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 Status
The amendments and remarks filed 03/04/2026 are acknowledged.
Claims 1-12, 14, 16-17, 19, 21-22, and 24 are pending.
Claims 1-4 are amended.
Claims 13, 15, 18, 20, and 23 are canceled.
Applicant’s election without traverse of Group I, claims 1-4, 8-10, 21, and 22, in the reply filed on 03/04/2026 is acknowledged. Applicant’s election of the following species in the reply filed 03/04/2026 is acknowledged: an antibody having rabbit Fc domains and mouse VH and VL domains. It is noted that claim 1 has been amended to recite specific sequences for each of the VH and VL CDRs 1-3.
Claims 5-7, 11-12, 14, 16-17, 19, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/04/2026.
Therefore, claims 1-4, 8-10, and 21-22 are under examination.
Priority
The instant application is a 371 of PCT/US2021/059368 and claims priority to provisional application 63/114,123. Priority is given with the earliest effective filing date of 11/16/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/05/2023, 12/03/2024, and 12/17/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Figures 1 and 7-10 are in color. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 1 and 10 are objected to because of the following informalities: The claims recite an acronym (i.e. BRAF, CDR, and MLH1). The first time an acronym is used, it must be accompanied by the definition of the abbreviation. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 8-10, and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations “a CDR1 amino acid sequence”, “a CDR2 amino acid sequence”, and “a CDR3 amino acid sequence” with respective SEQ ID NOs: for the each of the VH CDRs 1-3 and VL CDRs 1-3. The “a” amino acid sequence for each of the CDRs 1-3 makes it unclear if this requires the entire amino acid sequence of the named SEQ ID NO, or if only two consecutive recited amino acids within the sequence of the named SEQ ID NO are required for each of the sequences. Therefore, the scope of this claim is indefinite.
Claims 2-4, 8-10, and 21, which depend from claim 1, are therefore indefinite for the same reasons.
Note: This 112(b) rejection can be overcome by amending the claim to say “the” CDR1, CDR2, or CDR3 amino acid sequence.
Claim 2 recites the limitation “wherein the VH ABD comprises the sequence according to amino acid positions 20-133 of SEQ ID NO: 1 and the VL ABD comprises the sequence according to amino acid positions 23-129 of SEQ ID NO: 5.” The language of “comprises the sequence according to amino acid positions” makes it unclear if the same amino acids at those same positions are required or not. Therefore, the scope of this claim is indefinite.
Note: The Examiner recommends amending the claim to recite “wherein the VH ABD comprises amino acids 20-133 of SEQ ID NO: 1 and the VL ABD comprises amino acids 23-129 of SEQ ID NO: 5.”
Claim 4 recites the limitation “wherein the Ab or ABP comprises the heavy chain sequence according to SEQ ID NO: 2 and the light chain sequence according to SEQ ID NO: 6.” The language of “according to SEQ ID NO:” makes it unclear if the entire sequence of the recited SEQ ID NOs: are required or only a portion of the sequence is required. Therefore, the scope of this claim is indefinite.
Note: The Examiner recommends amending the claim to recite “wherein the Ab or ABP comprises a heavy chain comprising SEQ ID NO: 2 and a light chain comprising SEQ ID NO: 6.”
Claim 8 recites the limitation “a cell comprising a chimeric or recombinant antibody of claim 1”. It is unclear how a cell can comprise the antibody of claim 1 because a cell can either contain or express an antibody, but it cannot comprise an antibody. Further, it is unclear if the cell simply contains the antibody by injecting the cell with the antibody or if the cell is meant to express the antibody. If the cell is meant to express the antibody, then the claim should depend from a claim drawn to a nucleic acid that encodes the antibody. Therefore, the scope of this claim is indefinite.
Claim 9 recites the limitation “a method for detecting the presence of a human BRAF V600E protein in a cell or a tissue or organ or a portion of any of the foregoing comprising contacting the cell, tissue or organ or a portion of any of the foregoing with a chimeric or recombinant antibody of claim 1”. However, the claim does not require any detection steps or a process for making the protein or antibody detectable and it is unclear how one would perform a method for detecting simply by contacting the cell, tissue, or organ with the antibody. Therefore, the scope of this claim is indefinite.
Claim 10 recites the limitation “wherein the contacting comprises use of an immunohistochemistry (IHC) assay”. It is unclear what the “use of” an IHC assay encompasses because there are no listed components or method steps and the “use of” is dependent on the specific IHC assay. Further, claim 10 recites two different “or” embodiments and seems to be listing specific steps for the method of detection. However, the steps do not appear to be in any specific order, and therefore, is unclear what the order of the steps is in order to perform the method of detection.
Further, claim 10 recites the limitation “said rabbit constant region or portion thereof”. There is insufficient antecedent basis for this limitation in the claim. The lack of antecedent basis arises from claim 10’s dependence on claim 9, which depends from claim 1, where a “rabbit constant region or portion thereof” is not mentioned.
Additionally, the last step of claim 10 recites the limitation “the method further comprises determining whether the cell, tissue, organ or portion of any of the foregoing has reduced mismatch repair gene MLH1 expression or activity or has no mismatch repair gene MLH1 expression or activity” However, the claim does not recite any process or steps for “determining” reduced mismatch repair gene MLH1 expression or activity or no mismatch repair gene MLH1 expression or activity, and it is unclear what the ”determining” encompasses. Therefore, the scope of this claim is indefinite.
Claim 21 recites the limitation “the kit comprises components needed for an immunohistochemistry (IHC) assay.” The components “needed” for an IHC assay are dependent on the specific IHC assay. One IHC assay could “need” 4 specific components while another IHC assay could “need” only 3 specific components. Thus, it is unclear what is encompassed by “components needed”. Therefore, the scope of this claim is indefinite.
Claim 22 recites the limitation “(a) a rabbit antibody (Ab) heavy chain Fc region or portion thereof which is capable of specifically binding to a detectable secondary antibody or portion thereof.” It is unclear how the heavy chain Fc region or portion thereof is capable of specifically binding to a detectable secondary antibody or portion thereof. It could be that all rabbit antibody heavy chain Fc regions have this property or that the claimed heavy chain Fc region is modified in some way that allows for binding to a detectable secondary antibody. Therefore, the scope of this claim is indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 8 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 8 recites a cell comprising a chimeric or recombinant antibody of claim 1, or the cell is a bacterial, fungal, mammalian, yeast, insect or plant cell. Thus, the instant claim encompasses any mammalian cell. Therefore, the claims encompass a human organism (i.e. any mammalian cell).
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature without significantly more.
The claim(s) recite(s) a bacterial, fungal, mammalian, yeast, insect or plant cell. This judicial exception is not integrated into a practical application because the claim is directed to bacterial, fungal, mammalian, yeast, insect or plant cells themselves and does not alter the cells, which are naturally occurring. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements recited.
MPEP 2106.04(b)(II) states “When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
Step 1: It must first be determined if the claim is to a statutory category, and, if so
proceed to step 2A prong 1. The claims are directed to a bacterial, fungal, mammalian, yeast, insect or plant cell, and fall within the statutory category of a product.
Step 2A, prong 1: Prong 1 requires the Examiner to evaluate whether the claim
recites a judicial exception and, if so, proceed to prong 2. In this case, the claims are drawn to the judicial exception of a bacterial, fungal, mammalian, yeast, insect or plant cell. Therefore, the claims recite a judicial exception (natural product).
Step 2A, prong 2: Prong 2 requires the Examiner to evaluate whether the claim
recites additional elements that integrate the exception into a practical application of
that exception and, if not, proceed to step 2B. In order to integrate the recited judicial
exception into a practical application, the claim will apply, rely on, or use the judicial
exception that imposes a meaningful limit such that the claim is more than a drafting
effort to monopolize the judicial exception. Examiners evaluate integration by identifying
additional elements in the claim beyond the judicial exception and evaluating those
elements individually and in combination to determine whether they integrate the
exception into a practical application. Examples that have been found by the Courts in
which the exception was not integrated into a practical application include:
Mere instructions to implement an abstract idea on a computer
Adding generic instructions that the judicial exception should be used (“apply
it”)
Adding insignificant extrasolution activity to the exception (“mere data gathering”)
Generally linking the use of the exception to a particular technological environment or field of use
In this case, claim 8 is a naturally occurring bacterial, fungal, mammalian, yeast, insect or plant cell and the claim does not set forth any limitations that alter the cells from their natural counterpart.
Step 2B: Where a claim does not integrate the exception, a claim may nevertheless be patent eligible, for example where additional elements are “significantly more” than the exception such that the additional elements were unconventional in combination. Considerations include whether or not the claim adds a specific limitation or combination of limitations that not well-understood, routine, conventional activity in
the field, which is indicative that an inventive concept may be present; or simply
appends well-understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception, which is
indicative that an inventive concept may be present. In this case, the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more and do not add something “significantly more” so as to render the claims patent-eligible because the cells are products of nature.
As a whole, considering every step of the most recent guidelines for a proper
§101 analysis, claim 8 does not provide significantly more than the recitation of the judicial exception and is thus not patent eligible.
In summary, the above analysis conducted in line with all current guidance
issued by the USPTO sets forth the rationale and evidence for deeming the above
claims patent ineligible. It is appreciated that all inventions at some level embody, use,
reflect, rest upon, or apply a law of nature, natural phenomenon, or abstract idea.
However, the instant claims do not improve another technology, apply the judicial
exception with any specific machine, transform the gathered data into a different state
or thing, include any limitations which use or apply the exception, add a limitation that is
anything more than what is well-understood, conventional, or routine in the field, or any
other meaningful limitation beyond generally linking the use of the exception to a
particular technological environment.
Therefore, claim 8 is not patent eligible.
Claim Rejections - 35 USC § 112(a)
Written Description
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, 8-10, and 21-22 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.
Claim 1 is drawn to a chimeric or recombinant antibody (Ab) or antigen binding protein (ABP) capable of specifically binding a human BRAF V600E protein, wherein the Ab or ABP comprises a heavy chain variable region (VH) antigen binding domain (ABD) comprising a CDR1 amino acid sequence of SEQ ID NO: 9, a CDR2 amino acid sequence of SEQ ID NO: 10, and a CDR3 amino acid sequence of SEQ ID NO: 11; and a light chain variable region (VL) ABD comprising a CDR1 amino acid sequence of SEQ ID NO: 12, a CDR2 amino acid sequence of SEQ ID NO: 13, and a CDR3 amino acid sequence of SEQ ID NO: 14. Claim 22 is drawn to a chimeric or recombinant antigen binding protein (ABP) capable of specifically binding a human BRAF V600E protein comprising (a) a rabbit antibody (Ab) heavy chain Fc region or portion thereof which is capable of specifically binding to a detectable secondary antibody or portion thereof; and an antigen (Ag) binding region or an Ag-binding portion thereof comprising an Ab variable region from a species other than rabbit, wherein the variable region specifically binds to the human BRAF V600E protein; or (b) the chimeric or recombinant antigen binding protein of (a), wherein: the antigen binding region comprises a Fab region.
Regarding claim 1, it is possible, given the language of the claim which includes “a CDR1 amino acid sequence”, “a CDR2 amino acid sequence”, and “a CDR3 amino acid sequence” with the respective SEQ ID NOs: for the each of the VH CDRs 1-3 and VL CDRs 1-3, that any two amino acids in each of the sequences would suffice to meet the limitations of the claims. Because function of any protein, including an antibody, is dependent on the presence of each specific amino acid residue, and with the possibility of added, deleted, or substituted amino acids, a wide variety of antibodies is encompassed by the instant claim. The phrase “a CDR amino acid sequence” allows any fragment, including any two amino acids in sequence, to be encompassed in the instant claim. This would in theory encompass any possible antibody that binds to human BRAF V600E on earth. These antibodies have no correlation between their structure and function. Amending the claim to recite “the CDR amino acid sequence” would likely overcome this rejection. Regarding claim 22, the antigen binding protein (ABP) is defined solely by the desired function of binding a human BRAF V600E protein.
The specification teaches an antibody that binds to human BRAF V600E protein comprising SEQ ID NOs: 9, 10, and 11 for the VH CDRs 1-3 [page 22] and SEQ ID NOs: 12, 13, and 14 for the VL CDRs 1-3 [page 23]. However, the specification does not teach a functional antibody comprising anything less than these full sequences for each of these six CDRs. Regarding claim 22, while the specification teaches the specific CDRs of an antibody that binds to human BRAF V600E, this is not deemed to be predictive of all antibodies or fragments thereof that bind to human BRAF V600E. The specification is not deemed sufficient to reasonably convey to one skilled in the art that the inventors, at the time the invention was made, had possession of a genus of antibodies or fragments thereof that bind human BRAF V600E protein.
One means of providing adequate written description and evidence of possession of a claimed genus is through providing 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 this case, regarding claim 1, there is no disclosure of an antibody that is capable of binding a human BRAF V600E protein that only contains an amino acid sequence of only two amino acids for each of six the respective CDRs. One of skill in the art could not envisage such a structure that would bind to human VRAF V600E protein. Regarding claim 22, the genus is defined entirely by a desired function: binds to human BRAF V600E protein. The claim does not require any particular structure for antigen binding region or antigen-binding protein thereof comprising an antibody variable region from a species other than rabbit, nor can one of skill in the art envisage such a structure when provided only with a desired function.
See MPEP §2163(I)(A) which states:
"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 (i.e. human BRAF V600E protein) and envisage the structure of those six CDRs that will bind that antigen. The art recognizes that a complete set of six CDRs comprise the binding region of an antibody (see Sela-Culang et al., 2013 (instant PTO-892)), and that even a single amino acid change to these regions can completely abrogate the binding specificity of an antibody (see Kussie et al., 1994 (instant PTO-892)). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such changes with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions.
The functional characteristics of antibodies (including binding specificity and affinity are dictated on their structure. Amino acid sequence and conformation of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. For example, Vajdos et al., 2002 (instant PTO-892) teaches that even within the Fv, antigen binding is primarily mediated by the complementarity determining regions (CDRs), six hypervariable loops (three each in the heavy and light chains) which together present a large contiguous surface for potential antigen binding, and aside from the CDRs, the Fv also contains more highly conserved framework segments which connect the CDRs and are mainly involved in supporting the CDR loop conformations, although in some cases, framework residues also contact antigen [page 416, left column, second paragraph]. Vajdos further teaches that as an important step to understanding how a particular antibody functions, it would be very useful to assess the contributions of each CDR side-chain to antigen binding, and in so doing, to produce a functional map of the antigen-binding site [page 416, left column, second paragraph-right column, first paragraph]. The art also shows an unpredictable effect when making single versus multiple changes to any given CDR. For example, Brown et al., 1996 (instant PTO-892) describes how the VH CDR2 of a particular antibody was generally tolerant of single amino acid changes, however the antibody lost binding upon introduction of two amino changes in the same region [see Abstract].
Further note the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to "claim antibodies by describing something that is not the invention, i.e., the antigen". This decision has precipitated guidance to the Office instructing that the portion of MPEP 2163 regarding the "newly characterized antigen test" (indicating a well-characterized antigen is sufficient to satisfy written description for antibodies which
bind that antigen) should no longer be used and that contrary materials should not be relied upon as reflecting the current state of the law.
Additionally, regarding claim 22, the recited genus encompasses a broad genus of any antigen binding region or antigen-binding portion thereof comprising an antibody variable region from a species other than rabbit that specifically binds to the human BRAF V600E protein. Therefore, the skilled artisan cannot envision all antigen binding regions or antigen-binding portions thereof comprising an antibody variable region from a species other than rabbit that specifically binds to the human BRAF V600E protein as encompassed by the instant claims. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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 [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held
that:
...To fulfill the written description requirement, a patent specification must
describe an invention and does so in sufficient detail that one skilled in the art can
clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re
Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed."). Thus, an applicant complies with the written
description requirement "by describing the invention, with all its claimed limitations, not
that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
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. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if
the disclosure "indicates that the patentee has invented species sufficient to constitute
the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v.
Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir.
2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus
after only describing a limited number of species because there may be unpredictability
in the results obtained from species other than those specifically enumerated."). "A
patentee will not be deemed to have invented species sufficient to constitute the genus
by virtue of having disclosed a single species when ... the evidence indicates ordinary
artisans could not predict the operability in the invention of any species other than the
one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir.
2004).
Thus, based on the teachings of the instant specification and the art, Applicant has failed to meet the written description of an antibody that binds to human BRAF V600E protein that has any two amino acids in each of the six sequences for the set of CDRs and has failed to meet the written description of any antigen binding region or any antigen-binding portion thereof comprising an antibody variably region from a species other than rabbit that specifically binds to human BRAF V600E protein. Therefore, one of skill in the art would not conclude that Applicant was in possession of the antibodies that are able to bind human BRAF V600E protein that comprise less than the whole sequences for each of the six CDRs as claimed in claim 1, or in possession of the claimed genus of antigen binding regions or antigen-binding portions thereof comprising an antibody variably region from a species other than rabbit that specifically binds to human BRAF V600E protein.
Claims 2-4, 8-10, and 21, which depend from claim 1, are therefore deficient for the same reasons above and do not meet the written description requirement.
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 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nanninga, 1998 (instant PTO-892).
Nanninga teaches Escherichia coli (i.e. bacteria cell) [page 111, see Introduction section].
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by ThermoFisher, 2019 (instant PTO-892).
ThermoFisher teaches the BioModule Immuohistochemical (ICH) Staining for Tissue Unit (i.e. kit) that comprises qualified reagents and validated protocols to perform highly sensitive and specific immunohistochemical staining of tissues [see page 2; Introduction].
Allowable Subject Matter
The sequences of SEQ ID NO: 9 for the VH CDR1, SEQ ID NO: 10 for the VH CDR2, SEQ ID NO: 11 for the VH CDR3, SEQ ID NO: 12 for the VL CDR1, SEQ ID NO: 13 for the VL CDR2, and SEQ ID NO: 14 for the VL CDR3 of a chimeric or recombinant antibody of antigen binding protein that is capable of binding to human BRAF V600E protein, are free of the prior art. Therefore, if Applicant amends claim 1 to recite “the” CDR amino acid sequence, the antibody or antigen binding protein having all of the recited sequences would be allowable.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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, Jeffrey Stucker can be reached at (571) 272-0911. 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.
/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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