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 .
Applicant's election with traverse of Group I, claim 1-5, in the reply filed on 07/20/2026 is acknowledged. The traversal is on the ground(s) that all claims may be examined without undue burden to the Examiner. Additionally, Applicants assert Groups I and II are linked to form a single general inventive concept. This is not found persuasive because a search burden is not a requirement under 371 practice and while the groups share the technical feature of the antimicrobial system comprising gramine and harmol, the shared technical feature is not a special technical feature as it does not make a contribution over the prior art, as previously discussed, and unity is broken.
The requirement is still deemed proper and is therefore made FINAL.
Claim 6-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/20/2026.
Claim Status
Claims 1-14 are pending.
Claims 6-14 are withdrawn.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is less than 50 words in length and refers to the purported merits of providing superior antimicrobial benefits. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: the period “.” at the end of line 4 should be replaced with a semicolon “;”. Appropriate correction is required.
Claims 3, 4, and 5, are objected to because of the following informalities: a comma “,” is missing following “claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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.
Claim 5 is 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.
The claim recites “wherein from 1 to 80% by weight of the antimicrobial system is indole alkaloid based on the total weight of the indole alkaloid including any salts thereof and beta carboline alkaloid,” and it is unclear if the percent by weight of the indole is based on the total weight of the antimicrobial system, or if the percent by weight of the indole alkaloid is based on the total combined weight of the combination of the indole alkaloid and the beta carboline alkaloid, where both appear to be recited. The two recitations appear to be different where the antimicrobial system uses the open language comprising and may comprise additional unrecited components other than the indole alkaloid and beta carboline alkaloid. For purposes of examination, the limitation will be interpreted as wherein the antimicrobial system comprises 1 to 80% by weight of the indole alkaloid or a salt thereof, wherein the percentage is based on the total combined weight of the indole alkaloid or a salt thereof, and the beta carboline alkaloid.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mookerjee et al (US 20080194518 A1, hereinafter “Mookerjee”), in view of Vega et al (Industrial Crops and Products, 1996, 5, pp. 141-148, hereinafter “Vega,” cited on IDS dated 11/07/2024) and Ahmad et al (Jour Ethnopharmacology, 1992, 35, pp. 289-294, hereinafter “Ahmad”).
Mookerjee teaches antimicrobial compositions including a synergistic combination of three or more agents as an active ingredient, and are selected from plant derived oils, alkaloids, phenols, etc. (abs, ¶¶ 40, 68, claim 1). In embodiments, the phenol is selected from thymol (¶¶ 44, 78, claim 13). The antimicrobial compositions have a wide range of antimicrobial effectiveness, and are effective against gram-negative and gram-positive bacteria, including, but not limited to, Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherischia coli and Staphylococcus aureus (¶¶ 66, 106). Each active agent can be included in an amount as little as 0.000039%, or the combination can be 100% active agents (¶ 113). The antimicrobial compositions can be diluted using excipients or dilutants (¶ 113).
Mookerjee does not specifically teach gramine or harmol.
Vega teaches gramine (1-(1H-indol-3-yl)-N,N-dimethylmethanamine, see pg 6 of the instant specification) was a known alkaloid with bactericidal and fungicidal activity (i.e., antimicrobial) against Pseudomonas, etc. (abs, tables 3, 4). Against some bacteria species, the total inhibition occurred between 10 and 15 mM, and against others with higher resistance, total inhibition was not reached until 25 mM (pg 147 1st col last ¶).
Vega does not teach harmol.
Ahmad teaches harmol was a known alkaloid with antimicrobial activity against gram negative bacteria, gram positive bacteria, fungi, and dermatophytes (pg 289 2nd col 1st ¶, pg 290 figure, tables 1, 2). Harmol was shown to have antimicrobial activity against Staphylococcus aureus, Streptococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, etc. (table 1). The minimal inhibitory concentration varied based on the bacteria or fungi to be treated (tables 1, 2).
Regarding claims 1 and 3, where Mookerjee teaches antimicrobial compositions comprising a combination of antibacterial agents, including alkaloids, with synergistic activity and a wide range of antimicrobial effectiveness, it would have been obvious to modify the antimicrobial composition of Mookerjee by selecting from known alkaloids with antimicrobial activity against overlapping gram-negative and gram-positive bacterial species, including gramine as taught by Vega, and harmol as taught by Ahmad.
Regarding claim 2, it would have been obvious to further include thymol, a suitable active agent that can be used in combination with other antimicrobial agents, including alkaloids, as taught by Mookerjee.
Regarding claim 4, where Mookerjee teaches the amount of each active agent can vary, and Vega and Ahmad respectively teach the concentration of gramine and harmol can vary based on the desired bacteria to be inhibited, it would have been well within the relative skills of the skilled artisan to have routinely optimized the weight ratios between gramine and harmol, where each have antibacterial activity against overlapping, as well as different bacterial species, in order to achieve optimal bacterial inhibition for the desired bacteria. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding claim 5, where Mookerjee teaches each active agent can be included in an amount as little as 0.000039%, or the combination can be 100% active agents, it would have been obvious to formulate gramine and harmol within the ranges disclosed by Mookerjee, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the amount of gramine and harmol based on the desired antimicrobial activity and intended use of the antimicrobial composition, where Vega and Ahmad teaches the concentrations of each vary depending on the desired bacteria to be inhibited. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
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 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/722,521 (reference application), hereinafter ‘521, in view of Mookerjee et al (US 20080194518 A1, hereinafter “Mookerjee”) and Vega et al (Industrial Crops and Products, 1996, 5, pp. 141-148, hereinafter “Vega,” cited on IDS dated 11/07/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘521 disclose an antimicrobial system comprising a first component comprising 1-methyl-9H-pyrido[3,4-b]indol-7-ol (i.e., harmol) and a second component comprising a phenolic compound. The weight ratio of the first a second component is 0.75:8 to 0.75:48.
The claims of ‘521 do not disclose gramine, the components of claim 2, the weight ratio of gramine to harmol of claim 4, nor from 1-80 wt% of gramine based on the total weight of the combined gramine and harmol of claim 5.
Mookerjee and Vega are discussed above.
Regarding gramine, it would have been obvious to modify the antimicrobial system of ‘521 by including other known antimicrobial alkaloids, including gramine, as taught by Vega, in order to achieve desired antimicrobial properties. Further, the skilled artisan would have a reasonable expectation of success in adding an additional alkaloid where Mookerjee appears to teach more than one alkaloid can be used in combination in antimicrobial compositions
Regarding the components of claim 2, it would have been obvious to modify ‘521 by including thymol, a known antimicrobial agent suitable for antimicrobial compositions, as taught by Mookerjee, in order to broaden the spectrum of antibacterial effects and achieve desired antibacterial properties.
Regarding the ratio, where the claims of ‘521 disclose the first and second antimicrobial agents have a weight ratio of 0.75:8 to 0.75:48, and where the skilled artisan would recognize that the amount of gramine and harmol can vary based on the desired bacteria to be treated, it would have been well within the relative skills of the skilled artisan to have routinely optimized the weight ratios between gramine and harmol, where each have antibacterial activity against overlapping, as well as different bacterial species, in order to achieve optimal bacterial inhibition for the desired bacteria in need of inhibition. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding the wt% of gramine and harmol, where Mookerjee teaches it was known to formulate antibacterial compositions wherein each active agent can be included in an amount as little as 0.000039%, or the combination can be 100% active agents, and/or the composition can be diluted, it would have been obvious to formulate gramine and harmol in the system made obvious above within the ranges disclosed by Mookerjee, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the amount of gramine and harmol based on the desired antimicrobial activity and intended use of the antimicrobial composition, where Vega teaches the concentrations vary depending on the desired bacteria to be inhibited. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/722,518 (reference application), hereinafter ‘518, in view of Mookerjee et al (US 20080194518 A1, hereinafter “Mookerjee”) and Ahmad et al (Jour Ethnopharmacology, 1992, 35, pp. 289-294, hereinafter “Ahmad”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘518 disclose an antimicrobial system comprising a first component comprising 1-(1H-Indol-3-yl)-N,N-dimethylmethanamine (i.e., gramine) and a second component comprising a phenolic compound. The weight ratio of the first a second component is 0.5:9 to 2:10. The system comprises from 8-75 wt% of the indole alkaloid and the phenolic acid.
The claims of ‘518 do not disclose harmol, the components of claim 2, the weight ratio of gramine to harmol of claim 4, nor from 1-80 wt% of gramine based on the total weight of the combined gramine and harmol of claim 5.
Mookerjee and Ahmad are discussed above.
Regarding harmol, it would have been obvious to modify the antimicrobial system of ‘518 by including other known antimicrobial alkaloids, including harmol, as taught by Ahmad, in order to achieve desired antimicrobial properties. Further, the skilled artisan would have a reasonable expectation of success in adding an additional alkaloid where Mookerjee appears to teach more than one alkaloid can be used in combination in antimicrobial compositions
Regarding the components of claim 2, it would have been obvious to modify ‘518 by including thymol, a known antimicrobial agent suitable for antimicrobial compositions, as taught by Mookerjee, in order to broaden the spectrum of antibacterial effects and achieve desired antibacterial properties.
Regarding the ratio, where the claims of ‘518 disclose the first and second antimicrobial agents have a weight ratio of 0.5:9 to 2:10, and where the skilled artisan would recognize that the amount of gramine and harmol can vary based on the desired bacteria, etc., to be treated, it would have been well within the relative skills of the skilled artisan to have routinely optimized the weight ratios between gramine and harmol, where each have antibacterial activity against overlapping, as well as different bacterial species, in order to achieve optimal bacterial inhibition for the desired bacteria in need of inhibition. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding the wt% of gramine and harmol, where the claims of ‘518 disclose gramine 8-75 wt% based on the combined weight of gramine and the second agent, and where Mookerjee teaches it was known to formulate antibacterial compositions wherein each active agent can be included in an amount as little as 0.000039%, or the combination can be 100% active agents, and/or the composition can be diluted, it would have been obvious to formulate gramine and harmol in the system made obvious above within the ranges disclosed by the claims of ‘518 and Mookerjee, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the amount of gramine and harmol based on the desired antimicrobial activity and intended use of the antimicrobial composition, where Ahmad teaches the concentrations vary depending on the desired bacteria to be inhibited. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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