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 .
Claims 1-3, 14, 19-21, and 39-56 are pending.
Claims 4-13, 15-18, and 22-38 are canceled.
Claims 1-2 and 45 are amended.
Applicant’s election of Group I, claims 1-21 and 38-39, in the reply filed on 03/07/2025 is re-acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 40 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/07/2025.
Claims 1-3, 14, 19-21, 39, and 41-56 are under examination on the merits
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/06/2026 has been entered.
Priority
This application is a CON of U.S. Application Serial No. 17/710,243, filed March 31, 2022 and claims priority to NETHERLANDS 2027892, filed March 31, 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
IDS
The IDS filed 07/24/2026 has been considered.
Withdrawn Objections/Rejections
The objection to claim 45 is withdrawn in light of the corrective claim amendment dated 03/06/2026. The rejection for failure to comply with Sequence Disclosure Requirements is withdrawn in light of the corrective amendments to the claims dated 03/06/2026.
Maintained-Notice
Note that instant SEQ ID NO: 1 comprises HCDR1-3 SEQ ID NOs: 25-26-27; SEQ ID NO: 2 comprises HCDR1-3 SEQ ID NOs: 28-29-30; SEQ ID NO: 3 comprises instant HCDR1-3 SEQ ID NOs: 31-32-33; SEQ ID NO: 4 comprises HCDR1-3 SEQ ID NOs: 34-35-36; SEQ ID NO: 5 comprises HCDR1-3 SEQ ID NOs: 37-38-39; SEQ ID NO: 6 comprises instant HCDR1-3 SEQ ID NOs: 40-41-42; SEQ ID NO: 7 comprises HCDR1-3 SEQ ID NOs: 43-44-45; SEQ ID NO: 8 comprises HCDR1-3 SEQ ID NOs: 46-47-48; and SEQ ID NO: 9 comprises HCDR1-3 SEQ ID NOs: 22-23-24.
Maintained-Claim Rejections - 35 USC § 112
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 1-3, 14, 19-21, 39, and 41-56 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.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. 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. See, e.g., Moba, B. V. v. Dianwnd Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
The Application claims a broad genus of binding domains (which as part of binding moieties, see lines 4-9 at page 19 of the specification), which are still (even after the 09/08/2025 claim amendments) essentially defined only by their function of binding human PD-1.
The claims essentially encompass all of the art-known binding moiety forms because the instant specification defines a “binding moiety” as a ‘proteinaceous molecule’ that ‘includes for instance all antibody formats available in the art, such as for example a full length IgG antibody, immunoconjugates, diabodies, BiTEs, Fab fragments, scFv, tandem scFv, single domain antibody (like VHH and VH), minibodies, scFab, scFv-zipper, nanobodies, DART molecules, TandAb, Fab-scFv, F(ab)’2, F(ab)’2-scFv2, and intrabodies’ (see for example, lines 4-9 at page 19 of the instant specification). It is further noted that the specification discloses 3 CDR binding moieties having the HCDR1-3 of SEQ ID NOs: 1-9 (see for example, lines 24-27 of page 3 of the instant specification). The claim attempts to encompass formats for which there is no corresponding disclosure of a representative number of species or a demonstrated, evidenced structure-function correlation. Therefore, even the number of CDRs (3, 6, mor or less?) that are required to form a binding moiety that binds PD-1 as claimed is unspecified, with no demonstration that the HCDR1-3 of any or SEQ ID NOs: 1-9 would function without fixed LCDR1-3 sequences to bind PD-1 as required by the claims. The Application discloses 9 antibodies and states certain mutations which may be made, but does not provide evidence that those mutations (alone or in combination) would function to bind as claimed As amended, the HCDR1-3 ‘sequences’ are almost entirely composed of wildcards with a multiplicity of recited amino acids encompassed for each wildcard. These consensus sequences do not reasonably disclose a representative number of sets of 3 or 6 CDRs (noting that both binding moieties requiring 3 CDRs and binding moieties requiring 6 CDRs are encompassed by the claims as drafted) or sufficient structure to demonstrate a structure-function correlation between the limited fixed residues and the function of binding PD-1. The 9 antibodies disclosed are not deemed to be reasonably representative of the breadth of binding domains encompassed by the recited consensus sequences. Therefore, in view of this disclosure, Applicant is claiming a broad genus of PD-1 binding domains (with recited binding domains being part of the binding moieties (see for example, lines 4-9 of page 19 of the specification) without a representative number of species of said genus. The specification does not provide adequate written description for the entire claimed genus of species of binding domains/binding moieties or of CDRs which function together to bind PD-1 as claimed, because in the absence of empirical determination, one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genus claimed, specifically, which light and/or heavy chain CDR sequence combinations (bearing any mutations or not) might be included in the genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Applicant has not disclosed such a sufficient variety of CDR species for consideration to meet the written description requirement through a representative number of species as 9 disclosed antibodies cannot be deemed reasonably representative of the expansive genus of binding domains/binding moieties claimed. Thus, given the substantial antibody structure variation within the genus as well as the high level of unpredictability in the art, the disclosure of only 9 species having 100% homology is not sufficiently representative of the entire genus claimed (encompassing CDRs not described or even invented, multiple combinations of mutations in the CDRs, and/or interchangeability of the CDRs (HCDRs and LCDRs).
Furthermore, Applicant has not disclosed relevant, identifying characteristics of CDR region amino acid sequences that confer upon an antibody the ability to function as claimed because the instant specification does not provide structural antibody features that correlate with a functional ability to bind as claimed.
Absent a clear description of the at least minimal structural features correlating with a functional ability to function as claimed which are shared by members of a genus commonly sharing this function, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish which heavy and light chain CDR amino acid sequences may be mutated/varied/interchanged such that the resultant heavy and light chain variable regions comprise six CDRs that confer the ability to function as claimed.
Applicant only demonstrates PD-1 binding for antibodies comprising SEQ ID NOs: 9 (parent), 1, 2, 6, 5, 4, 3, and 10 (see for example, Table 1 at page 28 of the instant specification). Applicant points to these antibodies as providing 8 examples of antibodies that bind PD-1. However, this is not true when compared with the scope of the claims. For example, instant claim 1 requires HCDR1-3 such that:
HCDR1 comprises X1X2FX3S, wherein X1 can be Y, T, or H; X2 can be Y, Q, E, H, or D; X3 can be W, or Y;
HCDR2 comprises YIX1YSGX2X3SX5X6PX7X8KX9 (SEQ ID NO: 67), wherein X1 can be Y, V, or I; X2 can be S, or G; X3 can be T, Y, S, H, N, W, L, or Q; X5 can be F, V, or L; X6 can be N, or S; X7 can be S or A; X8 can be F or L; X9 can be S, T, G, D, R, or N; and
HCDR3 comprises GGYTGX1GGDWFDX2, (SEQ ID NO: 63), wherein X1 can be Y, H, V, or A; X2 can be P, V, Y, W, F, T, Q, H, or S.
Please find below, a clustal omega alignment of SEQ ID NOs: 1, 2, 6, 9, 5, 4 ,3, and 10 and a clustal omega alignment of the CDR1-3 of SEQ ID NOs: 1, 2, 6, 9, 5, 4 ,3, and 10.
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Looking to the alignment of the CDRs1-3, not all of SEQ ID NOs: 1, 2, 6, 9, 5, 4, 3, and 10 fall within the scope of claim 1 and are therefore not representative of the scope of claim 1.
For example, only SEQ ID NOS: 9 (represented as p9 in the alignments above), 1, 2, and 6 comply with the requirements of HCDR1 of claim 1. Of those 4 sequences, they only vary at one position in the 5 residue HCDR1 and (position 2) and are therefore not representative of the degree of variation claimed (up to 3 varied positions are once in HCDR1). Similar issues may be observed for the representation of HCDRs2 and 3 of claim 2 regarding the limited degree of embodiments which comply and the even further limited degree of variation exemplified within the embodiments that fall within the claim scope for which PD-1 binding is demonstrated.
Looking to claim 2, claim 2 requires HCDR1-3 such that:
HCDR1 comprises RXiX2X3X4, wherein X1 can be F, or Y; X2 can be T, A, or V; X3 can be M, or L; X4 can be S, N, V, or T;
HCDR2 comprises: WIX1X2X3X4GXX6X7X8X9X10X11X12X13X14, wherein X1 can be N, or D; X2 can be P, S, or T; X3 can be N, or Q; X4 can be T, or D; X5 can be N, S, T, K, L, or E; X6 can be P,Y,A, H, or F; X7 can be T, or S; X8 can be Y, F, or H; X9 can be A, G, V, or F; X10 can be Q, R, N, L, T, or S; X11 can be D, A, G, or S; X12 can be F, V, or A ; X13 can be T, K, H, G; X14 can be G, N, E, or D; and
HCDR3 comprises: X1X2GYCX3X4DX5CYPNX6X7X8DX9 (SEQ ID NO: 68), wherein X1 can be I, S, or V; X2 can be L, Q, or N; X3 can be N, G, S, or D; X4 can be T, S, P, N, or E; X5 can be N, or I; X6 can be W, Q, H, W, A, or L; X7 can be I, V, or L; X8 can be F, L, or I; X9 can be Y, S, N, I, R, H, V, T, K, A, or L.
Again, only 4 embodiments, SEQ ID NOs: 10, 5, 4, and 3 meet the requirements for HCDR1 of claim 2. None of these 4 embodiments vary at the second residue. For HCDR3, only 3 of the 4 embodiments meet the requirements of claim 2: SEQ ID NOs: 10, 5, and 4 (noting that X6 cannot be G as appears in SEQ ID NO: 3). Similar issues may be observed for the representation of HCDR2 of claim 2 regarding the limited degree of embodiments which comply and the even further limited degree of variation exemplified within the embodiments that fall within the claim scope for which PD-1 binding is demonstrated.
There is not disclosure for description of the claimed degree of variation on the individual residues (for example, X9 of HCDR3 of claim 2 is recited as possibly being Y, S, N, I, R, H, V, T, K, A, or L, but the only available embodiments shown disclose X9 as N or Y. This is not representative of the variation for the given residues. This issue concerning a lack of representative species may be observed for many of the variable/wildcard (X) residues recited. Additionally, there is not disclosure of a representative number of species shown to bind PD-1 having the degree of recited variation throughout the sequences (the number of varied residues). Applicant, in effect, merely suggests criteria by which an artisan could screen and may come up with some antibodies that bind PD-1. This does not meet the required description for 35 USC §112(a).
Furthermore, 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. For example, Al Qaraghuli et al (2020, Nature Scientific Reports 10:13969), state that the six CDRs form a continuous surface to form the paratope that binds the epitope of the cognate antigen. This suggests that a change in the CDR sequence may result in a conformationally different paratope which may fail to bind target as claimed. Here, a mutation in the CDRs may result in a paratope unable to bind PD-1. Rabia et al (2018, Biochemical Engineering Journal 137:365-374) teach what effects mutations can have on an antibody's stability, solubility, binding affinity and binding specificity. Rabia et al report that an increase in antibody affinity can be associated with a decrease in stability (p. 366, col. 2 last paragraph; Fig. 2). Tiller et al (2017, J. Biol. Chem. (2017) 292(40) 16638–16652) and Tsuji et al (2022, J Virol 96:e00071-22) teach that mutations in the CDRs (especially HCDR3 are unpredictable and accompanied by tradeoffs in performance (for example increased affinity may lead to decreased specificity); see references in their entirety paying particular attention to the abstract of Tiller et al and the abstract and results section of Tsuji et al). CDR paratope structures have been revealed to be more complex than previously understood by Fernández-Quintero et al (Commun Biol 3, 589 (2020). https://doi.org/10.1038/s42003-020-01319-z; see for example, page 11) teaching that these paratopes are flexible and exist in multiple conformations in solution. Additionally, Piche-Nicholas et al (MAbs. 2018 Jan;10(1):81-94. doi: 10.1080/19420862.2017.1389355) teach that a large body of data exists demonstrating that neonatal Fc receptor (FcRn) binding of an IgG via its Fc CH2-CH3 interface trends with the pharmacokinetics (PK) of IgG. Through analysis of a broad collection of therapeutic antibodies containing more than 50 unique IgG molecules, Piche-Nicholas et al demonstrated that variable domains, and in particular complementarity-determining regions (CDRs), significantly alter binding affinity to FcRn in vitro. Furthermore, a panel of IgG molecules differing only by 1–5 mutations in CDRs altered binding affinity to FcRn in vitro, by up to 79-fold, and the affinity values correlated with calculated isoelectric point values of both variable domains and CDR-L3 (see for example, the abstract at page 81). Furthermore, Zhu et al (Protein Eng Des Sel. 2025 Jan 10;38:gzaf005. doi: 10.1093/protein/gzaf005) teach that the antibody variable domains (HCVR and LCVR), located at the tips of the Y structure, are responsible for antigen binding and consist of two beta sheets, which are stabilized by a conserved disulfide bond. These beta sheets are connected by loops, forming a total of six complementarity-determining regions (CDRs) that confer antigen specificity. The variable domains also include several beta strands that contribute to the structural framework (see for example, column 1 of page 2). Zhu et al further teach that it is widely recognized that not all CDR residues contribute equally to binding affinity, with some playing more critical roles than others. While the HCDR3 loop is the most dominant in binding, the distribution of other CDR loops involved in interactions appears to be more random and less predictable. Zhu et al further teach that framework residues, as their name implies, are essential for maintaining the overall structural integrity of antibodies (see for example, page 13). Zhu et al highlight that the state of the art, rather than closing in on predicting antibody structure-function correlation, is still grappling with and uncovering further complexity and unpredictability in antibody structure-function correlation.
The above cited references underscore the unpredictability of even a single mutation in the CDRs. The instant claims allow for mutations in the CDRs whereupon the mutated paratope may fail to bind PD-1, as claimed. Thus, the claims need to specify exact CDR sequences of the anti-human PD-1.
Accordingly, absent empirical determination, one skilled in the art would be unable to predict or envision which CDR sequences comprised within the genus comprising the claimed CDR sequences may be combined/mutated such that the resultant antibody possesses an antigen-binding site capable functioning as claimed. The general knowledge and level of skill in the art does not adequately supplement the omitted description, because specific, not general guidance is needed. Since the disclosure fails to describe relevant, identifying structural characteristics, in the form of fixed heavy and light chain CDR amino acid sequence combinations, that correlate with the ability to function as claimed, and because the one disclosed species detailed above is not sufficient to describe the claimed genus, it is submitted that the written description requirement of 35 U.S.C. 112(a) has not been met.
The claims require a binding domain capable of binding human PD-1. The specification does not describe which amino acid residues of the binding domain are responsible for the functions claimed. Rather, the specification implies that these potential agents must first be screened in an assay to ascertain if the agents have the functions required by the instant claims. Although the specification provides a few examples of 9 antibodies, it fails to disclose the structures common to all members of the genus of binding domains encompassed by the broad definition provided by applicant (see for example, lines 4-9 of page 19 of the specification). The specification does not disclose the structure of all of the claimed variant binding domains and fails to disclose which sequences are responsible for the functions claimed. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described.
Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement. Here, applicant has not described a reasonable number of members of the genus of antibodies that would function in the method(s) as claimed, but rather has presented the public with an idea of how to perform an assay that might identify some peptides that fall within the scope of the claim. Of course, depending on what agents are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face.
In Ariad, the court further noted that the written description plays a particularly important role in the biological arts, where patentees might otherwise be tempted to claim a genus of compounds by its function or result:
“The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts. 5 See Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, 1, “Written Description” Requirement, 66 Fed. Reg. 1099, 1105-1106 (Jan. 5, 2001). This situation arose not only in Eli Lilly but again in University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 [69 USPQ2d 1886] (Fed. Cir. 2004). In Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. Id. at 918. We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification's function description, the specification did not provide an adequate written description of the claimed invention. Id. at 927-28. Such claims merely recite a description of the problem to be solved while claiming all solutions to it and, as in Eli Lilly and Ariad's claims, cover any compound later actually invented and determined to fall within the claim's functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention.”
Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). Emphasis added.
The Federal Circuit has clarified Written Description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AIA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of an antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional. Id.
While generically the structure of antibodies and variant antibody formats are known, the structure of the presently recited binding domains can vary substantially within the above given claimed recitations. As noted in Amgen, knowledge that an antibody binds to a particular epitope on an antigen tells one nothing at all about the structure of the antibody, wherein “instead of analogizing the antibody-antigen relationship to a ‘key in a lock,’ it [is] more apt to analogize it to a lock and ‘a ring with a million keys on it.” (Internal citations omitted). The relevant antibody art confirms this quandary, indicating that “knowledge of an epitope or antigen used to generate a monoclonal antibody is insufficient for making the original antibody available, even if suitable in vitro test systems for screening are used.” See p. 8, lines 3-5 of WO 2009/033743 A1. Therefore, those of skill in the art would not accept that the inventor had been in possession of the full genus of antibodies in the present claims.
Although screening techniques can be used to isolate CDR variant antibodies that possess the ability to function as claimed, Applicant is reminded that the written description requirement of 35 U.S.C. 112 is severable from the enablement provision. As stated in Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555, “The purpose of the 'written description' requirement is broader than to merely explain how to 'make and use'; the applicant must also 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.”
Therefore, the binding domains, as claimed are only disclosed by function/insufficient structure, without a representative number of species or unifying, conserved structure clearly enabling one skilled in the art to readily envisage the members of the genus claimed which would function as claimed in the claimed method(s). Therefore, the claims are deemed to fail to meet the written description requirement, as presently drafted.
Applicant’s Arguments and Responses:
A. Applicant request withdrawal of the rejections under 35 USC §112(a) for lack of written description (see pages 10-14 of the 03/06/2026 remarks).
Response: None of Applicant’s arguments are persuasive. Applicant merely concludes that there are a representative number of species and/or that there is a known structure-function correlation so as to described the claimed genus known to bind PD-1. The Examiner has clearly set forth why neither a representative species or a structure-function correlation is described in the instant disclosure nor in the state of the art, which supports a high degree of unpredictability in variation of the CDRs and biding. Therefore, the citation to Enzo Biochem, Inc is misplaced as there is nothing on the record to support an art-known structure-function correlation relieving Applicant of the requirement to satisfy the demands of the written description requirement in the instant disclosure. Furthermore, Applicant rebuffs the Examiner’s citation to Amgen v. Sanofi as improper. The Examiner, in light of the high degree of variation, disagrees and finds that there is little structure sufficiently disclosed, let alone described to bind PD-1. However, the Examiner does not rely upon Amgen alone. In addition to the evidentiary references provided to demonstrate the high degree of unpredictability n CDR mutation and binding function, the Examiner further relied upon University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004), Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 94 USPQ2d 1161, 1173 (Fed. Cir. 2010), and Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555—all of which support that the written description requirement must be met for the full scope of what is claimed. Applicant has failed to provide an evidenced argument showing that such description has been met. Therefore, the rejections are maintained at this time.
Conclusion
No claim is allowed.
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/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
Prosecution Insights