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 THE CLAIMS: Claims 1-15 are pending in this application.
Election/Restrictions
Applicant’s election of species in the reply, filed on August 18, 2026, is acknowledged. All claims were examined in its entirety.
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 1-15 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Teikoku et al., (WO2013/008909) in view of Usuda et al., (WO2019/160067).
Applicants claims a patch comprising the following:
PNG
media_image1.png
70
787
media_image1.png
Greyscale
Teikoku teaches a similar patch comprising loxoprofen, hydrate, hydroxy acid in a pasty preparation. (See paragraphs [0009] and [0029]-[0030], Examples and page 16.
Teikoku does not disclose the patch comprising a metal oxide.
Usuda teaches an external patch for medicinal use comprising a metal oxide. (See Abstract, paragraph [0002], Examples and claims 1-15).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to combine the teachings of Teikoku and Usuda to design a patch comprising metal oxide to improve its stability and formulation compatibility, and for the purpose of further improving the stability of the principal agent-loxoprofen. It is well known in the art that metal oxides are incorporated into external patches for medicine use because they combine antimicrobial, anti-inflammatory and regenerative properties with the ability to deliver active agents in a controlled manner and are stable in air and in solution with good solubility in water and common organic solvents. Additionally, it is well known in the art that metal oxides improve bioavailability, has sustained action and versatility in formulation, and has a well-established safety profile, making them suitable for various dosage forms in patches. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, would be motivated to combine the teachings of Teikoku and Usuda when confronted with an alternate patch a patch comprising metal oxide to improve its stability and formulation compatibility, and for the purpose of further improving the stability of the principal agent, and thus is an obvious alternative. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Teikoku and Usuda, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 1-15 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Morita et al., (JP2011-20997) in view of Usuda et al., (WO2019/160067).
Applicants claims a patch comprising the following:
PNG
media_image1.png
70
787
media_image1.png
Greyscale
Morita teaches a similar patch comprising loxoprofen, hydrate, hydroxy acid in a pasty preparation. (See paragraphs [0009] and [0029]-[0030], Examples and page 16.
Morita does not disclose the patch comprising a metal oxide.
Usuda teaches an external patch for medicinal use comprising a metal oxide. (See Abstract, paragraph [0002], Examples and claims 1-15).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to combine the teachings of Morita and Usuda to design a patch comprising metal oxide to improve its stability and formulation compatibility, and for the purpose of further improving the stability of the principal agent--loxoprofen. It is well known in the art that metal oxides are incorporated into external patches for medicine use because they combine antimicrobial, anti-inflammatory and regenerative properties with the ability to deliver active agents in a controlled manner and are stable in air and in solution with good solubility in water and common organic solvents. Additionally, it is well known in the art that metal oxides improve bioavailability, has sustained action and versatility in formulation, and has a well-established safety profile, making them suitable for various dosage forms in patches. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, would be motivated to combine the teachings of Morita and Usuda when confronted with an alternate patch a patch comprising metal oxide to improve its stability and formulation compatibility, and for the purpose of further improving the stability of the principal agent, and thus is an obvious alternative. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Morita and Usuda, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 1-15 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Teikoku et al., (WO2013/008909) in view of Tsujimoto et al., (JP2002-226336).
Applicants claims a patch comprising the following:
PNG
media_image1.png
70
787
media_image1.png
Greyscale
Teikoku teaches a similar patch comprising loxoprofen, hydrate, hydroxy acid in a pasty preparation. (See paragraphs [0009] and [0029]-[0030], Examples and page 16.
Teikoku does not disclose the patch comprising a metal oxide.
Tsujimoto teaches an external patch for medicinal use comprising metal oxides. (See Abstract, paragraphs [0001]- [0002], [0005]-[0008], Examples and claims 1-7).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to combine the teachings of Teikoku and Tsujimoto to design a patch comprising metal oxides to improve its stability and formulation compatibility, and for the purpose of further improving the stability of the principal agent-loxoprofen. It is well known in the art that metal oxides are incorporated into external patches for medicine use because they combine antimicrobial, anti-inflammatory and regenerative properties with the ability to deliver active agents in a controlled manner and are stable in air and in solution with good solubility in water and common organic solvents. Additionally, it is well known in the art that metal oxides improve bioavailability, has sustained action and versatility in formulation, and has a well-established safety profile, making them suitable for various dosage forms in patches. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, would be motivated to combine the teachings of Teikoku and Tsujimoto when confronted with an alternate patch a patch comprising metal oxide to improve its stability and formulation compatibility, and for the purpose of further improving the stability of the principal agent, and thus is an obvious alternative. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Teikoku and Tsujimoto, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Claims 1-15 (including claims dependent thereon) are rejected under 35 U.S.C. 103 as being unpatentable over Morita et al., (WO2013/008909) in view of Tsujimoto et al., (JP2002-226336).
Applicants claims a patch comprising the following:
PNG
media_image1.png
70
787
media_image1.png
Greyscale
Morita teaches a similar patch comprising loxoprofen, hydrate, hydroxy acid in a pasty preparation. (See paragraphs [0009] and [0029]-[0030], Examples and page 16.
Morita does not disclose the patch comprising a metal oxide.
Tsujimoto teaches an external patch for medicinal use comprising metal oxides. (See Abstract, paragraphs [0001]- [0002], [0005]-[0008], Examples and claims 1-7).
It would have been obvious to one having ordinary skill in the art at the time of the invention to be motivated to combine the teachings of Morita and Tsujimoto to design a patch comprising metal oxides to improve its stability and formulation compatibility, and for the purpose of further improving the stability of the principal agent-loxoprofen. It is well known in the art that metal oxides are incorporated into external patches for medicine use because they combine antimicrobial, anti-inflammatory and regenerative properties with the ability to deliver active agents in a controlled manner and are stable in air and in solution with good solubility in water and common organic solvents. Additionally, it is well known in the art that metal oxides improve bioavailability, has sustained action and versatility in formulation, and has a well-established safety profile, making them suitable for various dosage forms in patches. All of the moieties are taught in the art. Therefore, one of ordinary skill in the art, would be motivated to combine the teachings of Morita and Tsujimoto when confronted with an alternate patch a patch comprising metal oxide to improve its stability and formulation compatibility, and for the purpose of further improving the stability of the principal agent, and thus is an obvious alternative. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of Morita and Tsujimoto, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Conclusion
Claims 1-15 are pending in this application. Claims 1-15 are rejected. No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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, James Alstrum-Acevedo can be reached at 571-272-5548. 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.
/PAUL V WARD/ Primary Examiner, Art Unit 1622
Prosecution Insights