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 Ia (a pharmaceutically acceptable salt of formula I) and the species of the choline salt of Compound I-4. in the reply filed on February 11, 2026 is acknowledged.
The Examiner respectfully notes the elected species reads on claims 1-20.
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Claims 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 11, 2026.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 09/08/2022 has been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The claim set filed September 08, 2022 has been entered. Claims 21-22 are withdrawn from further consideration as being drawn to a nonelected species as discussed in greater detail in the Election/Restrictions section above.
Thus, claims 1-20 are examined on the merits herein.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 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.
(I) Claim 1, pg. 87, line 6 – pg. 90, line 30 recites the limitation of “In one aspect, the present application provides compounds of Formula (II)”, however, the Examiner respectfully notes claim 1 is drawn to a pharmaceutical composition comprising a pharmaceutically acceptable salt of a compound of Formula I and not of Formula II as discussed above.
Additionally, the Examiner respectfully notes Formula (II) as recited above is only recited within claim 1 and is not recited within any other claim within the claim set filed September 08, 2022.
Moreover, the Examiner respectfully notes the recited limitation of Formula (II) as discussed above appears to be text copied/pasted from the specification (see pg. 7, line 5 – pg. 10, line 29).
Therefore, in view of the foregoing reasons above, since the Examiner respectfully notes claim 1 recites Formula (II); consequently the Examiner reasonably interprets claim 1 is unclear and indefinite as to whether or not the pharmaceutical composition recited within claim 1 also comprises Formula (II) as recited above.
Claims 2-15 are included in this rejection as they either depend from or rely on the pharmaceutical composition of claim 1.
In the interest of compact prosecution and for the purposes of applying prior art the Examiner reasonably interprets the pharmaceutical composition recited within claim 1 only requires a pharmaceutically acceptable salt of a compound of Formula (I), especially in view of the elected compound of Formula (I) as recited within the Election/Restrictions section discussed in greater detail above.
(II) Claim 15, line 2, recites “wherein a melt and decompression onset is near 222°C”. The Examiner respectfully notes the physical limitation as recited within the claim above is not expressly associated within any structural element within the pharmaceutical composition.
Accordingly, it’s unclear and indefinite to the Examiner how this physical characteristic is supposed to be interpreted in view of claims 1 and 4 respectively.
Moreover, the Examiner respectfully notes claim 15 depends from claim 4, and wherein claim 4 relies on claim 1. Therefore, it’s unclear and indefinite as to what structure within the pharmaceutical composition of claim 15 corresponds to the physical limitation as recited within claim 15, line 2.
For example, is the physical limitation recited above within claim 15, line 2 associated with the choline salt of Compound I-4 already recited within claim 4; or is it associated with the pharmaceutical composition as a whole in view of claim 1 reciting a pharmaceutical composition comprising a pharmaceutically acceptable salt of Formula (I).
The Examiner respectfully notes the specification discloses concomitant melt and decompression onset for Form A is near 222°C (see pg. 51, lines 15-20).
Moreover, the specification discloses a choline salt form of TQL-1055 (e.g. Compound I-4) is provided as Form A (see pg. 51, lines 1-2).
Thus, in the interest of compact prosecution and in view of the disclosures above, the Examiner reasonably interprets the physical limitation discussed above is a physical limitation of the choline salt of Compound I-4 as recited within claim 4.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner et al. (Published 01 November 2018, WO-2018200656-A1, IDS filed 09/08/2022) in view of Berge et al. (Published January 1977, Journal of Pharmaceutical Sciences, Vol. 66, Issue 1, pp. 1-19, PTO-892).
Regarding claims 1-20, Garner teaches a pharmaceutical composition comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g. the pharmaceutical composition, required in claim 1, line 1). See pg. 107, claim 1, lines 1-5.
Gardner teaches exemplary compounds of Formula I within Table 1, see pg. 52, lines 15-20. Gardner teaches within Table 1 the compound known as compound I-4 depicted as,
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, see pg. 53, third recited compound.
Gardner teaches the pharmaceutical composition is formulated together with one or more pharmaceutically acceptable carriers, see pg. 23, lines 5-10. Garner teaches said carrier is used herein to mean a pharmaceutically acceptable material, composition, vehicle, such as a liquid filler, diluent, excipient, or solvent encapsulating material, see pg. 23, lines 15-20.
Gardner exemplifies said pharmaceutically acceptable carrier as including pyrogen-free water (e.g. the liquid formulation, required in claim 16, line 1; and the solvent required in claim 17, line 4); pH buffered solutions (e.g. the buffer, required in claim 18); sorbitol and mannitol (e.g. the excipient, required in claim 19), see pg. 23, lines 15-30.
Gardner teaches “pharmaceutically acceptable salts” refers to the relatively non-toxic, inorganic and organic base addition salts of the compounds of Gardner, see pg. 24, lines 20-25.
Garner teaches these salts can likewise be prepared by separately reacting the purified compound in its free form with a suitable base for example a pharmaceutically acceptable quaternary amine; wherein salts derived from appropriate bases include ammonium and N+(C1-4 alkyl)4 salts, see pg. 24, lines 20-30.
Gardner teaches representative organic amines useful for the formation of base addition salts include ethanolamine, see pg. 24, last line of the page – pg. 25, line 1.
Gardner teaches pharmaceutically acceptable salts are well known in the art. For example, S.M. Berge et al., describe pharmaceutically acceptable salts in detail in J. Pharmaceutical Sciences, 1977, 66, 1-19, incorporated herein by reference. See pg. 24, lines 1-4.
Although, the Examiner respectfully notes Gardner does not teach the elected choline salt of compound I-4, as required in claims 2-15 and 20.
However, in the same field of endeavor of the state of the art regarding pharmaceutical salts, Berge teaches choline salts are commercially-marketed salts that are FDA-approved, see pg. 2, Table 1.
Berge teaches the appropriate choice of a salt form has been found to reduce toxicity, and wherein Berge exemplifies certain salts of the strong base choline have proven to be considerably less toxic than their parent compound, see pg. 3, right column, paragraph 2. Berge further exemplifies choline as an almost completely non-toxic substance of actual importance to the physiological economy, see pg. 3, right column, paragraph 2.
Accordingly, in view of the teachings of Berge, the Examiner respectfully notes Berge proposes choline salts are an advantageous component in pharmaceutically acceptable salts in view of the salts of the strong base choline being proven to be considerably less toxic than their parent compound. Moreover, the Examiner respectfully notes the Berge reference discussed above is the identical reference Gardner teaches and incorporates by reference as written above.
Consequently, it would have been prima facie obvious to one of ordinary skill in the art at the invention’s effective filing date to have incorporated the choline salt as taught by Berge above into the pharmaceutically acceptable salt of Formula (I) of Gardner as discussed above, wherein the Examiner respectfully notes Gardner exemplifies Compound I-4 as the compound of Formula (I) above, as within the scope of the artisan as combining prior art elements according to known compounds to yield predictable results.
One of ordinary skill in the art would have been motivated to synthesize the choline salt of Compound I-4 of Gardner because Berge teaches choline is an FDA approved pharmaceutically acceptable salt which may reduce the toxicity of the parent compound as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to incorporate the teachings of Berge into the compounds of Gardner, because Gardner teaches the compounds of Formula (I) may be in the form of pharmaceutically acceptable salts including quaternary ammonium salts derived from ethanolamine, wherein the Examiner respectfully notes choline is a quaternary ammonium salt of ethanolamine.
Additionally, with respect to all limitations recited within claims 3-15, the Examiner reasonably interprets all of these limitations recited within each of these claims are all physical characteristics of the choline salt of Compound I-4. Since the combination of Gardner and Berge teach the choline salt of Compound I-4 as discussed above, all limitations recited within claims 3-15 are met by the combined teachings of Gardner and Berge as discussed above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the choline salt of Berge into the pharmaceutically acceptable salt of Compound I-4 of Gardner as discussed above as within the scope of the artisan as combining prior art elements according to known compounds to yield predictable results. One of ordinary skill in the art would have been motivated to incorporate the teachings of Berge as discussed above in order to make the pharmaceutically acceptable salt of Compound I-4 of Gardner; and more particularly motivated to make the choline salt of Compound I-4; because Berge teaches choline salts have been proven to be considerably less toxic than their parent compound as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success of incorporating the teachings of Berge into the compounds of Gardner as discussed above, because Gardner teaches Compound I-4 can be in the form of a pharmaceutically acceptable salt as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined 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 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.
(I) Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 22 and 25 of copending Application No. 17/774,637 (amended claim set filed 11/17/2025; Applicant: Adjuvance Technologies, Inc., application filed November 04, 2020, Notice of Allowability mailed 03/09/2026) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a pharmaceutical composition comprising a choline salt of Compound I-4.
Reference claim 1 recites an immunogenic composition comprising a varicella zoster virus antigen, wherein the varicella zoster virus antigen has the sequence of SEQ ID No. 9 and a compound of Formula I-4 or a pharmaceutically acceptable salt thereof.
Reference claim 4 recites wherein the compound of Formula I-4 is in choline salt form.
Reference claim 22 recites a method of increasing cell-mediated immunity in a patient by administering an immunogenic composition comprising said antigen and said compound of Formula I-4.
Reference claim 25 recites wherein said compound I-4 is in choline salt form.
With respect to all limitations recited within instant claims 3-15, the Examiner reasonably interprets all of these limitations recited within each of these instant claims are all physical characteristics of the choline salt of Compound I-4. Since ‘637 recites the choline salt of Compound I-4 as discussed above all limitations recited within instant claims 3-15 are met by the recitations of ‘637 as discussed above.
Although, the Examiner respectfully notes ‘637 recites an immunogenic composition, while instant claim 1 recites a pharmaceutical composition.
However, the Examiner respectfully notes neither the reference specification nor the instant specification expressly define their respective immunogenic or pharmaceutical composition.
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have formulated the recited immunogenic composition of reference claim 1 of ‘637 as a pharmaceutical composition as required within instant claim 1 because one of ordinary skill in the art would have understood the immunogenic composition of reference claim 1 and the pharmaceutical composition of instant claim 1 are both pharmaceutical compositions as ‘637 further recites within reference claim 22 administering an immunogenic composition comprising a choline salt of Compound I-4 to a patient. Therefore, the immunogenic composition of reference claim 1 is also a pharmaceutical composition because it’s a drug product as formulated for administration to the patient as recited within reference claim 22.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(II) Claims 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 22 and 25 of copending Application No. 17/774,637 (amended claim set filed 11/17/2025; Applicant: Adjuvance Technologies, Inc., application filed November 04, 2020, Notice of Allowability mailed 03/09/2026) in view of Gardner et al. (Published 01 November 2018, WO-2018200656-A1, IDS filed 09/08/2022). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a liquid composition comprising a choline salt of Compound I-4.
‘637 recites as written above. Although, ‘637 does not recite the liquid composition required in claims 16-20.
However, in the same filed of endeavor of compositions comprising Compound I-4, Garner teaches a pharmaceutical composition comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, see pg. 107, claim 1, lines 1-5.
Gardner teaches exemplary compounds of Formula I within Table 1, see pg. 52, lines 15-20. Gardner teaches within Table 1 the compound known as compound I-4 depicted as,
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, see pg. 53, third recited compound.
Gardner teaches the pharmaceutical composition is formulated together with one or more pharmaceutically acceptable carriers, see pg. 23, lines 5-10. Garner teaches said carrier is used herein to mean a pharmaceutically acceptable material, composition, vehicle, such as a liquid filler, diluent, excipient, or solvent encapsulating material, see pg. 23, lines 15-20.
Gardner exemplifies said pharmaceutically acceptable carrier as including pyrogen-free water (e.g. the liquid formulation, required in instant claim 16, line 1; and the solvent required in instant claim 17, line 4); pH buffered solutions (e.g. the buffer, required in instant claim 18); sorbitol and mannitol (e.g. the excipient, required in instant claim 19), see pg. 23, lines 15-30.
Gardner teaches a vaccine comprising an antigen associated with varicella zoster with an adjuvant containing compound I-4, see pg. 77, lines 5-10.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the teachings of Gardner into the compositions and methods recited by ‘637 as combining prior art elements according to known compositions to yield predictable results. One of ordinary skill in the art would have been motivated to create the immunogenic composition containing the varicella zoster antigen and Compound I-4 as recited by ‘637; as a pharmaceutical composition as taught by Garner above. One of ordinary skill in the art would have had a reasonable expectation of success to incorporate the teachings of Gardner into the immunogenic composition of ‘637, because both ‘637 and Gardner are drawn to compositions comprising a varicella zoster antigen and compound I-4 as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed in this 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.
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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.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691