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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18 and 35-37 and species: SEQ ID NOs: 79-84 for the heavy and light chain CDRs, SEQ ID NOs: 327-328 for the heavy and light chain variable region sequences, S as the substitution for X1 in formula 1, R as the substitution for X2 in formula 1, Y as the substitution for X3 in formula 1, A as the substitution for X4 in formula 1, S as the substitution for X5 in formula 1, A as the substitution for X1 in formula 2, G as the substitution for X2 in formula 2, G as the substitution for X3 in formula 2, S as the substitution for X4 in formula 2, D as the substitution for X5 in formula 2, R as the substitution for X1 in formula 3, S as the substitution for X2 in formula 3, S as the substitution for X3 in formula 3, Q as the substitution for X4 in formula 3, G as the substitution for X5 in formula 3, I as the substitution for X6 in formula 3, F as the substitution for X7 in formula 3, D as the substitution for X8 in formula 3, I as the substitution for X9 in formula 3, S as the substitution for X1 in formula 4, G as the substitution for X2 in formula 4, N as the substitution for X3 in formula 4, N as the substitution for X4 in formula 4, I as the substitution for X5 in formula 4, G as the substitution for X6 in formula 4, T as the substitution for X7 in formula 4, R as the substitution for X8 in formula 4, R as the substitution for X9 in formula R, not present as the substitution for X10 in formula 4, not present as the substitution for X11 in formula 4, H as the substitution for X12 in formula 4, S as the substitution for X1 in formula 5, K as the substitution for X2 in formula 5, N as the substitution for X3 in formula 5, N as the substitution for X4 in formula 5, P as the substitution for X5 in formula 5, A as the substitution for X1 in formula 6, A as the substitution for X2 in formula 6, W as the substitution for X3 in formula 6, D as the substitution for X4 in formula 6, D as the substitution for X5 in formula 6, S as the substitution for X6 in formula 6, L as the substitution for X7 in formula 6, S as the substitution for X8 in formula 6, G as the substitution for X9 in formula 6, P as the substitution for X10 in formula 6, anti-PD-1, simultaneously, PD-1, a method for preventing or treating cancer comprising administering the anti-CD300C monoclonal antibody, and a kit for prevent or treating cancer in the reply filed 07/15/2025 is acknowledged.
Claims 4, 6-7, 19-34, and 38 are withdrawn from consideration pursuant to 37 CFR1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 07/15/2025.
Claims 1-3, 5, 8-11, 13-18, and 35-37 are now under consideration in the instant Office Action.
Withdrawn Objections
Objections to the drawings, specifically figures 1a-1y, due to a lack of sequence identifiers are hereby with drawn in view of the submission of new drawings which have been amended to include the necessary requirements.
Withdrawn Rejections
Rejections of claims 5 and 12 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 are hereby withdraw in view of amendments to claim 5 and the cancellation of claim 12.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is 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.
Instant claim 5 has been amended to recite “…comprising the amino acid sequence or SEQ ID NO:...” at several instances. This is grammatically incorrect and leads to confusion since it is unclear what is meant by “the amino acid sequence or SEQ ID NO:…” . Does meant another amino acid sequence or the specifically recited SEQ ID NO:? Therefore, the claims do not clearly set forth the metes and bounds of what is their limitations and therefore, found indefinite.
Maintained Rejections
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 1-3, 8-11, 13-18, and 35-37 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.
Claims 1-3, 8-11, 13-18, and 35-37 are directed to an antibody that binds to CD300C. The instantly claimed antibody for CD300C suffers from written description issues due to the combinatorial language of the sequences. See MPEP §2163(I)(A) which states:
"The claimed invention as a whole 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 sequence described only by a functional characteristic, without any 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 claimed sequence.”
In this case, 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. The hyper variable regions (HVRs), i.e., complementarity determining regions (CDRs) of an antibody, are well established in the art as the portion of the binding region which imparts the specificity of an antibody. However, there is no way to a priori look at an antigen sequence (CD300C) 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 (PTO-892 filed 08/12/2025) who demonstrates that a single amino acid change in the heavy chain of an antibody which binds p-axophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (e.g., 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 (p.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 page 11).
Thus, the art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody. As a further example, see Chen et al., 1995 (PTO-892 filed 08/12/2025) which demonstrates single amino acid changes in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody.
The instant specification discloses twenty five pairs of heavy chain and light chain variable regions that make up an anti-CD300C antibody on page 59. However, as discussed above, without any way to determine how broad the genus of such antibodies are, there is no way to determine if these antibodies represent the full breadth of what is claimed. The disclosure of these specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions nor does it allow the skilled artisan to envisage the specific structure of such antibodies.
Additionally, the instant claims refer to the six CDRs that comprise the antibody in a combinatorial fashion wherein one CDR sequence is selected and can be placed in the context of any other CDR(s). Applicant has not provided sufficient disclosure and identities of all the CDRs of the antibodies that can arise from the combinatorial and substitutional language that is encompassed by the claims. Applicant has not demonstrated that they are in possession of all the molecules that fall within the immense scope of the claim that are able to achieve the claimed function.
Further, it is well-known in the art that specificity of an antibody stems from the interaction of six CDRs. Moreover, CDRs are not generally recognized as interchangeable, such that using one CDR from one antibody would not be reasonably expected to confer the same binding properties or even the same binding target when combined with two to five CDRs from other antibodies. For example, WO 2008068048 (PTO-892 filed 08/12/2025) discloses an antibody with a heavy chain comprising three CDRs (SEQ ID NO: 2) that binds secreted aspartyl protease from Candida sp. US 20170355756 (PTO-892 filed 08/12/2025) describes the same three CDRs in the heavy chain (C10-VH3) combined with a different light chain that binds human TDP-43. The instant claims fail to specify what the specific sequences, substitutions included as part of such, constitute the six CDRs of the antibody capable of binding to the target antigen.
As such, the disclosure of a large list of unknown, potential combinations of CDRs does not convey possession of all the potential antibodies that would arise from this combination as claimed and have the same binding properties; possession of the precisely defined sequences of the three CDRs per specificity is required. As written, the instant claims recite a large number of unknown CDRs that can be substituted with an even larger combination of five other unknown CDRs, replete with their own combinations of substitutions, to construct an undefined antibody. There is no evidence in the instant specification that a single CDR placed in the context of two to five other CDRs, regardless of what those other CDRs are, would result in the required function, nor that a single chain is correlated to the required function when combined with any other chain. As such, the specification fails to set forth a structure-function correlation sufficient to claim all possible antibodies defined by function and one-three CDRs or alterations thereof.
With respect to product claims 1-3, 8-11, 13-18, and 35-37, it is recognized that information which is well known in the art need not be described in detail in the specification (MPEP §2163(II)(A)(2)). See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. MPEP §2163(II)(A)(3)(a) also discusses Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004), where a method of using a PGHS-2 inhibitor did not meet the written description as the inhibitor itself was not sufficiently described, clearly indicating that written description of the compound is still required in a method of using that compound. In this case, it is clear from the specification that the invention is in a new antibody, or at the least disclosure of a new antibody that could not have been envisaged from the prior art indicates that the prior art was not in possession of all “anti-CD300C” antibodies. Thus, the prior art cannot provide sufficient written description of this genus of compounds and the specification as filed, does not sufficiently describe the genus either as there is an unknown amount of structurally distinct antibodies in this genus (see Amgen and Centocor decisions discussed above).
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., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. The claimed invention as a whole 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. An antibody described only by functional characteristic, such as antibody that binds to CD300C, 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). 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-CD300C antibodies encompassed by the instant claims, especially in view of the unpredictability of such an endeavor. The prior art as evidenced by Edwards et al., 2003 (PTO-892 filed 08/12/2025) 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”).
Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding.
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of antibodies that binds to CD300C. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
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. 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.
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. 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 one species within the genus.
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 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.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
With the exception of specifically disclosed antibodies with specific CDR sequences and heavy and light chain variable sequence pairs, the skilled artisan cannot envision the detailed chemical structure of all of the potential encompassed combination of 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 1-3, 8-11, 13-18, and 35-37 do not meet the written description requirement.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Applicant argues that the instant specification shows how “CDR 1-3 share structural commonality corresponding to SEQ ID NOs: 403-408 and functional commonality in recognizing the same antigen-binding epitope, forming CDR clusters. Each CDR is selected from specific sequence groups, which conserve essential residues contributing to antigen binding based on the general formulas of SEQ ID NOs: 403-408. One of skilled in the art would therefore understand that combinations across the CDR sets presented in the present specification will retain antigen-binding function based on their structural and functional commonality”. This is not found persuasive.
As noted above, it is acknowledged that Applicant provides pairing for sequences in the instant specification, see page 59 wherein twenty five pairs of heavy chain and light chain variable regions that make up an anti-CD300C antibody are disclosed. However, the claims as written are not commensurate in scope by the breadth they encompass because at each of the six CDRs, the claims recite various options of sequences that can be substituted in in a combinatorial fashion. This combinatorial fashion allows for far more combinations of CDRs to create an antibody than is supported in the specification. Additionally, CDRs are not generally recognized as interchangeable, such that using one CDR from one antibody would not be reasonably expected to confer the same binding properties or even the same binding target when combined with two to five CDRs from other antibodies. For example, WO 2008068048 (PTO-892 filed 08/12/2025) discloses an antibody with a heavy chain comprising three CDRs (SEQ ID NO: 2) that binds secreted aspartyl protease from Candida sp. US 20170355756 (PTO-892 filed 08/12/2025) describes the same three CDRs in the heavy chain (C10-VH3) combined with a different light chain that binds human TDP-43. The instant claims fail to specify what the specific sequences constitute the six CDRs of the antibody capable of binding to the target antigen.
Applicant argues that the structural commonality circumvents of the CDRs this issue; however, one of ordinary skill in the art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody. As a further example, see Chen et al., 1995 (PTO-892 filed 08/12/2025) which demonstrates single amino acid changes in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody. Thus, even minor changes to the identity of the CDRs are treating as structurally discrete entities.
As such, the disclosure of a large list of unknown, potential combinations of CDRs does not convey possession of all the potential antibodies that would arise from this combination as claimed and have the same binding properties; possession of the precisely defined sequences of the three CDRs per specificity is required. As written, the instant claims recite a large number of CDRs that can be substituted with any other five CDRs from a large list to construct an undefined antibody. There is no evidence in the instant specification that a single CDR placed in the context of two to five other CDRs, regardless of what those other CDRs are, would result in the required function, nor that a single chain is correlated to the required function when combined with any other chain. As such, the specification fails to set forth a structure-function correlation sufficient to claim all possible antibodies defined by function and one-three CDRs or alterations thereof.
Therefore, the rejection is maintained.
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 1-3, 8-11, 13-18, and 35-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the list of twenty five heavy and light chain variable region sequences pairs on pg. 59 of the instant specification, does not reasonably provide enablement for all the potential CDRs identities of the antigen binding region that can arise from the substitutions in the instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
A composition without any claimed use can be enabled for any use that would reasonably correlate with the entire scope of that claim (MPEP §2164.01(c)). In the specification, the utility of the antibody is to bind specifically to CD300C and activate T cells, thereby promoting immune cells to differentiate into M1 macrophages that inhibit the proliferation of cancer cells (see pg. 4).
As noted above, even single amino acid mutations can lead to unpredictable changes in binding properties. While skill in the art is high, the evidence of record establishes that predictability is low. The prior art demonstrates that while one residue might tolerate a change from one amino acid to another, this does not mean that same residue can be altered to any of the 20 natural amino acids nor that a different residue of the same CDR is similarly tolerant of change, even where those substitutions are conservative. Rather, while one position might not alter functionality when being mutated, other residues might completely abrogate binding of the whole molecule if they are altered to any amino acid other than the native amino acid. This lack of predictability outweighs the minimal guidance in the specification.
See the decision in Rasmusson v. SmithKline 413 F.3d 1318, 1325 (Fed. Cir. 2005) which stated:
“Thus, at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. [Citation omitted.] ‘If mere plausibility were the test for enablement under §112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the “inventor” would be rewarded the spoils instead of the party who demonstrated that the method actually worked.’”
In the instant case, Applicant provides twenty five antibodies via pairs of heavy and light chain variable region sequences on page 59 of the instant specification, which include unnamed CDRs sequences that correspond to the antigen binding region. Applicant then suggests (claims) that within these CDRs, at any of the suggested positions, that the amino acids can be substituted to a select number of other amino acids. Then, those CDRs complete with any number of possible combinations arising from the substitutions can be combined with any other two to five CDRs, and still maintain a single function commensurate with every variation within the scope of the claims, nor for the specifically claimed functions such as treatment of cancer by modulating immune cell function. Without the evidence to support this claim, this remains at best a plausible hypothesis with the onus of testing placed on others with no reasonable expectation of success. This is undue experimentation as CDRs and variable chains are not generally recognized as interchangeable and if a single amino acid in one CDR can alter function, then clearly altering three of the six CDRs required for binding to any arbitrary sequence would not provide a reasonable expectation of preserving the claimed functions.
Additionally, the amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability in antibody binding, the skilled artisan would need significant guidance in preparing an antibody with a targeted function. The skilled artisan recognizes that antibody binding is a wildly unpredictable endeavor that requires specificity in structure when targeting antigens. Without a proper structure provided by the Applicant for the invention(s), it is nearly impossible to envision and recognize all the potential structures amongst all potential possibilities of antibodies that would have a structure capable of binding, in addition to possessing the functionality needed to access it as a treatment.
As set forth above, inadequate guidance is presented in the specification to overcome the obstacles in practicing the claimed invention in its full scope. The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. Given the tremendous breath of scope involving the instant claims, it would require undue experimentation for one of skill in the art to practice the claimed invention in its full scope. Therefore, the specification fails to provide enough guidance for one skilled in the art on how to practice the instant method, thereby requiring trial and error experimentation to identify antibodies or recombinant proteins meeting the functional limitations of the claims. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention and the amount of direction provided by the inventor, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation.
Therefore, claims 1-3, 8-11, 13-18, and 35-37 are not enabled for their full scope.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Applicant argues that the supplementary materials provided in newly filed IDS documents provides the support and scientific background necessary to claim various CDR combinations with structural and functional commonalities equivalents. This is not found persuasive.
While the Examiner acknowledges that CDRs that bind to the same antigen may share structural similarities, it does not necessarily indicate that they are equivalent elements with identical structures. Each amino acid of the sequence is important to disclose when claiming an antibody as each contributes to the overall affinity of the antibody to an antigen. Even small changes in the sequence can result in drastic changes to functionality, see Chen et al. above. Additionally, the combinatorial fashion of claiming the CDRs as written also requires undue experimentation to decipher which combinations of six CDRs will bind to the selected target. Applicant has not shown possession of all the possible combinations of six CDRs listed in the claims in all of the potential antibodies that can be formed by the claim language.
For these reasons and the reasons listed above, the rejection is maintained.
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.
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Claims 1-3, 5, 8-11, 13-18, and 35-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 and 32-33, of copending Application No. 17/826,954, hereinafter ‘954. Although the claims at issue are not identical, they are not patentably distinct from each other because they contain the same antibody.
Instant claims 1-3, 5, 8-11, 13-18, and 35-37 are drawn to an antibody which binds CD300C comprising CDR sequences SEQ ID NOs: 79-84. These sequences are identical to ‘954’s SEQ ID NOs: 79-84 and read on the ‘954’s claims 20-21 and 32-33 as they share identical binding domain regions on their respective antibodies.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5, 8-11, 13-18, and 35-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-7, 10, 12, 22, of copending Application No. 18/290,409, hereinafter ‘409. Although the claims at issue are not identical, they are not patentably distinct from each other because they contain the same antibody.
Instant claims 1-3, 5, 8-11, 13-18, and 35-37 are drawn to an antibody which binds CD300C comprising CDR sequences SEQ ID NOs: 79-84 and 327-328. These sequences are identical to ‘409’s SEQ ID NOs: 79-84 and 327-328, and read on the reference ‘409’s claims 3-7, 10, 12, and 22 as they share identical binding domain regions on their respective antibodies, as well as additional therapies such as immunotherapeutic agents (e.g. anti-PD-1 antibodies) to treat cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Applicant’s arguments that the rejections will be addressed once the claims are deemed otherwise allowable is not found persuasive. The rejections of claims 1-3, 5, 8-11, 13-18, and 35-37 as provisionally rejected on the ground of nonstatutory double patenting are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675