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 . Claims 1-16, 18-20 and 24-26 are pending; claims 1-12 and 25-26 are examined; claims 13-16, 18-20 and 24 are withdrawn.
Applicant’s arguments, filed 09 July 2026, have been fully considered. Rejections and/or objections not registered from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 July 2026 has been entered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-6, 9-11, and 25-26 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Roentsch and Snyder (US 5,654,337 A, 08/05/1997) (hereinafter Roentsch).
Regarding claims 1, 3-6, 9-11, and 26, Roentsch discloses a topical gel comprising 20% mass ibuprofen, 10% urea, and 25% lecithin organogel, which contains 50% lecithin (i.e. 12.5% lecithin), and NaOH (Ex. 11, Ex. 1).
Regarding the recited weight ratio of NSAID to at least one phospholipid, as discussed above, Roentsch discloses 20% ibuprofen : 12.5% lecithin (i.e. 1.6 : 1).
Regarding claim 25, Roentsch further discloses wherein the lecithin is soya lecithin (col. 3, line 17). Accordingly, where the embodiment of the prior art differs only by the inclusion of the source of lecithin, the skilled artisan would immediately envision inclusion of soya lecithin as disclosed. See MPEP § 2131(III). As such, Roentsch anticipates the instant claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-12 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Roentsch and Snyder (US 5,654,337 A, 08/05/1997) (hereinafter Roentsch).
Regarding claims 1-7, 12, and 26, Roentsch discloses composition useful in the delivery of pharmaceutically active agents through the skin, formulated with a non-steroidal anti-inflammatory agent, such as ibuprofen or ketoprofen, that is rapidly absorbed through the skin (abs). The composition comprises 10-30% mass lecithin, 5-20% mass urea, and 5-10% mass ketoprofen (claim 9).
Together these would provide compositions as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding the recited weight ratio of the non-steroid anti-inflammatory drug (NSAID) and the at least one phospholipid, it would have been obvious to one of ordinary skill in the art to have selected an amount of the ketoprofen from the disclosed range of 5-10% mass and an amount of lecithin from the disclosed range of about 10-30% mass, such that the amounts selected would have equated to a weight ratio that overlaps with the instantly claimed weight ratio, thus making the claimed weight ratio obvious. See MPEP 2144.05(I). Moreover, in any case, the selection of appropriate weight ratios from disclosed ranges would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ratio ranges to arrive at the claimed weight ratios. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 2, 4, 6, and 12 reciting amounts of the at least one active agent, at least one phospholipid, and urea, the claimed ranges (i.e. about 0.1 wt. % to about 10.0 wt. %; about 0.1 wt. % to about 20.0 wt. %; and about 5.0 wt. % to about 50.0 wt. %, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 5-10% mass ketoprofen, 10-30% mass lecithin, and 5-20% mass urea, respectively). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 7-8, Roentsch further discloses wherein the composition may comprise ethyl alcohol (Ex. 12).
Regarding claims 9-10, Roentsch further discloses wherein the composition may comprise pH adjusting ingredients such as citric acid (col. 4, lines 37-46).
Regarding claim 11, Roentsch further discloses wherein the composition may be in the form of a gel (col. 2, lines 56-57).
Regarding claim 25, Roentsch further discloses wherein the lecithin may be a soya lecithin (col. 3, lines 14-18).
Response to Arguments
Applicants’ assertions regarding Garti has been considered but are moot because new rejections have been made.
Response to Declaration
The Examiner appreciates the data provided in the Declaration. The Examiner finds the objective data to be substantial, but unfortunately does not find the argument about patentability to be persuasive. To overcome a prima facie case of obviousness via submission of unexpected results, Applicant must demonstrate not only that the results would have been unexpected to one having ordinary skill in the art at the time of the invention, but also that the instant claims are commensurate in scope with the results provided. See MPEP 716.02(d). As discussed above in the rejections above, the disclosure of Roentsch renders claims 1-12 and 25-26 obvious, and a specific embodiment of Roentsch anticipates claims 1, 3-6, 9-11, and 25-26. Thus, it does not appear the presently amended claims, reciting a certain weight ratio of any species and amounts of NSAID and at least one phospholipid, in combination with any amounts of urea, would clearly distinguish over the prior art.
Then, assuming purely arguendo that the unexpectedness of the results has been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. Applicant must explain the “manner in which the specific compositions illustrated are considered to be commensurate in scope with the claimed invention”; see Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992); see also MPEP 716.02, citing same. In this instant case, for example, the data referenced in Examples 1 / Table 1 and the Examples of the Declaration are limited to liquid formulations comprising a specific combination of specific amounts of specific subclasses of NSAID, SPC/DPPC/HSPC/PE as the phospholipid, and urea, while instant claim 1 only requires a generic “topical” composition comprising “NSAID” and “at least one phospholipid” without specific amounts. Furthermore, the data was obtained with specific proportions of phospholipid to urea (for example, those shown in p. 21, Table 1 of the instant Specification, and those shown in 1-3 of the Declaration; see also Ex. 1, specifically para. [0080] of the Specification, discussing that SPC and urea have an interaction to change the properties of the solution depending on the concentration of each component, as well as its proportion to each other), while the instant claims are not so limited. Similarly, Tables 1-3 of the Declaration notes an approximate increase in solubility of about 2.26-2.69, 3.58-7.25, and 2.88-4.25-fold, respectively, but the claims are not limited to a specific degree of improvement. And finally, as noted by p. 22, para. [0093] of the instant Specification, the specific ratio of diclofenac sodium to SPC between 4:6 and 8:2 affords certain characteristics that are most effective in enhancing the stability of the formulation, notably without phase separation, but the claims are not limited to such specific ratios.
Therefore, it is not clear to the Examiner how the specific combination of specific amounts of specific subclasses of NSAID, SPC/DPPC/HSPC/PE as the phospholipid, and urea, is reasonably representative of the much more generic recitation of any unrestricted amounts of “NSAID” and “at least one phospholipid”, which may encompass subclasses such as sphingolipids, or betaine lipids, and urea. Moreover, it appears, based on the data provided in the Declaration and in the instant Specification Table 1, that not all concentrations of phospholipid (e.g., SPC) and urea would result in the alleged improved solubility. Note, for example, a 20% of SPC, even with 5% of urea added, is still too viscous to separate undissolved diclofenac. Similar situation occurs with 18-20% SPC + 40% urea, and with 10-20% SPC + 50% urea. However, the instant claims would encompass such embodiments.
Finally, Tables 1-3 of the Declaration highlights an approximate increase in solubility of about 2.26-2.69, 3.58-7.25, and 2.88-4.25-fold, respectively, noting specifically the significance of the 7.25-fold improvement in section 6.2 (p. 5) of Declaration, but the claims are not limited to a specific degree of improvement, or the species of NSAID or phospholipid utilized in achieving such result. Accordingly, the Examiner suggests amending the claims to more closely reflect the alleged unexpected results obtained in the Declaration, such as specific species of phospholipid, specific amount ranges of the specific subclasses of NSAID (it is noted that the current claim as amended only requires an amount of at least one active agent comprising NSAID, thus there is not a specific amount requirement of NSAID specifically), the at least one phospholipid, and urea.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tatapudy et al. (US 2007/0053968 A1, 03/08/2007), directed to transdermal drug delivery of pharmacologically active agents, comprising solvents, emulsifying agents, and permeation enhancing agents.
Piazza et al. (US 5,340,568 A, 08/23/1994), directed to topical application of anti-inflammatory agents, penetration enhancing agents, and a phospholipid.
Alhakamy et al. (US 2022/0023244 A1, 01/27/2022), directed to compositions for topical application comprising a non-steroidal anti-inflammatory drug, dispersing agents, buffering agents, and humectants.
Register (US 2021/0220259 A1, 07/22/2021), directed to topical compositions comprising rofecoxib, humectant, and moisturizing agents.
Garti et al. (US 2021/0137829 A1, 05/13/2021), directed to topical compositions comprising diclofenac, a phospholipid, a penetration promotor such as urea, a solvent such as ethanol, and pH adjusting agents such as citric acid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
