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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 16, 18, 26 and 29 are objected to because of the following informalities:
Claim 18 recites “gemtuzumab ozogamicin (GO), hP67.7, SGN-33A”. It is unclear if the agent that selectively binds to CD33 is all, one, or a combination of the claimed antibody drug conjugates. The examiner interprets the use of commas as a listing of multiple options for the CD33 selective binding agent.
Claim 26 recites “the presence of blast cells that express CD33 within the hematopoietic system; leukostasis; anemia; leukopenia; neutropenia; thrombocytopenia; chloroma; granulocytic sarcoma; and myeloid sarcoma”. The listing of elements with semicolons is grammatically incorrect and unclear.
Claims 1, 16, and 29 contain improper roman numeral numbering within the steps.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 16, 21 ,23, 36, and 37 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.
In making a determination of whether the application complies with the written
description requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is claiming and what Applicant has possession of. To satisfy the written description requirement, a patent specification must describe Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). See MPEP § 2163.
Claim 1 recites the limitation “characterizing a subject having cancer”. The specification of the instant application contains support for acute myeloid leukemia (AML). When turning to the specification, there are several sections (pg.2, lines 5-8; pg. 3, lines 20-24) that provide specific SNP location support for AML. For instance, Example 1 discusses cytarabine (ara-C) treatment for acute myeloid leukemia (AML) chemotherapy and the need for a comprehensive evaluation of genetic variation in the key ara-C pathway genes for association with clinical outcome in AML. A study was conducted to evaluate 94 SNPs within 16 ara-C metabolic pathway genes for association with multiple clinical outcome endpoints in pediatric AML patients. A multi-step approach was used to develop a composite pharmacogenomics-based polygenetic SNP Score composed of the 10 most informative SNPs as related to ara-C (designated as “ACS10”) (pgs.34-35). Elsayed (Elsayed et. al., 2022, Polygenic Ara-C Response Score Identifies Pediatric Patients with Acute Myeloid Leukemia in Need of Chemotherapy Augmentation, J. Clin. Oncol., Volume 40:7) teaches a polygenic score consisting of these 10 SNPs, ACS10, to predict poor outcomes in acute myeloid leukemia and suggests alternative treatment strategies (pg.773, Context). Claim 5 is drawn to multiple types of Leukemia, however, the specification contains support for specific SNP locations for genotyping Acute Myeloid Leukemia (AML). The instant claim language is broadly written to encompass characterization of any type of cancer in a subject.
Additionally, claims 1, 16, 21, 23, 36, and 37 recite the limitation “agent that selectively binds to CD33”. One skilled in the art would not know which agent to administer to the subject as the specification of the instant application contains support for specific antibodies that bind to CD33. When turning to the specification, there are several sections (e.g., pg.4, lines 8-10) that provide specific agents that selectively bind to CD33. For instance, Example 1 discusses that Gemtuzumab ozogamicin (GO) is an immunoconjugate between an anti-CD33 antibody (hP67.6) and a cytotoxin (calicheamicin) and states that GO and other CD33 antibodies are used in clinical immunophenotyping of AML patients (pg.43, par.2). Fathi (Fathi et. al., 2020, A general view of CD33+ leukemic stem cells and CAR-T cells as interesting targets in acute myeloblatsic leukemia therapy, Blood Research, Vol.55, No.1) teaches that clinical investigations have shown that gemtuzumab, the humanized anti-CD33 antibody, binds to CD33-antigens and enters the cells through endocytosis (pg.12, par.2). Claim 36 and claims 21, 23, and 37 suffer from the same issue due to their dependence from claims 1 and 16 respectively, and not further detailing the agent that selectively binds to CD33 in the method of the claimed invention. The claim language of the instant independent claim is written to broadly encompass any CD33 selective binding agent and does not have support based on the specification that the applicant has possession of the method as claimed.
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, 9, 25-26, and 28 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.
The term “… a high dose…a low dose…” in step (iii) of claim 1 is a relative term which renders the claim indefinite. The term “… a high dose…a low dose…” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much of the cytarabine is considered a high or low dose to be administered to the subject of the instant claim.
Claim 28 recites the limitation "the assigning a genotype ". There is insufficient antecedent basis for this limitation in the claim. Claim 1, in which claim 28 is dependent upon references assigning of a genotype score rather than a genotype.
Claims 9 and 25 contains the trademark/trade name MassARRAY and TaqMan. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a type of assay for identifying the presence of nucleotides of nucleic acids and, accordingly, the identification/description is indefinite.
Claim 26 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a biomarker, a condition, types of cytopenia, and a cancerous tumor is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: CD33 expression from blast cells serves as a target for Acute Myeloid Leukemia (AML); Leukostasis is an Acute Leukemia condition; anemia, leukopenia, neutropenia, and thrombocytopenia are types of cytopenias; and chloroma, granulocytic sarcoma, and myeloid sarcoma are a cancerous tumor.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 1, 4-6, 9, 16, 18, 21, 23-26, 28-30, and 36-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mathematical mental process) without significantly more.
Subject Matter Eligibility Test (see MPEP § 2106):
Step 1: Are the claims to a process, machine, manufacture, or composition of matter?
Yes, the claims are directed to a process (method for characterizing a subject having cancer).
Step 2A: Are the claims directed to a judicial exception?
Prong 1: Do the claims recite an abstract idea, law of nature, or natural phenomenon?
As discussed in MPEP 2106.04(II)(A)(1), the meaning of “recites” is “set
forth” or “describes”. That is, a claim recites a judicial exception when the judicial
exception is “set forth” or “described” in the claim. In the instant case, the claims
describe an abstract idea (the mental process of characterizing the subject having cancer based on a summation of the assigned genotype score).
Claims 1 recites a method for characterizing a subject having cancer where the characterization corresponds to the summation of assigned genotype scores determined by nucleotides present at a single-nucleotide polymorphism (SNP) location. Claim 4 recites the mental process of mathematical summation of the assigned genotype scores according to the method of claim 1.
Prong 2: Do the claims recite additional elements that integrate the judicial exception
into a practical application?
As discussed in MPEP 2106.04(II)(A)(2), “Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855F.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"); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature
(or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B.” The considerations to be used are set forth at MPEP 2106.05(a) through (c) and (e) through (h).
Claims 9, 16, and 25 recite the additional element of performing an assay for detecting the genotype of the subject and claims 23-24, 28-30 are drawn to treating the subject with a chemotherapeutic agent. The addition of sequencing analysis and treatment with a chemotherapeutic agent are considered insignificant extra-solution activity because there is no change to the nature of the claim. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). See MPEP §2106.05(g). There are no additional elements in claims 9, 16, 23-25, and 28; therefore, the judicial exception is not integrated into a practical application.
Step 2B: Do the claims recite additional elements that amount to significantly more than
the judicial exception?
The dependent claims 4-6, 9, 16, 18, 21, 23-26, 28-30, and 36-37 do not provide additional elements that amount to significantly more than the judicial exception; therefore, the judicial exception is not integrated into a practical application, meaning these claims do not contain eligible subject matter.
For these reasons, the claims are rejected under U.S.C. 35 101 as being directed
to non-statutory subject matter.
Claims Free of the Prior Art
Claims 1, 4-6, 9, 16, 18, 21, 23-26, 28-30, and 36-37 are free of prior art because they require assigning a genotype score based upon the nucleotides present at each of a set of single-nucleotide polymorphism (SNP) locations rs10916819, rs17103168, rs5841, rs2396243, rs1044457, rs1138729, rs4643786, rs11030918, rs12067645, and rs17343066, and the prior art does not teach genotype scores for these SNP locations.
The closest prior art, Lamba (US 20190203299 A1, published 07/04/2019), teaches a method of treating a subject with a cancer expressing CD33 comprising: performing an assay to detect the genotype of the subject for the CD33 single-nucleotide polymorphism rs12459419 ([0004]). The method further comprising determining a CD33 SNP score for a subject comprising adding genotype scores of the subject for the CD33 single nucleotide polymorphisms rs12459419 or rs3865444, rs1803254, rs35112940, and rs2455069 to yield the CD33 SNP score, wherein the genotype score for a single nucleotide polymorphism (SNP) with two wild-type alleles is 0, the genotype score separately for each of the SNPs rs12459419, rs3865444, rs1803254, and rs35112940 with one wild-type allele and one variant allele for is −1, the genotype score for the SNP rs2455069 with one wild-type allele and one variant allele is 1, the genotype score separately for each of the SNPs rs12459419, rs3865444, rs1803254, and rs35112940 with two variant alleles is −2, and the genotype score for the SNP rs2455069 with two variant alleles is 2, and adding the genotype scores to yield the CD33 SNP score ([0022]). The reference does not teach the specific SNP locations of instantly claimed independent claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Avanda Harvey-Butler whose telephone number is (571)272-6511. The examiner can normally be reached M-F, 9-5 ET.
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/A.H.B./Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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