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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 9, 2026 has been entered.
The amendment filed April 9, 2026 has been entered. Claims 1, 3, and 31 have been amended, claims 5-7, 10-13, 15-30, 32, 34-35, and 37-45 are cancelled, and claims 46-52 have been added.
Applicant’s arguments filed April 9, 2026 were fully considered but they were not persuasive. Rejections and response to amendments as they currently apply are addressed below.
Claims 1-4, 8-9, 14 ,31, 33, 36 and 46-52 are pending in this application.
Priority
This application is 371 National Stage Application of PCT/US20/45566, filed August 10, 2020, which claims the benefit of priority to U.S. Provisional Patent Application No. 62/884,464, filed August 8, 2019, and U.S. Provisional Patent Application No. 62/951,753, filed December 20, 2019.
Election/Restrictions
Applicant’s election of Group I claims and the following elected species:
PNG
media_image1.png
188
457
media_image1.png
Greyscale
in the reply filed on August 4, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In the amendment filed April 9, 2026, Applicant amended the claims such that the elected species is no longer encompassed by the claims. In the response filed April 9, 2026, Applicant requested the search be extended to the following species:
PNG
media_image2.png
192
430
media_image2.png
Greyscale
wherein R1 and R2 are hydrogen and 2-hydroxyethyl (C2alkyl substituted with one hydroxy). Thus, the Examiner has expanded the search to this species.
Claims 1-4, 8-9, 14 ,31, 33, 36 and 46-52 are encompassed by the election and are examined herein.
Based on the cited art, the search was further expanded to include
PNG
media_image3.png
186
402
media_image3.png
Greyscale
as well, which is encompassed by claims 1-4, 8-9, 14, 31, 33, and 36.
Drawings
The drawings are objected to because The structures in Figures 1A and 2A are blurry rendering them illegible. Specifically in Figures 1A and 2A the stereo-bonds are unclear (
PNG
media_image4.png
108
222
media_image4.png
Greyscale
, figure 1A) (
PNG
media_image5.png
144
154
media_image5.png
Greyscale
, figure 2A). The table in Figure 22 has a blurry parameter subscript, rendering it illegible (
PNG
media_image6.png
27
144
media_image6.png
Greyscale
). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 14 is objected to because of the following informalities: Claim 14 recites inter alia “
PNG
media_image7.png
54
281
media_image7.png
Greyscale
”, in which the claim states R4 can be hydrogen twice, which redundant.
Claims 50-51 are objected to under 37 CFR 1.75 as being substantial duplicates of claims 49-50 respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1-4, 8-9, 14 ,31, 33, 36 and 46-52 are rejected under 35 U.S.C. 103 as being unpatentable over Tevyashova (Antimicrobial Agents and Chemotherapy, 2013, IDS filed August 14, 2024) in view of Burke (US 9,738,677, IDS filed September 25, 2024).
Regarding claims 1-4, 8-9, 14 ,31, 33, 36 and 46-52: Tevyashova teaches structure-antifungal activity relationships for amphotericin B (AMB) and its semisynthetic derivatives (abstract, pg. 3816, figure 1). Tevyashova teaches the following compounds 1b and 1c of formula 1
PNG
media_image8.png
104
217
media_image8.png
Greyscale
PNG
media_image9.png
122
228
media_image9.png
Greyscale
and antifungal activity thereof (pg. 3818, figure 1, compounds 1b and 1c). The antifungal activity of these compounds was determined in liquid medium comprising water (i.e. a carrier, pg. 3816, col. 2, para. 3).
The compounds of Tevyashova differs from the elected compounds in the stereochemistry at the C2’ position of the mucosamine is opposite:
PNG
media_image10.png
96
135
media_image10.png
Greyscale
( Tevyashova)
PNG
media_image11.png
89
109
media_image11.png
Greyscale
(claimed) (i.e. epimer). Tevyashova does not explicitly teach administering to a subject for the treatment of a fungal infection.
However, Burke teaches an amphotericin B derivative with opposite stereochemistry at C2’ position of the mucosamine (abstract col. 2, lines 1-65). Burke teaches that opposite stereochemistry at this position has the added benefit of maintaining antifungal potency while having lower toxicity to human cells (abstract). Burke teaches the compounds can be utilized in pharmaceutical compositions with a carrier (col. 2, lines 45-67).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to modify the compounds of Tevyashova by switching the stereochemistry of the C2’ position of the mucosamine group as taught by Burke. A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success in order to improve the AmB analogues by maintaining antifungal activity and lowering toxicity to subjects. It would also have been prima facie obvious to administer the compounds for the treatment of fungal infections in a subject as the compounds are established generally to have anti-fungal activity.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 8-9, 14 ,31, 36 and 46-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/877,792 (US 20250387422, cited on PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1-4, 8-9, 14 ,31, 33, 36 and 46-52: The copending claims teach a composition comprising a lipid polymer excipient and a compound of the following formula:
PNG
media_image12.png
195
419
media_image12.png
Greyscale
-
PNG
media_image13.png
529
601
media_image13.png
Greyscale
PNG
media_image14.png
52
528
media_image14.png
Greyscale
(copending claim 1). The copending claims specifically teach the compound may be the elected compounds
PNG
media_image15.png
207
439
media_image15.png
Greyscale
PNG
media_image16.png
199
391
media_image16.png
Greyscale
(copending claim 19). The copending claims teach wherein the compositions can be used to treat a fungal infection (copending claim 51).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/877,792 (US 20250387422, cited on PTO-892) as applied to claims 1-4, 8-9, 14 ,31, 33, 36 and 46-52 above in view of Burke (US 9,738,677, IDS filed September 25, 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 33: As discussed above the elected compound is encompassed by the copending claims.
They do not teach formulation with a pharmaceutical carrier.
However, Burke teaches an amphotericin B derivative with opposite stereochemistry at C2’ position of the mucosamine (abstract col. 2, lines 1-65). Burke teaches that opposite stereochemistry at this position has the added benefit of maintaining antifungal potency while having lower toxicity to human cells (abstract). Burke teaches the compounds can be utilized in pharmaceutical compositions with a carrier (col. 2, lines 45-67).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to modify the composition of the copending application by including a pharmaceutical carrier as taught by Burke. A person of ordinary skill would have had the motivation to do so with a reasonable expectations of success given that Burke establishes inclusion of a carrier is a routine practice in the art of anti-fungal therapeutics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed April 9, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect the 103 rejections previously set forth in the Final office action mailed January 9, 2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 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, Scarlett Y Goon can be reached at 571-270-5241. 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.
/SAMUEL L GALSTER/Examiner, Art Unit 1693
Prosecution Insights