DETAILED 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 .
Applicants’ amendment to the claims filed on 12/13/2023 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-19 are pending.
Priority
Acknowledgement is made of this national stage entry of PCT/EP2022/064529 of Non-provisional Application No. 18/570,018, filed on 5/30/2022, which claims foreign priority under 35 U.S.C. 119(a)-(d) to European Patent Application No. EP21180241.8, filing date 6/18/2021. The certified copy has been filed in the present application on 12/13/2023.
It is noted, however, that applicant has not filed a certified copy of the English translation as required by 37 CFR 1.55.
Drawings
The Drawings filed on 12/13/2023 and 1/8/2024 are acknowledged and accepted by the examiner.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/13/2023, 3/25/2025, 7/3/2025, 1/28/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, Claims 1-7, 16-19 are drawn to the technical feature of a mixture of n-nonanoic esters of xylitol, sorbitol or erythritol, comprising: at least two of the esters which differ with regard to at least one esterification position of at least one nonanoyl radical in the xylitol, sorbitol or erythritol, with the proviso that n-nonanoic esters of erythritol with an average level of esterification of greater than 3.2 are excluded, classified in C07C69/33.
Group II, claims 8-14 are drawn to the technical feature of a process for enzymatic preparation of a mixture of n-nonanoic esters of xylitol, sorbitol or erythritol according to Claim 1, comprising; A) providing xylitol, sorbitol or erythritol and at least one n-nonanoyl group donor, B) reacting xylitol, sorbitol or erythritol with the at least one n-nonanoyl group donor in the presence of a lipase at a temperature of 75°C to 110°C, to give an n-nonanoic ester of xylitol, sorbitol or erythritol, and optionally C) purifying the n-nonanoic ester of xylitol, sorbitol or erythritol, classified in C11D3/0036.
Group III, claim 15 is drawn to the technical feature of a method of making a product, comprising: producing at least one selected from the group consisting of a viscosity regulator, active care ingredient, foam booster or solubilizer, antimicrobial, antistat, binder, corrosion inhibitor, dispersant, emulsifier, film former, humectant, opacifier, oral care agent, preservative, skincare agent, hydrophilic emollient, foam stabilizer and/or nonionic surfactant with at least one of the mixture of n-nonanoic esters of xylitol, sorbitol, or erythritol according to Claim 1, classified in C12P7/6454.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical feature for the following reasons:
The inventions of Groups I, II, III lack unity because even though the inventions of these groups require the technical feature of a mixture of n-nonanoic esters of xylitol, sorbitol or erythritol, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of ‘411 (WO 2020116411, Date of Filing: 2019-12-03, cited on IDS dated 12/13/2023) {herein ‘411}.
‘411 teaches a composition comprising n-nonanoic acid, xylitol and sorbitol (pages 1, para 2; page 2, para 2; page 3, para 5). It is known by those of ordinary skill in the art that mixing a polyol with n-nonanoic acid produces polyol esters. As such, absent evidence otherwise, it is the Examiner’s position that a composition comprising n-nonanoic acid, xylitol and sorbitol would necessarily produce a mixture (composition) of n-nonanoic esters of xylitol and sorbitol.
As such, the shared same or corresponding technical feature among Groups I, II and III are not a contribution of the prior art.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Notice of Potential Rejoinder
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Response to Restriction/Election
On 1/29/2026, an oral provisional election was made with traverse by Kirsten Grünberg, Reg. No. 47,297 to elected Group I with traverse and prosecute the invention of Group I, claims 1-7, 16-19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-7, 16-19 are pending.
Claims 8-15 stands withdrawn pursuant to 37 CFR 1.142(b).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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)(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.
Claims 1-7, 16-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by ‘411 (WO 2020116411, Date of Filing: 2019-12-03, cited on IDS dated 12/13/2023) {herein ‘411}.
Claims 1-4, 16-19 are drawn to a mixture of n-nonanoic esters of xylitol, sorbitol or erythritol, comprising: at least two of the esters which differ with regard to at least one esterification position of at least one nonanoyl radical in the xylitol, sorbitol or erythritol, with the proviso that n-nonanoic esters of erythritol with an average level of esterification of greater than 3.2 are excluded.
Claims 5-7 are drawn to a mixed composition comprising the mixture of n- nonanoic esters according to Claim 1, wherein said composition comprises less than 25% by weight, of free n-nonanoic acid, where the percentages by weight are based on the sum total of all n- nonanoic esters of xylitol, sorbitol and erythritol and n-nonanoic acid.
With respect to claim 1, ‘411 teaches a composition (composition B) comprising n-nonanoic acid, xylitol and sorbitol (pages 1, para 2; page 2, para 2; page 3, para 5). It is known by those of ordinary skill in the art that mixing a polyol with n-nonanoic acid produces polyol esters. As such, absent evidence otherwise, it is the Examiner’s position that a composition comprising n-nonanoic acid, xylitol and sorbitol would necessarily produce a mixture (composition) of n-nonanoic esters of xylitol and sorbitol. Since said composition does not include erythritol, it is the Examiner’s position that it would necessarily exclude n-nonanoic esters of erythritol with an average level of esterification of greater than 3.2. Additionally, absent evidence otherwise, it is the Examiner’s position that at least one esterification position of at least one nonanoyl radical in the xylitol and sorbitol would be different based on the chemical structures of the sugar alcohols. It is commonly known in the art that both xylitol (5 carbons with 5 hydroxyl groups) and sorbitol (6 carbon with 6 hydroxyl groups) possess different numbers of hydroxyl groups and carbon chain lengths, which leads to distinct regioselectivity.
With respect to claim 2, since the art teaches the structure of a mixture of n-nonanoic esters of xylitol and sorbitol, it is the Examiners position that the composition would necessarily comprise at least two regioisomers of the mono-n- nonanoic ester.
With respect to claim 3, since the art teaches the structure of a mixture of n-nonanoic esters of xylitol and sorbitol, it is the Examiners position that the composition would necessarily comprise mono-n-nonanoic ester and di-n- nonanoic ester.
With respect to claim 4, since the art teaches the structure of a mixture of n-nonanoic esters of xylitol and sorbitol, it is the Examiners position that the composition would necessarily have an average level of esterification of 1.0 to 4.0.
With respect to claim 5, ‘411 teaches a composition B comprising n-nonanoic acid, xylitol and sorbitol (pages 1, para 2; page 2, para 2; page 3, para 5). It is known by those of ordinary skill in the art that mixing polyol with n-nonanoic acid produces polyol esters. As such, absent evidence otherwise, it is the Examiner’s position that a composition comprising n-nonanoic acid, xylitol and sorbitol would necessarily produce s mixture of n-nonanoic esters of xylitol, sorbitol. Since said composition does not include erythritol, it is the Examiner’s position that it would necessarily exclude n-nonanoic esters of erythritol with an average level of esterification of greater than 3.2. Additionally, absent evidence otherwise, it is the Examiner’s position that at least one esterification position of at least one nonanoyl radical in the xylitol and sorbitol would be different based on the chemical structures of the sugar alcohols. It is commonly known in the art that both xylitol (5 carbons with 5 hydroxyl groups) and sorbitol (6 carbons with 6 hydroxyl groups) possess different numbers of hydroxyl groups and carbon chain lengths, which leads to distinct regioselectivity. Since the art teaches the structure a mixed composition comprising the mixture of n- nonanoic esters, it is the Examiners position that the composition would necessarily have less than 25% by weight, of free n-nonanoic acid, where the percentages by weight are based on the sum total of all n- nonanoic esters of xylitol, sorbitol and erythritol and n-nonanoic acid.
With respect to claim 6, since the art teaches the structure a mixed composition comprising the mixture of n- nonanoic esters, it is the Examiners position that the composition would necessarily have 0.05% by weight to 40% by weight, of free xylitol, sorbitol and/or erythritol, where the percentages by weight are based on the sum total of all n-nonanoic esters of xylitol, sorbitol and erythritol and all xylitol, sorbitol and erythritol.
With respect to claim 7, since the art teaches the structure a mixed composition comprising the mixture of n- nonanoic esters, it is the Examiners position that the composition would necessarily have 0.1% by weight to 60% by weight of at least one solvent.
With respect to claim 16, since the art teaches the structure of a mixture of n-nonanoic esters of xylitol and sorbitol, it is the Examiners position that mixture of n-nonanoic esters would necessarily comprise mono-n-nonanoic ester, di-n-nonanoic ester, and tri-n-nonanoic ester.
With respect to claim 17, since the art teaches the structure of a mixture of n-nonanoic esters of xylitol and sorbitol, it is the Examiners position that mixture of n-nonanoic esters would necessarily comprise an average level of esterification of 1.0 to 3.
With respect to claim 18, since the art teaches the structure of a mixture of n-nonanoic esters of xylitol and sorbitol, it is the Examiners position that mixture of n-nonanoic esters would necessarily comprise an average level of esterification of 1.1 to 2.7.
With respect to claim 19, since the art teaches the structure of a mixture of n-nonanoic esters of xylitol and sorbitol, it is the Examiners position that mixture of n-nonanoic esters would necessarily comprise an average level of esterification of 1.3 to 2.6.
For the reasons stated herein, the teachings of ‘411 anticipate claims 1-7, 16-19.
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 1-7, 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 10, 14 of U.S. Patent Application 18570395 of which is commonly owned, has common inventors and was filed after the instant application. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to an anhydro sugar alcohol n-nonanoic acid ester composition, comprising: A) an anhydro sugar alcohol, B) an anhydro sugar alcohol mono n-nonanoic ester, and C) an anhydro sugar alcohol di n-nonanoic ester, wherein the anhydro sugar alcohol is at least one selected from the group consisting of sorbitan and xylitan (claim 1 of ‘395) wherein the anhydro sugar alcohol n-nonanoic acid ester composition contains sorbitol n-nonanoic esters and/or xylitol n-nonanoic esters and a weight ratio of anhydro sugar alcohols to their corresponding sugar alcohols in the anhydro sugar alcohol n-nonanoic acid ester composition is greater than 60 to 40. (claim 8 of ‘395).
The instant application claims 1-3, 5-7, 16 are not patentably distinct from claims 1, 8, 10 of ‘395 because claims 1, 8, 10 of ‘395 recites ‘ an anhydro sugar alcohol n-nonanoic acid ester composition,
comprising: A) an anhydro sugar alcohol, B) an anhydro sugar alcohol mono n-nonanoic ester, and C) an anhydro sugar alcohol di n-nonanoic ester, wherein the anhydro sugar alcohol is at least one selected
from the group consisting of sorbitan and xylitan (claim 1); wherein the anhydro sugar alcohol n-nonanoic acid ester composition contains sorbitol n-nonanoic esters and/or xylitol n-nonanoic esters and a weight ratio of anhydro sugar alcohols to their corresponding sugar alcohols in the anhydro sugar alcohol n-nonanoic acid ester composition is greater than 60 to 40 (claim 8); 10. A formulation, comprising the anhydro sugar alcohol n-nonanoic acid ester composition as claimed in claim 1, wherein the formulation comprises from 0.01 % by weight to 10% by weight of the anhydro sugar alcohol n-nonanoic acid ester composition based on the total formulation (claim 10), which are not patentably distinct from the instant application claims 1-3, 5-7, 16.
The instant application claims 4, 17-19 are not patentably distinct from claims 4, 14 of ‘395 because claims 4, 14 of ‘395 recites ‘the anhydro sugar alcohol n-nonanoic acid ester composition
as claimed in claim 1, wherein the anhydro sugar alcohol n-nonanoic acid ester has an average degree of
esterification of 0.7 to 4.0 (claim 4); ‘the anhydro sugar alcohol n-nonanoic acid ester composition as claimed in claim 1, wherein the anhydro sugar alcohol n-nonanoic acid ester has an average degree of
esterification of 1.0 to 2.0’ (claim 14), which are not patentably distinct from the instant application claims 4, 17-19.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Status of Claims
Claims 1-7, 16-19 are pending.
Claims 8-15 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-7, 16-19 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/ Examiner, Art Unit 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656