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 .
Election/Restrictions
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 a 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).
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 to which the claims must be restricted.
Group I, claims 13-28, drawn to a bispecific antibody comprising first and second binding fragments that bind to different epitopes of TSLP and a pharmaceutical composition thereof
Group II, claims 29-32, drawn to a method of preventing or treating a TSLP-mediated disease comprising administering the bispecific antibody
The groups of inventions listed above 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:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of bispecific antibody comprising first and second binding fragments that bind to different epitopes of TSLP, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 2010/0166766, published February 19, 2013 (see IDS from 8/7/2023), which teaches monoclonal and bispecific anti-TSLP antibodies, wherein the bispecific antibody recognizes different antigenic epitopes from the same antigen [0111].
During a telephone conversation with Bradley Taub on January 30, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 13-28. Affirmation of this election must be made by applicant in replying to this Office action. Claims 29-32 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims 13-28 are under consideration in this office action.
Priority
The application is the national stage entry of PCT/CN2021/100657, filed July 17, 2021.
Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b) or 386(a) based upon CN202110147687.1, filed on February 3, 2021. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on August 7, 2023, May 17, 2024, and December 17, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs are being considered by the examiner.
The listing of references in the specification (pg 32-34) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg 8 and 33). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 16-17, 25, and 28 are objected to because of the following informalities:
Claims 16-17, and 25 use acronyms without first defining what they represent in the claims (see HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 in claims 16-17 and 25 and TSLP in independent claim 25). While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym. Claim 28 is included in this objection for being dependent on an objected base claim; however, claims 25 and 28 would be allowable if claim 25 were rewritten to correct the informality.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 14, 18-24, and 26 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 14, which is dependent on claim 13, recites the limitation "the binding of human TSLP to human TSLP receptor". There is insufficient antecedent basis for this limitation in the claim, because there is no limitation in claim 13 directed to binding of TSLP to its receptor.
Claims 18, 19, and 26, which are dependent on claims 16, 17, and 25, respectively, recite the limitation "the heavy chain variable region" and “the light chain variable region”. There is insufficient antecedent basis for these limitations in the claims, because there is no limitation in claims 16, 17, or 25 directed to heavy chain or light chain variable regions.
Claim 20, which is dependent on claim 13, recites the limitations “the first heavy chain constant region” and “the second heavy chain constant region”. There is insufficient antecedent basis for these limitations in the claim, because there is no limitation in claim 13 directed to a first or second heavy chain constant region.
Claim 21, which is dependent on claim 13, recites the limitation “the same light chain variable region”. There is insufficient antecedent basis for this limitation in the claim, because there is no limitation in claim 13 directed to a light chain variable region.
Claims 24, which are dependent on claims 13, respectively, recites the limitation "the heavy chain” and “the light chain”. There is insufficient antecedent basis for these limitations in the claim, because there is no limitation in claim 13 directed to heavy or light chains.
Claims 22-23 are included in this rejection for being dependent on a rejected base claim and for failing to cure the indefiniteness.
Claim Rejections - 35 USC § 112(a)
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 13-24 and 27 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 contains subject matter that 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
Claims 13-24 and 27 are directed to a bispecific antibody comprising two binding fragments that bind to non-overlapping epitopes of human TSLP. Claims 15-19 only describe one of the antigen-binding domains of the bispecific antibody, leaving the other antigen-binding domain entirely structurally undefined. Claims 14-15 do require specific function for the claimed antigen-binding domains (i.e. one capable of blocking the binding of human TSLP to human TSLPR and blocking the binding of human IL-7Ra to human TSLP:TSLPR complex), however, absent empirical demonstration, one skilled in the art could not envision the six CDRs that may be combined to arrive at an antigen-binding domain capable of binding TSLP and capable of these functional limitations. Thus, these claims are directed to broad genus of anti-TSLP antigen-binding domains that are defined by function, i.e. what they bind and block.
Antibodies generally share certain characteristics such as Fc regions or hinge regions. However, these structures are not correlated with the binding function of the antibody. It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three complementarity determining regions (CDRs) that provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity, which is characteristic of the immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences, which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites (see Almagro et al, Section 3 “Antibody Structure and the Antigen Binding Site” and Figure 1; PTO-892).
There is no way to a priori look at an antigen sequence (e.g., TSLP) and envisage the combination of six CDRs that will bind that antigen. First, even highly related CDRs may not bind the same target. See for example Kussie (instant PTO-892), who demonstrates that a single amino acid change in the heavy chain of an antibody that binds p-azophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (see abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (pg 7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on pg 11).
While the prior art teaches some understanding of the structural basis of antigen-antibody recognition, it is noted that the art is characterized by a high level of unpredictability, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the antigen-binding domains.
According to the specification, the applicant has disclosed at least two specific species of anti-TSLP antibody comprised of specific combinations of heavy chain CDRs and light chain CDRs. However, the specification does not provide adequate written description for the entire claimed genus of anti-TSLP antibodies, because one skilled in the art would be unable to immediately envision, recognize, or distinguish most of the members comprised within the genus claimed, specifically which heavy chain and light chain amino acid sequences should be combined to yield an antigen-binding region that is capable of binding TSLP.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody to demonstrate possession of the breadth of the genus of anti-TSLP antibodies encompassed by the instant claim, especially in view of the unpredictability of such an endeavor. The prior art, as evidenced by Edwards et al., 2003 (instant PTO-892), teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
To provide adequate written description and evidence of possession of the claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of one generic, broad genus that encompassed a diverse and huge number of possible antibodies and other agents that bind the disclosed epitope. The specification does not provide a consistent structure for all of the possible antibodies and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only two species within the genus.
For claims drawn to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011). An antibody described only by functional characteristic, such as antibody that binds TSLP, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995).
With the exception of specifically disclosed antibodies with specific CDRs, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. 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 product 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. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. 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).
Therefore, claims 13-24 and 27 do not meet the written description requirement.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-15, 17, 19, 21-22, 24, and 27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021155634, filed March 30, 2020 (instant PTO-892; machine translation retrieved from Patentscope on 2/2/2026).
The applied reference has common inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
WO ‘634 teaches antibodies that bind to human TSLP [0011]; the term “antibody” includes a bispecific antibody, which reads on the anti-TSLP bispecific antibody of instant claim 13. As there is no evidence that the WO ‘634 antibodies do not bind the epitopes of instant claims 14-15, WO ‘634 anticipates these anti-TSLP antibodies as well.
Regarding instant claim 19, WO ‘634 teaches an anti-TSLP antibody comprised of heavy chain variable region of SEQ ID NO: 25 and light chain variable region of SEQ ID NO: 24 [0102], which are identical to instant heavy chain variable region of SEQ ID NO: 20 and instant light chain variable region 21, respectively. The heavy chain variable region and light chain variable region of WO ‘634 are comprised of HCDR1-3 of instant SEQ ID NO: 35-37 and LCDR1-3 of SEQ ID NOs: 32-34, which reads on the bispecific antibody of claim 17. The heavy chain of SEQ ID NO: 38 of instant claim 24 is comprised of the heavy chain variable region of SEQ ID NO: 25 of WO ‘634, and the light chain of SEQ ID NO: 39 of instant claim 24 is comprised of the light chain variable region of SEQ ID NO: 24 of WO ‘634, which reads on the bispecific antibody of claim 24.
WO ‘634 teaches that the antibody is a Fab fragment or scFv [0024], which reads on claims 21 and 22. The antibody of WO ‘634 is provided as a pharmaceutical composition comprising the antibody and a pharmaceutically acceptable excipients, diluent, or carrier [0030], which reads on instant claim 27.
Claims 13-15, 17, 19, 21-22, 24, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 111171150 , published May 19, 2020 (“Liu”, instant PTO-892; machine translation retrieved from Patentscope on 2/3/2026)).
Liu teaches antibodies that bind to human TSLP (pg 2); the term “antibody” includes a bispecific antibody (pg 3), which reads on the anti-TSLP bispecific antibody of instant claim 13. As there is no evidence that the Liu antibodies do not bind the epitopes of instant claims 14-15, Liu anticipates these anti-TSLP antibodies as well.
Regarding instant claim 19, Liu teaches an anti-TSLP antibody comprised of heavy chain variable region of SEQ ID NO: 25 and light chain variable region of SEQ ID NO: 24 (pg 4), which are identical to instant heavy chain variable region of SEQ ID NO: 20 and instant light chain variable region 21, respectively. The heavy chain variable region and light chain variable region of Liu are comprised of HCDR1-3 of instant SEQ ID NO: 35-37 and LCDR1-3 of SEQ ID NOs: 32-34, which reads on the bispecific antibody of claim 17. The heavy chain of SEQ ID NO: 38 of instant claim 24 is comprised of the heavy chain variable region of SEQ ID NO: 25 of Liu, and the light chain of SEQ ID NO: 39 of instant claim 24 is comprised of the light chain variable region of SEQ ID NO: 24 of Liu, which reads on the bispecific antibody of claim 24.
Liu teaches that the antibody is a Fab fragment or scFv (pg 5), which reads on claims 21 and 22. The antibody of Liu is provided as a pharmaceutical composition comprising the antibody and a pharmaceutically acceptable excipients, diluent, or carrier (pg 2), which reads on instant claim 27.
Claims 13-15, 21-22, and 27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2010/0166766, published July 1, 2010 (“Presta”; IDS from 8/7/2023).
The claims are directed to a bispecific antibody that binds to non-overlapping epitopes of TSLP.
Presta teaches bispecific anti-TSLP antibodies, wherein the bispecific antibody recognizes different antigenic epitopes [0111], which reads on instant claim 13. The anti-TSLP antibodies of Presta are useful to block TSP binding to its receptor [0121]. As there is no evidence that the Presta antibodies do not bind the epitopes of instant claims 14-15, Presta anticipates these anti-TSLP antibodies.
Presta teaches that the binding fragment is an antibody fragment selected from the group consisting of Fab, Fab', Fab'-SH, Fv, scFv, and F(ab')2 [0019], which reads on claims 21-22. Presta also teaches a pharmaceutical composition for the antibody or fragment thereof [0032], which reads on instant claim 27
Claim Rejections - 35 USC § 103
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 13-15, 20-23, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0166766, published July 1, 2010 (“Presta”) in view of Merchant et al, published July 26, 1998 (instant PTO-892).
Presta teaches bispecific anti-TSLP antibodies, wherein the bispecific antibody recognizes different antigenic epitopes [0111], but Presta does not teach a bispecific antibody comprising first and second heavy constant regions with the amino acid substitutions as required by instant claim 20 and the same light chain as required by instant claim 23.
Merchant et al teaches methods of constructing bispecific antibodies with S354C:T366W/Y349'C:T366'S:L368'A:Y407V heavy chain variants and a common light chain (abstract, Figures 1-2, Table 1). The advantage of the Merchant et al technique is that the heavy chain mutations required for heterodimerization can be incorporated in to heavy chain of any antigen-binding specificity to improve efficiency in producing bispecific antibodies (pg 680, column 1).
Given that Presta teaches bispecific anti-TSLP antibodies, and further given that Merchant et al teaches modifications in the heavy chain constant region and common light chain to efficiently generate bispecific antibodies, it would have been obvious to one of ordinary skill in the art to apply the bispecific antibody structure of Merchant. One would do so and have a reasonable expectation of successfully generating a bispecific antibody that recognizes different epitopes of TSLP. The motivation to do so comes from Merchant et al, which teaches limitations of conventional bispecific antibody construction that is associated with both L chain and H chain mispairing (pg 677, column 21) and the advantages of the claimed mutations (abstract).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/ Examiner, Art Unit 1675