DETAILED CORRESPONDENCE
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 .
Status of Application
The claim set and remarks filed on 12/6/2024 are acknowledged.
Claims 1-34, 38, 39, 41-45, and 48 are cancelled.
Claims 35-37, 40, 46, 47, and 49-62 are pending.
Claim Rejections - 35 USC § 103
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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 35-37, 40, 46, 47, and 49-62 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR102265592B1 Machine English Translation) hereinafter Kim in view of Solioz et al. (US20180344852A1) hereinafter Solioz.
Regarding claims 35-37, 40, 46, 47, and 49-62, Kim is drawn to a composition comprising 5-aminolevulinic acid hydrochloride. The composition comprising 5-aminolevulinic acid hydrochloride according to the present invention contains 5-aminolevulinic acid hydrochloride, a substance used in photo dynamic therapy (PDT), thereby being able to be used as a cosmetic composition for alleviating acne skin (abstract).
Kim discloses a composition containing 5-aminolevulinic acid hydrate chloride according to the present invention can be used as an oral drug composition for fluorescence-induced malignant tissue visualization or as a cosmetic composition for improving acne-prone skin, by including 5-aminolevulinic acid hydrate chloride, which is a substance used in photodynamic therapy (PDT) [0021]. Kim discloses propylene glycol [0017]. Kim discloses a cosmetic composition for improving acne-prone skin containing 5-aminolevulinic acid hydrated chloride comprises 8 to 12 weight% of 5-aminolevulinic acid hydrated chloride, 10 to 20 weight% of propylene glycol [0063]. Kim discloses the propylene glycol prevents the formulation of the cosmetic composition from changing or degrading, thereby maintaining the formulation stability of the cosmetic composition, and has an antibacterial effect and inhibits the growth of bacteria, and can serve as a humectant, a watering agent, and a preservative [0126].
Kim does not explicitly disclose the presence of a chelating agent.
However, Solioz is drawn to a pharmaceutical topical gel solution that contains 5-aminolevulinic acid (5-ALA) (abstract).
Solioz discloses chelating agents such as EDTA [0053].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Kim, to comprise EDTA in the topical composition, as previously disclosed by Solioz, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Kim and Solioz are both in the field of topical compositions comprising aminolevulinic acid and Solioz discloses a composition according to the present invention comprising
a) 5-ALA or its HCl salt as an active ingredient; b) a first penetration enhancer selected from one or more water-miscible ether compounds, preferably non-ethoxylated water-miscible ether compounds; and c) a second penetration enhancer selected from one or more glycosaminoglycan compounds. [0028]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00am-5:00pm.
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, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615
Prosecution Insights