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 .
Claim Status
The amended claim set filed 27 Sep 2024 is acknowledged. Claims 15-23 are currently pending. Of those, all claims are new. Claims 1-14 are cancelled. Claims 15-23 will be examined on the merits herein.
References to the specification in this action will use paragraph numbers found in the pre-grant publication (US-20250009818-A1; PTO-892) to avoid potential ambiguity in the event of amendments to the specification that would affect the page and line numbers.
Priority
The instant application claims priority to foreign document IT102021000017855 (filed 6 July 2021) and is a 371 of PCT/IB2022/056244 (filed 6 July 2022). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, the foreign priority document does not recite the Lacticaseibacillus paracasei m.biome LIVESKIN88 (DSM 33788) strain that is required by claims 15-23. Therefore, the effective filing date for claims 15-23 used for searching the art is 6 July 2022. If the applicant disagrees with this examiner’s determination of effective filing date for any claim, the applicant may identify text within the prior applications that provides support the claimed language.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3 Jan 2024, 25 Apr 2024, and 2 Apr 2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
Drawings
The drawings are objected to because they do not comply with 37 C.F.R. 1.84 and/or do not show the details described in the specification. Reference is made to the following sections of 37 C.F.R. 1.84:
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. …
(o) Legends. Suitable descriptive legends may be used subject to approval by the Office, or may be required by the examiner where necessary for understanding of the drawing. They should contain as few words as possible.
(p) Numbers, letters, and reference characters. … (3) Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height. They should not be placed in the drawing so as to interfere with its comprehension. Therefore, they should not cross or mingle with the lines. They should not be placed upon hatched or shaded surfaces. When necessary, such as indicating a surface or cross section, a reference character may be underlined and a blank space may be left in the hatching or shading where the character occurs so that it appears distinct.
Figure 4: The text is in grey rather than black ink and is small.
Figure 5: The text does not use solid lines (resulting in blurry text upon reproduction) and is small. The title of the left panel is particularly difficult to read.
Figures 6-10: The text is lengthy (specifically the right panel), does not use solid lines (resulting in blurry text upon reproduction) and is small, and in some cases uses grey rather than black ink. It is requested that the lengthy text not used to label the figures be moved to the figure legend section of the specification.
Figure 12: The text is lengthy (specifically the right panel) and does not use solid lines (resulting in blurry text upon reproduction). Also, the label text in the left panel is small and blurred by non-solid lines. It is requested that the lengthy text not used to label the figures be moved to the figure legend section of the specification.
Figures 13, 16B, 18B, 19B: The text is not in black ink and has been placed on a shaded surface.
Figure 17: There appear to be labels on the lids of the plates, but the labels are not legible. Also, the text refers to “yellowing” of the media [0238] but there is no yellow in this figure because it is in black-and-white. See requirements for submitting color photographs below.
Figures 20-25: The text is small. The text in the upper right corner and the labels along the bottom are small, grey, and not in solid lines, rendering it illegible. In Figure 25, the letters used to indicate statistical significance cannot be read because they are too small and blurry.
Figure 32: The labels at the bottom of the bar graph do not use solid lines and are difficult to read due to the small size of the text.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(b)
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.
Claims 15-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 15 and 21, these claims contain the trademark/trade name LIVESKIN88™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a Lacticaseibacillus paracasei strain and, accordingly, the identification/description is indefinite. Claims 16-20 and 22-23 are also rejected because they depend from claims 15 or 21 and do not obviate this grounds of rejection.
Regarding claim 15, the claim recites “a skin disease caused by Streptococcus aureus, a wound, or aging skin.” The claim is indefinite because it is unclear whether the skin disease can be caused by any of Streptococcus aureus, a wound, or aging skin (i.e. (1) a skin disease caused by (a) Streptococcus aureus, (b) a wound, or (c) aging skin), or whether the subjects include those with any wound or aging skin including those that cannot be considered to have a skin disease (i.e. (1) a skin disease caused by Streptococcus aureus, (2) a wound, or (3) aging skin). Therefore, one of ordinary skill in the art would not be able to determine which subjects are included in the claim due to ambiguity in the wording.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Regarding claim 21, the claim recites “A composition comprising: Lacticaseibacillus paracasei m.biome LIVESKIN88 (DSM 33788), wherein said composition is formulated for topical administration.” The limitation “formulated for topical administration” could mean as little as bacteria present in water, because such a composition is capable of being applied topically. Applicants have asserted that the probiotic strain was originally isolated from a natural source (the vaginal mucosa of a healthy woman) and that no modifications were observed to the strain during the isolation process (Response to Request for Information filed 23 Feb 2026). Therefore, the isolated, deposited L. paracasei strain in water does not have markedly different properties from the natural bacteria before isolation. In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. In this case, like Myriad, the claimed composition differs from the natural product only by isolation that does not introduce markedly different properties.
This judicial exception is not integrated into a practical application because claim 21 does not have any additional elements that are claimed. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 21 does not have any additional elements that are claimed.
Regarding claim 22, the claim limits claim 21 and further recites “the composition is formulated as a gel, cream, emulsion, ointment or foam.” As analyzed above for claim 21, the bacteria is not markedly different from the natural product. (Step 2A Prong One: YES) The specific formulation as a gel, cream, emulsion, ointment or foam is an additional element. However, this judicial exception is not integrated into a practical application for the following reasons, see MPEP 2106.04(d). The formulation does not apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition because the claim is a product and isn’t limited to a particular disease or condition. It does not improve the functioning of a computer or use the judicial exception in a particular machine. The claimed formulation does not change the bacteria from one thing to a different thing, so it is not a particular transformation. Instead, the variety of different composition formulations and the generality with which they are claimed amount to generally linking the judicial exception to the technical environment of pharmaceutical compositions. (Step 2A Prong Two: NO) The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because, in addition to the analysis for Prong Two above, the formulations are also well understood, routine, and conventional activity. The instant specification [0077] teaches that the listed formulations are examples of products that “can be prepared according to the methods known in the art” and does not give any information on how to prepare these formulations other than pointing to the knowledge in the art. Also, Barnes et al. (2021; PTO-892) is a review of topical vehicles for cosmetics (Abstract). Barnes teaches that “common” topical vehicles include ointments, creams, gels, and foams, and also teaches that both ointments and creams are emulsions (Table 1). Therefore, the additional element also does not amount to significantly more (Step 2B: NO).
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 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/280,926 in view of Barnes et al. (2021; hereafter Barnes; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 21, ‘926 claim 1 teaches Lacticaseibacillus paracasei m.biome LIVESKIN88 deposited at the Deutsche Sammlung von Mikroorganismen und Zelikulturen GmbH (DSMZ) with deposit number DSM 33788, and ‘926 claim 2 (and dependent claims) teaches a composition comprising the bacteria of claim 1. ‘926 claim 9 teaches the composition can be for topical use.
The claims of ‘926 do not teach the composition is formulated as a gel, cream, emulsion, ointment or foam, as in claim 22.
Barnes is a review of topical vehicles for cosmetics (Abstract). Barnes teaches that “common” topical vehicles include ointments, creams, gels, and foams, teaches that both ointments and creams are emulsions, and teaches benefits for each different formulation (Table 1).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the generic topical formulation of the claims of ‘926 by choosing to formulate it in one of the common topical formulations of Barnes, thereby arriving at the claimed invention, because the combination would be desirable because using the teachings of the art when formulating the topical formulation would reduce the amount of experimentation needed to create a successful formulation, and would also allow the person of ordinary skill to gain the known benefits from these common formulations. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the use of known techniques to improve similar devices, methods or products in the same way is obvious because enhancing a particular class of devices, methods, or products has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. In the instant case, the claims of ‘926 teach a “base” product for topical application comprising all possible formulations, and Barnes teaches a comparable product for topical application wherein the use of a gel, cream, emulsion, ointment or foam as the formulation is taught as advantageous. Thus, one of ordinary skill in the art could have applied the known technique of Barnes to the base method taught by the claims of ‘926 to yield predictable results (i.e. the same advantages). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
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, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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