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 .
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 1-20 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. Regarding claim 1, it’s unclear what property or attribute the calibrated nanodroplets that fall under the scope of the claimed invention need to have in order to be considered calibrated as opposed to nanodroplets that are not calibrated. The claims further recite a “a low boiling fluorinated compound,” “a low boiling perfluorocarbon,” “gaseous low boiling fluorinated compound,” which are relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
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 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 1-15 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2018/272012 to De Gracia Lux (document already in record). De Gracia Lux teaches a method for the preparation of an aqueous suspension of calibrated nanodroplets (abstract; claims), said nanodroplets comprising an outer shell and an inner core (paragraphs 40-41, 67, 76-77), wherein said outer shell comprises an amphiphilic component and said inner core comprises a low boiling fluorinated compound such a perfluorocarbon (paragraph 30), said method comprising: a) Preparing an aqueous phase; b) Preparing an organic phase; wherein - said aqueous phase comprises an amphiphilic component and the organic phase comprises a low boiling fluorinated compound or - said organic phase comprises an amphiphilic component and a low boiling fluorinated compound; c) Injecting said aqueous phase into a first inlet and said organic phase into a second inlet of a microfluidic cartridge thereby mixing said aqueous phase and said organic phase in a mixing device of the microfluidic cartridge to obtain an aqueous suspension of calibrated nanodroplets; and d) Collecting the aqueous suspension of calibrated nanodroplets from the exit channel of the microfluidic cartridge (paragraphs 32-50; Example 1, claims).
wherein said organic phase comprises an amphiphilic component and a low boiling fluorinated compound (paragraphs 32-50; Example 1, claims). The organic phase comprises an amphiphilic component and a low boiling fluorinated compound (cparagraph 52). The low boiling fluorinated compound has a boiling point lower than 25 degrees C (claim 2). Said amphiphilic component comprises a phospholipid and a fatty acid (paragraphs 40-52). The method further comprises step b) comprises the preparation of an organic phase comprising a low boiling fluorinated compound, said method comprising the steps of: b.1) Condensing a gaseous low boiling fluorinated compound to obtain a liquid low boiling fluorinated compound; b.2) Preparing a liquid organic solution comprising an organic solvent; b.3) Cooling said liquid organic solution down to a temperature below the boiling point of said liquid low boiling fluorinated compound; b.4) Mixing said liquid low boiling compound and said liquid organic solution to obtain an organic phase (Examples; Claims).
Claim Rejections - 35 USC § 103
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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/272012 to De Gracia Lux (document already in record). The relevant portions of De Gracia Lux are given above.
wherein the temperature of the obtained organic phase at the end of step b.4) is at least 5°C lower than the boiling point of said low boiling fluorinated compound; wherein the temperature of the obtained organic phase at the end of step b.4) is at least 10°C lower than the boiling point of said low boiling fluorinated compound; wherein the temperature of the obtained organic phase at the end of step b.4) is at least 20°C lower than the boiling point of said low boiling fluorinated compound; wherein said temperature is between the boiling point and 15°C higher than the boiling point wherein said temperature is between the boiling point and 10°C higher than the boiling point.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the temperature at each step of the process, and in this way, would find the presently claimed temperatures through routine laboratory experimentation in the course of optimizing the method for the purpose of obtaining an aqueous suspension of nanodroplets. The expectation of success is high, as De Gracia Lux teaches that this is a result effective parameter for the preparation of stabilized nanodroplets (paragraphs 32 and 35-36). “‘[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.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP § 2144.05, II.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 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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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
August 22, 2026
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