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 .
Status of Claims
The amendments and arguments filed 4 May 2026 are acknowledged and have been fully considered. Claims 1, 3-14, and 16-21 are currently pending. Claims 1 and 13-14 amended; claims 2 and 15 are cancelled; claims 4-12 are withdrawn; claims 18-21 are new.
Claims 1,3, 13-14, and 16-21 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 19 is objected to because of the following informalities: “or the surfactant to lipid ratio of is 1.5:1” in line 2 should be “or the surfactant to lipid ratio is 1.5:1”.
Claim 20 is objected to because of the following informalities: “a lipid having and alkane” in line 2 should be “a lipid having an alkane”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 18-19 recite the trademark(s)/trade name(s) Brij® and Gelucire®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe surfactants and, accordingly, the identification/description is indefinite.
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 1, 3, 13-14, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tyagi et al. (Int. J. Pharm., 2016, Vol. 499, 301-320) in view of Bredehorst et al. (US 2018/0085452; of record).
Claim 1 is drawn to a lipid nanoparticle composition comprising one or more Janus kinase (JAK) inhibitors of an inflammatory cytokine encapsulated within nanostructured lipid carriers,
wherein the nanostructured lipid carriers have a surfactant to lipid ratio of 1:1 to 2:1 by weight and a solid to liquid lipid blend ratio of 50:50 to 90:10 by weight based on the total weight of lipid.
Claim 3 is drawn to the composition of claim 1, wherein the JAK inhibitor is tofacitinib (Applicant’s elected species).
Claim 14 is drawn to the composition of claim 1, wherein the nanostructured lipid carriers comprise greater than 50% solid lipid based on the total weight of lipid in the composition.
Claim 18 is drawn to the composition of claim 1, wherein the surfactant comprises Gelucire®.
Tyagi et al. teach nanostructured lipid carriers (NLCs) for the delivery methotrexate (Title, Abstract), further teaching methotrexate as an inflammatory cytokine inhibitor (Pg. 301 right column first paragraph). Tyagi et al. further teach the NLCs being formed from a 4:1 ratio of solid lipid mixture to liquid lipid, wherein the solid lipid mixture comprises a 1:2 ratio of stearic acid to the surfactant Gelucire® 50/13 (Pg. 302 right column second paragraph), corresponding to a surfactant to lipid ratio of 1.6:1, a solid to liquid lipid ratio of 80:20, and a solid lipid content of 80% based on the total weight of lipid in the composition as calculated by examiner, overlapping with the instantly claimed ranges.
As such, Tyagi et al. teach a lipid nanoparticle composition comprising an inhibitor of an inflammatory cytokine encapsulated within nanostructured lipid carriers, wherein the nanostructured lipid carriers have a surfactant to lipid ratio of 1:1 to 2:1 by weight and a solid to liquid lipid blend ratio of 50:50 to 90:10 by weight based on the total weight of lipid, wherein the nanostructured lipid carriers comprise greater than 50% solid lipid based on the total weight of lipid in the composition, and wherein the surfactant comprises Gelucire®.
The composition of Tyagi et al. differs from the instantly claimed composition in the following way:
the composition of Tyagi et al. does not comprise a JAK inhibitor.
Yet, as to 1: Tyagi et al. further teach the NLC composition for the treatment of rheumatoid arthritis (Title, Abstract).
Bredehorst et al. also teach compositions for treatment of rheumatoid arthritis (Par. [0003]). Bredehorst et al. further teach “tofacitinib has been approved by FDA to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate” (Par. [0487]). Bredehorst et al. further teach tofacitinib as suitable for delivery via liposomes (Par. [0347]), a lipid-based nanostructure.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Tyagi et al. to comprise tofacitinib as taught by Bredehorst et al. It would have been obvious to substitute one active ingredient for treating rheumatoid arthritis for another to obtain the predictable result of a composition for treatment of rheumatoid arthritis in a person who has had an inadequate response to, or who is intolerant of, methotrexate, with a reasonable expectation of success.
Based on all of the foregoing, claims 1, 3, 14, and 18-19 are rejected as prima facie obvious.
Claim 13 is drawn to the composition of claim 1, wherein the NLCs have a surfactant to lipid ratio of 1.5 by weight.
Claim 19 is drawn to the composition of claim 1, wherein the surfactant to lipid ratio is 1.5:1 or 2:1 and the surfactant is Gelucire®.
As discussed above, Tyagi et al. teach the NLCs having a surfactant to lipid ratio of 1.6 by weight and the surfactant comprising Gelucire®.
And as discussed in MPEP 2144.05(I), Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.")
In the instant case, NLCs having a surfactant to lipid ratio of 1.6 and a surfactant to lipid ratio of 1.5 are so close that prima facie one skilled in the art would have expected them to have the same properties.
As such, claims 13 and 19 are rejected as prima facie obvious.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tyagi et al. and Bredehorst et al. as applied to claims 1, 3, 13-14, and 18-19 above, and further in view of Fox et al. (WO 2018/232257) and Gupta et al. (Pharm Res, 2015, Vol. 32, 2912-2927; of record).
The teachings of Tyagi et al. and Bredehorst et al. have been set forth above.
Claim 16 is drawn to the composition of claim 1, wherein the nanostructured lipid carriers are less than 30nm.
Tyagi et al. and Bredehorst et al. do not teach the nanostructured lipid carriers being less than 30nm.
Fox et al. also teach nanostructured NLCs for the delivery of bioactive molecules for therapeutic purposes (Abstract). Fox et al. further teach NLCs having a size range from 20 to 60 nm have superior loading capacity (Par. [0153]), overlapping with the instantly claimed range.
Gupta et al. teach optimizing nanostructured lipid carriers for delivery of a pharmaceutical agent (Abstract). Gupta et al. further teach that variables including the amount of surfactant, the oil to total lipid ratio, and drug to lipid ratio have an effect on the particle size (Fig. 2C on pg. 2918).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the NLCs of Tyagi et al. and Bredehorst et al. to have a size less than 30nm as taught by Fox et al. utilizing the size optimization methods taught by Gupta et al. It would have been obvious to combine the known NLC composition, known size for superior loading capacity, and known methods for controlling size of NLCs to yield the predictable result of a tofacitinib NLC composition with improved loading capacity, with a reasonable expectation of success.
As such, claim 16 is rejected as prima facie obvious.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tyagi et al. and Bredehorst et al. as applied to claims 1, 3, 13-14, and 18-19 above, and further in view of Calderón-Colón et al. (J. Vis. Exp., 2015, 105).
The teachings of Tyagi et al. and Bredehorst et al. have been set forth above.
Claim 17 is drawn to the composition of claim 1, wherein the NLCs have a latent heat of melting of less than 2 J/g.
Tyagi et al. are silent as to the latent heat of melting of the NLCs.
Calderón-Colón et al. teach lipid nanoparticle delivery vehicles for drug delivery (Abstract). Calderón-Colón et al. further teach the latent heat of melting as being indicative of the crystallinity of the nanoparticle and determining the delivery and dose of the nanoparticle (Pg. 6 second paragraph).
And, as discussed by MPEP 2144.05, “ “where 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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the latent heat of melting of the NLCs is clearly a result-effective variable, determining the delivery and dose of the NLCs. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal latent heat of melting of the NLCs in order to best achieve the desired results.
As such, claim 17 is rejected as prima facie obvious.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tyagi et al. and Bredehorst et al. as applied to claims 1, 3, 13-14, and 18-19 above, and further in view of Tikekar et al. (Langmuir, 2012, Vol. 28, 9233-9243).
The teachings of Tyagi et al. and Bredehorst et al. have been set forth above.
Claim 20 is drawn to the composition of claim 1, wherein the solid lipid comprises a lipid having an alkane hydrocarbon between 19 and 24 carbons in length.
Tyagi et al. and Bredehorst et al. do not teach an alkane between 19 and 24 carbons in length.
Tikekar et al. also teach NLCs for drug delivery (Pg. 9233 left column first paragraph), further teaching eicosane (i.e., C20 alkane) as the solid lipid for NLCs (Pg. 9234 right column first paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Tyagi et al. and Bredehorst et al. to include eicosane as taught by Tikekar et al. It would have been obvious to substitute one solid lipid suitable for forming NLCs for drug delivery for another to obtain the predictable result of an NLC for delivery of tofacitinib, with a reasonable expectation of success.
As such, claim 20 is rejected as prima facie obvious.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tyagi et al. and Bredehorst et al. as applied to claims 1, 3, 13-14, and 18-19 above, and further in view of Ying et al. (MJFAS, 2017, Vol. 13, 248-252).
The teachings of Tyagi et al. and Bredehorst et al. have been set forth above.
Claim 21 is drawn to the composition of claim 1, wherein the liquid lipid is tocopherol.
Tyagi et al. and Bredehorst et al. do not teach tocopherol.
Ying et al. also teach NLCs as a carrier for an active agent (Abstract). Ying et al. further teach forming the NLCs with tocopherol as the liquid lipid (Pg. 249 third paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Tyagi et al. and Bredehorst et al. to include tocopherol as taught by Ying et al. It would have been obvious to substitute one liquid lipid suitable for forming NLCs for drug delivery for another to obtain the predictable result of an NLC for delivery of tofacitinib, with a reasonable expectation of success.
As such, claim 21 is rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 4 May 2026 have been fully considered but they are moot in view of the new grounds of rejection necessitated by Applicant’s amendments to the claims.
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.
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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