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 .
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.
3. Claims 1, 16 have been amended, claims 8, 10, 12-13, 15, 17-19, 23, 25-26, 28-33, 40 have been cancelled, claims 21-22, 24, 27, 34-39 have been withdrawn and claims 1-7, 9, 11, 14, 16, 20-22, 24, 27, 34-39 are pending as amended on 03/06/26.
4. The new ground of rejection set forth below for claims are necessitated by Applicant's amendment filed on 03/06/26. In particular, claim 1 has been amended to include features “wherein the ratio of the at least one compound of Formula (I) to the total amount of the bioactive lipophilic compound and the oil is from about 2:1 to about 12:1.” Now, the scope of independent claim 1 and the claims depends from claim 1 are changed. For this reason, the present action is properly made final.
5. Any rejections and/or objections made in the previous Office action and not repeated below are hereby withdrawn.
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
This application is a 371 of PCT/CA2020/051739 12/17/2020; PCT/CA2020/ 051739 has PRO 62/949,647 12/18/2019.
Response to Amendment
8. Applicant's amendment filed on 03/06/26, has been fully considered and entered.
Response to Arguments
9. Applicant's arguments with respect to rejection of claims 1-7, 9, 11, 14 under 35 U.S.C. 102(a)(1) as being anticipated by Borowy-Borowski (US 2008/0160077) and claims 16, 20 under 35 U.S.C. 103 as being unpatentable over Borowy filed on 03/06/26, have been fully considered but are moot in view of amendment. The previous rejections have been withdrawn. Applicants arguments regarding the presence of the amount of oil in Borowy-Borowski have been respectfully considered but are not persuasive because Borowy-Borowski expressly discloses in para [0060] from about 10% to about 80% by weight of a lipophilic carrier such as fish oil. As noted in the previous rejection of claim 16, Borowy-Borowski discloses surfactant such as PTS in an amount of from about 10 wt% to about 50 wt%, bioactive lipophilic molecule in an amount of from about 10 wt% to about 30 wt%, and oil (lipophilic career) in an amount of from about 10 wt% to about 80 wt% (para [0038], [0048], [0060]), overlap the claimed ratio of the at least one compound of Formula (I) to the total amount of the bioactive lipophilic compound and the oil is from about 2:1 to about 12:1, wherein at least the amount of 10 wt% to 12.5 wt% of bioactive lipophilic molecule and of 10 wt% to 12.5 wt% of oil (lipophilic career), and 40 wt% to 50 wt% of surfactant such as PTS fall into claimed range. It is well-settled that where claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 267 (CCPA 1976). However, in view of amendment to claims and response, a new ground(s) of rejection is made under 35 USC § 103.
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.
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 1-7, 9, 11, 14, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Borowy-Borowski (US 2008/0160077).
Regarding claims 1-6, 11, 14, Borowy-Borowski discloses a composition comprising a bioactive lipophilic compound such as CoQ10, an oil and a compound, e.g. polyoxyethanyl-tocopheryl-sebacate (PTS) (para [0003]-[0004], [0032], [0037], [0043]-[0047], [0053]), Borowy-Borowski further discloses surfactant such as PTS in an amount of from about 10 wt% to about 50 wt%, bioactive lipophilic molecule in an amount of from about 10 wt% to about 30 wt%, and oil (lipophilic career) in an amount of from about 10 wt% to about 80 wt% (para [0038], [0048], [0060]), overlap the claimed ratio of the at least one compound of Formula (I) to the total amount of the bioactive lipophilic compound and the oil is from about 2:1 to about 12:1, wherein at least the amount of 10 wt% to 12.5 wt% of bioactive lipophilic molecule and of 10 wt% to 12.5 wt% of oil (lipophilic career), and 40 wt% to 50 wt% of surfactant such as PTS fall into claimed range.
A prima facie case of obviousness exists for a composition, where Borowy-Borowski discloses surfactant such as PTS in an amount of from about 10 wt% to about 50 wt%, bioactive lipophilic molecule in an amount of from about 10 wt% to about 30 wt%, and oil (lipophilic career) in an amount of from about 10 wt% to about 80 wt%, overlapping the requirement of claim 1. It is well-settled that where claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 267 (CCPA 1976).
Regarding claims 7, 9, Borowy-Borowski discloses Polyethylene glycols having an average molecular weight from about 300 to about 5000 (para [0045]).
Regarding claim 20, Borowy-Borowski discloses a ratio of bioactive lipophilic molecule to the oil (lipophilic career) is 1:1 to 1:3 (para [0033]-[0034], [0052], results in 50 wt% to 75 wt%), overlapping claimed range of from about 20 wt% to about 60 wt%.
A prima facie case of obviousness exists for a composition, where Borowy-Borowski discloses a ratio of bioactive lipophilic molecule to the oil (lipophilic career) is 1:1 to 1:3, overlapping the requirement of claim 20. It is well-settled that where claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 267 (CCPA 1976).
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Borowy-Borowski (US 2008/0160077).
Amended claim 16 require the ratio of the at least one compound of Formula (I) to the total amount of the bioactive lipophilic compound and the oil is from about 6:1 to about 12:1.
Borowy-Borowski discloses surfactant such as PTS in an amount of from about 10 wt% to about 50 wt%, bioactive lipophilic molecule in an amount of from about 10 wt% to about 30 wt%, and oil (lipophilic career) in an amount of from about 10 wt% to about 80 wt% (para [0038], [0048], [0060]) but does not disclose or suggest the claim 16 features.
Conclusion
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 KUMAR R BHUSHAN whose telephone number is (313)446-4807. The examiner can normally be reached 9.00 AM to 5.50 PM (EST).
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/KUMAR R BHUSHAN/Primary Examiner, Art Unit 1766
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