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 .
Status of the Claims
Currently, claims 1-16 are pending in the instant application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the case of the instant Abstract, the legal phraseology “said” is used. The Abstract must be amended to remove legal phraseology.
Claim Objections
Claim 3 is objected to because of the following informalities: Chemical structures lacking legibility. Each of the compound recited in the instant claim are accompanied by chemical structures, however, each of the provided chemical structures appear to have formatting issues which affect legibility. Appropriate correction is required.
Applicant is advised that should claim 14 be found allowable, claims 10 and 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In the case of the instant claims, claim 14 encompasses the methods of both claims 10 and 12.
Claim Rejections - 35 USC § 112 – Second Paragraph
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 1-2, 4, 6, 8, 10, and 12 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.
Claim 1 is indefinite for reciting the terms “isomers” and “prodrugs” because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. It is generally understood in the art that isomers are defined as compounds having the same chemical formula, but in differing structural arrangement. Accordingly, any given isomer of a compound of Formula (A) may lie outside the limitations of the provided structure of the compound. Likewise, a prodrug is commonly understood to be a chemical precursor of a target drug, wherein the precursor compound is intended to be metabolized within the body to form said target drug. Any given potential prodrug of a compound of Formula (A) may lie outside the limitations of the provided structure of the compound.
Claim 2 is indefinite for the same reasons as claim 1, for reciting “isomers” and “prodrugs”, and a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim.
Claim 4 is indefinite for the same reasons as claim 1, for reciting the term “prodrug”, and a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim.
Claim 6 is indefinite for the same reasons as claim 1, for reciting the term “prodrug”, and a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim.
Claim 8 is indefinite for the same reasons as claim 1, for reciting the term “prodrug”, and a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim.
Claim 10 is indefinite for the same reasons as claim 1, for reciting the term “prodrug”, and a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim.
Claim 12 is indefinite for the same reasons as claim 1, for reciting the term “prodrug”, and a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim.
Claim Rejections - 35 USC § 112 – First Paragraph
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.
Claims 1-2, 4, 6, 8, 10, 12, 13, and 16 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 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.
Claim 1 recites “isomers” and “prodrugs” of a compound of Formula (A). Applicant’s disclosure does not meet the written description requirement to encompass such a breadth of compounds. It is generally understood in the art that isomers are defined as compounds having the same chemical formula, but in differing structural arrangement. A prodrug is commonly understood to be a chemical precursor of a target drug, wherein the precursor compound is intended to be metabolized within the body to form said target drug. Isomers and prodrugs of a compound of Formula (A) would encompass an innumerably large amount of compounds which could not be reasonably supported by Applicant’s provided disclosure.
Claim 2 recites “isomers” and “prodrugs” of a compound of Formula (A-I). Accordingly, the instant claim lacks sufficient written description for the same reason as claim 1, due to the innumerably large scope of any isomers or prodrugs of the recited compound.
Claim 4 recites “prodrugs” of a compound of claim 1. Accordingly, the instant claim lacks sufficient written description for the same reason as claim 1, due to the innumerably large scope of any possible prodrugs of the recited compound.
Claim 6 recites “prodrugs” of a compound of claim 3. Accordingly, the instant claim lacks sufficient written description for the same reason as claim 1, due to the innumerably large scope of any possible prodrugs of the recited compound.
Claim 8 recites “prodrugs” of a compound of claim 1. Accordingly, the instant claim lacks sufficient written description for the same reason as claim 1, due to the innumerably large scope of any possible prodrugs of the recited compound.
Claim 10 recites “prodrugs” of a compound of claim 1. Accordingly, the instant claim lacks sufficient written description for the same reason as claim 1, due to the innumerably large scope of any possible prodrugs of the recited compound.
Claim 12 recites “prodrugs” of a compound of claim 1. Accordingly, the instant claim lacks sufficient written description for the same reason as claim 1, due to the innumerably large scope of any possible prodrugs of the recited compound.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/367,424 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the inventions of both applications are drawn to exceedingly overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 of the instant application recites a compound of Formula (A):
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Claim 1 of the reference application recites a compound of Formula (I):
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137
477
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Firstly, Formula (I) of claim 1 of the reference application appears to encompass compounds of Formula (A) of claim 1 of the instant application. As the structure of Formula (A) appears to be embraced within the structure of Formula (I), each of the claims cannot be considered as patentably distinct from one another.
Secondly, each of the compounds listed in claim 3 of the instant application appear to be fit squarely within the limitation of Formula (I) of the reference application.
Thirdly, claim 12 of the reference application recites the following compounds 28, 29, 52-54, 60, 71, 74-75:
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347
416
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157
417
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530
423
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174
426
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353
419
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The indicated compounds found in the reference application appear to be encompassed by Formula (A) of the instant application. Furthermore, the above compounds are identical to compounds 28, 29, 52-54, 60, 71, 74-75 of claim 3 of the instant application.
The subject matter of the instant application and the reference application overlap to the extent that compounds of the instant application are encompassed by the compounds of the reference application and vice versa. Additionally, and as noted above, certain compounds are identical between the claims of each application. Accordingly, the claims of the instant application and the claims of the reference application cannot be considered as patentably distinct from one another.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11834450 (herein the ‘450 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant application and the ‘450 patent are overlapping in subject matter.
Claim 1 of the instant application recites a compound of Formula (A):
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Claim 3 of the instant application recites the following compounds:
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168
392
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180
394
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Claim 1 of the ‘450 patent recites the following compounds:
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228
425
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238
429
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The compounds recited in the’450 patent are encompassed by the Formula (A) of the instant application. Furthermore, claim 3 of the instant application appears to recite identical compounds to the indicated compounds of the ‘450 patent. Accordingly, the claims of the instant application and those of the ‘450 patent cannot be held as patentable distinct.
Conclusion
Claims 1-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren 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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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629