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 .
Status of Application
The Amendments and Remarks filed on 03/31/26 are acknowledged.
Claims 2, 8, and 14 were cancelled.
Claims 1, 3, 7, 9, 13, and 15 were amended.
Claims 1, 3-7, 9-13, and 15-20 are pending and included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/31/26 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Response to Amendments/Arguments
Claim Objection(s)
In light of the amendment of claim 7, the objection to this claim is withdrawn.
Rejection of claims under 35 USC § 112(b)
In light of the amendment of claims 1 and 7, the rejection of these claims under 35 USC § 112(b) as being indefinite is withdrawn.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
Maintained Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 13, 15-16, and 18-20 are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kroll (US 4,474,680).
Instant claim 1 is drawn to a method for producing a gas-filled medium, comprising:
providing a source of gas;
providing a surfactant solution;
mixing the gas and the surfactant solution in a manner that produces a plurality of bubbles, each bubble defining a membrane that is filled with nitric oxide gas; and
applying the plurality of bubbles topically to skin of a person and disrupting the membrane of each bubble to locally apply the nitric oxide gas contained therein to the skin to promote a healing response.
Kroll teaches a method of producing a foam by delivering a liquid/surfactant mixture at a pressure in the range of approximately 200 to 900 psig, comprising means providing a restricted passage, and a foam conveying line connected to the restricted passage, the pumping means being connected to deliver liquid/surfactant mixture through the restricted passage to the foam conveying line, and means for injecting a gas into the liquid/surfactant mixture downstream of the restriction to produce a foam (Col. 1, lines 30-45, Figure 1).
Regarding instant claims 1, 13, and 18-20, the limitations of a method and a system for producing a gas-filled medium are anticipated by the method of producing a foam by delivering a liquid/surfactant mixture at a pressure in the range of approximately 200 to 900 psig, comprising means providing a restricted passage, and a foam conveying line connected to the restricted passage, the pumping means being connected to deliver liquid/surfactant mixture through the restricted passage to the foam conveying line, and means for injecting a gas into the liquid/surfactant mixture downstream of the restriction to produce a foam (Col. 1, lines 30-45, Figure 1), as taught by Kroll. The limitation of applying the gas-filled medium topically to the skin is an intended use which is not given patentable weight.
Regarding instant claims 1, 3, 13, and 15, the limitations of the plurality of bubbles are anticipated by the bubbles (Col. 2, lines 23-26), as taught by Kroll.
Regarding instant claim 4, the limitation of a pressurized vessel is anticipated by the use of gas under high pressure to effect wide area coverage and high penetration of the foam into falling or moving masses of material (Col. 1, lines 46-48), as taught by Kroll.
Regarding instant claims 5 and 16, the limitations of the gas comprising one or more of nitric oxide, oxygen, or nitrogen is anticipated by the gas which is usually air, and which inherently contains oxygen and nitrogen (Col. 3, lines 52-55), as taught by Kroll.
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 of this title, 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.
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 6-12 and 17 are again rejected under 35 U.S.C. 103 as being unpatentable over Kroll (US 4,474,680), as applied to claims 1-5, 13-16, and 18-20 above, in view of Miller et al. (US 2017/0209485 A1).
Instant claim 6 is drawn to the method of claim 1, wherein the surfactant is selected from the group consisting of cetyl trimethyl ammonium bromide, cetrimonium bromide; dodecylbenzenesulfonic acid, cetylpyridinium chloride, stearalkonium chloride, polyquatemium-7, coco betaine, cocamidopropyl betaine, lauryl dimethyl ammonium chloride, polyquatemium-10, behentrimonium chloride, and cetrimonium chloride or a combination thereof.
The teaching of Kroll is discussed above.
Kroll does not expressly teach the surfactants recited in instant claim 6.
Miller teaches methods for topical applications of nitric oxide media, and more specifically for transdermal absorption of nitric oxide through the use of nitric oxide producing reagents in foam ([0003]). “A product that provides a topical application system may be contained in separate containers. For example, a first solution may be contained in a first container and a second solution may be contained in a second container. Each container may then dispense the respective topical component in a foam, or foamy suspension. The resultant, foam, topical components may then be combined and applied to the skin surface of a person” ([0010]). A suitable surfactant may be added to enable or promote the foaming of the respective component media ([0059]), and includes coco betaine or cocamidopropyl betaine ([0059]).
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 method of producing a foam by delivering a liquid/surfactant mixture at a pressure in the range of approximately 200 to 900 psig, as taught by Kroll, in view of the method for topical application of nitric oxide media, wherein a suitable surfactant may be added to enable or promote the foaming of the respective component media, and includes coco betaine or cocamidopropyl betaine, as taught by Miller, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both references teach methods for producing a gas filled medium or foam, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(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 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 6, 12, and 17, the limitations of the surfactant would have been obvious over the coco betaine or cocamidopropyl betaine ([0059]), as taught by Miller.
Regarding instant claim 7, the limitation of the method would have been obvious over the method of producing a foam by delivering a liquid/surfactant mixture at a pressure in the range of approximately 200 to 900 psig, comprising means providing a restricted passage, and a foam conveying line connected to the restricted passage, the pumping means being connected to deliver liquid/surfactant mixture through the restricted passage to the foam conveying line, and means for injecting a gas into the liquid/surfactant mixture downstream of the restriction to produce a foam (Col. 1, lines 30-45, Figure 1), as taught by Kroll. The limitations of first solution containing an acidic liquid, surfactant, and purified water would have been obvious over the second solution comprising water, lactic acid, citric acid, and cationic surfactant ([0011]), as taught by Miller. The limitation of a second solution containing a surfactant, nitrite, and purified water would have been obvious over the first solution comprising water, sodium nitrite, and cationic surfactant ([0014]), as taught by Miller. The limitation of using the pressure difference would have been obvious over the lower vapor pressure ([0070]), as taught by Miller. The limitation of applying the gas-filled medium topically to the skin is an intended use which is not given patentable weight. Nonetheless, this limitation would have been obvious over the topical application of the resultant foams to the skin to treat various skin disorders or wounds (Abstract and claim 21), as taught by Miller.
Regarding instant claim 9, the limitation of the plurality of bubbles would have been obvious over the bubbles (Col. 2, lines 23-26), as taught by Kroll, and the foam (Abstract and claim 21), as taught by Miller.
Regarding instant claim 10, the limitation of a pressurized vessel would have been obvious over the use of gas under high pressure to effect wide area coverage and high penetration of the foam into falling or moving masses of material (Col. 1, lines 46-48), as taught by Kroll.
Regarding instant claim 11, the limitation of the gas comprising one or more of nitric oxide, oxygen, or nitrogen would have been obvious over the gas which is usually air, and which inherently contains oxygen and nitrogen (Col. 3, lines 52-55), as taught by Kroll.
Response to Arguments
Applicant’s arguments (Page 7, filed 03/31/26) with respect to the following rejections have been fully considered but are not persuasive.
Rejection of claims 1-5, 13-16, and 18-20 under 35 U.S.C. 102(a)(1) as being anticipated by Kroll (US 4,474,680)
Rejection of claims 6-12 and 17 under 35 U.S.C. 103 as being unpatentable over Kroll (US 4,474,680), as applied to claims 1-5, 13-16, and 18-20, in view of Miller et al. (US 2017/0209485 A1)
Applicant argues that the foam generation taught by Kroll is an industrial process and necessarily produces a closed-cell, solid foam, and that the foam generated in Kroll does not result in a bubble defining a membrane that is filled with a gas, as recited in independent claims 1, 7, and 13.
This is not persuasive because instant claims do not exclude an industrial process as disclosed by Kroll and Kroll teaches individual foam bubbles (Col. 6, lines 1-2). Instant claims do not recite any specific dimensions of the bubbles to distinguish over the prior art foam bubbles. All the claimed limitations regarding the constituents for producing a gas-filled medium, i.e., a source of gas and a surfactant solution, along with the claimed step of mixing the gas and the surfactant solution are taught by prior art.
Applicant argues that the closed-cell, solid foam described in Kroll would preclude the ability to disrupt any membrane to locally apply a gas to skin of a person, as recited in independent claims 1, 7, and 13.
This is not persuasive because application of the gas to the skin of a person is a future intended use which is not given patentable weight.
Applicant argues that there would be no motivation to combine the industrial process described in Kroll with the nitric oxide foam described in Miller as it would be impossible to transform the closed-cell, solid foam in Kroll into a foam that contains nitric oxide based on the described manner for producing foam set forth in Kroll.
This is not persuasive because both Kroll and Miller teach methods for producing a gas filled medium or foam, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). Instant claims do not recite any additional features to distinguish over the method of producing a foam taught by Kroll and the suitable surfactants that promote foaming which are taught by Miller.
Therefore, the anticipation and obviousness rejections of 10/01/25 are maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-7, 9-13, and 15-20 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 15 of U.S. Patent No. 10,052,348 B2 (“the ‘348 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for producing a gas-filled medium, comprising: providing a source of gas; providing a surfactant solution; mixing the gas and the surfactant solution in a manner that produces a gas-filled medium; and applying the gas-filled medium topically to the skin, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claims 1, 11, and 15 of the ‘348 Patent are drawn to a method for treating skin disorders whereas instant claims do not recite treating skin disorders. However, instant claims 1 and 7 recite the application of the gas-filled medium topically to skin. One of ordinary skill in the art would have found it obvious to apply the gas-filled medium recited in instant claims to the skin of a subject in need of treatment of skin disorders.
Therefore, instant claims are obvious over claims of the ‘348 Patent and they are not patentably distinct over each other.
Claims 1, 3-7, 9-13, and 15-20 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 14 of U.S. Patent No. 10,751,364 B2 (“the ‘364 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for producing a gas-filled medium, comprising: providing a source of gas; providing a surfactant solution; mixing the gas and the surfactant solution in a manner that produces a gas-filled medium; and applying the gas-filled medium topically to the skin, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claims 1, 9, and 14 of the ‘364 Patent are drawn to a composition for transdermal absorption of nitric oxide whereas instant claims recite a method for producing a gas-filled medium. However, claims 1, 9, and 14 recite that the collapsible foam is obtained by mixing the first foam and the second foam, which are the same as the first solution and second solution recited in instant claim 7.
Also, the composition for transdermal absorption of nitric oxide recited in claims 1, 9, and 14 of the ‘364 Patent would have been obvious over instant claims 1 and 7 which recite the application of the gas-filled medium topically to skin. One of ordinary skill in the art would have found it obvious to apply the gas-filled medium recited in instant claims transdermally to the skin of a subject in need of treatment of skin disorders.
Therefore, instant claims are obvious over claims of the ‘364 Patent and they are not patentably distinct over each other.
Claims 1, 3-7, 9-13, and 15-20 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 15 of U.S. Patent No. 11,304,972 B2 (“the ‘972 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for producing a gas-filled medium, comprising: providing a source of gas; providing a surfactant solution; mixing the gas and the surfactant solution in a manner that produces a gas-filled medium; and applying the gas-filled medium topically to the skin, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claims 1, 11, and 15 of the ‘972 Patent are drawn to a method for transdermal absorption of nitric oxide whereas instant claims do not recite transdermal absorption of nitric oxide. However, instant claims 1 and 7 recite the application of the gas-filled medium topically to skin. One of ordinary skill in the art would have found it obvious to apply the gas-filled medium recited in instant claims for the transdermal absorption of nitric oxide.
Therefore, instant claims are obvious over claims of the ‘972 Patent and they are not patentably distinct over each other.
Claims 1, 3-7, 9-13, and 15-20 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12,150,953 B2 (“the ‘953 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for producing a gas-filled medium, comprising: providing a source of gas; providing a surfactant solution; mixing the gas and the surfactant solution in a manner that produces a gas-filled medium; and applying the gas-filled medium topically to the skin, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claim 16 of the ‘953 Patent are drawn to a method for effecting transdermal absorption of nitric oxide whereas instant claims do not recite a method for effecting transdermal absorption of nitric oxide. However, instant claims 1 and 7 recite the application of the gas-filled medium topically to skin. One of ordinary skill in the art would have found it obvious to apply the gas-filled medium recited in instant claims for the transdermal absorption of nitric oxide.
Therefore, instant claims are obvious over claims of the ‘953 Patent and they are not patentably distinct over each other.
Claims 1, 3-7, 9-13, and 15-20 are again provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 10 of copending Application No. 18/506,752 (“the ‘752 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for producing a gas-filled medium, comprising: providing a source of gas; providing a surfactant solution; mixing the gas and the surfactant solution in a manner that produces a gas-filled medium; and applying the gas-filled medium topically to the skin, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claim 10 of the ’752 Application are drawn to a method for providing nitric oxide therapy to the skin of a human or animal requiring treatment whereas instant claims do not recite a method for providing nitric oxide therapy to the skin of a human or animal requiring treatment. However, instant claims 1 and 7 recite the application of the gas-filled medium topically to skin. One of ordinary skill in the art would have found it obvious to apply the gas-filled medium recited in instant claims for providing nitric oxide therapy to the skin of a human or animal requiring treatment.
Therefore, instant claims are obvious over claims of the ‘752 Application and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1, 3-7, 9-13, and 15-20 are again provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 16 of copending Application No. 18/637,767 (“the ‘767 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for producing a gas-filled medium, comprising: providing a source of gas; providing a surfactant solution; mixing the gas and the surfactant solution in a manner that produces a gas-filled medium; and applying the gas-filled medium topically to the skin, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claim 16 of the ’767 Application are drawn to a method for effecting transdermal absorption of nitric oxide whereas instant claims do not recite a method for effecting transdermal absorption of nitric oxide. However, instant claims 1 and 7 recite the application of the gas-filled medium topically to skin. One of ordinary skill in the art would have found it obvious to apply the gas-filled medium recited in instant claims for effecting transdermal absorption of nitric oxide.
Therefore, instant claims are obvious over claims of the ‘767 Application and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant’s arguments (Page 8, filed 03/31/26) with respect to the double patenting rejections have been fully considered but are not persuasive.
Applicant acknowledges the double patenting rejections, but defers taking any action until allowance of a pending claim.
This is not persuasive because allowable subject matter has not yet been identified. The double patenting rejections are maintained for the reasons provided above.
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 extension fee 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.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
