DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a national stage entry of PCT/US2021/045706 filed on 08/12/2021 which claims priority to U.S. Provisional Application No. 63/066,709 filed on 08/17/2020.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 13 and new claims 15 and 16) drawn to a method for treating an angiogenesis-dependent disease or condition in a subject, comprising administering to the subject in need thereof a therapeutically effective amount of a compound of Formula I, II or III in the reply filed on January 20, 2026 is acknowledged. Applicant’s election without traverse of wet age-related macular degeneration as a species of an angiogenesis-dependent disease or condition and compound C47 as a species of a compound of Formula I, II or III in the reply filed on January 20, 2026 is also acknowledged.
It is noted that Applicant’s elected species of C47 cannot be found anywhere in the instant specification. However, since Applicant states that claim 13 reads on the elected species, it is presumed that the compound in claim 13 which is identified as compound C74 in the instant specification (pages 15-16) is the intended elected species. Thus the claims are being examined as they read on compound C74 as a species of a compound of Formula I, II or III.
Claims 3-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claim 14 is canceled.
Claims 1, 2, 13, 15 and 16 are being examined as they read on the elected species.
Drawings Objection
The drawings are objected to because the figures are not clear with low resolution and some are illegible and too small. All of the figures should be resubmitted in larger, clear and legible text. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 2, 13, 15 and 16 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 2, 13, 15 and 16 of the instant application as they read on the elected species claim a method for treating wet age-related macular degeneration in a subject, comprising administering to the subject in need thereof a therapeutically effective amount of compound C74 having the following structure:
PNG
media_image1.png
188
230
media_image1.png
Greyscale
.
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the breadth of the claims, the lack of sufficient working examples, insufficient guidance of the specification and the lack of predictability in the art.
With respect to the breadth of the claims, claims 1 and 13 of the instant application are drawn to the treatment of any angiogenesis-dependent disease or condition in a subject, which includes thousands of diseases including diseases of the retina such as wet age-related macular degeneration as well the treatment of thousands of cancer types. Furthermore, claims 1, 2 and 15 are also drawn to the use of thousands of compounds of Formula I, II or III. Thus, the rejected claims are extremely broad as they encompass the use of thousands of compounds for the treatment of thousands of diseases or conditions.
In the instant specification, Applicant teaches that angiogenesis-dependent diseases or conditions include ocular diseases or conditions including proliferative diabetic retinopathy (PDR), wet age-related macular degeneration (AMD), retinopathy of prematurity (ROP), or angiogenesis-associated with eye injuries; as well as cancer including renal cell carcinoma (e.g., clear cell renal cell carcinoma), brain cancer and breast cancer (page 16). The examples of the instant specification demonstrate that Pfn1 expression in renal cell carcinoma is a marker for poor prognosis and is overexpressed in tumor-associated vascular endothelial cells (TA-VEC) (page 21). Applicant further demonstrates that C74 which inhibits Pfn1’s effect on actin polymerization reduces migration and proliferation of certain renal cell cancer cells in vitro and in vivo (pages 23-24). Applicant further states that they have demonstrated the antiangiogenic effect of compound C74 targeting Pfn1-actin interaction in the settings of retinal and sub-retinal (choroidal) NV (Fig. 8). Applicant states that this data supports Pfn1-dependency for neovascularization and provide a strong scientific premise for the inhibition of the Pfn1-actin interaction to address diseases of aberrant angiogenesis in the eye (page 25). Thus Applicant’s data shows that C74 may be able to inhibit actin polymerization which may lead to reduction in angiogenesis. Thus Applicant’s data represent preliminary data which demonstrates that C74 may influence the angiogenesis pathway. However, no further data is presented demonstrating that this preliminary data will lead to any practical advantage in the treatment of any claimed disease or disorder.
The claims of the instant application are drawn to a method for treating any angiogenesis-dependent disease or condition in a subject such as wet age-related macular degeneration in a subject, comprising administering to the subject in need thereof a therapeutically effective amount of a compound of formula I, II, or III such as a compound C74. There is no disclosure and no working examples demonstrating the administration of any compound to any subject for the treatment of wet age-related macular degeneration or any other angiogenesis-dependent disease or condition and thus the instant specification does not provide any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application.
Moreover, it is noted that the claims encompass the use of thousands of compounds of formula I, II, or III. However, the instant specification only provides evidence that Applicant was in possession of one compound (C74), and the specification does not provide any evidence that Applicant was in possession of any other compound or that any other compounds as claimed exist.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.") Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus, since Applicant has not provided any evidence of possession of the claimed method for treating wet age-related macular degeneration or any other angiogenesis-dependent disease or condition in a subject in need thereof comprising administering C74 or any other compound of formula I, II or III, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Thus the claims of the instant application are not supported by the instant specification and thus a rejection under 35 USC 112 (a) for failing to comply with the written description requirement is proper.
Claims 1, 2, 13, 15 and 16 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 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 specification does not provide sufficient information to show that wet age-related macular degeneration can be treated comprising the administration of C74 as claimed.
The instant specification fails to provide information that would allow the skilled artisan to practice the instant invention without undue experimentation. Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art, the relative skill of those in the art, and the amount 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: Claims 1, 2, 13, 15 and 16 of the instant application as they read on the elected species claim a method for treating wet age-related macular degeneration in a subject, comprising administering to the subject in need thereof a therapeutically effective amount of compound C74 having the following structure:
PNG
media_image1.png
188
230
media_image1.png
Greyscale
.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Claims 1 and 13 of the instant application are drawn to the treatment of any angiogenesis-dependent disease or condition in a subject, which includes thousands of diseases including diseases of the retina such as wet age-related macular degeneration as well the treatment of thousands of cancer types. Furthermore, claims 1, 2 and 15 are also drawn to the use of thousands of compounds of Formula I, II or III. Thus, the rejected claims are extremely broad as they encompass the use of thousands of compounds for the treatment of thousands of diseases or conditions.
Guidance of the Specification/Working Examples: In the instant specification, the examples demonstrate that Pfn1 expression in renal cell carcinoma is a marker for poor prognosis and is overexpressed in tumor-associated vascular endothelial cells (TA-VEC) (page 21). Applicant further demonstrates that C74 which inhibits Pfn1’s effect on actin polymerization reduces migration and proliferation of certain renal cell cancer cells in vitro and in vivo (pages 23-24). Applicant further states that they have demonstrated the antiangiogenic effect of compound C74 targeting Pfnl-actin interaction in the settings of retinal and sub-retinal (choroidal) NV (Fig. 8). Applicant states that this data supports Pfn1-dependency for neovascularization and provide a strong scientific premise for the inhibition of the Pfn1-actin interaction to address diseases of aberrant angiogenesis in the eye (page 25). Thus Applicant’s data shows that C74 may be able to inhibit actin polymerization which may lead to reduction in angiogenesis. Thus Applicant’s data represent preliminary data which demonstrates that C74 may influence the angiogenesis pathway. However, no further data is presented demonstrating that this preliminary data will lead to any practical advantage in the treatment of any claimed disease or disorder. There are no working examples demonstrating the administration of any compound to any subject for the treatment of wet age-related macular degeneration or any other angiogenesis-dependent disease or condition. Thus Applicant’s data is merely speculative and does not provide any evidence that the claimed compounds will indeed lead to any effective treatment of any of the claimed diseases and conditions.
Thus, the specification fails to provide evidence in sufficient support for the use of C74 or any other compound of formula I, II or III in the treatment of wet age-related macular degeneration or any other angiogenesis-dependent disease or condition as recited in the instant claims.
State of the Art: Prior to the effective filing date of the claimed invention, compound C74 as claimed was known in the art. Ramesh et al. (Res. Chem. Intermed. (2017) 43:1767–1782 Provided on IDS 02/01/2023) teaches structurally diverse 4,4’-(arylmethylene)bis(3-methyl-1H-pyrazol-5-ol) compounds which have attracted interest because they exhibit a wide range of approved biological activities, being used as anticancer, antipyretic, antidepressant, antiviral, antifungal, antitumor, anti-inflammatory agents and inhibitors of mycobacterium tuberculosis (abstract and page 1768). Ramesh et al. specifically teaches
PNG
media_image2.png
148
130
media_image2.png
Greyscale
(page 1775). Vafaee et al. (Res. Chem. Intermed. (2015) 41:8343–8354 Provided on IDS 02/01/2023) also teaches pyrazoles, especially 1H-pyrazol-5(4H)-one derivatives including 4,4’-(arylmethylene)bis(1H-pyrazol-5-ols), are an important class of heterocyclic compounds with diverse and interesting biological activities (page 8343). These compounds are reported to possess significant antipyretic, antidepressant, antiviral, antifungal, antitumor, and anti-inflammatory activities (page 8343). Vafaee et al. teaches compound 3f
PNG
media_image3.png
156
146
media_image3.png
Greyscale
(pages 8345 and 8350). Although the state of the art prior to the effective filing date of the claimed invention recognized that this compound belongs in a class of compounds which may have anticancer activity, this compound was not known to be administered for the treatment of any cancer. Furthermore, there was no prior art found which teaches the administration of this compound for the treatment of wet age-related macular degeneration or any other angiogenesis-dependent disease or condition.
Thus the state of the art prior to the effective filing date of the claimed invention does not support the treatment of wet age-related macular degeneration or any other angiogenesis-dependent disease or condition comprising the administration of any compound as claimed in the instant application.
Predictability/Unpredictability in the Art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that the recitation encompasses treating wet age-related macular degeneration and any other angiogenesis-dependent disease or condition, which include a great number of diseases with different etiologies, comprising the administration of compound C74 or any other compound of formula I, II or III, which includes an infinite number of compounds having different structures, efficacies, potencies and thus widely varying dosages. Thus, the skilled artisan would view that the treatment of all disorders/diseases encompassed by the claims, by administering all compounds encompassed by the claims, is highly unpredictable. Moreover, one of skill in the art would recognize that it is highly unpredictable in regard to therapeutic effects, side effects and toxicity generated by administering all compounds encompassed by the claims for treating all disorders/diseases encompassed by the claims.
The Quantitation of Experimentation Required: In order to practice Applicant’s invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to demonstrate that C74 or any other claimed compound can be used treat wet age-related macular degeneration or any other angiogenesis-dependent disease or condition as claimed. One would need to perform extensive and complex pharmacokinetic and pharmacological experiments to determine efficacy, potency, etc. for each of the drugs in each of the conditions. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome.
In conclusion, 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 limitations of general ideas that may or may not be workable.” A method for treating wet age-related macular degeneration in a subject, or any other angiogenesis-dependent disease or condition in a subject comprising administering to the subject in need thereof a therapeutically effective amount of compound C74 or any other compound as claimed is not enabled by the instant specification.
Conclusion
Claims 1, 2, 13, 15 and 16 are rejected. Claim 14 is canceled. Claims 3-12 are withdrawn. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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, Adam C. Milligan can be reached at (571)270-7674. 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.
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
Prosecution Insights