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 claims foreign priority to CHINA 2022111743290 (09/26/2022).
Information Disclosure
An IDS was not filed in this application. Applicant is AGAIN reminded of the duty of disclosure as per 37 CFR 1.56 and detailed in MPEP § 2000.
Election/Restrictions
Applicant's election of species without traverse of the species ADRB1 inhibitor ACE (aka acebutolol) in the reply filed on 3/2/26 is acknowledged.
The Examiner determined the elected species reads on claims 1-7.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987). Accordingly, claim 8 is hereby withdrawn.
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
Status
Applicant cancelled all pending claims and presented new claims 9-11.
New 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.
Claims 9-11 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
Applicant introduced new claims 9-11 while stating support for the added claim limitation is found:
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The cited parts of the as-filed specification were reviewed and not found to support the new claim language. Specifically, there was no literal support for claim 9’s language of “0.05 milligrams per square centimeter (mg/cm2) of skin lesion per day”. In addition, based on the original disclosure one of skill in the art would not recognize that Applicant possessed such a scope.
As per MPEP 2163 II A: With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04 ("If applicant amends the claims and points out where and/or how the originally filed disclosure supports the amendment(s), and the examiner finds that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of the filing of the application, the examiner has the initial burden of presenting evidence or reasoning to explain why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims."). The inquiry into whether the description requirement is met is a question of fact that must be determined on a case-by-case basis. AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1297, 111 USPQ2d 1780, 1788 (Fed. Cir. 2014) ("Whether a patent claim is supported by an adequate written description is a question of fact."); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) ("Precisely how close [to the claimed invention] the description must come to comply with Sec. 112 must be left to case-by-case development."); In re Wertheim, 541 F.2d at 262, 191 USPQ at 96 (inquiry is primarily factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure).
The examiner could not locate support for such a new limitation, nor does there appear to be a written description of the limitation in the application as filed. See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that "[MPEP] § 2163.04 (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description rejection."). Thus, claims 9 and those that depend therefrom are rejected.
New 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 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.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shamloo et al. (US20200237724).
Shamloo teaches adrenergic receptor beta 1 (ADRB1) inhibitor compounds (Abstract, [0316]-[0319]) for treating psoriasis (claim 66, 68: “treating a subject for an inflammatory condition and the contacting comprises administering (e.g., oral, dermal, intranasal administration) the β1-selective adrenergic receptor modulating compound to a subject in need thereof”, “wherein the inflammatory condition is psoriasis.”) where the compound is acebutolol ([0303]) in a pharmaceutical composition ([0256]). Shamloo teaches dermal topical administration ([0265]: “Formulations suitable for topical administration may be presented as creams, gels, pastes, or foams”; [0280]: “In some instances, the route of administration is dermal, e.g., via topical application of a suitable pharmaceutical composition.”; [0259]). Shamloo teaches therapeutically effective amounts and methods for determining effectiveness of dosing, amounts per day, including specifically 0.050 mg ([0268], [0294]-[0299]).
Regarding claim 9, Shamloo does not teach the claimed therapeutically effective amount when administered topically is 0.05 mg/cm2 of skin lesion per day as claimed.
As per MPEP 2144.05 II. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In reKulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was “unexpectedly good”); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
In this case, Shamloo specifically suggested topical dermal formulation to achieve a therapeutic effect that would have motivated one of ordinary skill in the art to optimize the formulation including the amount in mg/cm2 per day in treating a psoriasis skin lesion. Shamloo discloses ranges encompassing the instant claims and provides guidance on how to optimize the formulation, thus one of ordinary skill in the art would have had a reasonable expectation of arriving at the claimed invention.
Regarding claim 10 depending from claim 9, Shamloo teaches topical administration in the same manner but does not specifically teach the intended result of “to inhibit increase of norepinephrine caused by … “ as in the claims. These results would be inherently present in the administration of the same compound in the same manner as claimed. In addition, a “clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (MPEP 2111.04).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shamloo et al. (US20200237724) as applied to claims 9-10 above and further in view of Rowe et al. (“Handbook of Pharmaceutical Excipients”, 6th ed., 2009, p. 238-240, 714-717).
Regarding claim 11, Shamloo teaches choice of pharmaceutical excipients per routine formulation known in the art ([0256]-[0258]: “the pharmaceutical compositions are formulated for administration in accordance with routine procedures as a pharmaceutical composition“). Shamloo does not specifically teach DMSO and SBE-B-CD as in the instant claim.
Rowe teaches both well-known excipients DMSO and SBE-B-CD as effective in pharmaceutical compositions (p. 238: “Dimethyl sulfoxide enhances the topical penetration of drugs”, “Penetration agent; solvent”; p. 714: “Biocompatibility enhancer; complexing agent; dissolution enhancer; osmotic agent; solubilizing agent; stabilizing agent”).
One of ordinary skill in the art following the teaching of Shamloo formulating a composition would have considered the well-known excipients of DMSO and SBE-B-CD as they are routinely used in such formulations and improve penetration and biocompatibility.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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 Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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