DETAILED ACTION
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
Applicant’s response dated 07 January 2026 to the previous Office action dated 08 August 2025 is acknowledged. Pursuant to amendments therein, claims 35-36 and 40-53 are pending in the application.
The claim objection made in the previous Office action is withdrawn in view of applicant’s cancelation of claim 39.
New rejections under 35 U.S.C. 112 are made herein in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 102 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but a new (modified) rejection under 35 U.S.C. 102 is made herein in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 103 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but new (modified) rejections under 35 U.S.C. 103 are made herein in view of applicant’s claim amendments.
Election/Restrictions
Claims 43-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 June 2025.
Claims 35-36, 40-42, and 49-53 are under current consideration.
Claim Rejections - 35 USC § 112
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 36, 51, and 53 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 recites the limitation "said strain" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 51 and 53 recite that the composition has a concentration of about 50 nmol but fail to specify what the concentration is of (i.e., concentration of what?), thus rendering the claims indefinite. Prior art rejections cannot be made for these claims because it is unknown what the concentration refers to.
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) 35-36, 41-42, and 50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cole et al. (Molecules, vol. 20, 10 April 2015, pages 6466-6487; of record).
Cole et al. discloses that GUMBOS formed from β-lactam antibiotics (i.e., effective in modulating the proliferation or viability of a carbanapem-resistant bacterial strain) and chlorhexidine diacetate (i.e., an antiseptic, effective in modulating the proliferation or viability of a gram-negative strain of a bacterial species when in contact with said strain) (1) extend the spectra of antibacterial activity with profound antibacterial activity; and (2) lower the concentration required to inhibit the growth of multi-drug-resistant bacteria better than the unreacted, stoichiometric equivalent of precursor ions (page 6484 section 4) wherein β-lactam antibiotics include carbenicillin (abstract) wherein GUMBOS are mixed with deionized water (i.e., a pharmaceutical carrier, formulated for delivery to a subject human or animal intravascularly or directly to a tissue of the subject) (page 6483 section 3.7).
Regarding the claimed recitations of “wherein the antiseptic and the antibiotic synergistically interact whereby the composition has a MIC against N. gonorrhoeae that is less than the sum of the MICs of the antiseptic and the antibiotic individually”, “wherein the antiseptic is effective in modulating the proliferation or viability of N. gonorrhoeae when in contact with said strain”, and “wherein the MIC is about 0.8-3.1 µM”, although Cole et al. does not explicitly recite such properties, the composition of Cole et al. as discussed above is presumed to inherently exhibit such properties because the claimed composition and the composition of Cole et al. are substantially identical per MPEP 2112(V) and 2112.01(I), and compositions that are physically the same must have the same properties per MPEP 2112.01(II).
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, 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.
Claim(s) 35-36, 40-42, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. in view of Zhang (US 2009/0156518 A1; published 18 June 2009; of record).
Cole et al. discloses that GUMBOS formed from β-lactam antibiotics (i.e., effective in modulating the proliferation or viability of a carbanapem-resistant bacterial strain) and chlorhexidine diacetate (i.e., an antiseptic, effective in modulating the proliferation or viability of a gram-negative strain of a bacterial species when in contact with said strain) (1) extend the spectra of antibacterial activity with profound antibacterial activity; and (2) lower the concentration required to inhibit the growth of multi-drug-resistant bacteria better than the unreacted, stoichiometric equivalent of precursor ions (page 6484 section 4) wherein β-lactam antibiotics include carbenicillin (abstract) wherein GUMBOS are mixed with deionized water (i.e., a pharmaceutical carrier, formulated for delivery to a subject human or animal intravascularly or directly to a tissue of the subject) (page 6483 section 3.7).
Regarding the claimed recitations of “wherein the antiseptic and the antibiotic synergistically interact whereby the composition has a MIC against N. gonorrhoeae that is less than the sum of the MICs of the antiseptic and the antibiotic individually”, “wherein the antiseptic is effective in modulating the proliferation or viability of N. gonorrhoeae when in contact with said strain”, and “wherein the MIC is about 0.8-3.1 µM”, although Cole et al. does not explicitly recite such properties, the composition of Cole et al. as discussed above is presumed to inherently exhibit such properties because the claimed composition and the composition of Cole et al. are substantially identical per MPEP 2112(V) and 2112.01(I), and compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Cole et al. does not disclose ceftriaxone as a β-lactam antibiotic as in claim 40.
Zhang discloses a pharmaceutical composition comprising beta-lactam antibiotic (title; claim 1) wherein the beta-lactam antibiotic can be carbenicillin or ceftriaxone (claim 2).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Cole et al. and Zhang by using the ceftriaxone of Zhang for the β-lactam antibiotic such as carbenicillin in the composition of Cole et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use therein a β-lactam known for use as an antibiotic in pharmaceutical compositions given that Cole et al. suggests using a β-lactam and Zhang teaches that ceftriaxone and carbenicillin are β-lactams known for use as antibiotics in pharmaceutical compositions, and given that it is prima facie obvious to substitute equivalents known for the same purpose (e.g., ceftriaxone and carbenicillin are β-lactams known for use as antibiotics in pharmaceutical compositions) per MPEP 2144.06(II), and given that the selection of a known material based on its suitability for its intended use (e.g., β-lactams known for use as antibiotics in pharmaceutical compositions) supports a prima facie obviousness determination per MPEP 2144.07.
Claim(s) 49 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giordano (US 2009/0111780 A1; published 30 April 2009).
Giordano discloses a composition comprising an antibacterial, an anti-inflammatory, and an anti-septic (claim 1) wherein the antibacterial can be carbenicillin (claim 3) and the anti-septic can be octenidine (claim 5).
Although Giordano does not disclose a specific formulation example comprising carbenicillin and octenidine, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Giordano as discussed above and to make the composition of Giordano as discussed above wherein the antibacterial is carbenicillin and the anti-septic is octenidine, with a reasonable expectation of success.
Regarding the claimed recitations of “wherein the antiseptic and the antibiotic synergistically interact whereby the composition has a MIC against N. gonorrhoeae that is less than the sum of the MICs of the antiseptic and the antibiotic individually” and “an antiseptic in ionic association with an antibiotic as an ion-pair solid-phase organic salt”, although Giordano does not explicitly recite such properties, the composition of Giordano as discussed above is presumed to inherently exhibit such properties because the claimed composition and the composition of Giordano are substantially identical per MPEP 2112(V) and 2112.01(I), and compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Response to Arguments
Applicant's arguments filed 07 January 2026 have been fully considered but they are not persuasive.
Applicant argues that since claim 40 was not anticipated by Cole et al. then claim 35 is not anticipated by Cole et al. (remarks page 6). In response, amended claim 35 encompasses subject matter that is not encompassed by claim 40, namely a composition comprising chlorhexidine and carbenicillin.
Applicant argues that applicant has shown unexpected results (remarks pages 6-7). In response, it is not readily clear from the specification examples exactly what inventive formulations (including all ingredients and concentrations thereof) and comparative formulations (including all ingredients and concentrations thereof), if any, were tested, and the results thereof that indicate unexpected results, such that it can be determined whether such asserted unexpected results are truly unexpected and whether such asserted unexpected results are commensurate in scope with the claimed subject matter. Applicant is encouraged to concisely indicate the inventive formulations (including all ingredients and concentrations thereof) and comparative formulations (including all ingredients and concentrations thereof) that were tested, and the results thereof that indicate unexpected results, and to do so in a declaration if all such information/data is not contained in the specification as filed. The burden is on applicant to establish that results are in fact unexpected and unobvious and of both statistical and practical significance, per MPEP 716.02(b). Such evidence of unexpected results must be commensurate in scope with the claimed invention per MPEP 716.02(d), and must compare the claimed subject matter with the closest prior art (or closer) per MPEP 716.02(e).
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 MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617