DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
1. Claims 3, 6-8, and 11-22 have been cancelled. Claim 4 has been withdrawn. Claim 5 is withdrawn from consideration due to the amended to make it dependent on the withdrawn claim 4.
Claims 1, 2, 9, and 10 have been amended. Claims 23-30 are new.
Claims 1, 2, 9, 10, and 23-30 are under examination.
2. All objections/rejections pertaining to claims 3, 6-8, and 11-20 are moot because the claims were cancelled with the reply filed on 11/28/2025.
The rejection of claim 1 (and its dependent claims 2, 5, 9, and 10) under 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in response to the amendment to claim 1 replacing the recitation “the bioactive agent” with “the at least one lipophilic bioactive agent”.
The rejection of claim 9 under 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in response to the amendment replacing the recitation “the solubilizer” with “the at least one solubilizer”.
The rejection of claim 10 under 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in response to the amendment to delete the recitation “the permeation enhancer” from the claim.
Specification
3. The claim listing is objected to because claim 4 has been withdrawn, and thus, the proper identification is “withdrawn, currently amended”.
Since claim 5 has been withdrawn, claim 5 should also be identified as “withdrawn, currently amended”.
4. The rejections of record are maintained; however, they have been modified to reflect the amendments to the previously presented claims and to include the newly presented claims in the basis for rejection.
Double Patenting
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web- based eTerminal Disclaimer may be filled out completely online using web- screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying- online/eterminal-disclaimer.
6. Claims 1, 2, 9, 10, and 23-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-28 of U.S. Patent No. 10,588,859, in view of Hsia et al. (WO 05/069916). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising the same liposomal concentrate, CoQ10 as lipophilic bioactive agent, the same solubilizer, and the same permeation enhancer (propylene glycol), and water. The patent specification discloses that the concentration of the lipophilic bioactive agent in the liposomal concentrate could be 18-26% or 21-22% (as recited in instant claims 1 and 23), that the liposomal concentrate comprises 1-20% or 4-12% phospholipids (as recited in instant claim 24 and 25) (see column 8, lines 43-56). The patent claims do not recite a method for treating cancer, as recited in the instant claim 20. Hsia et al. teach the pharmaceutical compositions comprising CoQ10 are suitable to treat cancer (see p. 1). Modifying the patent claims by further claiming a method for treating cancer would have been obvious to one of skill in the art.
Thus, the instant claims and the composition claims are obvious variants.
7. Claims 1, 2, 9, 10, and 23-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-29, and 31-33 of U.S. Patent No. 8,454,945, in view of Hsia et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising the same liposomal concentrate, CoQ10 as a lipophilic bioactive agent, the same solubilizer, and the same permeation enhancers (propylene glycol). The patent specification discloses that the concentration of the lipophilic bioactive agent in the liposomal concentrate could be 18-26% or 21-22% (as recited in instant claims 1 and 23), that the liposomal concentrate comprises 1-20% or 4-12% phospholipids (as recited in instant claim 24 and 25) (see column 8, lines 30-41). The patent claims do not recite a method for treating cancer, as recited in the instant claim 20. Hsia et al. teach the pharmaceutical compositions comprising CoQ10 are suitable to treat cancer (see p. 1). Modifying the patent claims by further claiming a method for treating cancer would have been obvious to one of skill in the art. Thus, the instant claims and the patent claims are obvious variants.
Claim Rejections - 35 USC § 103
8. 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
9. Claims 1, 2, 9, 10, and 23-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hsia et al. (WO 05/069916), in view of Harada et al. (PGPUB 2008/0207560).
Hsia et al. teach a concentrate comprising Phospholipon 90G, medium chain triglycerides (MCT), butylated hydroxytoluene (BHT; preservative), and CoQ10 (see p. 12, lines 18-24). Hsia et al. teach that CoQ10 could be pre-mixed with a solubilizer (such as a polyethoxylated fatty acid sorbitan ester), to facilitate uniform CoQ10 mixing with the other components; the polyethoxylated fatty acid sorbitan ester could be polysorbate 10, polysorbate 60, or polysorbate 80 (see p. 36, line 30 through p. 37, line 20). Modifying the concentrate by including a polyethoxylated fatty acid sorbitan ester would have been obvious to one of skill in the art to achieve the predictable result of obtaining a concentrate comprising uniformly distributed CoQ10 (claims 1 and 9). As evidenced by the specification, Phospholipon 90G is a lecithin (claims 1 and 10).
Hsia et al. teach using the concentrate to obtain a pharmaceutical cream comprising about 1-20% CoQ10 and an aqueous buffer, where the cream could further comprise a transdermal enhancer such as propylene glycol, to facilitate transdermal delivery of CoQ10. Further including propylene glycol would have been obvious to one of skill in the art to achieve the predictable result of enhancing the transdermal delivery of CoQ10 (claims 2, 26, and 27) (see p. 2, lines 22-23; p. 12, lines 10-29; p. 13, lines 10-17; paragraph bridging p. 16 and 17; p. 18, lines 23-29; paragraph bridging p. 18 and 19; p. 33, lines 1-2; p. 36, lines 30-33; p. 37, lines 26-28; Example 3).
Hsia et al. do not specifically teach that the concentrate comprises 21-22% CoQ10 (claims 1 and 23). However, Hsia et al. use the concentrate to obtain final products (such as creams) comprising 1-20% CoQ10. One of skill in the art would have readily recognized that the amount of CoQ10 in the concentrate is a result-effective variable with respect to obtaining the desired concentration in the final product. One of skill in the art would have found obvious to use routine experimentation and vary the amount of CoQ10 in the concentrate to obtain final products with desired CoQ10 concentrations. Routine optimization is not considered inventive and no evidence has been presented that the selection the claimed concentration ranges was other than routine or that the results should be considered unexpected in any way as compared to the closest prior art (see MPEP 2144.05 II). It is noted that a sufficient showing of a secondary consideration (e.g. unexpected results) would obviate this and any further rejection of this type. Submission of a secondary consideration such as latent properties must be supported by objective evidence of a probative value (see MPEP 716.01).
Hsia et al. do not specifically teach that Phospholipon 90G is present in the liposomal composition at a concentration within the ranges of 1-20 or 4-12 % (claims 24 and 25). Harada et al. teach using concentrations of 1-7% phospholipid for liposomal compositions comprising CoQ10, and exemplifies formulations with 4% phospholipid (see [0221] and Table 17). Using Phospholipon 90G at concentrations of 1-7% would have been obvious to one of skill in the art to achieve the predictable result of obtaining a composition suitable for CQ10 delivery. The range of 1-7% overlaps with the claimed ranges. In the case where the 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, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 I.
With respect to claim 28, Harada et al. teach that pentylene glycol could be used instead of propylene glycol (see [0167]). Using pentylene glycol instead of propylene glycol would have been obvious to one of skill in the art to achieve the predictable result of obtaining a composition suitable for CQ10 delivery.
Thus, the claimed invention was prima facie obvious at the time it was made.
10. Claims 1, 2, 9, 10, and 23-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hsia et al. taken with Harada et al., in further view of Rastogi (Contact Dermatitis, 2000, 43: 339-343, Abstract), as evidenced by Science Lab.com Data Sheet.
The teachings of Hsia et al. and Harada et al. are applied as above for claims 1, 2, 9, 10, and 23-28. Hsia et al. and Harada et al. do not specifically that phenoxyethanol as a preservative (claims 29 and 30). However, Hsia et al. teach that the liposomal composition could comprise preservatives. Rastogi teaches that phenoxyethanol was routinely used in the prior art as preservative (see Abstract). One of skill in the art would have found obvious to further add phenoxyethanol or substitute the preservative of Hsia et al. with phenoxyethanol to achieve the predictable result of obtaining a composition suitable for CoQ10 delivery.
With respect to the limitation of phosphatidylcholine lecithin (claim 30), as evidenced by the Science Lab.com Data Sheet, Phospholipon 90G is a phosphatidylcholine lecithin.
Thus, the claimed invention was prima facie obvious at the time it was made.
Response to Arguments
11. The arguments have been considered but not found persuasive. Hsia’s composition also provides flexibility in creating various compositions with a wide range of final CoQ10 concentrations. Hsia teaches that the concentrate can be formulated into a variety of final products (creams, oils, ointments, lotions, drops), each comprising CoQ10 in a concentration effective for the intended purpose; CoQ10 concentration in the final product could be 1-20% (see p. 13, lines 10-15; p. 16; p. 34, lines 18-19; p. 32, lines 1-2). One of skill in the art would have readily recognized that the amount of CoQ10 in the concentrate is a result-effective variable with respect to obtaining the desired concentration in the final product. Varying the amount of CoQ10 in the concentrate would have thus been obvious and would have only entailed routine experimentation.
For these reasons, the argument that Hsia fails to teach a liposomal concentrate as claimed is not found persuasive.
The applicant argues that Examples 2 and 3 in Hsia disclose composition comprising 10% CoQ10. While this is true, 10% is the concentration of CoQ10 in the final product, not the concentrate.
Conclusion
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action (specifically, including the new claims in the grounds for rejection). 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 ILEANA POPA whose telephone number is (571)272-5546. The examiner can normally be reached 8:00 am to 4:30 pm.
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/ILEANA POPA/Primary Examiner, Art Unit 1633