DETAILED ACTION
Status of Application
The response filed 06/26/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 34, 37, 39-41, 43-48 have been amended.
Claims 35-36, 42 have been cancelled.
Claims 34, 37, 39-41, 43-48 are pending in the case.
Claims 34, 37, 39-41, 43-48 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn or moot as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection and objection are applied:
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.
Claims 34, 37, 39-41, 43-47 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzal et al. (U.S. Pat. 2013/0101644) in view of Wong et al. (U.S. Pat. Pub. 2010/0093845).
Rejection:
Nazzal et al. teaches vitamin E compositions with triglycerides, and teaches a composition consisting of a binary blend of Vitamin E and MCT (medium chain triglycerides), from 100% vitamin E (viscosity of 3700mPa.s=3700cps) to 100% MCT (27mPa.s=27cps) – including 10% MCT/90% Vitamin E, 20% MCT/80% Vitamin E, 30% MCT/70% vitamin E (viscosity of about 500 mPa.s =500cps), and 40% MCT/60% Vitamin E (see figure 9, Example 8-9 [63]). The MCT referred to is caprylic/capric triglyceride (Miglyol 812) [60].
PNG
media_image1.png
828
844
media_image1.png
Greyscale
The vitamin E is a tocopherol/tocotrienol (Figure 1) the vitamin E purchased was alpha-tocopherol from Sigma ([60, 80]) and the MCT referred to is caprylic/capric triglyceride (Miglyol 812) purchased by Sasol, while Nazzal et al. is not explicit to the vitamin E form and MCT used, as the vitamin E purchased by Nazzal et al. was alpha-tocopherol from Sigma and MCT is caprylic/capric triglyceride (Miglyol 812) purchased by Sasol; it is implicit that the vitamin E used is the alpha tocopherol purchased and the MCT is the Miglyol 812 caprylic/capric triglyceride purchased ([60, 80], see full document specifically areas cited). The components are pharmaceutically acceptable as they are for incorporation in a drug delivery composition and therein capable of future intended ophthalmic use. The MCT would have the recited refractive index as the specification discloses that MCT like caprylic/capric triglyceride have the recited refractive index, and the component is physically the same it must have the same properties as “products of identical chemical composition cannot have mutually exclusive properties “ In re Spada, 911 F2D 705, 709, 15 USPQ2D 1655, 1658 (FED,CIR. 1990).
Nazzal et al. does not expressly teach the tocopherol acetate form but does teach the inclusion of Vitamin E/tocotrienol forms including alpha-tocopherol (Figure 1, [60, 80]) and derivatives [116].
Wong et al. teaches that the family of Vitamin E compounds include various forms like alpha-tocopherol and its known specific form of alpha-tocopherol acetate [22].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate alpha-tocopheryl acetate as suggested by Wong et al. and produce the claimed invention; as it is prima facie obvious to utilize the known alpha-tocopherol forms like acetate with a reasonable expectation of success absent evidence of criticality for the claimed form. As the structural components of the composition are met, its properties and and capacity for future intended use such as lack of vision impairment - are also met. As the tocopheryl acetate and medium chain triglycerides are the structural components of the composition, the MCT and tocopheryl acetate would have the recited refractive indexes as the specification discloses that these structural components have these refractive indexes, and the component is physically the same it must have the same properties as “products of identical chemical composition cannot have mutually exclusive properties “ In re Spada, 911 F2D 705, 709, 15 USPQ2D 1655, 1658 (FED,CIR. 1990).
Response to Arguments:
Applicant's arguments are centered on the assertion there is no reason to modify the binary blends of Nazzal to a blend of tocopherol acetate and MCT which is to the larger emulsion, and the assertion that the binary blend is not an eyedrop composition as claimed.
This is fully considered but not persuasive.
Nazzal exemplifies a composition consisting of the Vitamin E and MCT which is not an emulsion, wherein it would be prima facie obvious to utilize a known acetate form for alpha-tocopherol with a reasonable expectation of success absent evidence of criticality for the claimed form which is not presented.
In response to applicant's argument that the binary blend is not an eyedrop composition, the claims are composition claims not method of use claims - and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Accordingly, the rejection stands.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Nazzal et al. (U.S. Pat. 2013/0101644) in view of Wong et al. (U.S. Pat. Pub. 2010/0093845) as applied to claims 34, 37, 39-41, 43-47 above, further in view of Dhingra et al. (U.S. Pat. Pub. 2013/0303495).
Rejection:
The teachings of Nazzal et al. in view of Wong et al. are addressed above.
Nazzal et al. in view of Wong et al. does not expressly teach the recited type of medium chain triglycerides (MCT) but does teach the inclusion of MCT like caprylic/capric triglycerides which is commerically available as Miglyol 812.
Dhingra et al. teaches that medium chain triglyceride(C8-12) are known and commerically available under Miglyol 810, 812, 818, 829 (known as caprylic/capric/succinic triglycerides) and 840 [199].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate caprylic/capric/succinic triglycerides as suggested by Dhingra et al. and produce the claimed invention; as simple substitution of one known commerically available MCT for another is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the specific MCT form.
Response to Arguments:
Applicant's arguments are to Nazzal in view of Wong which are addressed above.
Accordingly, the rejection stands.
Conclusion
Claims 34, 37, 39-41, 43-48 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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, Brian Kwon can be reached at 571-272-0581. 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.
/GIGI G HUANG/Primary Examiner, Art Unit 1613
Prosecution Insights