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 .
DETAILED ACTION
Claims 1-16 are pending and are under consideration in the instant office action.
Priority
This patent application claims the benefit and priority of Chinese Patent Application No. 2023107869248 filed with the China National Intellectual Property Administration on June 29, 2023.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-6 and 9-12.are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Baraldi et al. (US 2008/0045549) as evidenced by Buddenkotte et al. (Allergy 65 (2010), pages 805-821)
Baraldi et al. disclose compounds of formula (I) which are adenosine A2B receptor antagonists which is used in the treatment of conditions and diseases mediated by the adenosine A2B receptor activity which includes acute inflammatory diseases involving degranulation of mast cells such as allergic dermatitis (abstract and [0008], Claim 9 and 18). They disclose preparation of the compounds of formula (I) [0134-0150]. With regards to screening these compounds for inhibiting inflammatory conditions, Baraldi et al. discloses specific methods [0193] and they disclose method for evaluating their effect on inhibiting adenosine A2B receptor by radiolabeled studies ( [0155-0156], [0196], Table 1). They further disclose a method for the modulation of adenosine A2B receptor activity in a mammal which method comprises administering to a mammal in need thereof a therapeutically effective amount of a compound of formula (I) for treatment of allergic dermatitis [0157-0158] and includes preventive, curative and palliative treatment [0160]. They disclose a pharmaceutical composition comprising the A2B antagonist compound of formula (I) for treatment of allergic dermatitis ([0165-0166] claim 18)
It is noted that Baraldi et al. does not refer to the method of treatment of the instantly claimed condition pruritis as recited in instant claims 11-12
However, Pruritis or dermal itch is a secondary side effects of dermatitis . This is evidenced by Buddenkotte et al. who discloses that Pruritus (itch) is a major characteristic and one of the most debilitating symptoms in allergic and atopic diseases and the diagnostic hallmark of atopic dermatitis (abstract). As such evidentiary documentation explicitly discloses that pruritic is one of the main symptoms of allergic dermatitis. Accordingly allergic dermatitis which is treated with an A2B antagonist disclosed by Baraldi et al, will inherently have pruritis or itching as a symptom which would be inherently treated by the A2B antagonists disclosed by Baraldi et al. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed method of treating Pruritis will inherently occur in the method of treating allergic dermatitis with an adenosine A2B antagonist taught by Baraldi et al., absence of evidence to the contrary.
It is noted that instant claims 1-4 are drawn to a method of preparing drugs or compounds which inhibit adenosine A2B receptors. With regards to instant claims 5-6 and 9-10, the claims are drawn to a reagent which is an Adenosine A2B receptor inhibitor. This agent and its preparation are explicitly taught by Baraldi et al. The ability of this agent to treat pruritis is the intended use of the reagent which inhibits the A2B receptor. Applicants are reminded that the intended use of a pharmaceutical compound is not given patentable weight, unless the claimed use results in a physical difference between the claimed composition and any prior art compositions. In re Hack, 114 USPQ 161. There is no functional or physical difference between the claimed compounds and the compounds disclosed by Baraldi et al. Further, absent evidence to the contrary, the compounds of Baraldi et al. which read on the instantly claimed compounds are deemed to be capable of performing the recited use of the claim.
In accordance with MPEP §2131.01, it is proper to rely upon a secondary reference for a rejection under 35 U.S.C. 102, provided that the additional reference is relied upon to demonstrate that a characteristic or property not disclosed by the primary reference is, in fact, inherent.
Therefore the compound, composition and the method disclosed by Baraldi et al. fully anticipates instant claims 1-6 and 9-12.
Claims 1-6 and 9-10 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Kalla et al. (US 2008/0318983)
Kalla et al. disclose compounds of Formula I and II which are adenosine A2B receptor antagonists (abstract and [0021]) and pharmaceutical formulations comprising therapeutically effective amount of the compounds of Formula I and Formula II [0028]. They also disclose the method of using the compounds of Formula I and Formula II in the treatment of a disease or condition in a mammal that is amenable to treatment with the adenosine A2B receptor antagonist (i.e. inhibiting and adenosine receptor characterized as A2B) by administering an effective dosage of this compound [0029]. They disclose that Type I hypersensitivity disorders, such as asthma, hay fever, and atopic eczema, are stimulated by binding to A2B-receptors of mast cells and therefore, blocking these adenosine receptors would provide a therapeutic benefit against such disorders [0009]. They disclose preparation of the compounds of formula I and II [0144-0200]. With regards to screening these compounds for inhibiting inflammatory conditions, Kalla et al. discloses] method for evaluating their effect on inhibiting adenosine A2B receptor by radiolabeled studies ( [0907-0911], They disclose a pharmaceutical composition comprising the A2B antagonist compound of formula I and II for administration [0206].
It is noted that instant claims 1-4 are drawn to a method of preparing compounds which use adenosine A2B receptors as a target. With regards to instant claims 5-6 and 9-10, the claims are drawn to a reagent which is an Adenosine A2B receptor inhibitor. This agent and its preparation are explicitly taught by Kalla et al. The ability of this agent to treat pruritis is the intended use of the reagent which inhibits the A2B receptor. Applicants are reminded that the intended use of a pharmaceutical compound is not given patentable weight, unless the claimed use results in a physical difference between the claimed composition and any prior art compositions. In re Hack, 114 USPQ 161. There is no functional or physical difference between the claimed compounds and the compounds disclosed by Kalla et al. . Further, absent evidence to the contrary, the compounds of Kalla et al. which read on the instantly claimed compounds are deemed to be capable of performing the recited use of the claim. Furthermore, it is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”).
Therefore the compound, composition and the method disclosed by Kalla et al. fully anticipates instant claims 1-6 and 9-10.
Claims 5-10 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Kotanska et al (Biomedicine and Pharmacotherapy 135 (2021)111164, pages 1-7)
Kotenska et al. discloses PSB-603 as a known potent and selective adenosine A2B receptor antagonist (abstract, page 2, col.1, 3rd para).
It is noted that although Kotenska et al. discloses that PSB-603 inhibits functions of the A2B receptor, they do not disclose PSB-603 as a reagent for prevention and/or treatment of pruritis. It is also noted that with regards to instant claims 5-10, the claims are drawn to a reagent which is an Adenosine A2B receptor inhibitor such as PSB-603. This agent is explicitly taught by Kotenska et al as Adenosine A2B inhibitor. The ability of this agent to treat pruritis is the intended use of the reagent which inhibits the A2B receptor. Applicants are reminded that the intended use of a pharmaceutical compound is not given patentable weight, unless the claimed use results in a physical difference between the claimed composition and any prior art compositions. In re Hack, 114 USPQ 161. There is no functional or physical difference between the claimed compounds and the compounds disclosed by Katnaska et al. . Further, absent evidence to the contrary, the compounds of Katanska et al. which read on the instantly claimed compounds are deemed to be capable of performing the recited use of the claim. Furthermore, it is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”).
Therefore the PSB-603 disclosed by Katenska et al. fully anticipates instant claims 1-6 and 9-10.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 13-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Baraldi et al. (US 2008/0045549) as evidenced by Buddenkotte et al. (Allergy 65 (2010), pages 805-821) as applied to claims 11-12 in 102(b) rejection above, and further in view of Kotanska et al (Biomedicine and Pharmacotherapy 135 (2021)111164, pages 1-7)
Baraldi et al. and Budddnekotte et al. teach as discussed supra and are applied here in the same manner. The cited references do not teach wherein the A2B antagonist is PSB-603 or where in the pruritic is Uremic, chronic or acute pruritic or histamine or chloroquine-induced pruritic as recited in instant claims 13-16.
However, Kotenska et al. discloses PSB-603 as a known potent and selective adenosine A2B receptor antagonist (abstract, page 2, col.1, 3rd para). Kotenska et al. also discloses that PSB-603 has an anti-inflammatory effect in acute models of local and systemic inflammation (page 6, col.1 para 2).
As such it would have been prima facia obvious to a person of ordinary skill in the art to utilize the well known selective adenosine A2B receptor antagonist PSB-603 taught by Kotenska et al in the methods of Baraldi et al, since the compounds taught by Baraldi et al. is a functional equivalent of PSB-603 in that they are both adenosine A2B receptor inhibitors. Substituting equivalents, namely adenosine A2B inhibitors motivated by the reasonable expectation that the respective species will behave in a comparable manner or even provide comparable results in related circumstances, see In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958) is prima facie obvious. Moreover, the express suggestion to substitute one equivalent for another need not be present to render the substitution obvious, see In re Font 213 USPQ 532. Due to the fact that Biraldi et al teach and provide the skilled artisan with the necessary motivation to use a adenosine A2B inhibitors , for the treatment of a allergic dermatitis which is characterized by pruritis , and Kotenska . teach that PSB-603 is a potent and well known A2B receptor inhibitor with local and systemic anti-inflammatory effect, one having ordinary skill in the art is clearly provided with direction and ample motivation to use not only PSB-603 but any other potent A2B receptor inhibitors in treatment of allergic dermatitis. With regards to instant claims 15-16, it is well known in the clinical arts that allergic dermatitis taught by Biraldi et al. may be chronic or acute and is histamine induced, as such it would be obvious to a person of ordinary skill in the art to treat all of these types of dermatitis, as there is evidence that the A2B receptor inhibitors are effective in treating these type of inflammatory skin conditions associated with pruritis.
With regards to the dosage claimed in instant claim 14, Kotenska et al. discloses dosage of 1,5 and 10 mg/kg in their mouse edema model (page 3, col.1, para 5). Baraldi et al. further discloses the dosage of the Adenosine A2B receptor inhibitor to be used in their methods to be in the range of from about 0.001 mg/kg/day to about 20 mg/kg/day [0174]. They further disclose that the amount of a compound of the present invention required for use in treatment will vary not only with the particular salt selected but also with the route of administration, the nature of the condition being treated and the age and condition of the patient and will be ultimately at the discretion of the administering physician or clinician. Accordingly, it would have been prima facia obvious to a person of ordinary skill in the art to optimize the dosage of PSB-603 in the treatment of allergic dermatitis in a subject (inherently treating pruritic) with guidelines for dosages provided by both Kotenska et al. and Baraldi et al. thus arriving at the instantly claimed dosage of 10 pM. . It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating pruritis with the A2B receptor inhibitors including PBS-603, motivated by the teachings of the references above.
Conclusion
Claims 1-16 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691