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 . 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.
Priority
The instant application is a 371 of PCT/EP2022/055224 filed on 03/02/2022 and claims foreign priority to PCTEP2021055348 filed on 03/03/2021. The certified copy of the foreign priority application filed on 09/01/2023 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/17/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The preliminary claim amendments filed on 09/01/2023 is acknowledged. Claims 4-7, 10, and 14 are amended. Claims 11-13 are cancelled. Claims 15-18 are newly added.
Accordingly, claims 1-10 and 14-18 are pending and being examined on the merits herein.
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 14 and 17-18 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 treatment of fibrosis of organs; liver diseases and disorders; acute kidney injury and chronic kidney disease; cardiovascular diseases and disorders; interstitial lung diseases and disorders; cell proliferative diseases and cancers; inflammatory and autoimmune diseases and disorders; gastrointestinal tract diseases and disorders; pancreatic diseases and disorders; abnormal angiogenesis-associated diseases and disorders; brain-associated diseases and disorders; neuropathic pain and peripheral neuropathy; ocular diseases and disorders; or transplant rejection, does not reasonably provide enablement for prophylaxis of the recited diseases and disorders. 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.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Formal, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
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 necessary
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, the breadth of the claims, and relative skill level
The invention relates to a method for the prophylaxis or treatment of fibrosis of organs; liver diseases and disorders; acute kidney injury and chronic kidney disease; cardiovascular diseases and disorders; interstitial lung diseases and disorders; cell proliferative diseases and cancers; inflammatory and autoimmune diseases and disorders; gastrointestinal tract diseases and disorders; pancreatic diseases and disorders; abnormal angiogenesis-associated diseases and disorders; brain-associated diseases and disorders; neuropathic pain and peripheral neuropathy; ocular diseases and disorders; or transplant rejection comprising administering an effective amount of the recited compounds to a subject in need thereof.
The claims are broad in that they encompass the prophylaxis of the various recited diseases and conditions.
In the absence of an explicit definition in Applicant’s specification, the claims are given their broadest reasonable interpretation. See MPEP 2111. Merriam-Webster (reference included with PTO-892) defines "prophylaxis" as meaning, "measures designed to preserve health (as of an individual or of society) and prevent the spread of disease." Thus, the broadest reasonable interpretation of “prophylaxis” includes “prevention”, and in the absence of a limiting definition by Applicant, “prevention” is interpreted as defined according to Institute for International Medical Education (IIME, reference included with PTO-892), which defines “prevention” as promoting health, preserving health, and to restore health when it is impaired, and to minimize suffering and distress (see page 16, “Prevention”. IIME further states that “Primary prevention refers to the protection of health by personal and community wide effects, such as preserving good nutritional status, physical fitness, and emotional well-being, immunizing against infectious diseases, and making the environment safe. Secondary prevention can be defined as the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health. Tertiary prevention consists of the measures available to reduce or eliminate long-term”
Therefore, in order to give the broadest reasonable interpretation to the claims, “prophylaxis" is thus interpreted to mean that the onset of a condition never occurs and the patient’s health is protected and preserved.
The relative skill of those in the art is high, that of an MD or PHD, someone with experience in the recited diseases.
The amount of direction or guidance provided and the presence or absence of working examples
Applicant discloses that their compounds are galectin-3 (gal-3) inhibiting compounds (see page 1 lines 1-7). Applicant discloses that gal-3 is widely distributed in the body and display a broad diversity of biological functions, including immunomodulation, host-pathogen interactions, angiogenesis, cell migration, wound healing, and apoptosis (see page lines 24-26). Applicant discloses that Gal-3 is highly expressed in many human tumors and cell types, indicating that Gal-3 is involved in the regulation of inflammatory and fibrotic processes (page 1 lines 25-30). Applicant discloses that there are several studies that support that gal-3 is involved in the development of various inflammatory/autoimmune diseases such as asthma, rheumatoid arthritis, multiple sclerosis, diabetes, cardiovascular diseases, heart failure, thrombosis, various organ fibrosis, and cancer (page 1 last three lines through page 2 lines 1-10). Thus, Applicant discloses that their compounds as well as in combination with other therapies may be useful for the treatment of the recited diseases and conditions by inhibiting gal-3 (page 2 lines 10-17)
Applicant further demonstrates that their recited compounds have gal-3 inhibition as seen in the binding assays on Table 10 (pages 94-96). Here, Applicant demonstrates that various species of their compounds had an IC50 value of less than ~0.1 um against Gal-3.
However, the instant disclosure does not identify a method that could be used by one of ordinary skill in the art to determine that a subject would have predictably developed a recited disease without the claimed methods in order to establish that such recited diseases was prevented.
The described disclosure and examples suggest that the instant compounds may be effective for treating several of the recited diseases by inhibiting gal-3. However, the disclosure does not demonstrate prevention of the recited diseases or a predictable method to identify patients who would have developed the recited diseases.
The state and predictability of the art
There are no art recognized methods that could be used to establish that a recited disease or condition was prevented using therapeutic treatment or to identify patients who would predictably develop the recited diseases in order to predictably identify that prevention was achieved using therapeutic approaches. Rather, the art indicates that such a preventative measure against the recited diseases was not predictable.
Sciacchitano (in IDS filed 01/27/2024) discloses that galectin-3 (gal-3) regulates basic cellular functions such as cell–cell and cell–matrix interactions, growth, proliferation, differentiation, and inflammation, and involved in the pathogenesis of many relevant human diseases, including cancer, fibrosis, chronic inflammation and scarring affecting many different tissues (see Abstract). Sciacchitano discloses that gal-3 is a multifunctional protein engaged in different biological events, in different tissues, playing a relevant role in many different clinical conditions and diseases (page 5 first paragraph under section 2). Sciacchitano further discloses in Table 1 (pages 32-35) the possible role of gal-3 in the various recited diseases and potential therapeutic treatment using gal-3 inhibitors.
However, Sciacchitano does not disclose or suggest a preventative measure against any of the recited conditions using a gal-3 inhibitor compound. Furthermore, preventive methods against the recited diseases are generally unpredictable or not readily available. For example, Penny (in PTO-892) discloses that the prevention of cancer using small molecules is a technology that is still in progress and not sufficiently well developed to allow for the demonstration of chemo-preventative agents to healthy subjects for cancer prevention (see Abstract). Rose (in PTO-892) discloses that the timing and dosages for the prevention of autoimmune disease is still unresolved (see section “Prevention” first two paragraph right column page 405) and is complicated by the fact that currently these diseases are still diagnosed after pathological process have already advanced (see Abstract), and research in prediction is still underway and not completed (see “Conclusions” page 406). Kim (in PTO-892) discloses that even though extensive research has been performed on prevention of inflammation-related diseases such as cancers, obesity, asthma, rheumatoid arthritis, atherosclerosis, ischemic heart disease, and ulcerative colitis, the overall incidence has not changed significantly and furthermore, the exact mechanism underlying the process of these diseases still remains hidden (see first paragraph). Corvol (in PTO-892) discloses that prevention of neurodegenerative diseases is a challenge for medical, social, and economic reasons (see left column first paragraph under “Conclusions” page 800), and that to predict the onset of these diseases at the asymptomatic stage raises ethical issues at a time when no preventative medication is as yet available (see Abstract). Yan (in PTO-892) discloses that predictive medicine in ophthalmology to detect disease before it manifests or by mitigating harm through prevention is challenging with some models having comprised predictive value and clinical usefulness (see first page left column first through third paragraph and right column last paragraph). Lastly, Verwij (in PTO-892) discloses that while preventative medicine appears desirable, there are on the other hand ethical problems introduced for administering a treatment to a health patient for the prevention of hypothetical diseases as opposed to the treatment of a patient who is already sick (page 25 second-fourth paragraphs). Verwij discloses that even minor adverse effects could be ethically problematic for patients who are treated in the absence of an actual disease (page 36 section 3.4.1).
Even though the teachings of Sciacchitano disclose that gal-3 may be a therapeutic target for some of the recited diseases, Sciacchitano does not teach or suggest preventative measures using gal-3 inhibitor compounds. Furthermore, the additional teachings described above establish that preventative measures against the recited diseases are unpredictable, and Verwij further establishes that while there may be some hypothetical protective effect of administering a preventative therapy against a disease or condition, such a preventative therapy may not be ethically justified or practically feasible. Therefore, taken together, the state of the art establishes that there are no predictable methods to prevent a recited disease or condition using therapeutic treatment or to identify patients who would develop the recited diseases in order to predictably identify that prevention was achieved using therapeutic approaches.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of a predictable method to identify patients who would develop a recited disease or condition without treatment, one of ordinary skilled in the art would not be able to predictably use the claimed agent to prevent the recited diseases or conditions. Furthermore, the quantity of experimentation to develop a method that could be used to prevent a recited disease or condition would be undue because a method to predictably identify a patient who would get the recited diseases or conditions does not exist and as described above, one of ordinary skill would have to further develop this method such that the recited method could then be used as a preventative measure against the recited diseases.
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claims 14 and 17-18 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 14 and 17-18 recite a method for the treatment of fibrosis of organs; liver diseases and disorders; acute kidney injury and chronic kidney disease; cardiovascular diseases and disorders; interstitial lung diseases and disorders; cell proliferative diseases and cancers; inflammatory and autoimmune diseases and disorders; gastrointestinal tract diseases and disorders; pancreatic diseases and disorders; abnormal angiogenesis-associated diseases and disorders; brain-associated diseases and disorders; neuropathic pain and peripheral neuropathy; ocular diseases and disorders; or transplant rejection comprising administering an effective amount of the recited compounds to a subject in need thereof.
Here, these instant claims recite a variety of broad diseases and conditions that is treated using the recited compounds. The disclosure, however, does not identify a representative number of the recited diseases and/or conditions within each claimed genus to perform the claimed function of treatment using the recited compounds, nor does the disclosure provide a structure-function relationship which would allow an ordinary skilled artisan to identify which recited diseases and/or conditions can be selected for the claimed treatment using the recited compounds.
MPEP 2173.05(g) states that “A claim term is functional when it recites a feature ‘by what it does rather than by what it is’” and that “Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.”
Applicant discloses that their compounds are galectin-3 (gal-3) inhibiting compounds (see page 1 lines 1-7). Applicant discloses that gal-3 is widely distributed in the body and display a broad diversity of biological functions, including immunomodulation, host-pathogen interactions, angiogenesis, cell migration, wound healing, and apoptosis (see page lines 24-26). Applicant discloses that Gal-3 is highly expressed in many human tumors and cell types, indicating that Gal-3 is involved in the regulation of inflammatory and fibrotic processes (page 1 lines 25-30). Applicant discloses that there are several studies that support that gal-3 is involved in the development of various inflammatory/autoimmune diseases such as asthma, rheumatoid arthritis, multiple sclerosis, diabetes, cardiovascular diseases, heart failure, thrombosis, various organ fibrosis, and cancer (page 1 last three lines through page 2 lines 1-10). Thus, Applicant discloses that their compounds as well as in combination with other therapies may be useful for the treatment of acute or chronic heart failure, cancer, chronic and acute kidney disease, idiopathic pulmonary fibrosis, type 2 diabetes, rheumatoid arthritis, psoriasis, scarring, systemic sclerosis, systemic lupus erythematosus and dry eye disease by inhibiting gal-3 (page 2 lines 10-17)
Applicant further demonstrates that their recited compounds have gal-3 inhibition as seen in the binding assays on Table 10 (pages 94-96). Here, Applicant demonstrates that various species of their compounds had an IC50 value of less than ~0.1 um against Gal-3.
Here, while Applicant has demonstrated their instant compounds are gal-3 inhibitors and may be effective for treating several of the recited diseases and conditions such as fibrosis of organs; liver diseases and disorders; acute kidney injury and chronic kidney disease; interstitial lung diseases and disorders; gastrointestinal tract diseases and disorders; pancreatic diseases and disorders; brain-associated diseases and disorders; neuropathic pain and peripheral neuropathy; ocular diseases and disorders; or transplant rejection, Applicant has not demonstrated or suggested these compounds can be used to treat all of the recited conditions and diseases such as cardiovascular diseases and disorders; cell proliferative diseases and cancers; inflammatory and autoimmune diseases and disorders; abnormal angiogenesis-associated diseases and disorders in view of the prior art.
The state of the prior art suggests that the role of gal-3 is unpredictable and discloses that its role can vary depending on the condition or disease.
Sciacchitano (in IDS filed 01/27/2024) discloses that galectin-3 (gal-3) regulates basic cellular functions such as cell–cell and cell–matrix interactions, growth, proliferation, differentiation, and inflammation, and involved in the pathogenesis of many relevant human diseases, including cancer, fibrosis, chronic inflammation and scarring affecting many different tissues (see Abstract). Sciacchitano discloses that gal-3 is a multifunctional protein engaged in different biological events, in different tissues, playing a relevant role in many different clinical conditions and diseases (page 5 first paragraph under section 2). Sciacchitano further discloses in Table 1 (pages 32-35) the possible role of gal-3 in the various recited diseases and potential therapeutic treatment using gal-3 inhibitors.
Furthermore, Sciacchitano discloses conflicting reports of the role of gal-3 in several diseases or conditions. For example, in diabetes mellitus, gal-3 may play either a protective role or can be a risk factor for vascular/renal/cardiac complications (see Table 1, Diabetes Mellitus row on page 32 and section 6.2.2 on page 13). Sciacchitano discloses that in pulmonary hypertension, there are also conflicting reports that gal-3 plasma levels are decreased in PAH patients or increased in PAH patients independent to etiology and are associated with severity of PAH (see Table 1 page 34 Pulmonary hypertension row and section 18.2 on page 23). Sciacchitano discloses that expression of gal-3 in cancers varied. Sciacchitano discloses that increased expression of Gal-3 was reported in breast carcinoma, in colon carcinomas, in gastric cancers, in hepatocellular carcinoma, in well differentiated thyroid carcinomas, in anaplastic large-cell lymphoma, in head and neck squamous cell carcinomas, in tongue carcinomas, and in non-small cell lung cancer. However, other studies demonstrated an opposite picture, with decreased Gal-3 expression in breast, ovarian cancer prostate tumors, advanced uterine adenocarcinoma, basal cell carcinoma of the skin, epithelial skin cancer and malignant salivary gland neoplasms, compared to the corresponding normal tissue (second paragraph page 11). Sciacchitano also discloses that gal-3 expression is down-regulated in the initial stages of colon neoplastic progression, whereas a dissociated cytoplasmic expression increased in later phases of tumor progression (second paragraph page 11).
Here, the teachings of Sciacchitano demonstrate that the role of gal-3 in diseases and conditions are unpredictable and that either up-regulation or down-regulation of gal-3 can be associated in diabetes, pulmonary hypertension, and/or cancers.
Therefore, it is not evident by the disclosure or the prior art, that the Applicant was in possession of a representative number of species of the recited diseases and conditions that can be treated by using the recited compounds. Furthermore, as discussed above, there is no disclosed or art recognized correlation between structure and function which would allow for the predictable identification of the recited diseases or conditions that can be treated using the recited compounds. Therefore, the instant claim does not meet the written description requirement under 35 USC 112(a).
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 1-10 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,319,672.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of US’672 recites the following compound structure:
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422
747
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The Ar1 includes various aryl structures such as
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102
110
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recited in claim 6 of US’672. Furthermore, claim 1 of US’672 recites that R1 represents hydroxy or methoxy, A can be 1,2,3-triazole-1,4-diyl, and R2 can be several structures that overlap with the R2 structures recited in the instant claims.
Claim 13 of US’672 recites a method for the treatment of an indication selected from fibrosis of organs; liver diseases and disorders; cardiovascular diseases and disorders; cell proliferative diseases and cancers; inflammatory and autoimmune diseases and disorders; gastrointestinal tract diseases and disorders; pancreatic diseases and disorders; abnormal angiogenesis-associated diseases and disorders; brain-associated diseases and disorders; neuropathic pain and peripheral neuropathy; ocular diseases and disorders; acute kidney injury and chronic kidney disease; interstitial lung diseases and disorders; and transplant rejection; comprising administering to a subject in a need thereof an effective amount of a compound according to claim 1 of US’672. Claim 12 of US’672 recites a pharmaceutical composition comprising the recited compound and a pharmaceutically acceptable carrier.
Here, US’672 recites the same base compound structure for the treatment of the same diseases or conditions. Furthermore, US’672 recites overlapping Ar1, R1, A, and R2 substituents such that an ordinary skilled artisan could have selected substituents from within the claims of US’672 to arrive at the compounds recited in the instant claims.
Claims 1-10 and 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-36 of copending Application No. 19/193,332 (‘332).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 16 of ‘332 recites the following compound structure:
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197
202
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The Ar1 includes various aryl structures such as
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102
110
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recited in claim 19 of ‘332. Furthermore, claim 16 of ‘332 recites that R1 represents -O-CH2-CO-R1x wherein R1x represents hydroxy, A can be 1,2,3-triazole-1,4-diyl, and R2 can be several structures that overlap with the R2 structures recited in the instant claims.
Claim 27 of ‘332 recites a method for the treatment of an indication selected from fibrosis of organs; liver diseases and disorders; cardiovascular diseases and disorders; cell proliferative diseases and cancers; inflammatory and autoimmune diseases and disorders; gastrointestinal tract diseases and disorders; pancreatic diseases and disorders; abnormal angiogenesis-associated diseases and disorders; brain-associated diseases and disorders; neuropathic pain and peripheral neuropathy; ocular diseases and disorders; acute kidney injury and chronic kidney disease; interstitial lung diseases and disorders; and transplant rejection; comprising administering to a subject in a need thereof an effective amount of a compound according to claim 16 of ‘332. Claim 26 of ‘332 recites a pharmaceutical composition comprising a recited compound and a pharmaceutically acceptable carrier.
Here, ‘332 recites the same base compound structure for the treatment of the same diseases or conditions. Furthermore, ‘332 recites overlapping Ar1, R1, A, and R2 substituents such that an ordinary skilled artisan could have selected substituents from within the claims of ‘332 to arrive at the compounds recited in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-10 and 14-18 are rejected.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693