DETAILED ACTION
Reissue
The present reissue application is directed to US 12,019,058 B2 (“058 Patent”). 058 Patent issued on June 25, 2024 with claims 1-23 from application 17/938,618 filed on October 6, 2022, which is a continuation of parent application 16/975,324, which is a 371 of PCT/EP2019/054188 filed on February 20, 2019, and claims priority to GB 1803129 filed on February 27, 2018.
This application was filed on May 12, 2025. Since this date is after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. Furthermore, the present application is being examined under the first inventor to file provisions of the AIA .
This application presents broadened claims, which are permitted because Applicant filed these claims and demonstrated an intent to broaden within two years of the issue date of 058 Patent.
The most recent amendment was filed on May 12, 2025. The status of the claims is:
Claims 1, 8-10, 14, 17, and 18: Amended
Claims 2-7, 11-13, 15, 16, and 19-23: Original
Claims 24-30: New
This is a first, non-final action.
References and Documents Cited in this Action
058 Patent (US 12,019,058 B2)
US 11,493,489 B2
Bisschops (US 2012/0203531 A1)
Suzuki (US 2009/0288473 A1)
Summary of Rejections and Objections in this Action
Examiner objects to the claim amendment.
Claims 24-30 are rejected under 35 U.S.C. 251 for including subject matter directed to non-elected inventions subject to a restriction requirement during the prosecution of 058 Patent.
Claims 1-23 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. US 11,493,489 B2.
Summary of the Claims
058 Patent is directed to a liquid chromatography system for purification of target products. Claim 1 is representative:
1. A liquid chromatography system configured to operate with at least one column and configured for purification of a sample comprising a target product using a predefined process, wherein the liquid chromatography system comprises a controller configured to:
control the operation of the chromatography system to run the predefined process,
retrieve column data accessible from a data storage, the column data being specific to each column, and
adapt at least one process parameter of the predefined process for each column based on the column data,
whereby the controller is further configured to adapt at least one process parameter of the predefined process for each column based on column data collected by at least one sensor, and
whereby the predefined process is adapted to each column to obtain the target product and maintain the performance of the liquid chromatography system.
Claims 1, 14, 24 and 30 are the independent claims. Claim 14 recites a method of controlling a liquid chromatography system corresponding to the apparatus recited in claim 1. Claims 24 and 30 recite a system and method for manufacturing a column for a liquid chromatography system.
Claim Amendment
Examiner objects to the claim amendment filed on May 12, 2025 because matter to be omitted by reissue must be marked with brackets, not strikethrough (see claims 1, 8-10, 14, 17, and 18). Furthermore, in claim 9, the deleted number “1” (in the phrase “according to claim 1”) should be enclosed in single brackets, not double brackets. See 37 CFR 1.173(d).
Claim Rejections - 35 USC § 251
Claims 24-30 are rejected under 35 U.S.C. 251 for including subject matter directed to non-elected inventions subject to a restriction requirement during the prosecution of 058 Patent. More specifically, claims 24-30 are directed to “Group II” (“column packing”) as discussed in the requirement for restriction mailed on January 24, 2022 in application 16/975,324 (the parent of 058 Patent). Group II is distinguished from Group I by Group II’s details with respect to the manufacture of a column for a liquid chromatography system, in contrast with Group I’s details with respect to controlling a liquid chromatography system. As noted in the 16/975,324 restriction requirement, the details of Group II are not required in Group I (and the details of Group I are not required in Group II).
Applicant elected Group I (see response filed on March 3, 2022 in 16/975,324) and eventually the Group II claims were canceled (see Notice of Allowance mailed on July 8, 2022 in 16/975,324). Applicant did not file a divisional application on the non-elected Group II invention; 058 Patent, filed as a continuation of 16/975,324, is directed to Group I. Where a restriction (or an election of species) requirement was made in an application and applicant permitted the elected invention to issue as a patent without filing a continuing application on the non-elected invention(s) or on non-claimed subject matter distinct from the elected invention, the non-elected invention(s) and non-claimed, distinct subject matter cannot be recovered by filing a reissue application. See MPEP 1412.01 II and In re Watkinson, 900 F.2d 230, 14 USPQ2d 1407 (Fed. Cir. 1990); In re Weiler, 790 F.2d 1576, 229 USPQ 673 (Fed. Cir. 1986); In re Orita, 550F.2d 1277, 1280, 193 USPQ 145, 148 (CCPA 1977); and In re Mead, 581 F.2d 251, 198 USPQ 412 (CCPA 1978). See also Ex parte Sandwick, Appeal No. 2018-008369 (PTAB July 23, 2019).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a controller configured to perform steps involving “each column” and “column data” but there is insufficient antecedent basis for these terms in the claim. The claim previously recites “A liquid chromatography system configured to operate with at least one column” but does not specifically recite that the system includes at least one column.
Similarly, claim 14 recites steps involving “each column” and “column data” but there is insufficient antecedent basis for these terms in the claim. The claim previously recites “A method for controlling a liquid chromatography system configured to operate with at least one column” but does not specifically recite that the system includes at least one column.
Claims 2-13 and 15-23 are also indefinite for the same reasons as their respective parent claims (claims 2-13 depend on claim 1 and claims 15-23 depend on claim 14).
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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. US 11,493,489 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding independent reissue claim 1, although the recited elements are not identical to the elements of claim 1 of US 11,493,489 B2, they are not patentably distinct from each other because they are of the same scope of invention with claim 1 of US 11,493,489 B2 anticipating the instant claim. Reissue claim 1 and claim 1 of US 11,493,489 B2 are directed to a liquid chromatography system comprising a controller configured to control the operation of the chromatography system to run a predefined process; retrieve column data accessible from a data storage, the column data being specific to each column; adapt at least one process parameter of the predefined process for each column based on the column data; whereby the controller is further configured to adapt at least one process parameter of the predefined process for each column based on column data collected by at least one sensor, and whereby the predefined process is adapted to each column to obtain the target product and maintain the performance of the liquid chromatography system. Given claim 1 of US 11,493,489 B2, it would have been obvious to create reissue claim 1 by slightly changing the wording of limitations and/or removing limitations.
Dependent reissue claims 2-13 recite limitations that correspond to claims 2-13 of US 11,493,489 B2, respectively, and are also rejected on the ground of nonstatutory double patenting over those claims.
Regarding independent reissue claim 14, although the recited elements are not identical to the elements of claim 14 of US 11,493,489 B2, they are not patentably distinct from each other because they are of the same scope of invention with claim 14 of US 11,493,489 B2 anticipating the instant claim. Reissue claim 14 and claim 14 of US 11,493,489 B2 are directed to method for controlling a liquid chromatography system comprising controlling the operation of the chromatography system to run a predefined process; retrieving column data accessible from a data storage, the column data being specific to each column; adapting at least one process parameter of the predefined process for each column based on the column data; whereby the liquid chromatography system further comprises a controller configured to adapt at least one process parameter of the predefined process for each column based on column data collected from at least one sensor, and whereby the predefined process is adapted to each column to obtain the target product and maintain the performance of the liquid chromatography system. Given claim 14 of US 11,493,489 B2, it would have been obvious to create reissue claim 14 by slightly changing the wording of limitations and/or removing limitations.
Dependent reissue claims 15-23 recite limitations that correspond to claims 15-23 of US 11,493,489 B2, respectively, and are also rejected on the ground of nonstatutory double patenting over those claims.
Allowable Subject Matter
Claims 1-23 may contain allowable subject matter if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) and double patenting set forth in this Office action.
Bisschops teaches, among other things, a liquid chromatography system and method including a computer controlling the operation of the chromatography system to run a predefined process, adapting at least one process parameter of the predefined process for each column, whereby the predefined process is adapted to each column to obtain the target product and maintain the performance of the liquid chromatography system (Figures 5-6; paragraphs [0073]-[0079]).
Suzuki teaches, among other things, a liquid chromatography system and method including a computer 7 controlling the operation of the chromatography system to run a predefined process, adapting at least one process parameter of the predefined process for each column 15, whereby the predefined process is adapted to each column to obtain the target product and maintain the performance of the liquid chromatography system (Figures 1-3; paragraphs [0024]-[0026] and [0048]-[0049]);
The prior art does not specifically disclose or fairly suggest a liquid chromatography system and method including the combination of all of the elements, steps, and limitations recited in claims 1-23 (including all of the limitations of any respective parent claims and as well as the claims may be understood with respect to 35 U.S.C. 112(b), particularly including:
adapting at least one process parameter of the predefined process for each column based on column data,
whereby the liquid chromatography system further comprises a controller configured to adapt at least one process parameter of the predefined process for each column based on column data collected from at least one sensor.
Conclusion
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which this reissue application is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Applicant is notified that any subsequent amendment to the specification and/or claims must comply with 37 CFR 1.173(b).
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Any inquiry concerning this communication or earlier communications from the examiner, or as to the status of this proceeding, should be directed to Examiner Christina Leung at telephone number (571) 272-3023; the Examiner’s supervisor, SPE Patricia Engle at (571) 272-6660; or the Central Reexamination Unit at (571) 272-7705.
/CHRISTINA Y. LEUNG/Primary Examiner, Art Unit 3991
Conferees:
/DEANDRA M HUGHES/Reexamination Specialist, Art Unit 3992
/Patricia L Engle/SPRS, Art Unit 3991