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 .
Priority
The present application U.S. Appln. Ser. No.: 17/912,300, Filed: September 16, 2022 is a 371 Nat. Stage Entry of WO 2021/188473 A1 (i.e., PCT/US2021/022464, Intern.’l Filing Date: 03/16/2021, Intern.’l Pub. Date: September 23, 2021), which claims priority from U.S. Prov. Appln. Nos. 62/990,364 and 63/002,292, respectively, Filed: March 16, 2020.
Status
This is in response to the August 4, 2025 Response to Restriction Requirement in the above-identified application.
Claims 1, 8 and 10 are under examination, Claims 1, 3, 6-8, 9, 10, 15-20, 23, 28, 35-36, 29 and 41-47 are pending, claims 1, 3, 6-7, 9,15-20, 24, 28, 35-36, 29 and 41-47 are withdrawn, claim 1, 17, 19-20 and 44-45 are original and claims 6, 7 are newly amended and claims 2, 4-5, 9, 11-14, 21-23, 25-27, 29-34, 37-38, 40 are cancelled in the above identified application.
Information Disclosure Statement
An Information Disclosure Statement (IDS) submitted on September 16, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, Information Disclosure Statements have been considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse is acknowledged of:
[A] Group I: Claims 1, 8 and 10 drawn to a method for reprogramming an
immunosuppressive microenvironment of a tumor; or myeloid-derived suppressor cells (MDSC) in a tumor into immunostimulatory myeloid cells comprising administering a delta opioid receptor (DOR) antagonist to a subject;
[B] Species Election:
Election Of:
Elected Species
[a]
Tumor Type
melanoma tumors
[b]
Type Of Myeloid Derived Suppressor Cells
myeloid-derived suppressor cells
(MDSCs);
[c]
Type Of Immunostimulatory Myeloid Cells
macrophages
[d] & [e]
A Delta Opioid Receptor (DOR) Antagonist/Species:
naltrindole hydrochloride
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Because Applicants did not distinctly and specifically point out the supposed errors in the DOR antagonist species restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
[C] With regard to the aforementioned elections, Applicants assert that:
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Applicants arguments set forth supra are not found persuasive for the following reasons:
In the conventional oncological arts, a "method of reprogramming an immunosuppressive environment of a tumor" effectively describes reversing the cancerous tumor's ability to suppress the body's immune system, allowing for a robust anti-tumor response. This concept is inherently equivalent to a method of treatment when the patient's immune system is restored to effectively clear the tumor, and for certain therapies.
(e.g., using opioid receptor (DOR) antagonists, including delta opioid receptor antagonists, such as naltrexone, known in the art to exhibit both delta and mu-opioid antagonist properties), where reprogramming action is an intrinsic part of how the drug functions.)
Thus, the shared technical features do not form a contribution over the art, in view of cited prior art of record.
[D] Applicants state that claims 46 and 47 were not included in Group II of the June 6, 2025 Restriction Requirement. Due to the aforementioned inadvertent error, claims 46 and 47 are now acknowledged to be included in Group II.
Based on the above, the requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 8 is objected to because of the following informalities: there indefinite articles are missing before elements defined in this claim as follows:
“The method of claim 1, wherein a delta opioid receptor (DOR) antagonist comprises a RNAi; a small molecule; a peptide; a protein; or an antibody that targets the delta opioid receptor”.
Appropriate correction is required accordingly.
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 1, 8 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the Applicants), regards as the invention.
In general, the claims of the present invention fail to define the metes and bounds of the claimed invention due to use of indefinite, vague, ambiguous or unclear or poorly defined functional terms and/or language (i.e., such that exact scope of the claimed invention cannot be ascertained) without support from the specification within the claim itself. Claims Must Particularly Point Out and Distinctly the claimed invention. Moreover, claims identified above also lack clarity, due to unnecessary use of repetitive and/or redundant terms.
[1] Claim 1 is rejected for lacking clarity and for being vague, ambiguous, indefinite and recites:
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A person of ordinary skill in the art would not be able to determine with reasonable certainty what the metes and bounds of the claimed invention are, i.e., given that terms as currently defined in claim 1 are expressed in very broad terms, which must be set forth with specificity and clarity to establish patentability. The claims must define specific definitions or key terms for:
the chemical formula, structure and corresponding name of the specific delta opioid antagonist;
what is the specific “tumor” is being treated what are its characteristics and what is the specific type of cancer that develops such tumors being treated;
what constitutes the associated immunosuppressive tumor microenvironment (TME);
specific myeloid-derived suppressor cells (MDSCs);
what is the process of “reprogramming” those myeloid-derived suppressor cells (MDSCs) entail; i.e., e.g.
what is the mechanism of action here, which should be defined and set forth in the claim to supported by the originally filed disclosure.)
What is the desired outcome of the reprogramming process?
Who is subject, patient population being treated?
Based on the above, given that no specific definitions to define the boundaries of the present invention, appropriate amendments are required to claim 1.
[2] Claim 8 is rejected for lacking clarity and for being vague, ambiguous, indefinite and recites:
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A person of ordinary skill in the art would not be able to determine with reasonable certainty what the metes and bounds of the claimed invention are; i.e., e.g., because in claim 8:
[A] it is unclear whether the phrase “that targets the delta opioid receptor”, which appears immediately after the term “antibody”, refers to the aforementioned term only or all of the other terms preceding it:
“RNAi; small molecule; peptide; protein; or antibody” that targets each of the delta opioid receptors that precede it.
[3] Claim 10 lacks clarity for recitation of “Dmt-Tic”, because all the other delta opioid antagonists are defined with complete chemical names and acronyms. It is suggested that the claim be amended to recite to state:
“2',6'-dimethyl-L-tyrosyl-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid (Dmt-Tic)”.
Based on the foregoing with regard to [1] to [3] supra, appropriate correction and amendment is required accordingly.
Claim Rejections - 35 USC § 112(a)
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, 8 and 10 are rejected under 35 U.S.C. 112(a), because the specification,
is enabling for:
a method for mediating immunosuppressive myelopoiesis in melanoma tumors comprising administering a therapeutically effect amount of naltrindole hydrochloride
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to a subject (i.e., human patient) in need thereof.
IT DOES NOT REASONABLY PROVIDE ENABLEMENT FOR CLAIMED/ELECTED INVENTION AS SET FORTH BELOW:
[A] TREATMENT METHODS OF CLAIMS 1 and 8
Which are comprised of:
ALL method(s) of reprogramming ALL immunosuppressive microenvironment(s) of ALL tumor(s) in ALL subject(s) or reprogramming ALL myeloid-derived suppressor cells (MDSC)
in ALL tumor(s) in a subject into ALL immunostimulatory myeloid cells comprising administering to ALL subject(s) ALL delta opioid receptor (DOR) antagonist(s) (i.e., claim 8); and
The method of claims 1, where ALL delta opioid receptor (DOR) antagonist(s) comprises ALL RNAi (processes); ALL small molecule(s); ALL peptide(s); ALL protein(s); or ALL antibody (antibodies) that targets ALL delta opioid receptor(s). (i.e., claim 8)
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation. (United States v. Teletronics Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
These factors include the following:
Amount Of Guidance Provided By Applicant and 3. Number of Working Examples.
The instant specification generally teaches methods for cancer immunotherapy, mediating immunosuppressive myelopoiesis and/or reprogramming/modulation of the proliferation of myeloid-derived suppressor cells (MDSC) or immunosuppressive microenvironment of a tumor, which comprises administering delta opioid receptor antagonists or corresponding pharmaceutical compositions thereof (i.e., e.g., as described throughout the instant specification; esp. see paras. directed to DOE antagonists (i.e., see treatment methods/ types of cancers, see paras. [0008]-[0020], [0049]-[0072]. For example
Other than that summarized above, in the specification:
there are NO WORKING EXAMPLES directed to:
ALL the different types of treatment methods, immunotherapies or cellular reprogramming corresponding technologies and the like; and/or
ALL different types of Opioid Receptor Antagonists,
except for:
the one (1) single invitro example directed to two (2) specific Delta Opioid Receptors (i.e., naltrindole hydrochloride and naltriben mesylate) used to treat melanoma skin cancer B16 tumor cells as exemplified below:
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The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation. (United States v. Teletronics Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
Regarding information above, the lack of working examples, other than one example, the ability to claim the broad scope without additional substantive examples cannot be simply willed into existence.
In the instant case, other than use of Example 1 supra in the instant specification, the originally filed disclosure is not sufficient to allow extrapolation of the limited examples to enable treatment of all variants of the overly broad claim directed to “reprogramming the immunosuppressive tumor microenvironment (TME)”, which appears to cover more than one invention. Moreover, for example:
all types of TME represent an expansive and complex concept that involves many different types of cells and mechanisms (e.g., Tregs, macrophages, etc.), secreted factors, and other elements, which include many different types of delta opioid receptor antagonists and makes difficult to ascertain and define the exact scope of the invention.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p).
As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190:
“The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However, there is no evidence that such compounds exist...the examples of the '881 patent do not produce the postulated compounds...there is...no evidence that such compounds even exist.”
The same circumstance appears to be true here. Hence, Applicants must show that the claims as written, other than those exemplified in the present invention and identified in examples can be made and used for the stated purpose, or limit the claims to be commensurate with that which is exemplified accordingly.
The Nature Of The Invention And Predictability In The Art.
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Scope Of The Claims.
The scope of the claims relates to:
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Thus, the scope of claims is very broad.
Nature Of The Invention.
The nature of this invention relates to methods for mediating immunosuppressive myelopoiesis in cancer tumors (i.e., specifically, melanoma associated tumors, which comprises administering delta opioid receptor antagonists reprogram immunosuppressive microenvironment to boost immunotherapy
Level Of Skill In The Art.
An ordinary artisan with expertise in the biological areas of molecular biology, immunology, biopharma, biotech, pharmacology, medicinal chemistry organic, biological, organic, and /or related drug development technologies would recognize the significance of biological mechanisms of action in mediating immunosuppressive myelopoiesis and with the ability to understand cancer biology associated with reprogramming a cancer/tumor microenvironment (TME) with a delta-opioid receptor (DOR) antagonist.
Below are technologies associated with the claimed invention:
1. Tumor Biology And Microenvironment
2. Immunology And Immuno-Oncology
3. Molecular Pharmacology And Drug Development
4. Advanced Research Methods
Cancer biology: Expertise in mechanisms of tumor growth, progression, and metastasis is critical. This includes understanding cellular proliferation, angiogenesis, and how cancer cells interact with surrounding tissue.
Tumor microenvironment (TME) analysis: The ability to characterize the complex cellular and non-cellular components of the TME is vital. This involves identifying different cell types (like cancer-associated fibroblasts and endothelial cells) and analyzing extracellular matrix composition.
Metabolic reprogramming: Knowledge of how cancer cells alter their metabolism (e.g., the Warburg effect) and how this affects the TME and immune cell function is required.
Tumor immunology: A deep understanding of how the immune system interacts with cancer cells and how tumors evade immune detection is fundamental.
Immunosuppressive myelopoiesis: Specific expertise is needed to understand the process by which immature myeloid cells are pathologically activated in cancer to become myeloid-derived suppressor cells (MDSCs).
Myeloid-derived suppressor cells (MDSCs): Expertise is needed to characterize the different subsets of MDSCs (monocytic and granulocytic), their role in promoting immunosuppression, and the mechanisms they use to inhibit T-cell function.
Immunomodulation and reprogramming: Knowledge of strategies to shift the TME from an immunosuppressive state to an anti-tumor one is necessary. This includes understanding how to promote anti-tumor responses and activate myeloid cells.
Immune checkpoint biology: Expertise in immune checkpoint molecules like PD-1, PD-L1, and CTLA-4, which are exploited by MDSCs and tumor cells to suppress immune responses, is crucial.
Receptor pharmacology: This includes specific knowledge of the delta-opioid receptor (DOR), including its structure, function, and signaling pathways. Expertise in how antagonists bind to and block DOR activity is necessary.
Medicinal chemistry: Skills in synthesizing and designing DOR antagonists are needed, with an understanding of structure-activity relationships (SAR) to optimize potency, selectivity, and drug-like properties.
In silico drug discovery: Computational methods such as molecular dynamics (MD) and virtual screening are used to predict DOR-ligand interactions and guide the design of novel antagonists.
Biomarker identification and development: To evaluate the efficacy of the DOR antagonist, robust biomarkers are needed to measure changes in the TME, such as the polarization of macrophages or levels of MDSCs.
Cellular & molecular biology techniques:
Researchers must be proficient in a variety of laboratory techniques, including:
Flow cytometry: To analyze the phenotype and function of immune cell populations like MDSCs.
Cell culture: For in vitro studies on cancer cells, immune cells, and DOR antagonist activity.
CRISPR/Cas9: For gene editing and studying the functional effects of genetic alterations.
Bioinformatics and computational
biology: Strong skills in computational analysis are needed to process large-scale molecular data, such as sequencing data, to uncover changes within the TME and understand drug mechanisms.
Preclinical and clinical trial
design: Experience is required to design and execute studies in animal models and, ultimately, human clinical trials. This includes knowledge of toxicology, pharmacokinetics, and regulatory requirements.
The process of finding new drugs that have in vitro activity against a particular biological target, (i.e., receptor, enzyme, etc.) is well known.
Additionally, while high throughput screening assays can often be employed, developing a therapeutic method for a complex invention as claimed, is generally not well-known or routine, given the complexity of certain biological systems. Screening of new drug candidates, while complex, is routine in the art.
MPEP §2164.01 (a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
That conclusion is clearly justified here as Applicants are not enabled for making or using all these compounds (i.e., as described in general terms, inc., but not limited to starting materials, intermediates, etc.) or pharmaceutical compositions thereof (i.e., e.g., by using not specifically reagents and/or, reactions conditions, etc. ) or treating the diseases taught in the specification.
Based on the foregoing and U.S. patent law, a claim directed to the specific method of using a DOR antagonist to mediate immunosuppressive myelopoiesis as identified by the subject matter of claim 1 represents a patentable claim based on the originally filed disclosure.
Appropriate action is required accordingly in the instant application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Relevant Background Information to Prior Art Rejections
The present invention relates to methods directed to interrelated concepts; i.e., e.g., relationship between reprogramming and immune modulation.
Reprogramming process described includes both modulating an immune response and immune cell activity, and can be seen as correcting immune dysregulation.
Immune dysregulation: Cancer promotes MDSC generation, which is a form of immune dysregulation. These cells prevent the immune system from mounting an effective anti-tumor response. Reprogramming aims to correct this dysregulation.
Modulating an immune response: Reprogramming MDSCs into immunostimulatory myeloid cells is, by definition, modulating the immune response. This action can lead to increased anti-tumor T cell function.
Modulating immune cell activity: Administering a delta opioid antagonist alters the function of immune cells. Delta opioid receptor agonists have been shown to modulate T-cell proliferation and cytokine production. Antagonists would have the opposite effect, thereby changing the cell's activity.
Reprogramming of the immunosuppressive microenvironment is considered inherent to, or equivalent to, the administration of a delta opioid antagonist based on the mechanism of action. The antagonist is the direct trigger that initiates the desired effect.
[A] general methods, which may include, but is not limited to :
a method of reprogramming:
an immunosuppressive microenvironment of a tumor in a subject; OR
myeloid-derived suppressor cells (MDSC) in a tumor in a subject into immunostimulatory myeloid cells (i.e., claim 1);
which comprises administering to the subject a delta opioid receptor (DOR) antagonist.
[B] mechanistic type claims
Methods to potentiate or increase an immune response in a subject in need thereof (e.g., an anti-tumor immune response) respectively, which comprises administering to the subject a delta opioid receptor (DOR) antagonist.
[C] Methods for treating a disease, such as cancer (i.e., inc. melanoma) comprising administering a delta opioid receptor antagonist to a subject in need thereof
Examples may include, but are not limited to
[1] a method for mediating immunosuppressive myelopoiesis in melanoma tumors comprising administering a therapeutically effect amount of naltrindole hydrochloride
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to a subject (i.e., human patient) in need thereof.
Rejections
[1] Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2007/131154 to Accelerated Technologies Corporation et al. (i.e., Intern.’l Filing Date: May 4, 2007; Intern.’l Pub Date: November 15, 2007; “WO ‘154 Appln").
The present invention relates to methods as explained under Relevant Background Information to Prior Art Rejections, see supra.
WO ‘154 Appln. generally discloses and relates to a method of reprogramming an immunosuppressive microenvironment of a tumor in a subject, which comprises the administration of a delta opioid receptor (DOR) antagonist.
In particular, the WO ‘154 Appln. specifically is directed to a method of using low doses of naltrexone (i.e., a DOR antagonist) to block endorphin receptors (i.e., effectively suppressing an immune response or “reprogramming the tumor environment) in various body cells of a human or animal patient, para. [09] for multiple disease treatment (i.e., e.g., which includes cancer and tumors, para. [04]), which reads on claim 1 of the present invention; i.e., e.g., where the method:
stimulates the immune system of a patient prior to the onset of an illness via a daily dose of naltrexone that is generally in the range of 0.5 to § milligrams per dose....
causes a stimulation of immune system function with marked improvement in disease fighting capability. ...
increases in endorphins resulting from the blockage of endorphin receptors by the naltrexone causes the immune system to become more effective at fighting infection.... .
The WO ‘154 Appln further teaches naltrexone:
may improve immune system function, resulting in a greatly enhanced ability to fend off debilitating diseases such as many forms of cancer, Para. [10]), which comprises administering to the subject a delta opioid receptor (DOR) antagonist
used as a preventative medicine taken daily as a vitamin supplement and may prevent many of the diseases that tend to be susceptible to a strong immune system, Para. [06];
where low doses of naltrexone raise endorphin levels, resulting in immune system function increase.... naltrexone induced, the increased levels of endorphins result in a... more robust immune system function, which results improved prognosis due to a greater ability of the immune system to overcome and defeat a disease, Para. [14)).
WO ‘154 Appln. further teaches a method to stimulate the immune system of a patient prior to the onset of an illness via a daily dose of naltrexone that is generally in the range of 0.5 to 5 milligrams per dose.... causes a stimulation of immune system function with marked improvement in disease fighting capability, Para. [10]), i.e., which reads on claim 8 of the claimed invention.
Therefore, WO ‘154 Appln. anticipates the claimed invention.
[2] Claims 1, 8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/02666 A1 to Flagship Pioneering et al. (i.e., Intern.’l Filing Date: July 25, 2017; Intern.’l Pub Date: February 1, 2018; “WO ‘266 Appln").
The present invention relates to methods as explained under Relevant Background Information to Prior Art Rejections, see supra.
The WO ‘666 Appln. discloses and teaches each element of the claimed invention:
methods for treatment of cancer
which includes, “skin cancer (such as malignant melanoma, basal and squamous cell skin cancers, Merkel Cell Carcinoma, lymphoma of the skin, Kaposi Sarcoma)”, ss page 264, Section IV Cancer, lines 29-31)
in a subject by administering to the subject:
an effective amount of a neuromodulating agent;
i.e., e.g., described therein as neuropeptide antagonist or naltrindole hydrochloride see Table 2L page 83 therein)
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in a dose (e.g., effective amount) and for a time sufficient to treat the cancer to a subject in need thereof;
where aforementioned methods:
“can also be used to potentiate or increase an immune response in a subject in need thereof, e.g., an anti-tumor immune response”
may include a step of selecting a subject in need of potentiating an immune response, e.g., selecting a subject who has cancer or is at risk of developing cancer.; and
neuromodulating agent:
may inhibit proliferation or disrupt the function of non-neural cells associated with the cancer, e.g., myeloid dendritic cells, myeloid derived suppressor cells,
inhibit tumor survival or promote tumor control.
can have one or more of the following activities: (a) inhibits an immune checkpoint, (b) activates anti-tumor immune response, (c) activate tumor-specific T cells from draining lymph nodes, and/or (d) stimulates a neoantigen-specific immune response.
Therefore, WO ‘266 Appln. anticipates the claimed invention.
Prior Art Information
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
House et al., “Suppression Of Immune Function By Non-Peptidic Delta Opioid Receptor Antagonists”, Neuroscience Letters 198 (1995) 119-122. See Abstract below:
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Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to GRACE C HSU whose telephone number is (571) 270-1689. The Examiner can normally be reached Monday-Friday 7:30 am - 6 pm. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jeffrey H. Murray can be reached on 571-272-9023.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicants is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/G.C.H./
Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624