Prosecution Insights
Last updated: August 12, 2026
Application No. 17/929,700

METHOD FOR MONITORING STABILITY OF POLYSACCHARIDE-PROTEIN CONJUGATE VACCINES

Non-Final OA §103§112
Filed
Sep 04, 2022
Priority
Sep 04, 2021 — IN 202121040146
Examiner
VARMA, AKASH K
Art Unit
1773
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Serum Institute Of India Pvt Ltd.
OA Round
1 (Non-Final)
66%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allowance Rate
383 granted / 579 resolved
+1.1% vs TC avg
Strong +34% interview lift
Without
With
+34.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
28 currently pending
Career history
607
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
46.0%
+6.0% vs TC avg
§102
10.9%
-29.1% vs TC avg
§112
34.9%
-5.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 579 resolved cases

Office Action

§103 §112
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 . Status of Claims Claims 1-3, 5-14, 16-23, 26-28 and 30-32 are currently pending Claims 4, 15, 24-25 and 29 are currently withdrawn from consideration Claims 5, 16, 23 and 26-27 are currently amended Claims 1-3, 5-14, 16-23, 26-28 and 30-32 are currently rejected Information Disclosure Statement The Information Disclosure Statement filed on 09/30/2023 is in compliance with the provisions of 37 CFR 1.97 and has been considered. An initialed copy of the Form 1449 is enclosed herewith. Election/Restrictions Applicant's election with traverse of species restriction (containing claims 1-3, 5-14, 16-23, 26-28 and 30-32) in the reply filed on 12/23/2025 is acknowledged. The traversal is on the ground(s) that the restricted inventions are not independent inventions and that examination of both claimed invention together would not present a serious burden on the U.S. Patent and Trademark Office. This is not found persuasive because the issue as to the meaning and intent regarding “independent and distinct” as used in 35 U.S.C 121 and 37 CFR 1.41 has been adequately addressed in MPEP §802.01. Therein, it is stated that the legislative intent was to maintain the substantive law on the subject of restriction practice prior to enactment of 35 USC 121. Such practice permitted restriction between distinct, albeit dependent inventions. If the intent had been otherwise, then only the term “independent” would have been used. Thus, restriction between the distinct inventions set forth in this application is proper even though these inventions are clearly related. With regard to applicants allegation that joinder of these distinct inventions would not present a serious burden to the U. S. Patent and Trademark Office, such allegations relied on the unsupported assumption that the search and the examination of both the invention would be coextensive. However, the issues raised in the examination of apparatus claims are divergent from those raised in the examination of process claims. Further, while there may be some overlap in the searches of the two inventions, there is no reason to believe that the searches would be identical. Therefore, based on the additional work involved in searching and examining both distinct inventions together, restriction of the distinct inventions is clearly proper. The requirement is still deemed proper and is therefore made FINAL. Claim Objections Claim 1 is objected to because of the following informalities: Line 1 states “the stability” and instead should state “a stability” for further clarity. FURTHERMORE, lines 4 and 7 each state “the said” and instead should either recite “the” or “said” not both. Appropriate corrections are required. Claim 3 is objected to because of the following informalities: Line 2 states “of polysaccharide-protein conjugate vaccine” and instead should state “of the polysaccharide-protein conjugate vaccine” for further clarity. Appropriate correction is required. Claim 5 is objected to because of the following informalities: Line 2 states “of polysaccharide-protein conjugate vaccine in pre-treatment step” and instead should state “of the polysaccharide-protein conjugate vaccine in the pre-treatment step” for further clarity. Appropriate correction is required. Claim 7 is objected to because of the following informalities: Lines 1-3 state “wherein the arrangement of columns is guard column followed by first column, first column followed by second column and second column followed by third column.” and instead should state “wherein an arrangement of the set of three chromatography columns is the guard column followed by first chromatography column, the first chromatography column followed by second chromatography column and the second chromatography column followed by third chromatography column.” for further clarity. Appropriate correction is required. Claim 9 is objected to because of the following informalities: Lines 1-2 state “of guard column” and instead should state “of the guard column” for further clarity. Appropriate correction is required. Claim 10 is objected to because of the following informalities: Line 2 states “and third chromatography column” and instead should state “the third chromatography column” for further clarity. Appropriate correction is required. Claim 11 is objected to because of the following informalities: Lines 1-2 state “of first column…of second column…of third column” and instead should state “of the first chromatography column…of the second chromatography column…of the third chromatography column” for further clarity. Appropriate correction is required. Claim 13 is objected to because of the following informalities: Lines 1-2 state “and chromatography columns in series” and instead should state “and the set of three chromatography columns in series” for further clarity. Appropriate correction is required. Claim 14 is objected to because of the following informalities: Line 1 states “the detector” and instead should state “the detectors” for further clarity. Appropriate correction is required. Claim 17 is objected to because of the following informalities: Line 2 states “in the range” and instead should state “in a range” for further clarity. Appropriate correction is required. Claim 22 is objected to because of the following informalities: Lines 1-2 state “in the form of high molecular weight, average molecular weight and low molecular weight.” and instead should state “in a form of the high molecular weight, the average molecular weight and the low molecular weight.” for further clarity. Appropriate correction is required. Claim 23 is objected to because of the following informalities: Line 1 states “the polysaccharide is” and instead should state “the polysaccharide-protein conjugate vaccine is” for further clarity. Appropriate correction is required. Claim 26 is objected to because of the following informalities: Line 1 states “the polysaccharide is” and instead should state “the polysaccharide-protein conjugate vaccine is” for further clarity. Appropriate correction is required. Claim 31 is objected to because of the following informalities: Lines 2-3 state “the range from…average molecular weight is in the range…and low molecular weight is in the range…” and instead should state “a range from…the average molecular weight is in a range…and the low molecular weight is in a range…” for further clarity. Appropriate correction is required. Claim 32 is objected to because of the following informalities: Lines 2-3 state “the range from…average molecular weight is in the range…and low molecular weight is in the range…” and instead should state “a range from…the average molecular weight is in a range…and the low molecular weight is in a range…”. 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 1-3, 5-14, 16-23, 26-28 and 30-32 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. Claim 1 recites the limitation "the distribution of the molecules” on lines 7-8, and “the percentage” on line 10. There is insufficient antecedent basis for these limitations in the claim. Claims 2-3, 5-14, 16-23, 26-28 and 30-32 are also rejected since these claims depend on claim 1. Claim 11 recites the limitation "in claims 7 and 10,” on line 1. A claim cannot depend on multiple dependent claims. Claim 12 recites the limitation "the length” on line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 31 recites the limitation "in claims 1 and 30,” on line 1. A claim cannot depend on multiple dependent claims. Claim 32 recites the limitation "in claims 1 and 30,” on line 1. A claim cannot depend on multiple dependent claims. 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. 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. Claims 1-3, 5-14, 16-23, 26-28 and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Manolya Saydam et al. (‘Immunogenicity and thermal stability of a combined vaccine against Haemophilus influenzae type b and Neisseria meningitidis serogroup C diseases’) (hereinafter “Manolya”) (see attached document) in view of Nitya Sharma et al. (‘Evaluation of impact of temperature and pH alterations on the size and antigenicity of meningococcal serogroup A and X polysaccharides and conjugates’) (hereinafter “Nitya”) (see attached document). Regarding Claim 1: Manolya teaches a method for determining a stability of a polysaccharide-protein conjugate vaccine (see 1. Introduction) (see 2.2. Thermal stability study) (see 2.7. Molecular sizing chromatography) (see 3.3. Thermal stability of vaccine), said method comprising the following steps: a) subjecting the said polysaccharide-protein conjugate vaccine to a high-performance size exclusion chromatography (HPLC-SEC) (see 2.7. Molecular sizing chromatography) using a mobile phase and chromatography columns in series to obtain an eluate (see FIGS. 1-3) (see 2.7. Molecular sizing chromatography); b) passing the said eluate through detectors and evaluating the eluate to obtain the distribution of the molecules with respect to molecular weight (see 2.7. Molecular sizing chromatography further discussing UV detector and refractive index detector); and c) analysing the molecular weight to obtain molecular size and/or molar mass profile of the polysaccharide-protein conjugate vaccine based on the percentage of high molecular weight (HMW), average molecular weight (AMW) and low molecular weight (LMW) molecules (see 2.7. Molecular sizing chromatography) (see 2.8. Saccharide determination) (see 3.1. Characterization of combination vaccine) (see 3.3. Thermal stability of vaccine). Although Manolya teaches a chromatography column and a guard column, Manolya does not explicitly teach a set of three chromatography columns in series, as recited in independent claim 1. Nitya further teaches a similar system and method including multiple columns in series along with a guard column (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 2: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches a pre-treatment step is carried out before step a) (see Manolya 2.1. Vaccines regarding saline as a buffer) (see Manolya 2.4. Determination of polysaccharide antibodies regarding phosphate buffered saline). Regarding Claim 3: The combination of Manolya in view of Nitya teaches the method as claimed in claim 2, wherein Manolya further teaches the pre-treatment step comprises of reconstitution of polysaccharide-protein conjugate vaccine using a buffer (see Manolya 2.1. Vaccines regarding saline as a buffer) (see Manolya 2.4. Determination of polysaccharide antibodies regarding phosphate buffered saline). Regarding Claim 5: The combination of Manolya in view of Nitya teaches the method as claimed in claim 3, wherein Manolya further teaches the buffer used for reconstitution of polysaccharide-protein conjugate vaccine in pre-treatment step is Tris buffer (see Manolya 2.1. Vaccines regarding saline as a buffer) (see Manolya 2.4. Determination of polysaccharide antibodies regarding phosphate buffered saline). Although Manolya teaches a phosphate buffered saline, it would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to substitute the phosphate buffer saline with Tris buffer, as modified by Nitya, for optimization purposes (see Manolya 2.1. Vaccines regarding saline as a buffer) (see Manolya 2.4. Determination of polysaccharide antibodies regarding phosphate buffered saline). Regarding Claim 6: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Nitya further teaches the set of three chromatography columns in series is connected with a guard column (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 7: The combination of Manolya in view of Nitya teaches the method as claimed in claim 6, wherein Nitya further teaches the arrangement of columns is guard column followed by first column, first column followed by second column and second column followed by third column (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 8: The combination of Manolya in view of Nitya teaches the method as claimed in claim 6, wherein Nitya further teaches the guard column comprises polymer based packed material having particle size 9 - 14 µm (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 9: The combination of Manolya in view of Nitya teaches the method as claimed in claim 8, wherein Nitya further teaches the polymer based packed material of guard column comprises polyhydroxymethacrylate based material (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 10: The combination of Manolya in view of Nitya teaches the method as claimed in claim 7, wherein Nitya further teaches the first and second chromatography columns comprises polyhydroxymethacrylate based material and third chromatography column is selected from hydroxylated polymethacrylate based material and hydrophilic vinyl polymer-based material (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 11: The combination of Manolya in view of Nitya teaches the method as claimed in claims 7 and 10, wherein Nitya further teaches particle size of first column is 34 - 36 µm, particle size of second column is 12 - 14 µm and particle size of third column is 9 - 14 µm (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 12: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Nitya further teaches the length of the set of three chromatography columns in series ranges from 85 - 95 cm (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 13: The combination of Manolya in view of Nitya teaches the method as claimed in claim 6, wherein Nitya further teaches the guard column and chromatography columns in series are connected using a connector (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Manolya and Nitya are analogous inventions in the art of teaching a system and method for determining a stability of a conjugate vaccine. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the method of Manolya to further include multiple (three) chromatography columns connected in series, as taught by Nitya, for optimization purposes and to effectively and efficiently allow an eluent to pass through (see Nitya 1. Introduction page 966) (see Nitya 2.4. HPSEC analyses regarding multiple columns in series and in connection with a guard column). Regarding Claim 14: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the detector in step b) is selected from UV detector, refractive index (RI) detector and multiangle light scattering (MALS) detector and combinations thereof (see Manolya 2.7. Molecular sizing chromatography further discussing UV detector and refractive index detector). Regarding Claim 16: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the mobile phase is a phosphate buffer saline having pH ranging from 7.2 to 7.5, preferably pH 7.4 (see Manolya 2.1. Vaccines regarding saline as a buffer) (see Manolya 2.4. Determination of polysaccharide antibodies regarding phosphate buffered saline) (see Manolya 2.6. PH determination). Regarding Claim 17: The combination of Manolya in view of Nitya teaches the method as claimed in claim 16, wherein Manolya further teaches the phosphate buffer saline comprises of sodium chloride in the range of 20 to 40 g, preferably 23.38 g (see Manolya 2.1. Vaccines regarding saline as a buffer) (see Manolya 2.4. Determination of polysaccharide antibodies regarding phosphate buffered saline) (see Manolya 2.6. PH determination). Regarding Claim 18: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the high performance size exclusion chromatography (HPLC-SEC) in step a) comprises a flow rate ranging from 0.1 to 1 ml per minute, preferably 0.30 to 0.80 ml per minute (see Manolya FIGS. 1-3) (see Manolya 2.7. Molecular sizing chromatography) (see Manolya 2.8. Saccharide determination). Regarding Claim 19: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the high performance size exclusion chromatography (HPLC-SEC) in step a) comprises a column temperature ranging from 25°C to 35°C (see Manolya FIGS. 1-3) (see Manolya 2.7. Molecular sizing chromatography) (see Manolya 2.8. Saccharide determination). Regarding Claim 20: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the high performance size exclusion chromatography (HPLC-SEC) in step a) comprises injection run time ranging from 60 - 70 min (see Manolya FIGS. 1-3) (see Manolya 2.7. Molecular sizing chromatography) (see Manolya 2.8. Saccharide determination). Regarding Claim 21: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the polysaccharide-protein conjugate vaccine is in liquid form or lyophilized form (see Manolya 2.2. Thermal stability study). Regarding Claim 22: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the molecular weight is obtained in the form of high molecular weight, average molecular weight and low molecular weight (see Manolya FIGS. 1-3) (see Manolya 2.7. Molecular sizing chromatography) (see Manolya 3.1. Charaterization of combination vaccine) (see Manolya 3.3. Thermal stability of vaccine). Regarding Claim 23: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the polysaccharide is a bacterial capsular polysaccharide, and is obtained from group Neisseria meningitidis (see Manolya 2.1. Vaccines). Regarding Claim 26: The combination of Manolya in view of Nitya teaches the method as claimed in claim 21, wherein Manolya further teaches the polysaccharide is selected from Neisseria meningitidis serotypes A, C, Y, W135 and X (see Manolya 2.1. Vaccines). Regarding Claim 27: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the polysaccharide-protein conjugate vaccine consists of a carrier protein is selected from CRM197, tetanus toxoid (TT) and combinations thereof (see Manolya 2.1. Vaccines). Regarding Claim 28: The combination of Manolya in view of Nitya teaches the method as claimed in claim 1, wherein Manolya further teaches the polysaccharide-protein conjugate vaccine is a multivalent vaccine (see Manolya 2.1. Vaccines) (see Manolya 2.7. Molecular sizing chromatography). Regarding Claim 30: The combination of Manolya in view of Nitya teaches the method as claimed in claim 28, wherein Manolya further teaches the multivalent vaccine comprises of Neisseria meningitidis serotype A - TT conjugate, Neisseria meningitidis serotype X – TT conjugate, Neisseria meningitidis serotype C - CRM197 conjugate, Neisseria meningitidis serotype Y - CRM197 conjugate and Neisseria meningitidis serotype W - CRM197 conjugate (see Manolya 2.1. Vaccines) (see Manolya 2.7. Molecular sizing chromatography). Regarding Claim 31: The combination of Manolya in view of Nitya teaches the method as claimed in claims 1 and 30, wherein Manolya further teaches the high molecular weight is in the range from 13000 kDa to 19000 kDa, average molecular weight is in the range of 2000 kDa to 11000 kDa and low molecular weight is in the range of 200 kDa to 2000 kDa for lyophilized polysaccharide-protein conjugate vaccine (see Manolya 2.1. Vaccines) (see Manolya 2.7. Molecular sizing chromatography) (see Manolya 2.8. Saccharide determination) (see Manolya 3.3. Thermal stability of vaccine page 6231). Regarding Claim 32: The combination of Manolya in view of Nitya teaches the method as claimed in claims 1 and 30, wherein Manolya further teaches the high molecular weight is in the range from 10000 kDa to 19000 kDa, average molecular weight is in the range of 1000 kDa to 10000 kDa and low molecular weight is in the range of 200 kDa to 1000 kDa for liquid polysaccharide-protein conjugate vaccine (see Manolya 2.1. Vaccines) (see Manolya 2.7. Molecular sizing chromatography) (see Manolya 2.8. Saccharide determination) (see Manolya 3.3. Thermal stability of vaccine page 6231). Other References Considered Smith et al. (U.S. 2019/0192648 A1) (hereinafter “Smith”) teaches compositions comprising polysaccharide-protein conjugates and methods of use. Fang Gao et al. (‘A physico-chemical assessment of the thermal stability of pneumococcal conjugate vaccine components’) (hereinafter “Fang”) (see attached document). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to AKASH K. VARMA whose telephone number is (571)272-9627. The examiner can normally be reached Monday-Friday 9-5 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin L. Lebron can be reached at (571)-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AKASH K VARMA/Primary Examiner, Art Unit 1773
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Prosecution Timeline

Sep 04, 2022
Application Filed
May 12, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
66%
Grant Probability
99%
With Interview (+34.5%)
3y 2m (~0m remaining)
Median Time to Grant
Low
PTA Risk
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