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 .
CONTINUING DATA
This application is a 371 of PCT/US21/19364 02/24/2021
PCT/US21/19364 has PRO 62/981,288 02/25/2020
This office action is in response to Applicant’s amendment submitted February 12, 2026. Claims 1, 3, 7, 11, 14, 16-17, and 19 are pending.
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.
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.
Claim(s) 1, 3, 7, 11, 14, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Marburg (US 5,623,057) in view of Lander (Biotechnol. Prog., 2000, 16, pp. 80-85, cited on IDS).
Marburg discloses a novel conjugate vaccine comprising partially
hydrolyzed, highly purified, capsular polysaccharide (Ps) from Streptococcus
pneumoniae bacteria (pneumococci, Pn) linked to an immunogenic carrier protein
(abstract). The polysaccharide is prepared by a) isolating crude pneumococcal polysaccharide, Pn-Ps; b) partially-hydrolyzing or mechanically-shearing the crude Pn-
Ps; and c) fractionating the partially-hydrolyzed Pn-Ps according to size and purity
(column 13, lines 5-10). The partial-hydrolysis is accomplished by a limited thermal
treatment in an aqueous medium. In a preferred embodiment, the Pn-Ps is subjected to
physical shear by passage through a homogenizer (step i)). A target endpoint of hydrolysis is
measured by solution viscosity or high-performance size exclusion chromatography
(HPSEC) (steps ii) and iii)) (column 14, lines 35-60). Marburg et al. discloses the working example in which a concentrated solution of Pn-Ps in water was prepared, CaCl₂ was added to the solution, and passed through a Gaulin homogenizer. The sheared Pn-Ps was
precipitated and filtered to recover the Pn-Ps. The Pn-Ps was resuspended and
analyzed for molecular size and polydispersity by HPSEC (example 10 at column 35,
line 55 to column 36, line 20).
Marburg et al. does not specifically disclose step iv), subjecting a subsequent sample of the aqueous solution from step I to steps ii, iii, and iv. Marburg et al. does not specifically disclose the method is carried out for a total time of from about 1 hour to about 6 hours (claim 16). Marburg et al. does not specifically disclose the method where the transferring of step ii is repeated at 2 second intervals (claim 17). Marburg et al. does not specifically disclose an “on-line method” as recited in claim 1. The current specification states that “on-line” means that batch samples are taken as part of an inline process and measured during the size-reduction process.
Lander teaches study of the breakage pattern of polysaccharides as
a model shear-sensitive compound in a Gaulin homogenizer characterized by molecular
size and polydispersity (page 80, abstract). Capsular polysaccharide 19F (Figure 1), derived from Streptococcus pneumonia was used in the investigation (page 80,
paragraph spanning left and right columns). Homogenization recycle experiments were
performed to study free radical formation, in which samples were taken from
the feed tank at predefined intervals (page 81, paragraph spanning left and right
columns, and figure 2). This meets the limitation “on-line” since the samples are measured during the size-reduction process. The recycle experiments showed reduction of the
polysaccharide molecular size across up to 10 passes (page 82, figure 5). The recycle
experiments were performed up 100 minutes (page 82, figures 3 and 4).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to combine Marburg et al. in view of Lander et al. to
repeat the homogenization process, to select the predefined intervals in which samples
are taken for analysis through routine experimentation, or to perform the measuring
continuously. One of ordinary skill in the art would have been motivated to combine
Marburg et al. in view of Lander et al. with a reasonable expectation of success
because both Marburg et al. and Lander et al. are drawn to size reduction of a capsular
polysaccharide using a Gaulin homogenizer, and Lander et al. teaches repeating the
homogenization process is predicted to reduce the polysaccharide molecular size.
Regarding the intervals in which samples are taken for analysis, Lander et al. teaches
the samples can be taken from the feed tank at predefined intervals. See also MPEP
2144.05 at II.A. provides "[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) In this case the combined teachings of Marburg et al. in view of Lander et al. suggest it would have been routine experimentation to determine the optimal or workable sampling intervals to measure the polysaccharide molecular size reduction. Regarding performing the measuring continuously, Marburg et al. further teaches monitoring relative analyte concentration as a function of elution volume, and it would have been obvious to one of ordinary skill in the art to perform the monitoring as a continuous operation in light of the batch or aliquot sampling process of the prior art. See MPEP 2144.04 at V.E.
Response to Arguments
Applicant argues that neither Marburg and Lander include real-time monitoring of polysaccharide size during the size-reduction process. This argument is not persuasive because the claims are amended to require an on-line process. The current specification states that “on-line” means that batch samples are taken as part of an inline process and measured during the size-reduction process. Lander teaches that homogenization is carried out while samples are taken from the feed tank at predefined intervals, so Lander appears to teach real-time monitoring of polysaccharide size during the size-reduction process.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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