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 01/10/24 and 02/19/26. The claim amendment filed 02/19/26 along with the election is non-complaint under 37 CFR 1.121 in that claims drawn to the species non-elected by Applicants have incorrect status identifiers. Appropriate correction is needed.
Election
2) Acknowledgment is made of Applicants’ election filed 02/19/2026 in response to the species election requirement mailed 12/23/2025. Applicants have elected the live form of the B420 strain of Bifidobacterium animalis ssp. lactis 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 17-32 have been canceled via the preliminary amendment filed 01/10/24.
Claims 1-16 have been amended via the preliminary amendment filed 01/10/24.
Claims 1-16 are pending.
Claims 8, 9, 12 and 13 have been withdrawn from consideration as being directed to a non-elected species.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 1-7, 10, 11 and 14-16 are examined on the merits.
Drawings
4) Acknowledgment is made of Applicants’ drawings filed 01/10/2024.
Priority
5) The instant AIA application, filed 01/10/2024, is the national stage 371 application of PCT/EP2021/064227 filed 05/27/2021, which claims priority to the European application 20177151.7 filed 05/28/2020. A certified copy of the foreign priority document is made of record.
Claim 1, as amended via the preliminary amendment filed on 01/10/24, includes the
limitations “bacteria of one or more species of Bifidobacterium animalis” which lack antecedent basis and descriptive support in the prior application(s) to which priority is claimed. Accordingly, instant claims are not afforded the effective filing date of the prior applications.
Specification
6) The listing of references in the specification is not a proper way of information disclosure. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objection(s) to Specification
7) Claim 1 and the specification are objected to for the following reason(s):
37 CFR 1.75(d)(1) provides, in part, that ‘the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.’
Claim 1, as amended via the preliminary amendment filed on 01/10/24, includes the
limitations “bacteria of one or more species of Bifidobacterium animalis”. Applicants stated that the amendment is supported throughout Applicants’ specification including at lines 23-25 of page 5. Lines 23-25 of page 5 of the specification are set forth below which do not provide antecedent basis or support for the above-identified limitations:
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Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ) First Paragraph
8) 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.
9) Claims 7 and 10 are 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, because the specification does not provide evidence that the claimed biological material is (1) known and readily available to the public; (2) reproducible, e.g. sequenced; or (3) deposited.
Claims 7 and 10 recite Bifidobacterium animalis strain 420 (B420). It is apparent that the claimed Bifidobacterium animalis strain 420 (B420) is required to practice the claimed invention. As the required element, the specifically recited Bifidobacterium animalis strain 420 (B420) 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. The last two paragraphs of page 12 of the as-filed specification specifically identify the strain 420 (B420) as Bifidobacterium animalis ssp. lactis strain 420 (B420) that is commercially available from DuPont Nutrition Biosciences ApS. This part of the as-filed specification states that the strain of Bifidobacterium animalis ssp. lactis has been deposited under the reference DGCC420 by DuPont Nutrition Biosciences ApS, of Langebrogade 1, DK-1411 Copenhagen K, Denmark, in accordance with the Budapest Treaty on 30 June 2015 at the Leibniz-Institut Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (DSMZ), Inhoffenstrasse 7B, 38124 Braunschweig, Germany, where it is recorded under registration number DSM 32073. A Notice or certificate of receipt from the depository documenting the deposition of the DGCC420 strain biological material with the accession number DSM 32073 is made of record. If this deposit has indeed been made under the provisions of the Budapest Treaty, then 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 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
10) 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.
11) Claims 1-7, 10, 11 and 14-16 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) The inconsistent limitations: bacteria of “one or more species” of Bifidobacterium animalis in line 3 of claim 1 [Emphasis added] and the limitations: bacteria of “the species Bifidobacterium animalis” in claims 2-7, 10, 11 and 14 render the claims ambiguous and indefinite. Furthermore, it is unclear what are encompassed within “one or more species” of Bifidobacterium animalis, since animalis itself is a species of the Bifidobacterium genus. One of ordinary skill in the art cannot understand in an unambiguous way that which is being claimed.
Since Bifidobacterium animalis are inherently bacteria and Bifidobacterium animalis is a bacterial species, for the purpose of distinctly claiming the subject matter, it is suggested that Applicants delete the phrase “bacteria of the species” from lines 1-2 of claims 2-7, 10 and 14. along with the deletion of the phrase “of bacteria of one or more species” from line 3 of the base claim 1. Along with these amendments, the limitation “are” in line 2 of claims 2, 10 and 14 should be replaced with --is--; the limitation “maintain” in line 2 of claims 3 and 6 should be replaced with --maintains--; the limitations “increase” and “slow” in claims 3-5 should be replaced with –increases-- and –slows-- respectively; and the limitation –is-- should be inserted after the limitation “animalis” in line 2 of claim 11.
(b) Claim 7 is ambiguous and indefinite in the limitations “Bifidobacterium animalis comprise strain 420 ....” . It is unclear how Bifidobacterium animalis, a bacterium, can comprise within it the recited strain 420 as opposed to the Bifidobacterium animalis being the Bifidobacterium animalis strain 420.
(c) Claim 11 is ambiguous and indefinite in the limitations “the bacteria comprise bacteria of the species Bifidobacterium animalis in a live form”. It is unclear how said bacteria can comprise within them bacteria of the species Bifidobacterium animalis as opposed to the Bifidobacterium animalis being in a live form.
Claim 1 is ambiguous, inconsistent 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.
(e) Claims 2-7, 10, 11 and 14-16, 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
12) Due to the absence of a specific definition or description, the claim limitations in claim 3 that use “/” therein such as “metabolic activity/cell viability” and “metabolic activity/cell viability”, are interpreted as “metabolic activity” or “cell viability”. Likewise, the claim limitation “(MMP-1)/pro-collagen balance” in claim 6 is interpreted as “MMP-1” or “pro-collagen balance”.
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
13) 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.
14) Claims 1-7, 10, 11 and 14-16 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by WO 2012150269 A1 as evidenced by Klein et al. (European J. Clin. Nutrition 62: 584-593, 2008).
WO 2012150269 A1, having Kirsti Tiihonen as a co-inventor, disclosed the use of the Bifidobacterium lactis 420 probiotic bacterium for a skin disorder such as thinning skin in the elderly, dry skin, rashes, UV-irritated or detergent-irritated skin, wrinkles, or pigmented or non-pigmented age spots (i.e., part of skin aging) in a method of treating a patient suffering from the disorder comprising topically administering to the patient a formulation comprising live Bifidobacterium lactis 420 probiotic bacterium. The topical application included application to the skin surfaces via spreading or gentle rubbing. The formulation applied to body surfaces such as the skin included cream, lotion, sprays, solution, dermatological gels and ointments, paste etc such that moisture evaporating from the body surface is maintained upon application to the body surface, i.e., a skin care composition. See claims 12, 9, 7 and 8; two full paragraphs above ‘Detailed Description of the Invention’; lines 9-10 on page 21; lines 1-2 and 21-25 on page 5; pages 8; 1st and last full paragraphs on page 18; and 1st paragraph on page 2. The prior art solution formulation meets the composition recited in claim 16 for oral administration. The prior art probiotic Bifidobacterium lactis 420 strain is the same as the instantly recited 420 strain of Bifidobacterium animalis absent evidence to the contrary. With regard to the limitations in claims 3-6, reciting the effect(s) of the bacteria, these effects are the inherent functions or effects of the prior art 420 probiotic intrinsic to and inseparable from the prior art strain. That the prior art B. lactis 420 is the same as the Bifidobacterium animalis subsp. lactis DGCC420 that is recorded under the registration number DSM 32073 as expressly stated in the last two full paragraphs of page 12 of Applicants’ as-filed specification is inherent from the disclosure of the prior art in light of what was well known in the art. For instance, see Abstract of Klein et al. European J. Clin. Nutrition 62: 584-593, 2008. No disclosure in the as-filed specification indicates that Applicants’ 420 strain of Bifidobacterium animalis is genetically or otherwise structurally modified in any way. Absent evidence of specific structural features that distinguish the claimed 420 strain of Bifidobacterium animalis from that of the prior art, there is sufficient overlap to reasonably conclude that the prior art Bifidobacterium animalis 420 strain is one and the same as the Applicants’ 420 strain of Bifidobacterium animalis necessarily having all the intrinsic characteristics, functions and effects of Applicants’ 420 strain of Bifidobacterium animalis. Since the Office does not have the facilities for examining and comparing these 420 strains of Bifidobacterium animalis, 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 1-7, 10, 11 and 14-16 are anticipated by WO 2012150269 A1. The reference of Klein et al. is not used as a secondary reference in combination with WO 2012150269 A1, but rather is used to show that every element of the claimed subject matter is disclosed by WO 2012150269 A1 with the unrecited limitation(s) being inherent as evidenced by the state of the art. See In re Samour 197 USPQ (CCPA 1978).
Double Patenting Rejection(s)
15) 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.
16) Claims 1-7, 10, 11, 14, 15 and 16 are rejected on the ground of non-statutory obviousness double patenting as being unpatentable over claims 6, 4, 5, 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 the Bifidobacterium lactis 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 57-58 of column 12 and lines 48-49 of column 4, which defines the preferred embodiment of the Bifidobacterium lactis probiotic bacteria identified Bifidobacterium lactis 420 species as being covered by the definition indicating that the 420 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 3-6 reciting the effect(s) of the bacteria, these effects are the inherent functions or effects of the prior art 420 probiotic strain intrinsic to and inseparable from the prior art strain.
Claim(s) Objection - Suggestion
17) In line 2 of claim 1, for clarity, it is suggested that Applicants replace the phrase “wherein the method comprising” with the phrase --wherein the method comprises--.
Conclusion
18) No claims are allowed.
Correspondence
19) 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.
20) 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
March, 2026
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