DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 01/15/2026 has been entered. Claims 11, 14, 25, 28, and 33-36 are cancelled. Claims 1-10, 12, 13, 15-24, 26, 27, 29-32, 37, and 38 are pending in this application. Claims 5, 6, 9, 10, 15-21, 29-32, and 37 are withdrawn. Claims 1-4, 7, 8, 12, 13, 22-24, 26, 27, and 38 are currently under examination.
Priority
This application is a 371 of PCT/EP2021/064257 filed on 05/27/2021 and claims foreign priority of PCT/IB2020000507 filed on 05/28/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) 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 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. 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 No. PCT/IB2020000507, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 4, 7, 8, 24, 26, and 27 recite “DNA alkylating agents”, “
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”, “
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”, “bis-chloroethylamine or bisbromoethylamine derivatives such as chlorambucil, norchlorambucil, bendamustin, bromobenzoic mustard or melphalan, Busulfan, N-(2-(2-(2-azidoethoxy)ethoxy)ethyl)-5-(bis(2-chloroethyl)amino )benzofuran-2-carboxamide (MBF) and 4-[Bis-(2-bromoethyl)amino ]benzoic acid”, “
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…
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”, “
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”, “N-(2-(2-(2-azidoethoxy )ethoxy )ethyl)-3-( 4-(bis(2-chloroethyl)amino )phenyl)propanamide (PPM, norchlorambucil-azide ), N-(2-(2-(2-azidoethoxy)ethoxy)ethyl)-4-( 4-(bis(2-chloroethyl)amino )phenyl)butanamide ( chlorambucilazide), 4-( 4-( 4-( ( 5-azi dopentyl)oxy)butyl)piperazin-1-yl)-7-chloroquinoline (Piperaquine-azide)” and/or “busulfan-azide (MsA)”, which are not disclosed or supported by the prior-filed Application No. PCT/IB2020000507. Thus, the priority date of claims 4, 7, 8, 24, 26, and 27 is 05/27/2021.
Election/Restrictions
Applicant's election with traverse of Group I invention (claims 1-10, 12, 13, 22-24, 26, 27, 37, and 38) and species (a specific ligand and its corresponding substituents: claim 24 and the first recited linker; a specific condition: distal embolization) in the reply filed on 01/15/2026 is acknowledged. The traversal is on the ground(s) that “the Groups do make a contribution over the prior including Kahn and all claims should be examined” (p. 10, last para.). This is not found persuasive because "Groups I/II/III are directed to a technical feature: a ligand of the neutrophil extra-cellular traps (NETs). This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Khan et al. (Cancers 11, 1328, p. 1-23, 2019), who teach that that anthracyclines (e.g., epirubicin, daunorubicin, doxorubicin, and idarubicin)… Therefore, the common technical feature of Groups I/II/III cannot be a special technical feature over the prior art”, as set forth no pages 5 to 6 of the Restriction/Election Requirement mailed on 07/15/2025, and the doxorubicin of Khan also reads on claims 5 and 9 of this Application. “Lack of unity of invention may be directly evident “ a priori ,” that is, before considering the claims in relation to any prior art, or may only become apparent “ a posteriori ,” that is, after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.“ (see MPEP § 1850 [R-01.2024], 37 CFR 1.475, II).
Also, Applicant elected ligand genus claim 24, not species. To advance the prosecution, this examiner mapped the elected linker “
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” to a specific ligand “
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(N-(2-(2-(2-azidoethoxy)ethoxy)ethyl)-5-(bis(2-chloroethyl)amino )benzofuran-2-carboxamide, MBF)” and claims read on this specific ligand are searched and examined here. Thus, claims 5, 6, 9, 10, 15-21, 29-32, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Claims 1-4, 7, 8, 12, 13, 22-24, 26, 27, and 38 are currently under examination. The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 1, 3, 4, 7, 24, 26, and 27 are objected to because of the following informalities: In claim 1, change the incorrect recitation “using” (line 2) to “applying” as a proper action; and insert the missing phrase “to a subject in need thereof” immediately after the recitation “(NETs)” (line 3) to identify ae targeting subject population. In claim 3, insert the missing phrase “the group consisting of” immediately after the recitation “selected from” (lines 1 to 2) to comply with Markush group format ending with conjunction “and”. In claim 4, change the incorrect conjunction “and”, which means a combination of 3 recited ligands, to “or”. In claim 7, insert the missing conjunction “or” immediately before the recitation “I” (iodine, last line on page 3; line 7 on page 4); and insert the missing punctuations between definitions of substituents. In claim 24, remove the strikethrough for the number “5” (last line). In claim 26, insert the missing period at the end of the claim. In claim 27, delete one of redundant recitation “4-[Bis-(2-bromoethyl)amino]benzoic acid (BBM)” (lines 3 to 4 and 8). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7, 8, 12, 13, 22-24, 26, 27, and 38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for ameliorating symptoms of or diagnosis of arterial or venous thromboembolism, does not reasonably provide enablement for treatment or prevention of arterial or venous thromboembolism. The term “treating” is defined “As used herein, the terms "treating" or "treatment" refer to both prophylactic or preventive treatment as well as curative or disease modifying treatment, including treatment of subject at risk” in the specification (p. 3, last paragraph). 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 and/or to use the invention commensurate in scope with these claims. Claims 2-4, 7, 8, 13, 22-24, 26, 27, and 38 depend from claim 1.
Applicants claim a method for treatment (encompassing curing or preventing) or prevention of arterial or venous thromboembolism recited in claims 1 and 12. However, no limiting definition of “preventing" or “prevention” is given in the instant Specification. In the absence of a limiting definition by the Applicants, "prevention" as described according to the Institute for International Medical Education (pages 15 and 16), is a preventive measure, such as preserving physical fitness in primary prevention and effective intervention to correct departures from good health in secondary prevention. More specifically, tertiary prevention, which is most relevant as used in the context of the instant invention, "consists of the measures available to reduce or eliminate long-term impairments and disabilities, [and to] minimize suffering caused by existing departures from good health". Thus, the claimed method for treatment or prevention of arterial or venous thromboembolism as interpreted by a skilled practitioner of the medical or pharmaceutical arts would be to reduce for long-term the occurrence of or to eliminate arterial or venous thromboembolism by the method.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The rejected invention is drawn to A method for treatment, prevention or diagnosis of arterial or venous thromboembolism, said method comprising using ligands of the neutrophil extra-cellular traps (NETs), wherein said ligands do not include digoxigenin and distamycin for interventional neuroradiology (claim 1); wherein said prevention comprises the prevention of a condition selected from the group consisting of: distal embolization and pulmonary embolism (claim 12).
Relative skill of those in the art: The relative skill of those in the art is from biomedical field (see the cited reference below).
Breadth of claims: The claim is extremely broad in that it encompasses the treatment (encompassing curing or preventing) or prevention of arterial or venous thromboembolism using the claimed method.
State of the prior art/Predictability or unpredictability of the art: There is no teaching or suggestion in the state of the prior art that application of certain pharmaceutical method can cure or prevent arterial or venous thromboembolism. Laridan et al. (Semin Thromb Hemost 2019; 45:86–93) disclosed that the involvement of NETs in both arterial and venous thrombosis creates the interesting possibility to develop novel therapeutic strategies targeting NETs, to either reduce thrombosis or improve thrombolysis. DNase1 can promote ex vivo stroke thrombus dissolution, providing proof of concept to target NETs as a novel prothrombolytic strategy in ischemic stroke. Treatment with DNase1 alone had no thrombolytic effect on ischemic stroke thrombi. Preclinical and clinical studies investigating these new therapeutic opportunities are now needed to fully understand the efficacy and safety of targeting NETs in thrombosis (page 90, right col., para. 2; page 91, left col., para. 1; right col., para. 2). One of skilled artisan would understand that contemporary treatment or management of arterial or venous thromboembolism is to minimize symptoms of, not to cure or to prevent, arterial or venous thromboembolism.
Amount of guidance/Existence of working examples: It is worth noting that there are no working examples in the instant application to show that the claimed method is effective for curing or preventing arterial or venous thromboembolism as recited in the claim. The exemplary embodiments of the Specification merely present assays: Example 1: Analysis of thrombus material captured by the surfaces; Example 2: Evaluation of the chromatin and platelet binding; Example 3: Evaluation of the effect of the linker on the binding properties of a given ligand on piperaquine; and Example 4: Evaluation of the clot-device detaching time.
Quantity of experimentation: In order to practice the full scope of the invention, one skilled in the art would need to undertake a novel and extensive research program to show that a curative or preventive measure can be achieved after applying the claimed method. Furthermore, one of ordinary skill in the art would need to test a representative number of animals before one of ordinary skill in the art would be able to conclude that any method can be used to cure or to prevent arterial or venous thromboembolism. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of use in curing or preventing arterial or venous thromboembolism, it would constitute an undue and unpredictable experimental burden.
Lack of a working example is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP § 2164. Genetech, 108 F.3d at 1366, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent 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 as discussed above, including the amount of guidance provided and the predictability of the art and the lack of working examples to practice the full scope of the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 7 and 8 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.
Regarding claims 7 and 8, the phrase "such as" (line 1 on page 4; line 3 of claim 8) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). To advance prosecution, the broadest recitation before the “such as” is examined.
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.
Claims 1-4, 12, 13, and 38 are rejected under 35 U.S.C. 102(1) as being anticipated by Jiménez-Alcázar et al. (Science 358, 1202–1206, 2017, hereinafter referred to as Jim ‘2017).
With regard to structural limitations “a method for ameliorating symptoms of or diagnosis of arterial or venous thromboembolism (or distal embolization or pulmonary embolism), said method comprising applying ligands (or DNA ligands, histone ligands, intercalating ligands, or groove-binding ligands; or adapted for adhesion to or removal of a thrombus; or used in a field other than interventional neuroradiology) of the neutrophil extra-cellular traps (NETs) (or within a thrombus) to a subject in need thereof, wherein said ligands do not include digoxigenin and distamycin for interventional neuroradiology (exemplified as thrombectomy intervention in the specification)” (claims 1-4, 12, 13, and 38):
Jim ‘2017 disclosed a noncanonical mechanism for vascular occlusion based on neutrophil extracellular traps (NETs). Two deoxyribonucleases (DNases), DNase1 and DNase1-like 3, degraded NETs in circulation during sterile neutrophilia and septicemia. In the absence of both DNases, intravascular NETs formed clots that obstructed blood vessels and caused organ damage. Vascular occlusions in patients with severe bacterial infections were associated with a defect to degrade NETs ex vivo and the formation of intravascular NET clots. DNase1 and DNase1-like 3 are independently expressed and thus provide dual host protection against deleterious effects of intravascular NETs. Fig. 3. DNase1 and DNase1L3 prevent vascular occlusion by NET clots during chronic neutrophilia. Histological analysis of D1–/– D1l3–/– mice coexpressing Csf3, which triggers neutrophilia, with D1 (Csf3/D1, N = 4), D1l3 (Csf3/D1l3, N = 4), or a control plasmid (Csf3/Ctrl, N = 4). (A) Hematoxylin and eosin (H&E) stains of lungs. Blood vessel of D1–/– D1l3–/– mouse coexpressing Csf3 with Ctrl shows a hematoxylin-rich clot (asterisk) with entrapped erythrocytes (black arrow) and few leukocyte nuclei (white arrow). (B) Quantification of blood vessels in lungs occluded by hematoxylin-positive clots per FOV. Baseline WTmice (BLWT, N = 4), baseline D1–/– D1l3–/ mice (BL, N = 4). (C) Immunostaining of occluded blood vessels for chromatin and the neutrophil marker myeloperoxidase (MPO). (D and E) Immunostaining for von Willebrand factor (vWF), fibrin, and DNA. (F) Survival of D1–/– D1l3–/ mice expressing Csf3 treated with immunoglobulin G (IgG) (N = 4), antiplatelet-IgG (anti-Plt–IgG) (N = 5), and dabigatran, an anticoalgulant (N = 5). (C) to (E) Dotted line indicates vessel wall.
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. Observation of a robust staining with fluorescent double-stranded DNA–intercalating dyes and antibodies against chromatin (fig. S3A). The colocalization of decondensed chromatin with the neutrophil granule-derived enzyme myeloperoxidase, antimicrobial cathelicidin peptides, and the NET surrogate markers citrullinated histones confirmed that the clots were composed of NETs (Fig. 3C and fig. S3, B and C) (page 1/28, Abstract; page 2/28, right col., para. 1; page 3/28, Fig. 3 and right col., para. 1; page 17/28, Fig. S3). Immunofluorescence stainings: Sections were incubated with anti-rabbit and anti-mouse IgG antibodies conjugated with Alexa Fluor 488 or Alexa Fluor 555 for 1 hour. After washing, DNA was labeled with 1 μg/ml DAPI (=
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) for 2 minutes (page 12/28, last para. to page 13/28, para. 1).
Thus, these teachings of Jim ‘2017 anticipate Applicant’s claims 1-4, 12, 13, and 38.
Claim Rejections - 35 USC § 103
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, 7, 8, 12, 13, 22-24, 26, 27, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Jiménez-Alcázar et al. (Science 358, 1202–1206, 2017, hereinafter referred to as Jim ‘2017) in view of Baraldi et al. (US 2004/0259799, Dec. 23, 2004, hereinafter referred to as Baraldi ‘799) and Park et al. (WO 2019/008441, January 10, 2019, hereinafter referred to as Park ‘441). Claims 1-4, 12, 13, and 38 are rejected here because they have been rejected by the primary reference under 102 above. The above disclosure of Jim ‘2017 is thus incorporated in its entirety here.
Jim ‘2017 did not explicitly disclose the limitations “said ligands of DNA alkylating agents have the general structure:
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(or N-(2-(2-(2-azidoethoxy)ethoxy)ethyl)-5-(bis(2-chloroethyl)amino )benzofuran-2-carboxamide (MBF =
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); or derivatized with a suitable linker:
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or
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)”, required by claims 7, 8, 22-24, 26, and 27.
Baraldi ‘799 disclosed numerous DNA-binding molecules: Benzoheterocyclic derivatives of distamycin A in which the pyrrole rings have been replaced by aromatic benzoheterocyclic rings and in which the formyl group has been replaced by an alkylating unit, of the general formula (IV):
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in which T is selected from the group cons1stmg of 4-[(ZCH2CH2)2N]C6H4CONH, (ZCH2CH2)2N, and CH2=CZCONH; Z is selected from the group consisting of F, Cl, Br and I; A is selected from the group consisting of O, S and NR1; B is CH or N. Compound 3:
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. Compound 4:
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(pages 2/8 to 3/8, [0003 and 0029-0035]; page 5/8, [0054-0057]).
Park ‘441 disclosed a need for improved linkers useful for preparing Antibody-drug conjugates (ADCs). In alternative embodiments, the linking unit comprises a reactive functional group capable of participating in a click chemical reaction. For example, azide-acetylene click chemistry may afford a triazole moiety in high yield. Preparation of compound Int-TG2-1:
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. Duocarmycins bind to the minor groove of DNA and alkylate the nucleobase adenine at the N3 position.
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. Preparation of ligand-drug conjugate compound C-6:
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(page 2/316, line 14; page 46/316, lines 19-28; page 140/316, lines 1-5; page 87/316, lines 5-7; page 39/316, line 3; page 247/316, lines 1-5).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the DNA-binding DAPI as taught by Jim ‘2017 with another DNA-binding moiety
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linked with
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via amide linkage for preparing click chemistry in view of Baraldi ‘799 and Park ‘441 to improve multiple functionalities of the drug-target conjugate, described above. Therefore, one of skill in the art would have a reasonable expectation that by substituting the DNA-binding DAPI as taught by Jim ‘2017 with another DNA-binding moiety
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linked with
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via amide linkage for preparing click chemistry in view of Baraldi ‘799 and Park ‘441, one would achieve Applicant’s claims 1-4, 7, 8, 12, 13, 22-24, 26, 27, and 38. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I]. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 [R-01.2024] [II.A].
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691