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 with traverse of Group I, encompassed by claims 1, 3-20, and 26, drawn to the maleate salt of Compound I, in the reply filed on 03/04/2026 is acknowledged. Regarding Groups I and II, the traversal is on the ground(s) that no undue search burden is present. This is not found persuasive because according to MPEP §803, “For purposes on the initial requirement, a serious search burden on the examiner may be prima facie shown by appropriate explanation of separate classification, or separate status in the art, or a different field of search as defined in MPEP §802.02. Similarly, a serious examination burden, for example, may be prima facie shown by appropriate explanation of non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph, and/or 35 U.S.C. 112(a) relevant to one invention that are not relevant to the other invention. A prima facie showing of serious search and/or examination burden may be rebutted by appropriate showings or evidence by the applicant.” As noted in the restriction requirement, Group I and Group II are classified differently (C07C 57/145 versus C07C 59/50), which requires different field of search because of the separate status in the art. Applicant has not pointed to any errors in the Examiner’s analysis of the classification of the different inventions.
Regarding Groups I and each of Groups III-VIII, Applicant traverses on the ground that the uses claimed by each of Groups III-VIII are dependent on the Group I compounds. However, Groups III-VIII are not dependent claims and instead encompass independent uses that do not depend on Group I.
The requirement is still deemed proper and is therefore made FINAL.
In the amendment as filed on 6/5/2026, applicants have amended claim 23; cancelled no claims; and added no new claims. Claims 22-25, 27, and 62-67 are withdrawn based on the restriction requirement. Therefore, claims 1, 3-20, 22-27, and 62-67 are currently pending and claims 1, 3-20, and 26 are presently under examination.
Priority
The instant application claims the benefit of U.S. Provisional Patent Application No.
63/387,884, filed December 16, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 4/5/2024, 4/12/2024, 8/28/2024, 7/24/2025, 1/28/2026, and 6/5/2026 are in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action.
In the IDS filed 06/05/2026, Applicant asserts that co-pending U.S. Application No. 19/372,677 has been placed in the file wrapper as non-patent literature. Examiner could not locate it, and therefore, it has not been considered.
Specification - Drawings
Acknowledgement is made of the drawings received 12/15/2023.
The drawings are objected to because:
In FIGs. 2-4, 6-8, 10, 14-16, 19, the labeling/writing within the thermogram is illegible. In FIGs. 21 and 23, the labeling of each atom in the crystal structure as C1, N4, etc. is illegible. As recited in 37 CFR 1.84:
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Each of claims 15 and 18 recite at least one functional limitation. Specifically, each of these claims recites at least one limitation that states: “an XRPD that converts to” an XRPD pattern under some particular conditions. These functional limitations are determined not to invoke 112(f).
Claim Objections
Claim 8 is objected to because of the following informalities: the claim does not end with the punctuation mark of a period, which is required by all claims. Appropriate correction is required.
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 3, 8, 15 and 18 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 3 and 8 are rejected as vague and indefinite for recitation of the broad use of the term “substantially equal”. The specification does not provide any definition for “substantially equal” and therefore, it is unclear what the metes and bounds of these terms are. The specification does teach (page 13, para [0070]), numerous, non-limiting embodiments for the term “substantially free”, but even so, “substantially free” is an altogether different term and is also not defined.
Claims 15 and 18 are rejected as vague for use of the phrase “an XRPD that converts to Pattern C…”. The compound cannot be characterized from an XPRD that converts to Pattern C. It can be characterized as Pattern C.
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 4-11, 13-14, 16-17, and 19-20 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 4-10 do not further limit claim 3, which is drawn to a specific crystalline form (Pattern D), which is described in the specification with Figure 1. Claim 3 is directed to a crystalline maleate salt of Compound I, designated as the form Pattern D, that exhibits an X-ray powder diffraction pattern having characteristic peaks at about 4.7 ± 0.2° 2-Theta, 9.4 ± 0.2° 2-Theta, 11.0 ± 0.2° 2-Theta, and 14.0 ± 0.2° 2-Theta. Each limitation of claim 3 is written in the alternative, with “or”, and is interpreted as a standalone limitation, and recitation of the same limitation in a later dependent claim does not further limit the claim. Thus, claims 4-10 do not further limit the limitations of claim 3.
Claim 11 is drawn to the crystalline maleate salt of claim 3, wherein the crystalline maleate salt is anhydrous. Claim 11 is not further limiting. Either water is in the crystal, or water is not in the crystal, If there was any water present, the XRPD would have shown water molecules.
Claims 13-14 do not further limit claim 12, which is drawn to a specific crystalline form (Pattern C), which is described in the specification with Figure 5. Claim 12 is directed to a crystalline maleate salt of Compound I, designated as the form Pattern C, that exhibits an X-ray powder diffraction pattern having characteristic peaks at about 4.5 + 0.2° 2-Theta, 9.0 J: 0.2° 2-Theta, 13 .5 + 0.2° 2-Theta, and 18.4 + 0.2° 2-Theta. Each limitation of claim 12 is written in the alternative, with “or”, and is interpreted as a standalone limitation, and recitation of the same limitation in a later dependent claim does not further limit the claim. Thus, claims 13-14 do not further limit the limitations of claim 12.
Claims 16-17 do not further limit claim 15, which is drawn to a specific crystalline form (Pattern B), which is described in the specification with Figure 9. Claim 15 is directed to a crystalline maleate salt of Compound I, designated as the form Pattern B, that exhibits an X-ray powder diffraction pattern having characteristic peaks at about 4.1 ± 0.2° 2-Theta, 8.2 ± 0.2° 2-Theta, 12.3 ± 0.2° 2-Theta, and 16.4± 0.2° 2-Theta. Each limitation of claim 15 is written in the alternative, with “or”, and is interpreted as a standalone limitation, and recitation of the same limitation in a later dependent claim does not further limit the claim. Thus, claims 16-17 do not further limit the limitations of claim 15.
Claims 19-20 do not further limit claim 18, which is drawn to a specific crystalline form (Pattern A), which is described in the specification with Figure 12. Claim 18 is directed to a crystalline maleate salt of Compound I, designated as the form Pattern A, that exhibits an X-ray powder diffraction pattern having characteristic peaks at about 4.2 ± 0.2° 2-Theta, 8.3 ± 0.2° 2-Theta, and 12.5 ± 0.2° 2-Theta. Each limitation of claim 18 is written in the alternative, with “or”, and is interpreted as a standalone limitation, and recitation of the same limitation in a later dependent claim does not further limit the claim. Thus, claims 19-20 do not further limit the limitations of claim 18.
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 § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 12, 15, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The following claim fails to meet the written description requirement with regards to identifying the specific crystalline form Patterns A, B, C, and D of Compound I.
The x-ray pattern of a pure crystalline substance can be used to identify compounds because the diffraction pattern is considered to be a "fingerprint" of a compound. The d value for the most intense line is found and compared, followed by the next two intense lines, and so on.
Identification of crystal structures is taught by Bhattacharya et al. (Brittain, ed. Polymorphism in Pharmaceutical Solids, 2009, page 334). As noted in the fourth full paragraph, "it is usually convenient to identify the angles of the 10 most intense scattering peaks in a powder pattern" or the last paragraph which states 5 characteristic XRD (X-Ray Diffraction) scattering peaks of sodium ibandronate was sufficient to determine the difference in the two polymorphic forms.
Thus, only four peaks (Patterns B, C, and D) or three peaks (Pattern A) cannot be used to identify an unknown compound.
Claim Rejections - 35 USC § 102 / 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 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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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) 1 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Han et al. (WO 2019/236699 A1, published December 12, 2019, cited on IDS filed on 04/05/2024)(hereinafter, ‘Han’) in view of Censi et al. (Molecules, 2015, 18759-18776).
Han teaches the compound corresponding to instantly claimed Compound 1 maleate salt in a solid form: Han teaches the instantly claimed compound (see reference Table 1, Compound 1-410, page 71) and teaches, (page 109, para [00107-00108]) that “in some embodiments, a compound of Formula (I) is prepared as a chloride salt, sulfate salt, bromide salt, mesylate salt, maleate salt, citrate salt or phosphate salt” (emphasis added). Furthermore, Han discloses (page 110, para [001110]) a process of crystallization, teaching “it should be understood that a reference to a pharmaceutically acceptable salt includes the solvent addition forms. In some embodiments, solvates contain either stoichiometric or nonstoichiometric amounts of a solvent, and are formed during the process of crystallization with pharmaceutically acceptable solvents such as water, ethanol, and the like” (emphasis added).
The reference shows the compound but is silent on the particular crystalline form; however, the ‘crystalline’ nature of the compound is an inherent characteristic and therefore included in the teachings of Han.
MPEP 2112 states:
“SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
The claiming of a new use, new function or unknown property, which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
In this case, the “unknown property” is the particular crystalline form. This is unknown because the reference is silent on this property. MPEP 2112 goes on to state:
“A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection.”
Again, the “CHARACTERISTIC” which the prior art is silent on is the crystalline form (crystalline form is considered to be in the category of chemical properties; see Zenith Laboratories Inc. v. Bristol-Myers Squibb Co. 30 USPQ2d 1285, 1288).
This is not an ordinary inherency situation where it is not explicitly stated what the product actually is. In every reference applied, the reference explicitly teaches exactly what the compound is. In fact, it is the opposite. In a normal inherency situation, the claim is of known structure, and the reference is of unknown structure. Here, the reverse is true, and hence the legal circumstances of inherency-in-the-prior-art do not apply. The only difference is the property about which the reference happens to be silent.
See for example Ex parte Anderson, 21 USPQ 2d 1241 at 1251, discussion of Rejection E. The claims had “numerical or functional values for certain properties which [the authors of the references] did not measure”. The PTO presented no reasoning as to why the prior art material would have been expected to have those properties. Instead, the decision states, “There is ample precedent for shifting the burden to an applicant to reproduce a prior art product whose final structure or properties are, at least, in part determined by the precise process used in its manufacture.” (page 1253).
In another example, certain claims of Ex parte Raychem Corp. 25 USPQ2d 1265 required a linearity ratio of less than 1.2. The decision notes that neither reference discloses any values of the linearity ratio. The PTO presented no reasoning as to what the ratio would be expected to be in the references. The Decision states: “However, this does not end the inquiry since, where the Patent and Trademark Office is not equipped to perform the needed testing, it is reasonable to shift the burden of proof to Raychem to establish that (1) the argued difference exists….”
And indeed, there have been a number of cases in which applicants have pointed to silence of the prior art with regard to this or that property: In re Pearson, 181 USPQ 641; In re Zierden 162 USPQ 102; In re Lemin, 140 USPQ 273; Titanium Metals Corporation of America v. Banner, 227 USPQ 773; In re Benner, 82 USPQ 49. Going further, if silence about properties of prior art compounds could be relied on, then one could not reject over references with no utility (see In re Schoenwald, 22 USPQ2d 1671), since applicants could always insert the utility into the claim as a property.
It is well settled that the PTO can require an applicant to establish that a prior art product does not necessarily possess the characteristics of the claimed product when the prior art and claimed products are identical or substantially identical. An applicant's burden under these circumstances was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially
identical processes, the PTO can require an applicant to prove that the
prior art products do not necessarily or inherently possess the
characteristics of his claimed product. . . . Whether the rejection is based
on 'inherency' under 35 U.S.C. § 102, or 'prima facie obviousness' under
35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same,
and its fairness is evidenced by the PTO's inability to manufacture
products or to obtain and compare prior art products (footnote omitted).
Furthermore, Censi teaches that many drugs can crystallize into different polymorphic forms, which may improve stability and solubility over the original form of these drugs (page 18761-18762, section 3, “The Polymorphism of Drugs: Anhydrous and Solvated Forms”, para 2-3).
Thus, it would have been obvious to one of ordinary skill in the art to make a crystalline form of Compound I. Han teaches the compound corresponding to instantly claimed Compound I maleate salt and suggests a process of crystallization. One would have been motivated and had a reasonable expectation of success to modify the form taught by Han since Censi teaches crystalline forms of drugs may offer improved stability and solubility of these drugs.
Overcoming the rejection is very straightforward. One simply replicates the prior art procedure. If the amorphous form does not appear at all in the product, or if on repetition, it sometimes does not appear in the product, then the rejection is overcome.
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.
Claims 1 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 10, 12, and 15-18 of U.S. Patent No 12,479,828 B2 (cited on IDS filed 1/28/2026) in view of Censi. Although the claims at issue are not identical, they are not patentably distinct from each other.
The previous 103 rejection is incorporated herein.
Reference claims 1-2, 4, 10, 12, and 15 are drawn to pharmaceutically acceptable salts of the genus of instant Compound I, and a composition thereof. Reference claims 16 and 17 are drawn to pharmaceutically acceptable salts of the exact species of compound of instant claim 1 (instant Compound I). Reference claims 16 and 17 are further drawn to maleate salts of Compound I. Reference claim 18 is drawn to a pharmaceutical composition comprising the maleate salt of instant Compound I.
Reference claims 16-18 do not teach crystalline forms of the maleate salt of compound I. However, Censi teaches that many drugs can crystallize into different polymorphic forms, which may improve stability and solubility over the original form of these drugs (page 18761-18762, section 3, “The Polymorphism of Drugs: Anhydrous and Solvated Forms”, para 2-3).
Thus, regarding instant claims 1 and 26, it would have been obvious to one of ordinary skill in the art to make a crystalline form of Compound I, as well as composition comprising said crystalline form. One would have been motivated and had a reasonable expectation of success to modify the amorphous form taught by ‘828 Patent since Censi teaches crystalline forms of drugs may offer improved stability and solubility of these drugs.
Claims 1 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 10, 12, 15, 19-20 and 30-31 of U.S. Patent No 11,566,015 B2 (cited on IDS filed 4/5/202) in view of Censi. Although the claims at issue are not identical, they are not patentably distinct from each other.
The previous 103 rejection is incorporated herein.
Reference claims 1-2, 4, 10, 12, 15, and 19 are drawn to the genus of instant Compound I, or its pharmaceutically acceptable salt, and a composition thereof. Reference claims 20 and 30 are drawn to pharmaceutically acceptable salts of the exact species of compound of instant claim 1 (instant Compound I), or a pharmaceutically acceptable salt thereof. Reference claim 31 is drawn to a pharmaceutical composition comprising instant Compound I, or a pharmaceutically acceptable salt thereof. ‘015 teaches, (col 177, lines 33-35) that “in some embodiments, a compound of Formula (I) is prepared as a chloride salt, sulfate salt, bromide salt, mesylate salt, maleate salt, citrate salt or phosphate salt” (emphasis added). Furthermore, ‘015 discloses (col 177, lines, 57-63) a process of crystallization, teaching “it should be understood that a reference to a pharmaceutically acceptable salt includes the solvent addition forms. In some embodiments, solvates contain either stoichiometric or nonstoichiometric amounts of a solvent, and are formed during the process of crystallization with pharmaceutically acceptable solvents such as water, ethanol, and the like” (emphasis added).
Censi teaches that many drugs can crystallize into different polymorphic forms, which may improve stability and solubility over the original form of these drugs (page 18761-18762, section 3, “The Polymorphism of Drugs: Anhydrous and Solvated Forms”, para 2-3).
Thus, it would have been obvious to one of ordinary skill in the art to make a crystalline form of Compound I. ‘015 teaches the compound corresponding to instantly claimed Compound I maleate salt and suggests a process of crystallization. One would have been motivated and had a reasonable expectation of success to modify the form taught by Han since Censi teaches crystalline forms of drugs may offer improved stability and solubility of these drugs.
Claims 1 and 26 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-2, and 52-54 of copending Application No. 19/485,160 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because maleate salt of Compound I of instant independent claim 1 overlaps in claimed matter with claims 1-2, and 52-54 of co-pending application.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008);Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Here, Compound I is recited in both the instant and reference applications. In co-pending 19/485,160, Applicant contemplates the drug as a maleate salt (page 7, para [0049]), “For example, often a drug is packaged in a pharmaceutically acceptable salt form, such as the maleate salt of the compound of Formula (I), and the dosage form strength refers to the mass of the molar equivalent of the corresponding free base. As an example, 47.56 mg of the maleate salt of the compound of Formula (I) is the molar equivalent of 40.00 mg of the free base of the compound of Formula (I)” (emphasis added).
Although the instant application does not claim a method of use, the disclosure of the instant application (page 12, para [0064]) recites “Compound I is a potent, selective, orally available MC2R antagonist that is useful in the treatment of a variety of diseases or conditions as described herein, such as such as Cushing's diseases, Cushing's syndrome, ectopic ACTH syndrome (EAS), and congenital adrenal hyperplasia (CAH)” (emphasis added).
The ordinary artisan would recognize as obvious that determination of whether “a method of treating congenital adrenal hyperplasia (CAH) in a subject comprising administering to the subject a compound of Formula (I)” (reference claim 1) is present in the instant claims, is implicit in the copending claim in view of Sun Pharmaceutical Industries, LTD. v. Eli Lilly and Company which states the following: “Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see 5,563,165 (“’165 patent”), at [57], col.1 11.11-14, col.3 11.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 1.49- col. 108 1.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
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/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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