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 .
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 01 May 2026, have been entered in full. Claims 3 and 7 are canceled. Claims 1, 2, 5 and 6 are amended.
Claims 1, 2, 4-6, 8-14 are under examination.
Information Disclosure Statement
The information disclosure statement(s) (IDS) (filed 01 May 2026) was received and complies with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. It has been placed in the application file and the information referred to therein has been considered as to the merits.
Withdrawn Objections And/Or Rejections
The rejection to claims 1-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,993,630, as set forth at pages 10-14 of the previous Office Action (04 November 2025), is withdrawn in view of the submitted terminal disclaimer. The terminal disclaimer filed on 01 May 2026 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 2, 4-6, 8-10, 12-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Falkenstein et al. (US 2012/0197007; published 8/2/12) in view of Haddad et al. (US 2012/0276576; published 11/1/12).
The basis for this rejection is set forth at pages 2-9 of the previous Office Action (04 November 2025).
APPLICANT’S ARGUMENTS: Applicant argues that claim 1 has been amended to recite "wherein the second solution has a pH between about 2.7 to about 3.2 and wherein the second solution with an increased pH value, is increased by 0.1 pH units compared to the first solution," thus requiring the first solution have a pH range of about 2.6 to about 3.1.
Applicant maintains that neither Falkenstein nor Haddad recite a "second solution with an increased pH value is increased by 0.1 pH units compared to the first solution".
Applicant’s arguments have been fully considered but are not found persuasive for the reasons:
a. Falkenstein et al. teach that in one embodiment the solution with a conductivity of about 21 mS/cm is a solution with a pH value of from pH 2.5 to pH 3.5.
Falkenstein et al. teach in the method that the first solution and the second solution both have a conductivity of about 21 mS/cm. Therefore, the first solution and the second solution have a pH value from pH 2.5 to pH 3.5. The pH range from 2.5 to pH 3.5, encompasses applying a second solution with an increased pH value with respect to the first solution.
b. Regarding Applicant’s argument that Falkenstein does not recite a "second solution with an increased pH value, is increased by 0.1 pH units compared to the first solution".
As was stated above, Falkenstein et al. teach a first solution and a second solution having a pH value from pH 2.5 to pH 3.5.
The pH range includes pH numbers 2.5 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4 and 3.5.
The first solution would still include pH numbers 2.6, 2.7, 2.8, 2.9, 3.0 and 3.1, which is the same pH numbers recited in the instant claims.
The pH range of the second solution would still include pH numbers 2.7, 2.8, 2.9, 3.0, 3.1 and 3.2, which is the same pH numbers recited in the instant claims.
A first solution having a pH of 2.6 is encompassed by the teachings of Falkenstein. A second solution having a pH of 2.7 is encompassed by the teachings of Falkenstein. Falkenstein’s teachings encompasses a 0.1 pH unit increase.
The scientific reasoning and evidence indicates that the rejection should be maintained.
Claim 11 remains rejected under 35 U.S.C. 103 as being unpatentable over Falkenstein et al. in view of Haddad et al., as applied to claims 1 and 10 above, and further in view of Makino et al. (US 5,817,238; published 10/6/98).
The basis for this rejection is set forth at pages 9-10 of the previous Office Action (04 November 2025).
APPLICANT’S ARGUMENTS: Applicant argues that claim 11 depends from amended claim 1 and is thus inventive over the combination of Falkenstein and Haddad for at least the same reasons. Applicant argues that Makino does not remedy.
Applicant’s arguments have been fully considered but are not found persuasive for the reasons stated above and reasons of record.
The scientific reasoning and evidence indicates that the rejection should be maintained.
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . 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. See 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 actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4, 5, 9,10, 12-14 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-9 of U.S. Patent No. 10,273,277 in view of Burg et al. (HOFFMAN-LA ROCHE WO 2009/010270; published Jan 22, 2009),
The basis for this rejection is set forth at pages 14-17 of the previous Office Action (04 November 2025).
APPLICANT’S ARGUMENTS: Applicant argues that claim 1 has been amended to recite "wherein the second solution has a pH between about 2.7 to about 3.2 and wherein the second solution with an increased pH value is increased by 0.1 pH units compared to the first solution," thus requiring the first solution have a pH range of about 2.6 to about 3.1.
Applicant argues that neither U.S. Patent No. 10,273,277 nor Burg recite a "second solution with an increased pH value is increased by 0.1 pH units compared to the first solution".
Applicant’s arguments have been fully considered but are not found persuasive for the reasons:
The claims of U.S. Patent No. 10,273,277 recite: A chromatography method for obtaining a protein, which comprises erythropoietin and a single poly (ethylene glycol) residue, comprising: a) applying a solution comprising a mixture of erythropoietin and conjugates of erythropoietin and poly (ethylene glycol) with one or more poly (ethylene glycol) residues per erythropoietin molecule to a column comprising SP Sephacryl ™ S 500 HR chromatography material, to which a solution with a conductivity of 21 mS/cm has been applied, b) applying a solution with a conductivity of 21 mS/cm to the column and thereby recovering free poly (ethylene glycol), and proteins comprising two or more poly (ethylene glycol) residues, and c) applying a solution with linearly increasing conductivity up to a final value of 62.5 mS/cm to the column and thereby recovering separately the protein, which comprises erythropoietin and a single poly (ethylene glycol) residue, and erythropoietin, whereby the protein comprising erythropoietin and a single poly (ethylene glycol) residue is recovered first, wherein the protein comprising erythropoietin and a single poly (ethylene glycol) is purified after one single chromatography step.
The method of claim 1, wherein the solution with a conductivity of 21 mS/cm is a solution with a pH value of from pH 2.5 to pH 3.5.
The method of claim 1, wherein the solution with a conductivity of 21 mS/cm is a phosphate buffered solution with a pH value of from pH 2.5 to pH 3.5.
Thus, the first solution and the second solution taught in the claims of U.S. Patent No. 10,273,277 have a pH value from pH 2.5 to pH 3.5.
The pH value range includes pH numbers 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4 and 3.5.
The pH range of the first solution would still include pH numbers 2.6, 2.7, 2.8, 2.9, 3.0 and 3.1, which is the same pH numbers recited in the instant claims.
The pH range of the second solution would still include pH numbers 2.7, 2.8, 2.9, 3.0, 3.1 and 3.2, which is the same pH numbers recited in the instant claims.
The US Patent’s teachings encompass a 0.1 pH unit increase.
The scientific reasoning and evidence indicates that the rejection should be maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 6/7/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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