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 .
Election/Restrictions
Applicant's election with traverse of group I claims 1-12 in the reply filed on 08/11/2026 is acknowledged. The traversal is on the grounds that the example does not provide a materially different process relative to the claims or a process with a materially different product. This is not found persuasive because it does not address the independence or distinctness of the inventions or all sources of burden imposed by the inventions. A serious burden on the examiner may be prima facie shown by appropriate explanation of separate classification, or separate status in the art, or a different field of search. Arguments of convenience or coextensiveness are insufficient, showing to demonstrate that there is no undue burden.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 11 is 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 11 rejected under 35 U.S.C. 112(b) because there are no units for the molecular weight. The molecular weight lacks clarity regarding the numerical boundaries.
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)(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.
(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.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hahn et al. (US 20160193598 A1).
Regarding claim 1, Hahn et al. discloses an adsorbent material which allows the direct capture of biomolecules (paragraph 0023). The adsorbent material comprises microparticles in ground form and is prepared by grinding anion-exchange resin and cation exchange resin (paragraph 0024). The ion exchange resin is preferably polystyrene cross-linked with divinylbenzene (paragraph 0034).
Hahn et al. discloses preparation of micro particles from ion exchange resins (Example 1, paragraph 0231). The preparation uses an anion exchanger resin from the list (paragraph 0232) and a cation exchanger resin from the list paragraph (0233). These resins are made of cross-linked polystyrene and divinylbenzene. The resins are wet ground in a coated ceramic mortar (paragraph 0234). The ground resin is suspended multiple times and centrifuged to purify the resin (paragraph 0234). The resin is washed in a 50% ethanol solution (paragraph 0236).
For the present invention, a commercially available synthetic adsorbent which is a styrene-divinylbenzene copolymer was crushed by a mortar, washed with ethanol aqueous solution, and filtered (specification, paragraph 0093). The differential pore volume of the present invention is attributed to crushing the particles of the commercially available synthetic adsorbent (specification, paragraph 0024).
Because of similar synthesis in Hahn et al. and the present invention, it is the position of the examiner that the adsorbent taught in Hahn et al. inherently has a differential pore volume of greater than 0.05 mL/g under a pressure condition of 0.5 psia to 30.0 psia. When the examiner has reason to believe that the functional language asserted to be critical for establishing novelty in a claimed subject matter may in fact be an inherent characteristic of the prior art, the burden of proof is shifted to Applicants to prove that the subject matter shown in the prior art does not possess the characteristics relied upon. In re Fitzgerald et al. 205USPQ 594.
Regarding claim 2, Hahn et al. discloses the adsorbent made of positively and negatively charged microparticles are added to a biological fluid (paragraph 0092). The particles form flocs which adsorb the biomolecules and purify the biomolecules from the biological fluid (paragraph 0093-0095). The biomolecules adsorbed are polypeptides (paragraph 0026) which are also defined as antibodies (paragraph 0216).
Regarding claim 3, Hahn et al. discloses the adsorbent particles are prepared from porous ion-exchange resins (paragraph 0122).
Regarding claim 4, Hahn et al. does not disclose pore size. Because of similar synthesis in Hahn et al. and the present invention, it is the position of the examiner that the adsorbent taught in Hahn et al. inherently has pores with a radius from 4 nm to 15 nm. When the examiner has reason to believe that the functional language asserted to be critical for establishing novelty in a claimed subject matter may in fact be an inherent characteristic of the prior art, the burden of proof is shifted to Applicants to prove that the subject matter shown in the prior art does not possess the characteristics relied upon. In re Fitzgerald et al. 205USPQ 594.
Regarding claim 5, Hahn et al. discloses the adsorbent material microparticles are solid and hydrophobic (paragraph 0025).
Regarding claim 6, Hahn et al. discloses the ion-exchange resin is preferably polystyrene-based (paragraph 0034).
Regarding claim 7, Hahn et al. discloses embodiment have an average particle size of at least 5 µm (paragraph 0147).
Regarding claim 8, Hahn et al. does not disclose corrected roundness. Because of similar synthesis in Hahn et al. and the present invention, it is the position of the examiner that the adsorbent taught in Hahn et al. inherently has a corrected roundness value greater than 0.10. When the examiner has reason to believe that the functional language asserted to be critical for establishing novelty in a claimed subject matter may in fact be an inherent characteristic of the prior art, the burden of proof is shifted to Applicants to prove that the subject matter shown in the prior art does not possess the characteristics relied upon. In re Fitzgerald et al. 205USPQ 594.
Regarding claim 9, Hahn et al. does not disclose crushing strength. Because of similar synthesis in Hahn et al. and the present invention, it is the position of the examiner that the adsorbent taught in Hahn et al. inherently has a crushing strength in the range of 100 gf/particle to 2000 gf/particle. When the examiner has reason to believe that the functional language asserted to be critical for establishing novelty in a claimed subject matter may in fact be an inherent characteristic of the prior art, the burden of proof is shifted to Applicants to prove that the subject matter shown in the prior art does not possess the characteristics relied upon. In re Fitzgerald et al. 205USPQ 594.
Regarding claim 10, Hahn et al. discloses recovery and purification of IgG from a CHO cell broth using the ground ion-exchange resins to adsorb the IgG (paragraph 0303). Hahn et al. discloses the IgG is monoclonal (paragraph 0307).
Regarding claim 11, Hahn et al. discloses the recovery and purification of IgG from a CHO cell broth (paragraph 0303). IgG has a molecular weight greater than 100000.
Regarding claim 12, Hahn et al. discloses the recovery and purification of IgG (immunoglobulin G) from a CHO cell broth (paragraph 0303).
Regarding claims 2, 10, 11, and 12, if it is not accepted that the reference anticipates the claims, it is also the position of the examiner that no specific structure is required for the synthetic adsorbent to perform the intended use of the above claims besides the adsorbent Hahn et al. already anticipates. Thus, the examiner concludes that the synthetic adsorbent can perform the intended use purifying the specific antibody of claims 2, 10, 11, and 12.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ipponmatsu et al.
JP 2014002008 A
Tajima et al.
US 8420379 B2
Rasmussen et al.
WO 2006039455 A1
Xu et al.
US 20210220814 A1
Kajita et al.
WO 2021065481 A1
Oishi et al.
WO 2020203923 A1
Hayashi et al.
US 20210213394 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A CALDERON whose telephone number is (571)272-9866. The examiner can normally be reached Monday-Friday 8-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina Johnson can be reached at 5712721176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID ANDREW CALDERON/Examiner, Art Unit 1742
/BENJAMIN A SCHIFFMAN/Primary Examiner, Art Unit 1742
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