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 .
Priority
This application is a 371 of PCT/IB2020/051430 02/20/2020 which claims benefit of provisional application 62/808,907 02/22/2019.
Claim Status
The claim set and Applicant’s remarks filed on June 05, 2026 have been entered.
Claims 2, 6-27 and 38-41 are canceled.
Claims 44-47 are new.
Thus, claims 1, 3-5, 28-37 and 42-47 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on January 05, 2026:
(I) The objection to claims 1 and 33 are withdrawn in view of Applicant’s amendment to these claims.
(II) The rejection of claims 1, 3-5 and 28-43 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of Applicant’s amendment to claim 1.
(III) The rejection of claims 1, 3-5 and 28-43 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to claim 1.
(IV) The provisional rejection of claims 1, 3-5 and 28-43 on the ground of nonstatutory double patenting of copending Application No. 17/799,992 is withdrawn in view of Applicant’s arguments on pg. 10, paragraph 1, which are found persuasive.
Response to Arguments
The objection to claim 43 is maintained as Applicant has not yet resolved the objection at issue as discussed below.
Furthermore, after reviewing and considering the amended claims, including the newly added limitation of “after addition of said aluminum salt, the solution is maintained at a temperature range from 38°C to 80°C”, required in the last two lines of claim 1, the Examiner notes new 103 rejections necessitated by this amendment have been made below.
Claim Objections
Claim 43 remains objected to because of the following informalities:
Claim 43, last line of the claim, recites “34,35B” which is clearly missing a blank space between the comma and the phrase “35B”.
Thus, to promote clarity the Examiner suggests inserting said blank space as discussed above.
Appropriate correction is required.
New Claim Rejection
The following is a modified rejection necessitated by Applicant's amendment, filed on June 05, 2026, where the limitations in pending claims 1, 3-5, 28-37 and 41-42 as amended now have been changed and claims 44-47 have been newly added.
Therefore, the rejection from the previous Office Action, dated January 05, 2026, has been modified and is listed below.
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.
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.
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.
Claims 1, 3-5, 28-37 and 42-47 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (Published 10 November 2016, US-20160324949-A1, PTO-892 mailed 05/21/2024) in view of Noyes et al. (Published 28 February 2015, Biotechnology and Bioengineering, Vol, 112, Issue 6, pp. 1154-1567, PTO-892) and Seal et al. (Published Sep.-Oct. 1941, The Journal of Infectious Diseases, Vol. 69, No 2, pp. 102-107, PTO-892 mailed 03/11/2025).
Han teaches isolated Streptococcus pneumoniae serotype 15B capsular polysaccharide (e.g. the bacterial capsular polysaccharide, required in claim 1, line 1 and claim 43) and processes for their preparation, see abstract; wherein the process comprises the steps of, see paragraph [0011]; (a) preparing a fermentation culture of Streptococcus pneumoniae serotype 15B bacterial cells, see paragraph [0012], the fermentation was a broth (e.g. a solution, required in claim 1, line 3), inactivated by the addition of N-lauroyl sarcosine and purified by ultrafiltration and diafiltration, see paragraph [0249]; (b) lysing the bacterial cells in said fermentation culture (e.g. the bacterial capsular polysaccharide and one or more contaminants, required in claim 1, lines 3-4), see paragraph [0013]; and (c) purifying Streptococcus pneumoniae serotype 15B capsular polysaccharide from the fermentation culture, see paragraph [0014], see paragraph [0015].
Han teaches the temperature of step (c) purifying Streptococcus pneumoniae serotype 15B capsular polysaccharide is maintained between 15°C and 45°C, where the Examiner notes 45°C is within the range required in claims 34-35 and 45-46, see paragraph [0115].
Han teaches the duration of step (c) is between 0.1 hr (i.e. 6 min) to 10 hrs (e.g. the time duration, required in claim 36), see paragraph [0114].
Han teaches the serotype 15B polysaccharide may then be isolated from the cell lysate using purification techniques known in the art, including the use of centrifugation (e.g. centrifugation, required in claim 37) and depth filtration (e.g. depth filtration required in claim 44), see paragraph [0046].
Although, Han does not expressly disclose using a flocculating agent (present claims 1, 3, 4, 5, 28-29, 33 and 36). Han also does not expressly disclose adjusting the pH to 5 or less (present claims 30-33); or the temperature is maintained at 50°C (present claim 47).
However, in the same field of endeavor of purifying bacterial polysaccharides, Noyes teaches particle conditioning operations and method development, see pg. 1554, title.
Noyes teaches a typical particle conditioning sequence is flocculation followed by centrifugation and filtration, see pg. 1554, right column, introduction, paragraph 1.
Noyes teaches the principal objectives of flocculation have typically been the removal of solids and impurities through the formation of larger particulates, where higher resolution purification from impurities such as and including protein have also been achieved. Common flocculation agents include salts (e.g. aluminum salts, required in claim 1, lines 8-9). See pg. 1554, right column, last paragraph – pg. 1555, left column, first paragraph.
Noyes teaches flocculations of fermentation growth were performed with 2% floc agent (e.g. the concentration of aluminum salt, required in claims 5, 28-29 and 33), at pH 4.0 (e.g. the pH, required in claims 30-33) with ten pneumococcal serotypes, where the individual wells were agitated for 1 hr before centrifugation and subsequent sampling of the supernatant, see pg. 1558, reproducibility, paragraph 1.
Noyes teaches the ten pneumococcal serotypes are of bacterial capsular polysaccharides from Streptococcus pneumoniae, see pg. 1556, left column, materials, paragraph 2.
Although, Noyes does not exemplify the salt is an aluminum salt as required by the instant claims.
However, in the same field of endeavor of flocculating agents, Seal teaches studies on the purification of alum-precipitated diphtheria toxoid, see pg. 102, title. Seal teaches precipitation with sodium alum, wherein the sodium salt (Na2SO4, Al2(SO4)3, 24H2O) (e.g. the aluminum salt, required in claims 3-4) was used instead of the usual potassium salt, see pg. 102, right column, paragraph 2, lines 1-3.
Seal teaches the required volume of alum was added in the form of a 10% solution to the untreated or the treated toxoids and the mixtures allowed to stand in the incubator at 37°C for one-half to 1 hour and overnight in the cold room, see pg. 102, right column, paragraph 2, lines 1-3.
Seal teaches different concentrations of alum and at various pH values, for example, Seal teaches an alum concentration at 2% and pH 4.0, see pg. 103, Table 1, last row of the table.
The Examiner notes the concentration of the flocculating agent and the pH of the solution taught by Seal as discussed above are consistent with the exemplification of the floc conditions as taught by Noyes above.
Accordingly, it would have been prima facie obvious before the invention’s effective filing date to have added the sodium alum, wherein the sodium salt is (Na2SO4, Al2(SO4)3, 24H2O) as taught by Seal as the flocculating agent, because Noyes teaches flocculating agents are commonly salts, as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to include the sodium alum as taught by Seal, because Seal teaches sodium alum as a flocculant under corresponding concentration and pH conditions as taught by Noyes. One of ordinary skill in the art would have had a reasonable expectation of success of incorporating the teachings of Seal into the teachings of Noyes, because Noyes teaches salts are common flocculating agents as discussed above.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the invention’s effective filing date to have incorporated the teachings of both Noyes and Seal into the method of Han above, as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results, because Noyes teaches flocculation of the ten pneumococcal serotypes are of bacterial capsular polysaccharides from Streptococcus pneumoniae and where flocculation via flocculating agents, which are commonly salts, have been successfully used for purification by removing impurities, such as proteins; and wherein the Examiner notes Han is drawn to isolation via purification of Streptococcus pneumoniae serotype 15B capsular polysaccharide from a cell lysate; and thus one of ordinary skill in the art would have been particularly motivated to include said teachings of Noyes and Seal in order to isolate the bacterial capsular polysaccharides from the Streptococcus pneumoniae of Han.
One of ordinary skill in the art would have had reasonable expectation of success of including the teachings of Noyes and Seal into the method of Han above, because Noyes teaches a typical particle conditioning sequence is flocculation followed by centrifugation and filtration; and Han teaches the serotype 15B polysaccharide may then be isolated from the cell lysate using purification techniques known in the art, including the use of centrifugation and depth filtration as discussed above.
With respect to the sequence of purification steps recited in present claim 1, lines 6-7, where the liquid is separated and then purified as recited in claim 1, lines 6-7, it would have been within the scope of the artisan through routine experimentation and optimization to separate the flocculated material taught by the combination of Han, Noyes and Seal and have arrived at the claimed invention required in claim 1, lines 6-7 as Han already teaches the purification methods of centrifugation and depth filtration in purifying the Streptococcus pneumoniae serotype 15B polysaccharide as discussed above. See MPEP 2144.04, section IV, C. “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”.
One of ordinary skill in the art would have had a reasonable expectation of success to incorporate the purification steps in present claim 1, lines 6-7 into the method of Han, as Han is drawn to using centrifugation and depth filtration in isolating via purification the Streptococcus pneumoniae serotype 15B capsular polysaccharide as discussed above.
Moreover, the Examiner notes present claim 37 recites separating the liquid by centrifugation; and present claim 44 recites purifying the liquid by depth filtration.
With respect to the limitation “the solution is maintained at a temperature ranging from about 50°C”, required in claim 47, the Examiner notes Han’s teaching of purifying Streptococcus pneumoniae serotype 15B capsular polysaccharide where the temperature is maintained at 45°C as discussed above corresponds to “about 50°C” as required in present claim 47 as evidenced by the instant specification which defines “about” to mean a statistically meaningful range such as a stated temperature, where such range can be within an order of magnitude (see pg. 150, lines 15-30).
Furthermore, MPEP 2144.05 (II)(A) states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical, "[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".
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the teachings of Noyes and Seal into the method of Han as discussed above as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to isolate the Streptococcus pneumoniae serotype 15B capsular polysaccharide via purification as taught by Han. One of ordinary skill in the art would have had a reasonable expectation of success of incorporating the teachings of Noyes and Seal into the method of Han, because Noyes teaches use of a flocculating agent in flocculations with ten pneumococcal serotypes of bacterial capsular polysaccharides from Streptococcus pneumoniae; where Noyes teaches salts as common flocculating agents; and Seal’s purification method of bacterial fermentation broths includes the use of sodium alum, wherein the sodium salt is (Na2SO4, Al2(SO4)3, 24H2O) as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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