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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/25 has been hereby entered.
2. Claims 1-9 are pending.
Claims 1-9 read on a method of separating a monoclonal antibody from Protein A affinity chromatography column are under consideration in the instant application.
3. 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.
4. Claims 1-9 stand rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20120141497; US Patent Application 20120022006; US Patent Application 20240043550 for the same reasons set forth in the previous Office Action, mailed on 08/12/25
Applicant’s arguments filed on 11/12/25 have been fully considered but have not been found convincing.
Applicant asserts that none of the prior art references teach that PEG was well know to be used in affinity chromatography.
Contrary to Applicant’s assertion, it is the Examiner’s position that the prior art references do show that it was well known in the art that elution buffer comprising ethylene glycol can improve yield and purity of the desired monoclonal antibody.
Moreover, as is evidences from WO’2010102114 and Gagnon et al ( J of Immunol. Method, 2008, v.336, p.222-228, the use of PEG in elution buffer for antibody purification in affinity chromatography was know and routinely used.
As has been stated previously, US Patent Application’497 teaches a method of a method of affinity purification from Protein A affinity chromatography column comprising a step of using an elution buffer comprising polyethylene glycol polymer( see entire document, paragraphs 0009-0011, 0015, 0047,0094, 0096 in particular).
US Patent Application‘ 006 teaches a method of affinity purification from Protein A affinity chromatography column comprising a step of using an elution buffer comprising polyethylene glycol polymer ( see entire document, paragraphs 0082; 0104; 0215
US Patent Application‘ 550 teaches a method of affinity purification from Protein A affinity chromatography column comprising a step of using an elution buffer comprising polyethylene glycol polymer ( see entire document, paragraphs 0098, 0122; 0340; 0379 in particular.
It would be well understandable and obvious to one skill in the art that said affinity purification method comprises separating a monoclonal antibody from a Protein A chromatography column by the elution buffer.
It is also the Examiner’s position that though US Patent Application’497; US Patent Application‘ 006 and US Patent Application‘ 550 do not explicitly teaches the improved purity or increase in yield of purified product ( i.e. separated monoclonal antibody from protein A) as recited in claim 1, said functional properties would be obvious properties of recited Protein A affinity purification method, because the referenced and claimed method are similar.
Claims 2-9 are included because it would be conventional and within the skill of the art to : (i) determine an effective concentration of PEG in the elution buffer or (ii) determine an effective range of elution buffer pH. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
From the combined teaching of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional, the reply must be complete. MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer
8. The claim 1-9 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No. US 20220348608 A1. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application No. US 20220348608 recited a method of purifying a target protein using affinity chromatography and elution buffer comprising PEG for the same reasons set forth in the previous Office Action, mailed on 04/16/25.
Applicant’s arguments filed on 07/16/25 have been fully considered but have not been found convincing.
Applicant asserts that claims of US Patent Application’608 do not render the claims obvious.
Contrary to Applicant’s assertion it is noted that the instant claims and claims of copending Application No. US 20220348608 A1 each recited the same a method of purifying a target protein using affinity chromatography and elution buffer comprising PEG.
Thus though claims of copending Application No. US 20220348608 do not explicitly recite that claimed method would reduced the volume of eluent, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared claims of copending Application No. US 20220348608. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). “{i}t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
6. No claim is allowed.
7. All claims are either identical to or patentably indistinct from claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114.
Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644