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
Pursuant to a preliminary amendment filed November 13, 2023, claims 1, 29, 31, 32, 35, 38, 40, 44-50, 52, 53, 55, 58, 59, 66-69 and 71 are currently pending in the instant application.
Response to Election/Restriction
Applicant's election of Group II, claims 29, 31, 32, 35, 38, 40, 44-50, 52, 53, 55, 58 and 59 directed to a method for treating a disease or disorder in a subject in need thereof; and Applicant’s election of Species as follows:
Species (A): wherein the disease or disorder is cancer (claim 31);
Species (B): wherein the immune response is induced in NK cells, dendritic cells or macrophages (claim 32);
Species (C): wherein the immunomodulating agent is selected from the group consisting of IL18, IL15, etc. (claim 35);
Species (C)(I): wherein the immunomodulating agent is selected from IL18 (claim 35);
Species (D): wherein the immune response comprises decreased presentation of antigens on B cells (claim 44); and
Species (E): no election, in the reply filed June 5, 2026 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of invention has been treated as an election without traverse (MPEP
§ 818.03(a)).
Claims 1, 66-69 and 71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 38, 40, 45-50, 52, 53, 55, 58 and 59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
Please Note: regarding Species (C), upon further consideration, the Examiner has rejoined the species immunomodulating agent to include IL-2. The examination of the species together does not represent an undue burden.
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 29, 31, 32, 35 and 44 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed May 3, 2023 is a 35 U.S.C. 371 national stage filing of International Application PCT/US21/58074, filed November 4, 2021, which claims the benefit of US Provisional Patent Application 63109795, filed November 4, 2020.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application 63/109795, filed November 4, 2020, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. The specific method steps recited in independent claim 29 does not have support for; “administering one or more immunomodulating agents that drive an immune response within the subject in combination with a treatment for the disease or disorder, wherein the immune response is associated with increased efficacy of the treatment.” Therefore, the priority date for the presently claimed invention is November 4, 2021, the filing date of International Application WO2022098882.
Applicants are invited to specifically indicate the location of the cited phrase pertinent to claim 29 of the instant application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on November 13, 2023 and June 5, 2026 have been considered. Initialed copies of the IDSs accompany this Office Action.
Claim Objections/Rejections
Specification Objection
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See; paragraph [0149]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Claims 32 and 35 is objected to because of the following informalities: Claims 32 and 35 recite terms such as “NK cells” and "IL18, IL15, IL2…and LTA2-B1”, where an abbreviation should be spelled out in the first encounter of the claims.
Appropriate correction is required.
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 29, 31, 32, 35 and 44 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 29 is indefinite for the recitation of the term “drive” such as recited in claim 29, line 2 because the term “drive” is a relative term that renders the claim indefinite. The term “drive” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite amount of urging or push as compared to some other value that qualifies an agent as ‘driving’ an immune response within all patients (e.g., increases lymphocyte production 100-fold as compared to untreated subjects, etc.), such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention and, thus, the metes and bounds of the claim cannot be determined.
Claim 29 is indefinite for the recitation of the term “associated with” such as recited in claim 29, line 4 because the term “associated” is a relative term that renders the claim indefinite. The term “associated” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite type and/or amount of association as compared to some other type or value that qualifies as the immune response being associated with the efficacy of the treatment, such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention and, thus, the metes and bounds of the claim cannot be determined.
Claim 29 is indefinite for the recitation of the term “increased efficacy” such as recited in claim 29, line 4 because the term “increased” is a relative term that renders the claim indefinite. The term “increased” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite amount of increase as compared to some other value (e.g., a healthy control, a previously treated patient, etc.) that qualifies as an increase in efficacy of the treatment, such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention and, thus, the metes and bounds of the claim cannot be determined.
Claim 29 is indefinite for the recitation of the term “efficacy of the treatment” such as recited in claim 29, line 4 because it is unclear whether the term “efficacy of the treatment” refers to the efficacy of administering the combination of one or more immuno-modulating agents and the treatment for the disease or disorder; or whether the term refers to the efficacy associated with the treatment for the disease or disorder alone. If the term refers to the latter, it is unclear how the efficacy of the treatment for the disease or disorder is separated from the efficacy associated with administering the combination of agents and, thus, the metes and bounds of the claim cannot be determined.
Claim 32 is indefinite for the recitation of the term “induced” such as recited in claim 32, line 1 because the term “induced” is a relative term that renders the claim indefinite. The term “induced” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite amount of induction as compared to some other value that qualifies as inducing an immune response as recited such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention and, thus, the metes and bounds of the claim cannot be determined.
Claim 32 is indefinite for the recitation of the term “NK cells, dendritic cells, or macrophages” such as recited in claim 32, line 2 because claim 32 depends from instant claims 1 and 31, wherein claims 1 and 31 do not recite the presence of NK cells, dendritic cells, or macrophages and, thus, the metes and bounds of the claim cannot be determined.
Claim 35 is indefinite for the recitation of the term “the immunomodulating agent” such as recited in claim 35, line 1. There is insufficient antecedent basis for the term “the immunomodulating agent” in the claim because claim 1, line 2 recites the term “one or more immunomodulating agents.” The Examiner suggests that Applicant amend the claim to recite, for example, “wherein the one or more immunomodulating agents is selected from.”
Claim 35 is indefinite for the recitation of the term “LIGHT” such as recited in claim 35, line 4 because it is unclear whether the term “LIGHT” refers to electromagnetic radiation comprising a wavelength; or whether the term refers to the protein TNSF14 and, thus, the metes and bounds of the claim cannot be determined.
Claim 35 is indefinite for the recitation of the terms such as “Persephin”, “RANKL”, “APRIL”, “VEGF”, “GDNF”, “Resistin”, and “EGF” in claim 35, lines 5-7 because it is unclear whether a patient (e.g., a cancer patient) would be administered all of the agents that recited herein such as “Persephin”, “RANKL”, “APRIL”, “VEGF”, “GDNF”, “Resistin”, and/or “EGF” because the recited agents are related to pathological states including the growth, metastasis, and/or survival of several cancers (e.g., they would not be used in a method of treating a disease or disorder). For example, VEGF is a potent immuno-suppressive agent that assists a cancer in growing and spreading as evidenced by Benchley (pgs. 1-2) and Goel (Abstract), while GDNF is found to be positively correlated with malignancy in human colon cancer patients, and enhances the migration of colon cancer cells by increasing VEGF-VEGR interaction as evidenced by Huang (Abstract) and, thus, the metes and bounds of the claim cannot be determined.
Claim 44 is indefinite for the recitation of the term “decreased presentation” such as recited in claim 44, line 2 because the term “decreased” is a relative term that renders the claim indefinite. The term “decreased” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite amount of ‘decrease’ as compared to some other value that qualifies as decreasing the presentation of antigens on B cells (e.g., as compared to antigen presentation on B cells in a healthy control, etc.), such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention and, thus, the metes and bounds of the claim cannot be determined.
Claim 44 is indefinite for the recitation of the term “antigens on B cells” such as recited in claim 44, line 2 because claim 44 depends from instant claim 29, wherein claim 29 does not recite the presence of B cells and/or antigens presenting on B cells and, thus, the metes and bounds of the claim cannot be determined.
Claim 31 is indefinite insofar as it ultimately depends from instant claim 29.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 32 and 44 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 32 recites (in part): “wherein the immune response is induced in NK cells, dendritic cells, or macrophages” such as recited in claim 32, lines 1-2 because claim 32 depends from instant claims 1 and 31, wherein claims 29 and 31 do not recite the presence of NK cell, dendritic cells, and/or macrophages. Thus, claim 32 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 44 recites (in part): “wherein the immune response comprises decreased presentation of antigens on B cells” such as recited in claim 44, lines 1-2 because claim 44 depends from instant claim 29, wherein claim 29 does not recite the presence of B cells. Thus, claim 44 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 29, 31, 32, 35 and 44 are rejected under 35 U.S.C. 102(a1)/102(a2) as being anticipated by Hacohen et al. (hereinafter “Hacohen”) (US Patent No. 11452768, issued September 27, 2022; also as US20160339090, published November 24, 2016) as evidenced by Mulder et al. (hereinafter “Mulder”) (HemaSphere, European Hematology Association, 2021, 1-12).
Regarding claims 29 and 31, Hacohen teaches methods of inducing a neoplasia/tumor specific immune response in a subject, vaccinating against a neoplasia/tumor, treating and or alleviating a symptom of cancer in a subject by administering the subject a neoplasia vaccine or a neo-antigenic peptide or composition of the invention and at least one checkpoint inhibitor, wherein the invention is directed to methods of treating or preventing a neoplasia comprising the steps of administering to a subject (a) a neoplasia vaccine or immunogenic composition, and (b) at least one checkpoint inhibitor (neoplasia vaccine and checkpoint inhibitor corresponding to administering immunomodulating agents to a subject that drive an immune response in combination with a treatment for a disease, wherein the disease is cancer, claims 29 and 31) (col 66, lines 42-53). Hacohen teaches that the neoplasia vaccine or immunogenic composition can be used for a patient that has been diagnosed as having cancer (interpreted as the disease being cancer, claim 31) (col 66, lines 54-56). Hacohen teaches that the neoplasia vaccine or immunogenic composition and one or more checkpoint inhibitors can be administered before, during, or after administration of the additional agent (interpreted as administering an agent in combination with the immunomodulating agent; and driving an immune response, claim 29) (col 67, lines 1-4). Hacohen teaches that the therapeutic agent is for example, a chemotherapeutic or biotherapeutic agent, radiation, or immuno-therapy, wherein any suitable therapeutic treatment for a particular cancer can be administered (interpreted as a treatment for the disease of cancer; and an immuno-modulating agent, claim 29) (col 67, lines 16-19). Hacohen teaches that the one or more additional agents are synergistic in that the increase immunogenicity after treatment, and/or the additional agent results in longer lifespan due to increased effectiveness of the combination therapy (interpreted as driving an immune response; and being associated with increased efficacy, claim 29) (col 69, lines 8-10 and 14-16). Hacohen teaches that the additional agent is administered to increase the efficacy of the combination therapy, wherein the additional agent is a chemotherapy treatment (interpreted as a treatment for the disease of cancer, and increasing efficacy of the treatment, claim 29) (col 69, lines 24-26).
Regarding claim 32, Hacohen teaches that taxanes are administered before vaccinations to enhance T-cell and NK-cell functions (interpreted as inducing a response in NK cells, claim 32) (col 67, lines 44-45).
Regarding claim 35, Hacohen teaches that the therapeutic agent can be a cytokine such as interferons (INFs), interleukins (ILs), or hematopoietic growth factors including IL-2 (interpreted as encompassing IL-2 and IL-18, claim 35) (col 68, lines 18-20). Hacohen teaches that high dose interleukin-2 (HD-IL2) is used in patients with metastatic ccRCC based on a durable complete remission rate of 7% (interpreted as IL-2, claim 35) (col 113, lines 56-60).
Regarding claim 44, Hacohen teaches that the combination chemotherapy can include Ibrutinib (interpreting Ibrutinib as reducing presentation of antigens on B cells, claim 44) (col 74, lines 1 and 25), where it is known that the inhibition of BTK by ibrutinib reduces the expression of the CXCL12 receptor C-X-C motif chemokine receptor 4 (CXCR4) on leukemic B cells as evidenced by Mulder (pg. 1, col 2, second full paragraph).
Hacohen meets all the limitations of the claims and, therefore, anticipates the claimed invention.
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(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 29, 31, 32, 35 and 44 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hacohen et al. (hereinafter “Hacohen”) (US Patent No. 11452768, issued September 27, 2022; also as US20160339090, published November 24, 2016) in view of Carroll et. al. (hereinafter “Carroll”) (US Patent No. 8679471, issued March 25, 2014; effective filing date September 14, 2006) as evidenced by Mulder et al. (hereinafter “Mulder”) (HemaSphere, European Hematology Association, 2021, 1-12).
The teachings of Hacohen as applied to claims 29, 31, 32, 35 and 44 are described supra.
Hacohen does not specifically exemplify IL-18 (claim 35, in part).
Regarding claim 35 (in part), Carroll teaches methods and compositions for modulating the presence and/or activity of regulatory T cells in a subject (Abstract). Carroll teaches a method for decreasing the number of CD4+CD25+FoxP3+ Tregs in a subject, the method comprising the step of administering a therapeutically-effective amount of interleukin 18 (IL-18) to the subject afflicted with at least one disorder selected from cancer, a retroviral infection or a parasitic infection, wherein the CD4+ CD25+ FoxP3+ Tregs are selectively depleted (interpreted administering an immunomodulating agent; IL-18; and cancer or infection, claims 29, 44 and 35) (col 2, lines 39-46). Carroll teaches that
the IL-18 is administered in conjunction with at least one additional therapeutic component including an antibody, an antibody-toxin conjugate, a toxin, a chemotherapeutic molecule, a DNA vaccine, an antisense molecule, an siRNA molecule, a stem cell, a tumor-specific T cell, or an antigen-presenting cell (interpreted as being administered as a combination therapy; and IL-18, claim 35) (col 3, lines 1-7).
It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of reducing the presence and/or activity of regulatory T cells in a subject as exemplified by Carroll, it would have been prima facie obvious for one of ordinary skill in the art at the time the invention was made to modify the method of administering a neoplasia treatment or immunogenic composition in combination with other agents before, during or after the administration of an additional agent, wherein immunomodulatory agents include checkpoint blockade inhibitors, monoclonal antibodies, drugs such as ibrutinib, rituximab, bevacizumab, trastuzumab, erlotinib, interferons, and/or interleukins including IL-1, IL-2, IL-4, and IL-12 for the treatment or prevention of neoplasia in a subject as disclosed by Hacohen to include additional immunomodulatory agents such as IL-18 as taught by Carroll with a reasonable expectation of success in using combination therapies to treat neoplasia in a subject, in significantly increasing the survival rate of a subject diagnosed with neoplasia, in reducing immuno-suppression such as by decreasing the presence and/or activity of regulatory T cells in a subject, and/or in improving clinical outcomes for cancer patients.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly
rejected under 35 USC §103(a) as obvious over the art.
Conclusion
Claims 29, 31, 32, 35 and 44 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684
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