Prosecution Insights
Last updated: April 19, 2026
Application No. 17/627,904

ANTIBODY SPECIFICALLY BINDING TO WRS PROTEIN, AND USE THEREOF

Non-Final OA §102§112§DP
Filed
Jan 18, 2022
Examiner
COUNTS, GARY W
Art Unit
1678
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Curebio Therapeutics Co. Ltd.
OA Round
1 (Non-Final)
59%
Grant Probability
Moderate
1-2
OA Rounds
3y 2m
To Grant
88%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allow Rate
479 granted / 813 resolved
-1.1% vs TC avg
Strong +29% interview lift
Without
With
+28.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
43 currently pending
Career history
856
Total Applications
across all art units

Statute-Specific Performance

§101
15.5%
-24.5% vs TC avg
§103
32.8%
-7.2% vs TC avg
§102
11.6%
-28.4% vs TC avg
§112
30.0%
-10.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 813 resolved cases

Office Action

§102 §112 §DP
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 Applicant’s election without traverse of Group I claims 1-6, and the selection of antibody composition (b) in the reply filed on 10/13/25 is acknowledged. After further consideration claims 11-14 are rejoined with claims 1-6 and the species restriction is withdrawn . Currently, claims 1-18 are pending. Claims 7- 10 and 15- 18 are withdrawn as being directed to non-elected inventions. Accordingly, claims 1-6 and 11-14 are under examination. Drawings The drawings are objected to because Figures 1-6 appear to disclose amino acids or polynuecleotides but the figures are very blurry and the exact information cannot be ascertained.. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. The drawings are also objected to because Figures 1-6 appear disclose sequences without disclosing the appropriate sequence identifiers. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Abstract Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The instant abstract utilized implied phrases see “The present invention relates to”. This language should be avoided. Specification The use of the term Tween 20 (e.g. page 72, para 405; page 73, para’s 404 & 406; page 76, para 434), which is a trade name or a mark used in commerce, has been noted in this application. It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Claim Objections Claim 1 is objected to because of the following informalities: Claim 1 the recitation “or a fragment thereof” should be --or an antigen binding fragment thereof--. Appropriate correction is required. Claim Rejections - 35 USC § 112 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, 4-6 and 11-14 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 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. Regarding the pending claim language of claims 1 and 11-14 , the recited language limits the claims to a n antibody, however said antibody is described only in terms of function rather than structure. In particular, the claims may be interpreted as reciting that the antibody, that has certain desired binding properties, namely that it binds to a polypeptide comprising SEQ ID NO: 2 in a WRS (tryptophanyl-tRNA synthetase protein. Regarding claims 1 , 4-6 and 11-14 , the claims encompass a large genus of products that may be characterized by substantial variability; put another way, the claimed genus encompasses many possible species of antibodies such monoclonal antibodies, polyclonal antibodies and antibody fragments each potentially binding one or multiple different fragments as claimed, each characterized by a potentially different antibody sequences. For example, regarding hybridoma obtained antibodies, every hybridoma created is going to produce a specific antibody, no two having the same sequence. The claims encompass a large and highly variable genus as there is no way to visualize what antibodies (which specific antibodies characterized by their own distinct sequences of heavy and light chain regions) would bind the specific fragments as claimed (the binders are described only in terms of what they bind , i.e. the antigens to which they bind, rather than structure specific to the binders themselves ), and the claims are not limited to any particular antibody producing hybridoma cell line(s). The recited claim language attempts to place limitations on the antibodies by what they do, and as a result places no limitations on the sequences/structure of the antibodies themselves (rather defines the antibodies only in terms of desired binding properties, thereby limiting the antibodies of the recited claims only to those that achieve the desired functions). The claim scope is potentially enormous depending on how many potential species of the recited genus that meet the structural requirements also meet the functional requirements (the binding described). The originally filed specification fails to disclose any sufficient identifying characteristics specific to the claimed genus of antibodies such to correlate antibody structure with the recited function in a way that would allow one to readily visualize what species of the claimed genus would also exhibit the required functional ability. For example, even in the case of binders that are antibodies, one cannot readily visualize the structure(s) of the antibodies that would be encompassed by the recited claims. Without some identified structure, one cannot readily distinguish between those antibodies encompassed by the recited language, from those excluded from the claim. As an example, consider binders that are antibodies: one cannot readily visualize what anti-WRS (tryptophanyl-tRNA synthetase) protein exhibit the desired binding functions, and bind one of the claimed fragments from those known WRS antibodies that do not bind these fragments. As presented (referring to claims 1 and 11-14 ), the pending claim language would encompass any and all antibodies produced by any hybridoma cell line produced using B-cells from a mammal immunized with WRS protein . Having the sequences of the fragments as claimed (i.e., fragments to which the binder binds) fails to provide sufficient structure specific to the antibodies (binders) to allow one to distinguish what species achieve the desired binding functions from those that do not. Although the specification and instant claims provide this limited reduction to practice for a particular species of the claimed antibody, the specification does not identify structural features of the antibody which impart the claimed binding function and which one of ordinary skill in the art would expect to be conserved across the entire claimed genus (i.e. the specification provides specific sequences for a particular species of antibody which fulfills the claimed binding function, but one of ordinary skill in the art would recognize that there are likely to be other species of antibodies with different CDR and heavy- and light-chain variable sequences which would fulfill the recited binding function). Accordingly, the disclosure of a single species defined by CDR and heavy- and light-chain variable sequences is not sufficient to reflect the breadth and variation within the claimed genus. A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that would exhibit the claimed functional property beyond the specific example provided in the specification. The structural features common to the members of the genus are unknown. “[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. For a claim 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, binding to a certain epitope), “[c] laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-a with A2 specificity, can result in a claim that does not meet written description even if the human TNF-a protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. vy . Abbott Labs ., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011). Along these same lines, a more recent Federal Circuit decision, Amgen v. Sanofi , 872 F.3d 1367 (Fed. Cir. 2017), describes how when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself; not just a description of the sequence to which the antibody binds. Amgen , 872 F.3d at 1378-79. It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” ( AbbVie , 759 F.3d at 1298, reiterating Enzo Biochem , Inc. , 323 F.3d at 964)(emphasis added). In the present case, there is insufficient evidence of such an established structure-function correlation in the case of antibodies, for example, that bind the very specific fragments identified by the claimed SEQ ID N O:2 . A claimed invention may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule defined solely by its ability to perform a function, such as to serve as an antigen recognizing construct, without a known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest, see MPEP 2163. As discussed in the recent case of Amgen Inc. v. Sanofi , 124 USPQ2d 1354 (Fed. Cir. 2017), see page 17: An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad , 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies. See, e.g., J.A. 1241 (549:5-16) (Appellants’ expert Dr. Eck testifying that knowing “that an antibody binds to a particular amino acid on PCSK9 .. . does not tell you anything at all about the structure of the antibody”); J.A. 1314 (836:9-11) (Appellees’ expert Dr. Petsko being informed of Dr. Eck’s testimony and responding that “[m]y opinion is that [he’s] right”); Centocor , 636 F.3d at 1352 (analogizing the antibody- antigen relationship as searching for a key “on a ring with a million keys on it’) (internal citations and quotation marks omitted). Amgen Inc. v. Sanofi further notes, pointing to Ariad Pharms., Inc. v. Eli Lilly & Co. , 94 USPQ2d 1161 (Fed Cir. 2010): To show invention, a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date.” Id. at 1350. Demonstrating possession “requires a precise definition” of the invention. Id. To provide this “precise definition” for a claim to a genus, a patentee must disclose “a representative number of species falling within the scope of the genus or 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.” Id. Amgen at pages 7-8. In this case, there is no disclosure of any species such to be sufficient to represent the claimed genus of antibodies having the recited functional properties. There is substantial variability in the genus. Since there are a substantial variety of compounds possible within the genus, without disclosure of any common partial structure or other sufficient identifying characteristics of the genus, the claimed genus is not sufficiently described. Regarding predictability, without some guidance such as structure-function correlation, it is not possible to visualize the species encompassed by the genus based on recitation of function alone. The teachings of Harlow & Lane (Antibodies, A Laboratory Manual, Cold Spring Harbor laboratory, 1988, pages 25-26 and 37-59) describe how the steps of the humoral immune response to an immunogen are dependent on APC, T-cell and B-cell recognition and processing of the immunogen in ways well known in the art to be highly unpredictable and heavily influenced by the particular immunogen and the specifics of the immunization protocol. Harlow et al. teach that even small changes in structure, such as loss of a single hydrogen bond, can profoundly affect antibody-antigen interaction (p. 25, last paragraph to page 26, second paragraph). The principles laid out in Harlow are further illustrated in the teachings of Edwards et al.("The remarkable flexibility of the human antibody repertoire; isolation of over one thousand different antibodies to a single protein, BLyS "” J. Mol. Biol. (2003) 334, 103-118, DOI:10.1016/).jmb.2003.09.054), which shows the immense combinatorial flexibility and capacity of the human antibody repertoire to generate binding sites to an individual protein antigen, the B-lymphocyte growth factor known as “ BLyS ” (see entire document). Edwards describes in detail how the breadth of antibody structures against a given immunogen can be influenced by the immunization and/or selection methods (see Discussion Section). Lloyd et al. ("Modelling the human immune response: performance of a 10e11 human antibody repertoire against a broad panel of therapeutically relevant antigens”, Protein Engineering, Design and Selection, Volume 22, Issue 3, 1 March 2009, Pages 159-168, https://doi.org/10.1093/protein/gzn058) also shows a repertoire of 1x10 11 human antibody variable regions can generate large numbers of unique, biologically active scFvs against a variety of polypeptide targets (see e.g., at page 161-62 bridging paragraph and in Table 1, cited herewith). Further, as another example in the art illustrating the potential scope of the genus of binders (e.g., just with respect to antibodies) encompassed by the pending claim language, see also Meyer et al., (“New Insights in Type I and II CD20 Antibody Mechanisms-Of-Action With a Panel of Novel CD20 Antibodies”, British Journal of Haematology , 2018, 180, 808-820, |https://doi.org/10.1111/bjh.15132). Meyer describes the core binding region of the well-known anti-CD20 antibody rituximab corresponds to amino acid residues 170ANPS173, wherein N171 is the key residue for binding. By contrast, the OBZ and B1 anti-CD20 antibodies share an overlapping epitope with rituximab (170OANPSEKNSP178); however, in contrast to rituximab residues at positions 176-178 contribute the most to binding (see page 809, left col., 2nd full paragraph). Meyer also described the production and characterization of a panel of new anti-CD20 antibodies which were shown to bind epitopes contained within or nearby the rituximab 170ANPS173 epitope but to bind to different residues than rituximab binds in this region (see page 811, “New CD20 mAbs with overlapping, but distinct epitopes,” see also page 815-16 bridging paragraph). More particularly, Meyer teaches the newly created anti-CD20 mAbs m1 and m2 were found to bind within but also in the vicinity of the rituximab binding site (m1 and m2) and elsewhere (m2):“detailed epitope mapping was performed for both mIgG2c-CD20 mAbs m1 and m2, by using PepScan technology. We identified the critical residues of m1 to be 168EPANPSEK175 by using linear (Figure $2A) and circular (Fig 2C, left) peptides with a positional amino acid scan covering the larger extracellular loop. Also for m2, a signal decrease below the WT binding signal occurred within the 1683EPANPSEK175 sequence motif but the binding signal to the linear (Figure S$2B) and circular (Fig 2C, right) peptide was rather low. This suggests that the epitope of both mAbs is located on the larger loop in the same region, however their binding characteristics are different. The data suggests that m1 binds a linear epitope, whereas m2 binds to a conformational epitope.” (see ibid). Moreover, while these antibodies of Meyers bind within or nearby the rituximab 170ANPS173 epitope they do so with heavy and light chain CDRs non-homologous to those of rituximab. The art establishes that even if multiple antibodies bind epitopes within the same small region of a given polypeptide, it is not uncommon for said antibodies to bind to different amino acid residues even within said small region and for said antibodies to have dissimilar CDRs. The above cited evidence establishes the unpredictability in the art; one cannot readily visualize or recognize the identities of the members of the claimed genus that would be encompassed by the claim and possess both the required functional and structural characteristics claimed. Applicant was not in possession of all binders as claimed capable of the recited binding function. The characteristics defining the genus of binder are unknown as the recited language sets forth only what the binders do and now what they are. There is no disclosure of partial structure or other common structural feature, common to the members of the claimed genus encompassed by the claim, which are responsible for the recited/required function. Recent court cases have indicated that recitation of an antibody which has specific functional properties in the absence of knowledge of the antibody sequences that give rise to said functional properties do not satisfy the requirements for written description. See AbbVie Deutschland GmbH y. Janssen Biotech. Inc. as well as Amgen v. Sanofi , as discussed above. Indeed, in Amgen the court indicates that that it is improper to allow patentees to claim antibodies by describing something that is not the invention, i.e. the antigen, as knowledge of the chemical structure of an antigen does not give the required kind of structure-identifying information about the corresponding antibodies, with the antibody-antigen relationship be analogized as a search for a key on a ring with a million keys on it. While it is within the skill level of the ordinary artisan to make and screen for antibodies having the claimed functional properties, one cannot envision their structure. Rather, the fact that screening would be necessary to determine which binders result in the desired functional ability (necessary in order to determine whether an antibody falls within the scope of the claim) is further evidence that the genus is not adequately described such to convey possession. Screening amounts to only a plan for identifying the claimed antibodies, and is not a description of the antibodies themselves. Similarly, it was held in the University of Rochester v. G.D. Searle & Co., Inc ., 358 F.3d 916, 927 (Fed. Cir. 2004) that the disclosure of "assays for screening compounds, including peptides, polynucleotides, and small organic molecules to identify those that inhibit the expression or activity of the PGHS-2 gene product," did not satisfy the written description requirement for claims requiring administration of a "compound that selectively inhibits PGHS-2"). See also, Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company , 598 F.3d 1336, 1344 (Fed. Cir. 2010) (recognizing distinction between requirements for written description and enablement), and Centocor , 636 F.3d 1350 ("The fact that a fully-human antibody could be made does not suffice to show that the inventors ... possessed such an antibody."). A biomolecule defined solely by its ability to perform a function, such as to serve as an antigen recognizing construct, without a known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. See MPEP 2163. For all of these reasons, the specification fails to convey evidence of possession of the entire genus of antibodies (as in claims 1, 4-6 and 11-14 ). 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 11-14 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. Claims 11-14 are rejected as indefinite because they recite a composition without providing a complete description of what comprises the composition. That is, a “composition” generally suggests multiple elements, while the claimed “composition” of claims 11-14 comprises only the antibody of claim 1 and no additional elements. Thus, it is unclear what elements other than the antibody the Applicant intends. Applicant is reminded that although the claims are read into the specification limitations from the specification are not read into the claims. Please clarify. 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 pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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. Claims 11-14 are 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 11 depends from claim 1 which is directed to an antibody, however, claims 11-12 recites a composition, wherein recitation of the composition and its intended use does not further limit the antibody of claim 1. Claims 13-14 depend from claim 12, directed to the antibody and a composition, however, the claims recite details relevant to the intended use of the composition, and these do not further limit either the antibody or the composition itself. 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. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( 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 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. Claim s 1, 4-6 and 11-14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Greene et al (US 9,399,770) . Greene et al discloses antibodies and compositions of the antibodies that specifically bind to a TrpSR1 protein (WRS protein) which comprises SEQ ID NO’s: 12, 16, 48 and 50 (all of which comprise current SEQ ID NO: 2) (e.g. col 5, lines 10-17, Tables 1-3 and 4-6) . Greene et al discloses that the antibody can be a monoclonal antibody (e.g. col 99, lines 50-7 5; col 111, lines 44-54). Greene et al discloses that the antibody can be a Fab (e.g. col 97, lines 55-67). With respect to claim 5 as currently recited the antibody or fragment thereof disclosed by Greene et al is inherently understood to be an antibody selected from the group consisting of IgG, IgA, IgM, IgE and IgD given that the group comprises all immunoglobulin types. With respect to claims 11-14, these claims are directed to a composition comprising an antibody or fragment thereof, wherein the antibody or fragment thereof is the only recited component of the composition. All other limitations recited in the claims are directed to the intended use of the composition (e.g. “for diagnosing cancer”; “for diagnosing infectious disease”; and defining the particular type of disease). These limitations are recitations of intended use which do not further limit either the antibody or fragment thereof or the composition comprising the antibody or fragment thereof. Recitations of intended use do not distinguish the claims over the prior art in a claim to a product (such as an antibody or composition) because a product is defined by what it is and not by what it is used for (see MPEP 2114 and 2115). Accordingly, as long as the prior art teaches all physical structures and limitations of the product claim, it is assumed to be capable of the recited intended use and is sufficient to meet the claims. As such, Greene, which teaches the antibody and composition comprising the antibody is understood to meet the instant claims, regardless of whether or not it teaches the same intended use. Claim s 1, 4-6 and 11-14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Glidden et al (US 2006/0078556). Glidden et al discloses antibodies and compositions of the antibodies that specifically bind to tryptophanyl-tRNA synthetase (WRS protein) (e.g. para 0004). The tryptophanyl-tRNA synthetase comprises the first 47 amino acids which is 100% match to the currently recited SEQ ID NO: 2). Glidden et al discloses that the antibody can be a monoclonal antibody or antibody fragment (e.g. para 0004, 0080, 0092-0094). With respect to claim 5 as currently recited the antibody or fragment thereof disclosed by Glidden et al is inherently understood to be an antibody selected from the group consisting of IgG, IgA, IgM, IgE and IgD given that the group comprises all immunoglobulin types. With respect to claims 11-14, these claims are directed to a composition comprising an antibody or fragment thereof, wherein the antibody or fragment thereof is the only recited component of the composition. All other limitations recited in the claims are directed to the intended use of the composition (e.g. “for diagnosing cancer”; “for diagnosing infectious disease”; and defining the particular type of disease). These limitations are recitations of intended use which do not further limit either the antibody or fragment thereof or the composition comprising the antibody or fragment thereof. Recitations of intended use do not distinguish the claims over the prior art in a claim to a product (such as an antibody or composition) because a product is defined by what it is and not by what it is used for (see MPEP 2114 and 2115). Accordingly, as long as the prior art teaches all physical structures and limitations of the product claim, it is assumed to be capable of the recited intended use and is sufficient to meet the claims. As such, Glidden , which teaches the antibody and composition comprising the antibody is understood to meet the instant claims, regardless of whether or not it teaches the same intended use. Allowable Subject Matter Claims 2-3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art of record is Green et al and Glidden et al (see supra). However, Greene nor Glidden disclose antibodies which comprise the instantly claimed CDRs or the instantly claimed heavy- and light-chain variable regions of claims 2-3. 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, 4-6 and 11-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2-6, 11 an 16 of copending Application No. 17/628,022 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and application 17/628,022 are directed to an antibody which binds specifically to a WRS protein which comprises an amino acid sequence of SEQ ID NO: 2 and even though the two SEQ ID NO: 2 sequences are comprised of different amino acids the broadest reasonable interpretation of the claims allows for the antibodies to bind to a full length WRS protein which would comprise the recited sequences and one of ordinary skill in the art would understand that the antibody claim s of 17/628,022 which recites specific CDRs would encompass the current antibody which specifically binds to the WRs protein. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT GARY W COUNTS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0817 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 7:00-4:00 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Gregory Emch can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-8149 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /GARY COUNTS/ Primary Examiner, Art Unit 1678
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Prosecution Timeline

Jan 18, 2022
Application Filed
Mar 26, 2026
Non-Final Rejection — §102, §112, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
59%
Grant Probability
88%
With Interview (+28.9%)
3y 2m
Median Time to Grant
Low
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