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 .
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.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/JP2023/004480, filed 02/10/2023. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 2022-031256, filed on 03/01/2022 in Japan.
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al., Sensitive and Quantitative Detection of Anti-PEG Antibodies by mPEG-coated SPR sensors, Anal. Chem., 89(16), (2017), p. 8217-8222 in view of N.R. Moudgal, R.R. Porter, The use of antigen-cellulose suspensions for the isolation of specific antibodies, Biochimica et Biophysica Acta, Volume 71, (1963), Pages 185-187 (first page provided), Nikolavna et al., SU1128956A (English machine translation attached) and Sallberg et al., US PG Pub No. 2008/0295185A1.
Zhang et al. teach methoxy-PEG as a better anti-PEG binding material to detect anti-PEG antibodies from blood samples/samples having many different proteins (see abstract and page 3, para 2 and page 6, conclusion). Further mPEG as taught by Zhang reads on the limitation m an integer of 1 to 6, see for example Figure 1.
Zhang et al. differs from the claimed anti-PEG-antibody binding material in that it fails to teach the material further comprising a cellulose oligomer (as shown in Formula 1 of claim 1).
Moudgal et al. teach (page 185) the use of cellulose-linked antigen to prepare insoluble antigen for use as a specific adsorbent to isolate antibodies.
Nikolaevna et al. teach immobilizing antigen on an insoluble carrier to form a specific immunosorbent that has the ability to adsorb antibodies from a mixture of components, see carriers such as cellulose.
Additionally, regarding antigen bound to carriers, see also Sallberg et al. at para [0127], Sallberg et al. teach it is also known to covalently link antigen to cellulose that is oligomeric (see antigen peptide bound carriers including proteins and oligo/polysaccharides, indicating for example, cellulose). See also para [0129], Sallberg refer to composite supports, such as a carrier used to attach a peptide to a solid support (used a linker, encouraging flexibility, overcome steric hindrance).
It would have been prima facie obvious to one having ordinary skill in the art to have modified Zhang et al., namely to have modified the anti-PEG-antibody binding material that is mPEG, to further include a carrier, such as cellulose, to produce cellulose linked PEG antigen (Moudgal, Nikolavna, Sallberg), as an obvious matter of a known technique to a known product, one further motivated to include a carrier such as oligo cellulose, as in Sallberg, because Sallberg teach cellulose as an oligo carrier species, and because Sallberg teach a carrier, when used as a linker to attach an antigen to a solid support, can encourage flexibility and overcome steric hindrance. As a result, this modification would be expected to improve the mPEG antigen, and its attachment to a sensor surface (solid support), by encouraging flexibility and decreasing the possibility of interference due to steric hindrance. One having ordinary skill in the art would have a reasonable expectation of success because it was well known in the art at the time to conjugate antigen to cellulose carriers (e.g., Moudgal and Nikolaevna), and also to use carrier to link peptide to a solid support (Sallberg).
Regarding the limitation “wherein n represents an average degree of polymerization, which is an umber of 6 to 16”, Sallberg teach regarding linkers, linkers as having “an appropriate length” between peptide and support to which the peptide is attached (para [0129]), that determination of an appropriate length of linker is a variable to be determine. As discussed above, length is a variable that has an effect on flexibility and on steric hindrance (see Sallberg cited previously above).
Sallberg et al. support that the number of repeats, which directly impacts length, is a result-effective variable (i.e., a variable which achieves a recognized result, namely in the present case, distance to a solid support, which effects flexibility and steric hindrance). It would have been prima facie obvious to have arrived at the claimed integer range through optimization of the length through routine experimentation, to uncover the optimum, workable number of repeat units that achieves a desirable length yielding the best detection/binding of targeted anti-PEG antibody.
Regarding claims 2 and 3, see the combination of the cited art as detailed above, it would have been obvious to modify the antigen as indicated above, the antigen (binding material) as part of a biosensor (claim 2), see the combination of the oligo-antigen reads on the claimed adsorbent (claim 3).
Regarding claim 4, see also Zhang et al., Zhang teach differentiating antibody isotypes, the methods comprising flowing sample through sensor as described above (sensor comprising immobilized antigen), further contacting with a secondary antibody under conditions that allow binding, detecting with the secondary antibody probe (using the cellulose oligomer by using it to capture the anti-PEG antibody that is then detected, identified, using secondary antibody probe). As indicated in detail above, it would have been obvious to have modified Zhang’s antigen (mPEG) with oligo cellulose for the reasons as indicated in detail above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677
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