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 .
Priority
This application, filed 21 March, 2024, is a national stage application of PCT/AU2022/051347, filed 11 November, 2022, which claims foreign benefit of application AU2021903639, filed 12 November, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8 May, 2024 is acknowledged and has been considered.
Election/Restrictions
Applicant’s election without traverse of Group I – Compositions (Claims 1-5, 8-9, 18 and 21-22), and further of Species “D-Lactic Acid”, in the reply filed on 9 June, 2026 is acknowledged.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 23 October, 2024, in the matter of Application N° 18/693,998. Said documents have been entered on the record.
Claims 1 and 5-8 have been amended. Claims 10-17 have been canceled. Claims 19-22 are new. No new matter was introduced.
Therefore, Claims 1-9 and 18-22 are pending.
Claims 6-7 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 June, 2026.
Thus, Claims 1-5, 8-9, 18, and 21-22 represent all claims currently under consideration.
For Purposes of Examination
The recitations “for disrupting a biofilm” in claim 1, “for treating or preventing a microbial infection” in claim 8, and “for disrupting or preventing biofilm formation on a non-living surface” in claim 21 merely state the intended use or purpose of the claimed compositions. These recitations do not impart structural limitations to the claimed composition. During examination, patentability is based upon the structural limitations positively recited in the body of the claim. Accordingly, these intended-use statements are not accorded patentable weight. See MPEP §2111.02(II).
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)(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 1-5, 8-9, 18, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schallenberger (WO 2014/106267 Al, cited in IDS).
In view of Applicant’s election of the species of 2-hydroxycarboxylic acid as “D-lactic acid” without traverse, Claims 1-5, 8-9, 18, and 21-22 are interpreted for purposes of examination as being limited to the elected species, namely a composition comprising the elected species, D-lactic acid (the preferred enantiomer), to the exclusion of unelected species.
Regarding Claims 1-5, 8, 18, and 21, Schallenberger teaches compositions comprising D-lactic acid (‘267, Pg 3, Lines 2-4 and Pg 9-10, Examples 1 and 2).
Regarding Claims 9 and 22, Schallenberger further teaches compositions comprising D-lactic acid in combination with one or more antimicrobial agents (‘267, Pg 3, Lines 2-4 and Pg 9-10, Examples 1 and 2).
As such, Schallenberger anticipates Claims 1-5, 8-9, 18, and 21-22.
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 1-5, 8-9, 18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-5, 8-9 and 11 of copending Application No. 19/470,864 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim substantially the same compositions comprising the elected species, D-lactic acid (and, where applicable, further comprising an antimicrobial compound). The differences between the claim sets are directed primarily to recitations of the intended use or purpose of the claimed compositions (e.g., disrupting a biofilm, dysregulating the metabolism of planktonic bacteria, etc.) Such intended-use limitations do not impart structural distinctions to the claimed compositions and, therefore, do not render the claimed subject matter patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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