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 .
Claim Objections
Claim 16 is objected to because of the following informalities: in line 2 the word influenza appears to be invertedly inserted as the claim is drawn to RSV F. 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, 8, and 16 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.
For claims 1 and 16, the term purity “wt%” finds support in the claims as filed (and the PCT and the provisional application), it is not used in the specification and thus lacks antecedent basis in the specification. Additionally, it is not clear if the term is the same as the purity % as defined in the specification (para 0026 of PGPub, “Unless otherwise specified the percentage purity of a substance is calculated using known densitometry image analysis techniques”) or if it is some other basis.
For claim 8, the meaning/members of Influenza A Group 1 and Influenza A Group 2 are not defined in the specification. Thus, the metes and bounds cannot be determined of the members of the groups.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Smith et al. (WO2011011390A1).
Smith et al. teach a 95% pure influenza HA (Example 3, Table 1).
Thus, the claim is anticipated by Smith et al.
Claim(s) 16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Pushko et al. (WO2010077717).
Pushko et al. teach “[p]urity of the recovered F protein BV #683 reached above 98% as determined by scanning densitometry (see Figure 10).” (para 198).
Thus, the claim is anticipated by Pushko et al.
Claim Rejections - 35 USC § 103
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.
Claim(s) 2-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (WO2011/011390), Wang et al. (20220135624) and Fiedler et al. (20240352076).
For claims 2, 5-7, and 10-15, Smith et al. teach purifying influenza HA with chromatography columns including TMAE and lentil lectin as well as four columns (example 2). For claims 8-9, Smith et al. teach that the influenza can be influenza B (Figure 1) and that tangential flow filtration can be used (Example 2).
Smith et al. do not teach Butyl-S resin hydrophobic interaction column or GP64 binding protein.
For claims 3 and 7, Wang et al. teach to remove contaminants and increase purity of viral proteins using HIC resin (butyl-S-Sepharose® Fast Flow). (para 234).
For claims 4 and 7, Fiedler et al. teach gp64 binding resins (para 135) and that they are particularly useful tools within the process of protein production (e.g. vaccine production) to provide for gp64 free samples. (abstract). One of ordinary skill in the art before the effective filing date would be motivated to add a GP64 binding resin to a method of purifying to make a better vaccine.
The level of skill in the art is high as evidenced by the ability to choose multiple chromatography columns and filters to make purity of the isolated influenza HA at 97% as shown in Smith et al. Table 1. The order/placement of filtration steps can be determined from routine optimization.
It would have been prima facie obvious before the date of effective filing to choose from among art known columns to use in a method to purify influenza.
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, 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. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.").
Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Here, the only desired result is purified influenza HA and the level of skill in the art is able to achieve purified influenza and use chromatography in the method.
"[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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thus, it would have been prima facie obvious before the effective filing date to modify the columns of Smith et al with the columns of Wang et al. and Fiedler et al. and optimize the column and filter order to purify influenza HA and have the expectation of success knowing that influenza HA has been purified successfully by chromatography before.
Claim(s) 16-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pushko et al. (WO2010077717A1), Wang et al. (20220135624) and Fiedler et al. (20240352076).
For claims 17, 20-22, and 25-30, Pushko et al. teach purifying RSV F with chromatography columns including TMAE (para 133) and lentil lectin affinity resin (Example 6) as well as multiple columns (example 6). For claims 23-24, Pushko et al. teach that the influenza can be RSV subtype B (para 82) and that tangential flow filtration can be used (para 127).
Pushko et al. do not teach Butyl-S resin hydrophobic interaction column or GP64 binding protein resin.
For claims 18 and 22, Wang et al. teach to remove contaminants and increase purity of viral proteins using HIC resin (butyl-S-Sepharose® Fast Flow). (para 234).
For claims 19 and 22, Fiedler et al. teach gp64 binding resins (para 135) and that they are particularly useful tools within the process of protein production (e.g. vaccine production) to provide for gp64 free samples. (abstract). One of ordinary skill in the art before the effective filing date would be motivated to add a GP64 binding resin to a method of purifying to make a better vaccine.
The level of skill in the art is high as evidenced by the purity of the isolated influenza HA at 98% as shown in Smith et al. Table 1 as well as the ability to choose multiple chromatography columns and filters to make the purified product. The order/placement of filtration steps can be determined from routine optimization.
It would have been prima facie obvious before the date of effective filing to choose from among art known columns to use in a method to purify influenza.
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, 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. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.").
Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Here, the only desired result is purified influenza HA and the level of skill in the art is able to achieve purified influenza and use chromatography in the method.
"[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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thus, it would have been prima facie obvious before the effective filing date to modify the columns of Pushko et al with the columns of Wang et al. and Fiedler et al. and optimize the columns and column and filter order to purify RSV F and have the expectation of success knowing that RSV F has been purified successfully by chromatography before.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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