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 the Application
Claims 16-18 and 21-33 are pending.
Amendment necessitated new claim rejection as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 31 and 32 are rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 31 and 32 are in an improper dependent form because claim 31 recites “useful substance ---a useful protein”, and thus broader than claim 17.
Dependent claim 32 doesn’t cure the above deficiency and is also in improper form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 16-18 and 21-33 are rejected under 35 U.S.C. 103 as being unpatentable over Coffman (US 20070066806A1).
Determining the scope and contents of the prior art
Coffman discloses a separation method of recombinant protein (using nucleic acid) or any protein with examples of antibody, enzyme etc., from a liquid comprising impurities with example of impurity DNA, nucleic acid comprising contacting the liquid, such as cell culture medium or a body fluid comprising useful substance, such as protein with impurity of nucleic acid and with another liquid comprising a compound of Mg with example of Mg carbonate, magnesium silicate, magnesium phosphate formed from two soluble salts thereby forming insoluble salt, such as Mg carbonate. The cited prior art provides that such contact forms a solid precipitate with impurity and separating the solid containing impurity from the liquid solution and thereby reducing impurity level in the liquid and producing protein, antibody, enzyme etc. (entire application, especially abstract, Figures, paragraphs 0003-0006, 0010-0023, 0034, 0052-0061, 0076, 0077, 0116, 0119, 0133-0174, Examples and claims). The cited prior art provides that such separation may be carried out by methods, such as filtration, centrifugation, microfiltration membrane, tangential flow filtration, filtration through charged media etc. (entire application, especially abstract, Figures, paragraphs 0003-0006, 0010-0023, 0034, 0052-0061, 0076, 0077, 0116, 0119, 0133-0174, Examples and claims). The cited prior art further discusses solubility product of different salts and their capability of forming insoluble salts
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With regards to limitation of the claims “water-insoluble magnesium compound” -Since the cited prior art teaches same magnesium compound as in the instant claims, the magnesium compound of the cited prior art is also expected to be water-insoluble whether or not realized by the cited prior art or not. This is because compounds are inseparable from their physical and chemical properties.
With regards to limitation of the claims “adsorbing a part of nucleic acid on the water-insoluble compound”-Since the cited prior art teaches using same magnesium compound and interaction with same impurities, nucleic acid, forming solid precipitate with the impurity-the chemical interaction between nucleic acid and magnesium compound, such as adsorption etc. are also expected to be the same whether or not realized by the cited prior art or not. This is because compounds are inseparable from their physical and chemical properties.
Ascertaining the differences between the prior art and the claims at issue
Coffman discloses separation method of any protein with examples of antibody, enzyme etc., from a liquid comprising impurities with example of impurity DNA, nucleic acid comprising contacting the liquid with a compound of Mg with example of Mg carbonate, magnesium silicate, magnesium phosphate formed from two soluble salts and thereby forming solid precipitates with impurity and separating the solid from the liquid but fails to teach adding the insoluble salt to the liquid with impurity or filling column with insoluble salt and passing liquid with nucleic acid impurity through the column.
Resolving the level of ordinary skill in the pertinent art
With regards to the above difference- the cited prior art teaches mechanism for using an insoluble salt for separation of nucleic acid impurity from target protein, method of making such insoluble salt using two soluble salts. Thus, with the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art that insoluble salt may be directly used or may be made by combination of two soluble salts with a reasonable expectation of success to separate of nucleic acid impurity from target protein. Further, based on the guidance provided by the cited prior art for forming insoluble salt and separation using methods such as filtration, centrifugation, microfiltration membrane, tangential flow filtration, filtration through charged media etc., it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of achieving separation by putting liquid with both soluble salts and liquid with impurity and nucleic acid through microfiltration membrane (also a column) as taught by the cited prior art or making a charged media with insoluble salt and using a column followed by passing liquid with impurity and nucleic acid.
Based on the above established facts, it appears that the teachings of above cited prior art read applicants’ process.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Coffman discloses same separation method of recombinant protein (using nucleic acid) or any protein with examples of antibody, enzyme etc., from a liquid comprising impurities with example of impurity DNA, nucleic acid comprising contacting the liquid with a compound of Mg with example of Mg carbonate, magnesium silicate, magnesium phosphate forming solid precipitates with impurity and separating the solid from the liquid.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that magnesium compound of the cited prior art separates nucleic acid from the liquid and can be made by teachings of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success.
Response to Arguments
Applicant’s remarks, amendment and affidavit, as filed on 12/08/2025, have been fully considered but not found persuasive.
Applicant provide an Affidavit and argued that purification efficiency is better when water insoluble salt is used instead of made by combination of two soluble salts with respect to antibody yield, DNA removal rate and after efficiency test:
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This is not found persuasive and the instant claims stand rejected. This is because (1) the first table is showing 8 samples, wherein wt% is only provided for 7 and 8 samples. This is not a true comparison. Applicant needs to provide (in addition to mM concentration of soluble salts, their wt% in the solution) for all experiments including after treatment efficiency test. Sample 5 is same as used by the cited prior art achieving 100% purification efficiency; (2) why 8 samples became 14 samples while showing antibody yield or DNA removal rate; (3) why control is showing 103% mAb yield; (4) run 11 has same efficiency as sample 5; (5) mAb yield or any graph has no error bars; (6) what are the amount of salts, soluble as well as insoluble, that are added for doing experiments 2-14 in mAb yield, DNA removal rate and magnesium concentration.
Rest of applicant’s argument is moot in view of new rejection as set forth above.
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.
Conclusion
No claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623