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 .
Election/Restrictions
Applicant’s election of Group II, claims 17, 20-23, 26, 29-32, and 35-36 in the reply filed on 8/21/2026 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)). Claims 1-2, 9-10, 12-13, and 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The Office also acknowledges the Applicant’s election of the following species of the compound:
PNG
media_image1.png
234
114
media_image1.png
Greyscale
This species appears to fall within the limitations of all of the elected claims and corresponds to a compound of claims 17 and 35 wherein R1, R2, R3, R4, R5, R7, R8, R11, and R12 are H; R6 and R9 are Br; and R10 is OH.
During the course of the search, the following species was also considered:
PNG
media_image2.png
103
367
media_image2.png
Greyscale
. This compound corresponds to a compound of claims 17 and 35 wherein R1, R2, R3, R4, R5, R6, R7, R9, R11, and R12 are H; R8 is OH; and R10 is OCH3.
Claim Status
Claims 1-2, 9-10, 12-13, 15-17, 20-23, 26, 29-32, 35, and 36 are pending. Claims 1-2, 9-10, 12-13, and 15-16 are withdrawn and claims 17, 20-23, 26, 29-32, and 35-36 are under examination.
Priority
The application was filed on 10/7/2024 and claims benefit of priority to:
PNG
media_image3.png
214
784
media_image3.png
Greyscale
See filing receipt dated 8/31/2026.
The Examiner notes that though the parent application: 17/724969 is filed as a “DIV” of 16/450772, that the NOA dated 1/12/2022 in parent app. no. 16/450772, now US 11390580, indicates that the restriction of record was withdrawn. See p. 2 of the OA. See MPEP 804.01.
Specification
The title and specification are objected to because the words “sphingolipid” and “sphingolipids” are misspelled as –shingolipid—and –shingolipids—in many locations.
Appropriate correction is required.
Claim Objections
Claims 17, 23, and 32 are objected to because of the following informalities:
In various place throughout claims 17, 23, and 32, the word –sphingolipid—is misspelled as –shingolipid--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 17, 20-23, 26, 29-32, 35, and 36 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.
The term “without substantially inhibiting mammalian sphingolipid synthesis” in claim 17, line 3 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification appears to lack any explicit definition for the term, and it is not clear from the examples what constitutes a substantial amount.
Claim 17 contains the following clause:
PNG
media_image4.png
176
845
media_image4.png
Greyscale
While the first two lines of the clause are clear in what compound is being excluded from the claimed method, it is not clear which compounds are being excluded in the final three lines of the claim. In particular the requirement that “then R6 and R7 are other than -H and -CH3 or -Br and H, respectively” is unclear. Does this limitation mean: i) that R6 and R7 are not H, CH3, and Br in any combination; ii) that R6 and R7 are not H or CH3, in any combination, or that R6 and R7 are not Br and H, in any combination; or iii) that when R6 is H, that R7 is not CH3; and that when R6 is Br, R7 is not H? The same issue occurs in independent claim 35.
Claims 22 and 31, recite the processes of claim 17 and 26 (which depends from claim 17) respectively, “further comprising contacting the fungus with an amount of an anti-fungal agent”. This limitation is indefinite because claim 17 already appears to require contacting a fungus with the anti-fungal agent having the claimed compound formula. Presumably, the limitation is intended to refer to another, additional anti-fungal agent as evidenced by claims 23 and 32. However, this is not clear from the present claim language.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 20, 29, and 30 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 20 recites the following compound:
PNG
media_image5.png
426
222
media_image5.png
Greyscale
. This compound appears to lack antecedent basis to independent claims 17, because in this compound R10 is -N(CH3)2. In independent claim 17, which all recite an identical compound structure, R10 can be -NH2, NHR13, or -NHCOR12, but there is no option for a secondary amine. In contrast, see the option “NR14R15” with respect to variables R3-R9, R11, and R12.
Likewise, claim 29, which depends from claim 26, which depends from independent claim 17, recites that R10 can be -NR14R15, which is an improper broadening of the definition from claim 17.
Claim 30, which depends from claim 26, which depends from independent claim 17, recites the following structures:
PNG
media_image6.png
232
150
media_image6.png
Greyscale
and
PNG
media_image7.png
232
132
media_image7.png
Greyscale
, wherein R10 is -N(CH3)2. These compounds improperly broaden claim 17 for the reasons discussed above.
Claim 30 further recites compounds
PNG
media_image8.png
228
136
media_image8.png
Greyscale
and
PNG
media_image9.png
222
128
media_image9.png
Greyscale
. These compounds are expressly prohibited by the first proviso in claim 17 “when R1, R2, R3, R4, R5, R6, R8, R11, and R12 are each -H, R9 is -Br, and -R10 is -OH or -OCH3, then R7 is other than -CH3”.
Claim 30 also recites the compounds:
PNG
media_image10.png
232
128
media_image10.png
Greyscale
and
PNG
media_image11.png
218
116
media_image11.png
Greyscale
. These compounds are expressly prohibited by the second proviso in claim 17 “when R1, R2, R3, R4, R5, R8, R9, R11, and R12 are each -H, and -R10 is -OH, then R6 and R7 are other than -H and -CH3 or -Br and H, respectively”.
Thus claim 30 teaches a multitude of species which improperly broaden the definition of compound set forth in claim 17.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 17, 20-23, 26, 29-32, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11390580 (‘580).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 2 and 4-13 of ‘580 recite the claimed processes using compounds which are species of the claimed compounds. Therefore, the claimed processes of ‘580 are species of the claimed process. Also see MPEP 2131.02.
Claims 17, 20-23, 26, 29-32, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11414378 (‘378).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 3-6 and 18-20 of ‘378 recite the claimed processes using compounds which are species of the claimed compounds. Therefore, the claimed processes of ‘378 are species of the claimed process. Also see MPEP 2131.02.
Claims 17, 20-23, 26, 29-32, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11858880 (‘880).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of ‘880 recite the claimed processes using compounds which are species of the claimed compounds. For example, see claims 4 and 14. Therefore, the claimed processes of ‘880 are species of the claimed process. Also see MPEP 2131.02.
Claims 17, 20-23, 26, 29-32, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12325678 (‘678).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of ‘678 recite the claimed processes using compounds which are species of the claimed compounds. For example, see claims 19-20. Therefore, the claimed processes of ‘678 are species of the claimed process. Also see MPEP 2131.02.
Claims 17, 20-23, 26, 29-32, and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 16, 18-19, 25-26, 32, 37, 41, 43, 46, 48-50, 52, 54, 56, and 63-64 of co-pending U.S. App. No. 19/195513 (‘513).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘513 recite the claimed processes using compounds which are species of the claimed compounds. For example, see claim 52. Therefore, the claimed processes of ‘513 are species of the claimed process. Also see MPEP 2131.02. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17, 20-23, 26, 29-32, and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8, 10, 17, 20-21, 26-29, 31-34, and 38 of co-pending U.S. App. No. 18/698584 (‘584).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘584 recite the claimed processes using compounds which are species of the claimed compounds. For example, see claims 17 and 20. Therefore, the claimed processes of ‘584 are species of the claimed process. Also see MPEP 2131.02. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17, 20-23, 26, 29-32, and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of co-pending U.S. App. No. 19/582745 (‘745).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘745 recite the claimed processes using compounds which are species of the claimed compounds. For example, see claims 10-11. Therefore, the claimed processes of ‘745 are species of the claimed process. Also see MPEP 2131.02. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17, 20, 22, 26, and 31 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Young (US2012/0010075, published on 1/12/2012).
Young teaches the following compound 147:
PNG
media_image2.png
103
367
media_image2.png
Greyscale
. See Table 1, p. 35. This compound corresponds to a compound of claims 17, 20, 22, 26, and 31, wherein R1, R2, R3, R4, R5, R6, R7, R9, R11, and R12 are H; R10 is OMe (OR13, wherein R13 is C1 alkyl); and R8 is OH. Young teaches that an effective amount of said compound is used to inhibit the growth of tomato blight (Phytophthora infestans) or LEPTNO (Leptosphaeria nodorum), both fungi, in combination with copper, another anti-fungal agent. See [0111-0114], including Table 2. Also see MPEP 2131.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 17, 20-23, 26, 29-32, and 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Young (US2012/0010075, published on 1/12/2012).
Applicant claims various methods of inhibiting the growth of fungus and/or fungal sphingolipid synthesis using a compound of the following formula:
PNG
media_image12.png
384
256
media_image12.png
Greyscale
.
The elected species is a compound of the following structure:
PNG
media_image1.png
234
114
media_image1.png
Greyscale
. This species corresponds to a compound of claims 17 and 35 wherein R1, R2, R3, R4, R5, R7, R8, R11, and R12 are H; R6 and R9 are Br; and R10 is OH.
Young discloses synergistic fungicidal compositions including hydrazone derivatives and copper. See whole document. The compositions have fungitoxic activity against phytopathogenic fungi, against fungal pathogens of mammals, including humans, and against wood decay causing fungi. See [0037-0038]. Regarding claims 23, 26, 32, and 36 Young specifically recites that the fungi include Candida species, Aspergillus species, Fusarium species, Coccidioides immitis, Cryptococcus neoformans, Histoplasma capsulatum, Microsporum species, and Trichophyton species. See [0038]. Regarding claims 17 and 35, the compositions may be administered in effective amounts to the fungus to or a mammal having the fungus in effective amounts. See [0039-0050]. Regarding claims 22, 23, 31, and 32, Young teaches that the mixtures may also comprise additional anti-fungal ingredients. See [0051]. When controlling fungal infections in mammals, the additional anti-fungal ingredients include fluconazole, amphotericin B, and caspofungin. See [0052].
The hydrazone derivatives of Young are of the following Formula I:
PNG
media_image13.png
165
339
media_image13.png
Greyscale
. See claim 1.
The following species of formulas 63, 71, 113, 138, 147, 163, 181, 182, 204, 280-286, 482, and 483 are taught:
PNG
media_image14.png
125
355
media_image14.png
Greyscale
PNG
media_image15.png
132
355
media_image15.png
Greyscale
PNG
media_image16.png
145
375
media_image16.png
Greyscale
PNG
media_image17.png
129
349
media_image17.png
Greyscale
PNG
media_image18.png
114
360
media_image18.png
Greyscale
PNG
media_image19.png
129
347
media_image19.png
Greyscale
PNG
media_image20.png
110
352
media_image20.png
Greyscale
PNG
media_image21.png
119
331
media_image21.png
Greyscale
PNG
media_image22.png
104
357
media_image22.png
Greyscale
PNG
media_image23.png
116
358
media_image23.png
Greyscale
PNG
media_image24.png
148
353
media_image24.png
Greyscale
PNG
media_image25.png
114
336
media_image25.png
Greyscale
PNG
media_image26.png
229
364
media_image26.png
Greyscale
PNG
media_image27.png
233
364
media_image27.png
Greyscale
PNG
media_image28.png
103
353
media_image28.png
Greyscale
PNG
media_image29.png
108
353
media_image29.png
Greyscale
.
See Table 1 on p. 12-105.
All of these compounds appear to be species of the claimed compounds in claims 17 and 35, wherein instant variable R2 is H and instant variable R1 is H or CH3 (C1 alkyl). Of the above species, compounds 63, 71, 113, 138, 163, 181, 182, and 204 correspond to those wherein R3, R4, R5, and R7 are H and R6 is Br. Compounds 147, 280-286, 482, and 483, which are also all species of claim 20, all teach instant variables R9, R11, and R12 are H; R8 is OH; and R10 is -OCH3, which corresponds to -OR13 wherein R13 is methyl, a C1 alkyl. Compounds 71, 113, 163, 181, 182, and 204 are all species of the meta-substituted Br embodiment of claim 29, wherein R8, R9, R10, R11, and R12 are selected from H, OH, Cl, Br, and CH3.
Young teaches that an effective amount of said compound is used to inhibit the growth of tomato blight (Phytophthora infestans) or LEPTNO (Leptosphaeria nodorum), both fungi, in combination with copper, another anti-fungal agent. See [0111-0114], including Table 2.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Regarding the elected species of compound, which is recited in claims 21 and 30, Young does not explicitly teach the claimed compound.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art to arrive at the claimed methods based on the teachings of Young with a reasonable expectation of success before the effective filing date of the claimed invention.
A person of ordinary skill would have been motivated to prepare and employ the elected species in the fungal inhibition method of Young, because of the significant structural similarity between the claimed species, and compounds 63, 71, 113, 138, 147, 163, 181, 182, 204, 280-286, 482, and 483 of Young, which were all shown to possess the desired antifungal activity when applied against two different fungi. The species exemplified in Young teach all ofthe substituents on the elected species (Br and OH) in different positions on both rings. The reference only fails to teach their combination in the claimed regiochemistry in a single compound. Therefore, it would have been prima facie obvious for the skilled artisan to obtain the claimed compound for use as an anti-fungal agent. Based on the exemplified compounds of Young, there is a reasonable expectation of success of that the claimed species can be predictably substituted for the exemplified compounds in the fungal inhibition method of Young. Also see MPEP 2144.08 and MPEP 2144.09.
With further respect to the claimed genus, as discussed above, since the exemplified compounds of Young are so close in structure to those claimed, especially the elected species, then they would also be expected to possess the same or similar bioactivity. The exemplified compounds of Young, discussed above, fall within the claimed genus, and the genus of Young further shares significant overlap with the claimed genus. Therefore, arriving at the claimed processes based on the teachings of Young would be prima facie obvious. Also see MPEP 2144.08 and 2144.09.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY C BONAPARTE whose telephone number is (571)272-7307. The examiner can normally be reached 11-7.
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 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.
/AMY C BONAPARTE/Primary Examiner, Art Unit 1692
Prosecution Insights