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 1-19 are pending in the application. Claims 1-19 are rejected.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/JP2023/011678, filed on March 24, 2023, which claims priority to Japanese Application No. JP2022-049233, filed on March 25, 2022.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on September 25, 2024 and March 27, 2026 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 8-11 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.
Claim 3 recites the limitation “an ischemic (arterial) ulcer” and is rejected as indefinite. It is unclear whether Applicant intended the recited parenthetical expression (i.e., arterial) to further limit “ischemic.” See MPEP § 2173.05(d).
Claim 8 recites “The composition according to claim 7” and is rejected as indefinite because it is unclear whether Applicant intended claim 8 to further limit a) the composition as recited in parent claim 7 or b) the method according to parent claim 7. Dependent claims 9-11 do not correct this issue of indefiniteness and are hence rejected.
Claims 9-11 each recite the limitation “The method according to claim 8” and are rejected as indefinite. There is insufficient lack of antecedent basis for this limitation in each claim as parent claim 8 does not provide for a method.
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 1-19 are rejected under 35 U.S.C. § 103 as being unpatentable over Murakami et al. (PCT Publication No. WO 2017/115780 A1; July 6, 2017) in view of Smith et al. (U.S. PGPub. No. 2005/0020639 A1; January 27, 2005) and Yang et al. (Innate Immunity. 2018, 24(8):501–512).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Regarding instant claims 1, 5, 6, 12 and 16, Murakami et al. teach an “ointment [which] stably comprises an oxazole compound that has specific inhibitory activity against PDE4 and that is represented by the following formula (11)” (see e.g., the abstract):
PNG
media_image1.png
193
538
media_image1.png
Greyscale
.
The above prior art compound of formula (11) corresponds to the instantly claimed N-({2-[4-(difluoromethoxy)-3-(propan-2-yloxy)phenyl]-1,3-oxazol-4-yl}methyl)-2-ethoxybenzamide. Murakami et al. also teach “Example 1” in paragraph [0229] wherein the above prior art compound is present in an amount of 3 mass%. Note that instant claims 5 and 6 are drawn towards non-limiting characteristics that would necessarily be present in the instantly claimed composition. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. See MPEP § 2112.01(II).
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 1, Murakami et al. does not teach the instantly claimed method of treatment for wound. However, Smith et al. teach “PDE4 inhibitors are particularly useful for the treatment of a great number of inflammatory, respiratory and allergic diseases, disorders or conditions and for wounds.” See e.g., paragraph [0004]. Smith et al. further teach compositions for the reduction of “scar formation in the healing of acute wounds.” See e.g., paragraph [0285].
Regarding instant claims 2-4 and 7-11, Murakami et al. does not teach a wound or various wound types (pressure ulcer, oral ulcer, etc.). However, Smith et al. teach methods of treating infection due to Herpes simplex which are known to cause mouth ulcers. See e.g., paragraph [0282]. Smith et al. further teach “conjunctivitis of whatever type, etiology, or pathogenesis” as well as “uveitis of whatever type, etiology, or pathogenesis.” See e.g., paragraphs [0271] and [0272]. Additionally, Smith et al. teach “dermatological and cosmetic uses, including antiphlogistic, skin-softening, skin elasticity and moisture-increasing activities.” See e.g., paragraph [0286].
Regarding instant claims 13-15 and 19, the teachings of Murakami et al. are generally focused on ointment formulations (i.e., for skin absorption) of the instant compound. See e.g., paragraph [0006]. However, Smith et al. teach topical administration, either dermally or transdermally, where typical formulations include ointments and dressings. See e.g., paragraph [0194]. Smith et al. further teach ocular administration in the form of, for instance, ointments. See e.g., paragraph [0210]. Smith et al. further teach formulations suitable for oral, buccal or sublingual administration such as muco-adhesive films, sprays and liquid formulations. See e.g., paragraphs [0179] and [0180].
Regarding instant claims 17 and 18, Murakami et al. also does not teach the instantly claimed dosing frequency requirements. However, Smith et al. teach an “overall daily dose...which may be administered in a single dose or, more usually, as divided doses throughout the day.” See e.g., paragraph [0203].
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Therefore, considering that Smith et al. teach compositions comprising PDE4 inhibitor compounds for the treatment of wounds, it would have been obvious to a person of ordinary skill in the art to substitute a PDE4 inhibitor taught by Smith et al. with the PDE4 inhibitor (i.e., also instant compound) taught by Murakami et al. Furthermore, considering that Yang et al. teach PDE4 inhibitors “may serve as positive regulators of macrophage recruitment for more efficient pathogen clearance and wound repair” (see e.g., the abstract), a person of ordinary skill in the art would reasonably expect the composition resulting from this substitution to be effective in treating wounds. MPEP § 2143(I) states:
The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art.
Therefore, at least in the interest of providing additional PDE4 inhibitor compounds for wound treatment methods, a person of ordinary skill in the art would have been motivated to employ the instantly claimed methods. “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." In re Williams, 36 F.2d 436, 438 (CCPA 1929).
In addition, it would have been obvious to a person of ordinary skill in the art to arrive at the instantly claimed methods for treating various wound types (e.g., pressure ulcer, oral ulcer, etc.) utilizing various formulations (e.g., ointments, dressings, etc.) based on the combined teaching of the prior art. It is within the ability of a skilled artisan to assess and determine the most effective treatment method for any given wound. Therefore, a skilled artisan looking to provide the appropriate treatment to a patient with a wound would have been motivated to employ the instantly claimed methods as necessary.
It would further have been obvious to arrive at the instantly claimed dosing frequency requirements based on the combined teachings of the prior art. The optimization of result-effective variables, i.e., variables that achieve a recognized result, such as dosing frequencies, are considered to be within the ability of the skilled artisan. Therefore, a skilled artisan would have been motivated to optimize the aforementioned result effective parameter as part of a routine optimization process. “[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).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 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, RENEE CLAYTOR can be reached at (571)272-8394. 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.
/D.M.S./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
Prosecution Insights