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 was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/CN2018/083989 filed 04/21/2018, which claims the benefit of the priority of Chinese Patent Application No. CN201810202734.6 filed 03/13/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements submitted on 03/10/2025 has been considered by the examiner.
Election/Restrictions
Claim 11 is withdrawn from further consideration pursuant to 37 CFR
1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/05/2024. Applicant’s election without traverse of Group I drawn to a kit, in the reply filed on 08/05/2024 is acknowledged.
Claim Status
Claims 1, 3, 10 is canceled. Claims 2, and 4 are amended. Claim 11 is withdrawn.
Claims 2, and 4-9 are being examined on the merits in this office action.
Claim Rejections Withdrawn
Claims 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn because the claim is canceled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 2, 4-6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Migliorini et al. (US20140106381A1 – hereinafter “Migliorini”) in view of Babos et al. (Bioconjugate Chem. 2013, 24, 5, 817–827) and Venrooji et al. (US6858438B2 – hereinafter “Venrooji”).
Migliorini teaches a plurality of branched citrullinated peptide units or multiple antigen peptides, wherein the peptide units are coupled by lysine residues (See below [0029-0036, 0073]), that the peptides are contained in a kit [0143].
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Migliorini teaches that the peptides were generated by modifying arginines into citrulline residues [0004]. Migliorini teaches a MAP or conjugate comprising a plurality of copies of a citrullinated linear synthetic peptide or of an antigenically effective fragment derived therefrom and has the structure below
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[0076-0077]. Examiner notes that the teachings of Migliorini teach a plurality of citrullinated peptides forming a first, second, third and fourth branch. Migliorini teaches use of citrullinated synthetic peptides for the diagnosis of rheumatoid arthritis (RA) (Abstract and claim 1).
However, Migliorini does not teach the sequences of instant peptides.
Babos teaches rheumatoid arthritis (RA) specific biotin–peptide conjugates derived from filaggrin epitope peptides and that the biotin was attached to the peptide SHQESTXGXSXGRSGRSGS, wherein X is citrulline (Abstract; Page 817, right col., 2nd paragraph, line 1-4). Babos teaches several peptides consisting of the amino acids SHQESTRGRSRGRSGRSGS, which contains five arginine residues that might be target of citrullination (Page 817, right col., line 3-5). Examiner notes that the peptide of Babos reads on the instant SEQ ID NOS. 1-4. Babos teaches that the biotinylation profoundly influence its recognition by antibodies, and thus the sensitivity of an ELISA (Page 826, left col., line 1-4), that the biotin−avidin interaction, applied in ELISA to anchor the peptides to the plates, is one of the strongest noncovalent interactions known and it is stable toward a variety of harsh conditions (Page 818, left col., line 11-14).
Further, Venrooji teaches citrullinated peptides of the sequences shown below:
S H Q E S T R G R S R G X S G R S G S (SEQ ID NO: 4)
S H Q E S T R G R S R G R S G X S G S (SEQ ID NO: 5)
S H Q E S T X G X S R G R S G R S G S (SEQ ID NO: 6)
S H Q E S T X G R S X G R S C R S G S (SEQ ID NO: 7) (Col. 4., lines 1-40). Venrooji teaches that the peptides are for the detection of rheumatoid arthritis (Abstract; claim 2). Examiner notes that all the peptides taught by Venrooji read on the instant peptides SEQ ID Nos. 1-4.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of Migliorini and use biotinylated peptide of Babos and Venrooji since Babos teaches that the biotinylation profoundly influence its recognition by antibodies, and thus the sensitivity of an ELISA (Page 826, left col., line 1-4) and Venrooji teaches that the peptides are for the detection of rheumatoid arthritis (Abstract; claim 2). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the peptide complex of Migliorini and use the biotinylated peptides of Babos and Venrooji since Babos teaches that the biotinylation profoundly influence its recognition by antibodies, and thus the sensitivity of an ELISA (Page 826, left col., line 1-4), and Venrooji teaches that the peptides are for the detection of rheumatoid arthritis (Abstract; claim 2). The disclosures render obvious claim 2 since one of ordinary skill in the art would be motivated to use the peptides of Babos and Venrooji in the kit of Migliorini since the peptide is similarly a citrullinated synthetic peptides for the diagnosis of rheumatoid arthritis (RA).
Regarding claims 4-5, Babos teaches biotinylated peptides that read on the instant sequences of SEQ ID NO: 1-4 (Page 817, right col., line 3-5). Further, Migliorini teaches a plurality of branched citrullinated peptide units or multiple antigen peptides, wherein the peptide units are coupled by lysine residues (See below [0029-0036, 0073-]), that the peptides are contained in a kit [0143].
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Examiner notes that the above structure discloses a plurality of peptides wherein the lysine of the first branched peptide unit and the lysine of the second branched peptide unit are coupled with one lysine.
Migliorini teaches a plurality of peptides shown below [0076]. Examiner notes that the format below reads on 4-6 citrullinated peptides.
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Further, Babos teaches rheumatoid arthritis (RA) specific biotin–peptide conjugates derived from filaggrin epitope peptides and that the biotin was attached to the peptide SHQESTXGXSXGRSGRSGS, wherein X is citrulline (Abstract; Page 817, right col., 2nd paragraph, line 1-4). Additionally, Venrooji teaches all the instantly claimed peptides. Examiner notes that the disclosure of Migliorini renders obvious claim 4-5.
Regarding claim 6, Babos teaches rheumatoid arthritis (RA) specific biotin–peptide conjugates derived from filaggrin epitope peptides and that the biotin was attached to the peptide SHQESTXGXSXGRSGRSGS, wherein X is citrulline (Abstract; Page 817, right col., 2nd paragraph, line 1-4).
Regarding claim 9, Examiner notes claim 9 is a product-by-process type claim(s). Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113. Claim 9 is drawn to a kit for measuring an anti-cyclic citrullinated peptide antibody which is prepared by the steps recited in claim 9. The substance and structure of the claimed kit is not affected by this limitation recited in the step, which merely reflects one version of a process that could be used to make the product. The kit could be made in other ways, thus, the limitations recited in the steps does not add patentable weight to the claim. If the product in this claim is the same as or obvious from a product of the prior art, the claim is unpatentable. The kit is clearly disclosed in the prior art, thus claim 9 is rejected as unpatentable over Migliorini, Babos and Venrooji.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Migliorini et al. (US20140106381A1 – hereinafter “Migliorini”) in view of Babos et al. (Bioconjugate Chem. 2013, 24, 5, 817–827) and Venrooji et al. (US6858438B2 – hereinafter “Venrooji”) as applied to claim 2 above, and further in view of and Arai et al. (US 20140051070A1 – hereinafter “Arai”).
The teachings of Migliorini, Babos and Venrooji are disclosed above and incorporated herein by reference.
Migliorini does not teach wherein the kit comprises a magnetic particle separation reagent as recited in claim 7.
With regards to the magnetic particle separation reagent, Arai teaches streptavidin-coupled magnetic particle with high biotin-binding capacity (Abstract; claims 1-3) that the streptavidin-coupled magnetic particle is coupled to a biotinylated protein (claims 4-6). Arai teaches that the reagent for measuring a component to be measured in a sample, which comprises the streptavidin-coupled magnetic particle and a biotinylated protein (claim 8). Arai teaches the particle size of the magnetic particles is for example 0.1-5 μm [0037]. Arai teaches that the reagent is important to increase the sensitivity of examinations for early detection of diseases, for increasing the accuracy of examinations, for attending to highly sensitive markers in trace amounts [0003].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the magnetic particle separation reagent as taught by Arai since Arai teaches that the reagent is important to increase the sensitivity of examinations for early detection of diseases, for increasing the accuracy of examinations, for attending to highly sensitive markers in trace amounts [0003]. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying Migliorini and use the magnetic particle separation reagent as taught by Arai for improved detection of diseases.
Regarding claims 7-8, Arai teaches streptavidin-coupled magnetic particle with high biotin-binding capacity (Abstract; claims 1-3) that the streptavidin-coupled magnetic particle is coupled to a biotinylated protein (claims 4-6). Arai teaches that the reagent for measuring a component to be measured in a sample, which comprises the streptavidin-coupled magnetic particle and a biotinylated protein (claim 8). Arai teaches the particle size of the magnetic particles is for example 0.1-5 μm [0037]. Arai teaches that the magnetic particle separation reagent comprises alkaline phosphatase [0089-0090, 0149], contains antibodies such as IgG, anti-IgG antibody [0066, 0073], and chemiluminescence substrate [0002, 0087-0090, 0094]. Further, Arai teaches the particle size of the magnetic particles is for example 0.1-5 μm [0037], that the magnetic particles are preferably superparamagnetic microparticles [0035], and the streptavidin-coupled magnetic particle having amino groups on their surface [0012-0013, 0034]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the magnetic particle separation reagent as taught by Arai since Arai teaches that the reagent is important to increase the sensitivity of examinations for early detection of diseases, for increasing the accuracy of examinations, for attending to highly sensitive markers in trace amounts [0003].
Response to Arguments
Applicant’s arguments, see Applicant Arguments, filed 03/03/2025, with respect to the rejection(s) of claim(s) 2-9 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Venrooji et al.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654