X”) specifically pertains to the “mesoporous silica binding peptide” having “a length of 8-18 residues”. However, the claim 5 as currently recited requires the limitations “where X is a place holder for a peptide sequence of 8 to 18 residues”, i.e. not limited to the “mesoporous silica binding peptide” sequences as currently recited in SEQ ID NOs: 1-16 of instant claim 1. No specific examples and/or guidance has been provided on record for such peptide sequences (of 8 to 18 residues) that are used at the recited “place holder” of claim 5, and that are different than the SEQ ID NOs: 1-16 of instant claim 1. Therefore, it is not clear as to what exactly is being encompassed by the claimed product as currently recited in instant claim 5. The metes and bounds of the invention as claimed does not appear to be properly defined. Since, claim 6 directly depends from claim 5, and does not specifically clarify the above discussed point, it is also rejected as being indefinite for the same reasons as discussed above. Appropriate correction is required.
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.
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 1-4 and 7-11 (as presented) is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimojo et al (JP 2013151454 A; An English machine translation attached herein as NPL cited as ref. [U] on PTO 892 form).
Claim 1 is directed to “A mesoporous silica binding peptide comprising an amino acid sequence selected from the group consisting of SEQ ID NOS: 1 - 16, excluding such peptides as linked in a naturally occurring protein sequence.”
Shimojo et al (2013; all citations per English translation attached) disclose a peptide (regarding instant claim 1) having an amino acid sequence (disclosed as SEQ ID NO: 11; WAGAKRLVLRRE; see p. 4, 4th paragraph; and claims, for instance) which is 100% identical to the instantly claimed peptide of SEQ ID NO: 1 in instant claim 1, and not part of a natural protein sequence; see homology below with the 12 AA peptide disclose with Accession Number BAQ44713):
SEQ ID NO: 1 (A_Genseq database)
RESULT 1
BAQ44713
(NOTE: this sequence has 10 duplicates in the database searched.
See complete list at the end of this report)
ID BAQ44713 standard; peptide; 12 AA.
XX
AC BAQ44713;
XX
DT 12-SEP-2013 (first entry)
XX
DE Gold (Au)-binding AuBP1 peptide, SEQ ID 11.
XX
KW diagnostic test; gold carrier; immunosensor.
XX
OS Unidentified.
XX
CC PN JP2013151454-A.
XX
CC PD 08-AUG-2013.
XX
CC PF 25-JAN-2012; 2012JP-00013115.
XX
PR 25-JAN-2012; 2012JP-00013115.
XX
CC PA (JAAT ) JAPAN ATOMIC ENERGY AGENCY.
CC PA (UYKY-) UNIV KYUSHU.
XX
CC PI Shimojo K, Naganawa H, Goto M, Kamiya N;
XX
DR WPI; 2013-M22265/55.
XX
CC PT Gold carrier useful in kit, immune sensor and immune marker for
CC PT inspecting disease, comprises immobilized protein comprising peptide and
CC PT protein having gold binding ability.
XX
CC PS Disclosure; SEQ ID NO 11; 49pp; Japanese.
XX
CC The present invention relates to a novel gold carrier comprising an
CC immobilized protein, where the protein is a fusion protein of a peptide
CC and a protein having gold binding ability. Also described are: (1) a
CC method for manufacturing the gold carrier, which involves immobilizing
CC the protein in the gold carrier; and (2) a method for detecting to-be-
CC measured substance in a test sample, involves reacting the gold carrier
CC and the test sample, and specifically detecting interaction between the
CC gold carrier and the to-be-measured substance in the test sample. The
CC gold carrier is useful in a kit, an immune sensor and in immune marker
CC for inspecting disease. The present sequence is a gold (Au)-binding AuBP1
CC peptide, used in the construction of gold carrier of the invention.
XX
SQ Sequence 12 AA;
Query Match 100.0%; Score 62; Length 12;
Best Local Similarity 100.0%;
Matches 12; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 WAGAKRLVLRRE 12
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Db 1 WAGAKRLVLRRE 12
The limitations of “mesoporous silica binding” is taken as an inherent functional feature of the peptide which would necessarily be the same, as the disclosed 12 AA peptide from Shimojo et al has the structural feature or the same amino acid sequence as recited in instant claim 1, SEQ ID NO: 1; i.e. “WAGAKRLVLRRE”.
Regarding instant claim 2, Shimojo et al disclose that the peptide is fused to a termini (i.e. N- or C-terminal fusion protein) of a heterologous protein (see Abstract, and p. 4, 5th paragraph, for instance) such as an antibody-binding protein (see p. 2, 3rd paragraph; for instance); wherein (regarding instant claims 3-4) the peptide is fused to the C-terminus of the heterologous protein (see for instance, p.6, Example 1 disclosing a fusion protein, albeit to a different peptide as an example, designated as “A3 peptide” that is fused to the C-terminus of the heterologous ZZ domain of protein A (designated as “ZZ-Trx-A3”) via a linking “protecting protein” such as thioredoxin (Trx; taken herein as a “linker peptide sequence”; it is noted that the term “linker peptide sequence” has not been specifically defined by applicants on record; see instant disclosure, p. [0015], [0017], for instance).
Regarding instant claim 11, the peptide disclosed by Shimojo et al has an amino acid sequence that consists of SEQ ID NO: 1, as recited in instant claim 1.
The limitations of instant claims 7-10, as currently recited (wherein “the mesoporous silica to which the peptide is binds consists essentially of silicon and oxygen”; “wherein the mesoporous silica to which the peptide binds is a clay that comprises on a molar basis, 20% to 35% silicon and 60% to70% oxygen”; “wherein the clay further includes on a molar basis, up to 10% of at least one trace metal selected from the group consisting of aluminium, calcium, gold, iron, magnesium, potassium, sulphur and thallium”; and “wherein the clay further comprises up to 6% aluminium”) mainly characterize the “mesoporous silica” to which the claimed peptide binds (taken herein as functional property limitations), and do not specifically further define and/or provide structural distinction other than the amino acid sequence for the peptides already recited in terms of SEQ ID NOs: 1-16 of instant claim 1, and therefore, have been taken to be met by the specific disclosure from Shimojo et al, as discussed above.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Shimojo et al (JP 2013151454 A; An English machine translation attached herein as NPL cited as ref. [U] on PTO 892 form) taken with Monthony et al (WO 2009/073977 A1; FOR cited as ref. [N] on PTO 892 form).
The detailed teachings of Shimojo et al as they pertain to claims 1-4 and 7-11 have been discussed above and are further relied upon in the same manner hereinafter.
However, the limitations of instant claims 5 and 6 (as reproduced below) have not been taught and/or disclosed by the cited prior art reference of Shimojo et al, as discussed above.
“5. (original) The mesoporous silica binding peptide of claim 4 wherein the linker peptide sequence is SGGGCGPXGPC (SEQ ID NO: 17) where X is a place holder for a peptide sequence of 8 to 18 residues.”
“6. (original) The mesoporous silica binding peptide claim 5 wherein the mesoporous silica binding peptide is fused to the C-terminus of the heterologous protein.”
Monthony et al (2009), while teaching polypeptides modified by protein trans-splicing technology (see Title, Abstract, and Fig. 1AB, and Example 1 on p. 26-27, for instance), disclose the use of peptide linkers including 7 amino acid peptide sequence SGGGCGP designated as SEQ ID NO: 11 (see p. 21, 2nd paragraph; Example 1 on p. 27, for instance) that can provide spacing as well as means for functional derivatization such as PEGylation (see p. 27, 2nd paragraph, for instance) and can be positioned at the C-terminus of a given target protein such as a maltose binding protein (MBP; see Fig. 11, for instance) for modifying the target proteins. Monthony et al also disclose several benefits of such peptide linker/spacer, in addition to its use in trans-splicing reaction, such as for site-specific PEGylation wherein glycine (G) residues are to provide some spaces around the cysteine, and the proline (P) residue is thought to minimize degradation by carboxyl peptidases (i.e. provide stability for the fusion protein; see p. 27, 2nd paragraph, for instance).
Thus, to a person of ordinary skill in the art, it would have been obvious to include such peptide linkers at the C-terminus of a heterologous protein that can be further employed for accommodating a desired peptide sequence of limited length, including the peptide as disclosed by Shimojo et al (i.e. SEQ ID NO: 1; as discussed above). Since, the techniques for such molecular manipulations for fusion proteins have already been disclosed in the cited prior art of Monthony et al, such modification to incorporate the desired linker peptide at the C-terminus of heterologous proteins (such as MBP as demonstrated by Monthony et al), would have been obvious and fully contemplated by an artisan in the art, at least for the benefits of flexibility and advantages as disclosed by Monthony et al (see teachings above), unless evidence provided on record to the contrary (which is currently lacking; see instant specification, [0042], for instance).
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
Claim 12 appears to be free of Prior art issues.
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657