Prosecution Insights
Last updated: April 19, 2026
Application No. 18/562,934

ANTIBACTERIAL COMPOSITION PRODUCTION METHOD, ANTIBACTERIAL COMPOSITION, ANTIBACTERIAL METHOD, ANTIBACTERIAL AGENT, COSMETIC, AND DERMATOLOGICAL TOPICAL AGENT

Non-Final OA §101§102§103§112
Filed
Nov 21, 2023
Examiner
ARMSTRONG, SUSANNAH SIPPLE
Art Unit
1616
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
USHIO DENKI KABUSHIKI KAISHA
OA Round
1 (Non-Final)
29%
Grant Probability
At Risk
1-2
OA Rounds
4y 0m
To Grant
66%
With Interview

Examiner Intelligence

Grants only 29% of cases
29%
Career Allow Rate
4 granted / 14 resolved
-31.4% vs TC avg
Strong +38% interview lift
Without
With
+37.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
59 currently pending
Career history
73
Total Applications
across all art units

Statute-Specific Performance

§101
4.6%
-35.4% vs TC avg
§103
38.1%
-1.9% vs TC avg
§102
13.2%
-26.8% vs TC avg
§112
24.2%
-15.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 14 resolved cases

Office Action

§101 §102 §103 §112
DETAILED ACTION 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 Claims The preliminary amendment of 11/21/2023 is acknowledged. Claims 1-6 and 8-12 are amended. Claims 1-12 are currently pending and are examined on the merits herein. Priority The instant application filed 11/21/2023, is a 371 filing of PCT/JP2022/015773, filed 03/30/2022, which claims foreign priority to JP2021-095365, filed 06/07/2021. Information Disclosure Statement The information disclosure statements (IDS) submitted on 02/01/2024 and 04/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Objections Claims 1 is objected to because of the following informalities: Claim 1 recites “by simple lipid”, which appears to be a grammatical error that should recite “by a simple lipid”. Appropriate correction is required. 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 1-5 and 9 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 1 recites “producing a free fatty acid group by simple lipid and Staphylococcus epidermidis.” This limitation is extremely unclear as it is not apparent what steps are carried out to produce the free fatty acid group, specifically, how the simple lipid and Staphylococcus epidermidis are used in the method to produce the free fatty acid. The instant specification defines step (A) as the step of producing the free fatty acid group. In step (A), for example, staphylococcus epidermis is cultivated with [a] simple lipid, to produce the free fatty acid group ([0018] of instant specification). Example 1 of the instant specification further defines the production of fermented coconut oil using Staphylococcus epidermidis with a standard culture medium of Staphylococcus epidermidis into which coconut oil is added (p. 14, Ex. 1). Thus, the claims should define the steps carried out to produce the free fatty acid group, specifically how the simple lipid and Staphylococcus epidermidis are used together. For the sake of compact prosecution, the claim will be interpreted as producing a free fatty acid group by cultivating Staphylococcus epidermidis with a simple lipid. Claim 4 recites “wherein the simple lipid comprises at least one type of oil and fat selected from the group consisting of […]”. Given this wording, it is unclear if the simple lipid comprises at least one type of oil and at least one type of fat, or if it comprises at least one type of oil or fat. For the sake of compact prosecution, the claim will be interpreted as the simple lipid comprising at least one oil or fat selected form the group listed. Claim 9 recites an “antibacterial method comprising: inhibiting Staphylococcus aureus by the antibacterial composition”. It is unclear what steps are carried out in the method to cause the inhibition of S. aureus. For example, is the Staphylococcus aureus contacted with the antibacterial composition? For the sake of compact prosecution, the method will be interpreted as such. Claims 2-3 and 5 are also rejected by virtue of their dependency on claim 1. 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. 1. Claim 10 is 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. The claim recites an “antibacterial agent comprising: the antibacterial composition according to claim 6. The terms “antibacterial composition” and “antibacterial agent” do not reasonably convey different products and claim 10 does not define the antibacterial agent as comprising any additional ingredients as comparted to the composition of claim 6. As such, claim 10 fails to further limit claim 6. 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 § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 1. Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The following flow chart shown in MPEP 2106(III) is used to determine whether claims are subject matter eligible. PNG media_image1.png 890 597 media_image1.png Greyscale Following the above flowchart, the claims are to a process and a composition of matter (Step 1), the claim are directed to a natural phenomenon (Step 2A), and the claims do not recite additional elements that amount to significantly more than the judicial exception (Step 2B). Therefore, the claims are not eligible subject matter under 35 USC 101. Analysis Step 1: The claims recite a method for producing an antibacterial composition and various embodiments of the antibacterial composition. Therefore, the claims are process and composition of matter claims. Step 2A: Step 2A is a two-prong inquiry according to the flowchart shown in MPEP 2106.04(II)(A). PNG media_image2.png 902 502 media_image2.png Greyscale Prong One: Yes. The claims recite a natural phenomenon. The claims recite a method comprising producing a free fatty acid group by simple lipid and Staphylococcus epidermidis as well as an antibacterial composition made by such a method and an antibacterial composition comprising a free fatty acid group derived from Staphylococcus epidermidis. Both Staphylococcus epidermidis and simple lipids are found naturally on the surface of human skin. Given that the claims do not specifically define the method steps for obtaining or deriving the free fatty acid group and how it differs from fatty acids in nature, said free fatty acid group would necessarily be produced on the surface of human skin when both a simple lipid and Staphylococcus epidermidis are present together. Thus, the claimed free fatty acid group and the composition comprising it is a product of nature (i.e. natural phenomenon). When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Although the claims define a method, where a process claim reciting a nature-based product is drafted in such a way that there is no difference in substance from a product claim, the claim is subject to the markedly different analysis for the recited nature-based product. For example, consider a claim that recites, in its entirety, "a method of providing an apple." Under the broadest reasonable interpretation, this claim is focused on the apple fruit itself, which is a nature-based product. See MPEP 2106.04(c)(I)(C). In the instant case, the method claims are focused on the free fatty acid group itself and a composition in which it is comprised. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception. See MPEP 2106.04(c)(II). In the instant case, free fatty acid groups derived or produced by Staphylococcus epidermidis, are found in nature and the claims do not recite the free fatty acid group in such a way that makes it markedly different from those found from nature. Thus, the free fatty acid group limitation is a product of nature exception. Prong Two: No. This judicial exception is not integrated into a practical application because the method and composition claims simply recite the intended use of the free fatty acid composition as an antibacterial agent. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. See MPEP 2111.02. In the instant claims, there is no specific recitation of integrating the defined composition in a treatment method. Reciting that the composition is used in an antimicrobial method of inhibiting S. aureus also does not define a treatment method for a specific disease or disorder which amounts to a practical application. Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Although the claims recite the intended use of the composition as an antibacterial agent, “if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. See MPEP 2111.02. Additionally, the antibacterial properties of the instant composition are inherent to the structure of said composition, meaning antibacterial properties do not serve to structurally define the composition. Many naturally occurring free fatty acids are also known to possess antibacterial properties, meaning that such a property would not differentiate between a naturally occurring free fatty acid and one which was particularly derived. As such, the claims do not amount to significantly more than the exception itself, the claim is not patent-eligible 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. Claims 1-4, 6-7, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshizumi, H., et al. (EP 0188628 A1, 07/30/1986, PTO-892), hereinafter Yoshizumi as evidenced by Chen CH, et al. (2011). An innate bactericidal oleic acid effective against skin infection of methicillin-resistant Staphylococcus aureus: a therapy concordant with evolutionary medicine. J Microbiol Biotechnol. 21(4):391-9 (PTO-892), hereinafter Chen and Boskou, D., et la. (2006). 4 - Olive Oil Composition, Olive Oil (Second Edition), AOCS Press, Pages 41-72, (PTO-892), hereinafter Boskou, and Boateng L, et al. (2016). Coconut oil and palm oil's role in nutrition, health and national development: A review. Ghana Med J. 50(3):189-196, (PTO-892), hereinafter Boateng. Yoshizumi discloses a process for producing fatty acids used for wide applications in chemical industries, such as industrial chemicals, medicines, perfumes, cosmetics, etc., which process comprises culturing bacteria belonging to the genus Staphylococcus and being capable of producing lipase in a medium containing fat or oil. This process enables the production of highly pure fatty acids economically on an industrial scale (abstract). Bacteria capable of producing lipase and belonging to the genus Staphylococcus used in the process include Staphylococcus epidermidis (p. 3, lines 33-37). In the process, fats or oils are hydrolyzed by lipase produced by the bacteria to form fatty acids. As examples of the mode of operation for the hydrolysis process, the following methods may be employed: (1) Fat or oil suitable for use as the raw material is first introduced into a medium in which the bacteria can grow and the medium is inoculated with the bacteria. Then the hydrolysis of the fat or oil is conducted in parallel with the growth of the bacteria. (2) The bacteria are first grown in a medium in which they can grow, followed by the addition to the medium of fat or oil which is the raw material. Then the hydrolysis of the fat or oil is conducted in parallel with the culturing (p. 7, lines 1-16). Any types of fats or oils containing glycerides are suitable for use in the process. Vegetable fats and oils such as olive oil, coconut oil or castor oil may be used (p. 8, lines 26-34). Fatty acids accumulate in the cultured medium as a result of the above process. The fatty acids may be readily refined by conventional methods such as extraction, fractional crystallization, column chromatography or the like, from the supernatant liquid obtained by filtration or centrifugation of the cultured broth to remove the bacterial cells (p. 8-9, lines 35-5). Example 3 teaches the hydrolysis of olive oil using various strains of the genus staphylococcus. Specifically, olive oil was added to a culture medium and the medium was inoculated with Staphylococcus strains which included several Staphylococcus epidermidis strands (Samples 9-13). Fatty acids were extracted 2 and 3 days after inoculation and the composition of the fatty acids was investigated via TLC. Results showed that fatty acid oleic acid was predominately formed (Ex. 3, p. 11-12). Fig. 5 shows the TLCs of various hydrolysates obtained by the hydrolysis of olive oil using various strains of Staphylococcus epidermidis (p. 3, lines 14-18). It can be seen in Fig. 5 that oleic acid is the primary product in S. epidermidis strands No. 5, 8, and 11 (p. 21). As such, Yoshizumi teaches the instantly claimed method of producing a free fatty acid group by simple lipid and Staphylococcus epidermidis (i.e., by culturing S. epidermidis in a medium containing an oil), as recited in claim 1. Regarding the recitation of “for producing an antibacterial composition”, such a statement is simply a recitation of intended use. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. See MPEP 2111.02. The fat or oil of Yoshizumi reads on the simple lipid of claims 1 and 2, while the olive oil and coconut oil read on the simple lipid of claim 4. Olive oil comprises the saturated C16 fatty acid, palmitic acid (C16:0), at 7.5-20.0%, as evidenced by Baskou (Table 4.1). Thus, olive oil is taught to contain 20% of a C8-C18 saturated fatty acid, based on the total amount of fatty acid moieties, which reads on the simple lipid of claim 3. Coconut oil comprises fatty acids, caprylic acid (C8:0) at 8%; capric acid (C10:0) at 7%; lauric acid (C12:0) at 49%; myristic acid (C14:0) at 8%; palmitic acid (C16:0) at 8%; and stearic acid (C18:0) at 2%, as evidenced by Boateng (p. 193, col. 2, para. 1). Thus, coconut oil is taught to contain 82% of several C8-C18 saturated fatty acids, based on the total amount of fatty acid moieties, which also reads on the simple lipid of claim 3. Since the method of claim 1 is anticipated above, so is the composition obtained by such a method, as recited in claim 6. Regarding the recitation of an “antibacterial composition”, the oleic acid of Yoshizumi, is known to have innate bactericidal activity, specifically against Staphylococcus aureus (S. aureus) and a number of other Gram-positive bacteria as evidenced by Chen (title; abstract). Furthermore, the antibacterial nature of a composition is inherent to the ingredients contained within said composition. Since the composition of Yoshizumi is produced in an identical method as instantly claimed, the composition must necessarily be the same as the claimed composition and must therefore have the same characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. As such, the oleic acid taught by Yoshizumi reads on the antibacterial composition of claim 6, as well as an antibacterial composition comprising a free fatty acid group derived from Staphylococcus epidermidis as recited in claim 7. The antibacterial agent of claim 10 simply recites comprising the antibacterial composition according to claim 6, without reciting additional components. As such, the oleic acid of Yoshizumi which reads on the antibacterial composition of claim 6, also reads on the antibacterial agent of claim 10. Yoshizumi teaches the fatty acids of the invention to be useful in cosmetics. As such, the oleic acid also reads on a cosmetic comprising an antibacterial composition, as defined in claim 11. Claim 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang, Y., et al. (2014). Staphylococcus epidermidis in the human skin microbiome mediates fermentation to inhibit the growth of Propionibacterium acnes: implications of probiotics in acne vulgaris. Appl Microbiol Biotechnol 98, 411–424, (PTO-892), hereinafter Wang. Wang discloses a study which demonstrates that skin microorganisms can mediate fermentation of glycerol, which is naturally produced in skin, to enhance their inhibitory effects on P. acnes growth. The skin microorganisms, most of which have been identified as Staphylococcus epidermidis (S. epidermidis), in the microbiome of human fingerprints can ferment glycerol and create inhibition zones to repel a colony of overgrown P. acnes. Succinic acid, one of four short-chain fatty acids (SCFAs) detected in fermented media by nuclear magnetic resonance (NMR) analysis, effectively inhibits the growth of P. acnes in vitro and in vivo. Both intralesional injection and topical application of succinic acid to P. acnes-induced lesions markedly suppress the P. acnes-induced inflammation in mice (abstract). As such, Wang teaches an antibacterial composition comprising a free fatty acid group (i.e., succinic acid) derived from Staphylococcus epidermidis as recited in instant claim 7. Claim 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Traisaeng, S., et al. ( 2019). A Derivative of Butyric Acid, the Fermentation Metabolite of Staphylococcus epidermidis, Inhibits the Growth of a Staphylococcus aureus Strain Isolated from Atopic Dermatitis Patients. Toxins (Basel). 11(6):311, (PTO-892), hereinafter Traisaeng. Traisaeng discloses that butyric acid is a short-chain fatty acid fermentation metabolite of the skin probiotic bacterium Staphylococcus epidermidis (S. epidermidis). Glycerol fermentation of S. epidermidis results in the production of butyric acid and effectively hinders the growth of a Staphylococcus aureus (S. aureus) strain isolated from skin lesions of patients with atopic dermatitis (AD) in vitro and in vivo. A derivative of butyric acid, BA–NH–NH–BA, was synthesized by conjugation of two butyric acids to both ends of an –NH–O–NH– linker. The butyric acid derivative significantly lowered the concentration of butyric acid required to inhibit the growth of AD S. aureus and ameliorated AD S. aureus-induced production of pro-inflammatory interleukin (IL)-6 and remarkably reduced the colonization of AD S. aureus in mouse skin. Such results describe a novel derivative of a skin microbiome fermentation metabolite that exhibits anti-inflammatory and S. aureus bactericidal activity (abstract). As such, Traisaeng teaches an antibacterial composition comprising a free fatty acid group (i.e., butyric acid) derived from Staphylococcus epidermidis as recited in instant claim 7. 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. 1. Claims 1-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshizumi, H., et al. (EP 0188628 A1, 07/30/1986, PTO-892), hereinafter Yoshizumi in view of Uyama, A., et al. (US 20190247353 A1, 08/15/2019, IDS dated 04/25/2025), hereinafter Uyama. The teaching of Yoshizumi are discussed above. The teachings of Yoshizumi differ from that of the instantly claimed invention in that Yoshizumi does not teach wherein the antibacterial composition comprises 5 to 50 mass% of a C8-18 free fatty acid relative to the total mass of the antibacterial composition, as defined in claims 5 and 8. Uyama teaches a medicinal agent having a strain-selective antibacterial activity for acne bacteria. The acne strain-selective antibacterial agent comprises at least one fatty acid selected from the group consisting of saturated fatty acids having 14 to 20 carbon atoms (C14:0 to C20:0) and a monounsaturated fatty acid having 18 carbon atoms (C18:1) in a free form or a salt form, or an ester thereof (abstract). The fatty acid may be selected from oleic acid (C18:1) ([0030]; [0032]). The antibacterial agent may contain the fatty acid or an ester thereof as appropriately corresponding to its formulation form. For example, the antibacterial agent contains 0.01 to 99.9 wt % of the fatty acid or an ester thereof in terms of a free form with respect to the total weight of the agent, for example 10 to 50 wt % ([0037]). Uyama further teaches a skin-care composition comprising at least one fatty acid selected from the group consisting of saturated fatty acids having 14 to 20 carbon atoms (C14:0 to C20:0) and a monounsaturated fatty acid having 18 carbon atoms (C18:1), and a carrier acceptable for skin application ([0042]). The composition is a cosmetic composition, which may be, a skin care cosmetic, a makeup cosmetic, a body care cosmetic, or a hair care cosmetic ([0049]). It would have been obvious to combine the compositions of Yoshizumi and Uyama before the effective filing date of the claimed invention by providing the oleic acid of Yoshizumi as the fatty acid in the compositions of Uyama to yield the instantly claimed invention. Uyama teaches an antibacterial agent comprising 10 to 50 wt % of a free fatty acid with respect to the total weight of the agent. The free fatty acid may be a monounsaturated fatty acid having 18 carbon atoms (C18:1) such as oleic acid. Thus, it would have been obvious to provide the oleic acid taught by Yoshizumi in an antibacterial agent composition at an amount of 10 to 50 wt % with respect to the total weight of the agent, as taught by Uyama, thereby reading on the amount of free fatty acid defined in claims 5 and 8. It would have been further obvious to use the oleic acid of Yoshizumi in one of the skin-care compositions of Uyama, thereby reading on the cosmetic and dermatological topical agent of claims 11 and 12. Generally, combining prior art elements according to known methods to yield predictable results is considered prima facie obvious. One of ordinary skill in the art would have had a reasonable expectation of success in providing the oleic acid of Yoshizumi at an amount of 10 to 50 wt % in an antibacterial agent, since such an amount is taught as a known and effective amount at which to incorporate free fatty acids in a composition for use. One of ordinary skill in the art would have also had a reasonable expectation of success in providing the oleic acid in a skin-care composition since Yoshizumi teaches its fatty acids as useful in medicines and cosmetics. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chen CH, et al. (2011). An innate bactericidal oleic acid effective against skin infection of methicillin-resistant Staphylococcus aureus: a therapy concordant with evolutionary medicine. J Microbiol Biotechnol. 21(4):391-9 (PTO-892), hereinafter Chen in view of Yoshizumi, H., et al. (EP 0188628 A1, 07/30/1986, PTO-892), hereinafter Yoshizumi. Chen teaches that free fatty acids (FFAs) are known to have bacteriocidal activity and are important components of the innate immune system. Among a series of FFAs, only oleic acid (OA) (C18:1, cis-9) can effectively eliminate Staphylococcus aureus (S. aureus) through cell wall disruption. The bacteriocidal activities of FFAs are also demonstrated in vivo through injection of OA into mouse skin lesions previously infected with a strain of MRSA (abstract). Chen discloses methods of culturing S. aureus, and then incubating the bacteria with oleic acid (OA) to determine minimal bacterial concentration (MBC), as well as methods of injecting OA to the site of a bacterial-induced skin lesion in mice (p. 392, Materials and Methods). Results demonstrated that OA is an effective FFA to inhibit S. aureus growth and that it alleviates skin lesions induced by USA300 (i.e., MRSA strain) (Results). As such, the methods of Chen read on antibacterial methods comprising inhibiting Staphylococcus aureus by an antibacterial composition, as recited in claim 9, wherein the antibacterial composition is oleic acid. The teachings of Chen differ from that of the instantly claimed invention in that Chen does not teach wherein the antibacterial composition (i.e., oleic acid) is obtained by the instantly claimed method. The teachings of Yoshizumi are discussed above. Yoshizumi discloses oleic acid produced by a method which reads on that of claim 1, wherein the oleic acid reads on the antibacterial composition of claim 6. It would have been obvious to combine the teachings of Chen with those of Yoshizumi before the effective filing date of the claimed invention by using the oleic acid of Yoshizumi as the oleic acid in the methods of Chen, thereby yielding the method of claim 9. It would have been prima facie obvious to substitute the oleic acid of Chen with the oleic acid of Yoshizumi, which is produced according to the instant invention, to inhibit S. aureus as taught by Chen since it entails no more than simple substitution of one known element for another to obtain predictable results. See MPEP 2143. One of ordinary skill in the art would have had a reasonable expectation of success since the oleic acid of Yoshizumi may be used in medicines. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex). 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, Sue X Liu can be reached at (571)272-5539. 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. /SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616 /Mina Haghighatian/Primary Examiner, Art Unit 1616
Read full office action

Prosecution Timeline

Nov 21, 2023
Application Filed
Nov 06, 2025
Non-Final Rejection — §101, §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
29%
Grant Probability
66%
With Interview (+37.5%)
4y 0m
Median Time to Grant
Low
PTA Risk
Based on 14 resolved cases by this examiner. Grant probability derived from career allow rate.

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