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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 June 2026 has been entered.
Status of Application, Amendments and/or Claims
The amendment and Applicant's arguments, filed 09 June 2026, have been entered in full. Claims 2, 4, 6, 7, 10-17, 19 and 22 are canceled. Claims 1 and 3 are amended. Claims 1, 3, 5, 8, 9, 18, 20, 21 and 23 are under examination.
Withdrawn Objections And/Or Rejections
The rejection to claims 1, 3-6, 8, 9, 18, 20, 21 and 23 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description, new matter, as set forth at pages 7-8 of the previous Office Action (09 March 2026), is withdrawn in view of the amendment (09 June 2026).
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5, 8, 9, 18, 20, 21 and 23 remain 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 claim(s) contains 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 make and/or use the invention.
The basis for this rejection is set forth at pages 2-6 of the previous Office Action (09 March 2026).
APPLICANT’S ARGUMENTS: Applicant argues that the standard for determining whether the specification meets the enablement requirement is whether any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Applicant argues that the Office Action maintains the instant disclosure fails to specifically teach direct contact with a cancerous tumor or endothelial cells. Applicant maintains that the instant specification discloses direct contact with a cancerous tumor or endothelial cells.
Applicant cites the instant specification at paragraphs 0072-0073. Applicant asserts that a skilled artisan, in light of the instant disclosure, would be readily enabled to directly target a cancerous tumor expressing inhibin or endothelial cells using any of the various disclosed methods, or using other acceptable methods known to those of ordinary skill in the art and would not require undue experimentation.
Applicant argues that the Office Action asserts that the in vitro assay data in Figure 25 is irrelevant to the in vivo route-of-administration question. Applicant notes that this characterization overstates the evidentiary burden. Applicant states Figure 25 establishes the biological principle: that an anti-a-inhibin antibody suppresses tumor-produced inhibin's stimulation of endothelial cell angiogenesis. Applicant asserts that the question of how to deliver the antibody to a tumor is a matter of pharmacological technique, not experimental discovery. Applicant notes enablement does not require the specification to repeat what is known to the skilled artisan See, e.g., Streck, Inc. V. Research & Diagnostic Sys., Inc., 665 F.3d 1269, 1285 (Fed. Cir. 2012); Falko-Gunter Falkner V. Inglis, 448 F.3d 1357, 1367 (Fed. Cir. 2006).
Lastly, Applicant argues that solely to advance prosecution, Claim 1 is amended to recite wherein the cancerous tumor that expresses inhibin is selected from a group consisting of an ovarian cancer tumor, a prostate cancer tumor, a renal cancer tumor, a lung cancer tumor, a gastric cancer tumor, or and a breast cancer tumor.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. The Examiner notes that Applicant cites paragraphs 0072-0073 of the specification, but the instant claims still fail to recite a particular route of administering the composition.
2. Regarding Applicant’s argument that the Office Action asserts that the in vitro assay data in Figure 25 is irrelevant to the in vivo route-of-administration and that this characterization overstates the evidentiary burden:
The Examiner has copied the section from the previous Office Action.
“Applicant directs the Examiner's attention to Figure 25. However, the employed assay is an in vitro assay for discerning angiogenesis. The enablement issue IS NOT whether the anti-alpha inhibin antibody has the biological function of reducing angiogenesis. The enablement issues IS regarding the route of in vivo administration. The angiogenesis assay does not correlate with contacting directly an environment that comprises cancerous tumors within or adjacent to endothelial cells, with a composition comprising an anti-alpha-inhibin antibody, wherein the cancerous tumors express inhibin in a living subject. One skilled in the art would not accept the specification's in vitro assay as reasonably correlating to the claimed method of delivering the antibody composition in vivo..”.
Thus, it was never stated that “the in vitro assay data in Figure 25 is irrelevant to the in vivo route-of-administration”.
3. Regarding Applicant’s argument that the question of how to deliver the antibody to a tumor is a matter of pharmacological technique, not experimental discovery and that enablement does not require the specification to repeat what is known to the skilled artisan.
The Examiner notes MPEP 2164.03: the “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.
The specification need not contain Examples if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. Lack of a working Example(s), however is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. If little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention to be enabling.
In the instant case, the specification teaches (and as cited by Applicant paragraphs 0072-0073):
[0072] In one embodiment, an inhibition agent can be provided in pharmaceutically acceptable formulations using formulation methods known to those of ordinary skill in the art. These formulations can generally be targeted to endothelial cells by standard routes. For example, the formulations may be administered in one embodiment directly to endothelium and/or to a tumor associated with the endothelium, for instance through exposure of the tissue and direct application thereto, or via direct injection of the formulation to the targeted tissue. In other embodiments, however, the formulations may be administered indirectly to the targeted tissue, e.g., via systemic administration.
[0073] The composition can be delivered intravenously in a systemic delivery protocol. For example, osmotic mini pumps may be used to provide controlled delivery of high concentrations of the treatment agents through cannulae to the site of interest, such as directly into a tumor.
The Examiner does not understand a method comprising “exposure of the tissue and direct application thereto” (see paragraph 0072). What do the method steps entail to carry out this particular procedure?
The specification teaches direct injection of the formulation to the targeted tissue (see paragraph 0072). The Examiner notes that the specification states using osmotic mini pumps to provide delivery of the composition through cannulae to the site of interest, such as directly into a tumor (see paragraph 0073). The specification teaches the protocol of “using osmotic mini pumps” as a systemic protocol to deliver agents directly into a tumor on one hand (see paragraph 0073), but also states that “formulations may be administered indirectly to the targeted tissue, e.g., via systemic administration” (see last sentence of paragraph 0072) (emphasis added by the Examiner). Thus, there is confusion as to whether the mini osmotic pumps are actually a form of direct delivery.
There is no actual teaching of directly applying the composition to a cancerous tumor. For example, how does one apply the recited composition directly to a kidney with a renal cancer tumor.
4. The Examiner directs Applicant’s attention to the prosecution history of this instant case wherein Groome et al. (WO 01/29079; published 4/26/01) was applied as prior art.
Groome et al. teach anti-alpha-inhibin antibodies. Groome et al. teach that the anti-alpha-inhibin antibody can be administered for the treatment of ovarian cancer, testicular cancer, pituitary cancer, uterine cancer, breast cancer and prostate cancer. Groome et al. teach that the pharmaceutical comprising said antibodies include intra-dermal, intraocular, intra-articular and topical administration (page 61, lines 19-20 and page 62, lines 6-15). Groome et al. teach pharmaceutical forms include transdermal patches and that the forms may also include injecting or implanting controlled releasing devices. Groome et al. teach that controlled release of the agents using hydrophobic polymers, polymer matrices, liposomes and/or microspheres (page 61, lines 19-20 and page 62, lines 5).
However, Applicant(s) argued in the prosecution history that Groome et al. failed to teach delivering (or targeting) the composition directly to a cancerous tumor that expresses inhibin and to endothelial cells. Applicant(s) argued in the prosecution history that Groome’s teachings of delivering anti-alpha-inhibin antibodies via intra-dermal, topical administration, transdermal patches, injecting or implanting controlled releasing devices, do not anticipate or make obvious the instant invention.
5. Lastly, the Examiner notes that while the instant specification does not have Written Description support for methods employing “intratumoral” delivery, the Munoz reference is being submitted.
The Munoz reference documents the unpredictability of intratumoral delivery. Munoz et al. teach that while placing a needle using image guidance into a target lesion is often straightforward, ensuring that the injected therapy is distributed throughout the target lesion without leakage into the surrounding tissue is not. Munoz et al. teach that substantial variations in drug deposition accuracy can occur within the same cancer histology, the same organ and even the same patient. Munoz et al. teach that these deficiencies in drug delivery may result in ineffective immune activation within the target lesion because of insufficient on-target deposition, and they may result in organ injury and systemic immune toxicities due to off-target leakage. Munoz et al. teach that it is entirely plausible the lack of clinical response in a clinical intratumoral immunotherapy trial may be a reflection of delivery failure rather than drug ineffectiveness (pages 1-2 and Figure 1). Munoz et al. teach several variables that affect intratumoral drug delivery. These include the stromal composition of the tumor, the organ in which it resides, the design of the injection needle and the rate at which the drug is injected (page 5, Discussion, see also Figure 5). Munoz et al. teach that intratumoral immunotherapy is a burgeoning paradigm in immuno-oncology with the potential to substantially increase the impact of immunotherapy across the cancer spectrum. Munoz et al. teach that while a tremendous degree of creativity has been applied towards the development of novel intratumoral immunotherapy agents, it is also critical to ensure that these therapies are delivered into the target lesions accurately (Munoz NM, et al. Influence of injection technique, drug formulation and tumor microenvironment on intratumoral immunotherapy delivery and efficacy. J Immunother Cancer Volume 9, pages 1-9; 2021).
The Examiner maintains that there is an inherent unpredictability regarding the claimed invention and the specification fails to provide guidance and teach working Examples. The skilled artisan would not know how to use the invention. The scientific reasoning and evidence as a whole indicates that the enablement rejection should be maintained.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Rejections-35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
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, 5, 8, 9, 18, 20, 21 and 23 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.
The instant claims are indefinite because of the following reasons:
1. Claim 1 is indefinite because of the recitation, “A method comprising targeting a cancerous tumor that expresses inhibin or endothelial cells….wherein the step of targeting the cancerous tumor or the endothelial cells includes direct application of the composition to the cancerous tumor and to the endothelium.
It is understood that the composition is being targeted to a cancerous tumor that expresses inhibin.
It is unclear what is meant by “or endothelial cells..” because the limitation reads on targeting endothelial cells that are not cancerous and/or do not express inhibin. This begs the question of why non-cancerous cells (i.e. the endothelial cells) are being targeted.
Additionally, the claim is unclear because it recites the limitation, “..direct application of the composition to the cancerous tumor and to the endothelium”. Once again, if only cancerous tumors that expresses inhibin are being targeted, why is the composition also being directly applied to the endothelium. See also claim 18 for the same issue.
The metes and bounds of claims 1 and 18 cannot be determined. Claims 3, 5, 8, 9, 20 and 21 are included in this rejection because they depend from claim 1 and do not resolve the issues discussed above.
2. Claim 1 is indefinite because a broad limitation together with a narrow limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation, “targeting a cancerous tumor that expresses inhibin or endothelial cells with a composition comprising an anti-a-inhibin antibody directly..” (see lines 2-3), and the claim also recites “..wherein the step of targeting the cancerous tumor or the endothelial cells includes direct application of the composition to the cancerous tumor and to the endothelium…” which is the narrower statement of the range/limitation.
See MPEP 211.03 Transitional Phrases: The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004).
The instant claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 3, 5, 8, 9, 18, 20, 21 and 23 are included in this rejection because they depend from claim 1 and do not resolve the issues discussed above.
3. Claim 1 is indefinite because of the limitations “directly” and “includes direct application”. The instant specification teaches the following:
[0072] In one embodiment, an inhibition agent can be provided in pharmaceutically acceptable formulations using formulation methods known to those of ordinary skill in the art. These formulations can generally be targeted to endothelial cells by standard routes. For example, the formulations may be administered in one embodiment directly to endothelium and/or to a tumor associated with the endothelium, for instance through exposure of the tissue and direct application thereto, or via direct injection of the formulation to the targeted tissue. In other embodiments, however, the formulations may be administered indirectly to the targeted tissue, e.g., via systemic administration. [0073] The composition can be delivered intravenously in a systemic delivery protocol. For example, osmotic mini pumps may be used to provide controlled delivery of high concentrations of the treatment agents through cannulae to the site of interest, such as directly into a tumor.
The specification fails to teach if the claim limitations “directly” and “includes direct application” mean that the composition is being applied “through exposure of the tissue and direct application thereto”. However, if this is the definition, the claim is still indefinite because it is unclear what the method step of “through exposure of the tissue and direct application thereto” entails and the specification fails to teach the steps.
The specification fails to teach if the claim limitations “directly” and “includes direct application” means that the composition is being applied “via direct injection of the formulation to the targeted tissue”. However, if this is the definition, the claim is still indefinite because “direct injection of the formulation to the targeted tissue” also reads on using osmotic mini pumps to provide delivery of the composition through cannulae to the site of interest, such as directly into a tumor. The specification teaches the osmotic mini pump protocol, as a systemic protocol (see paragraph 0073).
The metes and bounds of claim 1 cannot be determined. Claims 3, 5, 8, 9, 18, 20, 21 and 23 are included in this rejection because they depend from claim 1 and do not resolve the issues discussed above.
4. Claim 5 is indefinite because it depends from a canceled claim (see MPEP 608.01 (n)(V)). Therefore, the metes and bounds of claim 5 cannot be determined.
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, 5, 8, 9, 18, 20 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 9, 13-16, 18 and 19 of copending Application No. 18/700,754 in view of Groome et al. (Reference of record, WO 01/29079; published 4/26/01), Yan et al. (Reference of record, US 2009/0226441; published September 10, 2009), Theuer et al. (Reference of record, US 2011/0076263; published March 31, 2011) and Marrichi et al. (Reference of record, US 2013/0096280, published 4/18/13) as evidenced by Groome et al. (Journal of Immunological Methods Volume 165:167-176, 1993).
The instant claims are drawn to a method comprising targeting a cancerous tumor that expresses inhibin or endothelial cells with a composition comprising an anti-alpha-inhibin antibody directly, further comprising delivering an antibody that specifically binds an activin receptor-like kinase and/or endoglin to the cancerous tumor or the endothelial cells, wherein the step of targeting the cancerous tumor or the endothelial cells includes direct application of the composition to the cancerous tumor and to the endothelium, wherein following the targeting by the composition, paracrine activity of endothelial cells of the endothelium is reduced, thereby reducing angiogenesis in the endothelium, wherein the cancerous tumor is selected from a group consisting of an ovarian cancer tumor, a prostate cancer tumor, a renal cancer tumor, a lung cancer tumor, a gastric cancer tumor, and a breast cancer tumor.
The claims are further drawn to wherein the composition targets the cancerous tumor that expresses the alpha subunit of inhibin. The claims are further drawn to wherein the ovarian cancer tumor is an endometrial cancer tumor, a serous cancer tumor, or a mucinous cancer tumor. The claims are further drawn to wherein the delivery comprises sustained-release delivery of the anti-alpha-inhibin antibody directly to the cancerous tumor and to the endothelium, wherein the composition is delivered by use of a hydrogel delivery vehicle and wherein the cancerous tumor is within or adjacent to an endothelium of a subject.
The claims of copending Application No. 18/700,754 teach a method of reducing metastasis and/or tumor growth and/or changes in the vasculature in a subject with cancer comprising administering an effective amount of an inhibin antibody to the subject with cancer. The claims further teach wherein the cancer is selected from the group consisting of breast cancer, gynecological cancer, prostate, melanoma, squamous cell carcinoma, bladder cancer, lung cancer, testicular cancer, kidney cancer, colorectal cancer, and head and neck cancer. The claims further teach administering an anti-angiogenic. The claims further teach wherein the tumor growth is hypoxia induced tumor growth, wherein the method is for reducing metastasis, wherein the method is for reducing tumor growth and wherein the method is for changing vasculature. The claims further teach wherein the subject is human.
The claims of copending Application No. 18/700,754 further teach wherein the inhibin antibody is anti-inhibin R1 antibody.
Anti-inhibin R1 antibody is an antibody that binds to the alpha subunit of inhibin as evidenced by Groome et al. (page 168, right column, last full paragraph)(Groome et al. Immunoassays for inhibin and its subunits. Further applications of the synthetic peptide approach. Journal of Immunological Methods Volume 165:167-176, 1993).
MPEP 804 II B1. Nonstatutory Double Patenting teaches: Those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438,441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference' s claim(s) to a compound, the examiner should consider the reference' s specification, including all of the compound' s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02”.
In the instant case, the specification of copending Application No. 18/700,754 teaches administering to include:
“injection (e.g., subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal), by continuous intravenous infusion, cutaneously, dermally, transdermally, orally (e.g., tablet, pill, liquid medicine, edible film strip), by implanted osmotic pumps, by suppository, or by aerosol spray. Routes of administration include, but are not limited to, topical, intradermal, intrathecal, intralesional, intra-tumoral, intra-bladder, intravaginal, intra-ocular, intrarectal, intrapulmonary, intracranial, intraventricular, intraspinal, dermal, subdermal, intra-articular, placement within cavities of the body, nasal inhalation, pulmonary inhalation, impression into skin, and electroporation” (para 0066).
The claims of copending Application No. 18/700,754 do not teach that the cancerous tumors express the alpha subunit of inhibin or that the gynecological cancer is ovarian cancer tumor such as endometrial cancer tumor, a serous cancer tumor, or a mucinous cancer tumor.
The claims of copending Application No. 18/700,754 do not teach administering an antibody that specifically binds an activin receptor-like kinase and/or endoglin, sustained-release delivery or delivery by use of a hydrogel delivery vehicle.
Groome et al. teach immuno-interactive fragments of the alpha-subunit of inhibin for producing antigen-binding molecules (abstract and pages 1 and 12). Groome et al. teach antigen-binding molecules to include immunoglobulins that have affinity for the target antigen (page 10 and page 53-page 55, line 23). Groome et al. teach that the antigen-binding molecules of the invention can be used for the treatment of conditions associated with aberrant levels of inhibin (abstract and pages 1, 7 and 19). Groome et al. teach that conditions associated with an aberrant concentration of inhibin includes ovarian cancer, breast cancer and prostate cancer. Groome et al. teach ovarian cancer to include serous, mucinous, granulosa cell tumor (pages 10 and 14). Groome et al. teach that pharmaceuticals comprising the anti-alpha inhibin antibody are suitable for intra-dermal, intraocular, intra-articular and topical administration (page 61, lines 19-20 and page 62, lines 6-15). Groome et al. teach pharmaceutical forms include transdermal patches and that the forms may also include injecting or implanting controlled releasing devices. Groome et al. teach that controlled release of the agents using hydrophobic polymers, polymer matrices, liposomes and/or microspheres (page 61, lines 19-20 and page 62, lines 5).
Yan et al. teach methods and compositions for treating disorders associated with angiogenesis using activin receptor-like kinase (ALK-1) antagonists (abstract and para 0010). Yan et al. teach ALK-1 antagonist to include antibodies that bind ALK-1. Yan et al. teach that anti-angiogenic therapy in relationship to cancer is a cancer treatment strategy that is aimed at inhibiting the development of tumor blood vessels required for providing nutrients to support tumor growth (paras 0016, 0017, 0099, 0267 and claims).
Theuer et al. teach antibodies that specifically bind and block the activity of endoglin for the treatment of diseases/conditions associated with endoglin, angiogenesis and/or a combination thereof (abstract). Theuer et al. teach that endoglin is also known as CD105 and is expressed in endothelial cells (paras 0002, 0007 and 0459). Theuer et al. teach that anti-endoglin antibodies can be used to treat various types of cancers such as tumors in ovaries (paras 0109 and 0216).
Marrichi et al. et al. teach methods of recombinantly producing antibodies (abstract, paras 0003, 0012 and 0017). Marrichi et al. teach recombinant antibodies to include anti-inhibin (para 0076, line 11). Marrichi et al. et al. teach sustained- release preparations comprising the antibodies. Marrichi et al. teach suitable examples of sustained-release preparations include semipermeable matrices of solid hydrophobic polymers containing the antibody, which matrices are in the form of shaped articles, e.g., films, or microcapsule. Examples of sustained-release matrices include hydrogels (para 0325).
It would have been obvious for one of ordinary skill in the art before the effective filing date to modify a method of reducing metastasis and/or tumor growth and/or changes in the vasculature in a subject with cancer comprising administering an effective amount of an alpha-inhibin antibody and an anti-angiogenic to the subject, wherein the cancer is selected from the group consisting of breast cancer, gynecological cancer, prostate cancer, lung cancer and kidney cancer, as taught by the claims of copending Application No. 18/700,754, wherein the gynecological cancer is ovarian cancer tumor such as endometrial cancer tumor, a serous cancer tumor, or a mucinous cancer tumor, as taught by Groome et al., wherein the anti-angiogenics are an antibody that specifically binds an activin receptor-like kinase and an antibody that specifically binds endoglin, as taught by Yan and Theuer, respectively, and wherein the delivery of the antibodies is by use of a hydrogel delivery vehicle, as taught by Marrichi et al., to make the instant invention. One of ordinary skill in the art before the effective filing date, would have been motivated to modify the method and expect success for the following reasons:
The instant claims and the claims of copending Application No. 18/700,754 both teach administering an anti-alpha-inhibin antibody to a subject with a gynecological cancer, prostate cancer, renal cancer, lung cancer and breast cancer. Anti-inhibin R1 antibody, as taught in the claims of copending Application No. 18/700,754, is an antibody that binds to the alpha-subunit of inhibin as evidenced by Groome et al.
Endothelium is the membrane that lines the interior surface of blood vessels. The claims of copending Application No. 18/700,754 and Groome et al. teach administration that encompasses direct application of the antibody to a cancerous tumor that is within or adjacent to the endothelium of a subject.
Yan and Theuer teach anti-activin receptor-like kinase antibodies and anti-endoglin antibodies, as anti-angiogenics that can be employed to treat cancer. Both Groome and Marrichi et al. teach anti-inhibin antibodies in preparations comprising hydrophobic polymers for sustained-release delivery. Marrichi et al. teach hydrophobic polymers comprising hydrogels.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/R.M.D/Examiner, Art Unit 1647 6/24/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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