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 .
Election/Restrictions
Applicant’s election of:
(i) formulation SIME02 from example 2, Table 1; This formulation contains 0.1% weight % of sacha inchi seed oil and Tween 80 (first emulsifier; a polyethylene sorbitol ester) and Span 80 (second emulsifier; sorbitan monooleate), both emulsifiers have structural units comprising C18 alkyl chains; sacha inchi seed oil comprises >90 weight % of unsaturated fatty acids with C16-C20 chain length, mainly alpha-linoleic acid and linoleic acid; and this oil contains about 8-10% of monounsaturated fatty acids, mainly oleic acid; SIME02 does not contain organic solvents or preservatives.
It can be calculated from the given weight percentages of Table | for formulation SIME02 that the first and second emulsifier had a total molar concentration which was 80 - 150 % of the total molar concentration of unsaturated fatty acid(s) of the natural oil triglycerides.
From figure 6 it is seen that the oil particles of the formulation SIME02 have a negative zeta potential.
Formulation SIME02 was clear, homogenous and colorless, which means that the oil particles of the formulation had an average hydrodynamic diameter of 100 nm or less (this can be seen also from Figure 6) and an optical absorbance less than 0.3 absorbance units in 400 - 700 nm; and
(ii) treatment of dry eye disease, treating at least tear film instability and tear hyperosmolarity
in the reply filed on 6/25/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/25/2025.
Response to Arguments
Applicant’s arguments, see page 6 of 7, filed 2/17/2026, with respect to the rejection(s) of claim(s) 1-10, 16-19 under 35 USC 102/103 have been fully considered and are persuasive. The exception under 35 USC 102(b)(1)(A) applies, and disqualifies Laihia as prior art. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of ambiguity in claims.
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 1-10, 16-19 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.
The term “preferably” in claims 1, 2, 3, 4, 6, 9, and the phrase “more preferably” in claims 2, 3, 4, 6 is a relative term/ relative phrase, which render the claims indefinite. The term “preferably” and the phrase “more preferably” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claims 7, 8, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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, Ali Soroush can be reached at (571)272-9925. 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.
TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614
Prosecution Insights