DETAILED ACTION
Claims 1, 6-10, and 20-32 are pending and under consideration on the merits.
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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 5/4/2026 has been entered.
Status of the Rejections
The 112(b) rejection is withdrawn in view of the amendment, but a new rejection was added as detailed below.
The 103 rejections are revised in view of the amendment.
The double patenting rejections are maintained.
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 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 7 recites that when the azoxystrobin concentration is at about 0.5 to about 10%, there is a greater than about 95% fungal reduction, but base claim 1 as amended recites that the azoxystrobin concentration is about 0.25% to about 0.5%. How can the composition of claim 7 have the fungal reduction recited by claim 7 when at an azoxystrobin concentration of 10%, when a concentration of 10% is excluded by the range of base claim 1? Clarification is required.
Claim 8 recites that when the azoxystrobin concentration is at 1%, there is a greater than about 95% fungal reduction, but base claim 1 as amended recites that the azoxystrobin concentration is about 0.25% to about 0.5%. How can the composition of claim 8 have the fungal reduction recited by claim 8 when at an azoxystrobin concentration of 1%, when a concentration of 1% is excluded by the range of base claim 1? Clarification is required.
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.
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.
Claims 1, 6-10, 20-23, and 25-32 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (US Pat. Pub. 2017/0135932) in view of of Kitko et al. (US Pat. Pub. 2009/0155383) and Anwar et al. (International Journal of Nanomedicine 2016:11 147-161).
As to claims 1, 6-10, 20-23, and 25-32, Schwartz discloses a personal care composition for the hair (paragraph 9) that comprises an anti-dandruff active such as azoxystrobin (paragraph 61).
Regarding claims 10 and 20-23, the composition may be a shampoo or conditioner and may be a leave on treatment or a rinse off composition and may be in the form of a gel, foam, or mousse (paragraph 72).
As to claim 25, the shampoo of Schwartz is viewed as capable of use as a cleansing body wash or liquid hand wash.
As to claims 26-27, the composition may further comprise an anionic, amphoteric, or zwitterionic surfactant (paragraphs 74-82).
Regarding claims 28-29, the composition may comprise a Triquat cationic polymer (paragraph 127).
As to claims 30-31, the composition may comprise a silicone conditioning agent (paragraph 117).
Regarding claim 32, the composition may comprise a perfume (see, e.g., paragraph 125).
As to claims 1, 6-10, 20-23, and 25-32, Schwartz does not further expressly disclose the amount of azoxystrobin or the particle size of the azoxystrobin as recited by claim 1 or of the perfume as recited by claim 32, nor the deposition properties recited by claim 1, the fungal reduction amounts recited by claims 1 and 6-9, or the minimum inhibitory concentration against Malasezia recited by claim 10.
Kitko discloses personal care compositions that may comprise anti-dandruff actives (paragraphs 2 and 95) such as pyridinethione salts having a particle size of up to about 20 microns (paragraph 96) or selenium sulfide particles with a diameter of less than 15 microns (paragraph 100).
Anwar discloses the use of silver nanoparticles to treat dandruff on the scalp, and teaches that the potency of the particles was size-dependent, with 20 nm particles having higher potency than 50 nm particles (Abstract)
As to claims 1, 6-10, 20-23, and 25-32, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Schwartz composition by 1) selecting an amount of the azoxystrobin that is within the ranges of claim 1, because said amount is a result effective variable that will affect the anti-dandruff efficacy of the composition, and 2) selecting an azoxystrobin particle size within the recited ranges, since Anwar expressly discloses that the potency of an anti-dandruff active was found dependent upon the size of the particles of the active which establishes the particle size of an anti-dandruff active as a result effective variable and Kitko teaches an anti-dandruff personal care composition having selenium sulfide or pyridinethione salts as anti-dandruff actives and specifies different particle sizes depending upon the active thereby suggesting that different anti-dandruff actives may have different optimal particle sizes, which would have motivated the skilled artisan to undertake a routine optimization process to determine the appropriate particle size when azoxystrobin is used as the anti-dandruff active as in the Schwartz composition in order to maximize its potency, and using the ranges taught by Kitko as a starting point for the optimization. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 32, it further would have been prima facie obvious to by selecting an amount of the perfume that is within the recited range, because said amount is a result effective variable that will affect the overall sensory perception of the composition and therefore its attractiveness to the user. 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.
The resulting Schwartz composition as modified above will possess the functional deposition, antifungal efficacy as measured by fungal reduction, and minimum inhibitory concentration values recited by claims 1, 6-9, and 10, since it comprises the same ingredients in the same amounts recited by the claims, and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Claim 24 is rejected under 35 U.S.C. 103 as unpatentable over Schwartz et al. (US Pat. Pub. 2017/0135932) in view of of Kitko et al. (US Pat. Pub. 2009/0155383) and Anwar et al. (International Journal of Nanomedicine 2016:11 147-161) as applied to claims 1, 6-10, 20-23, and 25-32 above, and further in view of Edelson (US Pat. Pub. 2015/0313819).
The teachings of Schwartz, Kitko, and Anwar are relied upon as discussed above, but Schwartz does not further expressly disclose that the composition is in the form of a single unit dose.
Edelson discloses compositions for skin care, such as a shampoo (paragraphs 6 and 62). Edelson teaches that the composition may be packaged as a single unit dose (paragraphs 58-59).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the personal care composition of Schwartz, Kitko, and Anwar as combined supra by packaging it as a single unit dose as taught by Edelson, in order to obtain a formulation that is easy for the consumer to use without having to measure out an individual dose.
Response to Applicant’s Arguments
Applicant argues that the present amendment introduces a critical and nonobvious range for the azoxystrobin concentration of about 0.25-0.5 wt%. Applicant states that the cited art does not teach or suggest this concentration range in combination with the recited deposition and allegedly unexpectedly high antifungal efficacy achieved by the invention. Applicant asserts that the data in the specification showing that a 0.5% concentration showed better efficacy against fungal infection than 1% formulation (97% fungal reduction vs. 94.7% fungal reduction) is a counter intuitive and surprising result, and that by narrowing the concentration range in claim 1, the claims now are commensurate in scope with the allegedly unexpected result.
In response, whether unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110C and 130C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). MPEP 70602(d).
Here, claim 1 recites an azoxystrobin range of “from about .25% to about 0.5%,” while the allegedly unexpected results are shown only for a concentration of 0.5%. There is no evidence of record that the degree of antifungal activity obtained at a 0.5% concentration would still be present even if the amount of the azoxystrobin active was cut in half to 0.25%. In fact, claim 1 itself specifies only that the recited antifungal efficacy of a 0.5 % formulation is equal to that of a 1% formulation, leaving open the possibility that a 0.25% formulation within the scope of the claims needn’t possess the recited level of antifungal efficacy which forms the basis of Applicant’s argument that the claimed composition possesses unexpected results. Therefore, the results are still not commensurate in scope with the claims.
Regarding the particle size range, Applicant argues that the claimed range is a critical range for achieving maximum efficacy as predicted by a model, and that the combination of this range with the high fungal reduction achieved at lower concentrations is not taught or suggested by the cited art, such that arriving at the recited particle range is not routine optimization.
In response, evidence of unexpected results must compare the claimed invention with the closest prior art. MPEP 716.02(e). Here, the claims recite a particle size range of about 30-50 microns for the azoxystrobin, but the data on pages 24-25 of the specification nowhere discloses what the particle size of the azoxystrobin was in the tested composition. Therefore, it is not even possible to determine from the evidence of record that the tested composition was within the scope of the claims. Consequently, the data cannot be used to establish unexpected results of the claimed composition.
Additionally, and as affirmed by the PTAB at pages 8-9 of the Board decision, the existence of an optimal particle size is not an unexpected result in view of the prior art, which teaches that particle size of antidandruff agents is a result effective variable:
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For the foregoing reasons, the rejections are maintained.
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 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.
Claims 1 and 3, 6-10, and 20-32 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of copending Application No. 17/126,932 and in view of Schwartz et al. (US Pat. Pub. 2017/0135932), Edelson (US Pat. Pub. 2015/0313819, Anwar et al. (International Journal of Nanomedicine 2016:11 147-161) and/or Kitko et al. (US Pat. Pub. 2009/0155383) where indicated below.
This is a provisional nonstatutory double patenting rejection.
The teachings of Schwartz, Edelson, Anwar, and Kitko are relied upon as discussed above.
Although the reference claims are not identical, they are not patentably distinct because they recite a personal care composition comprising azoxystrobin having an MIC of less than 1 ppm against Malassezia, the composition being a shampoo, conditioner, or a leave on treatment, and which could also function as a body wash.
Although the reference claims do not recite the presence of a surfactant such as an amphoteric surfactant, a cationic polymer, a silicone conditioning agent, or a perfume, it would have been prima facie obvious to incorporate same in light of Schwartz, which teaches that it is advantageous to incorporate all of these ingredients into a shampoo composition comprising azoxystrobin.
Although the reference claims do not recite that the composition is a gel (claim 23), it would have been prima facie obvious to formulate the composition as a gel in light of Schwartz, which teaches that a gel is a suitable form for a personal care composition comprising azoxystrobin.
It further would have been prima facie obvious to select an amount of the perfume that is within the recited range, because said amount is a result effective variable that will affect the overall sensory perception of the composition and therefore its attractiveness to the user.
Although the reference claims do not recite amount of the azoxystrobin, it would have been prima facie obvious to select an amount of the azoxystrobin that is within the ranges of claims 1 and 3, because said amount is a result effective variable that will affect the anti-dandruff efficacy of the composition. 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. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite the particle size of the azoxystrobin, it would have been prima facie obvious to select an azoxystrobin particle size within the recited ranges, since Anwar expressly discloses that the potency of an anti-dandruff active was found dependent upon the size of the particles of the active which establishes the particle size of an anti-dandruff active as a result effective variable and Kitko teaches an anti-dandruff personal care composition having selenium sulfide or pyridinethione salts as anti-dandruff actives and specifies different particle sizes depending upon the active thereby suggesting that different anti-dandruff actives may have different optimal particle sizes, which would have motivated the skilled artisan to undertake a routine optimization process to determine the appropriate particle size when azoxystrobin is used as the anti-dandruff active, and using the ranges taught by Kitko as a starting point for the optimization. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a single unit dosage, it would have been prima facie obvious to formulate the composition as such as taught by Edelson, in order to obtain a formulation that is easy for the consumer to use without having to measure out an individual dose.
The resulting reference composition as modified above will possess the functional deposition, fungal reduction, and minimum inhibitory concentration values recited by claims 1, 6-9, and 10, since it comprises the same ingredients in the same amounts recited by the claims, and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Claims 1 and 3, 6-10, and 20-32 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of copending Application No. 17/126,393 and in view of Schwartz et al. (US Pat. Pub. 2017/0135932), Edelson (US Pat. Pub. 2015/0313819, Anwar et al. (International Journal of Nanomedicine 2016:11 147-161), and/or Kitko et al. (US Pat. Pub. 2009/0155383) where indicated below.
This is a provisional nonstatutory double patenting rejection.
The teachings of Schwartz, Edelson, Anwar, and Kitko are relied upon as discussed above.
Although the reference claims are not identical, they are not patentably distinct because they recite a personal care composition comprising 0.02- 10% azoxystrobin, the composition being a shampoo, conditioner, or a leave on treatment, and which could also function as a body wash, and further comprising a surfactant, a cationic polymer, a silicone conditioning agent, and a perfume in the amount of 7.5.
Although the reference claims do not specify the type of surfactant such as an amphoteric surfactant, it would have been prima facie obvious to incorporate same in light of Schwartz, which teaches that such a surfactant is suitable for use in a shampoo composition comprising azoxystrobin.
Although the reference claims do not recite that the composition is a gel (claim 23), it would have been prima facie obvious to formulate the composition as a gel in light of Schwartz, which teaches that a gel is a suitable form for a personal care composition comprising azoxystrobin.
Although the reference claims do not recite the particle size of the azoxystrobin, it would have been prima facie obvious to select an azoxystrobin particle size within the recited ranges, since Anwar expressly discloses that the potency of an anti-dandruff active was found dependent upon the size of the particles of the active which establishes the particle size of an anti-dandruff active as a result effective variable and Kitko teaches an anti-dandruff personal care composition having selenium sulfide or pyridinethione salts as anti-dandruff actives and specifies different particle sizes depending upon the active thereby suggesting that different anti-dandruff actives may have different optimal particle sizes, which would have motivated the skilled artisan to undertake a routine optimization process to determine the appropriate particle size when azoxystrobin is used as the anti-dandruff active, and using the ranges taught by Kitko as a starting point for the optimization. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a single unit dosage form, it would have been prima facie obvious to formulate the composition as such as taught by Edelson, in order to obtain a formulation that is easy for the consumer to use without having to measure out an individual dose.
The resulting reference composition as modified above will possess the functional deposition, fungal reduction, and minimum inhibitory concentration values recited by claims 1, 6-9, and 10, since it comprises the same ingredients in the same amounts recited by the claims, and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Claims 1 and 3, 6-10, and 20-32 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over all claims of copending Application No. 17/126,975 and in view of Schwartz et al. (US Pat. Pub. 2017/0135932), Edelson (US Pat. Pub. 2015/0313819, Anwar et al. (International Journal of Nanomedicine 2016:11 147-161), and/or Kitko et al. (US Pat. Pub. 2009/0155383) where indicated below.
This is a provisional nonstatutory double patenting rejection.
The teachings of Schwartz, Edelson, Anwar, and Kitko are relied upon as discussed above.
Although the reference claims are not identical, they are not patentably distinct because they recite the use of a personal care composition comprising azoxystrobin in the amount of 0.01-10 wt%, the composition being a shampoo, conditioner, or a leave on treatment, and which could also function as a body wash.
Although the reference claims do not recite the presence of a surfactant such as an amphoteric surfactant, a cationic polymer, a silicone conditioning agent, or a perfume, it would have been prima facie obvious to incorporate same in light of Schwartz, which teaches that it is advantageous to incorporate all of these ingredients into a shampoo composition comprising azoxystrobin.
It further would have been prima facie obvious to select an amount of the perfume that is within the recited range, because said amount is a result effective variable that will affect the overall sensory perception of the composition and therefore its attractiveness to the user.
Although the reference claims do not recite that the composition is a gel (claim 23), it would have been prima facie obvious to formulate the composition as a gel in light of Schwartz, which teaches that a gel is a suitable form for a personal care composition comprising azoxystrobin.
Although the reference claims do not recite the particle size of the azoxystrobin, it would have been prima facie obvious to select an azoxystrobin particle size within the recited ranges, since Anwar expressly discloses that the potency of an anti-dandruff active was found dependent upon the size of the particles of the active which establishes the particle size of an anti-dandruff active as a result effective variable and Kitko teaches an anti-dandruff personal care composition having selenium sulfide or pyridinethione salts as anti-dandruff actives and specifies different particle sizes depending upon the active thereby suggesting that different anti-dandruff actives may have different optimal particle sizes, which would have motivated the skilled artisan to undertake a routine optimization process to determine the appropriate particle size when azoxystrobin is used as the anti-dandruff active, and using the ranges taught by Kitko as a starting point for the optimization. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a silicone conditioner, it would have been prima facie obvious to incorporate same in light of Schwartz, which expressly suggests incorporating a silicone as a conditioner into a composition comprising azoxystrobin in order to form a hair care composition for treating dandruff.
Although the reference claims do not recite a single unit dosage, it would have been prima facie obvious to formulate the composition as such as taught by Edelson, in order to obtain a formulation that is easy for the consumer to use without having to measure out an individual dose.
The resulting reference composition as modified above will possess the functional deposition, fungal reduction, and minimum inhibitory concentration values recited by claims 1, 6-9, and 10, since it comprises the same ingredients in the same amounts recited by the claims, and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Claims 1 and 3, 6-10, and 20-32 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 11,701,316 and in view of Schwartz et al. (US Pat. Pub. 2017/0135932), Edelson (US Pat. Pub. 2015/0313819, Anwar et al. (International Journal of Nanomedicine 2016:11 147-161), and/or Kitko et al. (US Pat. Pub. 2009/0155383) where indicated below.
This is a provisional nonstatutory double patenting rejection.
The teachings of Schwartz, Edelson, Anwar, and Kitko are relied upon as discussed above.
Although the reference claims are not identical, they are not patentably distinct because they recite a personal care composition comprising a strobilurin such as azoxystrobin in the amount of 0.02-10 wt%, the composition being a shampoo, conditioner, or a leave on treatment, and which could also function as a body wash.
Although the reference claims do not recite the presence of a surfactant such as an amphoteric surfactant, a cationic polymer, a silicone conditioning agent, or a perfume, it would have been prima facie obvious to incorporate same in light of Schwartz, which teaches that it is advantageous to incorporate all of these ingredients into a shampoo composition comprising azoxystrobin.
It further would have been prima facie obvious to select an amount of the perfume that is within the recited range, because said amount is a result effective variable that will affect the overall sensory perception of the composition and therefore its attractiveness to the user.
Although the reference claims do not recite that the composition is a gel (claim 23), it would have been prima facie obvious to formulate the composition as a gel in light of Schwartz, which teaches that a gel is a suitable form for a personal care composition comprising azoxystrobin.
Although the reference claims do not recite the particle size of the azoxystrobin, it would have been prima facie obvious to select an azoxystrobin particle size within the recited ranges, since Anwar expressly discloses that the potency of an anti-dandruff active was found dependent upon the size of the particles of the active which establishes the particle size of an anti-dandruff active as a result effective variable and Kitko teaches an anti-dandruff personal care composition having selenium sulfide or pyridinethione salts as anti-dandruff actives and specifies different particle sizes depending upon the active thereby suggesting that different anti-dandruff actives may have different optimal particle sizes, which would have motivated the skilled artisan to undertake a routine optimization process to determine the appropriate particle size when azoxystrobin is used as the anti-dandruff active, and using the ranges taught by Kitko as a starting point for the optimization. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a silicone conditioner, it would have been prima facie obvious to incorporate same in light of Schwartz, which expressly suggests incorporating a silicone as a conditioner into a composition comprising azoxystrobin in order to form a hair care composition for treating dandruff.
Although the reference claims do not recite a single unit dosage, it would have been prima facie obvious to formulate the composition as such as taught by Edelson, in order to obtain a formulation that is easy for the consumer to use without having to measure out an individual dose.
The resulting reference composition as modified above will possess the functional deposition, fungal reduction, and minimum inhibitory concentration values recited by claims 1, 6-9, and 10, since it comprises the same ingredients in the same amounts recited by the claims, and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
Claims 1 and 3, 6-10, and 20-32 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of U.S. Pat. No. 11,980,612 and in view of Schwartz et al. (US Pat. Pub. 2017/0135932), Edelson (US Pat. Pub. 2015/0313819, Anwar et al. (International Journal of Nanomedicine 2016:11 147-161), and/or Kitko et al. (US Pat. Pub. 2009/0155383) where indicated below.
The teachings of Schwartz, Edelson, Anwar, and Kitko are relied upon as discussed above.
Although the reference claims are not identical, they are not patentably distinct because they recite a personal care composition comprising azoxystrobin, the composition being a shampoo, conditioner, or a leave on treatment, and which could also function as a body wash.
Although the reference claims do not recite the presence of a surfactant such as an amphoteric surfactant, a cationic polymer, a silicone conditioning agent, or a perfume, it would have been prima facie obvious to incorporate same in light of Schwartz, which teaches that it is advantageous to incorporate all of these ingredients into a shampoo composition comprising azoxystrobin.
It further would have been prima facie obvious to select an amount of the perfume that is within the recited range, because said amount is a result effective variable that will affect the overall sensory perception of the composition and therefore its attractiveness to the user.
Although the reference claims do not recite that the composition is a gel (claim 23), it would have been prima facie obvious to formulate the composition as a gel in light of Schwartz, which teaches that a gel is a suitable form for a personal care composition comprising azoxystrobin.
Although the reference claims do not recite the particle size of the azoxystrobin, it would have been prima facie obvious to select an azoxystrobin particle size within the recited ranges, since Anwar expressly discloses that the potency of an anti-dandruff active was found dependent upon the size of the particles of the active which establishes the particle size of an anti-dandruff active as a result effective variable and Kitko teaches an anti-dandruff personal care composition having selenium sulfide or pyridinethione salts as anti-dandruff actives and specifies different particle sizes depending upon the active thereby suggesting that different anti-dandruff actives may have different optimal particle sizes, which would have motivated the skilled artisan to undertake a routine optimization process to determine the appropriate particle size when azoxystrobin is used as the anti-dandruff active, and using the ranges taught by Kitko as a starting point for the optimization. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite the amount of the azoxystrobin, it would have been prima facie obvious to select an amount of the azoxystrobin that is within the ranges of claims 1-9, because said amount is a result effective variable that will affect the anti-dandruff efficacy of the composition. 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. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a silicone conditioner, it would have been prima facie obvious to incorporate same in light of Schwartz, which expressly suggests incorporating a silicone as a conditioner into a composition comprising azoxystrobin in order to form a hair care composition for treating dandruff.
Although the reference claims do not recite a single unit dosage, it would have been prima facie obvious to formulate the composition as such as taught by Edelson, in order to obtain a formulation that is easy for the consumer to use without having to measure out an individual dose.
The resulting reference composition as modified above will possess the functional deposition, fungal reduction, and minimum inhibitory concentration values recited by claims 1, 6-9, and 10, since it comprises the same ingredients in the same amounts recited by the claims, and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Claims 1 and 3, 6-10, and 20-32 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 11,433,070 and in view of Schwartz et al. (US Pat. Pub. 2017/0135932), Edelson (US Pat. Pub. 2015/0313819, Anwar et al. (International Journal of Nanomedicine 2016:11 147-161), and/or Kitko et al. (US Pat. Pub. 2009/0155383) where indicated below.
The teachings of Schwartz, Edelson, Anwar, and Kitko are relied upon as discussed above.
Although the reference claims are not identical, they are not patentably distinct because they recite a personal care composition comprising azoxystrobin, the composition being a shampoo, conditioner, or a leave on treatment, and which could also function as a body wash.
Although the reference claims do not recite the presence of a surfactant such as an amphoteric surfactant, a cationic polymer, a silicone conditioning agent, or a perfume, it would have been prima facie obvious to incorporate same in light of Schwartz, which teaches that it is advantageous to incorporate all of these ingredients into a shampoo composition comprising azoxystrobin.
It further would have been prima facie obvious to select an amount of the perfume that is within the recited range, because said amount is a result effective variable that will affect the overall sensory perception of the composition and therefore its attractiveness to the user.
Although the reference claims do not recite that the composition is a gel (claim 23), it would have been prima facie obvious to formulate the composition as a gel in light of Schwartz, which teaches that a gel is a suitable form for a personal care composition comprising azoxystrobin.
Although the reference claims do not recite the particle size of the azoxystrobin, it would have been prima facie obvious to select an azoxystrobin particle size within the recited ranges, since Kitko teaches an anti-dandruff personal care composition having selenium sulfide or pyridinethione salts as anti-dandruff actives and specifies different particle sizes depending upon the active, which would have motivated the skilled artisan to undertake an optimization process to determine the appropriate particle size when azoxystrobin is used as the anti-dandruff active as in the Schwartz composition, and using the ranges taught by Kitko as a starting point for the optimization. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite amount of the azoxystrobin, it would have been prima facie obvious to select an amount of the azoxystrobin that is within the ranges of claims 1-9, because said amount is a result effective variable that will affect the anti-dandruff efficacy of the composition. 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. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a silicone conditioner, it would have been prima facie obvious to incorporate same in light of Schwartz, which expressly suggests incorporating a silicone as a conditioner into a composition comprising azoxystrobin in order to form a hair care composition for treating dandruff.
Although the reference claims do not recite a single unit dosage, it would have been prima facie obvious to formulate the composition as such as taught by Edelson, in order to obtain a formulation that is easy for the consumer to use without having to measure out an individual dose.
The resulting reference composition as modified above will possess the functional deposition, fungal reduction, and minimum inhibitory concentration values recited by claims 1, 6-9, and 10, since it comprises the same ingredients in the same amounts recited by the claims, and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Response to Applicant’s Arguments
Applicant has not provided any substantive arguments against the rejections, which are therefore maintained.
Additionally, while Applicant argues that there is no requirement to file a terminal disclaimer or provide arguments against a provisional double patenting rejection, the Office notes that the claims also have been subjected to several nonprovisional double patenting rejections.
Conclusion
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/BENNETT M CELSA/ Primary Examiner, Art Unit 1600
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