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 .
Response to Arguments
Applicant's arguments, filed May 19, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Drawings
Applicants amended the drawings filed May 19, 2026, the issue identified in the February 20, 2026 Office Action has been fully resolved. Therefore, the drawings received on May 19, 2026 are acceptable.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Desgranges et al. (US 10,286,091, 2019) in view of Astafyeva et al. (Journal of Materials Chemistry B, 2015; cited on IDS filed May 9, 2023).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed February 20, 2026 and those set forth herein.
Applicant argues that a prima facie case of obviousness has not been established because the cited references do not teach or suggest, for instance, "the molar ratio between said biocompatible surfactant and said fluorocarbon is higher than 0.06.” Applicant argues that the skilled person would not be motivated to increase the molar ratio between the surfactant and the fluorocarbon beyond the critical molar ratio indicated in Astafyeva (0.01 for PFOB and 0.006 for both PFH and PFP) with a reasonable expectation of success because Astafyeva teaches that using a high amount of surfactant, and thereby a high molar ratio of surfactant-to-fluorocarbon leads to formation of foam in addition to the emulsion droplets. Applicant argues that the Office has improperly engaged in a hindsight analysis by focusing on an isolated disclosure rather than reading the reference as a whole. Applicant argues that Astafyeva criticizes higher surfactant to fluorocarbon ratios due to the formation of foam and micelles.
This argument is unpersuasive. Applicant’s argument selectively focuses on the mention of foam and micelle formation (a known process trade-off) while improperly ignoring the fundamental, explicit technical benefits disclosed by Astafyeva at high molar ratios. As discussed in the Office Action mailed February 20, 2026, Astafyeva discloses the effect of the surfactant to perfluorocarbon molar ratio on stabilized droplet diameter (page 2899, Fig. 4). Astafyeva discloses that the additional surfactant leads to stabilization bubbles at high molar ratio (> 0.006) and that coalescence is suppressed by surfactant (page 2903, column 2, ¶ 3; page 2904, column 1, ¶ 1). In the field of emulsion and nanodroplets, preventing coalescence is absolutely critical to achieving long-term physical stability. Therefore, Astafyeva provides a clear, affirmative motivation to a person of ordinary skill in the art to increase the surfactant-to-fluorocarbon ratio. Applicant’s reliance on Astafyeva’s mention of micelle and foam formation as criticism or a deterrent is flawed. The reference’s disclosure regarding foam and micelle formation at higher ratios represents a neutral description of surfactant physical chemistry and process trade-offs, rather than a negative teaching or an express statement directing a person of ordinary skill in the art away from higher concentrations. A reference does not teach away merely because it discloses a trade-off, a known disadvantage, or an alternative that is less than ideal, provided that the reference still signals that the combination will yield the desired functional result. A person of ordinary skill in the art would understand that once droplet surfaces are fully saturated with surfactant to achieve maximum thermodynamic stability, the formation of excess micelles in the continuous phase is an inherent, predictable physical chemistry phenomenon rather than a structural failure of the emulsion. A person of ordinary skill in the art seeking to maximize droplet stability would readily accept both micelle and foam formation as manageable, secondary process variables that can be easily accommodated or mitigated using routine engineering practices such as adding standard anti-foaming agents, altering sonication parameters, or degassing, whereas preventing droplet coalescence and adjusting diameter of stable droplet are fundamental formulation requirements that Astafyeva successfully solves by increasing the ratio. Accordingly, Astafyeva viewed as a whole does not teach away from the claimed invention (high molar ratio), and the Office’s reliance on it does not constitute hindsight analysis. The molar ratio of surfactant and fluorocarbon of Astafyeva encompasses that instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
The Office maintains that the claimed range of molar ratio (higher than 0.06) is the result of routine optimization of an effective parameter disclosed in the prior art. A person of ordinary skill in the art would have been motivated to adjust the molar ratio depending on the requirements of applications. The molar ratio is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal molar ratio of surfactant and fluorocarbon in order to best achieve the desired nanodroplet as the ratio determine stability and diameter of the nanodroplet as taught by Astafyeva. “[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. Applicant has provided no objective evidence or comparative data showing that the threshold of 0.06 produces any unexpected or synergistic results that qualitatively differ from the prior art teachings. In the absence of evidence showing a critical, unexpected change in property at the 0.06 threshold, the mere selection of a higher ratio represents nothing more than the exercise of routine experimentation. The specific critical molar ratios highlighted by Applicant, such as 0.01 for PFOB and 0.006 for both PFH and PFP, are merely exemplary threshold based on the specific fluorocarbons tested in Astafyeva. The critical molar ratio inherently varies and shifts predictably depending on the specific fluorocarbon utilized. A person of ordinary skill in the art would recognize that substituting or adjusting the specific fluorocarbon inherently necessitates a corresponding adjustment of the ratio, making the selection of ratio higher than 0.06 entirely desirable and predictable for alternative fluorocarbon selections.
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Desgranges et al. (US 10,286,091, 2019) and Astafyeva et al. (Journal of Materials Chemistry B, 2015; cited on IDS filed May 9, 2023) as applied to instant claims 1, 2, and 4-6 above, and further in view of Martin et al. (Langmuir. 2019).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed February 20, 2026 and those set forth herein.
Regarding new limitations of amended claim 19, “characterized in that the molar ratio between said biocompatible surfactant and said fluorocarbon is higher than 0.06,” as discussed above, Astafyeva discloses that the additional surfactant leads to stabilization bubbles at high molar ratio (> 0.006). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Further, the molar ratio is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Desgranges et al. (US 10,286,091, 2019) and Astafyeva et al. (Journal of Materials Chemistry B, 2015; cited on IDS filed May 9, 2023) as applied to instant claims 1, 2, and 4-6 above, and further in view of Abdelwahed et al. (Advanced Drug Delivery Reviews, 2006).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed February 20, 2026.
Double Patenting
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.
Claims 1, 2, 4-8, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, and 19 of U.S. Patent No. US 10,286,091 B2 (cited on PTO-892) in view of Martin et al. (Langmuir. 2019) and Abdelwahed et al. (Advanced Drug Delivery Reviews, 2006).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed February 20, 2026 and those set forth herein.
Applicant argues that none of the cited references suggests the claimed ratio (higher than 0.06).
This argument is unpersuasive. As discussed above and in the Office Action mailed February 20, 2026, Astafyeva teaches and suggests the benefit of high molar ratio (> 0.006). It would have been customary for an artisan of ordinary skill to determine the optimal molar ratio of surfactant and fluorocarbon in order to best achieve the desired nanodroplet as the ratio determine stability and diameter of the nanodroplet.
Claims 1, 2, 4-8, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, and 6 of copending Application No. 18/864,464 (US 2025 0295818) in view of Abdelwahed et al. (Advanced Drug Delivery Reviews, 2006).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed February 20, 2026 and those set forth herein.
Applicant argues that this rejection should be withdrawn if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date.
This argument is unpersuasive. The rejection under 35 U.S.C. 103 is maintained for the reason of record discussed above. Because this provisional nonstatutory double patenting rejection is not the only rejection remaining, it is properly maintained.
Conclusion
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 JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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