DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-10 are pending in this application.
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 .
Priority
This application is a 35 USC 371 National Stage filing of international application No. PCT/CN2022/143941 filed on 30 Dec. 2022, and claims benefit under 35 USC 119(a)-(d) to foreign application No. CN 202111296255.3 filed on 3 Nov. 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 25 Mar. 2024 has been considered by the examiner.
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 2-10 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. In claims 2-10, each of the recitation(s) of “preferably”, “more preferably”, “further preferably” and “still further preferably” render the claims indefinite because it is not clear if what follows those recitations are required limitations.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Schneider et al. (US 5,686,060 A; issued 11 Nov. 1997; see attached 892).
Regarding claims 1-3, 5, 8, and 10, Schneider et al. disclose a microbubble preparation prepared by adding 2 mL solution of diarachidoylphosphatidylcholine (DAPC) (surfactant) and dipalmitoyl-phosphatidic acid (DPPA, surface charge modifier) to 20 mL of PEG2000 solution. After mixing for 10 min at room temperature, the resulting solution was frozen during 5 min at -45oC and lyophilized during 5 h at 0.2 mbar. The powder was exposed to SF6 and then dissolved in 20 mL of distilled water. The suspension showed a bubble concentration of 5×109 bubble per mL with a medium diameter of 5.5 µm. After 10 d, the product looked as good as after its preparation and still contained 1-1.2×109 bubble per mL (example 3). Decantations were repeated 10 times in order to obtain narrow bubble size distributions and to eliminate all phospholipids which were not associated with microbubbles (example 6). (These examples read on a microbubble lyophilized preparation for ultrasonic radiography comprising polyethylene glycol and a surfactant wherein the polyethylene glycol has a percentage of a folded polymer chain of much less than 34%. In addition, these examples read on a contrast agent comprising a gas SF6 and a lyophilized preparation according to claim 1 and a preparation method charging a gas into a container filled with lyophilized preparation and a use method comprising dispersing the contrast agent in a physiologically acceptable solution to obtain a suspension of gas filled microbubbles.)
Regarding claim 4, Crude phospholipids (e.g. palmitic acid, fatty acid) were dissolved together with polyethylene glycol and the solution. The residue was suspended in water. The residues after freeze-drying were saturated with SF6 then dissolved in distilled water. See examples 5.
Regarding claims 6-7, a solution of DAPC and DPPA in hexane/ethanol was prepared and the solvent evaporated to dryness (dissolving surfactant in solvent A and drying the solution to obtain a dried product). The resulting powder and polyethylene glycol were dissolved in tert-butanol at 60oC (mixing the dried product with polyethylene glycol, dissolving the mixture in solvent B to obtain a mixed solution, dissolving the mixture in the solvent B and performing mixing at a temperature of 60oC). The solution was rapidly cooled to -45oC and lyophilized (filling the mixed solution into a container). The lyophilizate was introduced in a glass vial and the powder exposed to SF6. A 3% glycerol solution was then introduced into the vial and the lyophilizate dissolved by gentle swirling. The resulting suspension had 1.5×108 bubbles swirling (example 3).
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.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider et al. (US 5,686,060 A; issued 11 Nov. 1997; see attached 892).
Schneider et al. teach as discussed above. Schneider et al. teach stable microbubble suspensions comprising saturated phospholipids for ultrasound echography (see title). Schneider et al. teach that this can be done by dissolving the phospholipids in a suitable solvent together with a hydrophilic stabilizer substance like PEG and water and freeze drying…The freeze-drying technique under reduced pressure is very useful because it permits, restoration of the pressure above the dried powders with any physiologically acceptable gas (col. 6). Preferred surfactants include lecithins, etc (col.7). Schneider et al. teach fatty acids (col. 7). The isotonic agents are physiological solutions commonly used in medicine and they include aqueous saline solution (col. 7).
Scheider et al. do not expressly teach the limitations of claim 6 requiring mixing the dried product with polyethylene glycol dissolving the mixture into solvent B to obtain a mixed solution and filling the mixed solution into a container.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Scheider et al. so that the dried product containing the surfactant gets mixed with polyethylene glycol and dissolving that mixture in a solvent B such as tert-butanol and performing mixing at 60oC and filling the mixed solution into a container as taught by Scheider et al. because it would have been expected to advantageously enable lyophilization and subsequent exposure to SF6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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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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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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