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
Response to Amendments
The amendments made to the claims 06/10/2026 have been entered.
Information Disclosure Statement
The information disclosure statements received 06/10/2026 and 08/11/2026 have been considered.
Withdrawn Objections
In view of the amendments made, the objections made in the prior office action have been withdrawn.
Withdrawn Rejections
In view of the amendments made, the 112(a) scope of enablement rejection regarding claims 48 and 56 is withdrawn.
In view of the cancellation of claim 57, the 112(a) scope of enablement rejection of said claim is now moot and therefore withdrawn.
In view of the amendments made, the 112(a) written description rejection is withdrawn.
In view of the amendments, the 112(b) rejection regarding claim 56 is withdrawn.
Maintained Rejections
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)(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.
(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.
Claim(s) 28, 58-60 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Koike (US2020/0062765).
Koike on p. 5, Examples 5-7 discloses processes of preparing the following compounds:
Formula 10, Koike
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244
340
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Formula 11, Koike
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210
344
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Koike in para. [0061] discloses dissolving compound of Formula 10 above in ethanol and water and then adding sodium hydroxide. This embraces the elements of claim 28.
Koike in para. [0063] discloses crystalizing compound of Formula II in a solvent system comprising ethanol and water. The instant specification on p. 24-31 discloses preparation of crystalline form A of compound 1 adipate. The specification on p. 24 states “A suitable amount of an amorphous form of Compound 1 adipate was dissolved in 0.5 mL of a solvent to form a solution. An anti-solvent was added to the solution thus obtained to obtain a solid, which was confirmed to be the crystalline form A of compound 1 adipate.” Table 2, shown below, shows that the combination of ethanol and water is suitable to form crystalline form A. Koike discloses the same conditions that the instant specification states form crystalline form A. Therefore, while Koike does not disclose XRPD data or tetragonal crystal system, it embraces the elements of the claims.
Table 2
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534
350
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Claims 58-60 have been added to this rejection as applicant has made amendments to the claims.
Response to Arguments
Applicant argues that “Koike does not disclose that the compound disclosed in Example 6 of Koike is a crystalline form, let alone crystalline Compound 1 free base form A….”. Applicant continues “Further, the procedure of Example 6 of Koike is distinct from Example 5 of the present application used to prepare crystalline Compound 1 free base form A. For example, Example 6 of Koike uses an ethanol/water mixture whereas Example 5 of the present application uses ethanol.”
This argument is not persuasive. Claim 28 is shown below.
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108
600
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Note that the alcohol is required, in contrast to applicant’s arguments that the instant example 5, shown below, does not include water.
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572
666
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The MPEP section 2112(III) states:
III. A REJECTION UNDER 35 U.S.C. 102 AND 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. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
While this paragraph discusses products wherein the prior art seems to make identical, the instantly claimed method is identical to the method in Koike and similar logic can be applied. Essentially, as the claim is drawn to a method that is disclosed within the prior art, it is assumed that the product of the prior art’s method is the same as the instantly claimed method.
Applicant’s arguments raises written description issues. See New 112(a) rejection below.
New Rejections
Claim Rejections - 35 USC § 112(a)
Claims 28, 58-60 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has argued that the method for making a crystalline form of compound 1 free base does not involve water. The instant specification in Example 5 (p. 37), shown above, details the method of preparing crystalline form A of compound 1 Free base. The method involves dissolving compound 1 HCl in ethanol at 50oC, adding sodium hydroxide, cooling, and stirring. No water is involved.
Claim 28 states “A method of preparing the form A of claim 23, the method comprising: mixing a base with a solution comprising Compound 1 hydrochloride in water and an alcohol to obtain the form A of Compound 1 free base.” Water is explicitly included.
As claim 23 is drawn to the free base, the method of claim 28, and depending claims 58-60, would not produce the claimed crystalline form A of compound 1 free base in claim 1.
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.
Claim 74 is 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 74 states “The crystalline form of claim 23, wherein the XRPD pattern of form A comprises diffraction peaks listed in Table 11.”
Where possible, claims are to be complete in them-selves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circum-stances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
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 61-75 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 61-75 are drawn to additional properties of the crystalline form A of compound 1 free base. The instant specification, p. 37-39, sec. Example 5 lists XRPD peaks (Table 11) which include all peaks of claims 61-63. The same section also indicates that the form A “exhibited a weight loss of about 4% when heated to 150oC” (p. 38, l. 5-6). Endothermic peaks of a DSC curve are listed on p. 39, l. 3. The instant specification on p. 39, l. 11-13 states that “it is believed that the crystalline form A of Compound 1 free base includes about 1 molar water per molar Compound 1 free base.”
The additional properties are all inherent to form A. Because applicant, in claim 23, claims explicitly form A, these additional properties are all inherently claimed in claim 23. Therefore, dependent claims 61-75 do not further limit claim 23.
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.
Allowable Subject Matter
Claims 23, 55, and 56 are allowed.
Conclusion
Allowable subject matter indicated.
Claims 28 and 58-75 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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