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
Status of 18/634,055
Claims 1 and 3-13 are currently pending.
Priority
Instant application 18/634,055, filed 4/12/2024, claims priority as follows:
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Support for the instant claims is found in the provisional application.
Information Disclosure Statement
All references from the IDS submitted on 4/12/2024, 6/25/2024, 1/14/2025, 8/12/2025, 4/14/2026, and 6/22/2026 have been considered unless marked with a strikethrough.
Objection to the Abstract
The abstract of the disclosure is objected to for insufficient length, as it is less than 50 words. The abstract should generally be within the range of 50 to 150 words in length, and chemical abstracts in particular should provide the structure of the compound of a formula thereof in addition to methods of use. See MPEP § 608.01. Appropriate correction is required.
Election/Restriction
Applicant’s election of the compound of claim 4:
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As the single Wee1 inhibitor, B6.H12 as the single anti-CD47 antibody, and multiple myeloma as a single disease to treat, without traverse, in the reply filed 6/22/2026 is acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and no prior art was identified. Thus, the search was expanded to the additional disease or condition to treat of myelodysplastic syndromes and acute myeloid leukemia. During the search, an additional teaching of Wee1 inhibitor AZD1775 was identified, and an additional teaching of the anti-CD47 antibody magrolimab (Gilead) was identified. See the 103 rejections below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1, 3-4, 10-11, and 13 read on the expanded species. Claims 5-9 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Interpretation
Claims 1, 3-4, 10-11, and 13 are currently recited as “use” claims, which is not proper form in alignment with U.S. practice. The claims do not set forth any active, positive steps delimiting how this use is actually practiced. See MPEP § 2173.05(q). In the interest of compact prosecution, the claims are currently being interpreted as method of treatment claims.
Claim 4 recites the structure of the elected species of Wee1 inhibitor by Applicant. During the search, the Examiner learned the compound is also known in the art as ZN-c3 and azenosertib. Thus, these chemical names are considered to meet the limitation of the compound in claim 4.
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, 3-4, 10-11, and 13 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 applicant), regards as the invention.
Claim 1 recites the limitation, “effective amount” in reference to the amount of Wee1 inhibitor and anti-CD47 antibody used to treat the disease or condition of the instant claims. The “effective amount” is defined in the specification as an amount of active compound, or pharmaceutical agent, that elicits the biological response or medicinal response indicated (page 14, para [0045]). However, without a patient population recited in the instant claims, the desired biological or medicinal response is not clear, and thus the term “effective amount” is unclear. Claims 3-4, 10-11, and 13 do not resolve the issue and are therefore also rejected. Appropriate correction is required.
Claim 10 recites multiple instances of parentheses. The phrases within the parentheses are indefinite because they are exemplary language and it is not clear if the contents of the parentheses are required, or just examples of what is required. Stated differently, it is unclear if the compounds must come from the particular supplier, or not. Appropriate correction is required.
Claim 11 recites, “other brain cancers”, “solid tumor”, and “a liquid tumor”, in reference to the diseases or conditions considered treatable by the instant claims. The limitations are not defined by the claim or specification, and they are not known to one of ordinary skill in the art in light of the other diseases and conditions recited in the instant claim. Thus, the scope of the terms are indefinite and unclear. Appropriate correction is required.
Claim Rejection 101 and 112 – Use Claims
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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, 3-4, 10-11, and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claimed recitation of an "application" or use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See MPEP § 2173.05(q)/2173.05(p)(II); see also, Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products., Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claims 1, 3-4, 10-11, and 13 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 pre-AIA the applicant regards as the invention. The claims are seeking to limit a product claim according to a “use” without reciting active steps delimiting how this use is actually practiced.
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In the interest of compact prosecution, the claims are currently being interpreted as method claims.
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, 3-4, 10-11, and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one 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 instant specification, while being enabled for treatment of mice inoculated with RPMI-8226 multiple myeloma cells, does not reasonably provide enablement for treating all other diseases and conditions. 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.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples, and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the Invention
The invention is drawn to the use of combinations of Wee1 inhibitors and anti-CD47 antibodies, examples of which are found in paragraphs [0020] and [0021], respectively, to treat diseases and conditions.
Breadth of the Claims
The claims are broadly directed to the use of combinations of Wee1 inhibitors and anti-CD47 antibodies to treat diseases and conditions. The genus of diseases and conditions in the instant application embodies claim 11 and para [0041] of the specification:
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The claims do not recite a subject or a patient population to be treated.
Level of Ordinary Skill in the Art
The artisans using Applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical arts, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
For example, different types of diseases and conditions affect different organs and have different methods of growth and/or harm to the body, and different vulnerabilities. The skill thus depends on the diseases and conditions. There are some diseases where the skill level is high and there are multiple successful therapeutic treatments. The mechanism of action in these situations, however, is not necessarily the same as is alleged for these compounds.
State of the Prior Art and Predictability in the Art
At the time of filing, there were multiple Wee1 inhibitors known in the art, with the most advanced known as AZD1775 (Huang, P. Q. et. al. J. Med. Chem. 2021, 64, 13004-13024), and multiple anti-CD47 antibodies known in the art (Kuar, S. et. al. Antibody Therapeutics. 2020, 3 3, 179-192). The Examiner recognizes the Huang reference does not qualify as prior art under 35 U.S.C. 102(a)(1) and 102(a)(2) because it shares inventors with the instant application and is published within the year grace period; however, it can be used to understand the state of the art at the time of filing. None of the prior art has been shown to have a broad spectrum of treatment of all diseases and conditions of the instant disclosure. Further, there are different types of treatments available for diseases and conditions of the instant claims, such as glioblastoma, including surgery, chemotherapy, biological therapy, and radiation. Not every treatment option is effective for every patient, and for some patients, combinations of the above treatment options are necessary to manage their symptoms. Therefore, the ability to treat diseases and conditions of the instant claims is unpredictable, much less the ability to anticipate which patients are at risk for the diseases and conditions.
For example, the reference Huang above, was identified as the state of the prior art at the time of filing, and discloses the discovery of ZN-c3, a Wee1 inhibitor with balanced potency, ADME, and pharmacokinetic properties (abstract). The Examiner notes ZN-c3 is the same compound as the instant elected species. Huang discloses that Wee1 is present in elevated levels in breast cancer, lung cancer, cervical cancer, head and neck cancer, ovarian cancer, prostate cancer, melanoma, leukemia, glioblastoma, medulloblastoma, and hepatocellular carcinoma, and discloses instances of treatment of lung cancer cell line A427 with ZN-c3.
No other evidence of treating all other diseases and conditions was provided.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Furthermore, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the numerous diseases and conditions claimed herein. That two entire classes of compounds can be used to treat all diseases or conditions disclosed herein embraced by the claims is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all the diseases or conditions by administering the instant claimed combination of compound classes.
Amount of Direction Provided and Working Examples The only direction or guidance present in the instant specification is the listing of diseases and conditions applicant considers as treatable by the claimed combination of compounds and the activity of a single combination of a Wee1 inhibitor and an anti-CD47 antibody in mice inoculated with a multiple myeloma cell line. The specification does not show any examples where compounds or combinations of compounds of the claims were used to treat the full scope of diseases and conditions as set forth in claims, but merely demonstrates that a single combination can treat a multiple myeloma cell line in mice. (See MPEP 2164.02 (“Compliance with enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed… Lack of a working example, however is a factor to be considered, especially in a case involving an unpredictable and undeveloped art”.)
Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases and conditions out of all diseases and conditions would be benefited (treated or cured) and would furthermore then have to determine which of the claimed combinations of compounds in the instant invention would provide treatment of the claimed diseases and conditions.
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.
The specification fails to provide enough support of the broad use of combinations of Wee1 inhibitors and anti-CD47 antibodies to treat diseases and conditions, and a result, necessitates one of skill to perform an exhaustive search for which diseases can be treated by what compounds and combinations of compounds of the invention to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases and conditions can be treated by the compounds and combinations of compounds encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 4, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over
FortySeven, Inc. (WO 2021/076908 A1, cited in the IDS of 8/12/2025, herein after “FortySeven”) and further in view of Zeno Royalties & Milestones, LLC (WO 2019/173082 A1, cited in the IDS of 4/12/2024, herein after “Zeno”) and Pietsch (Pietsch, E. C. et. al. Blood Cancer Journal, 2017, 7, e536). This rejection applies to the expanded species of an additional disease or condition and an additional Wee1 inhibitor.
Determining the scope and contents of the prior art
The reference FortySeven teaches combination therapies for myelodysplastic syndromes and acute myeloid leukemia using an anti-CD47 antibody and a hypomethylating agent (abstract and para [0008]), and further teaches the combination with one or more additional therapeutic agents (page 37, para [00232]), including the Wee1 inhibitor AZD-1775 (adavosertib) (page 45, para [00233]).
The reference Zeno teaches 1,2-dihydro-3H-pyrazolo[3,4-D]pyrimidin-3-one compounds (abstract), and specifically teaches Example 9B (page 70):
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Which is the same compound as the instant elected species recited in claim 3. Example 9B was found to be a Wee1 inhibitor with an IC50 of ≤ 10 nm and is taught to treat a genus of cancers, including an acute leukemia (page 143, claim 25). The Examiner notes that Example 9B is also known in the art as ZN-c3.
The reference Pietsch teaches B6.H12 as an anti-CD47 antibody administered to mice in AML xenograft models with variable results (page 5, Figure 3).
Ascertaining the differences between the prior art and the claims at issue
The reference FortySeven fails to teach an anticipatory embodiment of the combination of Wee1 inhibitor Zn-c3 and of anti-CD47 antibody B6.H12 in treating myelodysplastic syndromes and acute myeloid leukemia.
Zeno fails to teach the addition of an anti-CD47 antibody in combination with the Wee1 inhibitor.
The reference Pietsch fails to teach the addition of a Wee1 inhibitor in combination with the anti-CD47 antibody.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of combinations of Wee1 inhibitors and anti-CD47 antibodies to treat diseases or conditions. An artisan possesses the technical knowledge necessary to make adjustments to the combinations to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said combinations of Wee1 inhibitors and anti-CD47 antibodies to treat diseases or conditions and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (B), it would have been prima facie obvious to one of ordinary skill in the art to substitute the Wee1 inhibitor and anti-CD47 antibody in the treatment of myelodysplastic syndromes and acute myeloid leukemia of FortySeven with the Wee1 inhibitor Example 9B, also known as Zn-c3, of Zeno and the anti-CD47 antibody B6.H12 of Pietsch because they have the same target as the combination of FortySeven, and are thus expected to exhibit similar properties. A skilled artisan would be motivated before the effective filing date to substitute one Wee1 inhibitor for another, and substitute one anti-CD47 antibody for another in an effort to discover additional methods of treatment of myelodysplastic syndromes and acute myeloid leukemia. One of ordinary skill would have readily predicted success of the combination of the Wee1 inhibitor Zn-c3 and the anti-CD47 antibody B6.H12 in treating myelodysplastic syndromes and acute myeloid leukemia in light of the teachings of FortySeven, Zeno, and Pietsch.
Claims 1, 4, 10-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over FortySeven, Inc. (WO 2021/076908 A1, cited in the IDS of 8/12/2025, herein after “FortySeven”) and further in view of Zeno Royalties & Milestones, LLC (WO 2019/173082 A1, cited in the IDS of 4/12/2024, herein after “Zeno”). This rejection applies to the expanded species where the anti-CD47 antibody is magrolimab and the disease or condition is myelodysplastic syndrome or acute myeloid leukemia
Determining the scope and contents of the prior art
The reference FortySeven teaches as disclosed above, and at least those teachings are incorporated herein. Furthermore, FortySeven teaches that the anti-CD47 antibody can be Hu5F9-G4, also known as magrolimab, which helps teach claim 10.
The reference Zeno teaches as disclosed above, and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
The reference FortySeven fails to teach an anticipatory embodiment of the combination of Wee1 inhibitor Zn-c3 and of anti-CD47 antibody magrolimab in treating myelodysplastic syndromes and acute myeloid leukemia.
Zeno fails to teach the addition of an anti-CD47 antibody in combination with the Wee1 inhibitor.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of combinations of Wee1 inhibitors and anti-CD47 antibodies to treat diseases or conditions. An artisan possesses the technical knowledge necessary to make adjustments to the combinations to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said combinations of Wee1 inhibitors and anti-CD47 antibodies to treat diseases or conditions and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (B), it would have been prima facie obvious to one of ordinary skill in the art to substitute the Wee1 inhibitor in the treatment of myelodysplastic syndromes and acute myeloid leukemia of FortySeven with the Wee1 inhibitor Example 9B, also known as Zn-c3, of Zeno because the compounds have the same target, and are thus expected to exhibit similar properties. A skilled artisan would be motivated before the effective filing date to substitute one Wee1 inhibitor for another in an effort to discover additional methods of treatment of myelodysplastic syndromes and acute myeloid leukemia. One of ordinary skill would have readily predicted success of the combination of the Wee1 inhibitor Zn-c3 and the anti-CD47 antibody magrolimab in treating myelodysplastic syndromes and acute myeloid leukemia in light of the teachings of FortySeven and Zeno.
Claims 1, 3-4, 10-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over FortySeven, Inc. (WO 2021/076908 A1, cited in the IDS of 8/12/2025, herein after “FortySeven”). This rejection applies to the expanded species where the Wee1 inhibitor is AZD1775, the anti-CD47 antibody is magrolimab and the disease or condition is myelodysplastic syndrome or acute myeloid leukemia.
Determining the scope and contents of the prior art
The reference FortySeven teaches as disclosed above, and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
The reference FortySeven fails to teach an anticipatory embodiment of the combination of Wee1 inhibitor AZD1775 and of anti-CD47 antibody magrolimab in treating myelodysplastic syndromes and acute myeloid leukemia.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of combinations of Wee1 inhibitors and anti-CD47 antibodies to treat diseases or conditions. An artisan possesses the technical knowledge necessary to make adjustments to the combinations to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said combinations of Wee1 inhibitors and anti-CD47 antibodies to treat diseases or conditions and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to one of ordinary skill in the art to combine the Wee1 inhibitor AZD1775 and the anti-CD47 antibody magrolimab in the treatment of myelodysplastic syndromes and acute myeloid leukemia because FortySeven teaches them as possible combinations in treating hematological cancers, and thus one of ordinary skill would expect the combination to be successful. The artisan would be motivated before the effective filing date of the claimed inventions to test combinations of compounds for the same purpose to improve the overall treatment of myelodysplastic syndromes and acute myeloid leukemia, and wo0uld have readily predicted success in light of the teachings of FortySeven.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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, 3-4, 10-11, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of U.S. Patent No. 11,261,192 B2 (herein after the “’192 Patent”) in view of FortySeven, Inc. (WO 2021/076908 A1, cited in the IDS of 8/12/2025, herein after “FortySeven”) and further in view of Pietsch (Pietsch, E. C. et. al. Blood Cancer Journal, 2017, 7, e536).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 19-21 of the ‘192 Patent recite methods for ameliorating or treating a cancer, inhibiting replication of a malignant growth or tumor, or ameliorating or treating a malignant growth or tumor with compounds of Formula (I):
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,
Which when R2 is
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, where Y is CH, m is 0, and X is a 6-membered monocyclic heterocyclyl substituted with a methyl group, R1 is H, A is a 6-membered monocyclic heteroaryl, and B is a 5-membered monocyclic carbocyclyl substituted with an ethyl group and a hydroxyl group, maps to the elected species of Wee1 inhibitor of instant claim 4, also known as ZN-c3. The claims of the ‘192 Patent fail to teach the combination of the Wee1 inhibitor with an anti-CD47 antibody in the method of treatment; however, the teachings of FortySeven and Peitsch above remedy the deficiencies.
Conclusion
Claims 1, 3-4, 10-11, and 13 are rejected. Claims 5-9 and 12 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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, Clinton Brooks can be reached at 571-270-7682. 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.
/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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