DETAILED ACTION
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 .
DETAILED ACTION
This Office Action is responsive to the Election/Restriction filed 12/11/2025.
Claims 1-60 are pending.
Priority
This application claims the following priority:
PNG
media_image1.png
76
673
media_image1.png
Greyscale
Election/Restrictions
Applicant’s election without traverse of Group I, and the following species: a) nausea or vomiting as the disease or condition, b)
PNG
media_image2.png
154
237
media_image2.png
Greyscale
as the Cbl inhibitor compound, and c) ondansetron as the serotonin receptor antagonist, in the reply filed on 12/11/2025, and the telephone call on 01/14/2026, is acknowledged. See the Interview Summary dated 01/20/2026.
Claims 7-9, 22-24, 44-45, 49-51, and 53-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and subject matter, there being no allowable generic or linking claim.
Claims 1-6, 10-21, 25-43, 46-48, and 52 are within the elected group and species.
Improper Multiple Dependent claims
Claims 5-6, 15-21, 25-34, 46-48, and 52 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claims. See MPEP § 608.01(n). Accordingly, the claims 5-6, 15-21, 25-34, 46-48, and 52, have not been further treated on the merits.
Claims 1-4, 10-14, 35-43 are examined on the merits herein.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, and 13-14 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 2 recites the limitation "the duration" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. Since claim 1, from which claim 2 depends, does not recite administering the Cbl inhibitor and serotonin receptor antagonist over a period of time, it is unclear what “duration” in claim 2 is referencing.
Claim 13 recites “the duration” in line 2. There is insufficient antecedent basis for this limitation in the claim.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(a)-Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 10-14, and 35-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a) a method of treating nausea and/or vomiting by administering a Cbl inhibitor compound of instant formula (I) and orally administering a 5-HT3 serotonin receptor antagonist, prior to administration of the Cbl inhibitor, does not reasonably provide enablement for a) a method of treating or preventing any disease or condition in a subject in need thereof by administering an effective amount of any Cbl inhibitor compound and any serotonin receptor antagonist (i.e., instant claims 1-4); b) a method of treating or preventing nausea or vomiting, or both, in a patient undergoing any Cbl treatment comprising administering to the subject an effective amount of any serotonin receptor antagonist (i.e., instant claims 10-14), or c) a method of treating or preventing any disease or condition in a subject in need thereof, comprising administering to the subject any Cbl inhibitor compound at specific doses, and subsequently administering the Cbl inhibitor compound at another specific dose (i.e., instant claims 35-43). 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.
The criteria for enablement set out in the In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the Claims
The instant claims are directed toward a) a method of treating or preventing any disease or condition in a subject in need thereof by administering an effective amount of any Cbl inhibitor compound and any serotonin receptor antagonist; b) a method of treating or preventing nausea or vomiting, or both, in a patient undergoing any Cbl treatment comprising administering to the subject an effective amount of any serotonin receptor antagonist, or c) a method of treating or preventing any disease or condition in a subject in need thereof, comprising administering to the subject any Cbl inhibition compound at specific doses, and subsequently administering the Cbl inhibitor compound at other specific doses.
As such, the breadth of the claims is great.
Level of Skill in Art
The level of skill in the art is a scientist with a PhD or a clinician.
State of the Prior Art
WO 2021/061853 to Sands (published 04/01/2021, IDS of 09/06/2023) teaches a method of treating cancer, by immunotherapy, in an individual, by administering a Cbl inhibitor, and specifically teaches administering
PNG
media_image3.png
111
256
media_image3.png
Greyscale
as the Cbl-b inhibitor (pgs. 80-87, claims 1, 5, 9, 39, 16, 33, 47, 52-53, 55-56, 61-64, ; pg. 36).
Sands specifically teaches the Cbl inhibitor as enhancing the antitumor efficacy of immune cells utilized in immunotherapy (Examples 1-10, beginning on pg. 64 of Sands).
[0003] of the instant specification states that Cbl-b inhibitor compounds have shown promise for potential immunotherapy applications through enhancing T-cell mediated anti-tumor activity by lowering the activation threshold of T-cells in a suppressive tumor microenvironment. Thus, the instant specification teaches that Cbl-b inhibitors have the potential to enhance, and in certain cases, synergize the efficacy of another cancer therapeutic.
US 2011/0135724 to Venkatesh (published 2011, PTO-892) teaches an orally disintegrating tablet form comprising a 5-HT3 blocking agent for the prevention of nausea and/or vomiting (abstract). Venkatesh teaches its tablet as providing an immediate prophylactic effect as well as a continuing beneficial effect up to 24 hours post-dosing ([0012]; pg. 10, claim 1). The tablet is administered to patients prior to undergoing cancer treatments, for the prevention of nausea and/or vomiting for up to 24 hours post-dosing ([0013]; pg. 12, claims 34-36).
Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892) teaches 5-HT3 receptor antagonists as the ‘gold standard’ in antiemetic therapy and as the first line treatment for moderately and highly emetogenic chemotherapy and radiotherapy regimens. Antiemetic therapeutic guidelines stress that the goal of therapy is to prevent cytostatic induced nausea and vomiting. Therefore the prophylactic use of the most effective antiemetic regimen, taking into consideration the emetogenicity of the chemotherapy and individual patient characteristics, must be adhered to in order to prevent acute, delayed, and anticipatory nausea and vomiting (abstract).
Thus, the prior art teaches Cbl-b inhibitors as potentiators of immunotherapy and teaches 5-HT3 serotonin antagonists as treatment for nausea and/or vomiting in patients undergoing cancer therapy.
Predictability in the Art
Pharmacology Corner (Serotonin (5-HT): receptors, agonists and antagonists, PTO-892) teaches that there are seven subtypes of serotonin (5-HT) receptor, 5-HT1-7, wherein 5-HT1/2/4/7 receptors are G-protein coupled receptors and 5-HT3 receptors are ligand dated ion channel receptors (pg. 2). Pharmacology Corner teaches 5-HT1 and 5-HT2 receptors as both further subdivided into three groups.
Pharmacology teaches that 5-HT2A/2C antagonists treat hypertension and psychotic disorders (pgs. 5-6), while 5-HT3 antagonists treat chemotherapy induced nausea and vomiting (pg. 6).
Thus, it is not predictable in the art that any serotonin receptor antagonist treats nausea and/or vomiting, or that any serotonin receptor antagonist targets the same serotonin (5-HT) receptors.
The instant specification teaches that certain Cbl-b have shown promise for several potential immunotherapy applications, and that they have the potential to enhance and synergize the efficacy of another cancer therapeutic.
As such, the art of treating diseases with Cbl-b inhibitors, which are a species of Cbl inhibitors, is unpredictable, since the prior art only teaches these inhibitors for enhancing immunotherapy and the instant specification teaches such a method as showing promise ([0003]).
As such, the art of treating any disease/condition or nausea and vomiting with a either a Cbl inhibitor, or a combination of any Cbl inhibitor and any serotonin receptor antagonist, is unpredictable.
Working Examples
In Example 1, ondansetron is administered at a 8 or 16mg dosage for two weeks followed by administration of
PNG
media_image2.png
154
237
media_image2.png
Greyscale
daily.
In Example 2, granisetron is administered orally in 1mg or 2mg dosages for four weeks, followed by
PNG
media_image2.png
154
237
media_image2.png
Greyscale
.
In Example 3, palonosetron is administered by IV in a 0.25 mg dosage or orally in a 0.5 mg dose, one day prior to chemotherapy.
In example 4, dolasetron is administered orally in 100mg dosages once daily.
In example 5, metoclopramide, a dopamine antagonist, is administered orally in a 10mg dose 30 minutes prior to administration of
PNG
media_image2.png
154
237
media_image2.png
Greyscale
, wherein the administration of a dopamine antagonist did not control the patient’s nausea or vomiting.
In example 6, diphenhydramine, a histamine antagonist, is administered orally or parenterally in 25mg or 50mg dosages 30 minutes prior to administration of
PNG
media_image2.png
154
237
media_image2.png
Greyscale
, wherein the administration of the histamine antagonist did not control the patient’s nausea or vomiting.
In each example, the concentration of
PNG
media_image2.png
154
237
media_image2.png
Greyscale
, is 25mg/320cc>20uM.
Thus, the instant specification exemplifies that nausea and vomiting symptoms are mitigated when a single oral dose of a 5-HT3 antagonist is administered 30-60 minutes prior to administration of
PNG
media_image2.png
154
237
media_image2.png
Greyscale
. The specification specifically teaches that the nausea and vomiting were controlled by ondansetron and granisetron, and that only oral administration is effective.
Direction and Guidance
In view of the above teachings of the prior art in reference to Cbl-b inhibitors and 5HT receptor antagonists, the unpredictability of the prior art, and the instant examples limited to methods of treating nausea and vomiting by orally administering a 5-HT3 antagonist prior to administration of
PNG
media_image2.png
154
237
media_image2.png
Greyscale
, the instant specification does not provide sufficient direction or guidance, to use the invention as instantly claimed.
Quantity of Experimentation
The amount of experimentation required to determine a) which diseases are treated by combinations of which Cbl inhibitor compounds and which serotonin receptor antagonists; b) which combinations of which Cbl inhibitor compounds and which serotonin receptor antagonists treat nausea and vomiting; and c) which diseases are treated by combinations of which Cbl inhibitor compounds at specific doses and then additional specific doses, would be astronomical. This amounts to invention, not development; it is an undue amount of experimentation.
Thus, while being enabling for a) a method of treating nausea and/or vomiting by administering a Cbl inhibitor compound of instant formula (I) and orally administering a 5-HT3 serotonin receptor antagonist, prior to administration of the Cbl inhibitor, the instant specification does not reasonably provide enablement for a) a method of treating or preventing any disease or condition in a subject in need thereof by administering an effective amount of any Cbl inhibitor compound and any serotonin receptor antagonist; b) a method of treating or preventing nausea or vomiting, or both, in a patient undergoing any Cbl treatment comprising administering to the subject an effective amount of any serotonin receptor antagonist, or c) a method of treating or preventing any disease or condition in a subject in need thereof, comprising administering to the subject any Cbl inhibition compound at one specific dose, and subsequently administering the Cbl inhibitor compound at another specific dose.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/061853 to Sands (published 04/01/2021, IDS of 09/06/2023) in view of Markman (Immunotherapy side effects, published 04/01/2022, PTO-892), Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), and US 2011/0135724 to Venkatesh (published 2011, PTO-892).
Sands teaches a method of treating cancer, by immunotherapy, in an individual, by administering a Cbl inhibitor, and specifically teaches administering
PNG
media_image3.png
111
256
media_image3.png
Greyscale
, a Cbl-b inhibitor (pgs. 80-87, claims 1, 5, 9, 39, 16, 33, 47, 52-53, 55-56, 61-64, ; pg. 36).
Regarding claims 1 and 10, while Sands teaches a method of treating cancer by immunotherapy by administering a Cbl inhibitor, to an individual, it differs from that of instant claim 1 in that it does not teach a serotonin receptor antagonist.
Sands teaches the immunotherapy as performed in combination with one or more additional modes of therapy (pg. 87, claim 65), and teaches that in some embodiments, additional therapeutic agents are co-administered simultaneously or sequentially in any order ([000214]).
Sands teaches that prophylactic agents are useful to prevent or impede side effects, such as nausea or vomiting ([00085]).
Markman teaches immunotherapy side effects (title). Nausea and vomiting are taught as side effects that can be managed with medication (pg. 3).
Schnell teaches chemotherapy-induced nausea and vomiting and the importance of acute antiemetic control (title).
Nausea and vomiting are two of the most feared side effects of cancer chemotherapy and radiotherapy. Chemotherapy-induced nausea and vomiting is categorized as acute, occurring within 24 hours of therapy, delayed, persisting for 6-7 days after therapy, or anticipatory, occurring prior to chemotherapy administration. Breakthrough and refractory nausea and vomiting are the symptoms of uncontrolled emesis. Good control of nausea and vomiting during the acute period correlates with the control of delayed emesis (abstract).
Schnell teaches 5-HT3 receptor antagonists as the ‘gold standard’ in antiemetic therapy and as the first line treatment for moderately and highly emetogenic chemotherapy and radiotherapy regimens. Antiemetic therapeutic guidelines stress that the goal of therapy is to prevent cytostatic induced nausea and vomiting. Therefore the prophylactic use of the most effective antiemetic regimen, taking into consideration the emetogenicity of the chemotherapy and individual patient characteristics, must be adhered to in order to prevent acute, delayed, and anticipatory nausea and vomiting (abstract).
Schnell teaches that emesis is determined by the emetogenic potential of the administered chemotherapy, patient variables and the dosage and efficacy of the prescribed antiemetic regiment (pg. 188, Col. 2, 1st full paragraph). The patient variables include gender, age, alcohol consumption, motion sickness, pregnancy-induced emesis, anxiety, previous cycles of chemotherapy (Table 2, pg. 189). Additionally, pharmacogenetics, impacts a patients response, wherein, for example, a genetic polymorphism has been identified that affects patients’ responses to antiemetic therapy, and ultra-rapid metabolizers of isoenzyme CYP2D6 have a significantly higher frequency of vomiting within 24 hours after chemotherapy (pgs. 188-189, “Risk Factors for the Development of Acute Nausea and Vomiting”).
Schnell teaches that the aim of antiemetic treatment is the total prevention of nausea and vomiting for each individual, thereby conferring the best patient outcome (pg. 190, col. 2).
An important aspect of prophylactic antiemetic therapy is control of nausea and vomiting over repeated cycles of chemotherapy. A decline in antiemetic effect has been shown during successive treatment cycles with standard antiemetic regimens. Good control of acute nausea and vomiting during first cycle chemotherapy is thus crucial, as emesis in prior chemotherapy cycles is a predictor for emesis in subsequent cycles (pg. 193, “Multiple-Cycle Chemotherapy).
Schnell teaches that treatment should be individualized by considering the important individual patient risk factors. In the outpatient setting, patients must be encouraged to continue with prophylactic antiemetics. All patients at risk of delayed emesis require sustained prophylaxis throughout the posttreatment period. The prescription of antiemetics during the delayed phase should be accompanied by patient counsel emphasizing the importance of prevention overtreatment and thus the need for regular self-administration. Effective preventative measures serve to enhance patients’ qualities of life and lead to improved compliance with subsequent chemotherapy cycles. Administration of appropriate antiemetic prophylaxis should be accompanied by close monitoring of the success of therapy (pg. 194, Therapeutic Recommendations”).
Venkatesh teaches an orally disintegrating tablet form comprising a 5-HT3 blocking agent for the prevention of nausea and/or vomiting (abstract). Venkatesh teaches its tablet as providing an immediate prophylactic effect as well as a continuing beneficial effect up to 24 hours post-dosing ([0012]; pg. 10, claim 1). The tablet is administered to patients prior to undergoing cancer treatments, for the prevention of nausea and/or vomiting for up to 24 hours post-dosing ([0013]; pg. 12, claims 34-36).
Ondansetron is specifically taught as the 5-HT3 blocking agent ([0014]), wherein it is administered in 16-24 mg amounts (pg. 12, claim 36).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a serotonin receptor antagonist, to the methods of Sands, to arrive at instant claims 1 and 10. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success because:
-Sands teaches an immunotherapy, cancer treatment, and teaches administering additional therapeutic agents,
-Sands teaches that a prophylactic agent is useful to prevent or impede side effects, such as nausea or vomiting
-Markman teaches nausea and vomiting as side effective of immunotherapy, cancer treatment,
-Schnell and Venkatesh teach administering serotonin receptor antagonists for the treatment of nausea and vomiting during cancer treatments, and Schnell teaches 5-HT3 receptor antagonists, such as ondansetron, as the gold standard in antiemetic therapy,
-Schnell teaches that effective prevention of nausea and vomiting enhance patients’ qualities of life and lead to improved compliance with subsequent chemotherapy cycles.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a method that decreases cancer treatment’s side effects, increases quality of life, and improves patient compliance with subsequent chemotherapy cycles.
Regarding claim 14, Venkatesh and Schnell teach ondansetron.
Claims 2-4, 11-13, are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/061853 to Sands in view of Markman (Immunotherapy side effects, published 04/01/2022, PTO-892), Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), and US 2011/0135724 to Venkatesh (published 2011, PTO-892), as applied to claims 1, 10, and 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Sands, Markman, Venkatesh, and Schnell are applied as discussed above, and incorporated herein.
While the combination of Sands, Markman, Venkatesh, and Schnell teaches a method of treating cancer and nausea and/or vomiting by administering a Cbl inhibitor and a serotonin receptor agonist, it differs from that of claims 2-4 and 11-13, in that it does not teach the timing of administration or dosage reductions and increases.
Sands additionally teaches administering the Cbl inhibitor 1-3 times per day in a range of from 1-2 days to 7-60 days, in amounts of 1-5000mg, 1-2500mg, 1-2000mg, 1-1500mg, 1-1000mg, 1-750mg, 1-500mg, 1-400mg, 1-300mg, 1-250mg, 1-200mg, 1-100mg, 1-10mg, 0.1-10mg, 0.1-5mg, and 0.1-1mg (pgs. 80-87 claims 11-13, 49-51).
Sands teaches that its pharmaceutical compositions are administered in a manner appropriate to the disease to be treated, and that the quantity and frequency of administration will be determined by such factors as the condition of the patient, and the type and severity of the patient’s disease, and appropriate dosages may be determined by clinical trials ([000247]-[000251]).
Collett teaches that the design of a dosage regimen determines the therapeutic benefit for patients. The principles of clinical pharmacokinetics are applied to design a dosage regimen for a patient that ensures the appropriate formulation of drug is chosen for an appropriate route of administration. One the basis of the patient’s drug handling parameters, which require an understanding of absorption, distribution, metabolism and excretion, the dosage regimen for the medicine in a particular patient, can be optimized. The pharmacist needs to ensure the appropriate regimen is prescribed to achieve optimal efficacy and minimal toxicity (pg. 2, 1st paragraph).
Collett teaches that clinical pharmacokinetics provides a basic understanding of the principles required to design a dosage regimen, wherein pharmacokinetics provides a mathematical basis to assess the time course of drug and their concentration in the body and enables absorption, distribution, metabolism, and excretion (ADME) to be quantified (pg. 2, 2nd paragraph).
Collett teaches that the design of the regimen, i.e. formulation, route of administration, dose size, and dose frequency, are important factors which influence what plasma concentration is achieved and maintained in the body over the prescribed course of drug treatment. Collett further teaches that other factors that require consideration are patients’ individuals needs and lifestyles (pg. 3, 3rd paragraph).
Collett teaches that to understand how the design of dosage regimen influences the time course of a drug in the body, consideration of the complex pharmacokinetic process of drug input, output, and distribution within the body must be considered (pg. 3, last paragraph). Collett teaches that pharmacokinetic models are hypothetical constructs which describe the fate of a drug in a biological system following its administration. The purpose of modeling is to characterize the ADME profile for a drug to indicate how the drug is handled by the patient and to characterize basic parameters (pg. 4, 1st paragraph).
Collett teaches that the greater the rate of drug input relative to the rate of drug output from the body compartment over the net absorption phase, the higher will be the peak concentration achieved in the body or plasma following oral administration of a single dose of drug.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosing regimen and dosing amounts of the combined method of Sands, Markman, Venkatesh, and Schnell, to arrive at instant claims 2-4 and 11-13. One of ordinary skill in the art would have been motivated to make such modifications, with a reasonable expectation of success, because:
-Sands teaches that its pharmaceutical compositions are administered in a manner appropriate to the disease to be treated, and that the quantity and frequency of administration will be determined by such factors as the condition of the patient, and the type and severity of the patient’s disease,
-Schnell teaches that treatment should be individualized by considering the important individual patient risk factors, and that emesis is determined by the emetogenic potential of the administered chemotherapy, patient variables, and the dosage and efficacy of the prescribed antiemetic regimen, and
-Collett teaches that the principles of clinical pharmacokinetics are applied to design an optimized dosage regimen for a patient, wherein absorption, distribution, metabolism, and excretion are studied, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such modifications, to predictably arrive at a method that is optimized to treat the cancer, while controlling the side effects of nausea and/or vomiting, to increasing the patient’s quality of life and compliance with subsequent cancer treatments.
Claims 35-43 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/061853 to Sands in view of Collett (Dosage Regimens, published 2016, PTO-892).
Sands and Collett are applied as discussed above, and incorporated herein.
While Sands teaches a method of treating cancer, by immunotherapy, by administering a Cbl inhibitor, to an individual, it differs from that of instant claims 35-43 in that it does not teach dosage regimens that increase or decrease the dosage amount, and the timing of such dosages.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosing regimen and dosing amounts of the Cbl inhibitors in the method of Sands, to arrive at instant claims 35-43. One of ordinary skill in the art would have been motivated to make such modification, with a reasonable expectation of success, because:
-Sands teaches that its pharmaceutical compositions are administered in a manner appropriate to the disease to be treated, and that the quantity and frequency of administration will be determined by such factors as the condition of the patient, and the type and severity of the patient’s disease,
-Sands teaches the administration of different dosages of the Cbl inhibitors over different time periods,
-Collett teaches that the principles of clinical pharmacokinetics are applied to design an optimized dosage regimen for a patient, wherein absorption, distribution, metabolism, and excretion are studied, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such modifications, to predictably arrive at a method that is optimized to treat the cancer, while minimizing the side effects, to both effectively treat the cancer and increase the patient’s quality of life and compliance with the treatments.
Regarding claim 43,
PNG
media_image4.png
111
256
media_image4.png
Greyscale
is a Cbl-b inhibitor.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 12,121,540 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US Patent No. 12,016,860 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-71 of US Patent No. 11,530,229 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of US Patent No. 12,049,471 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of US Patent No. 11,464,802 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of US Patent No. 11,951,133 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of US Patent No. 12,485,144 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of US Patent No. 11,401,267 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 of US Patent No. 12,234,230 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
US Patent No. 12,121,540
‘540 claims a method of immunotherapy comprising administering an effective amount of a Cbl inhibitor to a patient (Claims 1, 4, 44-48).
‘540 claims
PNG
media_image5.png
111
256
media_image5.png
Greyscale
(claims 6, 43).
‘540 claims administering the Cbl inhibitor 1-3 times daily in a range of 1-5000mg (claims 8-9).
US Patent No. 12,016,860
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘860 claims a method of treating colon or colorectal cancer by administering 0.1-50mg of
PNG
media_image5.png
111
256
media_image5.png
Greyscale
(claim 1).
US Patent No. 11,530,229
‘229 claims a method of treating cancer, modulating the immune response, inhibiting Cbl-b activity, by administering a compound of instant formula (I) when instant R4 is a C1-C2 alkyl substituted with -CN (claims 1, 42-48, 55-56, 59-65).
US Patent No. 12,049,471
‘229 claims a compound of instant formula (I) when instant R4 is a C1-C2 alkyl substituted with -CN (claims 1-4).
‘229 teaches its compounds as Cbl-b inhibitors for use in the treatment of cancer (abstract).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
US Patent No. 11,464,802
‘802 claims compounds of instant formula (I) when A is:
PNG
media_image6.png
103
248
media_image6.png
Greyscale
; X is a -C(R7)(R7)-6-membered nitrogen heterocycle; R3 and R4 form a 4-membered cycle (claims 1-53), and pharmaceutical compositions and kits thereof.
‘802 teaches its compounds as Cbl-b inhibitors for use in the treatment of cancer (abstract).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
US Patent No. 11,951,133
‘133 claims a method of modulating activity of an immune cell, comprising contacting the immune cell with an effective amount of a Cbl-b inhibitor, wherein the inhibitor is a compound of instant formula (I) when A is:
PNG
media_image6.png
103
248
media_image6.png
Greyscale
; X is a -C(R7)(R7)-6-membered nitrogen heterocycle; R3 and R4 form a 4-membered cycle (claim 1).
‘133 claims a method of inhibiting Cbl-b activity or a method of treating cancer by administering an effective amount of the Cbl-b inhibitor to an individual (claims 23-24, 27-32).
US Patent No. 12,485,144
‘144 claims a method of modulating the immune response, the method comprising administering an effective amount of a Cbl-b inhibitor to an individual to modulate the immune response in the individual, wherein the Cbl-b inhibitor is a compound of claim 1 (claims 1, 24-27, 31-36).
US Patent No. 11,401,267
‘267 claims a compound of instant Formula (I) (claims 1-30).
‘267 teaches its compounds as Cbl-b inhibitors for use in the treatment of cancer (abstract).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
US Patent No. 12,234,230
‘230 claims a compound of instant Formula (I) (claim 5).
‘230 teaches its compounds as Cbl-b inhibitors for use in the treatment of cancer (abstract).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
While ‘860, ‘540, ‘229, ‘471, ‘267, ‘230, ‘802, ‘133, and ‘144 teach a method of treating cancer by administering a Cbl inhibitor, to an individual, it differs from that of instant claim 1 in that it does not teach a serotonin receptor antagonist.
Venkatesh and Schnell are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a serotonin receptor antagonist, to the methods of ‘860, ‘540, ‘229, ‘471, ‘267, ‘230, ‘802, ‘133, and ‘144, to arrive at instant claims 1 and 10. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success because:
-‘860, ‘540, ‘229, ‘471, ‘267, ‘230, ‘802, ‘133, and ‘144 teaches an immunotherapy, a cancer treatment,
-Schnell and Venkatesh teach administering serotonin receptor antagonists for the treatment of nausea and vomiting during cancer treatments, and Schnell teaches 5-HT3 receptor antagonists, such as ondansetron, as the gold standard in antiemetic therapy,
-Schnell teaches that effective prevention of nausea and vomiting enhance patients’ quality of life and lead to improved patient compliance with subsequent chemotherapy cycles.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a method that decreases cancer treatment’s side effects, increases quality of life, and improves patient compliance with subsequent chemotherapy cycles.
Regarding claim 14, Venkatesh and Schnell teach ondansetron.
Although the claims of the above referenced patents, at issue, are not identical, they are not patentably distinct from each other.
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 12,121,540 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892), Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US Patent No. 12,016,860 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-71 of US Patent No. 11,530,229 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of US Patent No. 12,049,471 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of US Patent No. 11,464,802 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of US Patent No. 11,951,133 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of US Patent No. 12,485,144 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of US Patent No. 11,401,267 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
Claims 2-4, 11-13, and 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 of US Patent No. 12,234,230 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892) as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
‘860, ‘540, ‘229, ‘471, ‘267, ‘230, ‘802, ‘133, ‘144, Venkatesh, and Schnell are applied as discussed above, and incorporated herein.
While the combination of ‘860, ‘540, ‘229, ‘471, ‘267, ‘230, ‘802, ‘133, or ‘144, and Venkatesh, and Schnell teaches a method of treating cancer and nausea and/or vomiting by administering a Cbl inhibitor and a serotonin receptor agonist, it differs from that of claims 2-4 11-13, and 35-43 in that it does not teach the timing of administration or dosage reductions and increases in the compounds.
Collett is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosing regimens and dosing amounts of the combined methods of ‘860, ‘540, ‘229, ‘471, ‘267, ‘230, ‘802, ‘133, or ‘144, and Venkatesh, and Schnell, to arrive at instant claims 2-4, 11-13, and 35-43. One of ordinary skill in the art would have been motivated to make such modification, with a reasonable expectation of success, because:
-Schnell teaches that treatment should be individualized by considering the important individual patient risk factors, and that emesis is determined by the emetogenic potential of the administered chemotherapy, patient variables, and the dosage and efficacy of the prescribed antiemetic regimen,
-Collett teaches that the principles of clinical pharmacokinetics are applied to design an optimized dosage regimen for a patient, wherein absorption, distribution, metabolism, and excretion are studied, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such modifications, to predictably arrive at a method that is optimized to treat the cancer, while controlling the side effects of nausea and/or vomiting, to increasing the patient’s quality of life and compliance with subsequent cancer treatments.
Claims 1, 10, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 9, 10, 13, 15-19, 21-24, 27, 30, 33, 35, 38, 41-43, 45-48, 50, 51, 54, 55, 57-62, 65, 67-71, 75, 76, 78-80, 82, 83, 87-89, 92, 94, 97-101, 118, 124, 126, 131, 137-139, 145, 160, 165, 167, 170, 174, 176, 178, 183, 204 and 231-257 of copending Application No. 17/631,886 (claim set dated 08/19/2025) in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/708,175 (claim set dated 11/13/2024) in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-36 of copending Application No. 18/662,924 (claim set dated 09/30/2024) in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 124-126, 128, 130, 135, 137, 168, 173, 175-176, 183, 186, 194, 205, 215-217, 219-220, 222-223, 229-231, 236-238, 308-310, 312, and 353 of copending Application No. 16/964,979 (claim set dated 10/21/2025) in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Claims 1, 10, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 20-22, 25, 27-28, 30-31, 35 and 39-43 of copending Application No. 17/030,258 (claim set dated 09/29/2025) in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892).
Copending Application No. 17/631,886
Note: A notice of allowance for this application was mailed on 12/03/2025. As such, once this application becomes a printed patent, this provisional double patenting rejection will be converted to a double patenting rejection over the patent.
‘886 claims a method of modulating the immune response, the method comprising administering an effective amount oof a Cbl-b inhibitor to an individual, wherein the Cbl-b inhibitor are those compound of ‘866’s claim 1 (claims 137-139, 145, 183, 204,239-244, 256-257).
Copending Application No. 18/708,175
‘175 claims a method of treating or preventing a disease or condition in a subject by administering a Cbl-b inhibitor, wherein the disease is cancer (claims 1, 5, 18-22)
Copending Application No. 18/662,924
‘924 claims a method of treating or preventing a disease or condition in a subject in need thereof, by administering a Cbl-b inhibitor (claims 28-33), wherein the disease or condition is cancer (claims 34-36).
Copending Application No. 16/964,979
‘979 claims a method of treating a cancer responsive to inhibition of Cbl-b activity by administering a Cbl-b inhibitor to an individual to treat the cancer (claim 124, 215, 308-310, 312).
Copending Application No. 17/030,258
Note: A notice of allowance for this application was mailed on 11/21/2025. As such, once this application becomes a printed patent, this provisional double patenting rejection will be converted to a double patenting rejection over the patent.
‘258 claims a method of treating cancer by administering a Cbl inhibitor (claims 39, 41-42).
While the above referenced copending applications teach a method of treating cancer by administering a Cbl inhibitor, to an individual, it differs from that of instant claims in that it does not teach a serotonin receptor antagonist.
Venkatesh and Schnell are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add a serotonin receptor antagonist, to the methods of Sands, to arrive at instant claims 1 and 10. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success because:
-the above referenced copending applications teaches an immunotherapy, a cancer treatment,
-Schnell and Venkatesh teach administering serotonin receptor antagonists for the treatment of nausea and vomiting during cancer treatments, and Schnell teaches 5-HT3 receptor antagonists, such as ondansetron, as the gold standard in antiemetic therapy,
-Schnell teaches that effective prevention of nausea and vomiting enhance patients’ quality of life and lead to improved patient compliance with subsequent chemotherapy cycles.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a method that decreases cancer treatment’s side effects, increases quality of life, and improves patient compliance with subsequent chemotherapy cycles.
Regarding claim 14, Venkatesh and Schnell teach ondansetron.
These are provisional nonstatutory double patenting rejections.
Claims 2-4, 11-13, and 35-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 9, 10, 13, 15-19, 21-24, 27, 30, 33, 35, 38, 41-43, 45-48, 50, 51, 54, 55, 57-62, 65, 67-71, 75, 76, 78-80, 82, 83, 87-89, 92, 94, 97-101, 118, 124, 126, 131, 137-139, 145, 160, 165, 167, 170, 174, 176, 178, 183, 204 and 231-257 of copending Application No. 17/631,886 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892)..
Claims 2-4, 11-13, and 35-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/708,175 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892)..
Claims 2-4, 11-13, and 35-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-36 of copending Application No. 18/662,924 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892)..
Claims 2-4, 11-13, and 35-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 124-126, 128, 130, 135, 137, 168, 173, 175-176, 183, 186, 194, 205, 215-217, 219-220, 222-223, 229-231, 236-238, 308-310, 312, and 353 of copending Application No. 16/964,979 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892)..
Claims 2-4, 11-13, and 35-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 20-22, 25, 27-28, 30-31, 35 and 39-43 of copending Application No. 17/030,258 in view of US 2011/0135724 to Venkatesh (published 2011, PTO-892) and Schnell (Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control, The Oncologist, published 2003, PTO-892), as applied to claims 1, 10, 14, above, and further in view of Collett (Dosage Regimens, published 2016, PTO-892).
The above referenced copending applications, Venkatesh, and Schnell are applied as discussed above, and incorporated herein.
While the combination of any one of the above co-pending applications, and Venkatesh, and Schnell teaches a method of treating cancer and nausea and/or vomiting by administering a Cbl inhibitor and a serotonin receptor agonist, it differs from that of claims 2-4 11-13, and 35-43 in that it does not teach the timing of administration or dosage reductions and increases in the compounds.
Collett is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosing regimen and dosing amounts of the combined method of any one of the copending applications, and Venkatesh, and Schnell, to arrive at instant claims 2-4, 11-13, and 35-43. One of ordinary skill in the art would have been motivated to make such modification, with a reasonable expectation of success, because:
-Schnell teaches that treatment should be individualized by considering the important individual patient risk factors, and that emesis is determined by the emetogenic potential of the administered chemotherapy, patient variables, and the dosage and efficacy of the prescribed antiemetic regimen,
-Collett teaches that the principles of clinical pharmacokinetics are applied to design an optimized dosage regimen for a patient, wherein absorption, distribution, metabolism, and excretion are studied, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such modifications, to predictably arrive at a method that is optimized to treat the cancer, while controlling the side effects of nausea and/or vomiting, to increasing the patient’s quality of life and compliance with subsequent cancer treatments.
These are provisional nonstatutory double patenting rejections.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. 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.
/LAUREN WELLS/Examiner, Art Unit 1622