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 .
Status of the Claims
Claims 1 – 10 and 13 – 14 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Information Disclosure Statement
No information disclosure statement has been filed in this case. 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.
Claim Rejections - 35 USC § 112The 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 9 – 10 and 13 – 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 9 and 10, it is unclear what method step(s) are encompassing by using or use of the monoclonal antibody of claim 1.
Regarding claim 13, it is unclear how a TRABD2A protein-blocked T cell, TRABD2B protein-blocked T cell or TRABD2A protein and TRABD2B protein-blocked T cell differs from a regular T cell. It is not clear whether the TRABD proteins are inhibited, mutated or deleted. Claim 14 depends from claim 13 and thus inherits the deficiencies of claim 13.
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 – 10 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 a monoclonal antibody comprising the full heavy chain amino acid sequence and full light chain amino acid sequence set forth in SEQ ID NOs: 1 and 2, or the other full heavy chain amino acid sequence and full light chain amino acid sequence sets of present claims 1 and 2, does not reasonably provide enablement for a monoclonal antibody comprising fragments of each heavy or light chain amino acid sequence claimed. 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.
Scope of Enablement
Claims 1 – 10 are rejected under 35 U.S.C. 112(a) because, the claims recite “a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: [X] and [Y], respectively” and thus read on any sequence of a fragment or portion of SEQ ID NO: X and Y. However, a fragment of any of the sequences of the present claims may not necessarily function as intended. For example a fragment of a sequence of present claim 1 may not include one, two, or any of the CDRs that bind to the target of the claimed monoclonal antibody. Because CDRs binding to their target confers specificity and function to a monoclonal antibody, a fragment of a monoclonal antibody missing one or more CDR(s) may not serve its purpose.
In this regard, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ 2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
1) the nature of the invention;2) the scope or breadth of the claims;3) the state of the prior art;4) the predictability or unpredictability of the art; 5) the relative skill of those skilled in the art; 6) the presence or absence of working examples; 7) the amount of direction or guidance presented and,8) the quantity of experimentation necessary.
The relevant factors are addressed below on the basis of comparison of the disclosure, the claims and the state of the prior art in the assessment of undue experimentation.
Scope or breadth of the claims:
Present claim 1 and dependent claims thereon recite:
1. A monoclonal antibody, comprising: a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 1 and 2, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 3 and 4, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 5 and 6, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 7 and 8, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 9 and 10, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 11 and 12, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 13 and 14, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 15 and 16, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 17 and 18, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 19 and 20, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 21 and 22, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 23 and 24, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 25 and 26, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 27 and 88, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 29 and 30, respectively; a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 31 and 32, respectively; or a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: 33 and 34, respectively.
Present claim 8 recites:
8. A method of treating tumor, comprising inhibition of TRABD2A protein, TRABD2B protein or TRABD2A protein and TRABD2B protein.
Degree of predictability or unpredictability in the art: As taught by CHEN (Chen C, et al. Enhancement and destruction of antibody function by somatic mutation: unequal occurrence is controlled by V gene combinatorial associations. EMBO J. 1995 Jun 15;14(12):2784-94; see PTO-892: Notice of References Cited), random point mutations in the amino acids of the CDRs of an antibody can result in significant effects to the structure and function of the antibody (see Discussion, p. 2789). Thus, the level of unpredictability in the art is high, especially since the claims do not require a full heavy or light chain sequence that include the CDRs.
Relative skill possessed by those in the art: In view of the state and complexity of the prior art, and the scope of the claims, which are drawn to a monoclonal antibody having a heavy chain and a light chain, the level of skill in the art is high and is at least that of a medical doctor or Ph.D. scientist with several years of experience in the fields of antibody or antibody engineering and/or immunotherapy.
Presence or absence of working examples: The specification does not provide examples that define the effects resulting from the alterations of the CDRs of full heavy chain or full light chain of the claimed monoclonal antibody. Nor does the specification provide any examples of heavy and light chains lacking significant sequence identity with the disclosed heavy and light chains.
Amount of guidance or direction provided/Quantity of experimentation required: The specification only provides guidance regarding the effects of monoclonal antibodies having full heavy and light chains, such as the antibodies anti-TRABD2A-1 (amino acid sequences of heavy and light chains are set forth in SEQ ID NOs: 7 and 8, respectively), anti-TRABD2A-2 (amino acid sequences of heavy and light chains are set forth in SEQ ID NOs: 13 and 14, respectively) and negative control (amino acid sequences of heavy and light chains are set forth in SEQ ID NOs: 19 and 20, respectively) (paragraph 0230 of the pre-grant publication) and does not include any direction on how to prepare antibody fragments of the disclosed heavy and light chains that still function as claimed. In the absence of working examples, undue experimentation would be necessary to determine the structure and scope of those monoclonal antibodies (if any) that fall within the bounds of the claim, but which lack significant sequence identity with the specific monoclonal-antibody sequences disclosed.
Claims 1 – 10 are enabled for the monoclonal antibody of claim 1 comprising the complete heavy and light chain sequences e.g. a monoclonal antibody, comprising: a heavy chain amino acid sequence comprising SEQ ID NO: 1 and a light chain amino acid sequence comprising SEQ ID NO:2, etc.
Regarding claims 9 and 10, the claims appear only to be enabled for inhibiting the TRABD2 proteins and not any immune checkpoint. The present specification broadly states the use of a TRABD2A protein and a TRABD2B protein as immune checkpoints or the use of the claimed monoclonal antibodies as immune checkpoint inhibitors (paragraphs 0024 – 0029 of the pre-grant publication) but does not provide details on what immune checkpoint(s) are inhibited. Because immune checkpoints belong in a large family of proteins and are involved in complex signaling pathways, and only the inhibition of TRABD2A and TRABD2B proteins are defined in the specification, the inhibition of any immune checkpoint by the claimed monoclonal antibody is not enabled by the present application.
In summary, the claims do not require a full heavy chain with its CDRs or a full light chain with its CDRS of the claimed monoclonal antibody or specific immune checkpoints and thus contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 – 10 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 following quotation from section 2163 of the Manual of Patent Examination Procedure (MPEP) is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
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 BU 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.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 1 – 7 and 9 – 10 are rejected as lacking adequate descriptive support for a possession of a monoclonal antibody comprising “a heavy chain amino acid sequence and a light chain amino acid sequence set forth in SEQ ID NOs: [X] and [Y], respectively”.
The claims read on any sequence of a fragment or portion of SEQ ID NO: X and Y and thus requires the genus of any fragment of each SEQ ID NO, but does not provide a representative number of examples of such antibodies. The specification only presents full heavy and light chains of SEQ ID NO: X and Y, respectively, such as anti-TRABD2A-1 (amino acid sequences of heavy and light chains are set forth in SEQ ID NOs: 7 and 8, respectively), anti-TRABD2A-2 (amino acid sequences of heavy and light chains are set forth in SEQ ID NOs: 13 and 14, respectively) and negative control (amino acid sequences of heavy and light chains are set forth in SEQ ID NOs: 19 and 20, respectively) (paragraph 0230 of the pre-grant publication). No derivatives or variants or mutants thereof are disclosed. Thus, the application fails to provide examples of fragment species within the claimed genus.
Claim 8 recites a method of treating tumor, comprising inhibition of TRABD2A protein, TRABD2B protein or TRABD2A protein and TRABD2B protein but does not provide a representative examples of such a method. The specification teaches the use of specific monoclonal antibodies having specific structures that can treat tumors by inhibiting TRABD2A protein, TRABD2B protein or TRABD2A protein and TRABD2B protein; however, the present specification does not provide examples of other ways to treat cancer by inhibition of TRABD2A protein, TRABD2B protein or TRABD2A protein and TRABD2B protein.
Amending the claims to recite, for example, “the heavy chain amino acid sequence and the light chain amino acid sequence set forth in SEQ ID NOs: 1 and 2, respectively”, with similar amendments for the other heavy chain or light chain of each SEQ ID NO, can provide sufficient structures for the claimed monoclonal antibodies.
Amending claim 8 to depend from claim 1 that has been amended as suggested can provide specificity to claim 8.
In view of this uncertainty and the absence of a representative number of examples of the claimed genus, the claims are rejected for lack of adequate written description support.
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.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claim 13 recites a TRABD2A protein-blocked T cell, TRABD2B protein-blocked T cell or TRABD2A protein and TRABD2B protein-blocked T cell. This judicial exception is not integrated into a practical application because claim 13 recites features that do not distinguish the structure of the claimed T cells from those found in nature. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because TRABD2A, TRABD2B, and T-cells are products of nature and a TRABD2A protein and/or TRABD2B protein-blocked T cell may naturally occur.
The Mayo framework provides that first whether the claims at issue are directed to a patent-ineligible concept is determined. If the answer is yes, then the elements of each claim both individually and “as an ordered combination” are considered to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. The second step—known as the “inventive concept”—requires that claims include elements which would render the method both new and useful.
The recent Eligibility Guidance (2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance and 2018 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019) address the subject matter eligibility analysis for all claims (i.e., machine, composition of matter, manufacture and process claims). The analysis is to be used for evaluating whether a claim is drawn to patent-eligible subject matter.
Step 1 determines whether the claim is directed to a process, machine, manufacture, or composition of matter. If the claim is directed to a statutory category, proceed to Step 2.
Step 2 is the two-part analysis for claims directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions).
In Step 2A, determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea (judicial exceptions). “Directed to” means the exception is recited in the claim, i.e., the claim sets forth or describes the exception.
In Prong One of Step 2A it is determined if the claim recites a judicial exception. If the claim recites a judicial exception, then Prong Two of Step 2A determines whether the claims recites additional elements that integrate the exception into a practical application.
If the answer to Prong Two of Step 2A is no, Step 2B is used to determine whether the claim as a whole amounts to significantly more than the exception by the recitation of additional elements.
The present claims are directed to a product so Step 1 is satisfied.
With respect to Step 2A MPEP 2106.04(c) II(C)(2) teaches:
In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. The patentee in Myriad had discovered the location of the BRCA1 and BRCA2 genes in the human genome, and isolated them, i.e., separated those specific genes from the rest of the chromosome on which they exist in nature. As a result of their isolation, the isolated genes had a different structural characteristic than the natural genes, i.e., the natural genes had covalent bonds on their ends that connected them to the rest of the chromosome, but the isolated genes lacked these bonds. However, the claimed genes were otherwise structurally identical to the natural genes, e.g., they had the same genetic structure and nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.
In Ambry Genetics, the court identified claimed DNA fragments known as "primers" as products of nature, because they lacked markedly different characteristics. University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The claimed primers were single-stranded pieces of DNA, each of which corresponded to a naturally occurring double-stranded DNA sequence in or near the BRCA genes. The patentee argued that these primers had markedly different structural characteristics from the natural DNA, because the primers were synthetically created and because "single-stranded DNA cannot be found in the human body". The court disagreed, concluding that the primers’ structural characteristics were not markedly different than the corresponding strands of DNA in nature, because the primers and their counterparts had the same genetic structure and nucleotide sequence. 774 F.3d at 760, 113 USPQ2d at 1243-44. The patentee also argued that the primers had a different function than when they are part of the DNA strand because when isolated as a primer, a primer can be used as a starting material for a DNA polymerization process. The court disagreed, because this ability to serve as a starting material is innate to DNA itself, and was not created or altered by the patentee:
In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction--a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here--the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.
Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244. In sum, because the characteristics of the claimed primers were innate to naturally occurring DNA, they lacked markedly different characteristics from nature and were thus product of nature exceptions. A similar result was reached in Marden, where the court held a claim to ductile vanadium ineligible, because the "ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics". In re Marden, 47 F.2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 (CCPA 1931).
For Prong One of Step 2A the claims recite a judicial exception, i.e. a natural product which is a natural phenomenon. In particular, claim 13 recites T cells. Because the TRABD2A protein, the TRABD2B protein, and T cells are naturally occurring, a variety natural phenomenon can result in a TRABD2B protein-blocked and/or a TRABD2A protein-blocked T cell. For example, degradation enzymes or exposure to natural inhibitors of TRABD2B or TRABD2A protein can lead to natural TRABD2B protein-blocked and/or a TRABD2A protein-blocked T cells, therefore blocking them from T cells. Thus, the answer to Prong One of Step 2A is yes, the claims do recite a judicial exception.
For Prong Two of Step 2A the claims do not integrate the exception into a practical application. The judicial exception is not integrated into a practical application because no additional limitations are recited that distinguish the claimed T cells from those found in nature. So the answer to Prong Two of Step 2A is no.
With respect to Step 2B MPEP 2106.05 (I) teaches that
The second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)).
An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
With respect to Step 2B MPEP 2106.05 (d) teaches that:
Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry.
If the additional element (or combination of elements) is a specific limitation other than what is well-understood, routine and conventional in the field, for instance because it is an unconventional step that confines the claim to a particular useful application of the judicial exception, then this consideration favors eligibility. If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.
. . .
On the other hand, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) provides an example of additional elements that were not an inventive concept because they were merely well-understood, routine, conventional activity previously known to the industry, which were not by themselves sufficient to transform a judicial exception into a patent eligible invention. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 199 (1978) (the additional elements were "well known" and, thus, did not amount to a patentable application of the mathematical formula)). In Mayo, the claims at issue recited naturally occurring correlations (the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that a drug dosage will be ineffective or induce harmful side effects) along with additional elements including telling a doctor to measure thiopurine metabolite levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at 1967-68. The Court found this additional step of measuring metabolite levels to be well-understood, routine, conventional activity already engaged in by the scientific community because scientists "routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds." 566 U.S. at 79, 101 USPQ2d at 1968. Even when considered in combination with the other additional elements, the step of measuring metabolite levels did not amount to an inventive concept, and thus the claims in Mayo were not eligible. 566 U.S. at 79-80, 101 USPQ2d at 1968-69.
The T cells of claim 13 are defined by functional characteristics that may be found in T cells found in nature. Additional structural limitations may help distinguish the T cells from natural ones.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8 and 13 – 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019154414A1, published 08/15/2019 (see PTO-89).
Present claim 13 is directed to a TRABD2A protein-blocked T cell, TRABD2B protein-blocked T cell or TRABD2A protein and TRABD2B protein-blocked T cell.
According to the present specification (abstract), TRABD2A, TRABD2B or TRABD2A and TRABD2B expressed on T cells are inhibited.
WO2019154414A1 is directed to an agent and/or a medicament for detecting or eliminating HIV-infected T cells, characterized in that the substance is capable of inhibiting human TRABD protein activity or scavenging human TRABD protein, wherein the human TRABD protein is TRABD2A. See claims.
Because WO2019154414A1 teaches RABD2A-inhibited T cells with, it anticipates claim 13.
Regarding claim 14, WO2019154414A1 teaches that the substance is a human TRABD protein-specific antibody. See claims. WO2019154414A1 teaches CD8+ T cells were treated with a TRABD2A monoclonal blocking antibody which stimulated immunoreactive CD8+ T cells. See Example 17.
Regarding claim 8, When reading the preamble in the context of the entire claim, the recitation of “ a method of treating tumor” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Conclusion
No claim is allowed.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/PETER J REDDIG/Primary Examiner, Art Unit 1646