Prosecution Insights
Last updated: April 19, 2026
Application No. 17/965,573

GLYCOLIPID COMPOSITIONS AND METHODS OF USE

Final Rejection §103§DP
Filed
Oct 13, 2022
Examiner
CREWS, JARET JAMES
Art Unit
1691
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
President and Fellows of Harvard College
OA Round
2 (Final)
47%
Grant Probability
Moderate
3-4
OA Rounds
3y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allow Rate
34 granted / 72 resolved
-12.8% vs TC avg
Strong +70% interview lift
Without
With
+69.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
67 currently pending
Career history
139
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
34.3%
-5.7% vs TC avg
§102
18.2%
-21.8% vs TC avg
§112
24.6%
-15.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 72 resolved cases

Office Action

§103 §DP
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 . Information Disclosure Statement The Information Disclosure Statement (IDS) filed on 09/19/2025 has been considered. Claim Status The claim set and Applicant’s remarks filed September 19, 2025 have been entered. Claims 2-4, 6-9, 11-12, 15-17, 19-24, 27, 30, 33-36, 38-48, 50-82 and 88-95 are canceled. Thus, claims 1, 5, 10, 13-14, 18, 25-26, 28-29, 31-32, 37, 49 and 83-87 as amended are examined on the merits herein. Claim Interpretation (I) Claim 29 is drawn to the oligosaccharide that is conjugated to the glycolipid of claim 1, wherein “the oligosaccharide comprises galactose and/or glucose and/or fucose residues and/or 1 to 2 KDO residues”, see claim 29, lines 2-3. Because the claim language recites “comprises” when referring to the oligosaccharide conjugated to the glycolipid of claim 1, said oligosaccharide is construed as having at least one of the recited galactose, glucose, fucose or KDO residues and may also include other unnamed monosaccharide residues. In addition, the Examiner does not find anything in the Specification that would limit said oligosaccharide with the recitation of “comprises” to the specifically recited ones. Therefore, it would appear that this is the broadest reasonable interpretation. (II) Claim 1, line 1, recites a glycolipid comprising a tri-acylated, tetra-acylated, or penta-acylated diglucosamine, wherein the tri-acylated, tetra-acylated or penta-acylated diglucosamine comprises acyl chains ranging in length from 15-17 carbons. Because the claim language recites “comprising” or “comprises” when referring to both the number of acyl chains covalently linked to the diglucosamine structure or when referring to the acyl chain lengths of the acyl chains covalently linked to the diglucosamine structure within the recitation of “tri-acylated, tetra-acylated, or penta-acylated diglucosamine”; such recitation is reasonably construed by the Examiner to mean three, four or five acyl chains are directly covalently conjugated to the diglucosamine; and therefore this interpretation does not preclude additional acyl groups being present, for example when an additional acyl chain is indirectly connected to the diglucosamine via the acyl chain that is directly connected to the diglucosamine. Thus, the Examiner does not interpret the recitation of “tri-acylated, tetra-acylated, or penta-acylated” in such a way that said diglucosamine only contains three, four or five acyl chains that may be directly or indirectly connected to the diglucosamine of claim 1. Additionally, the Examiner respectfully notes the specification discloses an isolated glycolipid comprising a diglucosamine covalently conjugated to 3-5 acyl chains, each independently ranging in length from 14-17 carbons, where the glycolipid may be any of the glycolipids provided herein or a combination thereof, see pg. 8, lines 7-10. The Examiner respectfully notes the specification discloses it is to be understood that any of the aspects and embodiments described herein relating to glycolipids embrace and contemplate glycolipids that comprise, consist or consist essentially of a disaccharide, such as diglucosamine, covalently conjugated to 3-5 acyl chains, and optionally each chain may independently range in length from 4-17 carbons, see pg. 8, lines 13-18. The Examiner respectfully notes the specification discloses the glycolipid component comprises a diglucosamine substituted with one or more acyl chains, and preferably 3, 4 or 5 acyl chains. The Examiner respectfully notes the specification discloses the acyl chains may be unmodified or they may be modified, see pg. 19, lines 23-24. The Examiner also respectfully notes the specification discloses specific acyl chains may comprise chains that are not modified with additional acyl groups, however, even in view of this recitation the specification also explicitly states those foregoing examples are not to be considered limiting, see pg. 20, lines 8-25. Finally, the Examiner did not find anything within Applicant’s disclosure specifically excluding the possibility that the 3-5 acyl chains directly connected to the diglucosamine cannot be further modified with additional acyl chains. Therefore, the Examiner respectfully notes if the prior art teaches a glycolipid comprising three, four or five acyl chains that are directly connected to the diglucosamine, said glycolipid will read on claim 1. Thus, in view of the foregoing reasons above, the Examiner reasonably interprets the interpretation of claim 1 as discussed above is the broadest reasonable interpretation in view of the claim language recited in claim 1 and the context of the specification as a whole. Withdrawn Objections and Rejections With respect to the objections and/or rejections mailed in the non-final office action on May 19, 2025: (I) The objection of claims 5, 10, 13, 29, 32 and 83 is withdrawn in view of Applicant’s amendments to these claims discussed above. (II) The rejection of claims 1, 5, 14, 18, 25-26, 28-29 and 31 under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendment to claim 1 where the acylated diglucosamine comprises acyl chains ranging in length from 15-17 carbons. (III) The rejections of claim 3 under 35 U.S.C. 103 or on the grounds of non-statutory double patenting are withdrawn in view of Applicant canceling claim 3 as discussed in the Claim Status section above. (IV) The rejections of claims 1, 3, 5, 10, 13-14, 18, 25-26, 28-29, 31-32, 37, 49 and 83-87 on the ground of nonstatutory double patenting are all withdrawn in view of Applicant’s argument which is found persuasive by the Examiner as written in Applicant’s remarks, on pg. 10, double patenting rejection, second paragraph from the bottom of the page, as the Examiner respectfully notes the claims have maintained consonance with the groups set forth in the restriction requirement (drawn to Group I). Response to Arguments (I) The objection to claim 84 is maintained as the Examiner respectfully notes Applicant has not yet addressed the objection to claim 84 discussed below. (II) The rejection of claims 1, 3, 5, 10, 13-14, 18, 25-26, 28-29, 31-32, 37, 49 and 83-87 under 35 U.S.C. 103 is maintained. Applicant argues: (A) The non-final office action fails to provide the requisite reasoned explanation, see Applicant’s remarks, pg. 8, paragraph 2. (B) The pending claims relate to a glycolipid comprising a tri-acylated, tetra-acylated or penta-acylated diglucosamine comprising acyl chains ranging in length from 15-17 carbons, see Applicant’s remarks, pg. 9, paragraph 2. (C) The Examiner fails to identify any disclosure in Reed or Campbell that relates to a glycolipid comprising a tri-acylated, tetra-acylated or penta-acylated diglucosamine as the Examiner inaccurately points to the GLA of Reed to teach the limitations of claim 1, see Applicant’s arguments, pg. 9, paragraph 2. (D) The GLA of Reed is hexa-acylated and not tetra-acylated as asserted by the Examiner, therefore the Examiner fails to appropriately demonstrate that all features of claim 1 are taught or suggested by Reed or Campbell; and thus the Examiner fails to provide the requisite reasoned explanation of why a skilled person would have been motivated to modify unrelated compounds of Reed and Campbell to arrive at the present claims, see Applicant’s remarks, pg. 9, paragraph 2. (E) The Examiner fails to demonstrate that all claim limitations are taught by Reed, Campbell, Comstock and Weintraub, either alone or in combination, see Applicant’s remarks, pg. 9, b. Rejection over Reed, Campbell and Comstock, paragraph 1. (F) As described throughout the application as filed, tetra-acylated refers to the total number of acyl chains, not merely the number of acyl chains directly attached to the diglucosamine, see Applicant’s remarks, pg. 7, Claim Rejections under 35 U.S.C. § 102, paragraph 2. With respect to Applicant’s arguments (B)-(E), the Examiner respectfully notes Reed teaches a vaccine composition comprising the GLA structure as shown in the 103 rejection below. The Examiner also respectfully noted the GLA of Reed disclosed above is a tetra-acylated diglucosamine as required in claim 1. The Examiner also respectfully notes when R1, R3, R5 and R6 are C13-15 alkyl as discussed in the 103 rejection below this limitation corresponds to the acyl chains ranging in length from 15-17 carbons as required in the amendment to claim 1. The Examiner also respectfully notes the diglucosamine structure of Reed is a tetra-acylated diglucosamine wherein two acyl chains are modified with hydroxyls and two are modified with acyl chains. Therefore, the Examiner reasonably interprets the diglucosamine structure of Reed above corresponds to the tetra-acylated diglucosamine recited in claim 1 in view of the Examiner’s claim interpretation of claim 1 as discussed above. With respect to Applicant’s arguments (A) and (D), particularly with respect to the requisite reasoned explanation, the Examiner respectfully notes Reed teaches as discussed above and would be motivated to provide the GLA within the vaccine composition as taught by Reed; as Reed explicitly teaches these structural limitations are within the scope of the GLA structure of Reed as recited in the maintained 103 rejection below. Furthermore, with respect to Applicant’s argument (F), the Examiner respectfully notes the specification discloses an isolated glycolipid comprising a diglucosamine covalently conjugated to 3-5 acyl chains, each independently ranging in length from 14-17 carbons; where the specification discloses it is to be understood that any of the aspects and embodiments described herein relating to glycolipids embrace and contemplate glycolipids that comprise, consist or consist essentially of a disaccharide, such as diglucosamine, covalently conjugated to 3-5 acyl chains; and further discloses the glycolipid component comprises a diglucosamine substituted with one or more acyl chains, and preferably 3, 4 or 5 acyl chains. The Examiner also respectfully noted the specification discloses the acyl chains may be unmodified or they may be modified as discussed in greater detail in the Claim Interpretation section above. Finally, the Examiner did not find any reference within the disclosure that explicitly states, suggests or even hints at the possibility that the total number of acyl chains present within the diglucosamine structure of the glycolipid of claim 1 is interpreted to mean only a total of 3-5 acyl chains are attached directly or indirectly to said diglucosamine as argued by Applicant above. Nor did the Examiner find any reference within the disclosure that explicitly states, suggests or even hints that said modifications to the acyl chains, which may include modifications with additional acyl chains, are to be included within the total number of acyl chains present on said diglucosamine. The Examiner also respectfully notes this is particularly important as the specification states the contemplated glycolipids comprise diglucosamine, covalently conjugated to 3-5 acyl chains and a diglucosamine substituted with one or more acyl chains, and preferably 3, 4 or 5 acyl chains. Therefore, in view of the foregoing reasons above and within the context of Applicant’s disclosure, the Examiner reasonably interprets the GLA structure as recited in Reed as discussed in the 103 rejection below encompasses the structural limitations as recited in claim 1. Thus, Applicant’s arguments (A)-(F) have been fully considered but are not found persuasive. Specification The disclosure is objected to because of the following informalities: On pg. 19, line 28 it recites “a number of glycolipid species that diffe” which the Examiner reasonably interprets the recited word “diffe” is a misspelling of the word “differ”. Thus, to promote clarity the Examiner suggests replacing the word “diffe” with the word “differ” as discussed above. The Examiner also encourages the Applicant to review the entire disclosure, for example the specification, drawings and abstract etc., to see if additional typographical errors are present and if so to resolve them as needed. Appropriate correction is required. Claim Objections Claim 84 remains objected to because of the following informalities: Claim 84, line 2, recite “consisting essentially of glycolipid of claim 1”, which is missing the article “the” immediately before the recitation “glycolipid” to properly refer to the glycolipid of claim 1. Thus, the Examiner suggests inserting the word “the” immediately before the recitation “glycolipid” as discussed above. Appropriate correction is required. 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. 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. (I) Claims 1, 5, 10, 14, 18, 25-26, 28-29, 31-32, 37, 49, and 83-87 remain rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (Published 07 March 2013, US-20130058997-A1, IDS filed 12/28/2022) in view of Campbell et al. (Published 09 May 2013, US-20130116423-A1, PTO-892 mailed 05/19/2025). Regarding claims 1, 3, 5, 10, 14, 18, 25-26, 28-29, 31-32, 37, 49 and 83-87, Reed teaches a vaccine composition containing a synthetic adjuvant, see title; and compositions and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response based on the discovery of useful immunological adjuvant properties in a synthetic, glucopyranosyl lipid adjuvant (GLA) that is provided in substantially homogeneous form, see abstract. Reed teaches the vaccine formulations contain an antigen capable of eliciting an immune response against a human or mammalian pathogen, which the antigen may be derived from one or more bacterial pathogens including Staphylococcus spp., including S. aureus, see paragraph [0081]. Reed teaches vaccines and pharmaceutical compositions that include GLA and one or more of an antigen, a co-adjuvant and a carrier such as a pharmaceutical carrier, see abstract; wherein the antigen is derived from at least one infectious pathogen selected from a bacterium, a virus, or a fungus (e.g. required in claim 49), see paragraph [0019]. Reed teaches a vaccine composition comprising the GLA has the formula, PNG media_image1.png 319 440 media_image1.png Greyscale , see pg. 8, paragraph [0045], wherein R1, R3, R5 and R6 are C11-C20 alkyl, see pg. 8, paragraph [0046] and R2 and R4 are C11-C20 alkyl, see pg. 8, paragraph [0047] (e.g. acyl chains ranging in length from 14-17 carbons, required in claim 1). The Examiner notes the GLA of Reed disclosed above is a tetra-acylated diglucosamine as required in claim 1. The Examiner notes that at least one acyl chain is unmodified, required in claim 14, for example the acyl chains corresponding to R2 and R4 of the GLA of Reed depicted above. The Examiner also notes that at least one acyl chain is O-substituted, C16:0-OH, C17:0-OH, C14:0 or C15:0, required in claim 18. The Examiner further notes the diglucosamine is phosphorylated, required in claim 25. Moreover, the Examiner respectfully notes when R1, R3, R5 and R6 are C13-15 alkyl as discussed above this limitation corresponds to the acyl chains ranging in length from 15-17 carbons. The Examiner also respectfully notes the diglucosamine structure of Reed is a tetra-acylated diglucosamine wherein two acyl chains are modified with hydroxyls and two are modified with acyl chains. Therefore, the Examiner reasonably interprets the diglucosamine structure of Reed above corresponds to the tetra-acylated diglucosamine recited in claim 1 in view of the Examiner’s claim interpretation of claim 1 discussed above. Reed teaches pharmaceutical compositions (including GLA vaccines and GLA immunological adjuvants) may be formulated as a lyophilizate (e.g. lyophilized form, required in claim 5), see paragraph [0167]. Reed teaches the pharmaceutically acceptable carrier comprises a carrier selected from and including an oil-in-water emulsion or a liposome, wherein a liposome is used and the GLA is in the laminar structure of the liposome or is encapsulated (e.g. liposome form, required in claim 10), see paragraph [0012]. Reed teaches the co-adjuvant is selected from and includes a detergent (e.g. required in claim 31), see paragraph [0012]. Reed teaches a composition comprising an emulsion of oil-in-water wherein the GLA is incorporated in the oil phase and wherein an additional component is present, such as a co-adjuvant, see paragraph [0177]; wherein the oil-in-water emulsion contains 0.3 to 3% surfactant, such as polyoxyethylene sorbitan monooleate (e.g. the detergent is present at or less than 1%, required in claim 32); wherein the size of the oil droplets found within the stable oil-in-water emulsion are preferably less than 1 micron, see paragraph [0180]. The Examiner reasonably interprets the GLA incorporated into the oil droplets as discussed above wherein the oil-in-water emulsion comprises a surfactant such as polyoxyethylene sorbitan monooleate meets the structural limitation of “a micelle consisting essentially of the glycolipid of claim 1”, required in claims 83-84. Reed teaches the GLA vaccine composition is a liquid composition intended for either parenteral or oral administration (e.g. required in claim 37), see paragraph [0171]. Although, Reed does not teach wherein the acylated diglucosamine is conjugated to an oligosaccharide, required in claims 1, 26 and 28-29. However, in the same field of endeavor of vaccine compositions, Campbell teaches synthetic oligosaccharides for Staphylococcus vaccine, see title. Campbell teaches synthetic oligo-β-(1→6)-glucosamine structures and a methodology which essentially allows for the synthesis of any oligo-β-(1→6)-glucosamine species having a definite number of monosaccharide units, see abstract. Campbell teaches the term “oligosaccharide” refers to a compound containing two or more monosaccharide units, see paragraph [0028]. Campbell teaches exemplary bacteria known or suspected to express oligo-β-(1→6)-glucosamine structures include Staphylococcus spp., including S. aureus, see paragraph [0124]. Campbell teaches the oligosaccharide may be further attached to a carrier group, see paragraph [0172]; Campbell teaches the term carrier refers to a “lipid”, which is coupled to enhance the immunogenicity of the resulting oligosaccharide-carrier conjugate to a greater degree than the oligosaccharide alone, see paragraph [0034]; wherein conjugated refers to a chemical linkage, either covalent or non-covalent, that proximally associates an oligosaccharide with a carrier so that the oligosaccharide conjugate has increased immunogenicity relative to an unconjugated oligosaccharide, see paragraph [0036]. The Examiner reasonably interprets when the oligosaccharide of Campbell is attached to the glycolipid of Reed as discussed above via a glycosidic bond (i.e. an acid-liable bond, required in claim 26) the resulting oligosaccharide-glycolipid will meet the structural limitation of the glycolipid conjugated to an oligosaccharide as required in claim 1. It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date to have enhanced an innate immune response as taught by Reed by chemically conjugating the synthetic oligosaccharides of Campbell onto the glycolipid taught by Reed, as Campbell teaches a methodology which essentially allows for the synthesis of any oligo-β-(1→6)-glucosamine species, wherein the glycolipid of Reed already contains a diglucosamine core structure; and wherein both the compositions of Reed and Campbell are directed to initiating an immune response as discussed above. One of ordinary skill in the art would have been motivated to conjugate the oligosaccharide of Campbell to the glycolipid of Reed in order to enhance the immunogenicity of the resulting oligosaccharide-carrier conjugate to a greater degree than the oligosaccharide alone as taught by Campbell above. One of ordinary skill in the art would have had a reasonable expectation of success to have conjugated the oligosaccharide of Campbell to the glycolipid of Reed, as Campbell teaches a methodology which essentially allows for the synthesis of any oligo-β-(1→6)-glucosamine species and wherein the oligosaccharide can be attached to a carrier, such as a lipid; wherein methods of attaching an oligosaccharide to a carrier are conventional and a skilled practitioner can create conjugates in accordance with the invention of Campbell using conventional methods, see Campbell, paragraph [0131]; and in addition to Reed teaching the presence of two glucosamines on their glycolipid as discussed above. With respect to the limitation “wherein the detergent is present in a pharmaceutically acceptable amount”, required in claim 85, the Examiner is reasonably interpreting this to be a physical limitation that is met as Reed teaches vaccine compositions comprising GLA and co-adjuvants, such as detergents, and further teaches the detergent polyoxyethylene sorbitan monooleate from 0.3 to 3% within the oil-in water emulsion. Thus, the Examiner reasonably interprets the physical limitation of a ”pharmaceutically acceptable amount” of the detergent within the composition as required in claim 85 is met by the teachings of Reed above. It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have conjugated the synthetic oligosaccharide taught by Campbell onto the glycolipid of Reed 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 create the oligosaccharide conjugate above as Reed teaches the vaccine formulations contain an antigen, wherein the antigen may be derived from one or more bacterial pathogens including Staphylococcus spp., including S. aureus; additionally Campbell teaches exemplary bacteria known or suspected to express oligo-β-(1→6)-glucosamine structures includes Staphylococcus spp., including S. aureus as taught above. One of ordinary skill in the art would have had a reasonable expectation of success to have conjugated the synthetic oligosaccharide of Campbell with the glycolipid of Reed as discussed above, as Campbell teaches a methodology which essentially allows for the synthesis of any oligo-β-(1→6)-glucosamine species and where the oligosaccharide can be attached to a carrier, such as a lipid; and wherein Reed teaches the presence of two glucosamines on their glycolipid as discussed above. Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art. (II) Claim 13 remains rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (Published 07 March 2013, US-20130058997-A1, IDS filed 12/28/2022) in view of Campbell et al. (Published 09 May 2013, US-20130116423-A1, PTO-892 mailed 05/19/2025) as applied to claims 1, 5, 10, 14, 18, 25-26, 28-29, 31-32, 37, 49 and 83-87 above, and further in view of Comstock et al. (Published 27 November 2003, US-20030219413-A1, IDS filed 12/28/2022) and Weintraub et al. (Published 01 August 1989, Vol. 183, Issue 2, pp. 425-431, IDS filed 12/28/2022). Reed and Campbell address claims 1, 5, 10, 14, 18, 25-26, 28-29, 31-32, 37, 49 and 83-87 as written above. Reed further teaches bacterial lipopolysaccharide-derived adjuvants to be formulated in adjuvant combinations may be purified and processed from bacterial sources, see paragraph [0009]. Although, Reed and Campbell do not teach the glycolipid is obtained or derived from Bacteroides fragilis that overexpresses PSA relative to the polysaccharides claimed, required in claim 13. However, in the same field of endeavor of compositions with immunomodulatory effects, Comstock teaches compositions and methods for production and isolation of capsular polysaccharides which have been reported to have immunomodulatory effects, see paragraph [0003]; wherein the methods and compositions are for overexpressing and purifying immunomodulatory capsular polysaccharide A (PSA) in high yield, see abstract; from Bacteroides fragilis (B. fragilis), see paragraph [0003]. Comstock teaches the bacterial cells are B. fragilis, including B. fragilis NCTC9343, see paragraph [0033]. In addition, as evidenced by Weintraub, the bacteria known as B. fragilis NCTC9343 produces a lipidated polysaccharide A, see pg. 425, title. Weintraub teaches the chemical structure of lipid A derived from B. fragilis NCTC9343 as depicted in Figure 3, PNG media_image2.png 603 556 media_image2.png Greyscale , wherein the Examiner notes lipid A derived from B. fragilis NCTC9343 contains a diglucosamine core that is tetra-acylated, where three of the acyl chains are modified with a hydroxyl and one acyl chain is modified with an acyl chain, see pg. 430, left column, Fig. 3. It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have substituted the glycolipid taught by Reed above for the glycolipid produced by B. fragilis NCTC9343 as taught by the combination of Comstock and Weintraub above as a simple substitution of one known element for another to obtained predictable results. One of ordinary skill in the art would have been motivated to carry out the substitution above in order to create vaccines and pharmaceutical compositions for inducing or enhancing an immune response as taught by Reed; as Comstock teaches compositions of capsular polysaccharide A derived from B. fragilis NCTC9343 have been reported to have immunomodulatory effects as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to have made the substitution discussed above, as Reed teaches bacterial lipopolysaccharide-derived adjuvants to be formulated in adjuvant combinations may be purified and processed from bacterial sources. 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. 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. 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. 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, Renee Claytor can be reached at (571) 272-8394. 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. /JARET J CREWS/Examiner, Art Unit 1691 /RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Read full office action

Prosecution Timeline

Oct 13, 2022
Application Filed
May 09, 2025
Non-Final Rejection — §103, §DP
Sep 19, 2025
Response Filed
Dec 05, 2025
Final Rejection — §103, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
47%
Grant Probability
99%
With Interview (+69.8%)
3y 1m
Median Time to Grant
Moderate
PTA Risk
Based on 72 resolved cases by this examiner. Grant probability derived from career allow rate.

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