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 filing dated June 18, 2026.
Status of Claims
Claims 1-11 are currently pending and are the subject of this office action.
Claims 1-11 are presently under examination.
Priority
The present application is a 371 of PCT/KR2022/007479 filed on 05/26/2022 and claims priority to foreign application KOREA KR10-2021-0067636 filed on 05/26/2021 and claims priority to foreign application KOREA KR10-2022-0064451 filed on 05/26/2022.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (Maintained Rejection).
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) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et. al. (US10,100,010) and (Kim et. al. (WO 2017/164575, September 28, 2017, cited by Applicant), in view of Mehmood et. al. (Open Science (2015) 3:19-27, cited by Applicant) and in view of Loftsson et. al. (Journal of Pharmaceutical Sciences (1996) 85:1017-1025, cited by Applicant).
For claims 1, 6 and 10, Lee teaches compounds of Formula I:
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and in particular compound of example 8 (see column 17):
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which is identical to the instant compound of Formula 1).
Lee further teaches pharmaceutical compositions of the above compounds, wherein the compositions are suitable for parenteral administration such as injection. The pH of the formulations should be suitable adjusted. The composition may be in the form of an aqueous solution containing pharmaceutically acceptable carriers. For intravenous administration, the total concentration of solutes should be controlled in order to render the preparation isotonic (see column 13, line 4-45).
Kim also teaches the above compound and shows that the free base has very low solubility in water (see Table 4 on page 16).
Neither Lee nor Kim teaches the presence of cyclodextrin or a pH of 4.0 to 6.0 (Claim 1) or 5.0 to 6.0 (claim 6). However, Mehmood teaches that pharmaceutical excipients like isotonic agents (see section 3.1 on page 21) and cyclodextrins (see section 3.4 on page 21) are commonly used in injectable formulations. Further, Mehmood teaches that for parenteral preparations, it is desirable that the product pH be close to physiologic pH (see page 22, bottom of the page). Ph between 7.3 and 7.5 is considered a physiological pH.
Finally, Loftsson teaches that cyclodextrins help the solubilization of low water-soluble drugs and their stabilization (see entire document).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to formulate the above compound of Formula 1 as an injectable formulation (as disclosed by Lee and by Kim) with isotonic agents (as disclosed by Lee and by Mehmood) and with cyclodextrin (as disclosed by Mehmood and Loftsson) in order to improve the poor water solubility of the above compound (as disclosed by Kim).
Finally, knowing that the pH of injectable solutions should be close to physiological pH (7.3-7.5), the skilled in the art should be able to optimize the pH of the solution in order to achieve better solubility and stability as taught by Mehmood. Further the pH of 4.0 to 6.0 (Claim 1) or 5.0 to 6.0 (Claim 6) claimed is very close to the physiological pH (7.3-7.5).
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claims 1, 6 and 10 with a reasonable expectation of success.
For claim 2, Loftsson teaches that the cyclodextrin could be (2-hydroxypropyl)-beta-cyclodextrin (see page 1018, left column8, lines before the bottom), thus resulting in the practice of claim 2 with a reasonable expectation of success.
For claim 3, Loftsson teaches the solubility enhancement of different cyclodextrin for different drugs at different cyclodextrin concentrations (see table 5 on page 1021 and under Drug Solubilization on page 1020), and since dose formulation is routine practice in the pharmaceutical art, before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to achieve the optimal cyclodextrin/drug ratio in order to obtain an injectable formulation with the best solubility and stability, thus resulting in the practice of claim 3 with a reasonable expectation of success.
For claim 4, Mehmood teaches glycerin and mannitol among the isotonic agents that can be present in injectable formulations (see section 3.1 on page 21), thus resulting in the practice of claim 4 with a reasonable expectation of success.
For claim 5, Lee teaches that for intravenous administration, the total concentration of solutes should be controlled in order to render the preparation isotonic (see column 13, line 4-45). Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to control the osmolarity of the injectable formulation in order to render the preparation isotonic as required by Lee, thus resulting in the practice of claim 5 with a reasonable expectation of success.
For claim 7, none of the references requires the absolute presence of pH adjusting agents, thus resulting in the practice of claim 7 with a reasonable expectation of success.
For claim 8, Mehmood teaches that mannitol is an important agent for lyophilization of formulations (see section 2.1 on page 20), thus resulting in the practice of claim 8 with a reasonable expectation of success.
For claim 9, the prior art does not teach the exact freeze-drying aid to chemical formula 1 ratio. However, optimizing the amount of each excipient to obtain the best possible formulation is no more than routine experimentation, thus resulting in the practice of claim 9 with a reasonable expectation of success.
For claim 11, the prior art does not teach the exact concentration of the chemical formula 1. However, optimizing the amount of drug present in a formulation to obtain the best possible formulation is no more than routine experimentation, thus resulting in the practice of claim 11 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Examiner’s response:
First: Mehmood and Loftsson teach what is routine practice in the pharmaceutical art: that cyclodextrins are commonly used in the pharmaceutical industry to formulate drugs with poor solubility, like the instantly claimed compound. Both references are reviews of commonly used excipients in pharmaceutical formulations. The fact that none of them mentions the instantly claimed compound is irrelevant, since both references can be applied to a multitude of drugs, including the instant one. The skilled in the art knowing the low solubility of the instantly claimed compound will be motivated by the teachings of Mehmood and Loftsson to increase its solubility by formulating it with cyclodextrin and with isotonic agents which are commonly used in injectable formulations.
Second, the fact that some drugs make better complexes with cyclodextrin than others (Loftsson) will not deter the skilled in the art to try the different cyclodextrins available to optimize the solubility of the instantly claimed compound. Further, the fact that some drugs behave better than others does not mean that Loftsson teaches against the fact that cyclodextrin can still make a good complex with the instantly claimed compound. In fact, Loftsson teaches how to enhance complexation with cyclodextrins (see page 1021, left column, second paragraph).
Double Patenting (Maintained Rejections)
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.
1) Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/774,888 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both, the instant application and the co-pending application claim similar or identical formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Examiner’s response:
Due to the use of the word comprising, the instant claims do not exclude a “bulking agent for freeze drying”. So, the 17/774,888 application still teaches a formulation “comprising” the instant compound, cyclodextrin, mannitol and similar pH.
2) Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/560,955 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both, the instant application and the co-pending application claim similar or identical formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Examiner’s response:
First, the instant claims, due to the use of the word comprising, do not exclude containers.
Second, even if the instant claims would have excluded a container, the formulation of Application 18/560,955 still comprises a very similar formulation: same compound, same isotonizing agents, cyclodextrin, same pH, etc., as such, the instantly claimed formulations will be more than obvious over the formulation of application 18/560,955.
Conclusion
No claims are allowed.
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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 21, 2026.
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