DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the second Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Reply filed 23 June 2026, Applicant amended claims 1 and 5-8, cancelled claims 3-4 and 12, and added fifteen new claims, i.e., claims 15-29. Claims 2, 9-11, and 13-14 were cancelled previously by Applicant. Claims 1, 5-8, and 15-29 are pending.
Status of the Rejections and Objections
The objection to claim 12 is withdrawn in view of Applicant’s cancellation of the claim.
The objection to claim 5 is new.
The rejection of claims 1, 3-8, and 12 under 35 U.S.C. 112(a) for lack of enablement is withdrawn in view of Applicant’s amendment to claim 1 requiring that an “effective amount” of the fraction is administered to the individual. The examiner appreciates Applicant’s effort to advance prosecution.
The rejection of claims 15 and 20-26 under 35 U.S.C. 112(a) for failing to comply with the written description requirement is new and has been necessitated by Applicant’s claim amendments.
The rejection of claims 1, 3-8, and 12 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s (i) clarifying amendments to claims 1 and 5-8; and (ii) cancellation of claims 3-4 and 12. The examiner appreciates Applicant’s effort to advance prosecution.
The rejection of claims 1, 3-4, and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (“Anti-allergic effects of the ethanol extract of Syzygium formosum (Wall.) Masam leaves and its immunoregulatory mechanisms.” Journal of ethnopharmacology 211 (2018): 171-179) is withdrawn in view of Applicant’s narrowing amendment to claim 1 requiring that the fraction has a higher content of madecassic acid.
The rejection of claims 1, 3-8, and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Choi (KR 20130068307 A) is withdrawn in view of Applicant’s narrowing amendment to claim 1 requiring that the fraction has a higher content of madecassic acid.
All rejections under 35 U.S.C. 103 set forth in this Office action are new and have been necessitated by Applicant’s claim amendments.
Claim Objections
Claim 5 is objected to because of the following minor informality: The word “that” is missing between the words “formulation” and “comprises.” Appropriate correction is required.
Claim Rejections - 35 U.S.C. 112(a)
The following is a quotation of 35 U.S.C. 112(a):
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 15 and 20-26 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement.
Claims 15 and 20-26, all of which are new, contain subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the invention, as now claimed.
Referring to the specification of the present application as originally filed 29 May 2023, Table 4 — which is located on page 14 and expresses values in units of ppm — is reproduced below:
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Table 4 provides no support for the following range limitation recited in claim 15: “wherein the fraction includes each of asiatic acid, madecassic acid, corosolic acid, maslinic acid, betulinic acid, ursolic acid and oleanolic acid in a combined amount of 3,000 ppm to 300,000 ppm based on the total weight of the fraction.” Emphasis added. Table 4 supports only a combined amount of 255,600 ppm, which is equivalent to 25.56% of the total weight of the fraction.
According to Table 4, the concentration of asiatic acid in the fraction is 106,200 ppm (10.62%). Table 4 does not support the asiatic acid concentration of 41.55 wt% recited in claim 20. Table 4 also does not support a limitless concentration range (i.e., “or more”) of asiatic acid. On the basis of similar reasoning, Table 4 also does not support the ranges recited in claims 21-26, respectively. It is important for Applicant to recognize that the fraction includes unspecified compounds other than asiatic acid, madecassic acid, corosolic acid, maslinic acid, betulinic acid, ursolic acid, and oleanolic acid. This is why the combined amount shown in the bottom right corner of Table 4 is 255,600 ppm, not 1,000,000 ppm.
No other relevant disclosure concerning claims 15 and 20-26 is included in the specification.
Given that none of Applicant’s claims, as originally filed, compensates for the deficiencies in the specification identified above, the present application does not reasonably convey to persons skilled in the art that the inventors, at the time the application was filed, had possession of the concentration ranges recited respectively in claims 15 and 20-26. Thus, each of those claims recites new matter. 35 U.S.C. 132(a) (“No amendment shall introduce new matter into the disclosure of the invention.”); see also MPEP § 608.04. Accordingly, it is appropriate to reject claims 15 and 20-26 under 35 U.S.C. 112(a).
Claim Rejections - 35 U.S.C. 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 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(a) 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, 5-8, 15-19, and 27-29 are rejected under 35 U.S.C. 103 as unpatentable over Vu (“Phytochemical profile of Syzygium formosum (Wall.) Masam leaves using HPLC–PDA–MS/MS and a simple HPLC–ELSD method for quality control.” J. of Pharmaceutical and Biomedical Analysis 168 (2019): 1-12 & SD1-SD16), as evidenced by Park (“Variation of triterpenic acids in 12 wild Syzygium formosum and anti-inflammation activity on human keratinocyte HaCaT.” Plants 10.11 (2021): 2428), in view of one or more of the following: Hwang (KR 101704996 B1), Mora (US 6,891,063 B1), Lee (KR 102096414 B1).
Vu is directed to the phytochemical profile of Syzygium formosum (Wall.) Masam leaves. This rejection contains citations to the primary article (pages 1-12), as well as citations to the Supplementary Data, which are in the following format: SD[page number].
Vu discloses: “Syzygium formosum (Wall.) Masam is an evergreen tree of the Myrtaceae family (also known under the synonym Eugenia formosa) that is widely distributed across Southeast Asia, India, Taiwan, and Brazil. This multipurpose plant is ingested as food or tea and used in traditional Asian medicines. In Vietnam, the leaves are typically used in traditional medicine for the treatment of skin rash, allergy, scabies, sore throat, bronchitis, and cystitis. S. formosum (SF) leaf extract has pharmacological activities such as antibacterial activity, especially toward Staphylococcus aureus and Escherichia coli, anti-allergic, anti-inflammatory, and antioxidant activity, and Moloney murine leukemia virus inhibition.” Page 1 at Section 1.
Vu discloses: “For the profiling analysis of SF leaves, their bioactive compounds were enriched using liquid-liquid-extraction method. In brief, 1.50 g of sample powder was extracted with 10 mL of ethanol (70%, v/v) by ultrasonication (45 kHz, 60 min). The solution was centrifuged for 5 min at 3000 rpm. The supernatant was then concentrated in a rotary vacuum at 50℃ to yield the dry crude extract. The obtained extract was suspended in 10.0 mL of water and subsequently partitioned three times with ethyl acetate (10.0 mL). The ethyl acetate layers were combined and evaporated to dryness in the rotary vacuum apparatus. The residue was then dissolved in ethanol (2.0 mL) and filtered through a 0.22-μm PVDF filter before LC–MS analysis.” Page 2 at Section 2.2 (emphasis added).
Vu discloses: “Four major bioactive components, i.e., asiatic acid, maslinic acid, corosolic acid, and betulinic acid, were used as marker compounds to develop an analytical method, which were detected in SF leaves using HPLC–ELSD. The bioactivities of these four constituents have been reported in several pharmacological studies. Asiatic acid demonstrates analgesic and anti-inflammatory effects in fulminant hepatitis and acute lung injury models. Inhibitory effects of asiatic acid against fungi and bacteria, including S. aureus, E. coli, Enterococcus faecalis, and Candida albicans, have also been reported. Anti-inflammatory and antibacteria activities of maslinic acid, corosolic acid, betulinic acid have also been reported recently. Among them, corosolic acid was the most active against S. aureus, while maslinic acid was the most active against E. faecalis. Remarkably, all four compounds exhibit strong anti-inflammatory effects, explaining the traditional use of SF leaves for the treatment of allergy-related diseases in Vietnam. Furthermore, as the most predominant components in SF leaves, these components are potentially important marker compounds for the quality control of SF leaves and related products on the market. Quality control of herbal samples using multiple pharmacological active compounds is widely practiced, which explains the selection of these components as marker compounds for developing the analytical method.” Pages 7-8 at Section 3.3 (emphasis added). Table 5 shows that the content of the four major bioactive compounds in SF leaves is 22.1 mg/g of asiatic acid, 12.3 mg/g of corosolic acid, 10.5 mg/g of betulinic acid, and 5.4 mg/g of maslinic acid. Page 11; see also page SD1 at Figure S2 (showing asiatic acid has the highest concentration across extraction times ranging from 30 to 180 minutes).
In addition to asiatic acid, maslinic acid, corosolic acid and betulinic acid, Table 1 of Vu shows that the SF leaf extract includes oleanolic acid and ursolic acid. Page 4. However, Vu is silent as to whether the SF leaf extract also includes madecassic acid.
Figure 2 of Park (page 4), which is reproduced below, evidences (i) that asiatic acid and madecassic acid are extremely similar in chemical structure and (ii) both those triterpenic acids are produced in sequential steps in the major α-myrin metabolic pathway of Syzygium formosum.
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Furthermore, Table 1 of Park (page 3) and Section 4.2 of Park (page 10) evidence (iii) that both asiatic acid and madecassic acid were present in the leaf extract (70% ethanol) of all twelve samples of Syzygium formosum.
At this juncture, it is important to recognize that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” (Emphasis added) MPEP § 2112.01(I), citing In re Best, 562 F.2d 1252, 1255 (CCPA 1977). The substantial similarities between the extraction process of Vu (the primary reference) and Park (the evidentiary reference) — along with observations (i), (ii), and (iii) above — provide a sound basis for the examiner’s position that the SF leaf extract of Vu further comprises madecassic acid. MPEP § 2112(I) (“‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’”), quoting Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Applicant is reminded that “[t]here is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” MPEP § 2112(II) (emphasis in original), citing Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003). The burden regarding madecassic acid is shifted to Applicant. MPEP § 2112(V) (“once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant”).
Although Vu discloses that the SF leaf extract has anti-inflammatory properties and can be administered to treat skin rash and allergy, among other conditions (page 1), Vu is silent as to whether the extract can be administered to treat eczema, erythema, or acne. Consequently, Vu does not satisfy claim 1 of the present application. As explained below, one or more of the following three references compensates for this deficiency: Hwang, Mora, and/or Lee.
Hwang, which published in Korean, is directed to “a composition for preventing or treating allergic diseases, containing a Syzygium formosum extract.” Abstract. The examiner obtained an English machine translation of Hwang using Google Patents. Unless otherwise indicated, all citations refer to that translation, which accompanies this Office action.
Hwang teaches that leaves of Syzygium formosum can be extracted using an aqueous solution of 50-70% ethanol. Page 3/9; see also page 1/9 at claim 2.
Hwang teaches that the SF leaf extract can be administered to treat atopic dermatitis. Page 3/9; see also page 1/9 at claims 6 and 11. The examiner notes that atopic dermatitis is also known as eczema.
Mora is directed to pharmaceutical compositions comprising salts of asiatic acid and madecassic acid. Abstract.
Mora teaches that asiatic acid and madecassic acid can be topically or systemically administered to treat “erithema.” Abstract; see also column 12 at claim 7. The examiner notes that “erithema” is an alternating spelling of erythema.
Lee, which published in Korean, is directed to a “[c]osmetic composition for improving of acne skin.” Title. The examiner obtained an English machine translation of Lee using Google Patents. Unless otherwise indicated, all citations refer to that translation, which accompanies this Office action.
Lee teaches that asiatic acid and madecaic acid (madecassic acid) can be topically administered, as active agents, to treat acne. Page 1/10 at Claims; see also page 4/10 (madecassic acid) and page 6/10 (anti-acne skin creams with asiatic and madecassic acids).
Before the effective filing date of the claimed invention, the foregoing teachings of Hwang, Mora, and/or Lee would have motivated a person having ordinary skill in the art to topically or systemically administer the SF leaf extract disclosed in Vu to a person in need of treatment for eczema, erythema, or acne. The foregoing modification would have made with a reasonable expectation of success, especially considering Vu discloses that the SF leaf extract contains a significant concentration of asiatic acid (page 9 at Table 2). Therefore, claims 1, 15, 19, and 27-29 are prima facie obvious.
Regarding claims 5-8, Applicant is referred to the cream formulation taught on page 5/10 of Lee, which comprises cetearyl alcohol, glycerin, and xanthan gum.
Regarding claims 16-17, Lee teaches that “Asiatic acid (asiatic acid) is a natural organic compound that can heal skin wounds and promote recovery, the asiatic acid is contained in about 0.1 to about 10 parts by weight compared to 100 parts by weight of the cosmetic composition.” Page 4/10. A person having ordinary skill in the art would have optimized the concentration of SF leaf extract, which was known to contain 0.300–0.900 mg/ml of asiatic acid (Vu, page 9, at Table 2), within the parameters taught in Lee. MPEP § 2144.05(II)(A) (“‘[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.’”), quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Regarding claim 18, Applicant is referred to Sections 2.2 and 2.6 of Vu. Page 2; see also page SD1 at Figure S2 (showing extraction times ranging from 30 to 180 minutes). In the interest of compact prosecution, the examiner reminds Applicant that “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.” MPEP § 2113(I); see also MPEP § 2113(II) (“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion.”).
Conclusion
Claims 1, 5-8, and 15-29 are rejected.
Claim 5 is also objected to.
No claim is 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 PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
03 September 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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