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 371 National Stage Entry of PCT/CN2023/084168 filed on 27 March 2023. Acknowledgment is made of applicant’s claim for foreign priority to a People’s Republic of China Patent, under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202210179789.6 filed on 25 February 2022.
Information Disclosure Statement
The examiner notes that as of the time of writing this office action, no information disclosure statement (IDS) has been submitted with this Application.
Status of the Claims
Acknowledgement is made of claims in the filed Application 18/840,250; Original claims 1-8, are pending in the application. Thus, claims 1-8 represents all the claims currently under consideration.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter, process, machine, manufacture or composition of matter, because they are drawn to; “use of a compound”, (claim 1) and “The use according to”, (claims 2-8), (emphasis added).
A use claim is not considered a method for lack of distinct steps. Additionally, per MPEP § 2173.05(q), “Use” claims that do not purport to claim a process, machine, manufacture or composition of matter fail to comply with 35 U.S.C 101. In re Moreton, 288 F.2d 708, 129 USPQ 227, 228 (CCPA 1961), (“one cannot claim a new use per se, because it not among the categories of patentable invention specified in 35 U.S.C § 101”).
Rather, the claims as presented can be drawn to any of these distinct categories of invention, method or composition of matter. Accordingly, Applicant needs to make necessary amendments to overcome this rejection.
Claim Rejections - 35 USC § 112b
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.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding the instant claims 1-8, the phrases use of (claim 1) and The use (claims 2-8), (emphasis added), are ambiguous describing a compound, and possibly method of use or a composition thereof. The recited “use” claims lack active positive steps. Per the MPEP § 2173.05(q), attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b). Accordingly, Applicant is requested to clearly distinguish a category of invention under 35 U.S.C. 101 for each claim.
Claim interpretation: For the purpose of compact prosecution claims 1-8 are considered as being drawn to a compound of formula I or a pharmaceutical composition with the intended use of treating/preventing psoriasis. In the light of the specification and prior art, claims 5-8 are also considered as drawn to a method of treating.
Claim Rejections - 35 USC § 112a
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 1-8 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 treating or alleviating psoriasis comprising administering a therapeutically effective amount of the claimed compound, does not reasonably provide enablement for preventing psoriasis. 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 application 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 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
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 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). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not experimentation".
The factors that may be considered in determining whether a disclosure would
require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the nature of the invention,
2- the breadth of the claims,
3- the state of the prior art,
4- the predictability of the art,
5- the relative skill of those in the art,
6- the amount of direction or guidance provided,
7- the presence or absence of working examples and
8- the quantity of experimentation necessary to make or use the invention.
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). Undue experimentation is required by one skilled in the art to determine enablement of the instant disclosure as claimed due to the following:
Claim interpretation: The claim interpretation as discussed under 35 U.S.C. 112b above is incorporated herein. Thus, Instant claim 1 is interpreted as drawn to a compound of formula (I) or pharmaceutical composition thereof for treating and /or preventing psoriasis wherein, the compound is a compound of formula (I) as recited.
Regarding the nature of the invention and breath of the claims:
With regards to the nature of invention, the claims are drawn to a compound or a pharmaceutical composition and the intended use. On the breath of the claims: The instant claim 1 is drawn to a compound of formula (I) or a pharmaceutical composition comprising a compound of formula (I) for treating and /or preventing psoriasis; wherein the psoriasis is psoriasis vulgaris, psoriatic arthritis pustular psoriasis or erythrodermic psoriasis – claim 5.
Because treatment of psoriasis is enabled, the Wands factors are directed to the part of the claim drawn to preventing psoriasis. The claimed invention is directed towards preventing psoriasis with the compound(s) or pharmaceutical composition(s) of compound of formula (I). Applying the broadest reasonable interpretation to ‘preventing psoriasis’, would mean stopping psoriasis from developing, or stop the disease from occurring.
Regarding the state of the art and predictability in the art of lack thereof:
MPEP § 2164.05(a) states that if a publication demonstrates that those of ordinary skill in the art would not find that a particular invention was not enabled after the filing date, the publication would be evidence that the claimed invention was not possible at the time of filing.
Ogawa and Okada, 2020, (Ogawa and Okada, “The current landscape of psoriasis genetics in 2020”, Journal of Dermatological Science, 99 (2020) page 2-8; Published 20 May 2020), here on after, Ogawa, teaches the most common type of psoriasis is psoriasis vulgaris accounting for 90% of the cases and approximation 6-42% of psoriasis patients are also affected by chronic arthritis (psoriatic arthritis), in their lifetime (page 2).
Ogawa teaches psoriasis is a multifactorial genetic disease for which the genetic factors explain 70% of disease susceptibility (page 2). Ogawa discloses information from several databases such as 1000 Genome Project, genome-wide association studies (GWASs) and investigations done for several years that confirm genetic factors account for substantial portion of susceptibility in psoriasis. Importantly, GWASs studies have identified more than 80 loci associated with psoriasis susceptibility and actual developing of the disease. In addition, Ogawa’s review demonstrates genetic heterogeneity among different populations, with psoriasis-associated genetic variants differing across populations (page 3).
On causal factors of psoriasis, Ogawa discloses that in some studies a higher body mass index (BMI)/ obesity is a casual risk factor for psoriasis. Notably, Ogawa states, based on these findings patients can now be advised to lose weight in order to avoid worsening psoriasis (page 4-5).
Notably, Ogawa’s review cites several existing psoriasis treatments and potential drug candidates directed towards treatment of psoriasis or alleviating psoriasis there is nothing reported for preventing onset of psoriasis in an at-risk individual (page 5).
Therefore, prior art teaches psoriasis is a multifactorial, genetically complex disease.
Regarding predictability in the art, Prior art reveals prevention of psoriasis would have been unpredictable in view of the complex and multifactorial nature of the disease large number of genetic loci associated with psoriasis susceptibility and the heterogeneity of genetic risk among populations. In addition, while there are various therapeutic drugs known for treating psoriasis, the art does not establish that such therapeutic activity would predict efficacy in preventing the onset of psoriasis.
Regarding relative skill level, while the relative skill is high, that of an MD or PhD, that factor is outweighed by the unpredictable nature of the art as illustrated in the prior art discussed above. There is no absolute predictability even in view of the seemingly high level of skill in the art. That a compound treats psoriasis does not establish that one or ordinary skill could predict that the compound would prevent psoriasis from occurring in the first place.
Regarding the amount of direction provided, presence or absence of working examples: The specification shows assays and tests with psoriasis mouse models and administration, (Pages 35-39, section 1.4 and 1.5) related to treatment or alleviation of psoriasis. The specification states the compounds in the instant application have good efficacy in treating and alleviating psoriasis. Additionally, ‘by experimental studies’, the compounds in the instant application ‘have shown an improvement in the weight loss of mice’ – ‘furthermore after treatment with the compounds there was significant reduction in psoriasis symptoms in mice’ (Specification page 30).
As discussed previously, loss of excess weight stops psoriasis from worsening or helps alleviate the symptoms, but this would not be an indication that it stops the onset of psoriasis. Moreover, the specification does not disclose any model or data demonstrating that administration of compound of formula (I), or composition thereof, prior to the occurrence of psoriasis in a subject would prevent the occurrence of the disease.
Regarding quantity of experimentation necessary, Because of the unpredictability in the art, one skilled in the art would need to determine whether the compounds in the claimed invention are effective in preventing the onset of psoriasis across a genetically heterogenous population having numerous psoriasis-associated susceptibility loci.
Determining if compounds of formula (I) would be therapeutic for numerous psoriasis-associated susceptibility loci would require careful analysis and replicability of composition a compound of formula (I), formulation into a suitable dosage form, relevant assay testing to correlate clinical efficacy, identify off-targets, subjecting to animal trials and subjecting to clinical trials. All this is undue experimentation given the limited guidance and direction provided by applicant. As such the full scope of the claim, insofar as it encompasses preventing psoriasis is not enabled.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Regarding 35 U.S.C. 35 102(a)(2): The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Ye et al., 2021, (WO2021/057785; “IRAK Inhibitor and Preparation Method thereof and use thereof.” Published April 4, 2021, with Priority Date; September 24, 2019), hereon after, Ye.
Regarding instant claim 1, Ye discloses a genus of compounds of formula I – as shown below (Abstract), which is identical to the instant compound of formula (I).
PNG
media_image1.png
196
354
media_image1.png
Greyscale
The variables of Ye’s formula I compound; ring A, R1, R2, R3, W, n and m as defined by Ye completely overlap with the instant claim 1 (Summary of invention and claim 1). In addition, Ye’s invention discloses a method for preventing and /or treating diseases and disorders associated with interleukin-1 receptor kinase (IRAK). Ye invention is drawn towards compound suitable for treatment of cancer and inflammatory diseases related to IRAK and more particularly to regulating the function of IRAK-4 (Ye - Technical Field)
Regarding instant claim 2, Ye’s disclosure teaches the claimed compound may be selected from five structures of formula Ia, Ib, Ic, Id and Ie (Ye’s claim 4). The five structures are identical to structures of formula Ia-Ie in instant claim 2.
Regarding instant claim 3 and 4; Ye’s discloses compounds 001 to 292 (Ye’s claim 5) which are identical to compounds 001-292 in the instant application. Further compound 001 as limited in instant claim 4 is disclosed among Ye’s compounds as 001.
Regarding instant claim 5, Ye discloses a method or pharmaceutical composition of the claimed compound for preventing and /or treating diseases or disorders mediated by IRAK (Ye - claims 9 and 10).
Regarding instant claim 6, 7 and 8, Ye teaches a compound of formula I, or a stereoisomer, a racemate, a tautomer, an isotopically labelled compound, a prodrug, or a pharmaceutically acceptable salt thereof (Ye - claims 8 and 11), and further teaches examples where oral, intravenous and intraperitoneal method were used to in administration of the claimed compounds to mice (Examples 6, 8 and Table 8). Ye further provides examples where the compounds were prepared in solution or suspensions of require concentration for administration (Example 6, procedure).
Accordingly, Ye et al., WO2021/057785 anticipates the instant claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over, Ye et al., 2021, (WO 2021/057785, “IRAK Inhibitor and Preparation Method thereof and use thereof.” Published April 4, 2021; Priority Date - September 24, 2019), hereon after, Ye, in view of Chaudhary et al., 2015, (Chaudhary et al., Recent advances in the discovery of small molecule inhibitors of interleukin-1 receptor-associated kinase 4 (IRAK4) as therapeutic target for inflammation and Oncology Disorders”, Journal of Medicinal Chemistry, 2015, 58, page 96-110; Published on December 5, 2014), hereon after, Chaudhary.
Regarding claims 1-8, the foregoing discussions on the teachings of Ye under 35 U.S.C. 102 rejection above are incorporated herein.
Ye teaches compounds disclosed or pharmaceutical compositions, are IRAK inhibitors suitable for treatment of cancer and inflammatory diseases related to IRAK and more particularly to a compound for regulating a function of IRAK4 ( Ye - Technical Field). Thus, the pharmaceutical compositions of Ye’s claimed compounds are for preparing medicament for preventing and/or treating diseases or disorders mediated by IRAK (Ye - claim 9). Ye further lists certain conditions wherein the disease or disorders are selected from tumors, gout, systemic lupus erythematosus, multiple sclerosis, metabolic syndrome, atherosclerosis, myocardial infection, sepsis, inflammatory bowel disease asthma, rheumatoid arthritis, allergy and the like (Ye - claim 10).
How prior art differs from instant claims. While Ye’s disclosure lists inflammatory IRAK mediated diseases or disorders, Ye does not distinctly mention psoriasis as recited in the instant invention (instant claims 1 and 6).
Chaudhary, 2015, teaches interleukin-1 receptor-associated kinase 4 (IRAK4), a serine/threonine kinase plays a key role in both inflammation and oncology diseases (abstract). In addition, IRAK4 is a key signaling node for transducing the responses of interleukin-1 (IL-1) receptor family and Toll-like receptors (TLR) except of TLR3.
Regarding IRAK4 signaling in inflammation, Chaudhary, states that aberrant TLR and /or IL-1 family receptors signaling are associated with several inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, psoriasis, gout, among others; in addition, Chaudhary teaches pharmacological inhibition of IRAK4 kinases potently reduces the LPS induced TNF production response in female Lewis rats, reduces arthritis and inflammation and inhibits psoriatic responses in imiquimod induced mouse psoriasis (page 98). Chaudhary adds, a potent and selective IRAK4 inhibitor would be useful for autoimmune diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease and gout (page 106).
Per MPEP § 2143 (I)(A) and (D), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results; additionally, a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results.
Ye teaches methods of preparation of the claimed compounds and exhibits assays that show the compounds are IRAK inhibitors. Ye teaches treatment of IRAK mediated diseases and disorders and includes inflammatory diseases such as inflammatory bowel disease, rheumatoid arthritis but does not mention psoriasis. Chaudhary teaches pharmacological inhibition of IRAK4 kinases potently reduces the LPS induced TNF production response in female Lewis rats and inhibits psoriatic responses in imiquimod induced mouse psoriasis. Chaudhary also teaches a potent and selective IRAK4 inhibitor would be useful for treatment of autoimmune diseases such as inflammatory bowel syndrome, rheumatoid arthritis and psoriasis.
Therefore, it would have been obvious to one of ordinary skill in the art to take the compounds in the claimed Ye’s invention and combine with Chaudhary’s teachings and arrive at the instant claimed invention i.e., for treatment of psoriasis, with reasonable expectation of success.
One would have been motivated to do so because the claimed compound(s) show inhibition of cytokine TNF-α in LPS-induced Balb/c female mice, assay testing by Ye. In addition, psoriasis signaling is known to be through the same pathways as other inflammatory conditions as taught in prior art by Chaudhary. Accordingly, one would be motivated to further claim the IRAK4 inhibitor compounds for treatment of psoriasis. A skilled artisan in the art would reasonably expect to arrive at the same invention presently claimed for the reasons taught in prior art.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,617,770 B2, hereon after, ‘770, in view of Chaudhary et al., 2015, (Chaudhary et al., Recent advances in the discovery of small molecule inhibitors of interleukin-1 receptor-associated kinase 4 (IRAK4) as therapeutic target for inflammation and Oncology Disorders”, Journal of Medicinal Chemistry, 2015, 58, page 96-110; Published on December 5, 2014), hereon after, Chaudhary.
Regarding instant claims 1-, Claims 1-3 and 7-16 IN ‘770 are drawn to a genus compound of formula I, or a stereoisomer, a racemate, a tautomer or a pharmaceutically acceptable salt thereof (claim 1), (shown below), with limitations that recite definitions of terms (claims 2), and of radicals / variables as applied to ring A, W, R1, R2 and R3 and R, (claims 3 and 7-16).
Instant claim 1 is drawn to an identical genus compound of formula (I) or pharmaceutical composition, for treating and/or preventing psoriasis; wherein the compound of formula (I) is as shown above or a stereoisomer, a tautomer, an isotopically labelled compound, a prodrug or a pharmaceutically acceptable salt thereof. The definitions provided for the instant genus compound overlap completely with the those defined for variables in Patent ‘770. Additionally, the exemplified embodiments in ‘770 read on the instant application. ‘770 discloses a compound of formula I, or stereoisomer, the racemate, tautomer, isotopically labeled compound, prodrug or pharmaceutically acceptable salt or pharmaceutical composition. Notably, the genus compound of formula I in Patent ‘770 and embodiments clearly anticipate instant invention claim 1.
Instant Application
US Patent No. 12,617,770 B2
PNG
media_image2.png
140
248
media_image2.png
Greyscale
Claim 1
PNG
media_image3.png
208
388
media_image3.png
Greyscale
Claim 1
PNG
media_image4.png
133
226
media_image4.png
Greyscale
Claim 3 – compound 001
PNG
media_image5.png
237
539
media_image5.png
Greyscale
Claim 5 – compound 001
PNG
media_image6.png
110
212
media_image6.png
Greyscale
Claim 3 – compound 242
PNG
media_image7.png
227
583
media_image7.png
Greyscale
Claim 5 -compound 242
In addition, compounds claimed in ‘770 or pharmaceutical compositions, are IRAK inhibitors suitable for treatment of cancer and inflammatory diseases related to IRAK and more particularly to a compound for regulating a function of IRAK4 (‘770 – Technical Field Col 1). Chaudhary, 2015, teaches IRAK4 plays a key role in both inflammation and oncology diseases and the immune pathways that are associated with several inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, and psoriasis, among others.
Thus, while the claims are not exactly identical, they are not patentably distinct from each other. The instant application is drawn to compound of formula (I) that completely overlaps with the genus compound in ‘770 and the exemplified embodiments in ‘770, read on to the instant claim. In addition, ‘770 is drawn towards inhibitors of IRAK4. IRAK4 is associated with inflammatory pathways that drive psoriasis hence the instant application is drawn to a species of similar pathways as claimed in ‘770.
Accordingly, claims 1-3 and 7-16 anticipate instant claim 1 alone or in view of Chaudhary.
Regarding instant claim 2, Claim 4 in Patent ‘770 is drawn to, wherein compound of formula (I) is a compounds of formula Ia, formula Ib, formula Ic, formula Id, or formula Ie. The disclosed compounds Ia-Ie are identical to instant application compounds Ia – Ie as recited in instant claim 2. Thus claim 4 in ‘770 and instant claim 2 are not patentably distinct from each other, as such, claim 4 in ‘770 clearly anticipates instant claim 2.
Regarding instant claim 3-4, Claim 5 in ‘770 discloses a compound selected from a group consisting of structures 001 – 290. Claim 18 and 19 in ‘770 are further drawn to limitations of compound I, a compound which is illustrated as embodiment or structure 001. Instant claim 3 recites the compound of formula I is selected from a group of structures recited and shown as compounds 001-292. Instant claim 4 recites, wherein the compound of formula I is compound 001. Therefore, while the claims are exactly identical, they are not patentably distinct from each other. As such claims 5, 18 and 19 in ‘770 anticipate instant claims 3 and 4.
Regarding instant claims 5, Claim 1 in ‘770 is drawn to a compound of formula I or a stereoisomer, a racemate, a tautomer or a pharmaceutically acceptable salt thereof; claim 6 in ‘770 is drawn to a pharmaceutical composition comprising compound of claim 1 in ‘770; while claim 20 in ‘770 is drawn to a pharmaceutical composition comprising the compound of claim 18 in ‘770. Instant application is drawn to a method of treating psoriasis as recited (See Claim Interpretation above) – instant claim 5.
‘770 discloses claimed compounds are IRAK inhibitors that could be used for treatment of inflammatory diseases related to IRAK and more particularly for regulating function of IRAK-4. Chaudhary teaches IRAK4 plays a key role in both inflammation and the immune pathways that are associated with inflammatory conditions related to psoriasis. Thus, while the claims are not identical they are directed to a use that is treated through same pathway and same inhibitory target and therefore are not patentably distinct from each other. Claims 1, 6 and 20 anticipate and render obvious instant claim 5.
Regarding instant claim 6-8, Claims 1, 6 and 20 in ‘770 as discussed above are drawn to a compound of formula I or a stereoisomer, a racemate, a tautomer or a pharmaceutically acceptable salt and pharmaceutical compositions of the claimed compound. The disclosure further recites invention provides a compound of formula I or stereoisomer, a racemate a tautomer, an isotopically labeled compound, a prodrug, or pharmaceutically acceptable salt thereof (Summary of invention – ‘770). Instant application is drawn to use wherein the compound of formula (I), or a stereoisomer, a racemate, a tautomer, an isotopically labelled compound, a prodrug, or a pharmaceutically acceptable salt administered orally, parenterally or other routes of administration (instant claim 6); wherein is preferably administered orally (instant claim 7) and wherein the dosage form of oral administration is a tablet, film, sugar-coated tablet, granule, pill, powder, emulsion, suspension or solution (instant claim 8).
While the claims are not identical, claim 1, 6 and 20 in ‘770 render obvious the instant claims 6-8, alone or in view of the specification in ‘770 which discloses the administration of pharmaceutical composition of the claimed compounds orally or intravenously and prepared as a solution or a suspension. ‘770 further discloses claimed compounds are IRAK inhibitors that could be used for treatment of inflammatory diseases related to IRAK and more particularly to compound(s) for regulating function of IRAK-4. Furthermore, Chaudhary teaches IRAK4 plays a key role in both inflammation and the immune pathways that are associated with inflammatory conditions related to psoriasis.
Therefore, while the claims 1, 6 and 20 in ‘770 are not identical to instant claims 6-8, they are not patentably distinct from each. Accordingly, claims 1, 6 and 20 anticipate or render obvious instant claim 6-8 alone, or in view of ‘770 specification or further in view of Chaudhary.
Conclusion
Claims 1-8 are rejected. No claim is found allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULINE ONDACHI whose telephone number is (571)272-9419. The examiner can normally be reached Mon - Fri 8:00 am - 5:00 pm EST.
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, Kortney L. Klinkel can be reached at (571)270-5239. 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.
/P.O./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
Prosecution Insights