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
Claims 1-31 are pending in the application. Claims 1-31 are rejected.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/FI2023/050047, filed January 23rd, 2023, which claims priority under 35 U.S.C. 119(a-d) to FI20225050, filed January 24th, 2022.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on July 23rd, 2024.
Notes on Claim Construction
Various methods of making claims refer to the term “the crystalline product” or “crystallization of the product” where the claims do not previously refer to “a crystalline product” or “a product”. At least since the parent claims (which claim products per se) only refer to a single crystalline material that could be considered as “the crystalline product,” or a product subject to crystallization, the Examiner finds that the terms could only be reasonably interpreted in one way, i.e. that “the crystalline product” or “the product” is the only crystalline material previously recited in a particular claim tree. The only claim reciting multiple crystalline forms is instant claim 6 that is dependent upon claim 5 (reciting a crystalline form 3) and where the body of claim 6 refers to crystalline form 1. Claim 6, however, does not have a corresponding dependent method of making claim that refers to “the crystalline product” or “the product”.
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 1-31 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 1, 3, 5, 6, 8, 10, 12, 13, 14, 15 and 16 recite the limitation "the sulfate salt of 2-(5-methoxyisochroman-1-yl)-4,5-dihydro-1H-imidazole" in various locations. There is insufficient antecedent basis for this limitation in the claim. There appear to be two possible meanings of this term: (1) Applicant is using “the” as a means to select a particular counterion out of the genus of potential salt forming agents and (2) Applicant is using “the” to refer to a particular sulfate salt. The two possibilities do not correspond to the same scope since interpretation (1) would appear to be generic to different ratios including a hemisulfate salt. Dependent claims are rejected as indefinite for the same reason. It is suggested that Applicant replace “the sulfate salt of 2-(5-methoxyisochroman-1-yl)-4,5-dihydro-1H-imidazole” with “2-(5-methoxyisochroman-1-yl)-4,5-dihydro-1H-imidazole sulfate”.
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 19, 22, 25, 28 and 31 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. Claims 19, 22, 25, 28 and 31 each recite “wherein the disorder is anxiety.” The parent claims 18, 21, 24, 27 and 30, however, each recite treating “a disorder, condition or disease where…” such that the dependent claims only limit the “disorder” aspect of the parent claims. The term “condition” would still appear to embrace all types of disorders such that the dependent claims would encompass each and every embodiment embraced by the parent claims. Accordingly, the dependent claims do not set forth a narrowing limitation in terms of the scope being treated. 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. It is suggested that Applicant amend claims 19, 22, 25, 28 and 31 to recite “wherein the disorder, condition or disease is anxiety”.
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.
Claim(s) 10 and 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent PGPub No. 2015/0065550 A1 by Koskelainen et al. in view Background Information for the October ACPS Meeting, FDA, 2002 and in further view of Craig et al. International Journal of Pharmaceutics 1999, 179, 179-207.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Koskelainen et al. teach compounds of the following general formula and pharmaceutically acceptable salts thereof (pages 1 and 2):
PNG
media_image1.png
210
208
media_image1.png
Greyscale
.
As an example, Koskelainen et al. teach 2-(5-methoxyisochroman-1-yl)-4,5-dihydro-1H-imidazole sulfate on pages 10 and 11 as example 17, which is the compound recited in instant claim 10.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not teach which physical form 2-(5-methoxyisochroman-1-yl)-4,5-dihydro-1H-imidazole sulfate possessed. Additional limitations of dependent claims are addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
The FDA teaches that compounds in alternative physical forms can have different properties that affect their pharmaceutical properties as follows:
Many pharmaceutical solids can exist in different physical forms. Polymorphism is often characterized as the ability of a drug substance to exist as two or more crystalline phases that have different arrangements and/or conformations of the molecules in the crystal lattice (1). Amorphous solids consist of disordered arrangements of molecules and do not possess a distinguishable crystal lattice. Solvates are crystalline solid adducts containing either stoichiometric or nonstoichiometric amounts of a solvent incorporated within the crystal structure. If the incorporated solvent is water, the solvates are also commonly known as hydrates. Polymorphism refers to the occurrence of different crystalline forms of the same drug substance. Polymorphism in this commentary is defined as in the International Conference on Harmonization (ICH) Guideline Q6A (2), to include solvation products and amorphous forms.
Polymorphs and/or solvates of a pharmaceutical solid can have different chemical and physical properties such as melting point, chemical reactivity, apparent solubility, dissolution rate, optical and electrical properties, vapor pressure, and density. These properties can a direct impact on the processability of drug substances and the quality/performance of drug products, such as stability, dissolution, and bioavailability. A metastable pharmaceutical solid form can change crystalline structure or solvate/desolvate in response to changes in environmental conditions, processing, or over time.
Accordingly, in the interest of applying the compounds disclosed by Koskelainen et al. in the pharmaceutical utilities of the prior art, a person having ordinary skill in the art would have been motivated to prepare as many different polymorphic forms of the prior art to both understand how the products could change depending on storage conditions as noted by the FDA and determine which forms would possess the most useful properties for use in a pharmaceutical setting including an instantly claimed amorphous form. Craig et al. teach processes that can be used to generate amorphous forms including (page 180) freeze and spray drying, grinding and conventional drying.
Regarding instant claim 29, Koskelainen et al. teach pharmaceutical compositions on page 30 (claim 15 of the prior art) with a pharmaceutically acceptable carrier, diluent and/or excipient. Regarding instant claims 30 and 31, Koskelainen et al. teach application in the treatment of conditions where an alpha2A agonist is indicated to be useful on page 30 (claims 12-14 of the prior art) including anxiety (recited in claim 14 of the prior art). A person having ordinary skill in the art seeking to apply the instantly claimed amorphous form would have been motivated to apply it in the compositions utilities taught by Koskelainen et al.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 10 and 29-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,352,346 in view of U.S. Patent PGPub No. 2015/0065550 A1 by Koskelainen et al. in view Background Information for the October ACPS Meeting, FDA, 2002 and in further view of Craig et al. International Journal of Pharmaceutics 1999, 179, 179-207. The claims of the patent are generic to making the compound 2-(5-methoxyisochroman-1-yl)-4,5-dihydro-1H-imidazole sulfate where claim 2 of the patent recites the compound as a product. The rationale under 35 USC 103 is incorporated here by reference. A person having ordinary skill in the art seeking to extend and apply the synthesis method of the patent would have been motivated to prepare an amorphous form thereof and apply it in compositions and methods thereof for the reasons discussed under 35 USC 103.
Claims 10 and 29-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,249,127 in view of U.S. Patent PGPub No. 2015/0065550 A1 by Koskelainen et al. in view Background Information for the October ACPS Meeting, FDA, 2002 and in further view of Craig et al. International Journal of Pharmaceutics 1999, 179, 179-207. Claim 7 of the patent recites 2-(5-methoxyisochroman-1-yl)-4,5-dihydro-1H-imidazole sulfate. The rationale under 35 USC 103 is incorporated here by reference. A person having ordinary skill in the art seeking to apply the compound of the patent would have been motivated to prepare an amorphous form thereof and apply it in compositions and methods thereof for the reasons discussed under 35 USC 103.
Claims 10 and 29-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 17 and 25 of copending Application No. 18/551,059 in view of U.S. Patent PGPub No. 2015/0065550 A1 by Koskelainen et al. in view Background Information for the October ACPS Meeting, FDA, 2002 and in further view of Craig et al. International Journal of Pharmaceutics 1999, 179, 179-207. The claims of the copending case are generic to treating anxiety in an animal by administering tasipimidine or a pharmaceutically acceptable salt, which is generic to the salt discussed under 35 USC 103. The rationale under 35 USC 103 is incorporated here by reference. A person having ordinary skill in the art seeking to apply the method of the copending case would have been motivated to prepare an amorphous form thereof and apply it in compositions and methods thereof for the same reasons as discussed under 35 USC 103.
This is a provisional nonstatutory double patenting rejection.
Claims 10 and 29-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 19 of copending Application No. 18/551,084 in view of U.S. Patent PGPub No. 2015/0065550 A1 by Koskelainen et al. in view Background Information for the October ACPS Meeting, FDA, 2002 and in further view of Craig et al. International Journal of Pharmaceutics 1999, 179, 179-207. The claims of the copending case are generic to treating anxiety in a human by administering tasipimidine or a pharmaceutically acceptable salt, which is generic to the salt discussed under 35 USC 103. The rationale under 35 USC 103 is incorporated here by reference. A person having ordinary skill in the art seeking to apply the method of the copending case would have been motivated to prepare an amorphous form thereof and apply it in compositions and methods thereof for the same reasons as discussed under 35 USC 103.
This is a provisional nonstatutory double patenting rejection.
Claims 10 and 29-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7 and 10-20 of copending Application No. 19/115,955 in view of U.S. Patent PGPub No. 2015/0065550 A1 by Koskelainen et al. in view Background Information for the October ACPS Meeting, FDA, 2002 and in further view of Craig et al. International Journal of Pharmaceutics 1999, 179, 179-207. The claims of the copending case are generic to combinations comprising tasipimidine or a pharmaceutically acceptable salt, which is generic to the salt discussed under 35 USC 103. The rationale under 35 USC 103 is incorporated here by reference. A person having ordinary skill in the art seeking to apply the compositions of the copending case would have been motivated to prepare an amorphous form thereof and apply it in compositions and methods thereof for the same reasons as discussed under 35 USC 103.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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, 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.
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.
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
Prosecution Insights