DETAILED ACTION
Notice of 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 of the Claims
The amendments filed 7/28/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 7/28/2025, have been fully considered.
As noted by Applicant, “[c]laim 20 is amended to further recite that the composition further includes a citrate component” (Applicant Arguments, Page 6).
The rejection has been modified to address this limitation.
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 20 is rejected under 35 U.S.C. 103(a) as being unpatentable over Ahila Devi et al (J Biopest 6(2):231-236, 2013; of record) in view of Chethana et al (Pest Management in Horticultural Ecosystems 18(2):194-198, 2012 – Abstract only; of record), Wagh et al (J Pure and Applied Microbiol 11(3):1589-1598, 2017; of record), Vismaya et al (Industrial Crops and Products 32:118-112, 2010; of record), Saad et al (Middle East J of Agricultural Research 3(2):123-134, 2014; of record), Hai et al (Mediators of Inflammation Vol. 2019:9 pages, published 1/27/2019; of record), Crudden (US 2008/0292723), Horst et al (US 2004/0167220) and Wachtler et al (US 2019/0008147).
As amended, claim 20 is drawn to an antifungal composition comprising:
(a) aqueous Hibiscus leaf extracts in a concentration ranging from 2% to 30% w/v;
(b) Karanja oil (aka pongamia oil) in a concentration ranging from 1% to 5% w/v;
wherein said Karanja oil comprises Karanjin in a concentration ranging from 0.01 to 3.0% w/v of said composition;
(c) fermented aloe vera extracts in an amount ranging from 2 to 20% w/v; and
(d) a citrate component (e.g., citric acid, zinc citrate, etc.) in an amount ranging from 2 to 20% w/v.
Ahila Devi et al teach the “[a]ntifungal activity of plant extracts against Alternaria helianthi” (Title). In particular, as demonstrated by Table 1 (Page 233), “plant leaf extracts” from Hibiscus canabinus (“used at 10 percent concentration” (Page 232, Column 1)) inhibited mycelial growth, sporulation and spore germination by 27.63%, 11.29% and 15.85%, respectively.
As such, Ahila Devi et al specifically teach a composition comprising aqueous Hibiscus leaf extracts in a concentration ranging from 2% to 30% w/v.
However, Ahila Devi et al do not further teach:
(i) the inclusion of Karanja oil (aka pongamia oil) in a concentration ranging from 1% to 5% w/v, wherein said Karanja oil comprises Karanjin in a concentration ranging from 0.01 to 3% w/v of said composition;
(ii) the inclusion of fermented aloe vera extracts in an amount ranging from 2 to 20% wt/v; or
(iii) the inclusion of a citrate component (e.g., citric acid) in an amount ranging from 2 to 20% w/v.
Yet, as to (i): as further taught by Ahila Devi et al, similar to Hibiscus leaf extracts, “leaf extracts of… Pongamia glabra… inhibited the spore germination, mycelia growth, and spore production of A. helianthi” (Page 234, Column 2).
Additionally, as taught by Chethana et al, “pongamia oil (20%) caused… 69.94 percent inhibition” of Alternaria porri mycelial growth” (Abstract).
And, as taught by Wagh et al, aqueous extracts of Karanja leaf/bulb/rhizome (at 10%, 15% and 20% (Page 1591, Column 1)) “decreased drastically” radial mycelial growth of Alternaria carthami (Page 1595, Column 2; see also Page 1593, Table 4), further noting that other agents which “significantly inhibited mycelial growth of A. carthami” similarly “inhibited mycelial growth of… A. helianthi infecting sunflower” (Pages 1591-1592).
Accordingly, in further view of:
Ahila Devi et al (which specifically teach that “leaf extracts of… Pongamia glabra… inhibited the spore germination, mycelia growth, and spore production of A. helianthi”);
Chethana et al (which teach that “pongamia oil (20%) caused… 69.94 percent inhibition” of Alternaria porri mycelial growth); and
Wagh et al (which teach that aqueous extracts of Karanja leaf/bulb/rhizome “decreased drastically” radial mycelial growth of Alternaria carthami, and other agents which inhibit mycelial growth in Alternaria carthami similarly inhibit mycelial growth of Alternaria helianthi);
the ordinarily skilled would have reasonably predicted that pongamia oil would inhibit Alternaria spp. – in particular, Alternaria helianthi – mycelial growth, sporulation and spore germination, similar to Hibiscus canabinus.
Accordinglyl, it would have been prima facie obvious to further include Karanja oil (aka pongamia oil) in the Hibiscus canabinus (10% w/v) composition of Ahila Devi et al. As stated in MPEP 2144.06, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846 (CCPA 1980).
Furthermore, in doing so, it would have been obvious to determine the optimal amount of Karanja oil (aka pongamia oil) to include. As stated by MPEP 2144.05, “[g]enerally, 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” (see also In re Aller (220 F.2d 454 (CCPA): “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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the concentration of Karanja extract in an antifungal composition is clearly a result-effective variable as demonstrated by Wagh et al (Page 1593, Table 4). Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal concentration Karanja oil (aka pongamia oil) to include in the composition in order to best achieve the desired results.
And, as taught by Vismaya et al, the amount of Karanjin in pongamia oil is about 5.43% (Page 119, Table 1), which amounts to about 0.2715% w/v of the total composition, wherein the composition comprises 5% w/v pongamia oil.
As to (ii): as further taught by Ahila Devi et al, similar to Hibiscus leaf extracts, “plant leaf extracts” from Aloe vera (“used at 10 percent concentration” (Page 232, Column 1)) inhibited Alternaria helianthi mycelial growth, sporulation and spore germination by 74.19%, 81.00% and 52.07%, respectively (Page 233, Table 1).
Accordingly, it would have also been obvious to include Aloe vera extracts in the composition of Ahila Devi et al. As stated in MPEP 2144.06, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846 (CCPA 1980).
And, in doing so, it would have been obvious to determine the optimal amount of Aloe vera extract to include. As stated by MPEP 2144.05, “[g]enerally, 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” (see also In re Aller (220 F.2d 454 (CCPA): “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…”. Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
However, the prior art do not teach the inclusion of fermented Aloe vera extracts.
Yet, as taught by Saad et al, some antioxidants exhibit antifungal activity against Alternaria. Indeed, “all the treatments significantly reduced the growth of… tested fungi compared to control” (Abstract).
And, as taught by Hai et al, “Aloe vera fermentation had significantly enhanced” antioxidative activity (Page 3, Column 1).
Accordingly, based further on Saad et al and Hai et al, it would have been obvious to specifically utilize fermented Aloe vera extracts in the prima facie obvious compositions comprising aqueous Hibiscus leaf extracts and Karanja oil (aka pongamia oil). It would have been obvious to do so to increase the antioxidative activity in the Aloe vera extracts, in the expectation said increased antioxidant activity would enhance the fungicidal activity of the Aloe vera extracts.
And, as to (iii): As taught by Crudden, “compositions… comprising metal-acid solutions” (Abstract), wherein “[e]xemplary acids include… citric acid” (Paragraph 0036), exhibit “improved bioactivity” (Abstract) and find use against “Alternaria leaf blight, Alternaria leaf spot” and so on (Paragraph 0082). Specifically, Crudden demonstrates that compositions comprising “16% aqueous citric acid solution having dissolved therein silver citrate, copper citrate, and zinc citrate” (Paragraph 0146) reduced Alternaria leaf spot by up to 80% (Paragraph 0148; see also Table 21).
As similarly taught by Horst et al, “preservatives have long been used to prevent growth of stray… fungi and other pathogens” (Paragraph 0005). Specifically, Horst et al demonstrate that Alternaria solani “mycelial growth was completely inhibited” when treated with potassium sorbate and citric acid (Paragraph 0036).
And, as taught by Wachtler et al, “biocidal active substances having good antimicrobial activity against material-destroying bacteria, molds and yeasts are organic acids such as… citric acid” (Paragraph 0003). Specifically, Wachtler et al demonstrate that combining citric acid with a known anti-fungal agent provided synergistic anti-fungal activity against Alternaria alternata (Paragraph 0132; see also Table 2) and can be used against Alternaria in general (Paragraph 0117).
Accordingly, it would have also been obvious to further include, at minimum, citric acid (in an amount of about 16% w/v) in the composition of Ahila Devi et al. As stated in MPEP 2144.06, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846 (CCPA 1980).
For all the foregoing reasons, claim 20 is rejected as prima facie obvious.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/006,701 in view of Crudden (US 2008/0292723), Horst et al (US 2004/0167220) and Wachtler et al (US 2019/0008147).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘701 claims are similarly drawn to an antifungal composition comprising a natural surfactant (wherein, as stated by the Specification, “the surfactant is a naturally occurring surfactant. Preferably, it is a hibiscus leaf extract” (Paragraph 0020)), Karanj oil, and fermented aloe vera extracts.
It would have been obvious to further include a citrate component (e.g., citric acid, zinc citrate, etc.) in the claimed amount in view of Crudden, Horst et al and Wachtler et al as discussed above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/006,717 in view of Crudden (US 2008/0292723), Horst et al (US 2004/0167220) and Wachtler et al (US 2019/0008147).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘717 claims are similarly drawn to an antifungal composition comprising a natural surfactant (wherein, as stated by the Specification, “the surfactant is a naturally occurring surfactant. Preferably, it is a hibiscus leaf extract” (Paragraph 0020)), Karanj oil, and fermented aloe vera extracts.
It would have been obvious to further include a citrate component (e.g., citric acid, zinc citrate, etc.) in the claimed amount in view of Crudden, Horst et al and Wachtler et al as discussed above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. 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.
/CRAIG D RICCI/Primary Examiner, Art Unit 1611