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 .
Priority
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Election/Restrictions
3. Applicant’s election without traverse of Group I in the reply filed on June 27, 2026 is acknowledged.
4. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
5. As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species
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makes a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Status of Claims
6. Claims 128-134, 137-140, 143, 156, 160, 164, 166-167, 182-184, 203-204, 218, and 225 are pending in the instant application. Claims 130, 133, 138-140, 156, 160, 166-167, 182-184, and 225 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 128-129, 131-132, 134, 137, 143, 164, 203-204, and 218 read on an elected invention and species and are therefore under consideration in the instant application.
Claim Rejections - 35 USC § 112
7. 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.
8. Claim 203 is 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 claims are indefinite because they make express reference to the specification. The claims recite ‘compound selected from Table 1’ which are not present in the claims. According to MPEP 2173.05(s) “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 and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).”
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
9. 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
10. Claims 128-129, 134, 143, 204, and 218 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number: RN 1194968-52-9. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1194968-52-9, Entered STN: 02 Dec 2009].
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RN 1194968-52-9 anticipates compounds of formula (IV) wherein Y1 is N, R42 is cycopropyl, R43 is
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wherein i and j are 0, X4 is CH, X5 is CH, X6 is CH, X9 is CH, X10 is CH, X7 is NH, X8 is N, Y2 is CH, Y3 is NR, R is H, R41 is H, R47 is H.
Registry number 1194968-52-9 is available as prior art as of 02 Dec 2009, the day it was indexed into the CAS database.
Regarding the compositions of claim 204 and 218, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 1194968-52-9 discloses a mass solubility of 0.0 g/L, in unbuffered water at pH 7.514. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAS database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
11. Claims 128-129, 134, 164, 204, and 218 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number: RN 2199178-67-9. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2199178-67-9, Entered STN: 26 Mar 2018].
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RN 2199178-67-9 anticipates compounds of formula (IV) wherein Y1 is N, R42 is -CH2-aryl, R43 is
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wherein i and j are 0, X4 is CH, X5 is CH, X6 is CH, X9 is O, X10 is CH, X7 is O, X8 is CH, Y2 is CH, Y3 is O, R41 is Me, R47 is H.
Registry number 2199178-67-9 is available as prior art as of 26 Mar 2018, the day it was indexed into the CAS database.
Regarding the compositions of claim 204 and 218, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 2199178-67-9 discloses a mass solubility of 0.0 g/L, in unbuffered water at pH 7.040. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAS database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Double Patenting
12. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
13. Claims 128-129, 131-132, 134, 137, 143, 164, 203-204, and 218 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-161 of copending Application No. 19,492,006 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-161 anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. Claims 128-129, 131-132, 134, 137, 143, 164, 203-204, and 218 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-112 of copending Application No. 19,491,328 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-112 anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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