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 .
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.
Claim(s) 11, 13, 15, 18, 20, 22, 24, 27, 45. 47 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delmas et al (J ahes Sci. Tech.) in view of Yang et al (PNAS).
The Delmas et al reference teaches a composite structure, note entire reference. The composite comprises a protein and a binding agent, nucleation material. The nucleation material binds to the protein. The particle can be a protein, note page 358. There can be more than one binding agent to the particle, note figure 1. There can be more than one composite structure, note, figure 4. The sole difference between the instant claims and the prior art is collection and specific proteins. However, in the absence of unexpected results, it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to determine through routine experimentation the optimum, operable amount or numbers of structures in the Delmas et al reference in order to increase the yield of the crystalline protein.
Further, the Yang et al reference teaches crystallizing monoclonal antibodies on a surface, note, page 2. It would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to modify the Delmas reference by the teachings of the Yang et al reference to crystalize monoclonal antibodies on a surface with binding agent in order to increase the use of the composite and base materials.
With regards to claims 13 and 22, the Delmas reference teaches using proteins note section 2.6.
With regards to claims 15 and 24, the Delmas reference teaches using a liquid medium, note, section 2.6.
With regards to claim 18, the Delmas reference teaches the composite to have solid particles, note, sec 2.1.
Claim(s) 12, 21, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delmas et al (J ahes Sci. Tech.) in view of Yang et al (PNAS)..
The Delmas et al and Yang et al references are relied on for the same reasons as stated, supra, and differs from the instant claim in the specific areal density of the binding agent . However, in the absence of unexpected results, it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to determine through routine experimentation the optimum, operable density of the binding agent to the protein in the Delmas et al reference in order to increase the yield of the crystalline protein.
Claim(s) 19, 28 and 50 to 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delmas et al (J ahes Sci. Tech.) in view of Yang et al (PNAS)..
The Delmas et al and Yang et al references are relied on for the same reasons as stated, supra, and differs from the instant claim in the covalent bonding. However, in the absence of unexpected results, it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to determine through routine experimentation the optimum, operable bonding of the binding agent to the protein in the Delmas et al reference in order to ensure proper contact between the two materials.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delmas et al (J ahes Sci. Tech.) in view of Yang et al (PNAS)..
The Delmas et al and Yang et al references are relied on for the same reasons as stated, supra, and differs from the instant claim in the specific saturation condition. The Delmas et al reference does teach a liquids medium an agent to contact the protein and a means to grow crystals, note, section 2.6. However, in the absence of unexpected results, it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to determine through routine experimentation the optimum, operable conditions for growth in the Delmas et al reference in order to crystallize the protein, (instant claims 8, 29, 33 and 34)
Response to Applicants’ Arguments
Applicant's arguments filed December 10, 2025 have been fully considered but they are not persuasive.
Applicants’ argument concerning the combination of references is noted. The Yang et al reference that is used in the rejection is an article, and not a PCT publication. There is no mention in the article of such a publication. There is no seen showing of record that the teachings of the Yang et al article are the same as that of the PCT that is argued. A nexus between the two has not been shown on the record. Further, the Yang et al reference is relied on merely to show that it is well within the skill of the art to grow the claimed materials as crystals. The combination of the two references does teach the crystallization method as claimed with the same compounds.
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 ROBERT M KUNEMUND whose telephone number is (571)272-1464. The examiner can normally be reached M-F 8:00 am to 4:30 pm.
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RMK
/ROBERT M KUNEMUND/Primary Examiner, Art Unit 1714