DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendments
1) Acknowledgment is made of Applicants’ preliminary amendments filed 06/02/26, 05/20/26 and 05/30/24.
Election
2) Acknowledgment is made of Applicants’ election filed 05/20/2026 in response to the species election requirement mailed 03/23/2026. Applicants have elected the Ligilactobacillus salivarius and the Ls-33 species, and the skin care composition species. Because Applicants did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (M.P.E.P § 818.03(a)).
Status of Claims
3) Claims 10-17 have been canceled via the preliminary amendment filed 05/30/2024.
Claims 1-9 have been amended via the preliminary amendment filed 05/30/2024.
Claims 10-17 have been canceled via the amendment filed 06/02/26.
Claims 1-9 are pending.
Claims 6-8 are withdrawn from consideration as being directed to a non-elected species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 1-5 and 9 are examined on the merits.
Drawings
4) Acknowledgment is made of Applicants’ drawings filed 05/30/2024.
Information Disclosure Statement
5) Acknowledgment is made of Applicants’ information disclosure statement filed 03/19/25. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Priority
6) The instant AIA application, filed 05/30/2024, is the national stage 371 application of PCT/EP2022/083302 filed 11/25/2021, which claims priority to the European application 20211430.0 filed 11/30/2021. A certified copy of the foreign priority document is made of record.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ) First Paragraph
7) The following is a quotation of 35 U.S.C § 112(a):
(a) IN GENERAL. - The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out the invention.
8) Claim 5 is rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 5 recites Ligilactobacillus salivarius Ls-33. It is apparent that the claimed Ligilactobacillus salivarius Ls-33 is required to practice the claimed invention. As the required element, the specifically recited Ligilactobacillus salivarius Ls-33 must be known and be readily available to the public, or obtainable by a reproducible method set forth in the specification. If not so obtainable or available, the enablement requirements of 35 U.S.C § 112(a) may be satisfied by a deposit of the claimed strain at an acceptable depository. Page 10 of the as-filed specification states that Ligilactobacillus salivarius Ls-33 (DGCC9868) was deposited by DuPont Nutrition Biosciences ApS in accordance with the Budapest Treaty at the Leibniz- Institut Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (DSMZ), Germany on 23 February 2021 under registration number DSM33831. A Notice or certificate of receipt from the depository documenting the deposition of the DGCC9868 strain biological material with the accession number DSM 33831 is made of record. Since the deposit has been made under the provisions of the Budapest Treaty, a statement, an affidavit or declaration by Applicants or assignees having the authority and control over the conditions of the deposit, or a statement by an attorney of record who has a registration number over his or her signature, is required under 37 C.F.R § 1.801-1.809. The statement should state that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced, if viable samples cannot be dispensed by the depository. This requirement is necessary when biological material deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each state. The statement should identify the deposited bacterial strain by its depository accession number, establish that the deposited strain is the same as the one described in the specification/claim, and establish that the deposited strain was in Applicants’ possession at the time of filing.
Applicants’ attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 C.F.R § 1.801-1.809 for further information concerning deposit practice.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), Second Paragraph
9) The following is a quotation of 35 U.S.C § 112(b):
(B) CONCLUSION - The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
10) Claims 1-5 and 9 are rejected under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) Claim 1 is ambiguous and indefinite in the limitation ‘reducing …’. The term ‘reducing’ is a relative term which is not specifically defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. What precise level of reduction is encompassed, and reduction compared to what, is unclear.
(b) Analogous rejection applies to claim 4 with regard to the relative limitation “increases”.
(c) Claims 2 and 3 are ambiguous and indefinite in the limitation ‘the bacterium of the species Ligilactobacillus salivarius’. Claims 2 and 3 depend from claim 1, which do not include any recitation of ‘a bacterium of species’. For the purpose of distinctly claiming the subject matter and/or for proper antecedence, it is suggested that Applicants replace the above-identified limitation with --the Ligilactobacillus salivarius--.
(d) Claim 9 is ambiguous and indefinite in the limitations “the composition comprises a ..... composition”. Is this composition recited in the dependent claim 9, for example, the elected skin care composition, a composition that is comprised within ‘a composition’ of broader scope recited in the independent claim 1? If not, it is suggested that Applicants replace the above-identified limitations in claim 9 with the limitations --the composition is a .... composition--.
(e) Claims 2-5 and 9, which depend directly or indirectly from claim 1, are also rejected as being indefinite because of the indefiniteness identified above in the base claim.
Claim(s) Interpretation
11) The description of ‘skin aging’ within the as-filed specification does not exclude, instead includes thinning of the skin. For example, the as-filed specification expressly states the following:
Most obvious change during aging of the skin is the thinning of skin ....
Furthermore, encompassed within the scope of ‘skin aging’ in the instant specification are at least wrinkles and skin aging due to UV radiation.
Due to the absence of a specific definition or description, the claim limitations in claim 4 that use “/” therein such as “metabolic activity/cell viability” and “metabolic activity/cell viability” (see lines 3-4) are interpreted as “metabolic activity” or “cell viability”.
Notice Re Prior Art Available under Both Pre-AIA and AIA
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 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.
Rejection(s) under 35 U.S.C § 102
12) 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 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.
13) Claims 1-5 and 9 are rejected under 35 U.S.C § 102(a)(1) or 102(a)(2) as being anticipated by US 20200376045 A1.
US 20200376045 A1 disclosed a method of treating a skin disorder such as UV-irritated skin, wrinkles, pigmented age spots, keratoses, dry skin and thinning skin in a patient in need thereof such as the elderly comprising topically administering a formulation comprising an effective amount of 106 to 1012 CFU of the Lactobacillus salivarius Ls-33 probiotic bacteria. Said formulation is a topical formulation suitable for application to the body surface including skin surface such as a lotion, cream, ointment, sprays, solution, gel, or paste, i.e., a skin care composition. See claims 1, 7, 8, 12-15, 17, 18 and 23; and sections [0037], [0040], [0056], [0065], [0082] and [0084]. The relevant parts of claim 1 of US 20200376045 A1 is set forth below:
1. A method for treating a skin disorder ................ in a patient in need thereof, wherein:
the method comprises topically administering a formulation comprising an effective amount of a probiotic bacteria ......... to a skin of said patient;
the probiotic bacteria is ....... Lactobacillus salivarius Ls-33, ......;
and,
the disorder is selected from the group consisting of psoriasis, acne, atopic dermatitis, dry skin, rashes, UV-irritated skin, detergent irritated skin, thinning skin and asthma.
7. The method according to claim 1, wherein the formulation comprises the probiotic bacteria .........
8. The method according to claim 1, wherein the probiotic bacteria is .... Lactobacillus salivarius Ls-33.
12. The method according to claim 1, wherein the disorder is selected from the group consisting of psoriasis, acne, atopic dermatitis, dry skin, rashes, UV-irritated skin, detergent irritated skin and thinning skin.
15. The method according to claim 1, wherein the formulation is selected from the group consisting of a cream, lotion, spray, solution, gel, ointment, paste, plaster, paint, bioadhesive or suspension.
17. The method according to claim 1, wherein the method comprises topically administering to the skin of the patient the probiotic bacteria.
18. The method according to claim 17, wherein the method comprises topically administering from 106 to 1012 CFU of the probiotic bacteria per day.
23. The method according to claim 1, wherein the patient is a human.
The prior art probiotic Lactobacillus salivarius Ls-33 strain is the same as the instantly recited Ligilactobacillus salivarius Ls-33 absent evidence to the contrary. That the prior art Lactobacillus salivarius Ls-33 is the same as the Ligilactobacillus salivarius Ls-33 as claimed in instant claim 5 is inherent from the disclosure of the prior art in light of what is well known in the art. For instance, Yang et al. teach that Lactobacillus salivarius is synonymous with Ligilactobacillus salivarius. See 1st full paragraph under the section “1. Introduction’ and the first sentence of ‘Abstract’ on page 1 of 21. No disclosure in the as-filed specification indicates that Applicants’ Ligilactobacillus salivarius Ls-33 is genetically or otherwise structurally modified in any way. Absent evidence of specific structural features that distinguish the claimed Ligilactobacillus salivarius Ls-33 from that of the prior art Lactobacillus salivarius Ls-33, there is sufficient overlap to reasonably conclude that the prior art Lactobacillus salivarius Ls-33 is one and the same as Applicants’ Lactobacillus salivarius Ls-33 necessarily having all the intrinsic characteristics, functions and effects of Applicants’ Ligilactobacillus salivarius Ls-33 including anti-skin-aging effects and those recited in claims 2-4. Since the Office does not have the facilities for examining and comparing these Ls-33 strains, the burden is on the Applicants to show a novel or an unobvious difference between the instantly claimed product and the prior art product. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzerald et al., 05 USPQ 594.
Claims 1-5 and 9 are anticipated by US 20200376045 A1. The reference of Yang et al. is not used as a secondary reference in combination with US 20200376045 A1, but rather is used to show that every element of the claimed subject matter is disclosed by US 20200376045 A1 with the unrecited limitation(s) being inherent as evidenced by the state of the art. See In re Samour 197 USPQ (CCPA 1978). Note that the critical date of extrinsic evidence, Yang et al., showing a universal fact need not antedate the filing date. See MPEP 2124.
Double Patenting Rejection(s)
14) 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); and 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 §§ 706.02(1)(1) - 706.02(1)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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.aspto.gov/paients/process/fIle/efs/giiidance/eTD-mfo-I.jsp.
15) Claims 1-5 and 9 are rejected on the ground of non-statutory obviousness double patenting as being unpatentable over claims 6, 5, 4, 2, and 1 of US patent 10555977 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘977 patent claim a method for treating thinning skin, dry skin, rashes, UV-irritated skin, or detergent irritated skin comprising topically administering to a patient in need thereof a formulation formulated for administration to skin comprising Lactobacillus salivarius Ls-33 probiotic bacteria, which read on instant claims. As in In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008), that part of the specification of the ‘977 patent, for example, at lines 60-61 of column 12, which defines the Lactobacillus salivarius probiotic
bacteria identified the Ligilactobacillus salivarius Ls-33 strain as being covered by the definition indicating that the Ligilactobacillus salivarius Ls-33 strain was intended to fall within the coverage and/or meaning of the claims. Note that ‘[The specification] may be used to learn the meaning of terms and in interpreting the coverage of a claim’ [Emphasis added]. In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). With regard to the limitations in claims 2-4 reciting the effect(s) of the probiotic bacteria, these effects are the inherent functions or effects of the prior art 4Ls-33 probiotic strain intrinsic to and inseparable from the prior art strain.
Claim(s) Objection - Suggestion
16) In line 2 of claim 5, for clarity and to avoid redundancy, it is suggested that Applicants delete the parenthetic limitation “(Ls-33)”.
Conclusion
17) No claims are allowed.
Correspondence
18) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Supervisor of AU 1645, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
19) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
August, 2026
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