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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 90-96) in the reply filed on 23 January 2026 is acknowledged. The traversal is on the ground(s) that Jin (WO 2022/016266) does not provide a direct and unambiguous disclosure of the composition recited in the claims and that Jin does not teach a “functional role for galactose or raffinose at the concentrations recited in the pending claims” (Remarks, pg. 2-3). This is not found persuasive because even though Jin doesn’t explicitly teach the composition recited in claims 90-91, Jin provides sufficient guidance to a person of ordinary skill in the art to combine the teachings of para. 29 and 33 (see 103 rejection over Jin in para. 10-17 below). Thus, the shared technical feature does not make a contribution over the prior art. Additionally, the shared technical feature recited by the instant claims does not recite a function or concentration for galactose or raffinose.
The requirement is still deemed proper and is therefore made FINAL.
Claims 97-109 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 (election) requirement in the reply filed on 23 January 2026.
Claim Status
The amended claim set filed on 14 July 2025 is acknowledged. Claims 90-109 are currently pending. Claims 90-109 are new, and claims 97-109 are withdrawn. Claims 1-89 are cancelled. Claims 90-96 will be examined on the merits herein.
Priority
The instant application is a 371 of application PCT/IB2022/059321 (filed 30 September 2022) and claims priority to foreign application AU 2021903132 (filed 30 September 2021). Therefore, the effective filing date of claims 90-96 is 30 September 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 24 May 2024, 9 August 2024, 12 August 2024, and 6 June 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, each information disclosure statement is being considered by the examiner.
Regarding the IDS filed on 9 August 2024, the NPL documents Saini (cite no 8), Burton (cite no 10), and Wescombe (cite no 19; only abstract attached) could not be found among those submitted. Nevertheless, these references have been attached to this Action (note that the first author of the Saini reference is Mani) and are being considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification (see pg. 59) are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
Claims 94 and 96 are objected to because of the following informalities:
In claim 94, lines 3 and 5, “SEQ ID NOs” should read “SEQ ID NOs:”, and
In claim 96, organism genus names should be fully spelled out upon first use in the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 90-96 are rejected under 35 U.S.C. 103 as being unpatentable over Jin et al. (WO 2022/016266 A1; filed 20 July 2021; herein “Jin”).
Regarding claims 90-94, Jin teaches a method comprising formulating for administration a Streptococcus salivarius DB-B5 (para. 29 and 38). Jin teaches that the S. salivarius DB-B5 formulation may be combined with one or more additional probiotics, such as S. salivarius K12 and M18 (para. 33), and that the formulation may comprise protective agents, including galactose (para. 29).
Regarding the intended uses “improving the inhibitory profile of Streptococcus salivarius” recited in claim 90 and “upregulating one or more genes in Streptococcus salivarius” recited in claim 91, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Because the composition of Jin is substantially identical to the claimed compositions (i.e., comprising S. salivarius K12 and/or M18 and galactose), the composition of Jin is presumed to have the same properties, absent evidence to the contrary. MPEP 2112.02(II) states: “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).” Furthermore, MPEP 2112.01(I) states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.” Claims 92-94 further limit the intended use of claim 91. Because claims 92-94 do not limit the claimed method step or the structure of the composition recited in claim 91, claims 92-94 are also taught by Jin.
Regarding claims 90 and 95-96, Jin teaches that the formulation inhibits oral pathogens, including Prevotella spp., Porphyromonas gingivalis, and Fusobacterium nucleatum (para. 19). Additionally, because the composition of Jin is substantially identical to the claimed composition (i.e., comprising S. salivarius K12 and/or M18 and galactose), the composition of Jin is presumed to have the same properties, absent evidence to the contrary. MPEP 2112.02(II) states: “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).” Furthermore, MPEP 2112.01(I) states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Claims 95-96 further limit the intended use of claim 90. Because claims 95-96 do not limit the claimed method step or the structure of the composition recited in claim 90, claims 95-96 are taught by Jin.
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to formulate the S. salivarius DB-B5 strain in combination with S. salivarius K12 and/or M18 and galactose, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because Jin teaches that additional probiotics may also treat or prevent oral disease or other ailments (para. 33) and galactose is used as a protective agent (para. 29). Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because Jin teaches that the S. salivarius DB-B5 strain may be formulated with both additional probiotics and protective agents. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., S. salivarius K12 and/or M18 and galctose) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
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.
US 7,226,590
Claims 90-96 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 7,226,590 (‘590) in view of Ryu et al. (2020, Arch. Oral Biol.; herein “Ryu”).
Regarding instant claims 90-91, the ‘590 claims teach an antibacterial composition comprising a biologically pure culture of Streptococcus salivarius strain Mia (i.e., strain M18, see definition of the strain name at instant specification para. 6) (‘590 claims 2 and 18-25). The ‘590 claims also teach that the composition may comprise S. salivarius K12 (‘590 claim 7). The ‘590 claims teach that the antibacterial composition may further comprise one or more secondary antibacterial agents (‘590 claim 5) and that the composition may be an orally administrable composition (‘590 claims 11-17).
However, the ‘590 claims do not teach that the antibacterial composition was formulated to comprise galactose or raffinose, as in instant claims 90-91.
Regarding claims 90-96, Ryu teaches that D-galactose inhibits biofilm formation by cariogenic S. mutans and that D-galactose may be a beneficial component in oral hygiene products because it inhibits biofilm formation by S. mutans but increases biofilm formation of commensal oral streptococci (Abstract).
Therefore, it would have been prima facie obvious, to a person of ordinary skill in the art, to formulate the oral composition of the ‘590 claims to further comprise D-galactose, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because Ryu teaches that D-galactose inhibits biofilm formation of cariogenic S. mutans while promoting biofilm formation of commensal streptococci. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because the composition of the ‘590 claims may comprise additional antibacterial agents, and Ryu suggests that D-galactose may be useful in oral hygiene products. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., S. salivarius M18 and K12 and galactose) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Regarding the intended uses “improving the inhibitory profile of Streptococcus salivarius” recited in claim 90 and “upregulating one or more genes in Streptococcus salivarius” recited in claim 91, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Because the composition of Jin is substantially identical to the claimed compositions (i.e., comprising S. salivarius K12 and/or M18 and galactose), the composition of Jin is presumed to have the same properties, absent evidence to the contrary. MPEP 2112.02(II) states: “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).” Furthermore, MPEP 2112.01(I) states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.” Claims 92-94 further limit the intended use of claim 91. Because claims 92-94 do not limit the claimed method step or the structure of the composition recited in claim 91, claims 92-94 are also taught by Jin.
18/546,044
Claims 90-96 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12, 15, 20, 22-25, 29-31, 36, and 40 of copending Application No. 18/546,044 (‘044) in view of Ryu et al. (2020, Arch. Oral Biol.; herein “Ryu”). This is a provisional nonstatutory double patenting rejection.
Regarding claims 90-91, the ‘044 claims teach an oral composition comprising S. salivarius (‘044 claims 1-2, 4, 5-9, 12, 15, 20, 22-25, 29, 36, and 40), wherein the S. salivarius is S. salivarius M18, S. salivarius K12, or a combination thereof (‘044 claims 3 and 29-31).
However, the ‘044 claims do not teach that the oral composition was formulated to comprise galactose or raffinose, as in instant claims 90-91.
The teachings of Ryu with respect to instant claims 90-96 and the motivation to combine with the composition of the ‘044 claims are the same as that set forth in the rejection over US 7,226,590 above (para. 25-28).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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, DANIEL KOLKER can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BAILEY M MORGAN/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645