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 Claims
Claims 1-16 are pending.
Priority
Instant application 18256130, filed claims benefit as follows:
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The certified copy is found in the file wrapper but no certified translation is present.
Information Disclosure Statement
All references from the IDS received 06/07/2023, 02/06/2025, 11/17/2025 and 12/02/2025 have been considered unless marked with a strike-through.
Restriction Requirement
Applicant election of Group I, claims 1-6, 9-11, and 13-16 without traverse is acknowledged. Claims 7-8, 10 and 12 are withdrawn as not reading on an elected group. In addition, Applicant’s election of crystalline form I for initial examination is acknowledged.
Claims 4-6, 11, and 15-16 are withdrawn as not reading on the elected specie.
Claims 1-3, 9, 13 and 14 are examined herein. If the elected specie is not identified in the art, the Examiner will expand his search pursuant to MPEP 803.02. The elected specie was identified in the prior art based on the evidence of record.
Claim Rejection – 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 2-3, 9, 13 and 14 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.
Claim 1 recites “[c]rystalline form I….”. As claimed using the terminology ‘form I” this is viewed to encompasses all the data associated with the form as defined in the specification. Thus, additional peaks and/or characterization data as found in the claims rejected herein would not further limit claim 1. A way around this interpretation would be to remove the “form I” language recited in the claims. On amendment, the dependent claims would require additional data and would further limit because claim 1 then would only require the crystallographic parameters. Note that other claims also are drafted with “form I”, so the Examiner recommends removing this language from all of the relevant claims.
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 Rejection – 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) 1-3, 9, 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the article to WU et al. (“WU”, made of record on the IDS, Chinese Journal of New Drugs, 21(16), 2012).
The WU article teaches molecules and methods of preparation. For example, the WU article teaches:
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Here the final product meets the molecular structure of the compound in the instant claims. Further, the WU article teaches a method of preparation where the methyl ester is hydrolyzed and the free base is drawn as shown in the presence of ethanol as a solvent. Still further, the synthetic protocol leads to 0.184 mol of 1 which is indicated as having a melting point of 236.1-236.5 degrees C, showing that the molecule is crystalline. Further, ethanol is present such that this could be considered a ‘good solvent’.
Based on the instant specification ‘form I’ can be obtained by crystallization from a “good solvent” which may be a single solvent or a mixture of two or more solvents in any ratio, and for example may be at least one selected from the group consisting of methanol, ethanol, isopropanol, tetrahydrofuran and DMSO. Since the “good solvent” may be one of these listed, it is not a definition and other solvents may also be a “good solvent”.
Applicant would need to prove that the crystalline forms are different from those in the art with an affidavit. The burden has shifted to Applicant, as the office is not a laboratory.
Specifically, the ‘824 publication teaches a product resulting from ethanol that the evidence suggestions could be reasonably expected to be the instant form. With respect to the composition claim, at least a solvent is present when (I) crystalizes such a combination could be considered a composition, for example with ethanol.
Note on Rejoinder
In order for method of making claims to be rejoined once an allowable product claim is identified, such claims would need to be commensurate in scope. In order for method of making claims to be commensurate in scope they would need to include the specific solvents required to make the specific form. Otherwise, there would be a potential 112(a) issue and such claims would not be rejoined.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLINTON A BROOKS whose telephone number is (571)270-7682. The examiner can normally be reached M-F 8-5 with flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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