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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 09/29/2023. Claims 26-34 are currently pending and being examined.
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 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.
Claim Objections
Claim 26 is objected to because of the following informalities: Claim 26 recites “the first ultrasound configured” in line 4. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the first ultrasound insonation configured”. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: Claim 26 recites “the microbubble-microcluster composition” in line 5. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the microbubble-microdroplet cluster composition”. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: Claim 32 recites “the first ultrasound insonation step” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the first ultrasound insonation”. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: Claim 32 recites “the second ultrasound step” in line 1 & 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the second ultrasound insonation”. Appropriate correction is required.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 26-34 are rejected under 35 U.S.C. 103 as being unpatentable over Healey (USPAP 2016/0243234) in view of Carpentier (USPAP 217/0259086).
In reference to independent claim 26, Healey discloses a method of ultrasound delivery, comprising:
operating a transducer (para 0061 discloses “a pharmaceutical composition for delivery of drugs and a method for delivery has now been identified that uses phase shift technology of the current invention to generate large phase shift bubbles in vivo from an administered composition containing microbubble/microdroplet clusters, and which facilitates delivery of associated and/or pre-, and/or co- and/or post administered therapeutic agent(s).” all the anatomy ) to deliver a first ultrasound insonation comprising a first frequency and a first mechanical index to a microbubble-microdroplet cluster composition (para 0001 discloses “The present invention relates to ultrasound (US) mediated delivery of therapeutic agents, such as the delivery of a drug, gene, nanoparticle or radioisotope, using a bi-phasic microparticle system comprising gas microbubbles, emulsion microdroplets and clusters thereof.”),
the first ultrasound configured to activate a phase shift of the microbubble-microcluster composition (claim 12 discloses step “(iii) activating a phase shift of the diffusible component of the second component of the cluster composition from the step (i) by ultrasound irradiation of a region of interest within said mammalian subject”); and
operating the transducer to deliver a second ultrasound insonation comprising a second frequency and a second mechanical index to the microbubble-microdroplet cluster composition after the first ultrasound insonation, the second ultrasound insonation configured to facilitate extravasation of a therapeutic agent (claim 12 discloses “(iv) optionally, facilitating further extravasation of the therapeutic agent(s) administered in the step (i) by further ultrasound irradiation”), however
Healey is silent to operating a transducer positioned in a brain skull or vertebral column of a subject.
Carpentier, , a similar ultrasound treatment, teaches operating a transducer positioned in a brain skull of a subject (para 0022 discloses “The methods of the invention may comprise a former step consisting of implanting a US transducer within a burr hole in the skull of the patient, the US beam being applied with the US transducer.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the repetition as taught in Carpentier in the method of Healey “for opening the blood-brain barrier to substances that are not able to pass in efficient concentrations to tissue protected by the blood-brain barrier. The invention is particularly useful for the treatment of brain diseases in humans” para 0003, Carpentier.
In reference to dependent claim 27, Healey in view of Carpentier discloses the method of ultrasound delivery of claim 26, Healey further discloses the method wherein the first frequency (administered at step iii) comprises 0.2 to 0.3 MHz (para 0127 discloses “in steps ii, iii and iv, ultrasound of any frequency between 0.05 to 30 MHz may be used.”).
In reference to dependent claim 28, Healey in view of Carpentier discloses the method of ultrasound delivery of claim 26, Healey further discloses the method wherein the first mechanical index (administered at step iii) comprises 0.1 to 0.4 (para 0048 discloses “The clusters are readily activated in-vivo with low power ultrasound (i.e. with an MI of less than 1.9, preferably less than 0.7 and most preferably less than 0.4), which induce a liquid-to-gas transition (phase shift) of the diffusible component.” The MPEP specifically states “PRIOR ART WHICH TEACHES A RANGE OVERLAPPING, APPROACHING, OR TOUCHING THE CLAIMED RANGE ANTICIPATES IF THE PRIOR ART RANGE DISCLOSES THE CLAIMED RANGE WITH "SUFFICIENT SPECIFICITY"” MPEP 2131.03, II
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated' if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).).
In reference to dependent claim 29, Healey in view of Carpentier discloses the method of ultrasound delivery of claim 26, Healey further discloses the method wherein the second frequency (administered at step iv) comprises 0.2 to 0.4 MHz (claim 13 discloses “step (iv) has a frequency in the range of 0.05 to 2 MHz” step (iv) is the optional extravasation step).
In reference to dependent claim 30, Healey in view of Carpentier discloses the method of ultrasound delivery of claim 26, Healey further discloses the method wherein the second frequency (administered at step iv) comprises 0.4 to 0.6 MHz (claim 13 discloses “step (iv) has a frequency in the range of 0.05 to 2 MHz” step (iv) is the optional extravasation step).
In reference to dependent claim 31, Healey in view of Carpentier discloses the method of ultrasound delivery of claim 26, Healey further discloses the method wherein the second mechanical index (administered at step iv) comprises 0.025 to 0.15 (para 0127 discloses “in steps iii and iv a MI of <0.7 is preferred”).
In reference to dependent claim 32, Healey in view of Carpentier discloses the method of claim 26, however
Healey is silent to the first ultrasound insonation step and the second ultrasound step are repeated four times.
Carpentier, a similar ultrasound treatment, teaches the first ultrasound insonation step and the second ultrasound step are repeated four times (para 0100 teaches “the sonications are repeated every two, three, four, five, or more days”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the repetition as taught in Carpentier in the method of Healey in view of Carpentier “for opening the blood-brain barrier to substances that are not able to pass in efficient concentrations to tissue protected by the blood-brain barrier. The invention is particularly useful for the treatment of brain diseases in humans” para 0003, Carpentier.
In reference to dependent claim 33, Healey in view of Carpentier discloses the method of claim 26, Healey further discloses the method wherein the first ultrasound insonation lasts for 30-120 seconds (para 0319 discloses an example of the process wherein “Activation [step iii] was provided by a Vscan clinical ultrasound scanner with a 2 MHz probe for 45 seconds starting from the injection time. This was subsequently followed by [step iv] 5 minutes 500 kHz ultrasound irradiation at an MI of 0.1 or 0.2.”).
In reference to dependent claim 34, Healey in view of Carpentier discloses the method of claim 26, Healey further discloses the method wherein the second ultrasound insonation lasts for 3-10 minutes (para 0319 discloses an example of the process wherein “Activation [step iii] was provided by a Vscan clinical ultrasound scanner with a 2 MHz probe for 45 seconds starting from the injection time. This was subsequently followed by [step iv] 5 minutes 500 kHz ultrasound irradiation at an MI of 0.1 or 0.2.”).
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lewis (USPAP 20130046230) discloses an ultrasound treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783