Prosecution Insights
Last updated: April 19, 2026
Application No. 18/549,797

NOVEL DEALKOXYPHENYLATION REACTION

Non-Final OA §103§112§DP
Filed
Sep 08, 2023
Examiner
MILLER, DALE R
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Daiichi Sankyo Company Limited
OA Round
1 (Non-Final)
62%
Grant Probability
Moderate
1-2
OA Rounds
2y 8m
To Grant
78%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
434 granted / 699 resolved
+2.1% vs TC avg
Strong +16% interview lift
Without
With
+16.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
40 currently pending
Career history
739
Total Applications
across all art units

Statute-Specific Performance

§101
4.2%
-35.8% vs TC avg
§103
39.3%
-0.7% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
23.3%
-16.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 699 resolved cases

Office Action

§103 §112 §DP
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. DETAILED ACTION This Office Action is in response to Applicant's amendment filed on 11/1/2023 , in which claim s 4, 6, 7, 10-16, 23, 26, 31, 32 and 34 are amended. No claims are newly added or canceled. Claims 1-34 are pending in the application and are examined on the merits herein. Priority This application is a National Stage Application of PCT/ JP2022/010839 , filed on 3/11/2022 . The instant application claims foreign priority to JP 2021-040647 filed on 3/12/2021 . Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 9/8/2023 . Information Disclosure Statement The information disclosure statement s (IDS) dated 1/30/2024, 4/18/2025, 6/26/2025 and 9/16/2025 compl y with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the I DS documents ha ve been placed in the application file and the information therein has been considered as to the merits. Claim Rejections - 35 USC § 112, First Paragraph The following is a quotation of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. Claims 1-25 and 32-34 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for preparing certain saccharides , specifically those in dependent claim 23, using the claimed deprotection reaction, with a subset of lambda3-iodanes, specifically those in dependent claim 4 , does not reasonably provide enablement for preparing any R-OH substrate using the claimed deprotection reaction with any lambda3-iodane. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. With respect to the claimed method , attention is directed to In re Wands , 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. All of the Wands factors have been considered and those most relevant to the cited claims are discussed below. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. Nature of the invention: The rejected invention is drawn to method for preparing an R-OH product by reacting an R-O- Ph-O (C1-C5 alkyl) intermediate with a lambda3-iodane, in an aqueous fluorous alcohol. Relative skill of those in the art: The relative skill of those in the art is high. Breadth of claims /Existence of working examples : The claims are broad with respect to the nature of the R-OH starting product, the R-O-Ph-O(C1-C5 alkyl) intermediate and the lambda3-iodane . The genus of compounds having the claimed “R” group encompasses any product having an -OH group and any intermediate bearing an - O-Ph-O(C1-C5 alkyl) group. In contrast the working examples are limited to sugars having the O -Ph-O(C1-C5 alkyl) group at the 1-position or the anomeric position, further wherein either i) a hydroxy group at a carbon adjacent to the carbon at the 1-position or the anomeric position in the sugar is protected with an acyl group; ii) an amino group at a carbon adjacent to the carbon at the 1-position or the anomeric position in the sugar is protected with an imide group, an acyl group, or a carbamate group; or iii) a carbon adjacent to the carbon at the 1-position or anomeric position in the sugar has an azide group (N ₃ ) . The genus of lambda3-iodane includes any trivalent, hypervalent iodine compound, including P hICl ₂ , PhI(OH)O T s and PhI(OAc) ₂ , whereas the instant working examples are limited to iodanes of formula R¹-I(OR²) ₂ , wherein R¹ is an unsubstituted or substituted phenyl group, and R² is selected from the group consisting of H, acetyl, trifluoroacetyl, tosyl, methanesulfonyl, and a combinations thereof . Predictability or unpredictability of the art: In the field of organic synthesis, it is established that protection/ deprotection strategies are designed to range from generic to very specific in terms of the types of functional groups and reaction conditions applicable to a desired synthetic outcome. Even taking into account the subset of hydroxyl group protection/deprotection strategies, one of skill in the art is not able to predict a priori, that a particular protection/deprotection approach will be applicable to any compound bearing a hydroxyl group. In the instant case, one of skill in the art would not be able to reasonably predict that any compound bearing a hydroxyl group could be prepared by reacting any compound bearing an -O-Ph-O(C1-C5 alkyl) , with any lambda3-iodane. Quantity of experimentation: One of skill in the art would have to conduct a myriad number of experiments comprising trial and error deprotection reactions with a representative number of compound s bearing an -O-Ph-O(C1-C5 alkyl), with a representative number of lambda3-iodane s, under a wide range of reaction conditions, to determine if the claimed method can be used in the fully claimed scope to produce any product having a deprotected -OH group . Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. Therefore, in view of the Wands factors as discussed above, e.g., the breadth of the claims, the amount of guidance provided, the u npredictability of the art and the limited working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success. 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 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Claim s 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. ( Chem. Eur. J., 2010, IDS ), in view of Kurbatova et al. (Front. Immuno. , 2020, PTO-892) . Pedersen discloses the saccharide 33a/33b obtained by a reaction convert ing an -O-Ph-OMe group at the anomeric position of a sugar (27a/27b), to a hydroxyl group at the anomeric position of said sugar (33a/33b), using the deprotection conditions of Ph I (O C (O) -CF 3 ) 2 + BF 3 ·OEt 2 in a methylene chloride/water solvent. (Scheme 4) Pedersen also discloses that the saccharide 33a/33b is a mimic of the capsular saccharide of Streptococcus pneumoniae . (Abstract) Pedersen does not teach conjugating saccharide 33a/33b with a protein. Kurbatova et al. discloses that capsular saccharides of S. pneumoniae are conjugated to proteins, including receptors, cytokines and antibodies, as a means of formulating vaccines. (p. 2, Col. 1) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the S. pneumonia e capsular saccharide mimic of Pedersen could be conjugated to a protein, based on the teaching of Kurbatova, that such conjugation is effective for preparing vaccines. Accordingly, the instant claims are prima facie obvious over the teachings of the prior art. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438 , 164 USPQ 619 (CCPA 1970); and In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claims 1- 20 and 23-25 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 33-35 of copending application 18/549949 . Although the conflicting claims are not identical, they are not patentably distinct from each other because: The method of ‘949 anticipates the instant method . This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. Allowable Subject Matter Independent claim 1 would be allowable if the limitations of dependent claims 4 and 23 were incorporated into claim 1, as per the attached proposed e xaminers amendment. The closest applicable prior art is that of Pedersen et al. (Chem. Eur. J . , 2010, IDS) . Pedersen discloses a reaction to convert an -O-Ph-OMe group at the anomeric position of a sugar (27a/27b), to a hydroxyl group at the anomeric position of said sugar (33a/33b), using the deprotection conditions of Ph I (O C (O) -CF 3 ) 2 + BF 3 ·OEt 2 in a methylene chloride/water solvent . (Scheme 4) Pedersen does not disclose performing the above deprotection in a fluorous alcohol solvent. One of ordinary skill in the art could readily envision substituting methylene chloride with a fluorous alcohol, with a reasonable expectation of equivalent results. However, t he instant specification presents evidence of unexpected results showing that the yield of deprotected sugars is unexpectedly improved in fluorous alcohol solvents in direct comparison to yields in methylene chloride solvents. Such unexpected results overcomes a prima facie case of obviousness, making the proposed claim 1 novel and non-obvious over Pedersen et al. Moreover, the narrowing of claim scope as proposed, would overcome the rejection for lack of enablement because the working examples show sufficient support for enablement of the proposed claim 1. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM 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, Scarlett Goon can be reached on (571) 270-5341 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /DALE R MILLER/ Primary Examiner, Art Unit 1693
Read full office action

Prosecution Timeline

Sep 08, 2023
Application Filed
Mar 23, 2026
Examiner Interview (Telephonic)
Mar 27, 2026
Non-Final Rejection — §103, §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12594288
NUTRITIONAL COMPOSITIONS COMPRISING HUMAN MILK OLIGOSACCHARIDES AND NUCLEOTIDES AND USES THEREOF FOR TREATING AND/OR PREVENTING ENTERIC VIRAL INFECTION
2y 5m to grant Granted Apr 07, 2026
Patent 12589106
A NUTRITIONAL COMPOSITION COMPRISING A COMBINATION OF HUMAN MILK OLIGOSACCHARIDES TO IMPROVE THE GASTROINTESTINAL BARRIER
2y 5m to grant Granted Mar 31, 2026
Patent 12569509
METHOD AND COMPOSITION FOR PREVENTING AND TREATING VIRAL INFECTIONS
2y 5m to grant Granted Mar 10, 2026
Patent 12565687
GLUCOSE IN SOLID FORM AND PROCESS FOR MANUFACTURING GLUCOSE IN SOLID FORM
2y 5m to grant Granted Mar 03, 2026
Patent 12564661
IIMPROVED APPROACH TO REPAIR TISSUE DEFECTS BY BONDING INJECTABLE GELS TO NATIVE SOFT TISSUES
2y 5m to grant Granted Mar 03, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
62%
Grant Probability
78%
With Interview (+16.3%)
2y 8m
Median Time to Grant
Low
PTA Risk
Based on 699 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month