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
Status of 17/779,893
Claims 1-20 are currently pending.
Priority
Instant application 17/779,893, filed 5/25/2022, claims priority as follows:
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Provisional application 62/940,514 contains support for the instant claims, and thus, claims 1-20 are granted the effective filing date of 11/26/2019.
Information Disclosure Statement
All references from the IDS’s submitted 8/16/2022, 12/19/2022, and 1/24/2023 have been considered unless marked with a strikethrough.
Objection to Abstract
The abstract is objected to due to insufficient length. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. Appropriate correction is required.
Objection to Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figures 3-7, 9-12, 14-24, and 26-30 are not able to be interpreted as they are in black and white. It is unclear what lines correspond to the labels in the drawings. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Election/Restriction
Applicant’s election of Group I, claims 1-16, drawn to formulations comprising compound A and a pharmaceutically acceptable polymer, and unit dosage forms comprising a formulation of compound A and said polymer, in the reply filed 6/27/2025 is acknowledged. Applicant’s election of the single species of formulation as Formulation 12 from Table 16:
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Where compound A is the free base, and Acetone:Water 89:11 is the spray solvent. Further, Applicant’s election of the unit dosage form K9-983-37 from Table 34:
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in the reply filed 6/27/2025, is also 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. See MPEP § 818.01(a).
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species of the formulation was search and prior art was identified. See the 103 below. Because the spray solvent is a part of the spray drying process and not the spray dried intermediate formulation of the instant claims, the acetone:water combination was not searched. Additionally, the elected unit dosage formulation was not able to be fully searched as many of the elected components are trademarks/trade names and do not identify or describe the goods associated with the trademarks or trade names. Thus, the search was expanded to the generic versions of the compounds of the elected species and prior art was identified. Specifically, microcrystalline cellulose (MCC), lactose, croscarmellose sodium, silica, polyvinylpyrrolidinone, and sodium stearyl fumarate were searched. See the 103 below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-2, 4-8, and 10-14 read on the elected and expanded species. Claims 3, 9, and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
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 12 and 13 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.
Claims 12 and 13 contain the trademarks/trade names “Ac-Di-Sol” and “Cab-O-Sil”, respectively. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe components of the unit dosage form and, accordingly, the identification/description is indefinite.
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.
Claims 1-2, 4-8, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kyn Therapeutics (WO 2018/195397 A2, cited in the IDS of 8/16/2022, herein after “Kyn”) and further in view of Friesen (Friesen, D. T., et. al. Molecular Pharmaceutics. 2008, 5(6), 1003-1019). This rejection applies to the elected and the expanded species.
Determining the scope and contents of the prior art
The reference Kyn teaches compounds as aryl hydrocarbon receptor (AHR) inhibitors, compositions thereof, and methods of using thereof (abstract). Specifically, Kyn teaches compound I-40 (page 45, Table 1):
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Which is the same compound as instant compound A, of claim 1. Further, Kyn teaches that the invention encompasses a composition comprising a compound of the invention, or a pharmaceutically acceptable salt, ester, or salt of ester thereof, and a pharmaceutically acceptable carrier, adjuvant, or vehicle (page 74, para [0079]). The pharmaceutically acceptable carrier, adjuvant, or vehicle is further defined as a non-toxic carrier, adjuvant, or vehicle that does not destroy the pharmacological activity of the compound with which it is formulated, and includes examples such as polymers (page 74, para [0081]).
With respect to the unit dosage form claims elected, claims 8 and 10-14, the reference Kyn teaches that pharmaceutically acceptable compositions of this invention may be orally administered in tablets (page 75, para [0085]), which is a unit dosage form described in the instant specification (page 22, para [00123]), and further teaches that the tablets can be prepared with coatings and shells such as release controlling coatings (page 81, para [00108]), which satisfies the limitation of instant claim 10. Kyn additionally teaches the expanded species components of microcrystalline cellulose (page 81, para [00108]), lactose (page 81, para [00106]), cellulose-base substances (page 74, para [0081]), silicates (page 81, para [00106]), polyvinylpyrrolidinone (page 81, para [00106]), and sodium stearyl fumarate, under the teaching of a pharmaceutically acceptable carrier, adjuvant, or vehicle is further defined as a non-toxic carrier, adjuvant, or vehicle that does not destroy the pharmacological activity of the compound with which it is formulated (page 74, para [0081]).
The reference Friesen teaches spray-dried dispersions (SDD’s) of low solubility drugs that have been prepared using HPMCAS (abstract), and specifically the grade HMPCAS-M (page 1005, “Materials”). The SDD’s provide supersaturation in in vitro dissolution determinations and large bioavailability increases in vivo (abstract). Friesen teaches various free base compounds in SDD’s and includes examples of a 25 wt. % Compound 1/HMPCAS-M SDD and a 67 wt. % Compound 2/HPMCAS-M, indicating that HMPCAS-M based spray dried dispersions are compatible with different compounds at different concentrations (page 1010, Figure 2).
Ascertaining the differences between the prior art and the claims at issue
Kyn fails to teach the polymer HMPCAS-M in the designated wt. %, whereas Friesen fails to teach compound A of the instant claims and the additional unit dosage formulation.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of spray dry intermediate formulations comprising AHR inhibitors. An artisan possess the technical knowledge necessary to make adjustments to the formulations to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said spray dry intermediate formulations comprising AHR inhibitors and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to combine the teachings of Kyn and Friesen to arrive at the limitations of the instant claims because compositions of Compound A and spray dry dispersions of compounds with HMPCAS-M at varying concentrations are known in the art. One of ordinary skill in the art would have reasonably predicted that compound A would be successful because the reference Kyn teaches compound A in a pharmaceutical composition, and Friesen teaches multiple compounds formulated in spray dry dispersions with HMPCAS-M at varying concentrations. Further, a skilled artisan would have been motivated before the effective filing date to combine the teachings of Kyn and Friesen to identify additional formulations of AHR inhibitor compound A and ultimately to treat cancer. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions, a prima facie case of obviousness exists.
With respect to claims 5-7, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the concentrations of compound A and the pharmaceutically acceptable polymer HMPCAS-M recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal spray dry intermediate dispersions. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of a pharmaceutically acceptable polymer, HMPCAS-M, in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize, as is the amount of compound A. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the ratios of a compound and HMPCAS-M, disclosed by Friesen above, provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal ratio of compound A and HMPCAS-M to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
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.
The Examiner notes that upon expansion of the species, additional double patenting rejections will become available.
Claims 1-2 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 14-15 of U.S. Patent No. 10,570,138. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘138 patent recite compound A, and compositions thereof additionally comprising a pharmaceutically acceptable carrier, adjuvant, or vehicle.
Claims 1-2 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-19 of U.S. Patent No. 12,077,542. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘542 patent recite compound A, and compositions thereof additionally comprising a pharmaceutically acceptable carrier, adjuvant, or vehicle.
Conclusion
Claims 1-2, 4-8, and 10-14 are rejected. Claims 3, 9, and 15-20 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621