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 action is in response to Applicant’s amendment filed December 30, 2025 in reply to the First Office Action on the Merits mailed June 30, 2025. Claims 1 and 22-28 have been amended; claims 2, 3, 6-8, and 12-21 have been canceled; and claim 29 has been newly added. Claims 5, 9, 10, and 23 have been withdrawn. Claims 1, 4, 5, 9-11, and 22-29 are pending in the application.
Election/Restrictions – Original Presentation
Newly submitted claim 29, directed to a method of treating an infection in a subject in need thereof comprising administering to the subject a cluster composition, is independent or distinct from claims 1, 4, 11, 22, and 24-28, i.e. the invention originally claimed, directed to a cluster composition.
Since Applicant has received an action on the merits for the originally presented invention, claims 1, 4, 11, 22, and 24-28 have been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 29 is hereby withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. As noted, supra, claims 5, 9, 10, and 23 have previously been withdrawn. Claims 1, 4, 11, 22, and 24-28 are currently under examination.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Withdrawal of Prior Claim Rejections - Obviousness-Type Double Patenting
In view of the amendment to the present claims filed December 30, 2025, together with the amendment to the claims filed December 11, 2025 in copending Application No. 17/755,221, the Obviousness-Type Double Patenting rejection presented in the First Office Action on the Merits mailed June 30, 2025 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 102(a)(1) and 102(a)(2)
Healey et al. (U.S. Patent Application Pub. No. 2016/0243234) do not explicitly anticipate a cluster composition comprising both a suspension of clusters and an antimicrobial agent, as now stipulated in newly amended claim 1. Therefore, the 35 USC 102(a)(1) and 102(a)(2) rejection presented in the First Office Action on the Merits mailed June 30, 2025 is hereby withdrawn.
Drawings
The drawings remain objected to because of the following:
i). The two views in Fig. 1 lack labels for the y-axis and x-axis disclosing the units of “plasma concentration” and of “time” being depicted. The y-axis and x-axis of the two views also lack tick marks with corresponding values forming a numerical scale along the y-axis and x-axis.
ii) Figure 3 is not in compliance with 37 CFR 1.84(p)(4) because reference character “7” appears to have been used to designate two separate parts.
iii) Figure 4 appears to provide two labels, i.e. Fig. 4A and Fig 4B, for the same view.
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 Objections
Claim 9 is objected to for improper status identification. Claim 9 has been withdrawn, and should be properly identified accordingly.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 4, 11, 22, and 24-28 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 1 stipulates that the “cluster composition” is a suspension of clusters. Hence, the clusters must necessarily exist as clusters. Claim 1 stipulates in a wherein clause that “the microbubbles and microdroplets…have opposite surface charges and form the clusters via attractive electrostatic interactions”. Since the clusters must exist as clusters, it would follow that the microbubbles and microdroplets must be interacting via contact between their respective surface charges to form the electrostatic bonds between the microbubbles and the microdroplets. However, claim 1 then appears to counter this requirement by also stipulating that the microdroplet (i.e. the oil phase thereof) is “capable of diffusing into the gas microbubble so as to at least transiently increase the size thereof”. One of ordinary skill in the art cannot make heads or tails out of the claimed subject matter, and specifically cannot reconcile how the microbubble can contain the microdroplet, if, seemingly at the same time, the outer surfaces of the microbubble and microdroplet must contact each other to thus form electrostatic bonds to thus maintain the clusters that must exist as defined by the claim. One of ordinary skill in the art cannot definitively ascertain whether the microbubbles necessarily contain the microdroplets, or rather whether the microbubbles and microdroplets must contact via their outer surface charges to form an electrostatic bond, or some other scenario.
Claim 22 is indefinite for the following reasons:
1. Claim 22, which depends from claim 1, stipulates in a wherein clause that “the method of treatment of the infection of the subject comprises” the recited active steps. Claim 1, however, is directed to a composition, not to a method of treatment. Hence, claim 22 appears to be a mixed claim type, which is indefinite. A single patent claim in the United States simply cannot be directed to both a composition and to a method of treatment, nor is a composition ever properly defined by a set of requisite active steps for its intended use in a method of treatment.
***The subject matter currently under examination is the composition itself, and not its intended method of use.
2. Claim 22, (i), stipulates in a wherein clause that “(b) the antimicrobial agent is pre-, and/or co-, and/or post administered to the suspension of clusters”. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter. What does it even mean to “administer” the antimicrobial agent to the suspension of clusters? Is this an attempt at a product-by-process step to indicate that the antimicrobial agent is somehow added to the suspension of clusters? If so, what does it mean to “pre”, “co”, and “post” add the antimicrobial agent to the cluster composition, and how can the antimicrobial agent be added to the suspension “pre”, “co”, and “post” simultaneously? Or, alternatively, is this a failed attempt to stipulate that the antimicrobial agent is administered to the subject in a method of treatment before, at the same time as, or after the claimed “suspension of clusters” is administered to the subject? Or what?
3. Claim 22, (i), stipulates that the antimicrobial agent is “administered to” the cluster composition “before steps ii) to iii) or after any of steps ii) to iii)”. Prior to this statement there is no mention at all of “step ii)” or “step iii)”. Hence, there is insufficient antecedent basis for steps ii) and iii) in the claim.
4. Claim 22 recites the phrase “a region of interest”, which is not defined by the claim, and is arbitrary and subjective. Thus, one of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of “a region of interest”, and cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 27, which depends from claim 22, stipulates in a wherein clause that “the antimicrobial agent is pre-administered to the suspension of clusters”. The claim is indefinite for reasons discussed, supra, for claim 22.
***For examination, the claim is being interpreted as a product-by-process in which the antimicrobial agent is combined with the suspension of clusters before the mixture is then administered to the subject.
Claim 28, which depends from claim 27, stipulates in a wherein clause that “the suspension of clusters is administered when the antimicrobial agent concentration is at maximum plasma concentration (Cmax)”. Claim 27 is a product-by-process claim which requires the antimicrobial agent is combined with the suspension of clusters before the mixture is then administered to the subject. One of ordinary skill in the art thus cannot make heads or tails out of how the antimicrobial agent concentration reaches Cmax before the suspension of clusters is even administered.
Claims 4, 11, 22, and 24-28 are (also) indefinite for depending from an indefinite claim.
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 1, 4, 11, 22, and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Healey et al. (U.S. Patent Application Pub. No. 2016/0243234).
Applicant Claims
Applicant’s elected subject matter is directed to a composition comprising A) a suspension of “clusters” in an aqueous medium; wherein the “clusters” are 1-10 µm in diameter, have a circularity of <0.9, and comprise i) a gas microbubble comprising a phospholipid, and ii) a microdroplet comprising an oil phase containing a halogenated, low molecular weight hydrocarbon, and a surfactant; wherein the microbubble and the microdroplet have opposite surface charges and form the clusters via electrostatic attraction; and B) an antibiotic.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Healey et al. disclose a composition comprising A) a suspension of “clusters” in an aqueous medium; wherein the “clusters” are 1-10 µm in diameter, have a circularity of <0.9, and comprise i) a gas microbubble comprising e.g. a phospholipid, and ii) a microdroplet comprising an oil phase containing e.g. a halogenated, low molecular weight hydrocarbon, and e.g. a surfactant; wherein the microbubble and the microdroplet have opposite surface charges and form the clusters via electrostatic attraction; and B) an active agent; wherein the cluster composition can be co-administered with the active agent, and wherein the active agent can be e.g. an antibiotic (see e.g. abstract; paragraphs 0021, 0024-0026, 0041, 0048, 0062-0067, 0078, 0081, 0083, 0086, 0089, 0090, 0096; Examples).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Healey et al. do not explicitly anticipate the presently claimed cluster composition with one specific example. However, the Healey et al. disclosure is sufficient to render the claimed subject matter prima facie obvious within the meaning of 35 USC 103.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Healey et al., outlined supra, to devise Applicant’s presently claimed composition.
Healey et al. disclose a “cluster composition” comprising A) a suspension of “clusters” in an aqueous medium; wherein the “clusters” are 1-10 µm in diameter, have a circularity of <0.9, and comprise i) a gas microbubble comprising e.g. a phospholipid, and ii) a microdroplet comprising an oil phase containing e.g. a halogenated, low molecular weight hydrocarbon, and e.g. a surfactant; wherein the microbubble and the microdroplet have opposite surface charges and form the clusters via electrostatic attraction; and B) an active agent; wherein the “cluster composition” can be co-administered with an active agent. Since Healey et al. disclose that a suitable active agent can be e.g. the antibiotic bleomycin, or the antibiotic actinomycin, one of ordinary skill in the art would thus be motivated to provide e.g. bleomycin and/or actinomycin together with the cluster composition in e.g. a “kit”, with the reasonable expectation that the antibiotic active can be co-administered together with the “cluster composition”.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed December 30, 2025 have been fully considered but they are not persuasive.
i) Applicant contends that “the Office Action has not shown that Healey discloses or suggests the recited cluster composition including a suspension of clusters and an antimicrobial agent that is for use in a method of treatment of an infection”; that “other than the listing of the word antibiotics among drugs, the Office Action has not shown that Healey indicates ACT technology may be used in a method of treatment of infections, or that the listed antibiotics were generally known at the time to be antimicrobial agents for treatment of infections”; and that “bleomycin and actinomycin…have nothing to do with medical treatment of infections”.
The Examiner, however, would like to point out the following:
1. The present claims are directed to a composition, not to a method of using the composition, and, more specifically, not to a method of treating an infection. Healey discloses the claimed composition, and this is sufficient to preclude the patentability of the claimed composition. Healey need not disclose a method of treating an infection, and, more specifically, need not disclose that ACT technology may be employed to treat an infection.
2. Healey expressly discloses that their active agent can be an antibiotic, and specifically mentions two examples, i.e. bleomycin and actinomycin. Applicant’s assertion that antibiotics such as bleomycin and actinomycin have nothing to do with treatment of infections is not supported by any hard evidence whatsoever.
3. On the contrary, these antibiotics were known in the art at the time of filing the present application to have the capability to treat a bacterial infection, and thus their designation as antibiotics (see, e.g. Campbell et al. Lett Appl Microbiol. 2019; 69: abstract).
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617