DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicants’ amendment to the claims filed on 07/10/2024 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 1-20 are pending.
Priority
4. Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d) to European Patent Application No. EP23315074.7, filing date 03/31/2023. The certified copy has been electronically retrieved by the USPTO on 07/10/2024.
Information Disclosure Statement
5. The IDS filed on 07/01/2024 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Drawings
6. The Drawings filed on 03/29/2024 are acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 112(b)
7. 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.
8. Claims 7, 10-15, and 17-20 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.
Regarding claims 7, 10-15, and 17-20, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is suggested that applicants clarify the meaning of the claims.
Further regarding claims 14-15 and 20, the term "about" is a relative term which renders the claim indefinite. The term "about" is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claims. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165.
Claim Rejections - 35 USC § 102
9. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
10. Claim(s) 1-4, 6-7, 9-10, 13-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beigie et al. (WO 2019/126554 A1; examiner cited).
11. Claims 1-4, 6-7, 9-10, 13-16, and 18-20 are drawn to a method of purifying a heteromultimeric Fc domain-containing polypeptide, wherein the method comprises the following steps in the indicated order: a) providing a sample comprising the heteromultimeric Fc-domain-containing polypeptide and one or more mispaired variants thereof; b) contacting a protein A chromatography matrix with the sample and binding the heteromultimeric Fc domain-containing polypeptide to the protein A chromatography matrix; c) contacting the protein A chromatography matrix with a wash solution, wherein the wash solution comprises octanoate; d) contacting the protein A chromatography matrix with an elution solution; and e) collecting an eluate comprising the heteromultimeric Fc domain-containing polypeptide.
12. With respect to claims 1 and 4, Beigie et al. teach a method of purifying a heteromultimeric Fc domain-containing polypeptide from mispaired variants comprising providing a sample comprising the heteromultimeric Fc domain-containing polypeptide and one or more mispaired variants, contacting the heteromultimeric Fc domain-containing polypeptide with a protein A chromatography matrix, contacting the protein A chromatography matrix with caprylic acid (octanoate), contacting the protein A chromatography matrix with an elution solution and collecting the eluate comprising the heteromultimeric Fc domain-containing polypeptide [see Abstract; paragraphs 0005-0014; 0034].
With respect to claim 2, Beigie et al. teach the method further comprising purifying the heteromultimeric Fc domain-containing polypeptide over a multimodal chromatography matrix, binding and eluting the heteromultimeric Fc domain-containing polypeptide to the matrix and collecting the eluate comprising the heteromultimeric Fc domain-containing polypeptide [see paragraph 0110 and 0127].
With respect to claim 3, Beigie et al. teach the method further comprising purifying the heteromultimeric Fc domain-containing polypeptide over an ion exchange chromatography matrix, binding and eluting the heteromultimeric Fc domain-containing polypeptide to the matrix and collecting the eluate comprising the heteromultimeric Fc domain-containing polypeptide [see paragraph 0110 and 0127].
With respect to claim 6, Beigie et al. teach the method wherein the method further removes process-related impurities [see Abstract; paragraphs 0005-0014, 0034, 0110, and 0127].
With respect to claim 7, Beigie et al. teach the method wherein the heteromultimeric Fc domain containing polypeptide is a multispecific antibody [see paragraph 0034].
With respect to claim 9, Beigie et al. teach the method wherein the mispaired variants are high molecular weight and low molecular weight fragments of the product [see paragraph 0112].
With respect to claim 10, Beigie et al. teach the method results in the separation of the heteromultimeric Fc domain-containing polypeptide from said mispaired variants [Abstract; paragraphs 0005-0014, 0034, and 0112].
With respect to claim 13, Beigie et al. teach the method wherein the purity of the heteromultimeric Fc domain-containing polypeptide is greater than 95% of the total protein concentration [see paragraphs 0112-0113; Table A].
With respect to claim 14, Beigie et al. teach the method wherein the concentration of the caprylic acid is 50 mM [see paragraph 0008].
With respect to claim 15, Beigie et al. teach the method wherein the wash solution further comprises benzyl alcohol and/or hexylene glycol [see paragraph 0005].
With respect to claim 16, Beigie et al. teach the method further comprising purifying the heteromultimeric Fc domain-containing polypeptide over an ion exchange chromatography matrix, binding and eluting the heteromultimeric Fc domain-containing polypeptide to the matrix and collecting the eluate comprising the heteromultimeric Fc domain-containing polypeptide [see paragraph 0110 and 0127].
With respect to claims 18 and 19, Beigie et al. teach the method wherein the purity of the heteromultimeric Fc domain-containing polypeptide is greater than 95% of the total protein concentration [see paragraphs 0112-0113; Table A].
With respect to claim 20, Beigie et al. teach the method wherein the wash solution further comprises benzyl alcohol and/or hexylene glycol [see paragraph 0005].
Claim Rejections - 35 USC § 103
13. 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.
14. Claim(s) 5, 8, 11-12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beigie et al. (WO 2019/126554 A1; examiner cited) in view of Gauthier et al. (WO 2022/144836 A1, priority to 12/31/2020; examiner cited).
15. The relevant teachings of Beigie et al. as applied to claims 1-4, 6-7, 9-10, 13-16, and 18-20 are set forth in the 102(a)(1) rejection above.
With respect to claims 5, 8, 11-12, and 17, Beigie et al. teach a method of purifying a heteromultimeric Fc domain-containing polypeptide from mispaired variants comprising providing a sample comprising the heteromultimeric Fc domain-containing polypeptide and one or more mispaired variants, contacting the heteromultimeric Fc domain-containing polypeptide with a protein A chromatography matrix, contacting the protein A chromatography matrix with caprylic acid (octanoate), contacting the protein A chromatography matrix with an elution solution and collecting the eluate comprising the heteromultimeric Fc domain-containing polypeptide [see Abstract; paragraphs 0005-0014; 0034].
However, Beigie et al. does not teach the method of claim 5, wherein the Fc domain-containing polypeptide comprises a first and second polypeptide chain each comprising a CH2-CH3 region and a third polypeptide chain which does not comprise a CH2-CH3 region; the method of claim 8, wherein the heteromultimeric Fc domain-containing polypeptide does not comprise more than one copy of a polypeptide chain and the specific structures set forth in claims 11-12 and 17.
Gauthier et al. teach heteromultimeric Fc domain-containing polypeptides comprising a first polypeptide chain represented by the formula V1-C1-CH2-CH3, a second polypeptide chain represented by the formula V2-C2-CH2-CH3-V3-C3, and a third polypeptide chain represented by formula V4-C4 wherein the polypeptide does not comprise more than one copy of a polypeptide chain [see Abstract; p. 1-4; Figures 1-2]. Gauthier et al. teach that these constructs can be purified using methods known in the art such as Protein A Sepharose columns [see p. 81 and p. 97]. Gauthier et al. teach that these constructs are useful in the treatment or prevention of proliferative disorders [see Abstract].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Beigie et al. and Gauthier et al. to purify the constructs of Gauthier et al. using the methods of Beigie et al. because Beigie et al. teach methods for the purification of heteromultimeric antibodies using a wash solution comprising caprylic acid in a Protein A column that improves the removal of impurities. Gauthier et al. teach heteromultimeric Fc domain-containing polypeptides comprising a first polypeptide chain represented by the formula V1-C1-CH2-CH3, a second polypeptide chain represented by the formula V2-C2-CH2-CH3-V3-C3, and a third polypeptide chain represented by formula V4-C4 wherein the polypeptide does not comprise more than one copy of a polypeptide chain that can be purified by Protein A chromatography. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability and would have been motivated to combine the teachings of Beigie et al. and Gauthier et al. because Beigie et al. acknowledges a wash solution comprising caprylic acid in a Protein A column that improves the removal of impurities and Gauthier et al. acknowledges that heteromultimeric Fc domain-containing polypeptides can be purified using Protein A chromatography. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
16. Status of the claims:
Claims 1-20 are pending.
Claims 1-20 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
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