DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 06/11/2026, is acknowledged. Amendments to the specification have been entered.
Claims 17-20, 22-28, 30-36 are pending in this action. Claims 21, 29 have been cancelled. Claims 1-16 have been cancelled previously. Claims 17, 30 have been amended. Claims 17-20, 22-28, 30-36 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application is a 371 of PCT/JP2021/003258, filed January 29, 2021, which claims benefit of foreign priority to JP2020-021195, filed February 12, 2020. No English translations of priority application WO 2021/161811 A1 (i.e., PCT/JP2021/003258) has been received. As stated previously, a certified translation of Patent Cooperation Treaty (PCT) application not filed in English is required. 35 U.S.C. 119(b)(3), 372(b)(3) and 37 CFR 1.55(a)(4). Failure to provide a certified translation(s) may result in no benefit being accorded for the non-English application. 37 CFR 41.154(b) and 41.202(e).
Claim Objections
Claim 18 is objected to because of the following informalities: Claim 18 comprises the typographic error “density is 5x105 bubbles/ml to 5x1012 bubbles/ml” that needs to be corrected to “density is from 5x105 bubbles/ml to 5x1012 bubbles/ml” (see claim 26). Appropriate correction is required.
Claim Rejections - 35 USC § 112(1)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-20, 22-28, 30-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The present claims are directed to vasodilator compositions comprising micro bubbles and aqueous solvent, wherein the micro bubbles consist of a gas component, wherein the gas component comprises nitric oxide and at least another gas and the micro bubbles are surrounded by the aqueous solvent.
The written description requirement for a claimed genus (here as vasodilator compositions) may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. MPEP §2163.
In the present case, only example of using (i) 20 ml of Earle's balanced salt solution (EBSS), i.e., the composition consisting of 26 mmol/l NaHCO₃, 1 mmol/l NaH₂PO₄, 5.4 mmol/l KCl, 116 mmol/l NaCl, 5.5 mmol/l glucose, 2 mmol/l CaCl₂, and having pH 7.4, and (ii) 20 ml of medical nitric oxide (NO concentration of at least 99.0 v/v%) is provided (Para. 0055). Further, the instant specification teaches that the micro bubbles can be dispersed in whole or in part in the medium/liquid, wherein the liquid can be an aqueous solvent including water, an oily solvent, or a mixed solvent thereof (Para. 0015) No information is provided regarding the compounds that can be included OR must be excluded from said compositions to remain claimed pharmacokinetic characteristics/vasodilation, and/or to ensure that micro bubbles (including nitric oxide and another gas) are surrounded by the aqueous solvent.
The present specification provides no disclosure beyond the statement, that would have been amenable for use in the present invention, nor does it teach the specific structure, physical properties or a method of identification of compounds/solvents that can be included in claimed compositions. Furthermore, it has been held that a wish or plan for obtaining the chemical invention as claimed does not provide adequate written description of a chemical invention. Rather, a precise definition, such as by structure, formula, chemical name or physical properties, is required. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004).
While it is recognized that adequate written description of a limitation is not required to be stated in haec verba in the specification or claims as originally filed, adequate written support for claim limitations must arise from either an explicit or implicit suggestion by the disclosure to show that such a concept as claimed was actually in possession of applicant at the time of the invention. For the reasons provided supra, the applicant has failed to provide the necessary teachings, by describing the claimed invention with all of its limitations using such descriptive means that fully set forth the claimed invention, in such a way as to reasonably convey to one skilled in the relevant art that applicant had possession of the entire genus of drugs. Therefore, it is examiner’s position that the instant specification does not provide required written description of the claimed invention.
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 17-20, 22-28, 30-36 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 pre-AIA the applicant regards as the invention.
Newly amended claim 17 is not reasonably clear, because the structure of the claimed composition is not clearly delineated. In the present case, it is noted that claim 17 discloses compositions comprising micro bubbles and aqueous solvent, i.e., said compositions may include other/additional compounds even in a large amount. MPEP 2111.03. Further, said claim recites the limitation “the micro bubbles are surrounded by the aqueous solvent” that is unclear. Does this limitation imply that additional constituents that can be present in the claimed composition (i.e., comprising) are not included into the claimed aqueous solvent, OR do not interact with said micro bubbles? To this point, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Further, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Clarification is required. Clarification is required.
Newly amended claim 17 recites the limitation “the micro bubbles consist of a gas component, wherein the gas component comprises nitric oxide and at least another gas” that is unclear. To this point, it is noted that said claim discloses gas component comprising nitric oxide and at least another gas, i.e., may include other/additional compounds/constituents even in a large amount (i.e., comprising). Therefore, the gas component to be used in the claimed compositions is not clearly delineated. Clarification is required.
Claim 19 recites the limitation “a proportion of nitric oxide in the gas component is 80 (v/v)% or more” that is not clear. Can it be 100 (v/v)%? Similar is applied to claim 27. Clarification is required.
Claim 20 (dependent on claim 17) recites the limitation “the gas component other than nitric oxide does not react with nitric oxide” that is unclear, because it is not clearly stated to which gas component said limitation refers. Newly amended claim 17 discloses a gas component (i.e., singular) comprising nitric oxide and at least another gas. Similar is applied to claim 28. Clarification is required.
Claim 22 discloses a method by using a vasodilator composition kit comprising the vasodilator composition according to claim 17 and “other component”, wherein said vasodilator composition and “other component” are arranged in isolation. Claim further recites the limitation “the method comprising administering to a patient the vasodilator composition parenterally”. In the present case, the method steps are not clearly delineated, because it is not clearly stated how said “other component” should be used. Further, it is unclear what “other component” should be used for vasodilation method. Similar is applied to claims 23-24. Clarification is required.
Claims 18, 25-26, 30-36 are rejected as being dependent on rejected independent claim 17 and failing to cure the defect.
Response to Arguments
Applicant's arguments, filed 06/11/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New rejections have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Applicant is advised to clarify the claim language, the structure of the compositions to be used in the claimed method, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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