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 .
Restriction Response
Applicant’s election with traverse of Group II (claims 29-31) in the reply filed on 01/14/26 is acknowledged.
The traversal is on the ground(s) that: “… the art does not describe what is claimed … Table 31 describes an anti-dandruff shampoo containing 3-hydroxypropyl caprylate, 3-dydroxypropyl undecylenate, and climbazole … applicant has removed climbazole from the claims. Thus the claims are novel and share unity of invention.”
This is not persuasive because the teaching of Mayser is not limited to Table 31. In Table 30, Mayser also teaches a shampoo composition comprising 3-hydroxypropyl caprylate, 3-dydroxypropyl undecylenate, as well as hydroxyacetophenone, piroctone olamine (Octopirox) and polyquaternium-10. In Table 32, Mayser teaches a 2-in-1 shampoo composition comprising 3-hydroxypropyl caprylate, 3-dydroxypropyl undecylenate, as well as citric acid and zinc pyrithione (zinc omadine). Instant claims still recite the limitations of piroctone olamine and zinc pyrithione. Therefore, the technical feature of a mixture or comprising (i) one or more first compounds and (ii) one or more second compounds is not a special technical feature as it does not make a contribution over the prior art, Mayser (Tables 30 and 32).
Applicant argues that the use of 3-hydroxypropyl caprylate and 3-hydroxypropyl undecylenate in certain mixtures leads to surprising antimicrobial properties, as illustrated by the Examples the mixtures achieve antimicrobial performance that is synergistic rather than merely additive, the reported SI (synergy index) values demonstrate that the observed microbial suppression cannot be explained as the predictable sum of the components’ individual effects, and the claimed mixtures are inventive.
This is not persuasive because the claimed limitations of components (i) and (ii) are taught by Mayser in the same arrangement, i.e., a mixture or composition which are the shampoos. One of ordinary skill in the art would have expected the same synergy as argued by Applicant absent evidence of criticality or unexpected results. Applicant has not compared the claimed invention with that of the closest prior art, i.e., Mayser.
The lack of unity is still deemed proper and is therefore made FINAL.
Applicant’s right to search, examination, and rejoinder of non-elected claims when the elected subject matter is allowable according to MPEP § 821.04 is acknowledged.
Claims 16-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 29-31 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/27/24 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Claim Objections
Claim 29 is objected to because of the following informalities: In claim 29, line 3, the term “and” should be added after the semi-colon. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 29 recites the limitation "methylparaben and salts thereof”, followed by “preferably sodium methylparaben” (emphasis added). The term “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term "enhance" in claim 30 is a relative term which renders the claim indefinite. The term "enhance" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There are no quantifiable parameters associated with enhanced antimicrobial effects recited in the claims.
Claim 31 is included for not correcting the defects of the claim from which it depends.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mayser et al. (WO 2020/160741 A1 – “Mayser”).
Instant claim 29 is drawn to a mixture or composition comprising:
one or more first compounds selected from 3-hydroxypropyl caprylate, 3-hydroxypropyl undecylenate, or a combination thereof; and
one or more second compounds selected from a list which contains piroctone olamine, zinc pyrithione, citric acid, hydroxyacetophenone, phenoxyethanol, methylparaben, ethylparaben, and polyquaternium-10.
Mayser discloses a shampoo composition comprising 0.3% of hydroxyacetophenone, 0.3% of piroctone olamine, 0.3% of polyquaternium-10, 0.4% of 3-hdyroxypropyl caprylate, and 0.2% of 3-hdyroxypropyl undecylenate (Pages 51-52 - Table 30) (all amounts are in % by weight (b.w.) – Page 31 – parentheses in Table 13 heading on Page 31). Mayser also discloses a 2-in-1 shampoo composition comprising 0.1% of citric acid, 0.10% of zinc pyrithione, 0.3% of 3-hydroxypropyl caprylate, and 0.15% of hydroxypropyl undecylenate (Page 53 – Table 32).
Regarding instant claim 29, the limitations of a mixture or composition comprising compound(s) (i) and (ii) are anticipated by the shampoo composition comprising 0.3% of hydroxyacetophenone, 0.3% of piroctone olamine, 0.3% of polyquaternium-10, 0.4% of 3-hdyroxypropyl caprylate, and 0.2% of 3-hdyroxypropyl undecylenate (Pages 51-52 - Table 30) (all amounts are in % b.w. – Page 31 – parentheses in Table 13 heading on Page 31), and the 2-in-1 shampoo composition comprising 0.1% of citric acid, 0.10% of zinc pyrithione, 0.3% of 3-hydroxypropyl caprylate, and 0.15% of hydroxypropyl undecylenate (Page 53 – Table 32), as taught by Mayser.
Regarding instant claim 30, the limitations of the one or more first compounds being in an amount sufficient to enhance an antimicrobial effect of one or more second compounds, and/or the one or more second compounds being in an amount sufficient to enhance an antimicrobial effect of one or more first compounds are anticipated by the shampoo composition comprising 0.3% of hydroxyacetophenone, 0.3% of piroctone olamine, 0.3% of polyquaternium-10, 0.4% of 3-hdyroxypropyl caprylate, and 0.2% of 3-hdyroxypropyl undecylenate (Pages 51-52 - Table 30), and the 2-in-1 shampoo composition comprising 0.1% of citric acid, 0.10% of zinc pyrithione, 0.3% of 3-hydroxypropyl caprylate, and 0.15% of hydroxypropyl undecylenate (Page 53 – Table 32), as taught by Mayser. Mayser also teaches that: “… the addition of an 1,2-alkane dial as defined herein to a caprylic acid ester or undecylenic acid ester as defined herein leads to a synergistic increase in antimicrobial activity against Malassezia” (Page 15, lines 24-26). The fatty acid esters are selected from the group consisting of 3-hydroxypropyl caprylate and 3-hydroxypropyl undecylenate (Page 16, line 29 to Page 17, line 2). Also, the recited enhanced antimicrobial effect is a property associated with the composition that contains both the first compound(s) and the second compound(s). Since the prior art teaches the combination of both the first compounds and the second compounds the property of enhanced antimicrobial effect is also taught by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.). Please see MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
Regarding instant claim 31, the limitation of a mixture or composition comprising 0.1 to 99.9 wt% of the one or more second compounds, based on the total weight of the mixture or composition is anticipated by the shampoo composition comprising 0.3% of hydroxyacetophenone + 0.3% of piroctone olamine + 0.3% of polyquaternium-10 = 0.9% b.w. of second compounds (Pages 51-52 - Table 30) and the 2-in-1 shampoo composition comprising 0.1% of citric acid + 0.10% of zinc pyrithione = 0.2% of second compounds (Page 53 – Table 32), as taught by Mayser. According to MPEP 2131.03 (I), a specific example in the prior art which is within a claimed range anticipates the range.
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 29-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10, 12, and 20 of U.S. Patent No. 12,350,357 B2 (the ‘357 Patent).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a mixture or composition comprising: one or more first compounds selected from 3-hydroxypropyl caprylate, 3-hydroxypropyl undecylenate, or a combination thereof; and one or more second compounds selected from a list, and therefore, encompass overlapping or coextensive subject matter.
One difference is that instant claims recite a generic mixture or composition whereas claim 1 of the ‘357 Patent recites a skin or hair care product, claim 9 of the ‘357 Patent recites a sulfate-free product, claim 10 of the ‘357 Patent recites a shampoo, and claim 12 of the ‘357 Patent recites a hair or body cream. However, instant claims are not limited to any particular type of composition and one of ordinary skill in the art would have found it obvious to formulate the mixture or composition of instant claims in any suitable form, including those recited in the claims of the ‘357 Patent.
Another difference is that instant claim 29 recites one or more second compounds whereas claim 1 of the ‘357 Patent does not recite this limitation. However, the second compounds recited in instant claim 29 including benzoic acid and methyl paraben are recited in claim 10 (vi) of the ‘357 Patent, thereby rendering this limitation obvious.
Therefore, instant claims are obvious over claims of the ‘357 Patent and they are not patentably distinct over each other.
Claims 29-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 17-18 of U.S. Patent No. 12,576,018 B2 (the ‘018 Patent).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a mixture or composition comprising: one or more first compounds selected from 3-hydroxypropyl caprylate, 3-hydroxypropyl undecylenate, or a combination thereof; and one or more second compounds selected from a list, and therefore, encompass overlapping or coextensive subject matter.
One difference is that instant claims recite a generic mixture or composition whereas claim 1 of the ‘018 Patent recites a skin or hair care product. However, instant claims are not limited to any particular type of composition and one of ordinary skill in the art would have found it obvious to formulate the mixture or composition of instant claims in any suitable form, including those recited in the claim 1 of the ‘018 Patent.
Another difference is that instant claim 29 recites one or more second compounds whereas claim 1 of the ‘018 Patent does not recite this limitation. However, the second compounds recited in instant claim 29 including alkyltrimonium chloride would have been obvious over the palmitamidopropyltrimonium chloride recited in claim 1 of the ‘018 Patent.
Therefore, instant claims are obvious over claims of the ‘018 Patent and they are not patentably distinct over each other.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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