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 .
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.
Election/Restrictions
Applicant’s election without traverse of a HCl salt of compound 2:
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, in the reply filed on 20 November 2025, is acknowledged.
A search for the elected species retrieved prior art.
Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species in this Office Action.
The elected species reads on claims 212-215, 220, 222, and 224.
Realize that claim 1 and claims that depend on claim 1 (such as claims 2, 208-211, 219, 221, 223) are not subject to the Election of Species Requirement and are also examined in this Office Action. Examiner has added claim 225 in the interests of compact prosecution to the list of claims that are examined in this Office Action.
Claims 216-218 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 20 November 2025.
Current Status of 18/007,726
This Office Action is responsive to amended claims 1 December 2022.
Claims 1-2, 208-215, and 219-225 have been examined on the merits. Claims 1-2 are original. Claims 208-215, and 219-225 are new.
Priority
The effective filing date is 4 June 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7 January 2026; 19 August 2024; 8 December 2023; and 1 December 2022, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 225 is objected to as it has the name of each disease surrounded by parentheticals and the abbreviation not surrounded by parentheticals. Normally, claims are to be drafted with the limitation, for example: “mild cognitive impairment” not surrounded by parentheticals, followed by the abbreviation within parentheticals. This does not rise to the level of an indefiniteness rejection because the artisan understands what is being claimed. However, please revise accordingly into proper drafting style.
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.
Claim 2, 210-211, and 219-225 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.
Claim 2 recites the limitations: “The crystalline solid form” AND “said compound". There is insufficient antecedent basis for these limitations in the claim.
As drafted, “The crystalline solid form” AND “said compound” within claim 2 renders the metes and bounds of claim 2 undefined (hence rendering claim 2 indefinite under 35 USC 112(b)). The artisan has no idea where antecedent basis can be found for any one of: “The crystalline solid form” AND “said/the compound” since claim 2 depends on non-existent claim 0. Perhaps Applicants intend claim 2 to refer back to claim 1?
The term “substantially as shown”/”substantially similar” in claims 210-211 is a relative term which renders the claims indefinite under 35 USC 112(b). The term “substantially as shown”/”substantially similar” is not defined by the claims 210-211, 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. Hence, the term “substantially as shown”/”substantially similar” renders the metes and bounds of claims 210-211 undefined (hence rendering claims 210-211 indefinite under 35 USC 112(b)) since there is no definition or standard within the claims and/or Specification for “substantially as shown”/”substantially similar” to ascertain what is meant by “substantially as shown”/”substantially similar”. Please strike “substantially” within the rejected claims 210-211 to render moot this rejection.
Claim 219 recites the limitation "or salt form according to claim 1". There is insufficient antecedent basis for this limitation in the claim.
As drafted, “or salt form according to claim 1” renders the metes and bounds of claim 219 undefined (hence rendering claim 219 indefinite under 35 USC 112(b)) since the artisan has no idea where antecedent basis can be found to “the salt form” within claim 1; claim 1 is silent as to “a salt form”. Rather, claim 1 is drawn to “a crystalline solid form…Form A or Form B”. Examiner recommends striking “or the salt form” within any claim that refers back to claim 1 or any claim that depends from claim 1 since claim 1 is silent as to “salt forms”.
Claims 221 and 223 are similarly rejected as indefinite under 35 USC 112(b) for the same rationale as above.
Claim 220 recites the limitation "a crystalline solid form according to claim 212". There is insufficient antecedent basis for this limitation in the claim.
As drafted, “a crystalline solid form according to claim 212” renders the metes and bounds of claim 220 undefined (hence rendering claim 220 indefinite under 35 USC 112(b)) since the artisan has no idea where antecedent basis can be found to “the crystalline solid form” within claim 212; claim 212 is silent as to “a crystalline solid form”. Rather, claim 212 is drawn to “A salt form… ”. Examiner recommends striking “a crystalline solid form” within any claim that refers back to claim 212 or any claim that depends from claim 212 since claim 212 is silent as to “crystalline solid forms”.
Claims 222 and 224 are similarly rejected as indefinite under 35 USC 112(b) for the same rationale as above.
Claim 225 recites the limitation "the beta1-adrenergic receptor or beta2-adrenergic receptor mediated disease or disorder". There is insufficient antecedent basis for these limitations in the claim.
As drafted, the limitation "the beta1-adrenergic receptor or beta2-adrenergic receptor mediated disease or disorder" renders the metes and bounds of claim 225 undefined (hence rendering claim 225 indefinite under 35 USC 112(b)). The artisan does not know where antecedent basis can be found for “the beta1-adrenergic receptor or beta2-adrenergic receptor mediated disease or disorder" of claim 225. This might be resolved by changing the dependency of claim 225 (claim 225 currently depends on non-existent “claim 0”) so that claim 225 is revised to depend on claim 224.
The limitation “etc” (third line up from the bottom) renders the metes and bounds of claim 225 undefined (hence rendering claim 225 indefinite under 35 USC 112(b)). The artisan does not know what undisclosed limitations are encompassed by “etc.”. Please strike “etc” to render moot this rejection.
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 2, 208-211, and 225 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.
Dependent claim 2, which purports to depend from/refer back to “claim 0”, is rejected under 35 USC 112(d). Claim 0 is a non-existent claim number. A dependent claim cannot depend from a non-existent claim number.
Dependent claims 208-211 are rejected under 35 USC 112(d). Claims 208-211 do not further limit parent claim 1 since claim 1 refers to “Form A” or “Form B”, which inherently contains all the elements found in the claims 208-211. Thus, claim 1 necessarily will have the DSC and XRPD data recited in claims 208-211; if claim 1 did not have the DSC and XRPD recited within claims 208-211, it would not be “Form A” or “Form B”. Please cancel claims 208-211 to render moot this rejection. Also note that if Applicants amend claim 2 to depend on claim 1, then technically, that amended claim 2 can be rejected under 35 USC 112(d) in the next Office Action for the same rationale as above: that it would disclose the properties that are inherently disclosed within claim 1 and hence not truly further limit claim 1.
Dependent claim 225, which purports to depend from/refer back to “claim 0”, is rejected under 35 USC 112(d). Claim 0 is a non-existent claim number. A dependent claim cannot depend from a non-existent claim number.
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.
Claim Rejections - 35 USC § 102
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)(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.
Claims 212-215, 220, 222, and 224-225 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by:
CURASEN (WO 2020/198466 A1, Applicant provided reference-see IDS of 19 August 2024, with effectively filed date of 27 March 2019 from U.S. Provisional 62/824,876 hereinafter referred to as “priority”),
as evidenced by:
BERGE (Berge, Stephen M., et al. “Pharmaceutical Salts.” J. Pharm. Sciences. (January 1977), Vol. 66, No. 1, pp. 1-19).
The applied reference CURASEN has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The prior art reference CURASEN teaches the medicinal compound:
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, or a pharmaceutically acceptable salt thereof (see paragraph [0028]; priority Specification page 37). Furthermore, “hydrochloride” salt is an alternative embodiment of “pharmaceutically acceptable salt” (see para [0085]; priority Specification para [0056]). This anticipates instant claims 212-213.
The reference BERGE is relied upon for the beneficial teachings that “salt forms are crystalline solids” (page 2) and therefore, CURASEN as evidenced by BERGE anticipate instant claim 214.
Furthermore, CURASEN is silent as to “amorphous compound 2” and therefore necessarily anticipates instant claim 215.
CURASEN also teaches a pharmaceutical composition thereof further comprising a pharmaceutically acceptable carrier or excipient (para [00222] and [00252]; priority Specification para [0081]). This anticipates instant claim 220.
CURASEN teaches a method of modulating the activity of beta-1 adrenergic receptor and/or beta-2 adrenergic receptors in a patient comprising administering a HCl crystalline solid form (para [00219]-[00220] and [00235]; priority Specification para [0025]-[0029]). This anticipates instant claim 222.
CURASEN Para [0032]-[0034] (priority Specification para [0025]-[0029]) teaches a method of use of the HCl crystalline salt form, above, to treat the beta-1 adrenergic receptor and beta-2 adrenergic receptor-mediated diseases of instant claims 224-225.
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 212-215, 220, 222, and 224-225 are rejected under 35 U.S.C. 103 as being obvious over:
CURASEN (WO 2020/198466 A1, Applicant provided reference-see IDS of 19 August 2024, with effectively filed date of 27 March 2019 from U.S. Provisional 62/824,876 hereinafter referred to as “priority”),
in view of:
BERGE (Berge, Stephen M., et al. “Pharmaceutical Salts.” J. Pharm. Sciences. (January 1977), Vol. 66, No. 1, pp. 1-19).
The applied reference CURASEN has a common inventor and/or assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
This obviousness rejection is written as an alternative to the anticipatory prior art rejection, above.
Determining the scope and contents of the prior art:
The prior art reference CURASEN teaches a medicinal compound:
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(“underlying medicinal agent/compound”), that can be paired with a pharmaceutically acceptable salt (see paragraph [0028]; priority Specification page 37).
Furthermore, CURASEN is silent as to “amorphous compound 2” and therefore necessarily teaches instant claim 215.
BERGE teaches that “hydrochloride” (HCl) salt is a well-known FDA approved commercially marketed “pharmaceutically acceptable salt” (see Table I on page 2). This helps to teach instant claims 212-213.
BERGE teaches that pharmaceutically acceptable salts like HCl are chosen to manipulate the chemical, biological, physical, and economic characteristics of the underlying medicinal agents (see page 1).
Ascertaining the differences between the prior art and the claims at issue:
While CURASEN teaches the underlying medicinal compound:
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, and that the underlying medicinal agent can be paired with “a pharmaceutically acceptable salt” (see paragraph [0028]; priority Specification page 37), it teaches “hydrochloride” salt as one of a plurality of embodiments of “pharmaceutically acceptable salts” (see para [0085]; priority Specification para [0056]).
While BERGE teaches HCl salt as a well-known FDA approved commercially marketed “pharmaceutically acceptable salt” (see Table I on page 2); and while BERGE teaches that pharmaceutically acceptable salts like HCl are chosen to manipulate the chemical, biological, physical, and economic characteristics of underlying medicinal agents (see page 1), BERGE is silent as to the underlying compound disclosed within instant claim 212.
Resolving the level of ordinary skill in the pertinent art:
The artisan is knowledgeable in admixing medicinal compounds with pharmaceutically acceptable salts to form pharmaceutical compositions comprising medicinal agent and salt. Furthermore, the artisan is knowledgeable in pairing a pharmaceutically acceptable salts with underlying medicinal agents to manipulate the chemical, biological, physical, and economic characteristics of medicinal agents.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
The artisan would find the HCl salt of instant claim 212 prima facie obvious in light of the teachings of CURASEN in view of BERGE.
The artisan would be expected to mix the medicinal agent
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(which is taught in the prior art CURASEN reference to be paired with a pharmaceutically acceptable salt thereof (see paragraph [0028]; priority Specification page 37)) with the pharmaceutically acceptable salt hydrochloride (HCl) to form
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since HCl is a well-known FDA approved commercially marketed pharmaceutically acceptable salt (BERGE-see Table I on page 2).
The artisan would be motivated to pair the HCl salt of BERGE Table I page 2 with the CURASEN medicinal agent
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(CURASEN paragraph [0028]; priority Specification page 37) since pairing well-known pharmaceutically acceptable salts like HCl with medicinal agents permits the artisan to manipulate the chemical, biological, physical, and economic characteristics of the underlying medicinal agents (BERGE page 1). Thus this teaches instant claims 212-213. Furthermore, the salt form thus created would be crystalline (“salt forms are crystalline solids” (BERGE page 2)). This teaches instant claim 214.
CURASEN also teaches a pharmaceutical composition thereof further comprising a pharmaceutically acceptable carrier or excipient (para [00222] and [00252]; priority Specification para [0081]). This teaches instant claim 220.
CURASEN teaches a method of modulating the activity of beta-1 adrenergic receptor and/or beta-2 adrenergic receptors in a patient comprising administering the HCl crystalline solid form (para [00219]-[00220] and [00235]; priority Specification para [0025]-[0029]). This teaches instant claim 222.
CURASEN Para [0032]-[0034] (priority Specification para [0025]-[0029]) teaches a method of use of the HCl crystalline salt form, above, to treat the beta-1 adrenergic receptor and beta-2 adrenergic receptor-mediated diseases of instant claims 224-225.
Conclusion
Claims 2, 208-215, and 219-225 are not presently allowable as written.
The instant claim 1 is presently allowable as written.
A search for instant claim 1 does not retrieve any prior art in which Form A or Form B is made in the same manner as the instant invention.
The U.S. 11,040,944 B2 is not a double patent reference as the claims are not drawn to a polymorph of claim 1 and/or any of the salts of claim 212.
The US 12,448,352 is drawn to a distinct compound and therefore is not a double patent reference.
The instant Specification paragraph [0061] and [0089] each define “substantially free of amorphous compound” and hence no indefiniteness rejection is made against “substantially” within claim 2 or claim 215.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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