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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 July 2026 has been entered.
Status
Applicant’s response dated 31 July 2026 to the previous Office action dated 01 April 2026 is acknowledged. Pursuant to amendments therein, claims 35-36, 40-50, and 52 are pending in the application.
A new claim objection is made herein in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 112 made in the previous Office action are withdrawn in view of applicant’s claim amendments, but a new rejection under 35 U.S.C. 112 is made herein in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 102 made in the previous Office action is withdrawn in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 103 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but new (modified) rejections under 35 U.S.C. 103 are made herein in view of applicant’s claim amendments.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Claims 43-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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, 49-50, and 52 are under current consideration.
Claim Objections
Claim 52 is objected to because of the following informalities: the term “nmol” is misspelled in the last line. Appropriate correction is required.
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 35-36, 40-42, 49-50, and 52 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.
Claims 35 and 52 recite a concentration of 50 nmol, but 50 nmol is a unit of measure of an amount/quantity of 50 nanomoles, whereas concentration is a unit of measure of an amount in relation to another amount/mass/volume, such as nmol/L or nmol/kg, etc. As such, the recitation is unclear and renders the claims indefinite. For purposes of compact prosecution, such recitation is interpreted herein as an amount/quantity of 50 nmol. Dependent claims 36, 40-42, and 49-50 are rejected as depending upon claims 35 and 52 without remedying such deficiency.
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.
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, 41-42, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over 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).
Although Cole et al. does not disclose the claimed concentration (i.e., amount) of 50 nmol, 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 optimize antibacterial effectiveness by varying the amount/concentration of GUMBO in the composition of Cole et al. as discussed above through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Cole et al. teaches that such GUMBOs modulate bacteria proliferation, and thus are active agents/antibiotics, and therefore are result-effective variables, and given that it is obvious to optimize amounts of active ingredient. See, e.g., Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'"); Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"). Moreover, differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical, per MPEP 2144.05(II), which is not present here.
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(s) 35-36, 40-42, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. as applied to claims 35-36, 41-42, and 50 above, and further in view of Zhang (US 2009/0156518 A1; published 18 June 2009; of record).
Cole et al. is relied upon as discussed above.
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; of record).
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).
Although Giordano does not disclose the claimed concentration (i.e., amount) of 50 nmol, 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 optimize antibacterial and antiseptic effectiveness by varying the amount/concentration of carbenicillin and octenidine in the composition of Giordano as discussed above through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Giordano teaches that such carbenicillin and octenidine are antibacterial and antiseptic, and thus are active agents/antibacterials/antiseptics, and therefore are result-effective variables, and given that it is obvious to optimize amounts of active ingredient. See, e.g., Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'"); Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"). Moreover, differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical, per MPEP 2144.05(II), which is not present here.
Response to Arguments
Applicant's arguments regarding prior art rejections filed 31 July 2026 have been fully considered but they are not persuasive.
Applicant argues that the references do not teach the claimed concentration of 50 nmol (remarks page 6). In response, such amount/concentration of active agent would have been obvious given that it is a result effective variable as discussed above.
Applicant argues that the cited prior art is silent on N. gonorrhoeae, and Zhang is silent on reacted ion pairs (remarks pages 6-7). In response, such claimed recitation of N. gonorrhoeae is a recited property, and the composition of Cole et al. as discussed above is presumed to inherently exhibit such property 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). Moreover, Cole et al. is cited for GUMBOs (i.e., reacted ion pairs), and motivation to combine and expectation of success reasoning is discussed in the rejection.
Applicant argues that there is a long-felt need for gonorrhea medications (remarks pages 6-7). In response, a copy of the cited CDC paper has not been provided to be placed in the record to be considered, and long-felt need is measured from the date a problem is identified and efforts are made to solve it per MPEP 716.04, yet evidence documenting such is not in the record. Moreover, the need must not have been solved by others per MPEP 716.04, yet applicant acknowledges that cephalosporins do treat gonorrhea (remarks page 7), and thus the problem of gonorrhea treatment does not appear to be unsolved.
Applicant argues that applicant has shown unexpected results (remarks pages 7-9). In response, as noted previously, 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.
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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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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