DETAILED OFFICE ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of group I invention filed on 18 November 2025 is acknowledged.
Applicant's further election with traverse of the antibody comprising the CDRs 1-3 of SEQ ID NO: 2-4, and the corresponding VHH of SEQ ID NO: 1 filed on 18 November 2025 is acknowledged. The traversal is on the ground(s) that the Office has not shown a serious burden would be required to examine all species recited in the claims.
This is not found persuasive because the present claims recite a large number of independent antibody clones (about 30), which comprise distinct sequence structures. As addressed in the last Office Action, each set of SEQ ID NOs of an antibody represents unique and separately patentable sequences, requiring a unique search of the prior art. Searching all sets of the sequences (antibody clones) in a single patent application clearly would constitute an undue search burden due to the non-coextensive nature of these searches.
The restriction requirement is still deemed proper and is therefore made FINAL.
Applicant’s preliminary amendment filed on 18 November 2025 is acknowledged and entered. Following the amendment, claim 6 is amended, and the new claim 16 is added.
Currently, claims 1-16 are pending, and claims 1-4, 6-8, 10 and 15 are under consideration, to the extent that they read on the elected sequences. Claims 5, 9, 11-14 and 16 are withdrawn from further consideration as being drawn to a non-elected invention.
Note, the status identifier of claim 15 indicates “Withdrawn”, which is improper as claim 15 has been grouped in group I invention, and is under examination. Appropriate correction is required.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 7/9/2025 and 10/3/2025 are acknowledged and have been considered. A signed copy is attached hereto.
Priority acknowledgement
This application claims benefit of U.S. application 18/018,837, which is a national stage entry (371) of PCT/US2021/044802 with the international filing date of 08/05/2021, which claims benefit of U.S. provisional applications 63/061,562 filed 08/05/2020, 63/078,745 filed 09/15/2020, and 63/135,884 filed 01/11/2021, which is acknowledged.
Specification
The specification is objected to because the status of U.S. Application 18/018,837,
which has been issued as U.S. Patent No. 12,286,482, has not been updated yet.
Claims
Applicant is advised that should claim 1 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Claim 10 recites “for use in isolation, depletion ...”, which does not in any way alter the IL10Rb binding molecule of claim 1. 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).
Claims 1, 7 and 10 are objected to for the following informalities, appropriate correction is required:
Claim 1 recites “A IL10Rb binding molecule”; the following is suggested: “An IL10Rb binding molecule”.
Claim 7 recites “wherein the sdAb is humanized or otherwise comprises CDRs grafted onto a heterologous framework”; the following is suggested: delete “otherwise”.
Claim 10 recites “A IL10Rb binding molecule of claim 1”; the following is suggested: “The IL10Rb binding molecule of claim 1” since it is a dependent claim.
Rejections under 35 U.S.C. §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.
Claims 4 and 6 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.
Claim 4 recites “wherein the sdAb has at least 80%, alternatively at least 85%, alternatively at least 90%, alternatively at least 95%, alternatively at least 98%, alternatively at least 99% identity, or 100% identity to ...”, which is indefinite for the following reasons: a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation of “at least 80%, alternatively at least 85%” (for example), and the claim also recites “at least 99% identity, or 100% identity to ...” (for example), which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim. Claim 6 is similarly indefinite.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Written Description
Claims 1, 4 and 6 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 independent claim 1 recites “A IL10Rb binding molecule that specifically binds to the ECD of IL 10Rb”, without reciting any structural limitation for the binding molecule, which reads on any or all functional equivalents that specifically binds to the ECD of IL10Rb. Therefore, claim 1 encompasses a genus of molecules with extreme structural dissimilarity, as said binding molecule is defined only by a functional limitation. However, the specification merely discloses one type of the binding molecule, i.e., sdAb/VHH for the ECD of IL10Rb, and no other type of “IL10Rb binding molecule” meeting the limitations of the claim is ever identified or particularly described. Additionally, with respect to claims 4 and 6, which encompass various % variants (80-99%) of an VHH antibody comprising the amino acid sequence of SEQ ID NO:1 (elected), including variations in the CDR regions. Thus, the claims encompass a large number of the VHH variants of SEQ ID NO: 1. However, while the specification discloses the VHH of SEQ ID NO: 1, and a number of other VHH antibody clones, which are structurally independent, there is no % variant of SEQ ID NO: 1 (or any other VHH antibodies) ever made or particularly described in the specification.
The first paragraph of 35 U.S.C. § 112 "requires a 'written description of the invention' which is separate and distinct from the enablement requirement." “[A]pplicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 1111, 1116, 1117 (Fed. Cir. 1991).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Sufficient description of a genus requires the disclosure of either (1) a representative number of species falling within the scope of the genus or (2) description of structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. In the instant case, the specification merely discloses sdAbs/VHHs for the ECD of IL10Rb; and does not disclose any % variant of SEQ ID NO: 1 or any of the VHH antibodies recited, let alone, any variation in the CDR regions. Given the fact that the antibody variable regions especially CDRs are responsible for antigen binding specificity, and are highly sensitive to any change in sequence structure, it would be extremely unpredictable as to how the combined sequence changes as claimed would affect the retention of the desired functional property. See, for example, Rudikoff et al. (Proc. Natl. Acad. Sci. USA, 1982, 79:1979-1983), for reference. Further, there is no teaching in the specification regarding the structural-functional relationship of the VHH antibodies, or which 20% of the sequences of the VHH of SEQ ID NO: 1 (including CDRs) can be varied while retaining the ability of binding to the extracellular domain of IL 10Rb. Furthermore, there is no information in the specification about the effect of the changes in the CDRs as encompassed by the claims, on the functional property of the antibody. Thus, with the exception of the VHH comprising the CDRs of SEQ ID NO: 2-4, or comprising the amino acid sequence of SEQ ID NO:1 (elected), one of skill in the art cannot "visualize or recognize" the members of the claimed genus of the % variant thereof. "A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F.3d at 923; Eli Lilly,119 at 1568. Instead, the "disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Id. Accordingly, the specification does not provide adequate written description of the claimed genus. Due to the limited species disclosed (0 species for the % variant of SEQ ID NO: 1) that meets the limitations of the claims; the broad breadth of the claimed genus, and the lack of structural and functional relationship disclosed for the VHH, and lack of predictability for the encompassed VHH variants, one skilled in the art would not conclude that the applicant was in possession of the claimed genus at the time the application was filed.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
Therefore, only sdAbs/VHHs, but not the full breadth of the claims (“IL10Rb binding molecule”); and only the VHH comprising the three CDRs of SEQ ID NO: 2-4, or comprising the amino acid sequence of SEQ ID NO: 1 (elected); but not the full breadth of the claims (“at least 80%, …” variants) meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites “A IL10Rb binding molecule of claim 1 for use in isolation, …”, which “for use in …” does not in any way alter the features of or further limit the IL10Rb binding molecule of claim 1. Therefore, claim 10 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Rejections Over Prior Art:
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.
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.
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donnelly et al. (J Leukoc Biol. 2004 Aug;76(2):314-21; provided by applicant).
Donnelly discloses that several IL-10-related cytokines, including IL-22, IL-26, IFN-lambda1 (IL-29), IFN-lambda2 (IL-28A), and IFN-lambda3 (IL-28B) use a common second chain, IL-10 receptor-2 (IL-10R2; CRF2-4), to assemble their active receptor complexes; that the binding of these ligands to their respective R1 chains induces a conformational change that enables IL-10R2 to interact with the newly formed ligand-receptor complexes, which in turn activates a signal-transduction cascade; that activation by IL-10, IL-22, IL-26, or IFN-lambda can be blocked with neutralizing antibodies to the IL-10R2; and that the receptors for these cytokines are often present on cell lines derived from various tumors, including liver, colorectal, and pancreatic carcinomas; consequently, the receptors for these cytokines may provide novel targets for inhibiting the growth of certain types of cancer (abstract, for example). Additionally, Donnelly teaches a neutralizing anti-IL-10R2 monoclonal antibody (mAb), 1A8.3, and its use thereof (page 315, 2nd column, 2nd paragraph under “THE IL-22R COMPLEX”; and Fig. 1, for example). Therefore, the reference anticipates claims 1 and 10. Note, the “use” limitation recited in claim 10 does not in any way alter the structure or function of the IL10Rb binding molecule of claim 1, therefore, such a limitation does not carry any patentable weight.
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 of this title, 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.
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, 2, 8, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Donnelly et al. (J Leukoc Biol. 2004 Aug;76(2):314-21; provided by applicant), as applied to claims 1 and 10 above, and further in view of Hoey et al. (Exp Biol Med (Maywood). 2019 Dec; 244(17): 1568-1576. Epub 2019 Oct 9; provided by applicant).
The teachings of Donnelly are reviewed above. Donnelly does not teach an antibody to IL-10R2 (IL-10Rb), which is a single domain antibody (sdAb), or a kit of the antibody.
Hoey teaches that structural and biophysical studies have revealed that the small single variable domain found in camelids displays versatility in target recognition, which insight has served as the foundation to develop and engineer VHH domains with enhanced properties capable of targeting a range of therapeutically relevant protein antigens or low-molecular weight haptens; and the modular nature of VHH domains allows them to be introduced into constructs that are simply not possible with conventional antibodies (abstract). Additionally, Hoey teaches that VHH have advantages over conventional antibodies due to their small size and robustness arising from their unique physiochemical properties, including the ability to express VHH in both prokaryotic and eukaryotic expression systems, which can result in a lower cost of goods; the single domain nature of VHH arises from a short encoding gene, which small genetic footprint allows expanded functionality through the creation of modularity via genetic fusions to a wide-array of proteins, e.g. the creation of multispecific antibody fusions; and VHH domains possess high sequence homology to human VH3 genes, which may confer low immunogenicity for use in therapeutic applications; and that initial human trials of an anti-Van Willebrand factor VHH for thrombotic thrombocytopenic purpura (TTP) reported low clinical immunogenicity; nevertheless, despite the high sequence similarity, strategies have also been pursued to humanize camelid VHH domains (page 1570, 1st column, 3rd paragraph).
With respect to claims 2, 8 and 15, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to make an antibody to IL10Rb, and a kit thereof, wherein the antibody is a single domain antibody (sdAb), and may comprise a labeling agent, an imaging agent or a therapeutic agent, following the teachings of Donnelly and Hoey. The person of ordinary skill in the art would have been motivated to do so for research studies, cancer detection and potential therapeutic applications, and for the advantages of VHH; and for facilitating distribution (kit); and reasonably would have expected success because the technology of making a sdAb had been well established and many had been made prior to the filing of the present application.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Double Patenting Rejections:
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 8, 10 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,286,482. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-10 of the ‘482 patent are directed to an IL10Rb binding molecule comprising a single domain antibody (sdAb) that specifically binds to the extracellular domain of IL10Rb (claims 1-5, for example); wherein the IL10Rb binding molecule further comprising a labeling agent, an imaging agent, a tag and/or a therapeutic agent (claim 7); a pharmaceutical formulation comprising the IL10Rb binding molecule (claim 9); and a kit thereof (claim 10). As such, claims 1-10 of the ‘482 patent anticipate the present claims 1, 2, 8, 10 and 15. Therefore, the conflicting claims are not patentably distinct from each other.
Claims 1, 2, 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 9 of U.S. Patent No. 12,139,545. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1, 4 and 9-11 of the ‘545 patent are directed to an IL10R binding molecule comprising: (a) a first sdAb that binds to the ECD of IL10Ra; and (b) a second sdAb that binds to the extracellular domain of an IL10Rb, wherein the sdAb for IL10Rb comprises the CDR1-3 of SEQ ID NO: 100-102, respectively (claim 1, part (b)), or comprises the amino acid sequence of SEQ ID NO: 187 (claims 4, 9 and 10); and wherein the IL10R binding molecule is conjugated to a targeting domain that selectively binds to a cell surface molecule on a cell or tissue (claim 11). As such, claims 1, 4 and 9-11 of the ‘545 patent anticipate the present claims 1, 2, 8 and 10. Therefore, the conflicting claims are not patentably distinct from each other.
Claims 1-4, 6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9, 11, 15, 18, 19 and 21 of copending Application No. 18/904,938 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1, 7, 9, 11, 15, 18, 19 and 21 of ‘938 application are directed to an IL10R binding molecule comprising:(a) a first sdAb that binds to the ECD of IL10Ra; and (b) a second sdAb that binds to the extracellular domain of an IL10Rb; a pharmaceutical formulation thereof (claims 1 and 15, for example); and methods of treatment with the IL10R binding molecule or pharmaceutical formulation thereof (claims 18, 19 and 21); wherein, among others, an IL10Rb sdAb comprises the CDR1-3 comprising the amino acid sequences of SEQ ID NO: 55-57, respectively; or comprising the amino acid sequence of SEQ ID NO: 172 (claims 7, 9 and 11, for example). The CDRs of SEQ ID NO: 55-17, and VHH of SEQ ID NO: 187 of the IL10Rb sdAb of the ‘938 application are 100% identical to the present CDRs of SEQ ID NO: 2-4, and VHH of SEQ ID NO: 1, respectively (elected sequences). Thus, the claimed IL10R binding molecule of the ‘938 application comprises the presently claimed IL10Rb sdAb, and the claims of the ‘938 application anticipate the present claims 1-4, 6 and 10. Therefore, the conflicting claims are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of copending Application No. 19/242,803 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1 and 5-7 of ‘803 application are directed to an IL10R binding protein comprising a sdAb that specifically binds to IL10Ra (an anti- IL10Ra sdAb) and a sdAb that specifically binds to IL10RP (an anti-IL10RP sdAb (claim 1), wherein the anti-IL10Rb sdAb is a VHH antibody, and comprises, among other antibodies, the CDR1-3 of SEQ ID NO: 409-411, and the VHH of SEQ ID NO: 51 (claims 5-7), which sequences are 100% identical to the present CDRs of SEQ ID NO: 2-4, and VHH of SEQ ID NO: 1, respectively. Thus, claims 1 and 5-7 of the ‘803 application anticipate the present claims 1-4, 6 and 10. Therefore, the conflicting claims are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51, 53, 54 and 66 of copending Application No. 19/242,791 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 51, 53, 54 and 66 of the ‘791 application are directed to a binding protein comprising at least a first domain that binds to a first receptor and a second domain that binds to a second receptor, wherein, among others, the second receptor is IL10Rb; and a pharmaceutical composition (claim 51, part (v), and claim 66); wherein contacting with a cell expressing the first and second receptors with the binding protein results in intracellular signaling (claim 51, for example) (which indicates the binding to the extracellular domain of the receptors); wherein the first domain and the second domain are single domain antibodies (claim 53); and wherein the single domain antibodies are VHHs (claim 54). Thus, the claimed VHH antibody for IL10Rb in the claims of the ‘791 application anticipate the present claims 1, 2 and 10. Therefore, the conflicting claims are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion:
No claim is allowed.
Advisory Information:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DONG JIANG/
Primary Examiner, Art Unit 1674
12/10/25