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
Applicant's election with traverse of Group II, claims 34-38 in the reply filed on 02/04/2026 is acknowledged. The traversal is on the ground(s) that claims 34-38 are directed to a device for preparing the composition of claim 20 using the process set forth in claim 20. This is not found persuasive because this language in claim 34 is merely an intended use of the device. Although the claims state that the device of claim 34 is intended to produce the composition of claim 20, it is clear that the device could be used to prepare other compositions, and thus the requirement for restriction is met. It is further noted that Group I contains lists of lipids for use in the composition of claim 20 that are not even mentioned in Group II. Thus, at the very least, the device of Group II has no requirement to be used with the specific lipids recited in Group I, indicating that the restriction is proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 20-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
It is noted that, for rejoinder, claims 20-33 will need to be amended to include the limitations of an allowable elected claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sonication device of claim 34 and the dry heating piece of claim 38 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 34-38 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.
Claim 34 recites “the micro-bubble containing composition” in line 1. There is insufficient antecedent basis for this limitation in the claim. The limitation should be amended to recite “a micro-bubble containing composition.”
Claim 35 recites “a clamp”, “a lever”, and “a motor” in lines 2, 3, and 4, respectively. It is not clear if these structures are the same as the clamp, lever, and motor recited in claim 34. It is assumed that these structures are the same, but this must be clarified in the claims.
Claim 38 recites “a dry heating piece” in line 2. It is not clear what this structure is. The specification provides no information as to what a “dry heating piece” would be, nor is the dry heating piece shown in the drawings. The term is not a term of the art, and so it must be clarified.
Claim 38 also recites “the casing” in line 3. There is insufficient antecedent basis for this limitation in the claim. The casing is introduced in claim 36, but claim 38 depends from claim 34.
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 34, 35, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Pollaro et al. (US PGPub 2013/0039145, hereinafter Pollaro) in view of Luotola et al. (US PGPub 2008/0308404, hereinafter Luotola) and Unger (US 5922304, hereinafter Unger).
Regarding claim 34, Pollaro discloses a device for producing a microbubble-containing composition prepared by a process comprising (a) preparing a lipid mixture consisting of a first lipid, or two or more first lipids with different phase transition temperature, a second lipid bonding with a hydrophilic polymer moiety and one or more molecules capable of getting across a lipid membrane and decreasing van der Waals forces between lipid bilayers; wherein each of the first lipids includes a hydrophobic C8-C30 end, and the hydrophilic polymer moiety has a long chain with molecular weight of 200-200,000; (b) emulsifying the lipid mixture with an aqueous solvent by mechanical means to form a transparent lipid carrier solution and then adjusting the transparent lipid carrier to 20 Celsius degree; (c) placing the transparent lipid carrier solution in a closed vessel comprising a predetermined gas or a hydrophobic molecule; and (d) agitating the closed vessel containing the transparent lipid carrier solution by sonication to form said microbubble-containing composition (all method steps and the composition are considered to be intended use, see MPEP 2111.02; the device of Pollaro contains all the necessary structure to perform this method as recited), comprising: a mechanical agitator (figure 4) for emulsifying the lipid mixture with an aqueous solvent to form a transparent lipid carrier solution, a temperature controlling unit (claim 3, “heating element”) for adjusting the transparent lipid carrier to 20 Celsius degree, and a sonication device, for providing agitations on the transparent lipid carrier solution; wherein the mechanical agitator includes a clamp (figure 1, clamp plates 4 and 8 and rods 6) serving to clasp the closed vessel, a lever (figure 4, crank 20) connected to and allowed to be agitated together with the clamp, and a motor (motor 18) connected with the lever and providing integrally the clamp and the lever with power for reciprocation (see figure 4).
Pollaro is silent to a sonication device as recited. Luotola teaches a mixing device that includes a sonication device for a closed container (figures 1-3, sonication apparatus 15). To one of ordinary skill in the art before the effective filing date of the claimed invention, it would have been obvious to have provided the apparatus of Pollaro with the sonication device of Luotola for the purpose of allowing for different sizes of microbubbles, as Unger indicates that different types of mixing can be used to produce different sizes of microbubbles (Unger: column 9, lines 53-64).
Regarding claim 35, Pollaro discloses the mechanical agitator includes: a clamp (figure 1, clamp plates 4 and 8 and rods 6), for clasping the closed vessel containing the lipid mixture dissolved in distilled water; a lever (figure 4, crank 20), connected with the clamp to construct a agitating mechanism; a fastener (see figure 4, fasteners can be seen at both ends of the crank 20), connected to an end of the lever for restraining the movement of the lever; and a motor (motor 18), connected with the lever and providing power for a reciprocation motion.
Regarding claim 38, Pollaro discloses the temperature controlling unit further comprises a dry heating piece incorporated in the clamp, or the lever, or the casing for increasing the temperature within the casing (claim 3, “heating element”).
Allowable Subject Matter
Claims 36 and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 36 is deemed to contain allowable subject matter because it recites specifics of the temperature control unit not reasonably disclosed, taught, or suggested in the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The cited prior art generally discloses devices with agitation elements that shake or oscillate a closed container.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC C HOWELL whose telephone number is (571)272-9834. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARC C HOWELL/Primary Examiner, Art Unit 1774
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