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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6 November 2025 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 6 November 2025 in response to the final rejection mailed 6 May 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 6 November 2025 replaces all prior versions and listings of the claims.
Claims 1, 3-7, 11, 12, 14 and 15 are pending. Claims 12, 14, and 15 remain withdrawn. Claims 1 and 7 are amended. Claims 1, 3-7, and 11 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.
Claims 1, 3-7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Nitsas (WO 97/01348 A1) in view of Primor (WO 2013/065051 A1).
The instant claims are as of record, drawn to an ear protection composition which is non-irritating and non-sensitizing when topically applied to the skin, comprising Paraffinum Liquidum within the range of 98.0 to 99.9% w/v and an Oreganum oil within the range of 0.1 to 2.0% w/v.
Nitsas teaches a composition comprising 97% paraffinum liquidum (broadly, a film-forming, hydrophobic (water-repellent) material) and 3% Origanum hyrtum essential oil (antimicrobial agent; Oreganum oil; Oregano vulgaris subsp. hirtum, broadly Oreganum vulgaris comprises subsp. vulgare and compactum; Nitsas, Example 6, page 12; as required for instant Claims 1, 3, 7 and 11). The composition can be used for treatment of aural infections in humans and animals, including otitis, in the form of drops and for treatment of inflammations caused by germs in humans and animals in the form of a spray (topically; ear protection; waterborne ear canal disorders; Nitsas, Examples 6 and 7, pages 12-13; as required for instant Claims 1 and 4).
Nitsas does not teach the specific amount of Oreganum oil for topical application or that the composition is non-irritating and non-sensitizing.
Primor teaches pharmaceutical compositions for treating ceruminosis and associated disorders comprising olive-squalene, light mineral oil, and an additional oil such as oregano oil (Oreganum oil; Primor, page 9, lines 6-14). The additional oil, such as oregano oil, is present in an amount from 0.5-5 wt% (Primor, page 9, line 14; as required for instant Claims 1 and 7). The compositions, due to their oily nature, are not conducive to microorganism growth and thus do not require preservatives that may contribute to irritation or allergy (broadly, non-irritating and non-sensitizing; Primor, page 15, lines 15-19).
It would have been obvious to a person of ordinary skill in the art prior to the effective date of the instant application to have prepared a composition (as a topical within dropper tube and/or as a topical spray; Nitsas, Example 7, page 13; as required for instant Claims 6 and 7) comprising Paraffinum Liquidum and Oreganum oil for the intended purpose to be used as to treat otitis externa in a subject based upon the beneficial teachings provided by Nitsas as discussed above. A skilled artisan could reasonably incorporate the amounts of Oreganum oil as taught by Primor with the oil carrier of Nitsas in order to successfully arrive at an oily composition which does not require potentially irritating ingredients and is thus non-irritating and non-sensitizing.
In addition, the cited references are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teaching provided therein with respect to the claimed intended use in the manner disclosed therein, the adjustment of a particular conventional working condition therein (e.g. determining one or more suitable ranges, including dosing, amounts, and proportions, in which to provide therapeutically effective amounts in the composition), is deemed merely a matter of judicious selection and routine optimization that are well within the purview of the skilled artisan. From the teachings of the reference, 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 effective filing date, as evidenced by the references, especially in the absence of evidence to the contrary.
With respect to the USC 103 rejections above, please note that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
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 effectively filed, 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 submitted on 6 November 2025 regarding the rejection under 35 USC 103 have been carefully considered but are not deemed persuasive.
Applicant argues that the concentration of Oreganum oil as claimed is substantially lower than taught by Nitsas and that this lower concentration prevents irritation or sensitization while preserving effectiveness in treating or preventing external otitis.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., external otitis) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, the arguments are not found to be persuasive, because Nitsas teaches a composition comprising the same active ingredients as the instantly claimed invention of paraffinum liquidum (broadly, a film-forming, hydrophobic (water-repellent) material) and 3% Origanum hyrtum essential oil (antimicrobial agent; Oreganum oil; Oregano vulgaris subsp. hirtum, broadly Oreganum vulgaris comprises subsp. vulgare and compactum; Nitsas, Example 6, page 12); and for treatment of aural infections in humans and animals, including otitis, in the form of drops and for treatment of inflammations caused by germs in humans and animals in the form of a spray (topically; ear protection; waterborne ear canal disorders; Nitsas, Examples 6 and 7, pages 12-13).
Additionally, the instant specification does not provide evidence of the criticality of the claimed range. The Oreganum oil can be present in the range of 0.1-10 w/v% (Specification, [0034]), which overlaps both Nitsas and Primor, and thus is still effective for the claimed intended uses of protecting an ear from water entrapment and ear protection. It is concluded that based upon evidence gathered and presented in the specification, there are no known side-effects of the disclosed composition and that is it safe for users of all ages (Specification, [0086]). Additionally, the specification indicates irritation when applying undiluted Oreganum oil and that no irritation or sensitization occurred at a concentration of 2%; no data was provided for higher concentrations (Specification, [0079]). Taken together, this suggests that the composition - whether there is 0.1 w/v% or 10 w/v% Oreganum oil - is not only effective, but also does not cause irritation or sensitization.
Examiner still maintains that if not expressly taught by the cited reference, based upon the overall beneficial teaching provided therein with respect to the claimed intended use in the manner disclosed therein such as to be used as to treat otitis externa in a subject, the adjustment of a particular conventional working condition therein (e.g. determining one or more suitable ranges, including dosing, amounts, and proportions, including concentrations or dilutions thereof, in which to provide therapeutically effective amounts in the composition), is deemed merely a matter of judicious selection and routine optimization that are well within the purview of the skilled artisan.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655