DETAILED ACTION
Formal Matters
Claims 1-7, 9, and 20 are cancelled. Claims 8, and 10-19 are pending. Claims 10, 12, and 14 are withdrawn. Claims 8, 11, 13, and 15-19 are under examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a CIP of 17/157,118 filed on 1/25/2021, which is a divisional of 15/887,469 filed on 2/2/2018, which claims priority from US provisional applications 62/524,866 filed on 06/26/2017, 62/483,032 filed on 04/07/2017 and 62/453,701 filed on 2/2/2017.
Rejections Withdrawn
The rejection under USC 101 over claims 1-4, 6, 13 and 15-20 is withdrawn per applicant’s claim cancellations and amendments to claims 13 and 17.
The rejection under USC 112(a) for scope of enablement is withdrawn per applicant’s amendments and claim cancellations.
The rejection under USC 112(b) for “non-physiological concentration” is withdrawn as applicant has amended the claims.
The rejection under USC 112(b) for synthetic or semi-synthetic is withdrawn as applicant has now also provided “macrolide” to the claims.
The rejection under USC 112(b) for analog is withdrawn as applicant has deleted these recitations from the claims.
The rejection under USC 112(b) over claim 20 is withdrawn per applicant’s deletion of the claim.
The rejection under USC 102 over Brown is withdrawn as applicant has amended the claims to be in scope with the description of earlier priority documents. Thus, Brown (also from applicant) is no longer prior art over the claims.
The rejection under USC 102 over Gutierrez-Huante is withdrawn per applicant’s amendments to include macrolide.
The rejection under USC 103 over CN102283799 (2013; in applicant IDS) and Promega, Buffers is withdrawn per applicant’s amendments to the claims notably to provide the pH is “about 7.4”.
The rejection under USC 103 over Kaushik et al (NPJ Biofilms and Microbiomes, May 25, 2016, volume 2, pages 1-12, in applicant IDS) and Tsai is withdrawn per applicant’s amendments and arguments.
As these rejections are withdrawn, applicant’s arguments toward these rejections are now moot.
Note that applicant’s amendments to provide a pH value and adjust concentrations necessitated a further search and consideration of the prior art. Additionally, terminal disclaimers were not accepted for the reasons provided in the Terminal Disclaimer Review Decision from 7/30/2026. New and Maintained Rejections are listed below.
New Rejections – As Necessitated by Applicant’s Amendments
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 8, 11, 13, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buyck et al (Clinical Infectious Diseases, 2012, volume 55, pages 534-542) as evidenced by Thermofisher (RPMI 1640, https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.114.html, downloaded 10/13/2026).
Buyck teaches macrolides show high minimum inhibitory concentrations (MICs) against Pseudomonas aeruginosa when tested in recommended media (abstract). Buyck teaches using RPMI 1640 medium to grow eukaryotic cells and to test the azithromycin MIC values (abstract). Buyck showed activity of the macrolides (azithromycin) in the media against P aeruginosa (abstract). Buyck teaches that RPMI 1640 medium, where the azithromycin is added, contains NaHCO3 (sodium bicarbonate) and has a pH of 7.4 (page 538, Influence of pH). The figure 3 legend notes the pH used was 7.4. The standard bicarbonate concentration in RPMI 1640 medium is 2 g/L or 23.81 mM of bicarbonate (evidence from ThermoFisher). Note that the cell media is separate from the macrolide antibiotic until the antibiotic is added to the media which has the bicarbonate and the pH value. The forms are considered administrable since they are added to the cells.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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 8, 11, 13, and 15-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buyck et al (Clinical Infectious Diseases, 2012, volume 55, pages 534-542) and Charles et al (Drugs, 1997, volume 53, pages 349-357) as evidenced by Thermofisher (RPMI 1640, https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.114.html, downloaded 10/13/2026).
Buyck teaches the claims as discussed above.
Buyck does not teach gram positive bacteria being treated.
Charles teaches that erythromycin, azithromycin and clarithromycin have been shown to be equally effective against gram positive organisms (Summary). Charles teaches effectiveness with Streptococcal bacteria (section 4.1 and summary page 350). Charles teaches azithromycin with activity against Salmonella, Shigella and E coli (second column on page 351). Here, Charles also provides “C. trachomatis, L pneumophila and M.avium intracellulare complex (MAC)”. In section 4.2, Charles notes azithromycin being equivalent to amoxicillin and clarithromycin in patients with acute sinusitis which is commonly due to S pneumoniae among others.
One of ordinary skill in the prior art before the time of filing would have seen formulations with azithromycin like those in Buyck as being effective against some gram positive bacteria as Charles notes this effectiveness. Therefore, there was a reasonable expectation of success in practicing the method of Buyck with gram positive bacteria such as Streptococcus and obtaining reduction of the gram positive bacteria that have been reduced with azithromycin and other macrolides.
Maintained Rejections -Modified As Necessitated by Amendments
(Rejections Maintained Due to Terminal Disclaimers Not being Accepted)
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 8, 11, 13, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10, 11, and 12-13 of U.S. Patent No. 10940163. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim set provides for using bicarbonate in overlapping amounts along with azithromycin (a semisynthetic antibiotic) along with the ability to kill Staphylococcus bacteria. As the claims of ‘163 teaches the components, this would allow for formulations of each of these ingredients for later combination or administration as in the form of a kit.
Claims 8, 11, 13, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 15-17, 20-22, and 27-29 of U.S. Patent No. 11779595. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim set provides for using bicarbonate in overlapping amounts along with azithromycin (a semisynthetic antibiotic) along with the ability to kill Staphylococcus bacteria.
Claims 8, 11, 13, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-9, and 10-17 of U.S. Patent No. 11400106. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim set provides for using bicarbonate in overlapping amounts along with azithromycin (a semisynthetic antibiotic) along with the claim providing killing of bacteria and azithromycin is an antibiotic that can kill gram positive bacteria.
Claims 8, 11, 13, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-8, and 10-18 of copending application 18/236,164 (now US Patent 12678454). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim set provides for using bicarbonate in overlapping amounts along with azithromycin (a semisynthetic antibiotic) along with the ability to kill Staphylococcus bacteria. ‘164 provides for kits with multiple compositions for administration.
Conclusion
No claims are allowed.
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 MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK V STEVENS/
Examiner, Art Unit 1613
