NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/EP2021/076752, filed Sep. 29, 2021, which claims benefit of priority to Provisional Application 63/085,384, filed Sep. 30, 2020.
Claims 1-8, 10, 11, 13-23, and 72, as amended, are pending.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Mar. 28, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to compounds and compositions, and the compound species of Example 127, having the structural formula,
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in the reply filed on Oct. 30, 2025 (Remarks, pp. 23-25) is acknowledged.
The compound of Example 127 reads on claim 1 wherein:
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Claims 15, 17, 19-21, and 72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Oct. 30, 2025.
Because the elected compound is free of the prior art, search and examination has been extended to the next species. See MPEP § 803.02.
Claims 1-8, 10, 11, 13, 14, 16, 18, 22, and 23 are currently pending and under consideration.
Claim Rejections - 35 U.S.C. § 112(b) - Indefiniteness
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 1-6, 10, 11, 13, 14, 16, 18, and 22 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 pre-AIA the applicant regards as the invention.
Specifically, the claims recite compounds of formula (I), having the structural formula,
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wherein A is a "protein binder unit." However, this term is indefinite, because the specification provides no limiting definition for the term, which also has no clear-cut, commonly understood definition in the art.
The only "protein binding unit" disclosed by the instant specification is embodiment A (specification page 9, lines 1-2), having the structural formula,
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.
Beyond this, neither the claims nor the specification further define or describe the chemical structure(s), formula(s), or moieties encompassed by a "protein binder unit."
In the absence of a limiting definition set forth in the specification, a "protein binder unit" is given its broadest reasonable interpretation as any substance capable of binding to any protein, e.g., small molecule ligands, functional groups, antibodies, etc., which bind to any protein in any way, e.g., covalently or non-covalently.
In addition, claim 1 defines the Linker as having "a minimum length of from 6 to 26 atoms between a and b." By reciting a range as the minimum length, this recitation suggests that the Linker has a minimum length of 6, or 7, or 8, or 9, or 10, or 11, or 12, or 13, or 14, or 15, or 16, or 17, or 18, or 19, or 20, or 21, or 22, or 23, or 24, or 25, or 26 atoms, with no upper limit.
Further, claim 1 defines Z as either ZA or ZB, as follows:
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.
While one of XA, XB, XC, and XD is CY (a carbon atom linked to moiety Y of formula (I)), and the others are N or C, the claim fails to specify, when XA, XB, XC, and/or XD are C, whether the carbon atom(s) are unsubstituted (-CH-) or substituted, as they must be to satisfy valency requirements. XG, XH, XJ, and XK suffer from the same ambiguity. In other words, formula (I) fails to specify whether the carbon atoms of ZA and ZB can be substituted, and if so, by which atoms or functional groups.
Thus, the exact set of substances encompassed by formula (I) and excluded therefrom, cannot be unambiguously determined by one of ordinary skill in the art. While methods of assaying for protein binding activity are known in the art, the term "protein binder unit" includes substances with levels of protein binding activity which are detectable but too low to have any therapeutic utility, as well as substances which have not yet been identified.
As recognized by MPEP § 2173.05(g), a claim term is merely functional descriptive language when it recites a feature "by what it does rather than by what it is" (e.g., as evidenced by its specific structure or specific ingredients). In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971). The following factors are considered when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention, or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise.
Here, substances encompassed by the ambiguous term "protein binder unit" cannot be readily distinguished from substances which are excluded. Therefore, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
Claims 7, 8, and 23 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 pre-AIA the applicant regards as the invention.
Specifically, the claims are drawn to a PROTAC compound "containing" an E3 ubiquitin ligase binding unit of formula (Ia), having the structural formula,
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wherein Y is
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.
However, the scope of formula (Ia) is incomprehensible. Formula (Ia) as recited by claim 7 does not define Z or a linker. Further, claim 7 recites "wherein once to Z" and "twice to Z" without defining what is occurring once or twice to an undefined Z. Also left undefined by claim 7 are recited variable groups YA, YB, RA1, RA2, XG, XH, XJ, XK, and v.
Finally, a compound "containing," as recited by claims 7 and 8, is construed as a compound "comprising," which includes any additional functional groups, moieties, ligands, antibodies, and so on, without limit. Thus, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
Claim Rejections - 35 U.S.C. § 112(a) - Written Description
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 1-6, 10, 11, 13, 14, 16, 18, and 22 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to compounds of formula (I), which encompasses a nearly infinite number of compounds, such that one of ordinary skill in the art could not reasonably conclude that the applicant was in possession of the claimed genus as of the filing date.
The description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’). This matter is of particular importance in the evaluation of claims drawn to a chemical genus which identifies a core compound bearing variable substituents. "A generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification . . . demonstrates that the applicant has invented species sufficient to support a claim to a genus” with such breadth. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171 (Fed. Cir. 2010). An adequate written description requires a precise definition, such as by structure, formula, chemical name, or properties of species falling within the genus, sufficient to distinguish the genus from other materials. Id., quoting Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997).
Merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Ariad, 94 USPQ2D at 1171. 35 U.S. C. 112, first paragraph, requires a description of the invention that “clearly allow[s] persons of ordinary skill in the art to recognize that the inventor invented what is claimed.” Ariad at 1172, quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (1562-63) (Fed. Cir. 1991) (emphasis added).
A sufficient disclosure is one which reasonably conveys to one having ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date. Vas-Cath, 935 F.2d at 1563. The description must reasonably describe the invention, not simply indicate a result which one might achieve if one actually made the invention. Eli Lilly, 119 F.3d at 1568. To properly evaluate whether an applicant has complied with the written description requirement therefore requires an analysis of whether the skilled artisan would recognize, from the description provided, the applicants were in possession of sufficient compounds representing the full breadth of diversity of the genus claimed.
Here, the claims recite compounds of formula (I), wherein the [RA]v-Z-Y moiety, i.e., the E3 ubiquitin ligase binding domain, is reasonably well-defined, but is attached to Linker-A, which requires only that the Linker has a minimum of six (6) atoms, and A is any undefined "protein-binding unit."
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Formula (I) comprises a structurally defined E3 ubiquitin ligase binding domain [RA]v-Z-Y, attached to Linker-A comprising any linker of at least 6 atoms and any protein-binding unit.
Thus, the size of the claimed genus is nearly infinite, against which the specification exemplifies only THREE (3) compounds falling within general formula (I): Examples 127, 128, and 129.
While tripartite PROTAC (proteolysis targeting chimera) compounds are known in the art, comprising an E3 ubiquitin ligase binding domain and a protein-binding domain connected by a linker of variable length, a person of ordinary skill in the art would not recognize that the nearly infinite breadth of claimed formula (I) was actually in the applicants’ possession as of the filing date.
"[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1173-74 (Fed. Cir. 2010), quoting University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 930 (Fed. Cir. 2004). Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of “invention” – that is, conceive of the complete and final invention with all its claimed limitations – and disclose the fruits of that effort to the public. Id.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-6, 10, 11, 13, 14, 16, 18, and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Axford et al. (US 2022/0363671, of record).
Axford et al. claim methods of degrading a target protein in a biological sample comprising contacting the target protein with a Targeting Ligase Binder of formula (I), wherein the target protein is selected from the group listed in Table 1 (claim 30).
In particular, Axford et al. disclose that compounds of formula (I), e.g., a compound of formula (Iv), can be used as a Targeting Ligase Binder to prepare a bifunctional degrader of Formula (A),
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wherein (1) the Targeting Ligand is a group that is capable of binding to a Target Protein listed in Table 1, e.g., BRD1 (bromodomain-containing protein 1, p. 152); (2) the Linker is a group that covalently links the Targeting Ligand to the Targeting Ligase Binder; and (3) the Targeting Ligase Binder is a group that is capable of binding to a ligase (e.g., cereblon E3 ubiquitin ligase), e.g., a compound of Formula (Iv), having the structural formula,
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(paras. [0322]-[0327]; claims 1-4, 11, 18, and 30).
The Targeting Ligase Binder of formula (Iv) (page 21; claim 11) reads on claims 1-6, 10, 11, and 16, wherein Y is
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wherein YA and YB represent CH-CH;
v is 0, or v is 1 and RA is H; and
Z is ZA,
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wherein XA is CY XB is C, XC is N, XD is CH, XG and XH are C=C, and XJ is O, and
Y and linker are not attached at adjacent positions of Z;
A is a protein binding unit, i.e., a group capable of binding to a Target protein listed in Table 1, e.g., BRD1 (bromodomain-containing protein 1, p. 152), and
the Linker is a group that covalently links the Targeting Ligand to the Targeting Ligase Binder.
Axford et al. disclose that examples of Linkers and Target Ligands and synthesis thereof are provided in related U.S. Provisional Application 62/901,161 filed on Sep. 16, 2019, which is incorporated in its entirety (para. [0327]).
For example, the '161 provisional application claims linkers of formula (L-I),
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wherein L1 is selected from the group consisting of a bond, O, NR', C(O), C1-9 alkylene, C1-9
heteroalkylene, *C(O)-C1-6 alkylene, *C(O)-C1-6 heteroalkylene, *C1-6 alkylene-C(O), and
*C1-6 heteroalkylene-C(O), wherein * denotes the point of attachment of L1 to the
Targeting Ligand in Formula (I);
X1 and X2 are each a bond, carbocyclyl, heterocyclyl, or heteroaryl;
L2 is a bond, O, NR', C(O), C1-6 alkylene, C1-6 heteroalkylene, or *C(O)NR'-C1-6 alkylene, wherein * denotes the point of attachment of L2 to X2; or
X1-L2-X2 form a spiroheterocyclyl;
L3 is a bond, C1-6 alkylene, C2-6 alkenylene, C2-6 alkynylene, C1-6 heteroalkylene,
C(O), S(O)2, O, NR', *C(O)-C1-9 alkylene, or *C(O)-C1-9 heteroalkylene, wherein *
denotes the point of attachment of L3 to X2 in (L-I),
wherein no more than 2 of L1, X1, X2, L2, and L3 can simultaneously be a bond; and
R' is hydrogen or C1-6 alkyl (claim 65).
Thus, Axford et al. disclose, teach, and suggest linkers comprising C and H atoms, with at least two heteroatoms and a minimum length of 8 atoms, which may be saturated or unsaturated, and may include straight or branched chains or rings, as recited by claims 1-5.
In addition, Axford et al. claim compounds of formula (I) wherein the Targeting Ligase Binder has the structural formula,
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wherein Rd1 and Rd2 are each H, and Rd3 is, e.g.,
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wherein X7 is NR4, and R1a, R1b, R1d, and R4 are H (claim 3), i.e., indole, as recited by claims 13, 14, and 18.
The compounds of Axford et al. are claimed in pharmaceutical compositions comprising a pharmaceutically acceptable carrier or excipient (claim 13), as recited by claim 22.
It would have been predictable to one of ordinary skill in the art as of the effective filing date to modify the tripartite compounds of Axford et al. to arrive at the claimed compounds with a reasonable expectation of success, because, like the claimed compounds, the compounds of Axford et al. comprise an E3 ubiquitin ligase binding domain and a protein-binding domain connected by a linker of variable length, having the same utility as bifunctional protein degraders. Thus, the compounds of Axford et al. are not only structurally and functionally similar to the claimed compounds, but are also disclosed as useful for the same purpose.
As recognized by MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have (1) very close structural similarities and (2) similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The closer the chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., In re Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904 (and cases cited therein); and In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995).
A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).
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 1-6, 10, 11, 13, 14, 16, 18, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-64 of copending Application No. 18/625,479 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the compound species recited by reference claims 61-64 fall within the scope of formula (I) as recited by examined claim 1.
Specifically, reference claims 61-64 recite the compound species,
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or a pharmaceutically acceptable salt thereof, which reads on formula (I) as recited by examined claims 1-6, 10, 11, 13, 14, 16, 18, and 22.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 10, 11, 13, 14, 16, 18, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 18/979,903 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because at least one compound species recited by reference claim 21 falls within the scope of formula (I) as recited by examined claim 1.
For example, reference claim 21 recites the compound of Example 6 (2-((1r,4r)-4-(2-(4-(7-(2,4-dioxotetrahydropyrimidin-1(2H)-yl)-1-methyl-1H-indol-3-yl)piperidin-1-yl)ethyl)-cyclohexyl)-N-(imidazo[1,2-b]pyridazin-3-yl)-6-methoxy-2H-indazole-5-carboxamide, having the structural formula,
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or a pharmaceutically acceptable salt thereof, which reads on formula (I) as recited by examined claims 1-6, 10, 11, 13, 14, 16, 18, and 22.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure: WO2019/199816; WO2017/007612; CN 110483496; and USPN 10,479,780 (compounds 4-23-029, 4-23-030, 4-23-031, 5-1-072, 5-1-101, 5-1-104, and 5-1-116).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff 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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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629