Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of the antibody or the fragment thereof is a monoclonal antibody or a fragment thereof specifically binding to the serum form of human TK1 of claim 38; epitope GEAVAARKLF of claims 39 and 43; mAb with CDR regions as defined in SEQ ID NO: 5-10 of claim 40; and lymphoma of claim 31 in the reply filed on 8/7/2026 is acknowledged. The traversal is on the grounds that group A is not species further limitations for 24. This is not found persuasive because while the different claims do include further limitations to independent claim 24, these limitations are all directly dependent from claim 24 and claim different variations and embodiments that do not depend from the multiple different variants/species. Therefore, the dependent claims as written are different embodiments and therefore, different species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 25-30, 34-37, 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/7/2026.
Claims 24, 31-33, 38-40, 43-47 are under consideration in the instant Office Action.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (www) at page 20, lines 24-25. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code (www). See MPEP § 608.01.
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.
Claims 24, 31-33, 38-40, 43-47 are rejected under 35 U.S.C. 101 because the claimed method is directed towards a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims recite a natural correlation between serum thymidine kinase 1 (STK 1) and cancer relapse. This judicial exception is not integrated into a practical application because it is just an observation of a natural correlation and therefore, also an abstract idea. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1 Claims 24, 31-33, 38-40, 43-47 are to a statutory determining the presence of serum thymidine kinase 1 (STK1) and correlating it to a diagnosis and predicting patient cancer relapse.
Step 2A prong 1: Does the claim recite a judicial exception?
The correlation between biomarkers and the presence of a medical condition and/or the prognosis of a patient with a medical condition is a naturally occurring phenomenon.
The claim recites methods of observing the law of nature of naturally occurring biomarkers and correlating them with the presence and/or prognosis of a patient and is also directed to an abstract idea because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas without significantly more. The abstract idea recited in independent claim 24 is identified as abstract idea because all of the steps are: determining (observation or report of results), comparing and predicting which are all mental steps and do not require any active steps by the one performing the method.
The identified abstract idea falls within the subject matter grouping of certain methods of organizing human activity and the sub-grouping of managing personal behavior or relationships or interactions between people. The claims recite a method which organizes the human activity of determining a level of serum thymidine kinase I (STK1) material in a serum sample; comparing the determined level of STK1 material; and predicting cancer relapse of the patient The claims organize the steps lab workers required to perform in order to obtain and determine an action had been successfully performed, which is method of managing personal behavior. For example, similar to In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982), the claims recite a process that a lab technician should follow in order to prove that the destruction of cells has been produced. Accordingly, the claims recite an abstract idea. Additionally, the indexing, searching and validating can also be considered an abstract idea which falls within the subject matter grouping of mental processes as a human with the aid of pen and paper can index data, search data and validate data. Data gathering steps required to perform a mental process, to arrive at a determination of whether the assay was successful in destroying cells, do not add a meaningful limitation as they are insignificant extra-solution activity. Further, the remaining claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. It is well established that the mere physical or tangible nature of additional elements, such as the obtaining and detecting of steps, does not automatically confer eligibility on a claim directed to a natural phenomenon, here an abstract idea [see, e.g., Alice Corp v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59 (2014)]. There are no additional elements in the combination of elements in the claimed invention that add other meaningful limitations not already present when the elements are considered separately. The method for method for predicting cancer relapse and recording and reporting the results based on the measured one or more parameters is recited at a high level of generality and is not sufficient to ensure that the claims amount to significantly more than the abstract idea itself. The courts have found that arranging a hierarchy of groups is to be well-understood, routine, conventional activity when they are claimed at a high level of generality Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1331, 115 USPQ2d 1681, 1699 (Fed. Cir. 2015) (see MPEP 2106.05(d)). Therefore, the step does not relate to the abstract idea in a significant way to impose a meaningful limit on the scope. For all of these reasons, the claims recite the judicial exceptions of an abstract idea and a natural correlation.
Step 2A prong 2: Does the claim recite additional elements that integrate the exception into a practical application?
Regarding the method of using the judicial exception, the data gathering steps of determining the presence of biomarkers are required to use the law of nature and do not add a meaningful limitation to the methods as they are insignificant extra-solution or mere data gathering steps.
Step 2B:
The claim does not include additional elements that are sufficient to amount to
significantly more than the judicial exception because the claimed elements when considered separately and in combination, do not add significantly more to the exceptions. The natural law/phenomenon is analogous to the correlation of biomarkers found ineligible by the courts, for example, in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012), Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) (Using well -known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015) (ineligible claims were directed to a method of detecting paternally inherited cell
free fetal DNA, which is naturally occurring in maternal blood).
Regarding claim 24, the method of using the judicial exception, the extra solution activity of determining a level of serum thymidine kinase 1 (STK1) material in a body sample from a patient diagnosed with cancer using an antibody or a fragment thereof specifically binding to a serum form of human TK1 is directed toward a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. See prior art cited in the section below under 35 USC 103. The extra solution activity of determining the level of STK1 material comprises determining the level of STK1 material in a serum sample or a plasma sample using the antibody or the fragment thereof specifically binding to the serum form of human TK1; and predicting survival of the patient comprises predicting survival of the patient based on the determined level of STK1 material in the serum sample or the plasma sample is directed toward a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. See prior art cited in the section below under 35 USC 103.
Regarding claims 38-40 and 43-47, contacting the body sample with the antibody or the fragment thereof; and measuring an amount of antibody or fragment thereof bound to the STK1 material is a data gathering step and is not a practical application. It is not significantly more than the judicial exception, since it’s recited at a high generality and therefore encompasses routine, well known, and conventional means for data gathering. See prior art cited in the section below under 35 USC 103.
Regarding claims 43-47, determining the level of STK1 material in the body sample from a patient diagnosed with metastatic prostate cancer using the antibody or the fragment thereof specifically binding to the serum form of human TK1 is a data gathering step and is not a practical application. It is not significantly more than the judicial exception, since it’s recited at a high generality and therefore encompasses routine, well known, and conventional means for data gathering.
Regarding claim 40, using the antibody or the fragment thereof that is a monoclonal antibody or a fragment specifically binding to the serum form of human TK1 is a data gathering step and an insignificant extra solution activity that does not add a meaningful limitation Moreover, the limitation does not transform the claim to significantly more than the judicial exception. Eriksson et al., WO2015/094106 (IDS 12/20/2023) teaches the antibody or the fragment thereof is a monoclonal antibody or a fragment specifically binding to the serum form of human TK1 is routine and conventional in the art.
Regarding claim 39-40 and 43, using the monoclonal antibody or the fragment thereof that is selected from the group consisting of: a monoclonal antibody or a fragment thereof having specificity for GEAVAARKLF (SEQ ID NO: 1) of human TK1; a monoclonal antibody or a fragment thereof having specificity for at least one of NCPVPGKPGE (SEQ ID NO: 2), PVPGKPGEAV (SEQ ID NO: 3) and NCPVPGKPGEAV (SEQ ID NO: 4) of human TK1; and a monoclonal antibody or a fragment thereof having specificity for a conformation dependent epitope of human TK1 is an insignificant extra solution activity that does not add a meaningful limitation. Moreover Eriksson et al., WO2015/094106 (IDS 12/20/2023) teaches wherein the monoclonal antibody or the fragment thereof is selected from the group consisting of: a monoclonal antibody or a fragment thereof having specificity for GEAVAARKLF (SEQ ID NO: 1) of human TK1; a monoclonal antibody or a fragment thereof having specificity for at least one of NCPVPGKPGE (SEQ ID NO: 2), PVPGKPGEAV (SEQ ID NO: 3) and NCPVPGKPGEAV (SEQ ID NO: 4) of human TK1; and a monoclonal antibody or a fragment thereof having specificity for a conformation dependent epitope of human TK1 is known in the art.
Regarding claim 40, using the monoclonal antibody or the fragment thereof having a variable heavy (VH) domain complementarity determining region 1 (CDR1) having amino acid sequence SEQ ID NO: 5; a VH domain CDR2 having amino acid sequence SEQ ID NO:6;a VH domain CDR3 having amino acid sequence SEQ ID NO: 7; a variable light (VL) domain CDR1 having amino acid sequence SEQ ID NO: 8; a VL domain CDR2 having amino acid sequence SEQ ID NO: 9; and a VL domain CDR3 having amino acid sequence SEQ ID NO: 10 is an insignificant extra solution activity that does not add a meaningful limitation. Moreover Eriksson et al., teaches wherein the monoclonal antibody or the fragment thereof has a variable heavy (VH) domain complementarity determining region 1 (CDR1) having amino acid sequence SEQ ID NO: 5; a VH domain CDR2 having amino acid sequence SEQ ID NO:6;a VH domain CDR3 having amino acid sequence SEQ ID NO: 7; a variable light (VL) domain CDR1 having amino acid sequence SEQ ID NO: 8; a VL domain CDR2 having amino acid sequence SEQ ID NO: 9; and a VL domain CDR3 having amino acid sequence SEQ ID NO: 10 is routine and conventional in the art.
Regarding claim 46-47, comprising selecting a patient surveillance schedule for the patient based on the cancer relapse of the patient is an insignificant extra solution activity that does not add a meaningful limitation. The claim is also not a practical application. Eriksson et al., teaches serum TK1 activity measurements have been used for monitoring and for prognostic purpose in several different malignant diseases, but primarily in case of leukemia and lymphoma predicting relapse (see page 1) is routine and conventional in the art.
Thus, claims 24, 31-33, 38-40, 43-47 are rejected under 35 USC 101.
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 24, 31-33, 38-39, 43-47 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.
Independent claim 24 calls for an antibody or a fragment thereof specifically binding to a serum form of human TK1. Dependent claim 39 further calls for the antibody have a specific binding to the serum form of human TK1 and claim 39 calls for a monoclonal antibody or a fragment thereof having specificity for GEA V AARKLF (SEQ ID NO: 1) of human TK1. This leaves the antibody undefined by a specific structure and there is no structure/function correlation set forth and with no specific guidance that would help one of ordinary skill determine if the binding ability of the antibody is maintained or abrogated. These claims are only claiming the required antibody with a specific function by only what it binds and its intended results in the claimed method.
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) 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 et al., 1994 (instant PTO-892) 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, 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 mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions.
The specification discloses a specific antibody and in instant claim 40. 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.
As such, the disclosure of the multiple antibody sequences does not convey possession of other antibodies with the same binding properties; possession of the precisely defined sequence of six CDRs is required.
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 a variable structure, without any known or disclosed correlation between 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 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 (instant PTO-892) 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 the antibody of claim 204. 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 CDRs as in claim 40 or the specific antibody disclosed with six CDRs in the instant specification, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed 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 24, 31-33, 38-39, 43-47 do not meet the written description requirement.
Claim Rejections - 35 USC § 102
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.
Claims 24, 31-33, 38-40, 43-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klammer et al., WO2020/043868 (IDS 12/20/2023).
Klammer teaches methods for prognosis patients with diffuse large B-cell lymphoma (DLBCL), by using serum TK1 levels for determining the levels in these patient by comparison to controls (see page 1, lines1-5, 11-15, and 24; page 2, lines 1-3, 23-25) and reads on instant claims 24, 31-33. Prognosis reads on the relapse limitation since a prognosis will consider the risk of relapse or possibility of cancer returning. Klammer teaches that samples are obtained from blood and serum (see page 3, line 21; page 12, lines 24-29) and reads on instant claims 24 and 38. Klammer teaches using age of patient in method of considering prognosis of cancer (see pages 7 and 8) and reads on the requirement of age in claim 24. Klammer teaches immunoassay to measure TK1 levels and used in prognostic index (PI) (see page 13, page 15, lines 3-9) and reads on instant claims 24, 43-45. Klammer teaches solid surface for assay (see paragraph between pages 12-13) and reads on instant claim 44. Klammer teaches monoclonal antibodies against serum TK1 protein when they point to the antibodies produced in WO02015/094106 (see page 34, lines 5-14) and reads on instant claims 24, 39-40 and 43. This meet the instant claims because the reference in Klammer, WO02015/094106, discloses that wherein the monoclonal antibody or the fragment thereof is selected from the group consisting of: a monoclonal antibody or a fragment thereof having specificity for GEAVAARKLF (SEQ ID NO: 1) of human TK1; a monoclonal antibody or a fragment thereof having specificity for at least one of NCPVPGKPGE (SEQ ID NO: 2), PVPGKPGEAV (SEQ ID NO: 3) and NCPVPGKPGEAV (SEQ ID NO: 4) of human TK1; and a monoclonal antibody or a fragment thereof having specificity for a conformation dependent epitope of human TK1; teaches wherein determining the level of STK1 material comprises determining the level of STK1 material in the body sample using a kit for determining a level of STK1 material in a body sample comprising: a first monoclonal antibody or a first fragment thereof having specificity for an epitope selected from the group consisting of: GEAVAARKLF (SEQ ID NO: 1) of human TK1;at least one of NCPVPGKPGE (SEQ ID NO: 2), PVPGKPGEAV (SEQ ID NO: 3) and NCPVPGKPGEAV (SEQ ID NO: 4) of human TK1; and a conformation dependent epitope of human TK1; and a second monoclonal antibody or a second fragment thereof having specificity for an epitope selected from the group consisting of: GEAVAARKLF (SEQ ID NO: 1) of human TK1; at least one of NCPVPGKPGE (SEQ ID NO: 2), PVPGKPGEAV (SEQ ID NO: 3) and NCPVPGKPGEAV (SEQ ID NO: 4) of human TK1; and a conformation dependent epitope of human TK1. WO02015/094106 teaches wherein the monoclonal antibody or the fragment thereof has a variable heavy (VH) domain complementarity determining region 1 (CDR1) having amino acid sequence SEQ ID NO: 5; a VH domain CDR2 having amino acid sequence SEQ ID NO:6;a VH domain CDR3 having amino acid sequence SEQ ID NO: 7; a variable light (VL) domain CDR1 having amino acid sequence SEQ ID NO: 8; a VL domain CDR2 having amino acid sequence SEQ ID NO: 9; and a VL domain CDR3 having amino acid sequence SEQ ID NO: 10. Therefore, Klammer anticipates the instant claims 24, 31-33, 38-40, 43-45 because it teaches all of the requires limitations.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 24, 31-33, 38-39, 43-47 are rejected under 35 U.S.C. 103 as being unpatentable over Klammer et al., WO2020/043868 (IDS 12/20/2023) and Eriksson et al., WO02015/094106 (IDS, 12/20/2023.
See Klammer, as discussed above. While Klammer teaches the methods of detecting STK1 and relapse determination, Klammer does not explicitly teach claim 46 and 47.
Eriksson teaches that wherein determining the level of STK1 material comprises determining the level of TK1 material in a serum sample or a plasma sample using the antibody or the fragment thereof specifically binding to the serum form of human TK1 to monitor therapy and predict relapse (see page 1, lines 14-23) as in instant claim 24. Eriksson teaches serum TK1 activity measurements have been used for monitoring and
for prognostic purpose in several different malignant diseases, but primarily in case of leukemia and lymphoma (see page 1) as in instant claims 32-32.
Eriksson teaches that one of the embodiments relates to a method for estimating the likelihood of recurrence (relapse) of a tumor in a subject. And comprises correlating the measured amount of antibody or fragment thereof to a level of TK1 material using a pre-defined correlation between measured amount of antibody or fragment thereof bound to recombinant human TK1 and a concentration of recombinant human TK1 (see page 3, lines 15-29) as in instant claim 24. Eriksson teaches wherein the antibody or the fragment thereof is a monoclonal antibody or a fragment specifically binding to the serum form of human TK1 (see top of page 3, page 4, lines 8-9) as in instant claim 38. Eriksson teaches ELISA assay (see page 5, Fig. 3) as in instant claims 43-45. Eriksson teaches wherein the monoclonal antibody or the fragment thereof is selected from the group consisting of: a monoclonal antibody or a fragment thereof having specificity for GEAVAARKLF (SEQ ID NO: 1) of human TK1; a monoclonal antibody or a fragment thereof having specificity for at least one of NCPVPGKPGE (SEQ ID NO: 2), PVPGKPGEAV (SEQ ID NO: 3) and NCPVPGKPGEAV (SEQ ID NO: 4) of human TK1; and a monoclonal antibody or a fragment thereof having specificity for a conformation dependent epitope of human TK1 (see page 2, lines 25-34) as in instant claims 39 and 43. Eriksson teaches wherein the monoclonal antibody or the fragment thereof has a variable heavy (VH) domain complementarity determining region 1 (CDR1) having amino acid sequence SEQ ID NO: 5 (see SEQ ID NO: 6 of Eriksson); a VH domain CDR2 having amino acid sequence SEQ ID NO:6 (see SEQ ID NO: 7 of Eriksson); a VH domain CDR3 having amino acid sequence SEQ ID NO: 7 (see SEQ ID NO: 8 of Eriksson); a variable light (VL) domain CDR1 having amino acid sequence SEQ ID NO: 8 (see SEQ ID NO: 9 of ‘Eriksson); a VL domain CDR2 having amino acid sequence SEQ ID NO: 9 (see SEQ ID NO: 10 of Eriksson); and a VL domain CDR3 having amino acid sequence SEQ ID NO: 10 (see SEQ ID NO: 11 of Eriksson, page 11, lines 6-24) as in instant claim 40.
It would have been obvious to one of ordinary skill in the art at the time of the instant application to consider combining Klammer’s teachings of diffuse large B-cell lymphoma (DLBCL) methods for prognosis with Eriksson’s teachings of antibodies capable of binding to a serum form of human thymidine kinase 1. Eriksson provides motivation by teaching that the main reason for choosing an anti-TK1 antibody that is produced against the C-terminal of TK1 is that the C-terminal region is involved in the cell cycle regulation of TK1 (see page 1 lines 29-30). Eriksson further provides motivation by teaching that these amino acid sequences have been known in the art to be amino acid sequences that directly bind to STK1. One of ordinary skill in the art would have been motivated to combine the methods of Klammer and Eriksson as they both teach cancer diagnostics and prognostics. One of ordinary skill would be motivated to use the methods for the prognosis of cancer and especially DLBCL to monitor the progression and relapse of the cancer and determine best cancer treatment by using the claimed method of monitoring for progression and relapse of the disease as in instant claims 46-47. The artisan would have had reasonable expectation of success based on the cumulative disclosures of these prior art references.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24, 31-33, 38-40, 43-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28,30-36, 48, 58, 62 and 65 of copending Application No. 17/794,286. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘286 claims a method of predicting patient survival by determining STK1 protein in a serum sample with patient diagnosed with cancer. ‘286 requires the use of the same genus of STK 1 antibodies and the same antibody in their claim 58 is the same antibody. ‘286 claims wherein determining the level of STK1 material comprises determining the level of STK1 material in the body sample using a kit for determining a level of STK1 material in a body sample comprising: a first monoclonal antibody or a first fragment thereof having specificity for an epitope selected from the group consisting of: GEAVAARKLF (SEQ ID NO: 1) of human TK1;at least one of NCPVPGKPGE (SEQ ID NO: 2), PVPGKPGEAV (SEQ ID NO: 3) and NCPVPGKPGEAV (SEQ ID NO: 4) of human TK1; and a conformation dependent epitope of human TK1; and a second monoclonal antibody or a second fragment thereof having specificity for an epitope selected from the group consisting of: GEAVAARKLF (SEQ ID NO: 1) of human TK1; at least one of NCPVPGKPGE (SEQ ID NO: 2), PVPGKPGEAV (SEQ ID NO: 3) and NCPVPGKPGEAV (SEQ ID NO: 4) of human TK1; and a conformation dependent epitope of human TK1 and wherein one of the first monoclonal antibody or first fragment thereof and the second monoclonal antibody or second fragment thereof is immobilized to a solid support or intended to be immobilized to the solid support. While ‘286 claims methods of determining survival and therefore reads on relapse prediction, ‘286 only disclosed prostate cancer and not specific lymphoma diseases as in instant claims 31-33. One of ordinary skill in the art would be motivated to use this method in other cancers to determine their relapse in specific cancer populations that also have abnormal levels of STK1 with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Advisory Information
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.Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM).
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 on (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
Prosecution Insights