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 of the Claims
Claims 8, 10-15, 17, and 33-34 are pending.
Claim 8 is amended.
Claim 34 is new.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a DIV of application number 16/086,461, filed 09/19/2018, which is a national stage entry of and claims priority to Application Serial No. PCT/EP2017/057137, filed 03/24/2017; and further claims priority to Provisional Patent Application number 62/312,985 filed on 3/24/2016.
Information Disclosure Statement
All references from IDS(s) received 01/04/2022 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant’s arguments filed 3/30/2026, with respect to the rejections of claims 1, 3, 8, 10-15, 17, and 33 under 35 U.S.C. 103 and nonstatutory double patenting have been fully considered and are found not persuasive.
Claim 8 has been amended to recite:
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With respect to the 103 rejection, the Applicant argues that Chapman does not teach an overlapping method for detaching a tick from skin using nootkatone because Chapman teaches that after application of the citrus peel oil, the method requires removal of the tick using tweezers. The Examiner understands this argument as using the tweezers is considered mechanical removal and mechanical removal of a tick is referred to in the Specification as often resulting in leaving some portion of the tick embedded in the skin, increasing the chances of a bacterial infection. However, it is the Examiner’s understanding that this is mechanical removal of a tick without chemical intervention beforehand. Chemical intervention includes killing the tick (using nootkatone as an insecticide as taught by Goldblum) or treatment with a composition that would result in withdrawal of the ticks hypostome from the skin of the host. Since Chapman does teach chemical intervention before the use of the tweezers, it’s the Examiners understanding that it would not result in the complications from solely mechanical removal because the chemical intervention from the prior art would also lead to the tick hypostome to retract/”detach” from the host. The Examiner notes that the newest amendments to claim 8 are significant improvements to the claim and the issue lies with the word “detachment”. The Examiner requests an affidavit from the Applicant discussing that the instant method results in the hypostome removal of the tick from the skin while the prior art methods do not explicitly have this limitation. The Examiner believes this would help clarify on the record any discrepancies between definitions of tick “detachment” between the instant application and the prior art and would place the application in better condition for allowance. Therefore, the 103 rejection is maintained.
Further, the Applicant maintains the argument that Chapman does not teach nootkatone at all. The Examiner maintains her argument that Chapman teaches grapefruit oil, which contains nootkatone. Therefore, Chapman does teach nootkatone. The Examiner understands the argument that Chapmans reasoning for why the oil detaches the tick from skin is different than the instant application. However, Behle not only teaches that nootkatone is a component of grapefruit oil, it teaches that it is part of why grapefruit oil is toxic to disease-vectoring ticks (abstract). The Applicant argues against this point specifically saying that Behle fails to teach that grapefruit oil is toxic to ticks. The Examiner argues that Chapman teaches citrus oil as toxic to ticks, Behle teaches nootkatone is a component in that oil, and the nexus is the teaching of Goldblum that nootkatone is toxic to ticks. However, the Examiner believes the amendments to the claims help set apart the instant application from the prior as discussed above. Therefore, for the remainder of the arguments the Examiners reiterates that an affidavit would help clarify the record and set the instant application apart from the prior art.
With respect to the double patenting rejection, the Applicant argues that the ‘459 patent is directed towards a method of treating a sap-sucking infestation on a plant and not on human skin. The Examiner understands the point of the Applicant, however the Examiner points to MPEP 2144.09. Since the compositions of the instant claims and the claims of the ‘459 patent are the same, the rejection is based on the expectation that compounds/compositions similar in structure will have similar properties. Further, Schnieder teaches a method of detaching ticks from a mammal, including humans. Therefore, it would be obvious to substitute the patient population since nootkatone is known to be used in a human patient population for detaching ticks. Therefore, the double patenting rejection is maintained. However, for the same reasons as above, the double patenting rejection is maintained as the concept of detachment should be clarified through affidavit.
NEW/MAINTAINED REJECTIONS
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.
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 8, 10-15, 17, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Chapman, C. et al. (US5317041A; cited in IDS filed 1/04/2022; “Chapman”) in view of Goldblum, S. et al. (WO2014031790A1; cited in IDS filed 1/4/2022; “Goldblum”) and Schneider, L. (US5414014A; 1993; “Schneider”) as evidenced by Behle, R. et al. (J Med Entomol, 2011, 48(6):1120-7; cited in IDS filed 1/04/2022; “Behle”) and Krugener, S. et al. (Bioresource Technology 101 (2010) 457-462; “Krugener” and Furusawa, M. et al. (Chem Pharm Bull (Tokyo). 2005 Nov;53(11):1513-4; “Furusawa”).
Chapman teaches a method of using citrus peel oil to remove attached ticks from human and animal hosts (Claim 1). Chapman does not explicitly teach the use of nootkatone, however, Chapman does teach grapefruit oil as an option of citrus peel oil. As evidenced by Behle, nootkatone is a component of grapefruit oil that is toxic to the disease-vectoring tick (Abstract). Therefore, through broadest reasonable interpretation, the method described by Chapman would include nootkatone. Nootkatone ex valence is a type of nootkatone molecule, that is formed from different types of derivation process. The limitation of specifying nootkatone ex valence is a product-by-process limitation and that the molecule of nootkatone, no matter what process leads to its derivation, would fall under the category of nootkatone, synthetic, or not.
With respect to instant claims 8 and 10, Chapman teaches a method of applying nootkatone (by way of grapefruit oil) to human skin or animal hide for the removal of attached ticks (Claim 1).
With respect to instant claims 11-13, Chapman teaches the composition to comprise a carrier, such as an oil or isopropyl alcohol, as well as further comprising an oil solubilizer (aka emulsifier) (Claim 1).
Chapman and Behle fail to teach the use of nootkatone ex valencene that is limonene and bergapten-free.
Goldblum teaches an insect repellant comprising greater than 10% nootkatone including a carrier, such as water or ethanol, as required by instant claim 33, for applying to an animal or surface (Claim 1), as required by instant claim 1. Goldblum teaches the nootkatone can be used for the repellant of a tick. Goldblum does not explicitly claim the nootkatone is nootkatone ex valencene that is limonene and bergapten-free. However, Goldblum does teach that the nootkatone is derived from valencene (Detailed description, Section C), implying that it is nootkatone ex valencene. With respect to the limonene and bergapten-free, Goldblum teaches the compounds are obtained from the following vendors: Sigma- Aldrich (Product No. 74437 or Product No. 93785; St. Louis, Mo.); Aromor Flavors & Fragrances Ltd. (Code No. 4101 ; Israel); and Bedoukian Research, Inc. (Product No. 800; Danbury, CT).None of these products indicate the presence of limonene or bergapten and for example, the product of Sigma Aldrich (74437) is reported to have over 99% purity, indicating there could not be more than 1% of any impurity, including limonene or bergapten. Further, Goldblum primarily uses nootkatone from Bedoukian Research In (Product No. 800) and that this product is only 86+% nootkatone and described as “Nature Identical.” For nootkatone to be derived from ex valencene or to even be considered “natural,” it would not contain limonene or bergapten because these are not byproducts from the synthesis of nootkatone, rather they are byproducts when extracted from grapefruit oil (see Krugener and Furusawa below for examples of Examiner’s reasoning.)
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Therefore, Goldblum teaches nootkatone that is limonene and bergapten-free because it primarily uses “nature identical” nootkatone in its examples.
Therefore, it would be obvious to a person skilled in the art to use any type of nootkatone, including nootkatone ex valencene as taught by Goldblum, and apply it to the methods of detaching ticks, as taught by Chapman.
With respect to instant claims 14-15, Chapman teaches the composition comprising at least 25% citrus peel oil, 15% carrier fluid, and 10% oil solubilizer (Claim 1). Although not exactly the same, these ranges fall within the ranges required by instant claims 14-15, and therefore are taught by Chapman. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to instant claim 17, Chapman fails to explicitly teach a composition comprising an additive, such as an analgesic or antibiotic. However, Schneider teaches a method for removing attached sucking arthropods (including the tick) through a topical composition comprising a primary anesthetic, as well as an effective amount of antibiotic (Claim 1).
Therefore, with respect to instant claim 17, it would have been obvious to one skilled in the art at the time to take a known method of removing a tick through the use of nootkatone composition and enhance the composition using additives as known for removing attached ticks, such as antibiotics in order to reduce pain and/or reduce potential infection in a patient.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the method of removing attached ticks from skin using a nootkatone composition, as taught by Champan, and substitute the type of nootkatone for nootkatone ex valencene, as taught by Goldblum.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of removing attached ticks from skin using a nootkatone composition (by way of grapefruit oil), as taught by Chapman, and incorporate other active ingredients, such as antibiotics, that are known for the removal of attached ticks, as taught by Schneider. Further, it would have been obvious to optimize the concentration of the contents in the composition through routine optimization.
Therefore, claims 8, 10-15, 17, and 33 would have been obvious to a person skilled in the art at the time.
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, 10-15, 17, and 33-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. US11737459B2 in view of Schneider, L. (US5414014A; 1993; “Schneider”).
The claims of the ‘459 patent recite a method of treating a sap-sucking infestation with a nootkatone-composition that comprises 0.1-10% nootkatone ex valence that is limonene and bergapten-free (Claim 1), as required by the instant claims 8, 14 , and 15.
The claims of the ‘459 patent recite the composition for topical administration to skin (Claim 1), as required by instant claims 3 and 8, as well as the composition being in an aerosol (Claim 2), as required by instant claim 10.
The claims of the ‘459 patent recite the composition contains a from 90-99% of a carrier, including water (Claims 9 and 11), as required by instant claims 11 and 12.
The claims of the ‘459 patent fail to recite the composition comprising an additional additive such as an antibiotic, as required by instant claims 13 and 17.
However, Schneider teaches a method for removing attached sucking arthropods (including the tick) through a topical composition comprising a primary anesthetic, as well as an effective amount of antibiotic (Claim 1).
Therefore, with respect to instant claims 13 and 17, it would have been obvious to one skilled in the art at the time to take a known method of removing a tick through the use of nootkatone composition and enhance the composition using additives as known for removing attached ticks, such as antibiotics in order to reduce pain and/or reduce potential infection in a patient.
Although the ‘459 patent is directed towards a method of treating a sap-sucking infestation on a plant and not on human skin, however since the compositions of the instant claims and the claims of the ‘459 patent are the same, the rejection is based on the expectation that compounds/compositions similar in structure will have similar properties (See MPEP 2144.09(I)). Further, Schnieder teaches a method of detaching ticks from a mammal, including humans. Therefore, it would be obvious to substitute the patient population since nootkatone is known to be used in a human patient population for detaching ticks.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the methods of using nootkatone ex valencene to treat a sap-sucking infestation, as taught by the ‘459 patent, and incorporate other active ingredients, such as antibiotics, that are known for the removal of attached ticks, as taught by Schneider. Further, it would have been obvious to optimize the concentration of the contents in the composition through routine optimization.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the method of using nootkatone ex valencene to treat a sap-sucking infestation, as taught by the ‘459 patent, and substitute the patient population from plants to mammals, such as humans. A person would be motivated to do so because the prior art teaches nootkatone for removing attached ticks from mammal skin, and therefore would have the expectation that compounds/compositions similar in structure will have similar properties (See MPEP 2144.09(I)).
Therefore, claims 8, 10-15, and 17 would have been obvious to a person skilled in the art at the time.
Conclusion
Claims 8, 10-15, 17, and 33-34 are rejected.
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 NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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