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 .
Claims 1-20 are currently pending. Claims 1, 13, 17, 18, 19 and 20 are independent.
Priority
Applicant claims priority benefit as follows:
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Election/Restriction
Applicants’ election with traverse of Group I, drawn to a compound of formula (II), (IV) or (V) and compositions comprising the same in the reply filed on October 13, 2025 is acknowledged.
For the species requirement Applicant elected the group of compounds of formula (II)
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. Applicant did not identify the claims that are readable on the elected species.
Applicant traversed the restriction requirement on the grounds that “EP 1953237 fails to teach or suggest the claimed chemical compounds.” In the traversal arguments, Applicant explained what the abstract of the reference describes.
Applicant’s arguments have been considered but were found unpersuasive.
As discussed in the Restriction requirement, the reference EP 1953237 teaches the claimed chemical compounds in pages 15-17 and 19-20. See the 102 rejection below. Unity of invention is therefore lacking for the claims. Arguments that the search would not impose a serious burden on the Office are not germane to the showing of Lack of Unity.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 10/13/2025.
Examination
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Pursuant to MPEP 803.02, the elected species of compound of formula (II)
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was searched and was found patentable over the prior art . Examination was thus expanded to the compounds disclosed in the reference EP 1953237 which read on the claimed formula (V)
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. Examination was stopped and art has been applied against the claims.
Accordingly, claims 4 and 13-20, and subject matter of claims 1-3 and 5-12 outside of the examined scope, are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 10/13/2025.
Pursuant to Applicant’s response, claims 1-3 and 5-12 are the subject of this Office action.
Specification Objection-abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
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.
Claim(s) 1-3, 5, and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Dirk (EP 19523237-previously cited and provided by the ISA).
Dirk isclosed compounds of formula
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,
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(p. 15-19),
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(p. 19), and others at the table in page 25. The sophorolipids, such as the ones in pages 19-20 (example O.1.), are present in a composition with azelaic acid (see page 19), which is an antioxidant. The composition of example O.1. is combined in formulations with other surfactants to be formulated as cleaning products. See at least pages 27-28.
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 1-3 and 6-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4-6, 8-11 of copending Application No. 18/252,394 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds as claimed in claims 1-3 and 6-8 were covered by claims 2, 4-6 and 8 of the reference application and the compositions thereof of instant claims 9-12 were covered by reference claims 9-11.
For example, the elected compounds of formula
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of instant claim 6 were covered by
reference claim 2
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, 5 and 6, in which R1 is
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and R2 is H. The compounds of reference claim 6 in which R2 is H anticipate the compound of instant claim 7. These are the compounds claimed in the reference that are comprised in the compositions of claims 9-11 of the reference. In addition, what is covered by the reference compounds was described at pages 4-5 and Tables 1-2 of the reference
In regards to instant claims 11-12, these differ from the conflicting reference claims 9 and 11 in that instant claim 11 recites a particular further ingredient of the composition and instant claim 12 recites physical forms of the composition (e.g. suspension, emulsion). However, such specific further ingredient of the composition and particular forms of the composition were present in the reference disclosure and were covered by the compositions of reference claims 9 and 11.
What is covered by the compositions of the reference claims was disclosed in at least pages 20-21 of the reference application, as ingredients of the compositions (vitamins, moisturizers, etc.) and particular physical forms (suspension, emulsion, gels, etc.). It would have been prima facie obvious to one of ordinary skill in the art to select the additional ingredients and physical form of the composition from the disclosure of the invention claimed in the reference application since this is the embodiment that provides support to and falls within the scope of the composition claims of the reference application.
This rejection is proper under MPEP 804 II. B. 2. (a):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because ONLY "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 12-13 of copending Application No. 18/249,245 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims is prima facie obvious and covered by the claims of the reference application. Claims 1, 3 and 9 claim the compounds of formula
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and composition, wherein R1 and R2 are H, alkyl, substituted alkyl, acyl or substituted acyl.
The reference application teaches compounds of Examples 1, 4, 5, 6, 8, 11, 15, 17, 19, 20 and 21 as a representation of what is claimed at claims 1-4 and 12-13 of the reference application:
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. These are particular embodiments of the invention claimed in the reference application which also show the preferred definitions for the variables and substituents.
Finding of prima facie obviousness--rational and motivation
What is covered by the reference claims was exemplified in the reference application as discussed above. It would have been prima facie obvious to select the compound Examples 1, 4, 5, 6, 8, 11, 15, 17, 19, 20 and 21 from the disclosure of the invention claimed in the reference application since these are the embodiments that provide support to and fall within the scope of the claims of the reference application.
This rejection is proper under MPEP 804 II. B. 2. (a):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because ONLY "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 53 of copending Application No. 17/776,729 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds as claimed in claims 1-3 were covered and are anticipated by claim 53 of the reference application.
The compound of claims 1-3 is anticipated by the compounds of reference claim 53 of formula
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, wherein R1 is H or Ac, and R2 is
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The reference claim embodiment, with its variables, is so limited that the ordinary artisan would have at once envisaged the species wherein R1 is H or Ac and R2 is
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 12 of copending Application No. 18/839,504 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims is prima facie obvious and covered by the claims of the reference application. Claims 1-3 and 9 claim the compounds of formula
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and composition, wherein R1 and R2 are H or alkyl, substituted alkyl, acyl or substituted acyl.
The reference application teaches exemplary compound 2 in Table 1 as a representation of what is claimed at claims 1-2 and 12 of the reference application:
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. This is a particular embodiment of the invention claimed in the reference application which also shows the preferred definitions for the variables and substituents.
Finding of prima facie obviousness--rational and motivation
What is covered by the reference claims was exemplified in the reference application as discussed above. It would have been prima facie obvious to select the exemplary compound 2
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from the disclosure of the invention claimed in the reference application since this is an embodiment that provides support to and falls within the scope of the claims of the reference application.
This rejection is proper under MPEP 804 II. B. 2. (a):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because ONLY "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-3 and 5-12 are rejected. No claim is allowable.
Not every piece of prior art found in the search has been applied against the instant claims. See MPEP 904.03.
Elected formula (II) could be allowable after overcoming the double patenting rejections presented in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-4:30pm.
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, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621