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 .
Applicant’s Amendment
1) Acknowledgment is made of Applicant’s amendment filed 05/12/2026 in response to the non-final Office Action mailed 02/12/2026.
Status of Claims
2) Claims 1, 4, 5, 8, 12-14, 17 and 18 have been amended via the amendment filed 05/12/2026.
Claims 2 and 3 have been canceled via the amendment filed 05/12/2026.
Claims 1 and 4-18 are pending.
Claims 1, 4-10 and 18 are under examination.
Substitute Specification
3) Applicant’s substitute specification filed 05/12/26 is acknowledged.
Replacement Drawings
4) Applicant’s replacement drawings filed 05/12/26 are acknowledged.
Objection(s) Moot
5) The objection to claims 2 and 3 set forth in paragraph 17 of the Office Action mailed 02/12/26 is moot in light of Applicants’ cancellation of the claims.
Objection(s) Withdrawn
6) The objections to the specification and certain drawings set forth in paragraphs 7(a) to 7(c) are withdrawn in light of Applicants’ amendments thereto.
Prior Citation of Title 35 Sections
7) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action References.
Prior Citation of References
8) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Rejection(s) Moot
9) The rejection of claims 2 and 3 set forth in paragraph 9 of the Office Action mailed 02/12/2026 under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, with regard to the written description issue is moot in light of Applicant’s cancellation of the claims.
10) The rejection of claim 2 set forth in paragraph 12 of the Office Action mailed 02/12/2026 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is moot in light of Applicant’s cancellation of the claim.
Rejection(s) Withdrawn
11) The rejection of claims 1, 4-10 and 18 set forth in paragraph 9 of the Office Action mailed 02/12/2026 under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, with regard to the written description issue is withdrawn in light of Applicant’s claim amendments. A new rejection is set forth below to address the claims as amended.
12) The rejection of claim 18 set forth in paragraph 12(a) of the Office Action mailed 02/12/2026 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is withdrawn in light of Applicant’s claim amendment.
13) The rejection of claims 8 and 18 set forth in paragraph 12(b) of the Office Action mailed 02/12/2026 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is withdrawn in light of Applicant’s claim amendments.
14) The rejection of claims 1, 6-10 and 18 set forth in paragraph 15 of the Office Action mailed 02/12/2026 under 35 U.S.C § 102(a)(1) as being anticipated by Navarro-Lopez et al. (Acta Derm. Venereol. 99: 1078-1084, E-published 27 August 2019, of record) Navarro-Lopez et al. (2019) is withdrawn in light of Applicants’ claim amendments. Applicant’s arguments have been considered, but are moot in light of the withdrawal of the rejection.
15) The rejection of claims 1, 6, 9 and 10 set forth in paragraph 16 of the Office Action mailed 02/12/2026 under 35 U.S.C § 102(a)(1) as being anticipated by Jung et al. (J. Cutan. Med. Surg. 17: 114-122, 2013, of record) is withdrawn in light of Applicants’ claim amendments. Applicant’s arguments have been considered, but are moot in light of the withdrawal of the rejection.
Claim(s) Interpretation
16) The limitation in claim 1 “Lactococcus lactis/Lactococcus cremoris” is interpreted as ‘Lactococcus lactis (Lactococcus cremoris)’ as per the description at line 27 of the as-filed specification.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ), First Paragraph
17) 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.
18) Claims 1, 4-10 and 18 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 reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for the pre-AIA the Applicant, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an analysis of the scope of the claims and of the variable genus encompassed therein indicates the following.
Claim 1, as amended, is representative of the claimed method. Claim 1, as amended, is drawn to a method for preventing or treating a dry and/or sensitive skin condition in a subject comprising administering a composition comprising at least two bacterial species selected from the group consisting of Bifidobacterium animalis, Lactobacillus brevis, Lactobacillus reuteri, and Lactococcus lactis/Lactococcus cremoris, the elected species being all the four recited bacterial species. The limitation ‘administering’ encompasses parenteral, i.e., intravenous, subcutaneous, intramuscular, intraperitoneal, intrathecal, intratracheal etc administration, mucosal, intratracheal, oral and rectal administration. While the composition recited in claim 9 is formulated for oral administration, the composition is not required to be administered orally in the claimed method. Each of these bacterial species represents a genus encompassing different strains or isolates within each genus. The divergent strain members or strain species of said genus are required to prevent or treat any generic dry and/or sensitive skin condition including psoriasis in a subject upon administering of the composition, orally or non-orally, to the subject. However, a review of the instant specification indicates that at the time of the invention, Applicant was not in possession of the full scope of the variable genus and of the method as claimed.
The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics, and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). Sufficient description to show possession of a genus may be achieved by means of description of a substantial number of the members or species of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would allow the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. In the instant application, a representative number and variety of strains of the at least two recited bacterial species within the genus have not been correlated with the above-identified requisite dry and/or sensitive skin condition-preventing or a dry and/or sensitive skin condition-treating therapeutic and prophylactic functions. Note that possession may not be shown by merely describing how to obtain members of the claimed genus or how to identify their common structural features. Applicant should note that written description requires more than a mere statement that something is a part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. A mere statement that the invention includes the elements and steps recited in the claims is insufficient to meet the adequate written description requirement of the claimed invention. A convincing structure-function relationship must exist between the structure of a representative number of the various bacterial species and the function(s) of said species.
A review of the as-filed specification indicates that the scope of instant claims is broader than that which is justified within the as-filed specification. Applicant acknowledges that “the present invention describes claimed compositions that function by reducing levels of the pro-inflammatory markers, including IL-17 and IL-23 levels, increasing levels of the anti-inflammatory marker such as IL-10, and/or restoring gut barrier function”. See page 8 of 11 of Applicants’ AMENDMENTS/REMARKS filed 05/12/26. The only combination of bacterial species that was evaluated for effects on IL-17 and IL-23 produced by anti-CD3/anti-CD28-stimulated PBMCs after co-incubation in vitro was the combination of the very specific strains of Lactobacillus reuteri species, Lactococcus brevis species, Lactococcus lactis (Lactococcus cremoris) species and Bifidobacterium animalis species, i.e., L. reuteri W192, L. brevis W63, Lc. cremoris W224, and B. animalis W53 strains. See Table 1, Figure 7 and Figure 8 drawings and their descriptions on pages 18-19 of the as-filed specification. Further, human subjects suffering from psoriasis having skin irritability, skin itchiness, skin flakiness and skin redness were orally administered with 3 g of a sachet/powder composition comprising > 3.99 x 109 cfus of each of the specific W53, W63, W192 and W224 strains for 56 days. Said participants showed various degrees of improvement in skin irritability, skin itchiness, skin flakiness and skin redness in vivo. See Example 1, Table 1, and Figures 2-5 of instant application. Based on these evaluations, the specification stated the following (see lines 11-13 of page 19) [Emphasis added]:
..... the present invention is based on studies by the inventors in which they have shown that certain probiotic ...... strains are able to reduce IL-17 and IL-23 levels .....
However, this single combination of very specific strains of Lactobacillus reuteri species, Lactococcus brevis species, Lactococcus lactis (Lactococcus cremoris) species and Bifidobacterium animalis i.e., a mixture of W192, W63, W224, and W53, is not representative of the genus as claimed. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated”).
The written description inquiry is case-specific and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372. [Emphasis added]. According to MPEP 2163 [Emphasis added]:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. This is important in the instant application because the art recognizes that ameliorating a disease by probiotics is strain-specific. For example, see title; the 3rd full sentence of 1st full paragraph and the last full sentence of the paragraph bridging the two columns of page 6; and the last sentence under section ‘5. Conclusion’ of Fang et al. Strain-specific ameliorating effect of Bifidobacterium longum on atopic dermatitis in mice. J. Function. Foods 60: 103426, pages 1-9, September 2019 (of record). Further, Gao et al. (Peer J. 7: e7117, pages 1/24-24/24, June 2019, of record) taught that the probiotic effects are dependent on the nature of the strain by stating that “.... the efficacy ..... varies, depending on the types and strains of probiotics”. See third paragraph of page 2 of Gao et al. Further, with regard to the use of combinations of probiotics in human health, Hmar et al. (Endocr. Metab. Immune Disord. Drug Targets 24: 1-12, 2024, of record) taught that even though a product contains more probiotic strains, that does not always guarantee that the health benefits will be more significant. Hmar et al. further taught that “For specific combinations to be justified, there must be clinical proof ........ picking the right probiotic is essential yet tricky because of several factors, including probiotic products with the disease and strain-specific effectiveness exists ... various probiotic strains have diverse modes of action” [Emphasis added]. See Abstract of Hmar et al. The disclosure in Applicant’s as-filed specification itself indicates that not all probiotic bacterial species and strains, instead only “certain probiotic species and strains” are able to reduce IL-17 and IL-23 levels (see lines 11-13 of page 19) [Emphasis added]:
..... the present invention is based on studies by the inventors in which they have shown that certain probiotic species and strains are able to reduce IL-17 and IL-23 levels .....
While claim 1, as amended, recites the four specific probiotic bacteria species, each encompasses structurally, antigenically, genetically and functionally variable strains therein. The issue of strain variation is particularly important in the instant application because the pertinent probiotic literature even after the effective filing date of the instant application documents key differences between effective and ineffective probiotics in ameliorating psoriasis. For example, Lu et al. Nutrients 13(6), 2010, 11 June 2021 showed that not only certain probiotics are effective in ameliorating psoriasis, while other probiotics were ineffective in ameliorating psoriasis, but also certain strains within a specific probiotic bacteria species. Lu et al. demonstrated that while L. reuteri CCFM1132 ameliorated pathological characteristics of psoriasis and suppressed the release of IL-23/T helper cell 17 (Th17) axis-related inflammatory cytokines, another strain CCFM1040 of the same L. reuteri species neither alleviated the pathological characteristics nor reduced the levels of inflammatory cytokines. This clearly documents the art-recognized strain-specific anti-psoriasis effects of L. reuteri. See Abstract; and section 3.5 of Lu et al. Lu et al. also demonstrated that Bifidobacterium animalis strain CCFM1148 neither alleviated the pathological characteristics nor reduced the levels of inflammatory cytokines. See at least Abstract. This is relevant and important in the instant application because L. reuteri and Bifidobacterium animalis are two of the genus of bacterial species comprised in the composition that is administered in the instantly claimed method. The demonstration by Lu et al. is indicative of the importance of probiotic strain selection when treating a dry and/or sensitive skin condition such as psoriasis. The teachings of Lu et al. document the unpredictability associated with the anti-psoriasis therapeutic effect among different strains of the same probiotic bacterial species. Thus, what is stated in the as-filed specification as well as what is documented in the relevant probiotic literature clearly indicate that not all strains of probiotics or Lactobacteria, encompassed within the scope of the recited genus of ‘at least two bacterial species’ can be predicted to be capable of treating or preventing sufficient number of species within the dry and/or sensitive skin condition genus including psoriasis species and decreasing Il-17 and IL-23 levels. Clearly, at the time of the invention, Applicant was not in possession of the full scope of the method of preventing or treating a dry and/or sensitive condition in a subject as claimed, the method comprising administering at least two bacterial species as claimed. A mere idea or unsubstantiated function is insufficient for written description; characterization of a representative number of species in an unpredictable art, with their precise structure correlated with the requisite functions, is required in order to claim the broad genus. Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) states:
"When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" [Emphasis added].
A convincing structure-function correlation is lacking for the variant genus in the instant application. Clearly, the specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicant was in possession of each of the variant genus and the full scope of the claimed invention at the time of filing.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown in a variety of ways including by showing that the invention was “ready for patenting”. MPEP 2163. MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph is severable from its enablement provision. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph. Instant claims do not meet the provision of 35 U.S.C § 112 (pre-AIA ), first paragraph or 35 U.S.C § 112(a).
Conclusion
19) No claims are allowed.
20) Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
21) 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 Examiner’s Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
22) 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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