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 without traverse of group I, drawn to compositions comprising compounds of formula I and elected species:
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in the reply filed on 3/2/2024 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1-14 is contained herein.
Priority
This application is a continuation-in-part of US Patent Application No. 17/900,071, filed on August 31, 2022, which claims priority to and benefits of Chinese Patent Application Nos. 202210500289.8 and 202210500291.5 filed on May 10, 2022.
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record. References which do not have a publication year have been lined out and not considered.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-14 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 17, and 20-60 of US Patent 11,840,526. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The instant claims may be drawn to a composition comprising the formula I or salts thereof with HPLC purity of equal to over 90% with an impurity content of the dione as stated therein less than 0.1%. Patent ‘526 claims the same compositions with the exception that the purity of formula I or salt thereof may be at least equal to or over 95% or 99% with respect to HPLC purity (note other dependent claims are identical in scope regarding solvents, purification limitations, etc.) that falls within the scope of the instant claims. Thus the compositions recited in the patent may anticipate the claimed compositions in the instant application and thus the claims are not independent and distinct from each other.
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)(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 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over UNOH, YUTO, "Discovery of S-217622, a Noncovalent Oral SARS-CoV-2 3CL Protease Inhibitor Clinical Candidate for Treating COVID-19", Journal of Medicinal Chemistry (2022), Vol. 65, pp. 6499-651 -mentioned in IDS.
The instant Application claims a composition which may comprise the compound of claim 3 as the fumarate salt that is representative of formula I where the HPLC purity is >-90% along with the impurity (6E)-6-[(6-chloro-1-methyl-1H-indazol-5-yl)imino]-3-[(1-methyl-1H-1,2.4-triazol-3-yl)methyl]-1-(2.4,5-trifluorobenzyl)-1,3,5-triazinane-2,4-dione in a content of <0.1%.
UNOH teaches a composition comprising the fumarate salt of the claimed compound of claim 3 in pyridine-d5 (see page 6507, bottom left column) where the purity is stated to be 98.2% by HPLC. The document is silent regarding the impurity (6E)-6-[(6-chloro-1-methyl-1H-indazol-5-yl)imino]-3-[(1-methyl-1H-1,2.4-triazol-3-yl)methyl]-1-(2.4,5-trifluorobenzyl)-1,3,5-triazinane-2,4-dione. However, based on the information disclosed in the specification at pages 34-35, one skilled in the art would have presumed that this impurity was either absent in the prepared fumarate salt or had a content of less 0.1%. Applicants reproduced the synthetic procedure in UNOH for making the free base compound in claim 3 (see comparative examples 1 and 2) and it was shown that the recited impurity was observed to be just over 0.1%:
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.
The free base was subsequently converted into the fumarate salt as stated previously carrying this impurity and filtered to provide the salt. Thus again, one skilled in the art would have presumed that this impurity was either absent completely in the prepared fumarate salt or had a content of less 0.1% due to the exceptional purity via further purification.
The reference shows the same composition, but is silent on the particular impurity. 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 impurity. 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."
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).
Overcoming the rejection is very straightforward. One simply replicates the prior art procedure. If the claimed 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.
In reference to dependent claims reciting a process of making the claimed compositions; these claims contain a product-by-process step which is 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). Thus the claims are anticipated.
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
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