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 .
Election/Restrictions
Newly submitted claim 21 is directed to a species that is independent or distinct from the invention originally claimed for the following reasons: claim 21 recites the composition further comprising an antioxidant in the lipid phase, which is not required by the elected species of composition comprising ropivacaine, hyaluronic acid, glycerol, and a phospholipid elected in the remarks filed 31 March 2025.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Claims
The amendments and arguments filed 25 February 2026 are acknowledged and have been fully considered. Claims 1-17 and 19-21 are currently pending. Claims 15-17 and 19 are amended; claim 18 is cancelled; claims 1-14 and 21 are withdrawn; claim 21 is new.
Claims 15-17 and 19-20 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The objection to claims for minor informalities is withdrawn in view of Applicant’s amendment to the claims. Further, the rejections of claims under 35 U.S.C. 112(b) and 35 U.S.C. 103 are withdrawn in view of Applicant’s amendments to the claims. 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 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 15 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinow et al. (US 2015/0024031 cited on Applicant’s IDS filed 6 August 2026) in view of Chen (US 2006/0067952 cited on Applicant’s IDS filed 6 August 2026), Thayer (C&EN, 2007, Vol. 85, Issue 25, 17-30), and Bergström et al. (J Pharm Sci, 2006, Vol. 95, 680-688) as evidenced by IOI Oleochemical (“Miglyol® 812N”, 2019) and Lu et al. (BMC Anesthesiology, 2022, Vol. 22, 113).
Claim 15 is drawn to an echogenic composition for the treatment of pain comprising:
a continuous aqueous phase comprising an emulsifier and a polyol;
a lipid phase dispersed into droplets having an average diameter of about 500 nm to about 5 µm within the aqueous carrier comprising a triglyceride,
wherein the triglyceride is liquid at 25°C and wherein an undissolved crystalline anesthetic agent (more specifically ropivacaine (Applicant’s elected species)) is within the lipid phase droplets; and wherein the lipid phase is emulsified within the continuous aqueous phase.
Claim 20 is drawn to the composition of claim 15, wherein the polyol is glycerol (Applicant’s elected species) and is present in an amount of from about 0.25 to about 2.5% (w/v) of the composition.
Rabinow et al. teach pharmaceutical compositions for reducing pain comprising a dispersion of microparticles comprising an analgesic agent (Abstract). Rabinow further teach Formulation #4 (Table 1 on pg. 11 and pars. [0089-90]) comprising a dispersion of ropivacaine and 1,2-dimyristoyl-sn-glycerol-3-phosphoglycerol in an aqueous phase comprising water, 2.25% w/v glycerol, and Lipoid® E80 (i.e., an emulsifier) and the dispersed droplets having an average size of 3µ, overlapping with the instantly claimed range.
As such, Rabinow et al. teach a composition for the treatment of pain comprising: a continuous aqueous phase comprising an emulsifier and a polyol; a lipid phase dispersed into droplets having an average diameter of about 500 nm to about 5 µm within the aqueous carrier, wherein ropivacaine is within the lipid phase droplets; and wherein the lipid phase is emulsified within the continuous aqueous phase.
The composition of Rabinow et al. differs from the instantly claimed composition in the following ways:
the composition of Rabinow et al. does not comprise a triglyceride;
Rabinow et al. are silent as to the ropivacaine being undissolved;
the composition of Rabinow et al. does not comprise crystalline ropivacaine;
Rabinow et al. are silent as to the state of matter of the lipid phase at 25°C; and
Rabinow et al. are silent to the composition being echogenic.
Yet, as to 1 and 4: Rabinow et al. further teaches the compositions as being delivered by injection (Par. [0102]).
Chen also teaches injectable oil-in-water emulsions of drugs (Abstract). Chen further teaches triglycerides as being suitable oils for use as carriers of drugs that have been extensively used in injectable emulsions, such as Miglyol® 812 (Pars. [0102-0103]). As evidenced by IOI Oleochemical, Miglyol® 812 has a melting point of about 6°C, and as such, is a liquid at 25°C.
And as discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, both 1,2-dimyristoyl-sn-glycerol-3-phosphoglycerol and Miglyol® 812are taught in the prior art to be suitable lipid carriers for drugs in injectable compositions. 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 Rabinow et al. to include Miglyol® 812 as taught by Chen. One would have been motivated to do so to provide a composition of injectable ropivacaine, with a reasonable expectation of success.
As to 2: As discussed in MPEP 2112.01(I), "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
As evidenced by Lu et al., ropivacaine has low fat solubility (Pg. 1 right column second paragraph). As Rabinow et al. teach ropivacaine, the instantly claimed undissolved in the oil is necessarily present.
As to 3: Rabinow et al. further teach the pharmacokinetics of the active ingredient can be modified by using specific crystal forms (Par. [0079]).
As taught by Thayer, “a drug’s behavior depends on much more than the molecular structure; its solid form dictates its properties, including stability, hygroscopicity, dissolution rate, solubility, and bioavailability (Pg. 17 left to middle column bridging paragraph).
And as taught by Bergström et al., due to the differing physiochemical properties for different solid states of a compound, the search for various crystal modification is an essential part of drug development (Pg. 680 left column first paragraph), additionally teaching two crystal forms of ropivacaine (Title).
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))).
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 Rabinow et al. to comprise crystalline ropivacaine. It would have been obvious to combine the known ropivacaine composition with the known crystal forms of ropivacaine to obtain a ropivacaine composition with optimal stability, hygroscopicity, dissolution rate, solubility, and bioavailability, with a reasonable expectation of success.
And, as to 5: As discussed in MPEP 2112(I), "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id.
Further, as discussed in MPEP 2112(II), There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency).
And as discussed in MPEP 2112.01(I), "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
In the instant case, the echogenicity of the composition is a property inherent to the instantly claimed composition as evidenced by the instant specification at Pars. [0159-160] and Figs. 2B and 39-40. As Rabinow et al., Chen, and Bergström et al. teach all of the structural limitations of the instantly claimed echogenic composition, the instantly claimed echogenicity is necessarily present, regardless of whether or not it was recognized by the prior art.
Based on all of the foregoing, claims 15 and 20 are rejected as prima facie obvious.
Claim 19 is drawn to the composition of claim 15, wherein the lipid phase is present in an amount from about 10% to about 40% (w/v) of the composition.
Rabinow et al. further teach the amount of microparticles comprising the analgesic agent (i.e., the lipid phase) being an optimizable variable, wherein the amount of the lipid phase present determines the efficacy of the composition at reducing pain and inflammation (Par. [0018]).
And, as discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “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 concentration of the lipid phase is clearly a result effective variable, determining the efficacy of the composition at reducing pain and inflammation. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal concentration of the lipid phase in order to best achieve the desired results.
As such, claim 19 is rejected as prima facie obvious.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Rabinow et al., Chen, Thayer, and Bergström et al. as applied to claims 15 and 19-20 above, and further in view of Davis et al. (Int J Pharm, 2020, Vol. 588, 119703; of record).
The teachings of Rabinow et al., Chen, Thayer, and Bergström et al. have been set forth above.
Claim 16 is drawn to the composition of claim 15, wherein the emulsifier is hyaluronic acid present in an amount from about 0.15% to about 1% (w/v) of the composition.
Rabinow et al., Chen, Thayer, and Bergström et al. do not teach hyaluronic acid.
Davis et al. also teach injectable emulsions of local anesthetics for treatment of pain (Abstract). Davis et al. further teach emulsions comprising 1.25% w/v hyaluronic acid in the aqueous phase (Sec. 2.2 on pg. 2), and the compositions with hyaluronic acid in the aqueous phase improving the maximum possible anesthetic effect and a longer lasting presence in the subject than the compositions without hyaluronic acid (Figs. 3A and B).
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 Rabinow et al., Chen, and Bergström et al. to comprise hyaluronic acid in the aqueous phase as taught by Davis et al. It would have been obvious to use the known technique of including hyaluronic acid in the aqueous phase to improve the similar local anesthetic emulsion in the same way, by improving maximum possible anesthetic effect and longevity, with a reasonable expectation of success.
And as discussed in MPEP 2144.05(I), 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, a composition comprising about 1% w/v of hyaluronic acid and a composition comprising 1.25% w/v of hyaluronic acid are so close that one of ordinary skill in the art would reasonably expect them to have the same properties.
As such, claim 16 is rejected as prima facie obvious.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rabinow et al., Chen, Thayer, and Bergström et al. as applied to claims 15 and 19-20 above, and further in view of Pichot et al. (Int J Mol Sci, 2013, Vol. 14, 11767-11794; of record).
The teachings of Rabinow et al., Chen, Thayer, and Bergström et al. have been set forth above.
Claim 17 is drawn to the composition of claim 15, wherein the lipid phase further comprises a phospholipid present in an amount from about 0.1% to about 2% (w/w) of the lipid phase.
Rabinow et al. teach the lipid phase comprising the phospholipid 1,2-dimyristoyl-sn-glycerol-3-phosphoglycerol, but do not teach the phospholipid present in the amount of 0.1% to 2.0% (w/w).
However, Pichot et al. teach that phospholipids are used as emulsion stabilizers due to their amphiphilic character, indicating that the stability of the emulsion is directly related to the concentration of phospholipids present.
And as discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “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 concentration of the phospholipid is clearly a result-effective variable, determining the stability of the emulsion. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal concentration of the phospholipid in order to best achieve the desired results.
As such, claim 17 is rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 25 February 2026 have been fully considered but they are not persuasive.
Applicant’s arguments regarding emulsion particle size and crystallinity of the active agent are moot in view of the new grounds of rejection set forth above necessitated by Applicant’s amendment.
Applicant argues on pg. 4 of the remarks that Examiner’s reliance on the specification as evidence for inherency is improper, citing In re Dow Chem. Co. and Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc.
This argument is not persuasive. As discussed in MPEP 2112(I), "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Further, as discussed in MPEP 2112(II), There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency).
And as discussed in MPEP 2112.01(I), "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
In the instant case, the instant specification has demonstrated that compositions having the instantly claimed structure necessarily demonstrate echogenicity (Pars. [0159-160] and Figs. 2B and 39-40). As Rabinow et al., Chen, and Bergström et al. teach all of the structural limitations of the instantly claimed echogenic composition, the instantly claimed echogenicity is necessarily present, regardless of whether or not it was recognized by the prior art.
Additionally, In re Dow Chem Co. and Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc. are discussing that the motivation to combine references must come from outside of the applicant’s disclosure. As the motivation to combine the teachings of Rabinow et al., Chen, and Bergström et al. comes solely from the prior art, the rejection is proper.
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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