DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/20/2026 has been entered.
Status of Application
The response filed 01/20/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 34 have been amended.
Claims 34-37, 39-48 are pending in the case.
Claims 34-37, 39-48 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All grounds not addressed in the action are withdrawn or moot as a result of amendment.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 and Objection
Due to the amendment of the claims the new grounds of rejection and objection are applied:
Claim Objections
Claim 42 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 41. Claim 42 recites “the medium chain triglycerides are decanoyl/octanoyl glycerides” which is a substantial duplicative of claim 41 which recites “the medium chain triglycerides are caprylic/capric triglycerides” as decanoyl/octanoyl glycerides are also known as caprylic/capric triglycerides; wherein it is reciting the same thing (C8 and C10 fatty acids for the triglycerides). When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Response to Arguments:
Applicant's arguments are centered on the assertion that claim 41 and 42 are to two distinct commercial preparation of medium chain triglycerides citing the specification that MIGLYOL 810 are decanoyl/octanoyl glycerides and MIGYLOL 812 are caprylic/capric triglycerides, and are not substantial duplicates of each other. This is fully considered but not persuasive. As seen by PubChem as listed in Applicant’s IDS -decanoyl/octanoyl glycerides are also known as caprylic/capric triglycerides wherein they are the same thing and claim 42 is a substantial duplicate of claim 41. MIGLYOL 810 and MIGYLOL 812 are both caprylic/capric triglycerides (also known as decanoyl/octanoyl glycerides) and their differences lay in the ratio of C8 to C10 (ratio of caprylic to capric) in the commercial products which is not in the claim (see Sasol product sheet).
Accordingly, the objection stands.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 34-35, 39-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nazzal et al. (U.S. Pat. 2013/0101644).
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].
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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 immediately envisioned 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). As the structural properties of the composition are met, its properties and capacity for future intended use is also met.
All the critical structural elements are taught by the cited reference and thus the claims are anticipated.
Response to Arguments:
Applicant's arguments are centered on the assertion that anticipation teaches every element claim either explicitly or impliedly but Nazzal is to emulsions of tocotrienol which does not disclose ocular administration and are not disclosed to be suitable for ocular administration, and the instant claims do not recite emulsions and recites formulation of ocular administration.
This is fully considered but not persuasive.
Nazzal teaches and exemplifies a binary composition consisting of Vitamin E and MCT (medium chain triglycerides) and are not an emulsion as asserted by Applicant. It exemplifies the binary composition from 100% vitamin E to 100% MCT – including 10% MCT/90% Vitamin E, 20% MCT/80% Vitamin E, 30% MCT/70% vitamin E, and 40% MCT/60% Vitamin E (see figure 9, Example 8-9). The vitamin E purchased was alpha-tocopherol from Sigma and the MCT is caprylic/capric triglyceride (Miglyol 812) purchased by Sasol, wherein it is immediately envisioned that the vitamin E used is the alpha tocopherol purchased and the MCT is the Miglyol 812 caprylic/capric triglyceride purchased. The components are pharmaceutically acceptable as they are for incorporation in a drug delivery composition and therein capable of the future intended ophthalmic use. Applicant's argument that Nazzal does not disclose ocular administration or being suitable for ocular administration, is not persuasive as 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. As the composition contains the same structural components the composition it would have the same properties and capacity of future intended use .
Accordingly, the rejection stands.
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 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzal et al. (U.S. Pat. 2013/0101644) as applied to claims 34-35, 39-47 above, in view of Wong et al. (U.S. Pat. Pub. 2010/0093845).
Rejection:
The teachings of Nazzal et al. are addressed above.
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 composition contains the same structural tocopherol form, the tocopheryl acetate would have the recited refractive index as the specification discloses that tocopheryl acetate to have this 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).
Response to Arguments:
Applicant's arguments are centered on the assertion to Nazzal which are addressed above.
Applicant also asserts that the combination of Nazzal and Wong would not lead to emulsion that are not suitable for ocular administration which is not what is claimed, and claim 34 is not rejected under this combination of references where claim 34 is nonobvious.
This is fully considered but not persuasive. With regards to the assertion that Nazzal and Wong would not lead to emulsion that are not suitable for ocular administration which is not what is claimed, this is not persuasive as addressed above Nazzal exemplifies a composition consisting of the claimed Vitamin E and MCT -not an emulsion - wherein it would be prima facie obvious to utilize the known acetate form for alpha-tocopherol with a reasonable expectation of success absent evidence of criticality for the claimed form. With regards to the assertion that claim 34 is not rejected under this combination of references where claim 34 is nonobvious, this is not persuasive and confusing as claim 34 is rejected under anticipation is the rejection presented above is directed to claim 36-37 for obviousness (it is noted that anticipation is the epitome of obviousness for the composition of claim 34).
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) as applied to claims 34-35, 39-47 above, in view of Dhingra et al. (U.S. Pat. Pub. 2013/0303495).
Rejection:
The teachings of Nazzal et al. are addressed above.
Nazzal 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 centered on the assertion to Nazzal which are addressed above. Applicant also asserts that the combination of Nazzal and Dhingra would not lead to emulsion that are not suitable for ocular administration which is not what is claimed, and claim 34 is not rejected under this combination of references where claim 34 is nonobvious.
This is fully considered but not persuasive. With regards to the assertion that Nazzal and Dhingra would not lead to emulsion that are not suitable for ocular administration which is not what is claimed, this is not persuasive as addressed above Nazzal exemplifies a composition consisting of the claimed Vitamin E and MCT -not an emulsion – wherein 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.
Accordingly, the rejection stands.
Conclusion
Claims 34-37, 39-48 are rejected.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613