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 Amendment
Applicant’s arguments filed 11/10/2025 have been entered. Claims 1,7-17 and 19-37 are pending in the application, the claim objection and 112(b) rejections previously set forth are withdrawn in view of the arguments and amendment.
Response to Arguments
Applicant's arguments filed 04/21/2022 have been fully considered but they are not persuasive.
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1,7-17,19-21,23 and 27-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 27 recite a process consisting of, it is unclear what is required by the term consisting of, and if there is support in the original disclosure for this limitation. The instant specification discloses on page 8, lines 24-28 “The term "comprises" or "comprising" is used in the present description, it does not exclude other elements or steps. For purpose of the present invention, the term "consisting of' is considered to be an optional embodiment, of the term "comprising of'. If hereinafter a group is defined to comprise at least a certain number of embodiments, this is also to be understood to disclose a group which optionally consists only of these embodiments”, this definition appears broader than ordinary meaning of consisting of, see MPEP 2111.03 for details on the use of transitional phrases.
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 1,7-17,19-21,23 and 27-34 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.
Claims 1 and 27 recite a process consisting of, it is unclear what is required by the term consisting of, and if there is support in the original disclosure for this limitation. Each of the three examples provided in the specification use steps including sanitation, charge, and equilibration, it is unclear if this process is a more limited subset of the full process as described in the instant disclosure, or if the recited purity could be achieved without the other steps in the examples.
Claim 28 recites the limitation of the protein mixture, it is unclear from the language in claims 27 and 28 at which step the recited impurity is required, claim 27 recites the protein mixture at multiple points, including in the last paragraph of the eluted protein mixture, examiner suggests adding eluted to the protein mixture in claim 28.
Claim 21 recites the limitation a CHT column is performed after Protein A chromatography, the language of consisting of precludes additional steps being added.
Claim 32 recites the limitations of optionally further comprises additional chromatography columns selected from a cation exchange, a Hydroxyapatite, a [[HIC]] Hydrophobic interaction chromatography, and a multimodal chromatography, the language of consisting of precludes additional steps being added.
Claim 33 recites the limitations of wherein a cation exchange chromatography is performed before the anion exchange chromatography.
Additional claims are rejected as dependent on a rejected claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
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, 7-14, 16, 17, 19-21, 23-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong (US PG Pub 2022/0203347), with evidence from Sutter (US PG Pub 2021/0130396), in view of Yang (US PG Pub 2023/0124565).
With respect to claims 1 and 27, With respect to claim 1, see 112 rejections above. Wong teaches methods of purifying an polypeptide which can be an antibody from an impurity using ion exchange material (0009, 0014, 0018-0019, 0038, 0117-0123, 0165-0196), a process of purifying an antibody or a fusion protein), in embodiments the polypeptide has a pi of about any of 6, 7, 7.5, 8, 8.5, 9, 9.5, or 10 (0229, with a pI of 7.5 to 7.9), a portion of the process consisting of: in embodiments purifying by affinity chromatography prior to passing through ion exchange (0188, 0205), step b) loading the composition on anion exchange chromatography material (a) loading the protein mixture onto an anion exchange resin (0018-0019, 0038, 0117-0123, 0165-0196)), impurities preferentially bind to the resin while the product breakthrough is collected (0003, 0049, eluting the protein mixture in a flow through mode whereby product-related impurities bind to the anion exchange resin), d) washing the anion exchange chromatography material with equilibration buffer (0038), washing the ion exchange material with the equilibration buffer (0009-0015, 0036-0045, 0115-0123, 0163-0179), in embodiments the wash buffer is the same as the load buffer (0206), in embodiments the pH of the equilibrium buffer is about 6-10, or any of 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 or 10.0 (0135, 0149, using a buffer having the pH in the range of 7.0 to 7.5).
Alternatively with respect to the pH, Wong teaches purification of various polypeptides, and pH values which include the recited range, without showing unexpected results, the claimed pH cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have optimized, by routine experimentation, the loading buffer pH in order that the polypeptide to be purified does not bind (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 223), and as evidenced by Sutter, Sutter teaches methods for purifying proteins (abstract), including various proteins (0019), using anion exchange (0006-0009), and that the skilled person knows how to adapt the pH and/or the salt condition of the buffer in view of the pI (Isoelectric Point) of the protein to be purified in order that the protein to be purified does not bind (0057, 0068).
With respect to the limitations of the impurities, examiner notes "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency." Absent clarification of differences over the art, the recited impurities and purity are considered inherent. In the interest of compact prosecution Wong teach purification of antibodies, contaminants removed include variants and aggregates or derivatives of the polypeptide (0083, 0211) and HMW (0216, 0564-0565, and high molecular weight (HMW) impurity), analyzed by SE-HPLC (0188-0189, 0565), Wong teaches the amount of aggregated protein may be reduced by a number of ranges of 5% to about 99% (0216), analyzed by SEC (0564-0565).
Wong teaches in examples virus inactivation prior to Protein A (0192), after anion exchange (0191, 0193), not specifically b) Subjecting the protein mixture obtained from affinity chromatography to viral inactivation. Yang teaches a similar system as discussed above, and steps of virus inactivation before and after anion exchange (0012, 0085-0090), and between chromatography steps (0128), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to subject the protein mixture obtained from affinity chromatography to viral inactivation, as a matter of design choice in view of Yang.
Yang teaches methods of preparing and purifying high purity antibodies (abstract, 0001-0012), antibodies having an isoelectric point of 7-9 (0030), passing through an anion exchange column, and use of a buffer with a pH of 7.0-8.0, with an example of 7.5 (0018-0022, 0103-106); flow through anion exchange (0104, 0163-0166), antibodies include all therapeutic antibodies typically used in the art (0030), and virus inactivation between chromatography steps, and selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (see MPEP 2144.04 IV. C), in the absence of new or unexpected results.
With respect to claims 7-9, 23-26, 28-31, the process according to claim 1 is taught above. Wong teaches purification of antibodies, contaminants removed include variants and aggregates or derivatives of the polypeptide (0083, 0211) and HMW, analyzed by SE-HPLC (0188-0189, 0565), the amount of aggregated protein may be reduced by a number of ranges of 5% to about 99% (0216), analyzed by SEC (0564-0565), and methods of measuring are known in the art (0216), examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113, in the interest of compact prosecution, Wong teaches purification of impurities and variants using flow through anion exchange chromatography (0038-0049), and aggregated polypeptide can be high molecular weight (HMW) protein (0216). See 112 rejections above.
With respect to claims 10-11, the process according to claim 1, is taught above. Wong teaches the polypeptide may have a pI between about any of 6 to 10, 7 to 9, or 8 to 9, about any of 6, 7, 7.5, 8, 8.5, 9, 9.5, or 10 (0229, with a pI selected from 7.5, 7.6, 7.7, and 7.9).
With respect to claim 12-14, the process according to claim 1, is taught above. Wong teaches pH of about 6-10, or any of 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 or 10.0 (0135, 0149) as discussed above, wherein the buffer has a pH selected from 7.0, 7.1, 7.2, 7.3, 7.4, and 7.5.
With respect to claims 16 and 17, the process according to claim 1, is taught above. Wong teaches wherein the antibody is capable of binding to an IgE, the antibody is Omalizumab (0235).
With respect to claims 19 and 20, the process according to claim 1, is taught above. Wong teaches wherein the anion exchange is a strong anion exchange, wherein the strong anion exchange is POROS 50 HQ resin is functionalized with quaternized polyethyleneimine groups (0185).
With respect to claim 21, the process according to claim 1, is taught above. Wong teaches (0188, 0198), wherein a CHT column is performed after Protein A chromatography.
With respect to claim 32, Wong teaches optionally further comprises additional chromatography columns selected from a cation exchange, a Hydroxyapatite, a Hydrophobic interaction chromatography, and a multimodal chromatography (0197).
With respect to claim 33, Wong teaches emobidments with a cation exchange chromatography is performed before the anion exchange chromatography (0190-0196).
With respect to claim 34, Wong teaches embodiments not requiring the need for a Hydroxyapatite, a [[HIC]] Hydrophobic interaction chromatography, and a multimodal chromatography, as discussed above.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wong (US PG Pub 2022/0203347), with evidence from Sutter (US PG Pub 2021/0130396) in view of Yang (US PG Pub 2023/0124565), in view of Sutter.
With respect to claim 13, the process of purifying an antibody or fusion protein with p1 of 7 to 8 from the protein mixture as claimed in claim 1, is taught above. The taught combination teaches buffers as discussed above, Sutter teaches a similar system as discussed above and that buffers include but are not limited to phosphate buffers, Tris buffers including sodium phosphate (0053, 0057), Yang teaches Tris-HCL (0106, 0165-0167, buffer is selected from Sodium Phosphate, Tris-HCl, HEPES, Glycine-NaOH, and Tris-Acetate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a sodium phosphate buffer as taught by Sutter as sodium phosphate is known in the art as a loading buffer in methods to purify antibodies and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Conclusion
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 JEANNIE MCDERMOTT whose telephone number is (571)272-4479. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vickie Kim can be reached at 571-272-0579. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANNIE MCDERMOTT/Examiner, Art Unit 1777
/BRADLEY R SPIES/ Primary Examiner, Art Unit 1777