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 ELECTION/RESTRICTION
Applicant’s election of group I, drawn to Letermovir of the formula I having residual solvents in the reply filed on 11/10/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
An action on the merits of claims 20-27 is contained herein.
Priority
This application is a national phase entry under 35 U.S.C. 371 of international application PCT/IB2021/057299, filed 8/7/2021, which claims priority to IN202021035411.8, filed 8/17/2020.
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record.
Specification
Applicant is reminded of the proper content of an Abstract of the Disclosure, see MPEP 608.01(b).
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., "The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics." Exemplification of a species could be illustrative of members of the class. For processes, the type reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
It is recommended that the structure of Formula I be inserted into the abstract to accurately illustrate the claimed invention.
Additionally, the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
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.
Claims 20-27 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 pre-AIA the applicant regards as the invention.
The instant claims recite "in accordance with ICH guidelines". However, the specific residual solvent amounts obtained from these guidelines which may fully define the metes and bounds of the claims in itself are not recited.
MPEP 2173.05(s) states, “Reference to Figures or Tables. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words …’ ”
This condition is not met here, since it is practical to define the invention in words, simply by putting these solvent amounts in the claims. See Ex parte Fressola, 27 USPQ2d 1608, 1609.
Furthermore as described at page 14 in the disclosure regarding the definition of "in accordance with ICH guidelines"; the solvent limit amounts are not clearly universal and may involve exceptions as stated therein:
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Thus, the claim and claims which depend from it which do not fully rectify the issue are considered indefinite. Correction is required. The examiner will assume all reasonable possibilities in terms of applying prior art (e.g. an amorphous state of formula I that has undergone a purification process) until the issue is resolved.
In claim 20 for step b) recites “MTBE solutions” wherein previous step a) refers to one MTBE solution which is unclear.
Claims 25-27 (dependent on claim 24) recite “Letermovir according to” in the preamble. It is unclear if the claims are drawn to the compound itself or the process of making thereof as claim 24 recites “A precipitation process”. Thus the scope is unclear. The examiner will assume that these claims are drawn to “Letermovir” made by the process of claim 24 itself until the issue is resolved.
Claim Rejections - 35 USC § 112
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 25-26 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 25-26 do not further limit claim 24 with respect to “MTBE solutions” since claim 24 refers to one MTBE solution.
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)(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.
Claims 20-23 and 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over WO 2014/202737-mentioned in IDS.
WO 2014/202737 teaches amorphous Letermovir that was characterized by ICH guidelines and contain less than 5000 ppm and/or heptane less than 5000 ppm (see page 57, table 5).
Additionally note that the claims are product-by-process steps which are limited to the structure and not recited steps. See MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
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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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624