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.
Claim Status
Claims 2, 4-9, and 11 are pending. Claims 1, 3, 10 is canceled. Claims 2 is amended. Claim 11 is withdrawn.
Claims 2, and 4-9 are being examined on the merits in this office action.
Claim Rejections Withdrawn
The rejection of claims 2, 4-6, and 9 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 (US6858438B2 – hereinafter “Venrooji”) is withdrawn in view of the claim amendments.
The rejection of claims 7-8 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 (US 20140051070A1 – hereinafter “Arai”) is withdrawn in view of the claim amendments.
Claim Rejections - 35 USC § 112 - New
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 5 depends on claim 2 and recites “…wherein each of the branched peptide units respectively has 4 to 6 citrullinated peptides, and the biotinylated antigen has 4 to 6 branched peptide units”. This limitation does not further limit claim 2.
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 § 103 - New
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), Venrooji et al. (US6858438B2 – hereinafter “Venrooji”), Zhang-1 et al. (Mol. Med. reports 16: 3439-3444, 2017) and Zhang-2 et al. (Oncology reports 29: 1955-1961, 2013).
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.
Similarly, Zhang-1 teaches the instant arrangement of MAP and specifically teaches peptides arranged as a single component connected with lysine residues as shown below
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Further, Zhang-2 teaches a peptide design similar to the instant invention wherein the peptide component is arranged as shown below
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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). It would have been obvious to arrange the instant peptides as taught by Zhang-1 and Zhang-2 wherein each branched unit comprises at least 4 peptides and each component comprises at least 4 peptide unit since Zhang-1 teaches that such an arrangement improved the quality of the peptide antigen (3443, left col., 2nd paragraph). 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 and arrange the peptides as taught by Zhang-1 and Zhang-2, since the peptides of Babos and Venrooji are similarly citrullinated synthetic peptides for the diagnosis of rheumatoid arthritis (RA). Examiner notes that the instant citrullinated peptides are known in the art. Citrullinated peptides are known to be arranged in a way such that each branch unit comprises at least 4 peptides. It is also known to have a single component that comprises peptide units as taught by Zhang-2. Therefore, prior art teaches all the components of the claimed invention and thus one of ordinary skill in the art would arrive to the instant invention.
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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Similarly, Zhang-1 teaches the instant arrangement of MAP and specifically teaches peptides arranged as a single component connected with lysine residues as shown below
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Further, Zhang-2 teaches a peptide design similar to the instant invention wherein the peptide component is arranged with peptide units as shown below
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One of ordinary skill in the art would be motivated to arrange the peptide units as taught by Zhang-1 and arrange them as a single component as shown by Zhang-2. The disclosures render obvious claims 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). It would have been obvious to couple the peptides with biotin as taught by Babos since Babos teaches that the positioning of the biotin label within a peptide sequence can markedly influence the antibody binding (Abstract)
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, Venrooji Zhang-1, and Zhang-2.
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) , Venrooji et al. (US6858438B2 – hereinafter “Venrooji”), Zhang-1 et al. (Mol. Med. reports 16: 3439-3444, 2017) and Zhang-2 et al. (Oncology reports 29: 1955-1961, 2013) as applied to claim 2 above, and further in view of and Arai et al. (US 20140051070A1 – hereinafter “Arai”).
The teachings of Migliorini, Babos, Venrooji, Zhang-1, and Zhang-2 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 10/01/2025, with respect to the rejection(s) of claim(s) 2, 3-9 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 Zhang-1 et al., and Zhang-2 et al.
Conclusion
No claims are allowed.
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.
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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
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