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 1-11 are pending in the instant application.
Claims 10, 11 are withdrawn, as being drawn to a non-elected invention.
Claims 1-9 are examined herein.
Priority
The instant application is a National Stage entry of International Application No. PCT/US2022/029112, filed on 13 May 2022, which claims priority from U.S. Provisional Patent Application No. 63/340,629, filed on 11 May 2022 (see the Application Data Sheet submitted on 13 November 2023 below)
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There seems to be a discrepancy between the priority claim in the Application Data Sheet submitted on 13 November 2023 and that in the filing receipt of 15 November 2024, which states:
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It is also noted that the Abstract page submitted on 13 November 2023 indicates that:
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Appropriate clarification/correction is required.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 13 December 2023 (two documents) are acknowledged and considered.
Election/Restrictions
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 from the following groups to which the claims must be restricted.
Group (I): a compound of formula (I), or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition thereof, as recited in claims 1-9;
Group (II): a method of treating a neurodegenerative disease, comprising administering to a patient in need of such treatment a therapeutically effective amount of a compound of Claim 1, as recited in claims 10-11.
The inventions listed as Groups I-II 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: even though the common feature of Groups I-II is a compound of formula (I), said common technical feature is not a special technical feature because it is rendered obvious by Liu et al. (US 2019/0152948, published 23 May 2019, cited in IDS), in view of Bohm et al. (ChemBioChem 2004, 5, 637-643, cited in PTO-892).
Liu (US 2019/0152948) discloses (page 42) compound Example 159 below
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as a modulator of IL-12, IL-23, and/or IFNa [0014].
The difference between instant compound Example 4, page 51 (compound of instant claims)
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(which is a compound of instant formula (I) of claim 1
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for which the following definitions apply:
X = N, R1 is -NHCD3; R2 is C3 cycloalkyl unsubstituted; R3 is C1 fluoroalkyl; R4 = H)
and prior art compound Example 159, page 42 (Liu)
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is a CHF2 vs. CH3 (F versus H) substitution in the alkyl chain in substituent R3.
Bohm teaches fluorine substitution in contemporary medicinal chemistry; Bohm teaches (page 637, left column, third paragraph) replacement of an oxidizable C-H group by a C-F group in compounds to increase metabolic stability of the molecule, and improve bioavailability.
It would have been obvious for a person of ordinary skill in the art to replace an oxidizable C-H group by a C-F group in compound Example 159 taught by Liu to arrive at the instant invention. The person of ordinary skill in the art would have replaced one or more oxidizable C-H groups by C-F groups in compound Example 159 taught by Liu, because Bohm teaches such a replacement increases metabolic stability of the molecule, and improves bioavailability. Thus, a person of ordinary skill in the art would have replaced C-H bond with C-F bond in compound Example 159 of Liu, with the expectation that the resulting compound retains the biological activity taught by Liu as modulator of IL-12, IL-23, and/or IFNa, and has improved metabolic stability/bioavailability.
Since the common technical feature is rendered obvious by Liu in view of Bohm, the common feature, a compound of formula (I), is not a special technical feature. Therefore, no unity of invention exists.
Further, this application contains claims directed to the following patentably distinct species:
compounds of formula (I), or compounds of claim 7;
diseases to be treated.
These species are independent or distinct because, for example, the genus of compounds of formula (I) encompasses a variety of possible compounds having different structural elements X, R1, R2, R3, R4. Each combination of elements requires different structural search and/or a different classification based on its structural elements. Based on their structural elements, the instant compounds of formula (I) can be classified, at a minimum, in CPC class C07D401/12, A61K31/444, A61K31/501.
If Applicant elects an invention of Group I, Applicant is required to elect a specific compound of formula (I), having a distinct chemical structure, from the genus of claim 7 or another disclosed.
If Applicant elects an invention of Group II, Applicant is required to elect a specific compound of formula (I), having a distinct chemical structure, as well as a specific disease to be treated.
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, all the claims are generic.
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 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).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Applicant’s election without traverse of Group (I), claims 1-9, drawn to a compound of formula (I), or a pharmaceutically acceptable salt thereof or a composition comprising said compound, during the telephone interview of 15 January 2026 with Ms. Jing G. Sun, Ph. D., Attorney for Applicant, is acknowledged. Claims 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
The restriction requirement is herein maintained and is made FINAL.
Applicants’ election without traverse of compound Example 9 (page 59 Specification) below:
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as the species of a compound of formula (I) or of a compound of claim 7, for initial examination, during the telephone interview of 15 January 2026 with Ms. Jing G. Sun, Ph. D., Attorney for Applicant, is acknowledged.
In the interest of compact prosecution, the examiner has extended the search to encompass any compound of instant formula (I), or any compound listed in claim 7, and the following objections and rejections are made below.
Claims 1-9 have been examined and the following objections and rejections are made below.
Claims Objections
Claims 10-11, while currently withdrawn, are objected to because of the following informality: The withdrawn claims are objected to for being presented in a non-compliant form. Specifically, the claims are withdrawn because of the election made by the Applicant on 15 January 2026. As such, claims 10, 11 should be identified as "(Withdrawn)" until such time as examiner rejoins the claims for examination. Appropriate correction is required. See MPEP 714(C).
Objection to the Specification
The Specification is objected to because on page 1, lines 4-7, it reads:
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Appropriate correction of the priority statement is required.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2019/0152948, published 23 May 2019, cited in IDS), in view of Bohm et al. (ChemBioChem 2004, 5, 637-643, cited in PTO-892).
Liu (US 2019/0152948) teaches sulfone pyridine alkyl amide-substituted heteroaryl compounds as modulators of IL-12, IL-23, and/or INFa [0014], and compositions thereof (as in instant claims 8, 9), useful to treat, for example, Alzheimer’s disease [0342].
Liu teaches [0024] broadly compounds of formula (I) as compounds of the invention
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,
wherein
Y is, for example, N or -CH- [0025], [0032];
R1 is, for example, CD3 [0026];
R2 is, for example, -C(O)R2a [0027], where R2a is, for example, -(CH2)rORb, or –(CH2)rNR11R11, or –(CH2)r-3-14-carbocycle optionally substituted [0028], where r is, for example 0 [0041]; Rb is for example, alkyl [0035]; R11 is for example C1 alkyl [0033];
R3 is
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where X is, for example, O; and R6 is, for example, H, halogen or C1-4 alkyl [0032];
each of R4 and R5 is, for example, H [0031].
The difference between compounds of instant formula (I) of claim 1
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wherein X is N or -CH-;
R1 is -NHCD3;
R2 is -N(CH3)2, -OR2a or C3-6 cycloalkyl optionally substituted; where R2a is C1-3 alkyl;
R4 is hydrogen, halogen or C1-3 alkyl; and
R3 is C1 fluoroalkyl,
and the subgenus of formula (I) (see above) disclosed by Liu is
R3 = C1 fluoroalkyl (instant compounds) vs. CH3 (Liu).
Liu specifically teaches (Specification, [0632], page 71) the compound (Example 252) below:
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which is a R3 = CH3 vs. R3 = CHF2 in the instant elected species.
Li further teaches the following compounds Table 1, page 25:
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Example 159, page 42
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Example 173, page 48
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Examples 175, 176, page 50
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Example 177, page 51
The difference between the compounds above taught by Liu and compounds of instant formula (I) is R3 = CH3 (Liu) vs. R3 = C1 fluoroalkyl in a compound of instant formula (I).
Liu further teaches the following compound:
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Table 7, page 52
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The difference between compound Example 180 in Liu and the instant compounds is
R3 = CH3 (Liu) vs. R3 = C1 fluoroalkyl in a compound of instant formula (I)
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wherein X is N;
R1 is -NHCD3;
R2 is C3 cycloalkyl unsubstituted;
R4 is halogen (F).
Liu teaches the following compounds:
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Table 8, page 54-55
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The difference between compounds Examples 87, 198 in Liu and the instant compounds is
R3 = CH3 (Liu) vs. R3 = C1 fluoroalkyl in compounds of instant formula (I)
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wherein X is N;
R1 is -NHCD3;
R2 is C3 cycloalkyl unsubstituted or substituted with 2 methyl groups;
R4 is C1 alkyl.
Liu also teaches the compounds below:
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page 71
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Example 252, page 71
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Example 253, page 72.
which correspond to R3 = CH3 vs. R3 = C1 fluoroalkyl in instant compounds of claim 7.
Liu does not teach the instant elected species.
Liu does not teach the instant compounds of formula (I) where R3 is C1 fluoroalkyl.
Bohm teaches fluorine substitution in contemporary medicinal chemistry; Bohm teaches (page 637, left column, third paragraph) replacement of an oxidizable C-H group by a C-F group in compounds to increase metabolic stability of the molecule, and improve bioavailability, while retaining biological activity/therapeutic effect.
It would have been obvious for a person of ordinary skill in the art to replace one or more oxidizable C-H group by C-F groups in a compound (Examples above) taught by Liu to arrive at the instant invention. The person of ordinary skill in the art would have replaced one or more oxidizable C-H groups by C-F groups in a compound taught by Liu (Examples above), because Bohm teaches such a replacement increases metabolic stability of the molecule, and improves bioavailability, while retaining therapeutic effect. Thus, a person of ordinary skill in the art would have replaced C-H bond with C-F bond (R3 -CH3 replaced by -CHF2, or -CH2F, or -CF3) in a compound of Liu, with the expectation that the resulting compound retains the biological activity taught by Liu as modulator of IL-12, IL-23, and/or IFNa, and has improved metabolic stability/bioavailability.
Further, regarding claims 3, 4, a person of ordinary skill in the art would have replaced one or more oxidizable C-H groups by C-F groups (R3 -CH3 replaced by -CHF2, or -CH2F, or -CF3) in a compound Y = CH from the genus of compounds of formula (I) taught by Liu to arrive at the instant invention. The person of ordinary skill in the art would have replaced one or more oxidizable C-H groups by C-F groups in a compound from the genus of formula (I) where Y = CH taught by Liu, because Bohm teaches such a replacement increases metabolic stability of the molecule, and improves bioavailability. Thus, a person of ordinary skill in the art would have replaced C-H bond with C-F bond in a compound of Liu, with the expectation that the resulting compound retains the biological activity taught by Liu as modulator of IL-12, IL-23, and/or IFNa, and has improved metabolic stability/bioavailability.
As such, claims 1-9 are rejected as prima facie 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 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 1-9 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20, 23, 24 of U.S. patent 11,021,462 (cited in PTO-892), in view of Bohm et al. (ChemBioChem 2004, 5, 637-643, cited in PTO-892).
Claims 1-20, 23, 24 of U.S. patent 11,021,462 are drawn to a compound of formula (I)
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,
wherein
Y is, for example, N or -CH-;
R1 is, for example, CD3;
R2 is, for example, -C(O)R2a , where R2a is, for example, -(CH2)rORb, or –(CH2)rNR11R11, or –(CH2)r-3-14-carbocycle optionally substituted, where r is, for example 0 [0041]; Rb is for example, alkyl; R11 is for example C1 alkyl;
R3 is
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where X is, for example, O; and R6 is, for example, H, halogen or C1-4 alkyl;
each of R4 and R5 is, for example, H.
The difference between compounds of instant formula (I) of claim 1
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wherein X is N or -CH-;
R1 is -NHCD3;
R2 is -N(CH3)2, -OR2a or C3-6 cycloalkyl optionally substituted; where R2a is C1-3 alkyl;
R4 is hydrogen, halogen or C1-3 alkyl; and
R3 is C1 fluoroalkyl,
and the subgenus of formula (I) (see above) disclosed by claims 1-20, 23, 24 of U.S. patent 11,021,462 is
R3 = C1 fluoroalkyl (instant compounds) vs. CH3 (claims of U.S. patent 11,021,462).
Claims 13-20 of U.S. patent 11,021,462 specifically disclose the compounds below:
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, which are R3 = CH3 vs. R3 = C1 fluoroalkyl in compounds of the instant claims 1, 2, 5, 6, 7, 8, 9.
Claims 23, 24 of U.S. patent 11,021,462 specifically disclose the compound below:
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which is a R3 = CH3 vs. R3 = CHF2 in the instant elected species.
Claims 1-20, 23, 24 of U.S. patent 11,021,462 recite that R3 = CH3. Claims 1-20, 23, 24 of U.S. patent 11,021,462 do not recite that R3 = C1 fluoroalkyl, as in the instant claims.
Bohm is as above.
It would have been obvious for a person of ordinary skill in the art to replace one or more oxidizable C-H groups by C-F groups in compounds taught by claims 1-20, 23, 24 of U.S. patent 11,021,462 to arrive at the instant invention. The person of ordinary skill in the art would have replaced one or more oxidizable C-H groups by C-F groups, in a compound taught by claims 1-20, 23, 24 of U.S. patent 11,021,462, because Bohm teaches such a replacement increases metabolic stability of the molecule, and improves bioavailability, while retaining therapeutic effect. Thus, a person of ordinary skill in the art would have replaced C-H bond with C-F bond
(R3 -CH3 replaced by -CHF2, or -CH2F, or -CF3) in a compound of 1-20, 23, 24 of U.S. patent 11,021,462, with the expectation that the resulting compound retains the biological activity and has improved metabolic stability/bioavailability.
Conclusion
Claims 1-9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached on (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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/IRINA NEAGU/Primary Examiner, Art Unit 1629