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Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim.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 Objections
Applicant is advised that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1 and 2 differ in only two respects:
Step b) of claim 1 the depth filter is contacted with an acidic solution to regenerate the depth filter and in claim 2 the depth filter is contacted with an acidic solution after step a). However, one of ordinary skill in the art would immediately recognize that in claim 1, step a) would have to necessarily occur first, otherwise the depth filter would not need to be regenerated because the filtering of the aqueous composition containing the polypeptide and impurities is what would load the filter with impurities and necessitate the need for regeneration. Additionally, by repeating steps a) and b) multiple times, as recited, will also necessarily require the depth filter to be regenerated after step a).
The preamble, claim 1 is directed to a method for purifying a therapeutic polypeptide and claim 2 is directed to a method for producing a therapeutic polypeptide. However, the actual steps of the method are identical and therefore are directed to the exact same subject matter.
Claims 11 and 21 are objected to because of the following informalities:
Claims 11 and 21 appear to have a typo and it is believed they should read, “…selected from the group consisting of…”
Appropriate correction is required.
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.
Claims 1, 3-4, 8-13, 20 and 22 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.
Claim 1 recites the limitation "said purified therapeutic polypeptide" in line 5. There is insufficient antecedent basis for this limitation in the claim. For examination purposes the claim is assumed to recite, "said therapeutic polypeptide".
Claim 10 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”.
Claims 12 and 22 recite the group consisting of XOSP depth filter, PDD1 depth filter or VR02 depth filter. These appear to be a trade names for a particular depth filter. It is not clear if the particular depth filter media by these names has always been consistent with respect to the particular structure and content of the depth filter and conceivably the structure and content of the depth filter may be modified by the manufacturer in the future. Thus, the claims would be indefinite as the metes and bounds of the claim could change over time. Additionally, claims 11 and 21 appear to recite the generic structures of the named depth filters of claims 12 and 22, respectively. If that is the case, then claims 11 and 12 as well as 21 and 22 would be duplicate claims. However, it is unclear if claims 11 and 12 and 21 and 22 are related in this way.
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) 1-4, 8-13 and 16-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seay et al. US 2022/0135620 and Lin et al. WO 02/089951.
Claims 1 and 2, Seay teaches a method for purifying/producing 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 (abstract, par 3, 5, antibodies being a therapeutic polypeptide). Seay 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). Seay 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 Seay 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 and 18, 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, 11-12, 19 and 21-22, Seay further teaches the depth filter is an XOSP depth filter, which is polyacrylic fiber and silica (par 41, 104).
Claims 10 and 20, Seay further teaches the method reduces the enzymatic hydrolysis activity rate of the flow-through (abstract).
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).
Conclusion
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/BENJAMIN M KURTZ/Primary Examiner, Art Unit 1779