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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 12 March 2026, in which claim 1 is amended to change the scope and breadth of the claim, and claims 14-15 are amended to conform to amended claim 1.
This application is the national stage entry of PCT/IB2021/051330, filed 17 Feb 2021; claims benefit of provisional application 63/143,795, filed 30 Jan 2021; claims benefit of provisional application 63/068,338, filed 20 Aug 2020; and claims benefit of provisional application 62/980,134, filed 21 Feb 2020.
Claims 1-16 are pending in the current application. Claim 11, drawn to non-elected species, is withdrawn. Claims 1-10 and 12-16 are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 12 March 2026, with respect that claims 1, 4-6 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) has been fully considered and is persuasive, as amended claim 1 recites the method comprising a step of flocculation comprising the addition of a flocculating agent. Upon reconsideration, Yuan et al. does not disclose each and every limitation of the claimed invention.
This rejection has been withdrawn.
Applicant’s amendment, filed 12 March 2026, with respect that claims 1, 4-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) has been fully considered and is persuasive, as amended claim 1 recites the method comprising a step of flocculation comprising the addition of a flocculating agent. Upon reconsideration, Yuan et al. does not teach or fairly suggest each and every limitation of the claimed invention.
This rejection has been withdrawn.
Applicant’s amendment, filed 12 March 2026, with respect that claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) in view of US’090 (Bahler et al., US 7,659,090, issued 09 Feb 2010, of record) has been fully considered and is persuasive, as amended claim 1 recites the method comprising a step of flocculation comprising the addition of a flocculating agent. Upon reconsideration, Yuan et al. in view of US’090 does not teach or fairly suggest each and every limitation of the claimed invention.
This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 12 March 2026, with respect that claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) and further in view of Whittington (Applied Biochemistry and Biotechnology, 1990, vol 23, The Hurnana Press Inc., p91-121, of record) has been fully considered and is persuasive, as amended claim 1 recites the method comprising a step of flocculation comprising the addition of a flocculating agent, and Applicant’s remarks are persuasive that Yuan et al. teaches their invention does not include a step of chromatography. Upon reconsideration, Yuan et al. in view of Whittington alone does not provide motivation to modify the prior art method in a manner that would have arrived at a method including all features as claimed.
This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 12 March 2026, with respect that claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) and further in view of Whittington (Applied Biochemistry and Biotechnology, 1990, vol 23, The Hurnana Press Inc., p91-121, of record) as applied to claims 1, 4-6, 14, and 16 above, and further in view of Devesa-Rey et al. (Desalination, 2011, 280, p63-71, of record) has been fully considered and is persuasive, as amended claim 1 recites the method comprising a step of flocculation comprising the addition of a flocculating agent, and Applicant’s remarks are persuasive that Yuan et al. teaches their invention does not include a step of chromatography. Upon reconsideration, Yuan et al. in view of Whittington further in view of Devesa-Rey et al. alone does not provide motivation to modify the prior art method in a manner that would have arrived at a method including all features as claimed.
This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 12 March 2026, with respect that claims 1-3, 7-10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kowarik et al. (US 2015/0238588, published 27 Aug 2015, of record) in view of Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) has been fully considered and is persuasive, as amended claim 1 recites the method comprising a step of flocculation comprising the addition of a flocculating agent. Upon reconsideration, Kowarik et al. in view of Yuan et al. does not teach or fairly suggest each and every limitation of the claimed invention.
This rejection has been withdrawn.
The following are new grounds of rejection necessitated by Applicant’s amendment, filed 12 March 2026, in which claim 1 is amended to change the scope and breadth of the claim,
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.
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.
Amended Claims 1-2, 4-6, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shaligram et al. (BioProcess International, 2016, November Supplement, 6 pages, cited in PTO-892) in view of Santana et al. (Fraser-Reid et al., eds., Glycoscience: Chemistry and Chemical Biology, 2008, 2nd edition, volume 1, Springer-Verlag Berlin Heidelberg, pages 2699-2723, cited in PTO-892) and Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record).
Shaligram et al. teaches the general polysaccharide conjugate vaccine process includes steps following fermentation of centrifugation, secondary clarification, a first ultrafiltration/diafiltration, activated carbon filtration, filtration, another ultrafiltration/diafiltration, chromatography, and another ultrafiltration/diafiltration (page 1, figure 1). The polysaccharides of the vaccine are derived from bacteria such as Streptococcus pneumoniae (page 1, left column, paragraph 2; page 5, middle column, paragraphs 2-3). Adding a flocculating agent to a bioreactor before centrifugation can improve depth-filtration-based clarification (page 5, left column, paragraph 3). Shaligram et al. further teaches the use of ion-exchange chromatography in the general process (page 1, figure 1). Shaligram et al. teaches working examples of case studies at page 4, middle and right columns.
Shaligram et al. does not specifically disclose the method comprising a step of acid hydrolysis (claim 1).
Santana et al. teaches a review of the level of skill in the art regarding polysaccharide-based vaccines from bacteria (page 2699, abstract). The carbohydrate portion of bacterial cell wall glycoconjugate contains the major antigenic determinants that distinguish various serotypes of bacteria (page 2700, paragraph 1). In the design of a glycoconjugate vaccine, the selection of the polysaccharide size is actually dictated by the conjugation technology and the removal of free CPS from the final product rather than by immunological consideration. Molecular sizing of the polysaccharides can be seen as a simple and effective means to ensure consistency of the final conjugate vaccine (page 2707, paragraph 3). The methods for depolymerization more frequently employed are acid or enzymatic hydrolysis and ultrasonic irradiation. The mixture of fragments is separated into fractions of selected molecular sizes by methods such as ion exchange chromatography or gel filtration or ultrafiltration (page 2707, paragraph 5). In the example of Method D, the polysaccharide was hydrolyzed with acetic acid to fragments having between 5 and 15 repeating units (page 2710, paragraph 4).
Yuan et al. teaches a process for producing a solution containing substantially purified capsular polysaccharides from a cellular Streptococcus pneumoniae lysate broth (abstract). Yuan et al. teaches the embodiment of working example 1 of the method in which the carbon adsorption was changed to 2 CUNO R32SP carbon disks (column 11, line 15-25), suggesting the use of multiple activated carbon filters in series.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shaligram et al. in view of Santana et al. and Yuan et al. in order to modify the method of Shaligram et al. by addition of an acid hydrolysis step. It would have been obvious to one of ordinary skill in the art to combine the prior art steps taught by Shaligram et al. in view of Santana et al. and Yuan et al. to yield a predictable result because all of Shaligram et al., Santana et al., and Yuan et al. are drawn to methods for purification of bacterial polysaccharides for vaccine products, and Shaligram et al. teaches the general polysaccharides conjugate vaccine process involves the combination of purification steps with the expectation that each step in combination merely performs the same function as it does separately. Regarding claim 16, the cartoon illustration in Shaligram et al. depicts the activated carbon filtration as a stack of disks, suggesting multiple activated carbon filters in series such as taught by Yuan et al.
Regarding the order in which the claimed steps are performed, it is improper to read a specific order of steps into method claims where, as a matter of logic or grammar, the language of the method claims did not impose a specific order on the performance of the method steps, and the specification did not directly or implicitly require a particular order. See MPEP 2111.01 at II. In this case language of the method claims did not impose a specific order on the performance of the method steps and the specification does not clearly require a particular order. Further, even if the claimed “first” and “second” ultrafiltration/diafiltration steps c) and f) are interpreted to require the order of these steps rather than simply to clarify that steps c) and f) are separate steps, Yuan et al. teaches a first and second ultrafiltration/diafiltration step performed in this order.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 12 March 2026, have been fully considered and not found to be persuasive.
Regarding Applicant’s remarks concerning the teachings of Yuan et al., in the new grounds of rejection above Yuan et al. is relied upon to teach that it would have been obvious to one of ordinary skill in the art that the cartoon representation of activated carbon filtration depicted in Shaligram et al. would have been understood to represent a stack of carbon disks, or multiple activated carbon filters in series. See MPEP 2123 at I. providing ““The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983)” In this case the teachings of Yuan et al. are relied upon to teach how one of ordinary skill in the art would have understood the literature of the art, rather than what Yuan et al. describe as their own invention. Further, regarding Applicant’s remarks that Yuan et al. teaches away from a method including a chromatography step, Shaligram et al. teaches the general polysaccharide conjugate vaccine process includes multiple steps including a chromatography step, suggesting one of ordinary skill in the art would have looked to the state of the art taught by Shaligram et al. that the general process includes multiple steps and does not teach away from including a chromatography step.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shaligram et al. (BioProcess International, 2016, November Supplement, 6 pages, cited in PTO-892) in view of Santana et al. (Fraser-Reid et al., eds., Glycoscience: Chemistry and Chemical Biology, 2008, 2nd edition, volume 1, Springer-Verlag Berlin Heidelberg, pages 2699-2723, cited in PTO-892) and Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) as applied to claims 1-2, 4-6, 12, and 16 above, and further in view of US’090 (Bahler et al., US 7,659,090, issued 09 Feb 2010, of record).
Shaligram et al. in view of Santana et al. and Yuan et al. teaches as applied to claims 1-2, 4-6, 12, and 16 above.
Shaligram et al. in view of Santana et al. and Yuan et al. does not specifically the method wherein the acid hydrolysis step is performed at a temperature of 90°C or higher (claim 13).
US’090 teaches improved methods for the reduction or removal of protein impurities from a complex cellular Streptococcus pneumoniae lysate or concentrate comprising serotype 3 polysaccharides involving steps relating to post-lysis heating or pH adjustment. In certain methods, the lysate is heated for a time and at a temperature sufficient to denature proteins present in the lysate and cause their aggregation and precipitation. In one embodiment, the lysate is heated to at least 60° C for at least 30 minutes to cause protein aggregation and precipitation (abstract). Implementing a heating step for Streptococcus pneumoniae serotype 3 recovery was driven by a need to decrease the protein load before purification steps. Batches of purified polysaccharide were prone to batch failures due to residual protein levels above the set specification level of 5% w/w protein/polysaccharide (column 7, lines 25-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shaligram et al. in view of Santana et al. and Yuan et al. further in view of US’090 in order to select the optimal temperature of the acid hydrolysis step through routine experimentation. One of ordinary skill in the art would have been motivated to combine Shaligram et al. in view of Santana et al. and Yuan et al. further in view of US’090 with a reasonable expectation of success because both Shaligram et al. and US’090 are drawn to purification of Streptococcus pneumoniae polysaccharides which one of ordinary skill in the art would have understood to include removal of proteins present, and US’090 teaches heating in order to denature proteins present in the lysate and cause their aggregation and precipitation. See also MPEP 2144.05 at II.A. providing “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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” In this case US’090 teaches the general conditions of heating to at least 60° C in order to cause protein aggregation and precipitation, suggesting it would have been routine experimentation by one of ordinary skill in the art to discover the optimum or workable temperature range for this same purpose.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shaligram et al. (BioProcess International, 2016, November Supplement, 6 pages, cited in PTO-892) in view of Santana et al. (Fraser-Reid et al., eds., Glycoscience: Chemistry and Chemical Biology, 2008, 2nd edition, volume 1, Springer-Verlag Berlin Heidelberg, pages 2699-2723, cited in PTO-892) and Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) as applied to claims 1-2, 4-6, 12, and 16 above, and further in view of Whittington (Applied Biochemistry and Biotechnology, 1990, vol 23, The Humana Press Inc., p91-121, cited in PTO-892).
Shaligram et al. in view of Santana et al. and Yuan et al. teaches as applied to claims 1-2, 4-6, 12, and 16 above.
Shaligram et al. in view of Santana et al. and Yuan et al. does not specifically teach the flocculation agent is aluminum (claim 14).
Whittington teaches a review of fermentation broth clarification techniques. The process enabling technology of flocculation is also reviewed, since it is possible to enhance centrifugal separation efficiency using this technique (page 91, abstract). Broth clarification is one of the most essential and ubiquitous initial operations in the sequence of separation processes used to purify the products of modern fermentation-based biotechnology (page 91, paragraph 1). Whittington teaches a series of elementary tests describing the procedures needed to optimize a coagulation of flocculation process for a particle suspension prior to its incorporation in a clarification process scheme (page 95, paragraph 4). Whittington teaches coagulants used are usually a metal salt such as the aluminum salt alum or aluminum sulfate (page 96, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shaligram et al. in view of Santana et al. and Yuan et al. in view of Whittington in order to select the flocculating agent to be an aluminum coagulant. One of ordinary skill in the art would have been motivated to combine Shaligram et al. in view of Santana et al. and Yuan et al. in view of Whittington with a reasonable expectation of success because Shaligram et al. teaches adding a flocculating agent to a bioreactor before centrifugation can improve depth-filtration-based clarification, and Whittington teaches what was well known in the pertinent art regarding fermentation broth clarification in the context of purifying products of modern fermentation-based biotechnology, suggesting it would have been obvious to apply a well known process according to its intended purpose to yield a predictable result.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 12 March 2026, have been fully considered and not found to be persuasive.
Regarding Applicant’s remarks concerning the teachings of Yuan et al. in this new grounds of rejection are addressed as above.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shaligram et al. (BioProcess International, 2016, November Supplement, 6 pages, cited in PTO-892) in view of Santana et al. (Fraser-Reid et al., eds., Glycoscience: Chemistry and Chemical Biology, 2008, 2nd edition, volume 1, Springer-Verlag Berlin Heidelberg, pages 2699-2723, cited in PTO-892) and Yuan et al. (US 8,652,480, issued 18 Feb 2014, of record) as applied to claims 1-2, 4-6, 12, and 16 above, and further in view of Devesa-Rey et al. (Desalination, 2011, 280, p63-71, cited in PTO-892).
Shaligram et al. in view of Santana et al. and Yuan et al. teaches as applied to claims 1-2, 4-6, 12, and 16 above.
Shaligram et al. in view of Santana et al. and Yuan et al. does not specifically teach the method wherein the flocculation agent is calcium (claim 15).
Devesa-Rey et al. teaches calcium lactate is proposed as a coagulant-flocculant (page 63, abstract). Suspended materials are often removed with synthetic flocculants. Aluminum sulfate is one of the most efficient and widely used flocculants, although problems related to its toxicity have led to the development of new eco-friendly materials (page 63, left column, paragraph 2). Calcium lactate is proposed as a new eco-friendly flocculant and the optimal operational conditions required for efficient removal of the suspended solids are described therein (page 63, right column, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shaligram et al. in view of Santana et al. and Yuan et al. further in view of Devesa-Rey et al. in order to select the flocculating agent to be a calcium lactate coagulant. One of ordinary skill in the art would have been motivated to combine Shaligram et al. in view of Santana et al. and Yuan et al. further in view of Devesa-Rey et al. with a reasonable expectation of success because Shaligram et al. teaches adding a flocculating agent to a bioreactor before centrifugation can improve depth-filtration-based clarification, and Devesa-Rey et al. teaches calcium lactate as an improvement over the most widely used flocculant aluminum sulfate, suggesting it would have been obvious to apply a well known process according to its intended purpose to yield a predictable result.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 12 March 2026, have been fully considered and not found to be persuasive.
Regarding Applicant’s remarks concerning the teachings of Yuan et al. in this new grounds of rejection are addressed as above.
Amended Claims 1-10, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shaligram et al. (BioProcess International, 2016, November Supplement, 6 pages, cited in PTO-892) in view of Santana et al. (Fraser-Reid et al., eds., Glycoscience: Chemistry and Chemical Biology, 2008, 2nd edition, volume 1, Springer-Verlag Berlin Heidelberg, pages 2699-2723, cited in PTO-892) and Kowarik et al. (US 2015/0238588, published 27 Aug 2015, cited in PTO-892).
Shaligram et al. teaches as above. Shaligram et al. teaches the general polysaccharide conjugate vaccine process includes steps following fermentation of centrifugation, secondary clarification, a first ultrafiltration/diafiltration, activated carbon filtration, filtration, another ultrafiltration/diafiltration, chromatography, and another ultrafiltration/diafiltration (page 1, figure 1). The polysaccharides of the vaccine are derived from bacteria including but not limited to Streptococcus pneumoniae (page 1, left column, paragraph 2; page 3, table 2). Adding a flocculating agent to a bioreactor before centrifugation can improve depth-filtration-based clarification (page 5, left column, paragraph 3). Shaligram et al. further teaches the use of ion-exchange chromatography in the general process (page 1, figure 1).
Shaligram et al. does not specifically disclose the method comprising a step of acid hydrolysis (claim 1). Shaligram et al. does not specifically disclose the method comprising a chromatography step comprising both IEX membrane chromatography and HIC (claim 3). Shaligram et al. does not specifically disclose the polysaccharide is E. coli O polysaccharide O25B (claims 7-10).
Santana et al. teaches as above. Santana et al. teaches a review of the level of skill in the art regarding polysaccharide-based vaccines from bacteria (page 2699, abstract). In the example of Method D, the polysaccharide was hydrolyzed with acetic acid to fragments having between 5 and 15 repeating units (page 2710, paragraph 4).
Kowarik et al. teaches a novel E. coli O polysaccharide, O25B, and compositions, e.g., pharmaceutical compositions, comprising O25B and/or bioconjugates comprising O25B. Such compositions can be used as vaccines (abstract). Kowarik et al. teaches known methods for preparing the bioconjugates include extraction of antigenic polysaccharides/oligosaccharides from host cells, purifying the polysaccharides/oligosaccharides, chemically activating the polysaccharides/oligosaccharides, and conjugating the polysaccharides/oligosaccharides to a carrier protein (page 20, paragraph 194). The bioconjugates described herein can be purified generated library, or a library obtained by identifying and by any method known in the art for purification of a protein, for example, by chromatography (e.g., ion exchange, anionic exchange, affinity, and sizing column chromatography), centrifugation, differential solubility, or by any other standard technique for the purification of proteins (page 23, paragraph 214).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shaligram et al. in view of Santana et al. and Kowarik et al. in order to modify the method of Shaligram et al. by addition of an acid hydrolysis step, to combine known methods of chromatography such as taught by Kowarik et al., and to select the polysaccharide of the polysaccharide conjugate vaccine to be E. coli O polysaccharide O25B. It would have been obvious to one of ordinary skill in the art to combine the prior art steps taught by Shaligram et al. in view of Santana et al. and Kowarik et al.to yield a predictable result because all of Shaligram et al., Santana et al., and Kowarik et al. are drawn to methods for purification of bacterial polysaccharides for vaccine products, and Shaligram et al. teaches the general polysaccharides conjugate vaccine process involves the combination of purification steps with the expectation that each step in combination merely performs the same function as it does separately. Regarding claim 16, the cartoon illustration in Shaligram et al. depicts the activated carbon filtration as a stack of disks, suggesting multiple activated carbon filters in series. Regarding the selection of the polysaccharide to be E. coli O polysaccharide O25B, Shaligram et al. teaches the polysaccharides of the vaccine can be derived from various bacteria, and Kowarik et al. teaches it is desired to obtain O25B for use in a vaccine, suggesting one of ordinary skill in the art would have been motivated to perform the method in order to purify the O25B. Regarding claims 2-3, Kowarik et al. suggests these are chromatography methods are known to one of ordinary skill in the art, where the ordinary artisan would understand affinity to mean hydrophilic or hydrophobic interaction, and suggests a reasonable expectation of success to combine these known methods of purification according to their intended purpose to yield predictable results in this context.
Regarding the order in which the claimed steps are performed, it is improper to read a specific order of steps into method claims where, as a matter of logic or grammar, the language of the method claims did not impose a specific order on the performance of the method steps, and the specification did not directly or implicitly require a particular order. See MPEP 2111.01 at II. In this case language of the method claims did not impose a specific order on the performance of the method steps and the specification does not clearly require a particular order. Further, even if the claimed “first” and “second” ultrafiltration/diafiltration steps c) and f) are interpreted to require the order of these steps rather than simply to clarify that steps c) and f) are separate steps, Shaligram et al. teaches at least a first and second ultrafiltration/diafiltration step performed in the general process.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 12 March 2026, have been fully considered and not found to be persuasive.
Regarding Applicant’s remarks concerning the teachings of Kowarik et al., in the new grounds of rejection above Kowarik et al. is relied upon to teach the general level of knowledge in the art of purifications relevant to purification of polysaccharide conjugate vaccines, and that it would have been obvious to one of ordinary skill in the art to select the polysaccharide of the polysaccharide conjugate vaccine to be E. coli O polysaccharide O25B. In this case Shaligram et al. teaches the polysaccharides of the vaccine are derived from various bacteria, and teaches the general process for preparing or purifying such polysaccharides conjugate vaccines, and Kowarik et al. teaches it is desired to prepare such a vaccine including the E. coli O polysaccharide O25B. See MPEP 2123 at I. providing ““The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983)” In this case the teachings of Kowarik et al. are relied upon to teach what polysaccharide one of ordinary skill in the art would have been motivated to purify according to the general process of Shaligram et al., and the general level of knowledge, rather than what Kowarik et al. describe as their own invention.
Conclusion
No claim is found to be allowable.
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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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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