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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 November 2025 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 18 November 2025 in response to the final rejection mailed 7 August 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 18 November 2025 replaces all prior versions and listings of the claims.
Claims 15, 17, 18, 20-22, and 29-37 are pending. Claims 29-35 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 15, 36, and 37 are amended.
Claims 15, 17, 18, 20-22, 36, and 37 are being examined on the merits.
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 15, 17, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Corthesy-Theulaz et al. (US 2005/0191072 A1) in view of de Carvalho et al. (Food Microbiol, 2015, 56-65), Béjaoui et al. (J Med Food, 2013, 1115-1120), and Rezvanpanah et al. (Brazil J Microbiol, 2011, 1453-1462).
The instant claims are as of record, drawn to an herbal preparation comprising carvacrol, γ-terpinene, thymol, and p-cymene formulated for human oral administration with the intended use of treating a subject suffering from gastric Helicobacter pylori infection.
Corthesy-Theulaz et al. teach a nutritional composition (herbal preparation) comprising at least one of an essential oil selected from a group comprising origano (vulgaris) (Origanum vulgare L.), savory (Satureja hortensis L.), and thyme (Thymus vulgaris L.) for use in prevention or treatment of infection by a gastric Helicobacter-like organism (Corthesy-Theulaz et al., Claim 1, page 5; as required for instant Claims 15, 36, and 37). The composition can be used for inhibition of H. pylori (Corthesy-Theulaz et al., Table 1 and Table 3, pages 2-3; as required for instant Claims 15, 36, and 37) and provided in a form suitable for consumption (administered orally) by a human (formulated for human oral administration; treat a subject suffering from gastric Helicobacter pylori infection; Corthesy-Theulaz et al., Claim 6, page 5, as required for instant Claims 15, 36, and 37). Additionally, the composition provides a way of delivering essential oils topically in the stomach via the mouth (administered orally) and can comprise a lipid source (liquid carrier), including sunflower oil (Corthesy-Theulaz et al., [0025], page 2 & [0044], page 3; as required for instant Claim 22).
Corthesy-Theulaz et al. do not teach specific terpenes or amounts of the compounds within the composition expressed in percent of total peak area in a GS/MC chromatogram.
The following table summarizes the teachings of de Carvalho et al., Béjaoui et al., and Rezvanpanah et al.:
% total peak area
Thymus vulgaris
Origanum vulgare
Satureja hortensis
de Carvalho et al., 2015
Bejaoui et al., 013
Rezvanpanah et al., 2011
Mean
1:1:2
Table 1, page 62
Table 1, page 1117
Table 1, page 1457
Spec. page 8, line 8
Carvacrol
3.14
83.37
48.69
45.07
45.97
γ-terpinene
6.36
4.13
31.95
14.15
18.60
thymol
43.19
0.00
1.11
14.77
11.35
p-cymene
28.55
3.02
2.69
11.42
9.24
α-terpinene
0.06
0.88
3.89
1.61
2.18
trans-β-caryophyllene
0.35
1.09
0.71
0.72
0.72
linalool
5.57
0.00
0.00
1.86
1.39
α-pinene
2.60
0.16
1.34
1.37
1.36
β-myrcene
0.00
0.72
1.78
0.83
1.07
1,8-cineole (eucalyptol)
1.29
0.00
0.00
0.43
0.32
Limonene
0.14
0.00
0.61
0.25
0.34
β-pinene
0.00
0.00
0.72
0.24
0.36
The percentages of total peak area as shown in the column labelled 1:1:2, which comprises the ratio and types of essential oils as taught in the instant specification (page 8, line 8), overlap the “about” claimed values of instant Claims 15, 17, 18, 36, and 37.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of de Carvalho et al., Béjaoui et al., and Rezvanpanah et al. with those of Corthesy-Theulaz et al. to arrive at the instantly claimed invention. The prior art discloses antibacterial activity of all three essential oils (de Carvalho et al., Conclusion, page 64; Béjaoui et al., Table 3, page 1118; Rezvanpanah et al., Abstract, page 1453) with the compositions as shown in the above table, and thus a skilled artisan would be motivated to combine them into orally administrable compositions as taught by Corthesy-Theulaz et al. for the purpose of treating H. pylori infection in a human and could do so with a reasonable expectation of success.
Claims 15, 17, 18, 20-22, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Corthesy-Theulaz et al. (US 2005/0191072 A1) in view of de Carvalho et al. (Food Microbiol, 2015, 56-65), Béjaoui et al. (J Med Food, 2013, 1115-1120), and Rezvanpanah et al. (Brazil J Microbiol, 2011, 1453-1462) as applied to Claims 15, 17, 18, and 22 above, and further in view of Rossines (WO 2009/043987 A1).
The instant claims and teachings of Corthesy-Theulaz et al., de Carvalho et al., Béjaoui et al., and Rezvanpanah et al. are as of record.
Corthesy-Theulaz et al., de Carvalho et al., Béjaoui et al., and Rezvanpanah et al. do not teach administration twice daily, 65 mg or 130 mg dosage forms, or a capsule formulation.
Rossines teaches an antibiotic composition comprising essential oils derived from herbs (herbal composition) such as oregano, thyme, and savory (Rossines, page 9) which can be administered orally in various dosage forms, including a capsule (Rossines, page 13; as required for instant Claims 15, 36, and 37). The essential oils may comprise carvacrol, thymol (Rossines, page 9), and terpenes (e.g., y-terpinene and p-cymene; Rossines, page 2; as required for instant Claims 15, 36, and 37) and a vehicle (carrier, see Rossines page 5) such as water, vegetable or mineral oils, or saline (liquid; Rossines, page 12; as required for instant Claim 22). The composition is administered orally twice daily (Rossines, page 29; as required for instant Claims 20, 21, and 36) and doses range from 10-100 mg/kg/day, depending on age, weight, and severity of infection (Rossines, page 20), which means that an 80 kg person would receive a total dose per day ranging from 80-800 mg, which separated into two doses daily would be 40-400 mg, encompassing the dosage form ranges of Claims 20, 21, and 36. The range is also wide enough to account for inclusion of additional ingredients, such as a carrier within the required 65 and 130mg dosage forms.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to take the composition of Corthesy-Theulaz et al. comprising the ingredients of de Carvalho et al., Béjaoui et al., and Rezvanpanah et al., and provide it in the doses as taught by Rossines. A skilled artisan would know that routes of administration and dosages vary depending on a variety of parameters, for example dependingon the condition of the patient, the type of infection and the severity of the infection to be treated (Rossines, page 13) and thus would be motivated to provide different doses of the anti-H. pylori composition and could do so with a reasonable expectation of success.
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.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 18 November 2025 have been fully considered but they are not persuasive.
Applicant argues that there is no motivation to combine the prior art or a reasonable expectation of success in making the proposed composition. As discussed above, Corthesy-Theulaz et al. teaches a nutritional composition comprising at least one of an essential oil selected from a group comprising origano (vulgaris) (Origanum vulgare L.), savory (Satureja hortensis L.), and thyme (Thymus vulgaris L.) for use in prevention or treatment of infection by a gastric Helicobacter-like organism. The specific extracts of de Carvalho et al., Béjaoui et al., and Rezvanpanah et al. were also shown to have antibacterial efficacy, and thus a skilled artisan could reasonably expect that combining those three extracts would have anti-H. pylori efficacy and would be motivated to use them in the composition of Corthesy-Theulaz et al. due to this efficacy.
Applicant argues that the cited art differs substantially and do not disclose anti-H. pylori activity, however Corthesy-Theulaz et al. discloses the anti-H. pylori efficacy of various essential oils (Corthesy-Theulaz et al., Table 1 and Table 3, pages 2-3), including oregano, savory, and thyme.
Applicant additionally argues that the prior art only discloses in vitro data, which cannot reliably predict in vivo data, according to Bergonzelli et al., where a single carrot seed essential oil was tested in vivo and demonstrated poor efficacy when administered to mice. The rest of the quoted paragraph, however, goes on to indicate that lack of efficacy in mice does not necessarily indicate lack of efficacy in humans due to differences in gastric acidity (Bergonzelli et al., Discussion, page 3246). Applicant also cites Seyhan, wherein it is indicated that the majority of compounds with in vitro efficacy fail clinical trials. A lack of in vivo data presented in Corthesy-Theulaz et al., however, does not negate the claims or teachings of the disclosure wherein the composition is provided in a form suitable for consumption by a human (Corthesy-Theulaz et al., Claim 6, page 5). Applicant goes on to argue that one cannot simply blend together essential oils and expect predictable anti-H. pylori efficacy, but as previously stated, Corthesy-Theulaz et al. discloses the anti-H. pylori efficacy of various essential oils (Corthesy-Theulaz et al., Table 1 and Table 3, pages 2-3), including oregano, savory, and thyme, which when combined have the chemical composition of the instant claims, and thus the efficacy of these essential oils against H. pylori was known in the art.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, both Corthesy-Theulaz et al. and Rossines disclose antibacterial essential oil compositions that may comprise savory, thyme, and oregano. Additionally, the compositions of specific essential oils of these herbs with specific chemical profiles which have antimicrobial efficacy were also known in the art at the time of filing as taught by de Carvalho et al., Béjaoui et al., and Rezvanpanah et al. A skilled artisan could reasonably select those essential oils to provide an antimicrobial composition with efficacy against H. pylori infection in humans, as taught by Corthesy-Theulaz et al.
Conclusion
No claims are allowed.Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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.
/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655