DETAILED ACTION
Claims 1-7, 10, 22, 26, 28, 32-33, 38, 40-46, and 53-54 are pending.
Information Disclosure Statement
The information disclosure statement filed on 01/27/2025 has been considered by the examiner.
Claim Objections
Claims 1-7, 10, 22, 26, 28, 32-33, 38, 40-46, and 53-54 are objected to because of the following informalities:
1.The claim recites an abbreviation and/or acronym of “FcγRIIa” which should be spelled out at their first usage followed by the abbreviation/acronym in parenthesis. Appropriate correction is required.
2.Further, claim 10 is missing a period after the claim. 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.
3.Claim 3 is 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 reducing the progression of cancer, does not reasonably provide enablement for eliminating the progression of cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure enables one skilled in the
art to make and use the claimed invention in its full scope without resorting to undue
experimentation include: (1) the quantity of experimentation necessary; (2) the amount of
direction or guidance presented; (3) the presence or absence of working examples; (4) the
nature or complexity of the invention; (5) the state of the prior art; (6) the relative skill of those in
the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims. See
In re Wands, 8 USPQ2d. 1400 (Fed. Cir. 1988).
All Wands factors listed above have been considered with regard to the instant claim,
with the relevant factors discussed below.
Nature of the invention: The invention is a method for reducing or eliminating cancer progression in a subject by administering an antithrombotic agent.
The quantity of experimentation needed to make or use the invention based on the
content of the disclosure: The specification does not teach nor mention eliminating the progression of cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most connected, to use the invention commensurate in scope with these claims. Specifically, eliminating cancer progression by administering an antithrombotic agent is not well supported by the specification.
The working examples and guidance provided: The specification fails to provide any working examples on an antithrombotic agent eliminating the progression of cancer. The specification does not provide any support for eliminating the progression of cancer by using antithrombotic agents. The specification provides two examples, but neither even recite eliminating the progression of cancer. On page 66 lines 21-25 of the instant specification, it states that low platelet FcγRIIa is found to be associated with regression or stable disease. The specification does not state the elimination of cancer progression.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most connected, to use the invention commensurate in scope with these claims. Biomarkers and diseases are complex and thus the inventor needs to show how the methof of the instant application will enable a skilled artisan to use an antithrombotic agent to eliminate the progression of cancer.
Absent specific guidance, one skilled in the art before the effective filing date of the claimed invention would not know how to practice the claimed invention and would require undue experimentation to practice over the full scope of the invention claimed.
The state and unpredictable nature of the prior art: The state of the prior art for using an antithrombotic agent to eliminate the progression of cancer was unpredictable before the effective filing date of the claimed invention. The nature of the invention is complex and unpredictable, involving the effects of an antithrombotic agent on cancer progression.
Du et al., Cancer systems biology: embracing complexity to develop better anticancer therapeutic strategies. Oncogene. 2015 Jun;34(25):3215-25. doi: 10.1038/onc.2014.291. Epub 2014 Sep 15. PMID: 25220419 teaches that at a protein level, the frequent involvement of complex signaling networks makes it difficult to anticipate the influences of oncogenic perturbations to predict how to effectively reverse those influences with pharmacological agents (see page 3215). Du teaches that cancer treatments are complex and unpredictable (see page 3215). Furthermore, in re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991),
the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was
appropriate given the relatively incomplete understanding in the biotechnological field involved,
and the lack of a reasonable correlation between the narrow disclosure in the specification and
the broad scope of protection sought in the claims.
The level of one of ordinary skill: Based on the complexity and unpredictability of
biomarkers and diseases, the level of a person having ordinary skill in the art is not high enough
to determine how the antithrombotic agent will eliminate the progression of cancer.
The breadth of the claims: The claims are drawn to a method of measuring the levels of FcγRIIa in a subject, and based on those levels, administering an antithrombotic agent to reduce or eliminate cancer progression.
Due to the large quantity of experimentation necessary to determine the use of an antithrombotic agent in order to eliminate cancer progression, the lack of direction/guidance presented in the specification, the complex nature of the invention, and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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.
4.Claim 38 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 38 is dependent on a cancelled claim. Claim 38 recites “the method of claim 37…” However, claim 37 has been cancelled, therefore the limitations of the claim is unknown.
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.
5.Claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53-54 are rejected under 35 U.S.C. 101 because the claimed method is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1
This part of the eligibility analysis evaluates whether the claim falls within any statutory
category per MPEP 2106.03
Regarding instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53, Example 43 of “2019 PEG” is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53.
Regarding claim 1 of example 43 of the “2019 PEG” and per Step 1, the claim is
directed to a process, which is one of the statutory categories of invention as the claim recites
“A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a
blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3)
to identify the patient as having a non-responder phenotype; (b) administering a treatment to the patient having a non-responder phenotype.” (Step 1: YES).
Similarly, instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53-54 are directed to a statutory method that measures naturally occurring levels of FcγRIIa and correlating the levels with a cancer patient needing treatment for venous thromboembolism (Step 1: YES).
In the instant application, claim 54 recites the marker “FcγRIIa”, which is a protein. Because proteins are a composition of matter, the marker FcγRIIa is a composition of matter, which is a statutory category of invention. As explained in the MPEP, it is not necessary to identify a single category into which a claim falls, so long as it is clear that the claim falls into at least one category. MPEP 2106.03(I). Here, because the marker FcγRIIa is a composition of matter, the claim is to at least one statutory category of invention (Step 1: YES).
Step 2A, Prong 1: Does the claim recite a judicial exception?
This part of the eligibility analysis evaluates whether the claim recites a judicial
exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a
judicial exception when the judicial exception is “set forth” or “described” in the claim.
Regarding instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53, Example 43 of the “2019 PEG” shows a similar fact pattern.
Regarding claim 1 in Example 43 of the “2019 PEG” and per Step 2A, prong 1, the
claim recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a
blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3)
to identify the patient as having a non-responder phenotype,” and according to broadest
reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the
ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent
phenotype.
Specifically, limitation (a) in claim 1 of Example 43 of the “2019 PEG” recites “calculating
a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic
Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder
phenotype,” which has a BRI that requires performing an arithmetic calculation (division) in
order to obtain the ratio of C11 to C13 levels, and then using this ratio to identify whether the
patient has the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or
greater and thus is not responding, or will not respond, to glucocorticoids). This limitation therefore recites a mathematical calculation. The grouping of “mathematical concepts” in the
2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG
Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping
of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be
practically performed in the human mind, and is in fact performed in the human mind on a daily
basis, for instance by school-aged children studying mathematics. Note that even if most
humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them
complete the recited calculation, the use of such physical aid does not negate the mental nature
of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract
ideas.
In addition, limitation (a) describes a naturally occurring relationship between the ratio
of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a
law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls
within the mathematical concept and mental process groupings in the “2019 PEG”, and a law of
nature), and the analysis must therefore proceed to Step 2A Prong Two.
Similarly, instant claims 1-7, 10, 26, 28, 32-33, 38, 40-46, and 53, recites measuring protein biomarker FcγRIIa and correlating the levels of FcγRIIa with the presence and progression of diseases, and thus is considered a law of nature. Consequently, instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53-54 recite the judicial exception of applying and using a law of nature.
Regarding instant claim 54, Example 44 of the “2019 PEG” shows a similar fact pattern.
Claim 1 in example 44 is drawn to denveric acid. The markedly different characteristics analysis
is used to determine if the nature-based product limitation is a product of nature exception.
MPEP 2106.04(c)(I). Although the claim also recites a non-nature based product limitation (the
container), the markedly different characteristics analysis should be applied only to the nature-
based product limitation. MPEP 2106.04(c)(I)(A). The markedly different characteristics analysis
is performed by comparing the nature-based product limitation in the claim to its naturally
occurring counterpart to determine if it has markedly different characteristics from the
counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring
denveric acid. When the claimed denveric acid is compared to this counterpart, the comparison
indicates that there are no differences in structure, function, or other characteristics. Therefore,
the claimed denveric acid is a product of nature exception. Association for Molecular Pathology
v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of
nature” which cannot be patented).”
Similarly, instant claim 54 recites the use of the marker FcγRIIa. The closest natural counterpart to marker FcγRIIa is naturally occurring FcγRIIa. When the claimed marker is compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics. Therefore, FcγRIIa is a product of natural exception.
Accordingly, instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53-54 recite a judicial exception (a law of nature, a product of nature) and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong 2: Does the claim recite additional elements that integrate the exception into a practical application?
Regarding instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53, Example 43 of “2019 PEG” shows a similar fact pattern.
In claim 1 of example 43 of the “2019 PEG” and per Step 2A, prong 2, the claim as a
whole does not integrate the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any additional
elements recited in the claim beyond the judicial exception, and (b) evaluating those additional
elements individually and in combination to determine whether the claim as a whole integrates
the exception into a practical application. Besides the abstract idea, the claim 1 of example 43
of the “2019 PEG” recites the additional element of “(b) administering a treatment to the patient
having a non-responder phenotype”. Although this limitation indicates that a treatment is to be
administered, it does not provide any information as to how the patient is to be treated, or what
the treatment is, but instead covers any possible treatment that a doctor decides to administer
to the patient. In fact, this limitation is recited at such a high level of generality that it does not
even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into
account when deciding which treatment to administer, making the limitation’s inclusion in this
claim at best nominal. Thus, limitation (b) of example 43 of the “2019 PEG” fails to
meaningfully limit the claim because it does not require any particular application of the recited
calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial
exception. Accordingly, limitation (b) of example 43 of the “2019 PEG” does not integrate the
recited judicial exception into a practical application and the claim is therefore directed to the
judicial exception.
Similarly, instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53 do not have additional elements that would integrate the judicial exception cites above into a practical application. Instant claims 1-4, 7, 22, and 45 recite “administering an antithrombotic agent”. Like example 43 where the general treatment was found lacking any significance and at best was equivalent to adding the words “apply it” to the judicial exception. The recitation of an “antithrombotic agent” is broad and is considered a general treatment. Example 43 failed with a general treatment, and like Example 43, instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53 recite a general treatment.
Regarding instant claim 54, Example 44 of the “2019 PEG” shows a similar fact pattern.
In claim 1 of example 44 of the “2019 PEG” and per Step2A, Prong two, the evaluation is
performed by (a) identifying whether there are any additional elements recited in the claim
beyond the judicial exception, and (b) evaluating those additional elements individually and in
combination to determine whether the claim as a whole integrates the exception into a practical
application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Claim 1 recites an additional
element (the container). Although this limitation indicates that the denveric acid is held in the
container, it does not provide any information as to how the denveric acid is contained, or what
the container is, but instead covers any possible container that a doctor or pharmacist decides
to use. Because denveric acid must be placed in a container in order to store and use it, merely
reciting a generic “container” thus fails to meaningfully limit the claim because it is at best the
equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the
container does not integrate the recited judicial exception into a practical application and the
claim is therefore directed to the judicial exception (Step 2A: YES)”.
While example 44 recites a container which still was not deemed sufficient, instant claim 54 does not even recite any container and contains no more than the biomarker (the natural product). Example 44 did not pass Step 2A prong 2 with an additional element (the container). Accordingly, instant claim 54 does not have additional elements that would integrate the judicial exceptions cited above into a practical application.
Therefore, claim 54 does not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
Regarding instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claims do not recite any active steps. While claims 1-4, 7, 22, and 45 recite “administering an antithrombotic agent”, it does not add significantly more and is equivalent to just “applying” a treatment. Accordingly, instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53 are not eligible (Step 2B: NO).
Regarding instant claim 54, this part of the eligibility analysis evaluates whether the
claim as a whole amounts to significantly more than the recited exception, i.e., whether any
additional element, or combination of additional elements, adds an inventive concept to the
claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, the claim does not
even recite a container or any additional elements. (Step 2B: NO). The claim is not eligible.
Thus, instant claims 1-7, 22, 26, 28, 32-33, 38, 40-46, and 53-54 are rejected under 35 USC 101.
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.
6.Claims 1, 3-7, 10, 22, 26, 28, 32, 33, 41-46, and 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider et al., (US 20200166508A1) (IDS filed on 01/27/2025), in view of Bezuhly et al., (WO2014087240A2) (IDS filed on 01/27/2025).
Schneider teaches determining that a level of FcyRIIa protein on platelets from the subject is increased relative to a reference (see [0006]) (instant claims 1, 3-4, and 45). Schneider teaches administering an antithrombotic agent to a subject who has increased FcγRIIa (see [0008]), and the antithrombotic agent is a small molecule and an adenosine diphosphate (ADP) receptor antagonist and/or a protease-activated receptor (PAR) (see [0008]) (instant claims 1, 3-4, 7, 10, and 45). Schneider teaches further comprising quantifying the number of molecules of FcyRIIa protein on individual platelets (see claim 1 of Schneider) (instant claim 5). Schneider teaches the levels of FcγRIIa is determined using an assay selected from the group consisting of flow cytometry, immunoassay, ELISA, western blotting, and radioimmunoassay (see claim 4 of Schneider) (instant claim 26). Schneider teaches wherein determining the level of FcyRIIa protein on the platelets comprises contacting the platelets with a capture reagent (see [0111] “Platelet FcγRIIa may be captured with capture reagents fixed to a solid support, such as a biochip, a multiwell microtiter plate, a resin, or a nitrocellulose membrane that is subsequently probed for the presence or level of a marker”) (instant claim 28). Schneider teaches the reference is a cancer-free subject (see [0016] “the reference value is a level of FcγRIIa on the surface of platelets from a disease-free individual”) (instant claim 32) and wherein the increase is by at least about 1.5, 2, 3, 4, or 5-fold (see [0016] “In still other embodiments, the increased level is increased by at least about 1.5-5-fold, 2-5-fold, 5-10-fold…”) (instant claims 33 and 45). Schneider teaches administering an anti-platelet agent (see [0098]) (instant claim 45). Schneider teaches quantifying the number of molecules of FcyRIIa protein on individual platelets (see [0004]) (instant claim 46). Schneider teaches wherein the level of platelet FcyRIIa is determined by contacting a sample comprising platelets from the subject with an FcyRIIa-binding conjugate to form a bound complex of the FcyRIIa-binding conjugate (see [0004] “Subsequently an antibody that binds to FcγRIIa (e.g., primary antibody conjugated with a detectable label) and/or a secondary conjugated antibody will be added”, see [0143], see claim 10 of Schneider) and an FeyRIIa protein molecule on the surface of the platelets (see abstract “compositions and methods are provided for determining platelet reactivity where the levels of FcγRIIa on the surface of platelets is measured”, see [0004]), and detecting binding between the FcyRIIa-binding conjugate and the FcyRIIa protein molecule (see [0143] “In a first portion, the device includes a site for the application of a liquid sample. This first portion of the device also includes an analyte-binding conjugate, such as an antibody that specifically binds an antigen of interest (e.g., FcγRIIa, platelet surface proteins). The analyte binding conjugate typically binds the analyte to form a complex. Complex formation (e.g., formation of an antigen/antibody conjugate complex) may occur at any point in the interior flow pathway after the analyte contacts the analyte-binding conjugate”, see claim 10 of Schneider, see [0011]) (instant claim 53). Schneider teaches a kit, wherein the kit comprises a FcyRIIa capture reagent (see [0009]) (instant claim 54).
Schneider does not explicitly teach treating a subject with cancer with an antithrombotic agent, administering two antithrombotic agents, cancer being breast or lung cancer, nor does Schneider teach the progression and incidence of death rate being reduced.
Bezuhly teaches a method for treating a selected subject, the method comprising: administering an antithrombotic agent to the selected subject, wherein the subject has cancer (see claim 1 of Bezuhly, see claim 4 of Bezuhly teaching the use of known antithrombotic agent Ticagrelor) (instant claims 1, 3-4 and 45). Bezuhly teaches the cancer being breast cancer or lung cancer (see claim 2 of Bezuhly) (instant claim 6). Bezuhly teaches the antithrombotic agent being a small molecule compounds and an adenosine diphosphate (ADP) receptor antagonist (see claim 4 teaching the use of Ticagrelor which is a known small molecular compound and ADP receptor antagonist) (instant claims 7 and 10). Bezuhly teaches administering at least two antithrombotic agents to the subject (see [0049]) (instant claim 22). Bezuhly teaches wherein the incidence of death is reduced (see claim 11 of Bezuhly) (instant claim 41). Bezuhly teaches the progression of cancer is reduced, the cancer invasion and metastasis is reduced, and the cancer growth is ameliorated (see abstract “Compositions, kits and methods for preventing and treating cancer in a subject (e.g., human) by preventing, reducing or eliminating cancer (e.g., cancerous tumor) metastasis include administration of an anti-platelet agent that inhibits metastasis of cancer cells in a subject having cancer, and optionally, one or more additional anti-cancer agents.”, see [0030] “Treatment can include, for example, preventing, reducing or eliminating cancer metastasis in a subject, decreasing platelet activation in a subject, improving patient (subject) survival, etc.”, see [0046]) (instant claims 42-44).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the method of determining platelet reactivity by determining the level of FcγRIIa expressed on platelets taught by Schneider, with the methods of treating a subject who has cancer taught by Bezuhly. Schneider provides motivation by teaching that the FcyRIIa marker is found on platelets (see abstract). Schneider provides motivation by teaching that FcyRIIa expressed at an increased level is indicative of a need for anti-thrombotic therapy (see [0015]). Schneider further teaches that a marker profile may be obtained from a subject sample and compared to a control amount of platelet in FcyRIIa and may facilitate the determination of cancer status (see [0121]). Bezuhly provides motivation by teaching that antithromboticagents, clopidogrel and ticagrelor, can prevent platelets from sticking to cancer cells, thereby preventing or reducing metastases and improving patient survival (see [0005], see [0073], see [0078]). It would have been obvious to one of ordinary skill in the art at the time of the instant application to detect a biomarker and then administer a treatment. The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
7. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider et al., (US 20200166508A1) (IDS filed on 01/27/2025), in view of Linn (US 20070185053A1) (IDS filed on 01/27/2025).
Schneider teaches a method for treating a selected subject having or having a thrombotic disease, the method comprising: administering an antithrombotic agent to the selected subject (see [0097], see [0008] teaching the use of prasugrel, ticagrelor, clopidogrel, and vorapaxar which are known anti-thrombotic agents),
wherein the subject is selected by determining that a level of FcyRIIa protein on platelets from the subject is increased relative to a reference (see [0005] – [0006]), thereby treating the selected subject having a propensity to develop a thrombotic disease (see [0006]) (instant claim 2).
Schneider does not explicitly teach the subject having or heaving a propensity to develop a venous thromboembolism.
Linn teaches using antithrombotic medications to treat a patient with venous thromboembolism, including deep vein thrombosis and pulmonary embolism (see [0035] “Another aspect of the invention is that the antithrombotic is delivered by needle-free injection to provide prophylaxis (i.e., prevention) of venous thromboembolism including deep vein thrombosis and pulmonary embolism in patients undergoing treatments including”, see [0036] “Another aspect of the invention is that the antithrombotic medication is delivered by needle-free injection to treat emergent acute venous thromboembolism or deep vein thrombosis in patients while or after clot formation is occurring or has already occurred”) (instant claim 2).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the methods of determining platelet reactivity by determining the level of FcγRIIa expressed on platelets taught by Schneider with the methods of using antithrombotic medication to treat venous thromboembolism taught by Linn. Linn provides motivation by teaching that antithrombin medications prevent the growth or formation thrombi (see [0006]). Linn provides motivation by teaching that antithrombin medications can also treat emergent conditions while or after clot formation is occurring or has already occurred (see [0036]). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
8. Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider and Bezuhly as applied to claims 1, 3-7, 10, 22, 26, 28, 32, 33, 41-46, and 53-54 above, and in view of Linn (US 20070185053A1) (IDS filed on 01/27/2025).
The teachings of Schneider and Bezuhly as it pertains to claims 1, 3-7, 10, 22, 26, 28, 32, 33, 41-46, and 53-54 are discussed in the 35 USC 103 rejection above.
Schneider does not teach the incidence or severity of venous thromboembolism (VTE) is reduced.
Linn teaches incidence or severity of venous thromboembolism (VTE) is reduced (see [0013] “Compared to placebo, LMWHs produced a 70-80% risk reduction for DVT in numerous studies without an increase in major bleeding in high-risk orthopedic patients”, see [0035] teaching the prevention of venous thromboembolism) (instant claim 40).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the method of determining platelet reactivity by determining the level of FcγRIIa expressed on platelets taught by Schneider, with the methods of treating a subject who has cancer taught by Bezuhly, with the methods of using antithrombotic medication to treat venous thromboembolism taught by Linn. Linn provides motivation by teaching that antithrombin medications prevent the growth or formation thrombi (see [0006]). Linn provides motivation by teaching that antithrombin medications can also treat emergent conditions while or after clot formation is occurring or has already occurred (see [0036]). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MCKENZIE A DUNN whose telephone number is (571)270-0490. The examiner can normally be reached Monday-Tuesday 730 am -530pm, Wednesday-Friday 730 am-430 pm.
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, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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