DETAILED 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/27/2026, 01/07/2026, 07/09/2025, and 12/13/2024 x4 have been considered by the examiner.
Status of the Claims
The response filed 02/24/2026 is acknowledged.
Claims 1-13 are pending.
Applicant’s election without traverse of Group I, claims 1-6 in the reply filed on 02/24/2026 is acknowledged.
Claims 7-13 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/24/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-6, are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Augustine, Acta Biomaterialia, 2018.
Augustine teaches a sustained release formulation (Augustine, entire document, e.g., Abstract), comprising sodium alginate and darunavir (Augustine, entire document, e.g., Abstract). The drugs are made into nanoparticles in a sodium alginate solution which is then lyophilized and encapsulated as microparticles (Augustine, entire document, e.g., pg. 346, 2.2.1 and 2.2.3). Microparticles may be considered a carrier. Sodium alginate is a suspending agent, alternatively, chitosan may be considered a suspending agent.
Augustine anticipates the subject matter of instant claims 1-3 and 5.
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.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston, The Laryngoscope, 133, S1, 2022 published 09 June, 2022 and Withington, US 4140760.
Johnston teaches oral fosamprenavir, amprenavir, ritonavir, saquinavir, or darunavir inhibit pepsin; fosamprenavir and darunavir abrogate pepsin mediated laryngeal damage in laryngopharyngeal reflux (Johnston, e.g., title, abstract).
Thus, Johnston teaches an oral formulation for treating reflux comprising an effective amount of an HIV protease inhibitor.
Johnston does not expressly teach the oral formulation comprising sodium alginate and a pharmaceutically acceptable carrier.
Withington teaches liquid preparations for treating reflux in a subject comprising sodium alginate, preservatives, colors, and flavors (Withington, e.g., Example 1). Withington teaches the formulation is palatable, easily swallowed (Withington, e.g., c3:39-63), stable over a storable time frame, easy to dose and pour (Withington, e.g., example 1), and effective to suppress reflux by forming a mechanical barrier in the stomach (Withington, e.g., ¶ spanning c5-c6). Withington does not expressly teach the oral formulation comprises an effective amount of an HIV protease inhibitor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a composition for treating reflux comprising fosamprenavir, amprenavir, ritonavir, saquinavir, or darunavir according to Johnston by formulating the HIV protease inhibitor, e.g., fosamprenavir, in a liquid suspension comprising sodium alginate as known from Withington with a reasonable expectation of success. The skilled artisan would have been motivated to formulate Johnston’s oral HIV protease compositions for treating reflux using Withington’s known formulation techniques to predictably arrive at a liquid formulation which includes the benefits of being palatable, easily swallowed, stable over a storable time frame, easy to dose and pour, and effective to suppress reflux by forming a mechanical barrier in the stomach in the same way with a reasonable expectation of success. The skilled artisan would have seen this modification as combining two composition each of which is taught by the prior art as useful for treating reflux to arrive at a third composition useful for the same purpose. See MPEP 2144.06. The skilled artisan would have had a reasonable expectation of success because Johnston indicates a need for oral formulations of the HIV protease inhibitors which are effective against pepsin.
Alternatively:
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a composition comprising sodium alginate for treating reflux as understood from Withington by including a protease inhibitor, e.g., fosamprenavir, amprenavir, ritonavir, saquinavir, or darunavir, effective to inhibit pepsin as reported by Johnston to improve the composition in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to abrogate pepsin mediated laryngeal damage in laryngopharyngeal reflux. The skilled artisan would have had a reasonable expectation of success since both references teach compositions useful for treating reflux.
The formulation suggested by the combined teachings of Johnston and Withington comprise an effective amount of an HIV protease inhibitor, sodium alginate, and a pharmaceutically acceptable carrier in the same way as claimed. Thus, the prior art composition is capable of sustained release as claimed.
Accordingly, the subject matter of claims 1-6 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Augustine, Acta Biomaterialia, 2018 and Docherty, US 20210330683 A1.
Augustine teaches a sustained release formulation (Augustine, entire document, e.g., Abstract), comprising sodium alginate and darunavir (Augustine, entire document, e.g., Abstract). Darunavir is made into nanoparticles in a sodium alginate suspending agent solution which is then lyophilized and encapsulated as microparticles (Augustine, entire document, e.g., pg. 346, 2.2.1 and 2.2.3). Microparticles may be considered a carrier.
Augustine does not expressly teach wherein the formulation is a liquid or wherein the formulation comprising a suspending agent, a preservative, a sweetener, a flavoring, water, or combination. To the extent that claim 5 was intended to require the formulation of claim 1 further comprising a suspending agent, a preservative, a sweetener, a flavoring, water, or combination, Docherty provides this teaching.
Docherty teaches compositions for enhanced delivery of antiviral agents (Docherty, e.g., Title, Abstract, claims). Docherty teaches antiviral agents may be formulated as liquid suspensions, e.g., liquid darunavir compositions (Docherty, e.g., 0074, 0163, 0571-0583, and claim 3) may be formulated with a suitable vehicle such as water, wherein the liquid formulation contains suspending agents, emulsifying agents, polysaccharide viscosity agents, preservatives, and flavoring agents (Docherty, e.g., 00569 and 0571-0572).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify Augustine’s formulations of darunavir containing crosslinked sodium alginate particles using formulation techniques known from Docherty with a reasonable expectation of success. Since Augustine teaches their formulations are effective for oral administration the skilled artisan would have been motivated to use oral formulation techniques known for oral delivery of antivirals such as liquid suspensions suggested by Docherty to realize Augustine’s oral formulation objective. The skilled artisan would have had a reasonable expectation of success because Docherty suggests liquid suspensions are effective for oral formulation of antiviral agents including darunavir.
Augustine does not expressly teach wherein the HIV protease inhibitor is amprenavir or its prodrug fosamprenavir.
Docherty teaches compositions for enhanced delivery of antiviral agents (Docherty, e.g., Title, Abstract, claims). Docherty teaches amprenavir or its prodrug fosamprenavir were art recognized antiviral agents alternative to darunavir (Docherty, e.g., 0074, 0163, and claim 3). Docherty further evidences the fact that, before the filing date of the presently claimed invention, the skilled artisan understood that amprenavir or its prodrug fosamprenavir, like darunavir, were in need of enhanced delivery techniques (Docherty, e.g., 00162-00164). Docherty teaches sodium alginate may be used as an excipient to formulate amprenavir or its prodrug fosamprenavir for enhanced delivery (Docherty, e.g., 0164). Docherty teaches the formulations may include slow-release formulations such as enterically coated granules (Docherty, e.g., 0569).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to combine the teachings of Augustine and Docherty to arrive at the presently claimed subject matter with a reasonable expectation of success.
Starting from Augustine, the skilled artisan would have substituted amprenavir or its prodrug fosamprenavir for darunavir in Augustine’s formulations to predictably achieve sustained release and improved bioavailability of amprenavir or its prodrug fosamprenavir. The skilled artisan would have seen this modification as the substitution of one known antiviral agent for another where each were known to benefit from formulation techniques for improved bioavailability. An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. See MPEP 2144.06. The skilled artisan would have had a reasonable expectation of success since Docherty suggests amprenavir or its prodrug fosamprenavir would benefit from the same formulation techniques which improving delivery of darunavir.
Starting from Docherty, the skilled artisan would have been motivated to improve enhanced delivery oral formulations comprising amprenavir or its prodrug fosamprenavir known from Docherty using techniques known from Augustine to improve the oral formulations in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to formulate at least a portion of the dose of amprenavir, or its prodrug fosamprenavir, in Docherty’s compositions using a crosslinked sodium alginate particle technique known from Augustine with a reasonable expectation of successfully improving the bioavailability of amprenavir or its prodrug fosamprenavir and enabling sustained release of amprenavir or its prodrug fosamprenavir in the same way shown for darunavir by Augustine. The skilled artisan would have expected a combination of the formulation strategies suggested by each reference would predictably result in further enhancement of amprenavir or its prodrug fosamprenavir delivery by combining improved bioavailability and sustained release. The skilled artisan would have had a reasonable expectation of success since Docherty suggests amprenavir or its prodrug fosamprenavir would benefit from formulation techniques effective for improving delivery of darunavir.
Accordingly, the subject matter of claims 1-6 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2 and 5-14 of US 18047173 in view of Withington, US 4140760 and Docherty, US 20210330683 A1.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach an oral formulation comprising fosamprenavir for treating reflux in a subject.
The reference claims do not expressly teach the oral formulation further comprising sodium alginate and a pharmaceutically acceptable carrier.
Withington teaches liquid preparations for treating reflux in a subject comprising sodium alginate, preservatives, colors, and flavors (Withington, e.g., Example 1). Withington teaches the formulation is palatable, easily swallowed (Withington, e.g., c3:39-63), stable over a storable time frame, easy to dose and pour (Withington, e.g., example 1), and effective to suppress reflux by forming a mechanical barrier in the stomach (Withington, e.g., ¶ spanning c5-c6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a composition for treating reflux comprising fosamprenavir according to the reference claims by formulating fosamprenavir in a liquid suspension comprising sodium alginate as known from Withington with a reasonable expectation of success. The skilled artisan would have been motivated to use Withington’s formulation techniques to predictably arrive at a liquid formulation which includes the benefits of being palatable, easily swallowed, stable over a storable time frame, easy to dose and pour, and effective to suppress reflux by forming a mechanical barrier in the stomach in the same way with a reasonable expectation of success. The skilled artisan may have seen this modification as combining two composition each of which is taught by the prior art as useful for treating reflux to arrive at a third composition useful for the same purpose. See MPEP 2144.06. The skilled artisan would have had a reasonable expectation of success because the reference claims indicate a need for oral formulations of the HIV protease inhibitors which are effective for treating reflux.
The formulation suggested by the combined teachings of the reference claims and Withington comprise an effective amount of an HIV protease inhibitor, i.e., fosamprenavir, sodium alginate, and a pharmaceutically acceptable carrier in the same way as claimed. Thus, the prior art composition is capable of sustained release as claimed.
The combined teachings of the reference claims and Withington do not expressly teach amprenavir. However, fosamprenavir was known to be a prodrug of amprenavir as evidenced by Docherty. See Docherty, e.g., amprenavir or its prodrug fosamprenavir (Docherty, e.g., 0074, 0163, and claim 3). Since amprenavir is the active drug form of the prodrug fosamprenavir, the skilled artisan would have reasonably concluded that the two drugs have the same biological activity in the context of treating reflux. Based the structural similarity of the active drug in each case, and the fact that both are protease inhibitors, the skilled artisan would have expected similar effectiveness for treating reflux.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a formulation suggested by the reference claims and Withington by including amprenavir with a reasonable expectation of success. The skilled artisan would have considered this a combination of two equivalent protease inhibitors, or a substitution of one protease inhibitor for another, where each provide the active drug amprenavir when administered orally. The skilled artisan would have had a reasonable expectation of success because Docherty suggests amprenavir or its prodrug fosamprenavir may be formulated similarly for oral administration.
Accordingly, the subject matter of claims 1-6 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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