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 .
Response to Amendments
Amendments filed February 24, 2026 are acknowledged.
Any rejections not explicitly maintained herein are withdrawn.
Election/Restrictions
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.
Status of the Claims
5. Claims 1, 24, 26, 30-34, 40-45, 54, 57, 59-61, 63-67, 69-71, 73-74, 78-79, and 95 are pending in the instant application. Claims 26, 31-34, 40-45, 57, 59-61, 63-67, 69, 71, 73, and 78-79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and species. Claims 1, 24, 30, 54, 70, 74, and 95 read on an elected invention and species and are therefore under consideration in the instant application.
Claim Rejections – Improper Markush Group
6. The nonstatutory Markush grouping rejection is based on a judicially approved “improper Markush grouping” doctrine. Claims 1, 24, 30, 54, 70, 74, and 95 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
In the present case, at least (1) applies. It cannot be said that all members of the Markush group have a single structural similarity from which the activity flows. Specifically, the species of the Markush group do not share a “single structural similarity” because there are no required structural features within the compounds of formula I such that each member of the group would have at least one structural feature, which feature is essential to the activity/function of the claimed compounds, in common.
In addition, at least (2) applies since each alternatively usable member of the Markush group does not share a common use. Rather, the specification discloses that the compounds are useful as modulators of NR2F6; however, there is no common core in the compounds of formula I-A that are known as modulators of NR2F6. It is suggested that applicant amend the claims to contain only proper Markush groupings to compounds sharing a single structural similarity and a common use, wherein the common use shared by the compounds is a result of the structural similarity essential to the function of the compounds.
The question of whether the lack of a specific statutory basis is a fatal flaw against a holding of an Improper Markush group was decided in In re Harnish, 206 USPQ 300, 305, where the court said, “…we think it should be clear from our actions in Weber and Haas II that we there recognized the possibility of such a thing as an "improper Markush grouping." We were and are aware that it does not have a specific statutory basis …” The court went on to reverse the rejection, (which had been made by the Board under Rule 196(b)) but not on the lack of a specific statutory basis but rather, “Clearly, they are all coumarin compounds which the board admitted to be "a single structural similarity." We hold, therefore, that the claimed compounds all belong to a subgenus, as defined by appellant, which is not repugnant to scientific classification. Under these circumstances we consider the claimed compounds to be part of a single invention so that there is unity of invention…” Thus, the rejection was overturned not because of any lack of a specific statutory basis, but because of the specific facts in the case. The Markush group was held proper in that case, as was the case also in Ex parte Price 150 USPQ 467, Ex parte Beck and Taylor, 119 USPQ 100, and Ex parte Della Bella and Chiarino 7 USPQ2d 1669. Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371. Note In re Milas 71 USPQ 212 in which the structural difference between vitamin A and D was sufficient to uphold the improper Markush rejection. Also see In re Winnek 73 USPQ 225 and In re Ruzicka 66 USPQ 226 in which structural differences were small and yet a similar holding was maintained. All these cases involved compounds in the pharmaceutical art known to be structure-sensitive. Of particular interest is Ex Parte Hozumi, 3 USPQ2d 1059, which reversed an improper Markush rejection “in view of the relatively large proportion of the structure of the compounds in the claimed class which is common to the entire class.” Here, by contrast, the amount in common is none, relative to the entire molecule.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
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.
7. Claims 1, 24, 30, 54, 70, 74, and 95 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.
Claim 1 recites the limitation:
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but there is no
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in the claims. Examiner cannot ascertain the metes and bounds of the claimed scope and what variables this limitation is referring to.
The proviso in claim 1 recites the limitation:
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but B cannot be -CH2---aryl. Examiner cannot ascertain the metes and bounds of the claimed scope.
As such, the claims are indefinite. Appropriate correction is required.
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 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.
8. The following is a quotation of the appropriate paragraphs of pre-AIA 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.
9. Claims 1 and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number: RN 1442549-01-0. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1442549-01-0. Entered STN: 30 Jun 2013].
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Registry number 1442549-01-0 is available as prior art as of 30 Jun 2013, the date it was indexed into the CAS database. Registry number 1442549-01-0 anticipates compounds of formula I-A wherein R1 is methyl, A is imidazole substituted with methyl and ethyl, L1 is -C(O)-NRL1-, RL1 is H, B is heterocyclyl.
Regarding the compositions of claim 74, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 1442549-01-0 discloses a mass solubility of 0.12 g/L, in unbuffered water at pH 11.08. 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 CAPlus 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.
10. Claims 1, 24, 30, 54, 74, and 95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number: RN 1013117-40-2. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1013117-40-2. Entered STN: 09 Apr 2008] and [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1013119-25-9. Entered STN: 09 Apr 2008].
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Registry number 1013117-40-2 is available as prior art as of 09 Apr 2008, the date it was indexed into the CAS database. Registry number 1013117-40-2 anticipates compounds of formula I-A wherein R1 is H, A is aryl substituted with Cl, L1 is -C(O)-NRL1-, RL1 is H, B is
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substituted with oxo and Cl.
Regarding the compositions of claim 74, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 1013117-40-2 discloses a mass solubility of 0.21 g/L, in unbuffered water at pH 8.51. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
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Registry number RN 1013119-25-9 is available as prior art as of 09 Apr 2008, the date it was indexed into the CAS database. Registry number RN 1013119-25-9 anticipates compounds of formula I-A wherein R1 is H, A is aryl substituted with F, L1 is -C(O)-NRL1-, RL1 is H, B is
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substituted with oxo.
Regarding the compositions of claim 74, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 1013119-25-9 discloses a mass solubility of 0.42 g/L, in unbuffered water at pH 8.81. 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 CAPlus 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.
Claim interpretation note:
There is a proviso in claim 1 that states:
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; however, in the prior art, B is not simply
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but rather
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substituted with oxo and Cl, which would not be covered in the present proviso and would not be provided out by the claim limitation as currently written. As such, the claims are anticipated.
Conclusion
11. No claims are allowed.
12. 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.
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/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623