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
Claims 1, 3-4, 6, 8-11, 13-14, 16-20, 22, 28, and 36 are pending in the instant application.
Claims 1, 4, 11, and 18 are amended.
Claims 22, 28, and 36 are withdrawn from consideration.
Claims 1, 3-4, 6, 8-11, 13-14, 16-20, and 39-40 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 63/091236, filed on 13 October 2020 and PCT/US2021/054868, filed on 15 October 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 13 October 2020.
Information Disclosure Statement
No information disclosure statement (IDS) submitted by applicant.
Response to Arguments
The amendment filed on 18 February 2026 has been entered.
In view of applicant amendment to claim 11, the objection of record is withdrawn.
In view of applicant amendment to claim 4, the 112(b) rejection of record is withdrawn.
In view of applicant amendment to claim 1, the 112(b) rejection of record is withdrawn.
In view of applicant amendment to claim 18, the 112(b) rejection of record is withdrawn.
In view of applicant amendment to claim 1, the 102(a)(1) rejections of record are withdrawn. The instant invention as amended cannot at once be envisaged by the prior art. And the synergistic effects demonstrated are not obvious.
With respect to the 103 rejection, Applicants arguments have been considered but are not found persuasive. The synergistic results are not commensurate in scope. The specification states PBA and acyclovir are synergistic, pointing to Figures 6A-6F; and PBA and trifluridine are synergistic, pointing to Figures 5A-5I. However, Figured 5A-5I do not demonstrate synergism. The only example provided is PBA and acyclovir, while the data provided makes this combination allowable, additional data is required to demonstrate synergism for the other combinations as synergy is known to be unpredictable and may not apply across one drug class. The rejection is maintained and amended below.
In addition, new 103 rejections are necessitated by amendment.
All rejections and objections not found below have been withdrawn.
NEW REJECTIONS
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, 3-4, 6, 9-11, 13-14, 16-20, and 39-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shenk et al. (WO2012103524A2).
Regarding claims 1 and 3, Shenk discloses the composition comprising 4-PBA for the treatment of human cytomegalovirus (HCMV) (paragraph [0302]). Shenk discloses the additional therapeutic agent can be antiviral, such as nucleoside analogs including acyclovir and trifluridine (paragraph [0244]). Shenk further expands the list of possible antivirals to also include ganciclovir, valacyclovir, famciclovir, penciclovir, and ribavirin (paragraph [0247]).
Shenk does not disclose a preferred embodiment of 4-PBA and one of the above listed antivirals.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong E of KSR applies – obvious to try to combine from a finite list. Shenk discloses a method for treating viral infections and discloses this method can be used in combination with additional therapeutic agents. As the invention as a whole is directed to viral infections the skilled artisan would be guided to choosing an antiviral as the additional agent. As Shenk supplies a finite list of antivirals it would be obvious for the skilled artisan to combine 4-PBA with the recited antivirals.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claims 4 and 13, Shenk discloses the dose of 4-PBA from 0.2 mM to 10 mM (Fig. 10), overlapping with the instant recited range. Additionally Shenk discloses the dose can range from 250 nM to 100 µM, or 0.01 mg/kg to 100 mg/kg (paragraph [0084]).
Regarding claim 6, in turning to the instant specification “drug delivery agent” is defined as a pharmaceutically acceptable carrier, diluent, or excipient (paragraph [0081]). Shenk discloses the pharmaceutical composition comprise a pharmaceutically acceptable carrier, diluent, or excipient (paragraph [0183]).
Regarding claim 9, Shenk discloses the composition can comprise additional therapeutic agents (paragraph [0222]).
Regarding claim 10, Shenk discloses the additional therapeutic agent can be antiviral, anti-inflammatory, or pain relievers (paragraph [0224]).
Regarding claim 11, Shenk discloses the antiviral agent can be acyclovir (paragraph [0224]).
Regarding claim 14, Shenk discloses the additional agents aspirin, ibuprofen (paragraph [0224]).
Regarding claim 16, Shenk discloses the composition can be formulated for ophthalmic administration (paragraph [0194]).
Regarding claim 17, Shenk discloses suitable excipients for mucosal dosage forms, such as ophthalmic solutions (paragraph [0214]).
Regarding claim 18, Shenk discloses the excipients can be ethanol and mineral oil (paragraph [0214]).
Regarding claim 19, Shenk discloses the composition can be formulated for topical administration (paragraph [0194]).
Regarding claim 20, Shenk discloses the composition can include polyethylene glycol (paragraph [0206]), a mucosal penetrating agent.
Regarding claim 39, Shenk discloses the viral infection is herpes simplex virus (HSV) (paragraph [0021]).
Regarding claim 40, Shenk discloses the HSV infection is type 1 (paragraph [0021]).
MAINTAINED REJECTIONS
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, 3-4, 6, 8-11, 13-14, 16-20, and 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shenk et al. (cited above) in view of Kesisoglou et al. (Advanced Drug Delivery Reviews.2007;59:631–644).
The teachings of Shenk are disclosed above and incorporated by reference herein.
Regarding claim 8, Shenk does not explicitly disclose the composition is formulated as a nanoformulation, microformulation, or macropformulation.
Kesisoglou teaches that reducing the particle size of the active pharmaceutical ingredient to sub-micron range and producing a nanoformulation can lead to increased bioavailability, especially when the API is poorly soluble as nanosizing increases surface area.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong D of KSR applies – combining known a known technique to a known method.
As 4-PBA is poorly soluble it would be obvious to one skilled in the art to increase the drug’s bioavailability by formulating the composition such that the particle size is in the nanometer range. Scheck teaches the formulation of a pharmaceutical composition comprising 4-PBA for the treatment of viral infections, and Kesisoglou teaches the nanosizing of APIs to produce a nanoformulation. Applying the technique of Kesisoglou to the formulation of Shenk one would arrive at the instant invention.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Conclusion
Claims 1, 3-4, 6, 8-11, 13-14, 16-20, and 39-40 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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