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 .
Applicants amendment filed August 5, 2025 has been received and entered. Claims 6-7 have been canceled. Accordingly, claims 1-5, and 8-28 are pending in the instant application, of which claims 8-27 have been withdrawn from further consideration as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 102
1. The rejection of claim(s) 1-7 and 28 under 35 U.S.C. 102(a)(1) as being anticipated by He et al is withdrawn in view of Applicants amendment.
The following new grounds of rejection are applied to the amended claims:
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)(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.
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.
2. Claim(s) 1-5 and 28 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Burki et al.
The claims are drawn to a serotype 35B S. pneumoniae polysaccharide-protein conjugate comprising a 35B S. pneumoniae polysaccharide conjugated to a protein, the conjugate having a molecular weight of 1,000 kD to 7,000 kD, wherein the protein comprises CRM197 and wherein the polysaccharide-protein conjugate has a polysaccharide to protein mass ratio of from 0.5 to 2.0.
Burki et al (US Publication 2021/0346488, filed September 23, 2019, with priority to September 23, 2018) disclose of purified capsular polysaccharides from Streptococcus pneumoniae serotype 35B having an average molecular weight of between 50 kD and 1000 kD. (See claim 1). Burki et al further disclose of the polysaccharide conjugated to CRM197. (See claim 11). Burki et al further disclose of polysaccharide/protein ratios of about 0.5 to 2.0. (See claim 10). Burki et al further disclose of vaccine compositions. (See claim 10).
Applicants claimed range of 1000 kD to 7000 kD overlaps with the disclosure of Burki et al at 1000 kD. "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed range of compositions.). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
Alternatively, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
It is noted that Bruki et al do not characterize the lysine consumption of the polysaccharide-protein conjugate. However, a composition and its properties are inseparable. Therefore, if the prior art teaches the identical composition, (serotype 35B S. pneumoniae having a molecular weight of 1000 kD conjugated to CRM197) the properties applicant discloses and/or claims (lysine consumption of 4 mol/mol protein to 8 mol/mol protein) are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, the 1000 kD serotype 35B S. pneumoniae polysaccharide-protein conjugated to CRM197 as disclosed by Burki et al is deemed to anticipate/render obvious the instantly claimed 1000 kD S. pneumoniae 35B polysaccharide-protein conjugated to CRM197.
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.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 September 29, 2025