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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application as Application No. KR10-2021-0186397, filed on June 21st, 2024. The priority date is December 23rd, 2021.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed June 21st, 2024 and May 8th, 2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
The drawings filed on June 21st, 2024 are accepted. The applicant is notified that while the disclosure does not refer to color in Figure 11, Figure 11 is currently in grayscale, and any color resulting from staining is not distinguishable. The applicant is not required to file color drawings, but if the applicant wishes to do so, to improve the clarity of information conveyed in the disclosure, then the applicant is advised to review the following guidelines:
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The use of the terms ATCC, DMEM, R&D Systems, Nikon, Sigma (registered as Sigma-Aldrich and Millipore Sigma), LONZA, Invitrogen, Applied Biosystems, ANOVA, SPSS, and IBM, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The applicant’s assistance is requested in correctly reciting any trademarks and tradenames they become aware of in the disclosure, even if not explicitly pointed out by the examiner.
Claim Rejections - 35 USC § 112
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 10-18 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 10 recites the phase “effective component”, but it is not clear what objective the component is effective toward, as the recitation of “treating or ameliorating a respiratory disease “ in the preamble is non-limiting. When reading the preamble in the context of the entire claim, the recitation "treating or ameliorating a respiratory disease" is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claims is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Claim 18 is 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 18 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no reference to “the composition” in claim 10.
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
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 (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 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.
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 10-18 are rejected under 35 U.S.C 103 as being unpatentable over Lee et al. (WO2021137677A1).
Claim 10 recites “A method for treating or ameliorating a respiratory disease, the method comprising administering a Lysimachia mauritiana extract as an effective component to a subject in need thereof”. Claim 11 recites “The method of claim 10, wherein the Lysimachia mauritiana extract is prepared by using water, Cl-C4 lower alcohol, or a mixture thereof as an extraction solvent”. Claim 12 recites “The method of claim 10, wherein the respiratory disease is selected from the group consisting of asthma, chronic obstructive pulmonary disease, bronchitis, pharyngitis, tonsillitis, laryngitis, and a combination thereof”. Claim 13 recites “The method of claim 10, wherein the Lysimachia mauritiana extract is prepared by extracting an aerial part of Lysimachia mauritiana”. Claim 14 recites “The method of claim 10, wherein the composition is prepared in a formulation selected from the group consisting of powder, granule, pill, tablet, capsule, candy, syrup, and beverage”. Claim 15 recites “The method of claim 10, wherein the composition is included in a functional health food. Docket No: S35224GR04”. Claim 16 recites “The method of claim 10, wherein the composition is a pharmaceutical composition, and further comprises a pharmaceutically acceptable carrier, excipient, and/or diluent”. Claim 17 recites “The method of claim 10, wherein the subject is an animal”. Claim 18 recites “The method of claim 10, wherein the composition is included in an animal feed”.
When reading the preamble of claim 10 in the context of the entire claim, the recitation "for treating or ameliorating a respiratory disease" is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Lee et al teaches the effects of 109 plant extracts in terms of anti-inflammatory or skin soothing effects, an antioxidant effect, and a broad antibacterial effect against various bacteria (paragraph [19]). One example of a plant extract in the referenced invention is Lysimachia mauritiana Lam., English name: Spoon-leaf yellow loosestrife (see paragraphs [20]; instant claim 10). The composition can be used as a cosmetic composition, a pharmaceutical composition, or a food composition (see paragraph [24]; instant claim 15).
All parts of the plant may be used for the plant extract, and the extraction site is not limited ( paragraph [33]; instant claim 13). Lee at al. explicitly teaches the use of certain aerial plant parts for the extract: stem, leaf, fruit, flower, branch, bark, and seed (paragraph [33]; instant claim 13). In the present invention, the type of extraction is not limited and may be obtained with water, a lower alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof (Lee at al. paragraph [36]; instant claim 11).
Lee et al. teaches an antibacterial effect of a Lysimachia mauritiana extract against several bacteria species, including Staphylococcus aureus, Aspergillus niger, Streptococcus mutans, and Porphyromonas gingivalis (paragraphs [120]-[129] and [267]-[269], and based on the examiner’s reading of partially translated Table 71), suggesting a broad antibacterial effect, including an antibacterial effect against Streptococcus (instant claim 12). Therefore, one of skill in the art would have a reasonable expectation of success at administering a Lysimachia mauritiana extract to a subject, with a result of ameliorating bacterial infections of the respiratory tract, including those of the pharynx, tonsils, and larynx (instant claim 12).
Lee et al. teaches the pharmaceutical composition may be in the form of a powder, granule, tablet or capsule (paragraph [69], instant claim 14). Lee et al. recites “The composition of the present invention may be administered orally or parenterally, and may be administered in the form of a general pharmaceutical preparation, for example, in various formulations of oral and parenteral administration in clinical administration, and when formulated, it may be prepared using diluents or excipients
such as fillers, extenders, binders, wetting agents, disintegrants, surfactants, and the like, which are commonly used” (paragraph [73]; instant claims 10, 16, and 18). Solid preparations for oral administration include tablets, pills, powders, and capsules (see paragraph [74]; instant claim 14). Lee et al. further recites “the present invention also includes a food used as a feed for animals” (paragraph [92]; instant claims 15 and 18), implying administering the invention to an animal subject (instant claims 17 and 18).
Lee et al explicitly teaches an antibacterial food comprising the plant extract (paragraph [85]; instant claim 15).
As noted above, while Lee et al. does not explicitly give an example of administering a Lysimachia mauritiana extract to a subject in need thereof, and only provides an example of how the composition may be administered orally. However, the recitation of oral administration, and the animal feed embodiment, recited above, both imply administering the composition to a subject (instant claims 10, 17, and 18). Therefore, a method comprising administering a Lysimachia mauritiana extract to a subject is obvious to one of skill in the art over Lee et al.
Relevant and Prior Art Made of Record
The relevant and/or prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including the following:
Li and Yan (CN-109045218-A) recite Lysimachia foenum-graecum as a component of a composition for treating upper respiratory tract inflammation (Abstract).
Seo et al. (KR-20210087406-A) June 21st 2024 IDS, Foreign Patent Document #5; citations below are based on a Google Translate machine translation of the original document downloaded from Google Patents.
Seo et al. teaches that an allergy is a kind of hypersensitivity reaction caused by an immune imbalance which is a reaction to a specific antigen called an allergen, diseases include asthma (see paragraph [0014]; instant claims 10 and 12). Seo et al. discloses certain plant extracts have “an anti-allergic effect by inhibiting allergy-causing IgE” (Seo et al. paragraph [0032]). A plant included in the referenced invention is Lysimachia mauritiana Lam., English name: Spoon-leaf yellow loosestrife (Seo et al. paragraph [0034]; instant claim 10). Seo et al. discloses extracting aerial plant parts: stems, leaves, fruits, flowers, shoots, branches, bark, sap, or seeds (Seo et al., paragraph [0103]; claim 13). The extraction method may be obtained by extraction with water, a lower alcohol having 1 to 6 carbon atoms, or a mixed solvent thereof (Seo et al. paragraphs [0046]-[0048]; instant claim 11).
Seo et al teaches that the pharmaceutical composition may be in the form of an extract, powder, granule, tablet or capsule (paragraph [0070]; instant claim 14). The composition may be administered orally or paternally, and may be administered in the form of general pharmaceutical preparations, for example, oral and parenteral various formulations during clinical administration (Seo et al., paragraph [0074]; instant claim 10). Seo et al. recites “When formulating, it may be prepared using diluents or excipients such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants” (Seo et al. paragraph [0074]; instant claim 16). Solid dosage forms for oral administration include tablets, pills, powders, granules, and capsules; and can be mixed in gelatin (see paragraph [0075]; instant claim 14).
Seo et al. recites “When the plant extract of the present invention is provided as a food composition, the composition may include a food-grade additive that is food-gradely (sic) acceptable in addition to the active ingredient” (paragraph [0087]; instant claim 15). Seo et al. explicitly recites a health functional food: “In addition, the above food composition may include a health functional food. In this specification, "health functional food" refers to a food that uses physical, biochemical, or biotechnological methods, etc., to add value so that the function of the food acts or manifests for a specific purpose” (paragraph [0089]; instant claim 15). The health functional food may be manufactured by mixing in other ingredients, and it includes food used as animal feed: “In addition, the health functional food of the present invention may be manufactured by mixing other appropriate auxiliary ingredients that may be included in food and known additives, depending on the choice of a person skilled in the art. Examples of foods to which the ingredients may be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, chewing gum, dairy products including ice cream, various soups, beverages, tea, drinks, alcoholic beverages, and vitamin complexes, and may be manufactured by adding the ingredients to juices, teas, jellies, and juices prepared using the food extract of the present invention as the main ingredient. It also includes foods used as animal feed” (paragraph [0094];’ instant claims 10, 14, 15, 17 and 18).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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, Anand Desai can be reached at (571) 272-0947. 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.
/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights