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
Status of 18/686,168
Claims 1-29 are currently pending.
Priority
Instant application 18/686,168, filed 2/23/2024, claims priority as follows:
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Support for the instant claims is identified in the earliest provisional application dated 8/23/2021.
Information Disclosure Statement
All references from the IDS submitted on 3/26/2025 and 7/3/2025 have been considered unless marked with a strikethrough.
Objection to Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figure 1 is not able to be interpreted. Figure 1 contains numbered parts that are not described in the specification. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Election/Restriction
Applicant’s election of Group I, claims 1-6, drawn to a composition, without traverse, in the reply filed 4/10/2026 is acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Claims 1-6 are the subject of this Office Action. Claims 7-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim. Though no species of composition was elected, the Examiner began by searching the contents of Table 1 of the instant specification and identified prior art. See the 102 and 103 rejections below.
Claim Interpretation
Claim 2 recites the limitation, “the composition is shelf stable for up to about 60 months”. This is considered a functional limitation, and if the composition meets the structural limitations previously recited in claim 1, the claim from which 2 depends, then the functional limitations would flow from embodiments meeting the structure. It does not further limit the composition, or stated differently, does not further limit the structural limitations, and thus is not granted patentable weight.
Claim 6 recites the limitation, “the composition is stored at room temperature”. Similar to above, this is considered intended use of the composition because it is not what the compound is, but rather what the compounds does. Storing the composition at room temperature is an intended use of the composition and does not further limit the composition, and is thus not granted patentable weight.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, claim 2 recites, “the composition is shelf stable for up to about 60 months”, which is currently being interpreted as an intended use and is not granted patentable weight. The limitation “the composition is stored at room temperature” recited in claim 6 is also currently being interpreted in this manner, and is not granted patentable weight. See the “Claim Interpretation” section above. Appropriate correction is required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kaplan (US 2002/0128326 A1).
The reference Kaplan discloses topical drug compositions containing sensitizing agents as the active components (abstract), and specifically discloses compositions containing squaric acid dibutylester (para [0011]). One of the compositions contains squaric acid dibutylester in a 0.005% concentration along with polyoxyethylene 20 sorb. monopalmitate and isopropyl myristate, both of which qualify as excipients under Applicants definitions in paragraphs [0034] and [0045] of the instant specification. Further, in accordance with Applicant’s definition of “essentially free” in paragraph [0017] of the specification, the composition is essentially free of water and DMSO. The composition additionally has a volume of 1.0 mL, which satisfies the last limitation of instant claim 1.
Additionally, Kaplan discloses another composition with squaric acid dibutylester in a 0.010% concentration with polyoxyethylene 4 sorbitan monolaurate that is essentially free of water and in a volume of 1.0 mL (para [0011]). Thus, Kaplan anticipates claims 1-3 and 6.
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.
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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan (US 2002/0128326 A1) as applied to claims 1-3 and 6 above.
Determining the scope and contents of the prior art
Kaplan teaches as disclosed above, and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
Kaplan fails to teach a composition where the concentration of squaric acid dibutylester is in an amount of at least about 5%, or is in an amount of at least about 10%.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of compositions containing a squaric acid ester. An artisan possess the technical knowledge necessary to make adjustments to the compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said compositions containing a squaric acid ester and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
It would have been prima facie obvious to one having ordinary skill in the art to arrive at the concentrations of squaric acid dibutylester recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the composition to provide optimal alopecia areata treatment compositions. The concentration of each individual ingredient in the composition is a result effective parameter that will affect the physical properties of the final composition. The amount of squaric acid dibutylester in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the ratio of squaric acid dibutylester, disclosed by Kaplan above, provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal ratio of squaric acid dibutylester to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Conclusion
Claims 1-6 are rejected. Claims 7-29 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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