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 .
Receipt is acknowledged of IDS filed on 04/11/2023.
Claims 1-17 are pending.
Claims 1-7 and 14-17 are withdrawn.
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 10/31/2025 is acknowledged. The traversal is on the ground(s) that Groups I, III, V, VI, and VII that corresponds to allowable Group II claims be reinstated for allowance upon allowance of Group II claims. This is not found persuasive because a rejoinder is for previously restricted claims that depend from an allowed claim. Since no claims are allowed, a rejoinder consideration will not be performed at this time.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 8 and 10-13 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 8, A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “size inferior to 50 μm”, and the claim also recites "in particular of from 200 nm to 50 μm, more in particular of from 1 to 50 μm, even more in particular of from 1 to 5μm" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 8, A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “a polydispersity index below 10%”, and the claim also recites “preferably below 6%" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 8, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 13, the phrase "such as" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Examples of the above types of indefinite language is also present in claims 10, 11, and 12.
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.
Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over LEE ( WO 2011/017524) in view of OJHA (Shelf-Life Evaluation and Lyophilization of PBCA-Based Polymeric Microbubbles. Pharmaceutics. 2019.).
Regarding claim 8, LEE teaches a method of forming dried microbubbles, wherein the microbubbles comprise a shell and a gas core (claim 1), with a diameter of 28.0 µm (page 15, paragraph 3), polydispersity index of 5.2% (page 15, paragraph 3), the microbubbles are made to be administered to a subject (claim 17) and are therefore physiologically inert (Applicant’s specification, page 8, paragraph 3), the microbubbles are collected on a petri dish containing water into a monolayer (page 21, paragraph 4), which reads on adsorbed on a hydrophilic surface in the form of at least one monolayer. The microbubbles were then dried (page 21, paragraph 4).
Regarding claim 9, LEE teaches the microbubbles are collected on a petri dish containing water into a monolayer (page 21, paragraph 4), which reads on adsorbed on a hydrophilic surface in the form of at least one monolayer.
Regarding claim 10, LEE teaches the generated bubbles flowed into a collection tube and was then collected onto the petri dish (page 17, paragraph 1), which reads on contacting said hydrophilic surface with the tip of a tube through which said microbubbles exit.
Regarding claims 11 and 12 , LEE teaches polyvinyl alcohol can be added to the composition (page 9, paragraph 1), which instant claim 11 and 12 define as an amphiphilic polymer that is both a surfactant and a cryoprotectant.
Regarding claim 13, LEE teaches the microbubbles are collected on a petri dish containing water into a monolayer (page 21, paragraph 4), which reads on adsorbed on a hydrophilic surface in the form of at least one monolayer. The microbubbles were then dried (page 21, paragraph 4), which reads on the method produced dried monodisperse microbubbles adsorbed on a hydrophilic surface in the form of at least one monolayer.
Additional disclosures: LEE teaches the microbubbles are used for ultrasound imaging (claim 20). The shell thickness can be precisely controlled during the process (page 18, paragraph 1) and the shell thickness can be adjusted to increase the stability of the microbubble for a desired radius (page 18, paragraph 3). Scanning electron microscopy was used to image the microbubbles to determine the presence of shells (page 15, paragraph 3).
LEE does not teach freeze-drying the microbubbles.
OJHA teaches that lyophilization (freeze-drying) is widely used to increase shelf-life and promote product development for microbubbles that are used for ultrasound imaging (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate freeze drying the microbubbles. The person of ordinary skill in the art would have been motivated to make those modifications, because freeze-drying is widely used to increase shelf-life, and reasonably would have expected success because it is an alternative way of drying microbubbles vs evaporating as taught in LEE and the references are in the same field of endeavor such as microbubbles used for ultrasound imaging.
The reference does not specifically teach the shell thickness as claimed by the Applicant. The shell thickness 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 the ordinary skill to determine the optimal shell thickness in order to best achieve desired results, such as finding the optimal shell thickness to have stability for a desired radius of microbubble. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the shell thickness would have been obvious at the time of Applicant’s invention.
The reference does not specifically teach the amount of time the collection of microbubbles onto the hydrophilic surface takes as claimed by the Applicant. The amount of time the collection of microbubbles onto the hydrophilic surface takes 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 the ordinary skill to determine the optimal amount of time the collection of microbubbles onto the hydrophilic surface takes in order to best achieve desired results, such as allowing enough for time for an optimal amount of microbubbles to collect onto the surface, while not doing it for too long that the surface collects too many microbubbles that could lead to it noy drying properly to form the monolayer. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of time the collection of microbubbles onto the hydrophilic surface takes would have been obvious at the time of Applicant’s invention.
The reference does not specifically teach the amount of time the freeze drying takes as claimed by the Applicant. The amount of time for freeze drying 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 the ordinary skill to determine the optimal amount of time for freeze drying in order to best achieve desired results, such as freeze-drying the product for long enough to achieve the final freeze-dried product. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of time of freeze drying would have been obvious at the time of Applicant’s invention.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618