FINAL ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
This action is in response to papers filed 11/14/2025 in which claims 2, 14, and 17-18 were canceled; claims 12-13 and 15 were withdrawn; claims 1, 4, 6-7, 10, 12-13, and 15 amended; and claim 19 was newly added. All the amendments have been thoroughly reviewed and entered.
Claims 1, 3-11, 16 and 19 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Interpretation
Claims 1, 3-11, 16 and 19 are structured as a product-by-process. Thus, claims 1, 3-11, 16 and 19 will be interpreted and examined for art rejections purposes (102 and 103 rejections) as product-by-process type claims. MPEP 2113 [R-1] states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Thus, while the structure implied by the process steps should be consider when assessing patentability of product-by-process claims over the prior art; however, burden of proof is placed upon Applicant to show that the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Also see MPEP § 2113.
New Objections
Claim Objections
Claim 6 is objected to because of the following informalities: for claim language clarity, please amend claim 6 to “the method of claim 3 in which the α-bisabolol is encapsulated and the encapsulated α-bisabolol is incorporated into the fibers of the wearable fabric during manufacture.”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: for claim language clarity, please amend claim 10 to “the method of claim 5, in which the α-bisabolol is encapsulated in capsules and the α-bisabolol is the sole substance in the capsules.” Appropriate correction is required.
New Rejection
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 19 is not further limiting from claim 1 because Saccharomyces cerevisiae is the same yeast as baker’s yeast because “Saccharomyces cerevisiae” is the scientific name of the yeast and “baker’s yeast” is the common name of the same yeast.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained-Modified Rejections
Modification Necessitated by Applicant’s Claim Amendments
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-11, 16, and 19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chazey III et al (WO 2021/073775 A1; filing date: 17 January 2020).
The product-by-process claim interpretation applies here.
Regarding claims 1 and 19, Chazey teaches a method reducing skin irritation comprising applying an encapsulated α-bisabolol to the skin ([0001]-[0003], [0008]-[0022], [00107]-[00112], [00119], [00123]-[00159]; Examples 1-5; claims 1-12). The structure of α-bisabolol as taught by Chazey is structurally the same as the claimed α-bisabolol and thus, how the α-bisabolol is produced (“producing using Saccharomyces cerevisiae in culture medium, followed by distillation”) is immaterial to the patentability of the product itself. It is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claims 3 and 4, Chazey teaches the α-bisabolol is incorporated in clothing fabric via washing the clothing fabric in a laundry product containing the α-bisabolol ([0001]-[0003], [0008]-[0022], [00101]-[00103], [00106], [00120], [00123]-[00159]; Examples 1-5; claims 1-12).
Regarding claim 5, as discussed above, Chazey teaches the α-bisabolol is encapsulated.
Regarding claim 6, as discussed above, Chazey teaches the α-bisabolol is encapsulated. Chazey teaches the α-bisabolol is incorporated into the fibers of the clothing fabric ([0001]-[0003], [0008]-[0022], [00101]-[00103], [00106], [00120], [00123]-[00159]; Examples 1-5; claims 1-12).
Regarding claims 7 and 8, Chazey teaches the α-bisabolol is incorporated in a cosmetic product, a skin-care product or a hair-care product ([0001]-[0003], [0008]-[0023], Examples 1-5; claims 1-12)
Regarding claim 9, Chazey teaches the laundry product is loaded with α-bisabolol in an amount from about 0.001 to about 1 wt.% ([0001]-[0003], [0008]-[0022], [00101]-[00103], [00106], [00120], [00123]-[00159]; Examples 1-5; claims 1-12).
Regarding claim 10, Chazey teaches an encapsulated α-bisabolol in capsules ([00107]-[00119]).
Regarding claim 11, Chazey teaches the α-bisabolol is part of an encapsulated fragrance (Examples 1-5).
Regarding claim 16, Chazey teaches the skin-care product is loaded with α-bisabolol in an amount from about 0.001 to about 1 wt.% ([0001]-[0003], [0008]-[0023], Examples 1-5; claims 1-12).
As a result, the aforementioned teachings from Chazey are anticipatory to claims 1, 3-11, 16, and 19 of the instant invention.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicant argues “the resultant product of the process incorporated in claim 1 as amended herein, provides a product which as is demonstrated by applicant's examples are indicative of a "... difference in structure, function or other characteristics" which distinguish the products of the process now required in amended claim 1 over a 'naturally occurring' α-bisabolol.” Applicant further alleges “[a] search of Chazey's specification provides no indication of any distillation step for bisabolol, but only that it is provided as "Dragosanol® 100 (ex Symrise AG). There is no indication of any of the process steps recited in claim 1 which are expressly or inherently present in Chazey. Respectfully, the absence from the reference of any claim limitation negates anticipation.” Applicant cited Kloster SpeedsteelAB v. Crucible, Inc., Atlas Powder Co. v. E.I. DuPont De Nemours, and Kalman v. Kimberly-Clark Corp. to support Applicant’s position. (Remarks, pages 7-8).
In response, the Examiner disagrees. Applicant’s citation of Kloster SpeedsteelAB v. Crucible, Inc., Atlas Powder Co. v. E.I. DuPont De Nemours, and Kalman v. Kimberly-Clark Corp., do not support Applicant’s position because claim 1 only requires a single structure of “α-bisabolol” and does not recite any additional structure or characteristic that would differentiate from α-bisabolol. Thus, the breadth of claim 1 is a method of reducing skin irritation comprising one step of applying α-bisabolol to the skin. As discussed in the pending 102 rejection, Chazey teaches a method reducing skin irritation comprising applying an encapsulated α-bisabolol to the skin, thereby anticipates the claimed method of independent claim 1.
While claim 1 has been amended to recited “the α-bisabolol is produced using Saccharomyces cerevisiae in culture medium, followed by distillation,” this amendment does not add or provide any structure or characteristic to the α-bisabolol, as said recitation is merely further defining the process of how the α-bisabolol is produced. Applicant alleges that the Examples in the specification “are indicative of a ... difference in structure, function or other characteristics" which distinguish the products of the process now required in amended claim 1 over a 'naturally occurring' α-bisabolol.” However, Example 1 described that the production of using Saccharomyces cerevisiae in culture medium, followed by distillation, provided a purified (-)-α-bisabolol of about 99% purity and less than 0.10% farnesol. This characteristic feature of “purified (-)-α-bisabolol of about 99% purity and less than 0.10% farnesol” is not in claim 1. Since this characteristic feature is not in claim 1, the α-bisabolol of claim 1 remained to be anticipated by Chazey, as Chazey teaches the same structure of α-bisabolol, as well as, uses the same α-bisabolol for reducing skin irritation.
As a result, for at least the reason discussed above, claims 1, 3-11, 16, and 19 remained rejected as being anticipated by the teachings from Chavez in the pending 102 rejection as set forth in this office action.
Claim(s) 1, 7, 8, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maurya et al (Current Pharmaceutical Biotechnology, 2014, 15: 173-181).
The product-by-process claim interpretation applies here.
Regarding claims 1 and 19, Maurya teaches a method of reducing skin irritation comprising applying to the skin an α-bisabolol (Abstract; Introduction; pages 173-175 and 179-180). The structure of α-bisabolol as taught by Maurya is structurally the same as the claimed α-bisabolol and thus, how the α-bisabolol is produced (“producing using Saccharomyces cerevisiae in culture medium, followed by distillation”) is immaterial to the patentability of the product itself. It is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claims 7 and 8, Maurya teaches the α-bisabolol is incorporated into cosmetic products (Abstract; Introduction; pages 173-175 and 179-180).
As a result, the aforementioned teachings from Maurya are anticipatory to claims 1, 7, 8, and 19 of the instant invention.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicant argues “[t]here is no indication that the a-(-)-bisabolol used was obtained by the process steps, required now of claim 1. Rather, absent such a statement as skilled artisan may presume that a naturally occurring extract of 'oil of chamomile' was the source, and such differs from the product according to claim 1 as is now presented hereinabove.” Applicant goes to argue that “[t]he applicant again points out that the Examples provided in applicant's specification as filed, in particular Examples 4 and 5, both of which demonstrate the technical improvements which are indicative of a "... difference in structure, function or other characteristics" which distinguish the products of the process now required in amended claim 1 over a 'naturally occurring’ α-bisabolol. Thus, Applicant alleges “[t]he foregoing supports the applicant's view that the 'product by process' of claim 1 distinguishes the α-bisabolol, produced from any 'naturally occurring' product. Considering Maurya, a skilled artisan would conclude that the a-(-)-bisabolol evaluated was a 'plant bisabolol' which however, performed differently than that obtained by the process according to claim 1 as presently set forth. Such belies a structural difference of the product produced by the currently claimed process. And that such a product had a different "... function, or other characteristics..." suggests a different "in kind".” (Remarks, pages 8-9).
In response, the Examiner disagrees. claim 1 only requires a single structure of “α-bisabolol” and does not recite any additional structure or characteristic that would differentiate from α-bisabolol. Thus, the breadth of claim 1 is a method of reducing skin irritation comprising one step of applying α-bisabolol to the skin. As discussed in the pending 102 rejection, Maurya teaches a method of reducing skin irritation comprising applying to the skin an α-bisabolol, thereby anticipates the claimed method of independent claim 1.
While claim 1 has been amended to recited “the α-bisabolol is produced using Saccharomyces cerevisiae in culture medium, followed by distillation,” this amendment does not add or provide any structure or characteristic to the α-bisabolol, as said recitation is merely further defining the process of how the α-bisabolol is produced. Applicant alleges that the Examples 4 and 5 in the specification “are indicative of a ... difference in structure, function or other characteristics" which distinguish the products of the process now required in amended claim 1 over a 'naturally occurring' α-bisabolol.” However, Examples 4 and 5 used the α-bisabolol produced in Example 1 and said Example 1 described that the production of using Saccharomyces cerevisiae in culture medium, followed by distillation, provided a purified (-)-α-bisabolol of about 99% purity and less than 0.10% farnesol. This characteristic feature of “purified (-)-α-bisabolol of about 99% purity and less than 0.10% farnesol” is not in claim 1. Since this characteristic feature is not in claim 1, the α-bisabolol of claim 1 remained to be anticipated by Maurya, as Maurya teaches the same structure of α-bisabolol, as well as, uses the same α-bisabolol for reducing skin irritation.
As a result, for at least the reason discussed above, claims 1, 7, 8, and 19 remained rejected as being anticipated by the teachings from Maurya in the pending 102 rejection as set forth in this office action.
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.
Claim(s) 1, 3-11, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chazey III et al (WO 2021/072775 A1; filing date: 17 January 2020), and further in view of Son et al (Biochem. J., 2014, 463: 239-248; cited in IDS filed 12/19/2022).
The methods of claims 1, 3-11, 16, and 19 are discussed above by Chazey, said discussion being incorporated herein its entirety.
Alternatively, with respect to the α-bisabolol is α-bisabolol produced by a biotechnological process such as using Saccharomyces cerevisiae in a culture medium, follow by distillation, as recited in the claim 1, it would have been obvious to use -bisabolol produced by a biotechnological process such as using Saccharomyces cerevisiae in a culture medium, follow by distillation in view of the guidance from Son.
Son teaches α-bisabolol synthesized using a yeast culture medium and said α-bisabolol further distilled to form a high purity α-bisabolol (Abstract; Introduction; pages 239-246). Son teaches the α-bisabolol is known to be widely added into cosmetic product due their anti-inflammatory, skin-soothing, and moisturizing properties (Abstract; Introduction; pages 245-246).
It would have been obvious to one of ordinary skill in the art to incorporate the α-bisabolol synthesized via a yeast culture medium of Son as the α-bisabolol in Chazey, and produce the claimed invention. One of ordinary skill in the art would have been motivate do to so because Son teaches that α-bisabolol synthesized using a yeast culture medium is known and a well-establish process for producing α-bisabolol, and such α-bisabolol produce using yeast provide a resultant α-bisabolol with high purity. One of ordinary skill in the art would have reasonable expectation of success of incorporate the α-bisabolol synthesized via a yeast culture medium of Son as the α-bisabolol in Chazey because Chazey indicated that the preferred α-bisabolol used is a highly pure α-bisabolol (Chazey: [0021]), and the α-bisabolol of Son is within the scope of said highly pure α-bisabolol of Chazey.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicant argues “a search of Chazey's specification provides no indication of any distillation step for bisabolol, but only that it is provided as "Dragosanol® 100 (ex Symrise AG). This is not remediated by a review of Son, which also does not appear to have any distillation step as well.” Applicant further alleges “Chazey is also deficient in that it fails in any manner to disclose that the "... α-bisabolol is produced using Saccharomyces cerevisiae ... " as is required by claim 1. This is not remediated by Son, who teaches the need for 'transgenic yeast'” Thus, Applicant alleges “the joint of consideration of Chazey and Son does not render the current claim 1, as well as all depending claims as being obvious for at least the reasons set forth above.” As such, Applicant further alleges that the Examiner’s obviousness analysis using Chazey and Son was based on improper hindsight analysis. (Remarks, pages 10-11).
In response, the Examiner disagrees. The Examiner’s obviousness analysis is not based on improper hindsight because Son does teach and suggest producing α-bisabolol using Saccharomyces cerevisiae in culture medium, followed by distillation (see 103 rejection, pages 12-13 of this office action). While Son teaches transgenic yeast, the transgenic yeast is a genetically engineered Saccharomyces cerevisiae and thus, meets the claimed “Saccharomyces cerevisiae in culture medium” as claim 1 does not exclude genetically engineered Saccharomyces cerevisiae.
As discussed in pending 103 rejection, Son indicated that the α-bisabolol synthesized using a yeast culture medium and further distilled provided a high purity α-bisabolol (see 103 rejection, page 12 of this office action), which appeared to be the same characteristic feature obtained from Applicant’s used of α-bisabolol produced using Saccharomyces cerevisiae in culture medium, followed by distillation (see Applicant’s specification, Example 1). Furthermore, as per page 2, lines 35-40 of the Specification, it was indicated that the bisabolol used was particularly from the biotechnological production method described in “Biochem. J. (2014) 463, 239-248,” which is the cited Son reference. Thus, the α-bisabolol from Son is the same α-bisabolol used in the claimed method. This is preponderance of evidence to support the Examiner’s obviousness analysis. As such, Applicant is noted that "[e]xpected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
As a result, for at least the reasons discussed above, claims 1, 3-11, 16, and 19 remained rejected as being as being obvious and unpatentable over the combined teachings of Chavez and Son, in the pending 103 rejection as set forth in this office action.
Conclusion
No claim is allowed.
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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613