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
Claims 13-29 are pending in the present application file.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 13-19, drawn to a cryptolepine salt derivative with a chemical structure shown in formula (I).
Group II, claim(s) 20-28, drawn to a preparation method of the cryptolepine salt derivative according to claim 13.
Group III, claim(s) 29, drawn to a method of preventing and controlling plant virus or sterilizing.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
a compound or salt of instant formula (I)
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: 13-29
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Where a single claim defines alternatives of a Markush group, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in Rule 13.2, is considered met when the alternatives are of a similar nature. When the Markush grouping is for alternatives of chemical compounds, the alternatives are regarded as being of a similar nature where the following criteria are fulfilled:
(A) all alternatives have a common property or activity; AND
(B)(1) a common structure is present, that is, a significant structural element is shared by all of the alternatives; OR
(B)(2) in cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
The phrase “significant structural element is shared by all of the alternatives” refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity.
The phrase “recognized class of chemical compounds” means that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention, i.e. each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
Although the chemical compounds of Groups I-III, as well as the species of instant formula (I) share a common structure of instant formula (I), the common structure is not a significant structural element because it represents only a small portion of the compound structures and does not constitute a structurally distinctive portion in view of CAS Registry No. 949082-59-1 (which entered STN October 3, 2007). CAS Registry No. 949082-59-1 corresponds to a compound of instant formula (I) wherein R1 is hydrogen, R2 is hydrogen, R3 is C1 alkyl (methyl), R4 is halogen (Cl), R5 is hydrogen, and X- is Cl-. Further, the compounds of these groups do not belong to a recognized class of chemical compounds.
During a telephone conversation with Jennifer Burnett on August 24, 2026 a provisional election was made with traverse to prosecute the invention of Group I (claims 13-19; directed to a cryptolepine salt derivative with a chemical structure shown in formula (I)), as well as a species of I-20. Affirmation of this election must be made by applicant in replying to this Office action.
Because the 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 §818.01(a)). The requirement is still deemed proper and is therefore made FINAL.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present formula (I) appears free of the prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under 35 U.S.C. 102, which are not allowable.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 13-15 and 18-19 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 16-17 and 20-29 do not read on the presently searched and examined subject matter. Therefore, claims 16-17 and 20-29 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The following continuity data is acknowledged in the present application file:
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) filed January 17, 2025 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claim 13 is 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.
Present claim 13 is directed to a cryptolepine salt derivative with a chemical structure of formula (I), where the variable R2 is defined as “selected from at least one group consisting of hydrogen and protecting group” and X- is defined as “selected from salt-forming anion”.
Present claim 14 provides where “R2 is selected from at least one group consisting of hydrogen, p-toluenesulfonyl, benzenesulfonyl, benzyloxycarbonyl, tert-butoxycarbonyl and benzyl” and “X- is selected from at least the group consisting of Cl-, Br-, I-, CH3COO-, NO3-, HSO4-, H2PO4-, BF4-, and SbF6-“.
The present specification details exemplary compounds of the disclosure of formula (I-1) to (I-71) on pages 7-9.
The present specification discloses where “the derivative of cryptolepine have certain drug effects, specifically: 1. There have been studies to synthesize 11-position aniline indole quinoline derivative and show potential anti-tumor activity through in vivo and in vitro experiments. 2. It has been found that cryptolepine salt derivative containing aniline structure have a significant inhibitory effect on methicillin-resistant Staphylococcus aureus.” See paragraph 3 of the present specification. Examples are provided demonstrating the anti-tobacco Mosaic virus (TMV) activity and bactericidal activity of the compounds of the invention in pages 21-25.
The present specification further provides where “by introducing different substituents, the substituents can improve the virus prevention and control ability and bactericidal activity of the cryptolepine salt derivative. The cryptolepine salt derivative containing amino structure (that is when R5 is selected from -NHR) introduce primary amines with different substituents at the C-11 site, wherein the primary amines can be used as both hydrogen bond donors and hydrogen bond acceptors to increase the hydrogen bond site between molecule and target protein, and thus to improve the biological activity of the compound.” See paragraph 32 of the present specification.
There are no methods or guidance provided which permits the person of ordinary skill in the art to extrapolate from the definition provided for compounds of Formula (I), all compounds potentially encompassed by the present claims or disclosure.
The Applicant is reminded of the written description guidelines
set out by the USPTO in MPEP 2163:
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 (see i)(A), above), reduction to drawings (see i)(B), above), 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 i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
While the genus of compounds of the present invention are described by the specification to comprise the compounds I-1 to I-71 provided in pages 7-9, the description of compounds of the present invention is not sufficiently detailed to show Applicant was in possession of the full scope of the claimed invention, any compound of Formula (I) comprising any protecting group for R2 or any salt-forming anion for X-.
Namely, the definitions for the moieties for R2 and X- as provided in the present claims, are not sufficiently detailed in order to stand on their own as being adequately described.
MPEP 2163 goes on to describe what a "representative number of
species" is:
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The species described in the specification do not cover the entire genus such that it is a representative sample of the genus as the species are close together in structure and only describe an extremely small portion of the claimed genus.
Therefore, the claim lacks written description and is properly rejected under 35 U.S.C. 112(a).
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 13-15 and 18-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “salt derivative”, and in particular “derivative” in present claims 13-15 and 18-19 is a relative term which renders the claims indefinite. The term “derivative” or “salt derivative” is not defined by the present claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of molecules or compounds encompassed by the meaning of derivative, which is a relative, ambiguous term in the art, has been rendered indefinite.
There is no definition for the counter ion X- in the definition for Formula (I )in present claim 13. The claim is indefinite as the scope of products encompassed by the present claims is unclear.
Applicant may amend the claim to provide a definition for the variable X-, to overcome this aspect of the rejection.
Present claims 18-19 recite the limitation “wherein the cryptolepine salt derivative comprises” in lines 1-2 of claims 18-19.
From MPEP 2111.03(I):
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)
The term ‘comprising’ renders claims 18-19 indefinite as the claims encompass additional, unrecited elements. One of ordinary skill in the art would not be appraise of the scope of compounds encompassed by the present claims.
Applicant can amend claims 18-19 to recite “selected from the group consisting of”, rather than “comprising”, to overcome this aspect of the rejection.
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.
Claims 13-15 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (Zhou, Pan, et al. "Intramolecular trapping of an iminium salt: rapid construction of quindoline derivatives." Chemical Communications 60.3 (2024): 292-295.).
The prior art discloses Compound 2u in Scheme 2 on page 293, which corresponds to Applicant’s elected species, present compound I-20, 5-(2,2-dimethylpropyl)-10-[(4-methylphenyl)sulfonyl]- 10H-Quindolinium chloride. Compound 2u corresponds to a compound of instant formula (I) wherein R1 is hydrogen, R2 is p-toluenesulfonyl, R3 is C4 alkyl (2,2-dimethylpropyl), R4 is hydrogen, R5 is hydrogen, and X- is Cl-. Compound 2u is embraced by instant claims 13-15.
Claims 13-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2021/105761 A1 (Djavaheri-Mergny et al.; Publication Date: June 3, 2021; International Filing Date: September 10, 2020).
The prior art discloses SYUIQ-FM05 as N’-(7-Fluoro-5-N-methyl-10H-indolo[3,2-b]quinolin-5-ium)-N,N-dimethylpropane-1,3-diamine iodide on page 15. SYUIQ-FM05 has the following structure:
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SYUIQ-FM05 corresponds to a compound of instant formula (I) wherein R1 is halogen, R2 is hydrogen, R3 is C1 alkyl (methyl), R4 is hydrogen, R5 is -NHR, where R is C4 alkyl substituted with amino substituted with C1 alkyl and X- is I-. SYUIQ-FM05 is embraced by instant claims 13-14.
Claims 13-15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 949082-59-1 (which entered STN October 3, 2007).
CAS Registry No. 949082-59-1 is directed to 2-chloro-5-methyl-10H-indolo[3,2-b]quinolin-5-ium chloride having the following structure:
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CAS Registry No. 949082-59-1 corresponds to a compound of instant formula (I) wherein R1 is hydrogen, R2 is hydrogen, R3 is C1 alkyl (methyl), R4 is halogen (Cl), R5 is hydrogen, and X- is Cl-. CAS Registry No. 949082-59-1 is embraced by instant claims 13-15. CAS Registry No. 949082-59-1 also corresponds to compound I-34 of instant claim 18.
Conclusion
Claims 13-15 and 18-19 are rejected.
Claims 16-17 and 20-29 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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