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 .
This is the first action on the merits.
Election/Restrictions
Applicant's election without traverse of Group (I) in the reply filed on December 19, 2025 is acknowledged. Group V, drawn to macrocyclic compounds of formula (I) and compositions thereof, embraced by claims 1-5 and 7 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elected, without traverse, the following species, Example 9:
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and indicated claims 1-5 and 7 read on said species. The initial search did not reveal any applicable art references. therefore, the search was expanded.
Claims 1-14 are pending and claims 1-5, 7, 13 and 14 are under examination. Claims 13 and 14 are new claims. Claims 6 and 8-11 are withdrawn based on the restriction requirement.
Claim Objections
Claims 1, 2 and 13 are objected to because of the following informalities: a ”~” is used throughout the claims and should be replaced with “-“ in many different groups, e.g. C1~6 alkyl. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the term “and” is required between the terms “phenylcarbamoyl” and “phenoxycarbonyl” on page 3, the 5th line from the bottom of the page. Appropriate correction is required.
Claims 1 and 2 are objected to because of the following informalities: the term “and” is required between the terms “alkoxy” and “cyano” on page 4, first line; and page 5, line 17. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the term “C1~C4 alkoxy,” “C1~C4 alkyl,” “C1~C4 alkoxycarbonyl substituted by hydroxy C1~C4 alkoxy,” and “hydroxymethyl substituted by C3~C5 cycloalkyl,” should be replaced with “C1-C4 alkoxy,” “C1-C4 alkyl,” “C1-C4 alkoxycarbonyl substituted by hydroxy C1-C4 alkoxy,” and “hydroxymethyl substituted by C3-C5 cycloalkyl,” on page 4, lines 12-14. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the terms “oxo(=O)” and “thio(=S)” should be replaced with “oxo (=O)” and “thio (=S)” on page 4, lines 16-17. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the colon should be removed after the term “from” on page 18, line 2. Appropriate correction is required.
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 1, 3, 4 and 13 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.
In claim 1, the phrase, “or a mixture thereof” is vague. Claim 1 is drawn to a compound, not a composition. Thus, claim 1 is rejected under 112(b).
The rejection may be overcome by removing said phrase.
Regarding claim 3, the terms “carboxyl” and “aldehyde” lack antecedent basis, see page 6, the definitions of R1 and R2-R4.
The rejection may be overcome by amending to C1-C6 aldehyde and C1-C6 carboxyl.
With regards to claim 4, the following compounds lack antecedent basis based on R1:
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.
There may be others. Thus, claim 4 lacks antecedent basis.
To overcome the rejection, the claim may be converted to an independent claim.
In claim 13, the term “hydroxyl” lacks antecedent basis.
The rejection may be overcome by removing said term.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-3, 7, 13 and 14 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.
This is a written description rejection.
The analysis for adequate written description considers the following:
(a) Actual reduction to practice;
(b) Disclosure of drawings or structural chemical formulas;
(c) Sufficient relevant identifying characteristics, such as (i) complete/partial structure, (ii) physical and/or chemical properties, and (iii) functional characteristics when coupled with known or disclosed correlation with structure; and
(d) Representative number of samples.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571,39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written basis for the scope of the compounds of formula (I), wherein R1-R2 or R2-R3 form a ring, which demonstrate antiviral activity. The mere fact that Applicant may have discovered several specific compounds of formula (I), is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
The rejection is made under 35 USC 112 (a), as written description is lacking.
The rejection may be overcome by narrowing the scope of the rings formed between R1-R2.
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.
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) 1-4, 7 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuetz et al. (European Journal of Medicinal Chemistry, 2020, 207, 112810, 1-19).
The reference teaches the following species:
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, see page 4. The compounds were tested in a toxicity assay as a pharmaceutical composition, see page 3 for the Biological evaluation at 10 and 20 uM.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-3, 7, 13 and 14 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Pan et al. (CN 107033157).
The present application claims compounds of formula (I), wherein R1= NH2, R2= H, R3= OCH3 and R4= OCH3:
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, see claim 5, page 13.
The ‘157 patent teaches claims compounds of formula (I), wherein R1= OCH3, R2= H, R3= NH2 and R4= OCH3:
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, see page 6. The composition is taught on page 1 of the WIPO translation.
The only difference between the claimed and cited species is the substitution at R1 and R3, R1= OCH3 and R3= NH2 versus Applicant’s R1= NH2 and R3= OCH3.
These compounds are positional isomers and are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In re Grabiak 226 USPQ 870, states "[w]hen chemical compounds have "very close" structural similarities and similar utilities, without more a prima facie case may be made", In re Deuel 34 USPQ2d 1210, "a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (emphasis added) (e.g. ortho v. para)". Analogs differing only in the position of a single moiety are well known to be prima facie obvious in the law, as cited above, and require no secondary teaching.
Thus, said claims are rendered obvious.
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 claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7, 13 and 14 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of copending Application No. 18717918. Although the conflicting claims are not identical, they are not patentably distinct from each other because some the species found in claims 5 and 6 of the ‘918 application are embraced by the present claims.
Other species found in claims 5 and 6 of the ‘918 application are positional isomers of the claimed compounds embraced by claim 1 of the present application. Moreover, there is not patentable distinction between compounds and methods of using said compounds. These compounds are positional isomers and are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Furthermore, the cited species shown below, left, is the same as the compound 6, bottom right, that is found in claim 6 of the ‘918 application.
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This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 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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/SUSANNA MOORE/Primary Examiner, Art Unit 1624