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
Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/25/26.
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 24 is 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.
Claim 24 recites various concentrations of phosphoric acid in combination with various concentrations of acetic acid. However, the specification as originally filed, teaches the various recited concentrations of both acids when those acids are used by themselves. Namely, paragraphs 24 and 26, teach the various concentrations when the acidic solution is phosphoric or acetic, respectively. Paragraph 28 recites concentrations of phosphoric acid when combined with acetic acid. Additionally, original claim 18 makes the same distinction between the concentrations based on whether acetic acid or phosphoric acid are used by themselves or in combination with each other. The combined acid concentrations taught by the specification as originally filed do not include the concentrations of newly submitted claim 24 and therefore claims 24 constitutes new matter.
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 16-21 and 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.
Each of the above claims depend from now cancelled claim 2. Therefore, it is unclear what claim is further limited by these claims. These claims are identical to claims 3-4, 8-11 and 13 and thus to assume they depend from claim 1 would raise duplicate claim issues.
Claim 20 recites the limitation "the enzymatic hydrolysis activity rate". There is
insufficient antecedent basis for this limitation in the claim. For examination purposes
the claim is assumed to recite, “an enzymatic hydrolysis activity rate of the flow-
through”.
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 (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 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.
Claim(s) 1, 3-4, 8-11, 13, 16-21 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ambhaikar et al. WO 2020/159838 and Lin et al. WO 02/089951.
Claim 1, Ambhaikar teaches a method for purifying a therapeutic polypeptide comprising: filtering an aqueous composition containing the therapeutic polypeptide and impurities through a depth filter, recovering the flow-through and thereby obtaining the therapeutic polypeptide (pg. 2, line 8 – pg. 3, line 31; pg. 20, lines 12-26). Ambhaikar does not teach contacting the depth filter with an acidic solution to regenerate the depth filter.
Lin teaches a process for regenerating a depth filter, used to filter cell components (pg. 2, par 1-2), by filtering an aqueous composition containing impurities through a depth filter to recover a flow-through (pg. 2, par 1-3), contacting the depth filter with an acidic solution (pg. 6, par 2) after filtering (pg. 6 par 3) and repeating steps a) and b) one or more times (fig. 2-3).
Lin recognizes that depth filters can become plugged relatively quickly and must be replaced and can also be expensive (pg. 3, par 4). Ambhaikar uses a depth filter to filter a slurry, as in Lin, which will become plugged and need to be replaced. The particular method of regenerating a depth filter is not particular to the specific use of the depth filter. Therefore, one of ordinary skill in the art would readily recognize that the method of regenerating the depth filter of Lin could likewise be used to regenerate the depth filter used in Ambhaikar as a way to extend the useful life of a filter to effectively reduce the cost of filtering by reducing the requirement to replace the depth filter as often (Lin, pg. 3, par 4-5). The claim would have been obvious because the technique (regenerating) for improving a particular class of devices (depth filters) was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations. KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claims 3, 16, Lin further teaches the acidic solution has a pH below 4 (pg. 6, par 2).
Claims 4, 8, 17-18 and 24, Lin teaches the acidic solution can use hydrochloric acid, sulfuric acid, nitric acid or the like (pg. 6, par 2) but does not teach phosphoric acid and acetic acid. Phosphoric and acetic acid are well-known the art and would have been well within the grasp of one of ordinary skill in the art especially because Lin recognizes “or the like” for possible acids. Phosphoric and acetic acid would have been recognized as being the like to the non-exhaustive list of Lin. The claim would have been obvious because "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 the product not of innovation but of ordinary skill and common sense.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007). The particular concentration of acid used is clearly a result effective variable as the concentration of the acid will determine the pH of the solution and Lin recognizes the pH should be below 4. Thus, the recited concentrations appear to be an optimization of the amount of acid to achieve the desired pH of the solution. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, In re Aller, 105 USPQ 233 (1955).
Claims 9, 11, 19 and 21, Ambhaikar further teaches the depth filter is an XOSP depth filter, which is polyacrylic fiber and silica (pg. 45, line 3-15).
Claims 10 and 20, Ambhaikar teaches the method and the same depth filter material. The recitation of the reduction of the enzymatic hydrolysis activity rate of the flow-through will be inherent in the method of Ambhaikar as the result is directly affected by the material of the depth filter.
Claims 13 and 23, Lin further teaches the regeneration step is typically conducted between 30 seconds and 30 minutes but longer times may be required depending on the level the depth filter is plugged (pg. 6, par 1).
Response to Arguments
Applicant provided a statement that the prior art to Seay was commonly owned by the applicant and therefore ineligible as prior art under 102(b)(C). Therefore, the previous prior art rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amendments made to the claims as well as new prior art as detailed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN M KURTZ whose telephone number is (571)272-8211. The examiner can normally be reached Monday-Friday 8:30-5.
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/BENJAMIN M KURTZ/Primary Examiner, Art Unit 1779
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