DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 1, 2025 has been entered.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 83 – 92 are currently pending.
Claims 83-92 are herein acted on the merits.
Priority
This application, 18/089,651, filed 12/28/2022 is a continuation of 17/541,439 filed 12/03/2021 is a continuation of 16/948,408, filed 09/17/2020, now U.S. Patent 11,219,624 is a continuation of 16/947,735, filed 08/14/2020, now U.S. Patent 10,869,870. 16/947,735 is a division of 16/566,625, filed 09/10/2019, now U.S. Patent 10,758,543. 16/566,625 is a continuation of 14/714,820, filed 05/18/2015, now abandoned. 14/714,820 is a continuation of 13/112,370, filed 05/20/2011, now abandoned. 13/112,370 claims priority from provisional application 61/347,132, filed 05/21/2010.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 9/30/25, is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
The rejection of claims 83 – 92 under 35 U.S.C. 103(a) as being unpatentable Rodgers et al. in US 2008/0312259 (published: December 18, 2008) in view of Segura-Orsoni, S. in U.S. 2008/0207570 (published: August 28, 2008) is not persuasive. The rejection is herewith maintained. Applicant argues that Rodgers topical administration amounts to nothing more than a common listing of routes of administration and forms for “pharmaceutical compositions.” Applicant argues M.P.E.P. § 2181 (emphasis added) explains that "If one employs means plus function language in a claim, one must set forth in the specification an adequate disclosure showing what is meant by that language. Following with what Applicant argues support in the specification.” Further, Applicant states Dr. Yeleswaram details the different topical formulations investigated using ruxolitinib phosphate. Yeleswaram Declaration at 9-13. From that discussion, it is evident that even using the same active agent in different formulations produces different results and thus, highlights that any bald reference to a form of pharmaceutical formulation is not "a means for effecting skin permeation of [ruxolitinib] or a pharmaceutically acceptable salt thereof," as rationalized by the Office. Applicant argues Rodgers' description amounts to nothing more than a common listing of routes of administration and forms for "pharmaceutical compositions." But there is no specific topical formulation described in Rodgers that would amount to recited "a means for effecting skin permeation of the phosphoric acid salt to the patient" consistent with Applicant's specification. Applicant continues to argue the formulation having 2% ruxolitinib phosphate in solubilized cream was not physically stable beyond several days of storage at controlled room temperature. Applicant argues Segura-Orsoni fails to render the claimed subject matter prima facie obvious.
In response to the Declaration and argument, the Examiner’s contention is that the arguments mostly relate to the limitation “a means for effecting skin permeation of the phosphoric acid salt.” Applicant has not shown that a lotion, ointment, emulsion would not affect skin permeation of the phosphoric acid salt, as the reason for a topical route of administration is to administer to the “transdermal, epidermal, ophthalmic and to mucous membranes.” [0050] Even more so, the specification does not provide adequate disclosure showing any data specific for “a means for effecting skin permeation of the phosphoric acid salt to the patient,” in order to overcome the teachings of the prior art. The argument relates to the API, not specific to the skin permeation of the phosphoric acid salt, as claimed. Examiner points out no support is seen in Specification at page 3, II. 7-11 Specification at page 4, line 16-page 5, line 14 Specification at page 5, II. 20, 21, 25-29 Specification at page 6, II. 3-20, 25-page 11, line 8 Specification at page 11, II. 19-28 Specification at page 12, II. 1-10, 14-23, 27- - page 13, line 6 Specification at page 13, II. 10-page 14, line 10 Specification at page 14, line 14-24 Specification at page 15, II. 1-13 Specification at page 15, line 17-30 Specification at page 16, II. 4-13 Specification at page 16, line 17- page 17, line 29 Specification at page 19, line 7 to page 22, line 20 Specification at page 22, line 22 to page 23, line 2 Specification at page 29, Example 3, line 9 to page 34, line 22 (including corresponding Tables 2-5) Specification at page 34, line 25 to page 45, line 5 (including corresponding Tables 6-20) Specification at page 45, line 9-page 46, line 1 (including Table 21) Specification at page 46, Example 5, line 2 to end of page 48 Specification, Example 6, page 49, line 1 to page 53, end of the page (including corresponding Tables 24-26) Specification at page 54, Example 7 and corresponding Figures 2-7.
Furthermore, the Examiner’s contention that the argument of the importance of range is not persuasive. The Examiner respectfully reiterates, the claims require about 0.5% to about 1.5% of the ruxolitinib phosphate, Applicant’s data results of a 2% ruxolitinib phosphate (vs. those within a claimed range) in solubilized cream does not commensurate in scope with claims. The claims do not require a solubilized cream with the specific components tested, but only a “means for effecting skin permeation of the phosphoric acid salt to the patient.” The arguments are not persuasive.
The T.D filed over the ODP rejections 12226419 (US Applic. No. 18588626. ) has been acknowledged and approved. The rejection is herewith withdrawn.
The following rejections are made:
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 83-92 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 gastric cancer or while being enabling for means for effecting skin permeation of (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile to the patient, does not reasonably provide enablement a means for effecting skin permeation of the phosphoric acid salt to the patient. 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.
The instant claims are drawn to a pharmaceutical composition for topical skin application to a human patient, comprising: (1) about 0.5% to about 1.5% by weight of the composition, on a free base basis, of 1:1 (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt, and (2) a means for effecting skin permeation of the phosphoric acid salt to the patient.
The instant specification fails to provide information that would allow the skilled artisan to practice a means for effecting skin permeation of the phosphoric acid salt to the patient.
[In re Sichert, 196 USPQ 209 (CCPA 1977)]
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).1
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 Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
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:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a pharmaceutical composition for topical skin application to a human patient, comprising: (1) about 0.5% to about 1.5% by weight of the composition, on a free base basis, of 1:1 (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt, and (2) a means for effecting skin permeation of the phosphoric acid salt to the patient.
The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites the fact that while Applicant demonstrated a means for effecting skin permeation of the API, nowhere in the specification did applicant demonstrate the specific means for effecting skin permeation of the phosphoric acid salt as contemplated by the recitation in claim 83. Importantly, given that applicant has failed to demonstrate means for effecting skin permeation of the phosphoric acid salt, the examiner maintains that applicant has not enabled the breadth of the claims.
2. The breadth of the claims
The claims are thus very broad insofar as they recite the “means for effecting skin permeation of the phosphoric acid salt”.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the means for effecting skin permeation of the phosphoric acid salt. No reasonably specific guidance is provided concerning means for effecting skin permeation of the phosphoric acid salt. The latter is corroborated by the working example 6, Table 24-26 on pages 49-53.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the formulation could be predictably used for effecting skin permeation of the phosphoric acid salt as inferred by the claims and contemplated by the specification. 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 83-92 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. The Applicant must clearly and precisely detail the invention, demonstrating that the inventor was in possession of the full scope of what they claim to have invented at the time of filing. The specification provides no description or detail regarding a pharmaceutical composition for topical skin application to a human patient, comprising: (1) about 0.5% to about 1.5% by weight of the composition, on a free base basis, of 1:1 (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt, and (2) a means for effecting skin permeation of the phosphoric acid salt to the patient. The Examiner points out no support is seen in Specification at page 3, II. 7-11 Specification at page 4, line 16-page 5, line 14 Specification at page 5, II. 20, 21, 25-29 Specification at page 6, II. 3-20, 25-page 11, line 8 Specification at page 11, II. 19-28 Specification at page 12, II. 1-10, 14-23, 27- - page 13, line 6 Specification at page 13, II. 10-page 14, line 10 Specification at page 14, line 14-24 Specification at page 15, II. 1-13 Specification at page 15, line 17-30 Specification at page 16, II. 4-13 Specification at page 16, line 17- page 17, line 29 Specification at page 19, line 7 to page 22, line 20 Specification at page 22, line 22 to page 23, line 2 Specification at page 29, Example 3, line 9 to page 34, line 22 (including corresponding Tables 2-5) Specification at page 34, line 25 to page 45, line 5 (including corresponding Tables 6-20) Specification at page 45, line 9-page 46, line 1 (including Table 21) Specification at page 46, Example 5, line 2 to end of page 48 Specification, Example 6, page 49, line 1 to page 53, end of the page (including corresponding Tables 24-26) Specification at page 54, Example 7 and corresponding Figures 2-7, as argued.
Claim rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 83 – 92 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rodgers et al. in US 2008/0312259 (published: December 18, 2008) in view of Segura-Orsoni, S. in U.S. 2008/0207570 (published: August 28, 2008).
Claim Interpretation: Claim limitation “a means for effecting skin penetration of the phosphoric acid salt” has been interpreted under 35 U.S.C. 112, sixth paragraph, because it uses a non-structural term “means for” coupled with functional language “effecting skin penetration of the phosphoric acid salt” without reciting sufficient structure to achieve the function. Furthermore, the non-structural term is not preceded by a structural modifier.
Since this claim limitation invokes 35 U.S.C. 112, sixth paragraph, claim 82 is interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112, sixth paragraph limitation: As disclosed in Example 6 of the present specification (Skin Permeation Studies), an emulsion, more specifically, an oil-in-water or water-in-oil emulsion appears to be the corresponding structure that achieves the claimed function of “effecting skin penetration of the phosphoric acid salt.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not wish to have the claim limitation treated under 35 U.S.C. 112, sixth paragraph, applicant may amend the claim so that it will clearly not invoke 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112, sixth paragraph.
For more information, see Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. § 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Rodgers teaches and claims a method of treating atopic dermatitis comprising administering a therapeutically effective amount of the active compound (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt (Claims 12 and 19) wherein the composition is suitable for topical administration (Claim 9; reasonably construed as a formulation suitable for topical skin application to a human patient with atopic dermatitis). Rodgers teaches that when present in, for example, an emulsion (a topically applied formulation) the active compound is present in up to 10% of the composition (p [0051]). The % of active compound in Rodgers overlaps with and thus render prima facie obvious the % by weight amounts recited in instant Claims 83 and 85 – 87. See MPEP 2144.05: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). As disclosed in Example 6 of the present specification (“Skin Permeation Studies”), emulsion compositions, e.g. oil-in-water or water-in-oil emulsion composition, qualify as a means for effecting skin penetration of the phosphoric acid salt.
Instant Claims 84, 88-92 are drawn to an intended use of the composition of Claim 83. As discussed in MPEP 2103:
The subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. The following are examples of language that may raise a question as to the limiting effect of the language in a claim:
(A) statements of intended use or field of use,
(B) “adapted to” or “adapted for” clauses,
(C) "wherein" clauses, or
(D) “whereby” clauses.
Instant Claim 84 is drawn to a use of the composition of instant Claim 83, i.e. suitable for application to the patient’s skin for up to 84 consecutive days. Instant Claims 88 is drawn to a patient has a skin disorder of instant Claim 84, i.e. autoimmune skin disorder associated with JAK1 and/or JAK2, chosen form PV, BP, psoriasis, dermatitis. The language “wherein the composition is suitable for application to the patient’s skin for up to 84 consecutive days” does not require any steps to be performed nor does it further limit the structure of the emulsion rendered obvious by Rodgers. The language “patient has a skin disorder” does not require any steps to be performed nor does it further limit the structure of the emulsion rendered obvious by Rodgers. As such, the language of Claim 84 and 88-92 do not further limit the scope of the composition of Claim 83 and is therefore not accorded patentable weight.
Further, it is noted that the language “suitable for application to the patient’s skin for 84 consecutive days” “patient has a skin disorder” are reasonably construed as being indistinct from ‘A composition suitable for application to the skin of a patient for 84 consecutive days’ (a preamble) which is taken to be an intended use and is therefore not accorded patentable weight. As discussed in MPEP 2111.02 (II): "If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction." Pitney Bowes, Inc. v. Hewlett- Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473,478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997).
In the present case, the language of Claims 84 and 88-92 merely recites the purpose or intended use of the composition of Claim 83 and is therefore not accorded patentable weight.
It is noted that, as discussed above, Rodger’s teaching of a topical emulsion composition (a means for effecting skin permeation) comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt in amounts that overlap with the amounts instantly claimed render prima facie obvious instant Claims 83 – 92.
However, should one argue that the instant specification limits those structures that qualify as a “means for effecting skin permeation” to an oil-in-water (or water-in-oil) emulsion), it would have been prima facie obvious to modify the emulsion of Rodgers with an oil-in-water emulsion in view of Segura-Orsoni, for the reasons set forth below.
Segura-Orsoni teaches topically active oil-in-water emulsions having a high proportion of oily phase in the inner phase, wherein said emulsions combine the occlusive and emollient properties of an ointment without having the drawbacks of a greasy feel, while at the same time promoting the therapeutic properties of a biologically active agent contained therein. Segura-Orsoni teaches these emulsions are especially useful for the treatment of dermatological diseases, conditions or afflictions, notably psoriasis (Abstract).
Segura-Orsoni teaches the emulsion compositions for the topical treatment of psoriasis comprising at least one therapeutic agent (Abstract, p [0099] and [0017] – [0020]) said composition comprise: a) from 25% to 60% by weight of a fatty phase, b) from 1% to 15% by weight of a nonionic emulsifying system, c) from 1% to 30% by weight of at least one penetrating agent and d) from 5% to 50% by weight of water (Claim 1).
Segura-Orsoni teaches the composition comprises at least one biologically active agent (i.e. therapeutic agent) in amounts ranging from about 0.01 to 0.5% by weight (p [0077], Claim 14) which fall within or overlap with the % by weight amounts recited in instant Claims 83 and 85 – 92.
Segura-Orsoni teaches the stable emulsion compositions in the form of a cream (Formulation 3, p [0116]) wherein said formulation comprises a fatty phase (isopropyl palmitate, a mineral oil, petroleum jelly (p [0027]), the Applicant-defined ‘stabilizing component’ xanthan gum (p [0070] – [0072]), an emulsifying system comprising glyceryl monostearate/ceteareth surfactant couple, which offers the advantage of rigidifying the interfacial film and, consequently, of substantially increasing the stability of the emulsion, p [0037], Claim 4).
Segura-Orsoni does not teach an oil-in-water emulsion composition wherein the active therapeutic agent is the instantly claimed (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to formulate the topical emulsion composition of Rodgers comprising the active agent, (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt as an oil-in-water emulsion. One would have been motivated to do so because Segura-Orsoni teaches oil-in-water emulsions known to be advantageous for topical application to the skin, said compositions that combine the occlusive and emollient properties of an ointment without having the drawbacks of a greasy feel, while at the same time promoting the therapeutic properties of a biologically active agent contained therein, for the treatment of skin disorders such as psoriasis.
As such, one would have had a reasonable expectation of success that formulating the (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt of Rodgers as the therapeutic agent in the oil-in-water emulsion of Segura-Orsoni (a means for effecting skin permeation) would be therapeutically effective for the treatment of psoriasis.
Conclusion
Claims 83 –92 are rejected. No claims are allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1627
1 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”.