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 .
Amendments Received
Amendments to the claims were received and entered on 11/07/2025.
Status of Claims
Claim 2 is cancelled and claim 19 is newly added.
Claims 1, 3, and 5-19 are currently pending.
Claims 1, 15 and 19 are under consideration, as claims 3, 5-14, and 16-18 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/IB2020/055326 filed on June 5, 2020 and claims priority to Italian application IT102019000008097, filed on June 5, 2019. Acknowledgment is made of applicant’s claim for foreign priority and papers submitted under 35 U.S.C. 119(a)-(d). The present application and all claims are being examined with an effective filing date of June 5, 2019. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Withdrawn Objections
In view of Applicant’s amendments, the objection to claim 15 is hereby withdrawn.
Maintained/Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gueniche, A. (US2010/0226892A1, cited in a previous office action), Balzaretti et al. (The vaginal isolate Lactobacillus paracasei LPC-S01 (DSM 26760) is suitable for oral administration, Sept 2015, Front. Microbiol. 6:952, pg. 1-13, cited in a previous office action) and Jeong et al. (Probiotic Lactic Acid Bacteria and Skin Health, Critical Reviews in Food Science and Nutrition, 56:2331–2337 (2016), cited in a previous office action).
Regarding claims 1 and 15, Gueniche teaches that skin irritation involves a cascade of reactions involving cytokines (e.g., TNF-α) and chemokines (e.g., IL-8) and that NF-kB activation results in the transcriptions of many genes involved in inflammation, including cytokines and chemokines (Specification, para 0011 and 0015). Gueniche further teaches the use of Lactobacillus paracasei as an active agent for preventing and/or treating skin irritation and disorders, through topical or oral administration. More specifically, Gueniche teaches “a cosmetic treatment method for preventing and/or treating irritative skin disorders, especially irritated skin, comprising the administration, especially orally or topically, of an effective amount of at least one microorganism belonging to the species Lactobacillus paracasei , a fraction thereof, or a metabolite thereof” (para 0025-0028 and 0031). Gueniche further teaches that such microorganisms may be employed in live (viable), semi-active, or inactivated forms; in one particular embodiment, “these microorganisms are employed in a live form” (para 0100-0101). The non-pro-inflammatory nature of L. paracasei (ST11) is confirmed using a co-culture model with Caco-2 cells and IL-8 readouts (see Example 2, para 0218-0226 and Fig. 1), supporting Gueniche’s teaching that L. paracasei strains such as ST11 can modulate immune responses associated with skin irritation, forming a basis for their inclusion in topical or oral skin care formulations. With respect to the limitation requiring hyaluronic acid or a salt thereof, Gueniche teaches said composition can advantageously also include “active agents which promote desquamation”…such as the active hydrating agent hyaluronic acid (para 0160). Gueniche also teaches the formulation of such compositions as anti-sun creams, after-sun milks or lotions, and other topically applied skincare formulations (para 0165), and discusses UV radiation as an environmental factor affecting skin health (para 0003). Accordingly, Gueniche teaches/suggests the use of viable L. paracasei in compositions further comprising hyaluronic acid, formulated to protect or repair UV-damaged skin, supporting its application in treating sun-induced skin inflammation or barrier disruption. With respect to the specific L. paracasei strain, Gueniche discloses several exemplary compositions comprising Lactobacillus paracasei strain ST11 (Examples 1a-1j, para 0203-0217), but does not expressly teach the specific Lactobacillus paracasei strain, LPC-S01.
Balzaretti et al. teaches the Lactobacillus paracasei strain LPC-S01 (DSM 26760), a human vaginal isolate included in probiotic preparations for vaginal (topical) use marketed in Europe (pg. 10, left column, 1st para). Balzaretti states that LPC-S01 has been evaluated for oral administration and immunomodulatory potential and discloses that LPC-S01 possesses probiotic properties, including the ability to reduce NF-κB activation in Caco-2 cells (pg. 7, left column last para-right column, 1st para), and that the strain performs similarly to other L. paracasei strains, such as Shirota and DG, with respect to immunomodulation (pg. 10, left column, last para-right column, first para). Comparative genomic analysis further reveals that LPC-S01 possesses the genetic features of a niche-generalist member of its species (pg. 12, right column), supporting a broader range of potential applications.
Jeong et al. teaches that “the probiotic L. paracasei was shown to decrease skin sensitivity and increase the recovery rate of skin barrier function” (pg. 2331, bottom right column) and “accelerates the recovery of skin barrier function and inhibits substance P-induced skin inflammation by modulating reactive-associated inflammatory mechanisms. Specifically, L. paracasei was shown to abrogate the release of substance P-induced TNF-α expression” (pg. 2333, right column). Jeong et al. further teaches that oral administration of L. paracasei “improves skin barrier function and prevents local skin inflammation by modulating the immune system in a disease-dependent manner” (pg. 2334, bottom left column), and strain KW3110 induces IL-12 expression and inhibits IgE secretion (pg. 2333, left column). These disclosures confirm that, at the time of the present invention, L. paracasei species were generally recognized for their topical anti-inflammatory and barrier-enhancing effects—providing further support for the expectation that one species member (ST11) could be substituted with another (LPC-S01) in Gueniche’s formulations (see MPEP 2144.06, “Substituting equivalents known for the same purpose”) and expect predictable results.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to substitute the Lactobacillus paracasei strain ST11 disclosed in Gueniche with the LPC-S01 strain taught by Balzaretti et al., motivated by the similar probiotic and immunomodulatory properties demonstrated in both strains, including reduction of NF-kB activation and IL-8 expression in Caco-2 cell models, and expect predictable results. Said practitioner would further be motivated to incorporate hyaluronic acid, as taught by Gueniche, as an active hydrating agent that promotes desquamation and supports restoration of the skin barrier. Combining two compositions (L. paracasei and hyaluronic acid) each of which is taught by the prior art to be useful for the same purpose (supporting skin barrier function), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). Said practitioner would also be motivated by the teachings of Jeong et al. which confirms that L. paracasei strains are known to improve skin barrier function and reduce skin sensitivity and inflammation. In view of Gueniche’s teachings that hyaluronic acid is advantageously included in topical formulations for irritated or UV-damaged skin, and the suggested functional equivalence between LPC-S01 and other strains with respect to anti-inflammatory properties, a person of ordinary skill in the art would have reasonable expectation of success in arriving at a formulation according to claim 1. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gueniche, Balzaretti et al., and Jeong et al., as applied to claim 1 above, and further in view of Takayama et al. (WO2018216744, English translation relied upon, cited in a previous office action).
The combined teachings of Gueniche, Balzaretti et al., and Jeong et al., as applied to claim 1 have already been discussed. Briefly, Gueniche Regarding claim 19, Gueniche teaches that a composition for topical application, as described above, may comprise 10³-10¹²cfu/g of microorganism (para 0097), which may be in live (viable) form (para 0100). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (see MPEP 2144.05). However, neither Gueniche, Balzaretti et al., nor Jeong et al. explicitly teach the claimed ranges of hyaluronic acid.
Takayama et al. teaches topical cosmetic compositions comprising Lactobacillus paracasei (Specification, pg. 2-3), further comprising hyaluronic acid, or a salt thereof (pg. 7). Takayama et al. specifically discloses an exemplary cream formulation wherein hyaluronic acid sodium is present in an amount of 0.1% (pg. 21). It is noted that 0.1% lies within the claimed 0.01-2 wt% range for low molecular weight hyaluronic acid and within the 0.005-1 wt% range for medium/high molecular weight hyaluronic acid. In the absence of evidence of criticality or unexpected results associated with the endpoints or subranges, selecting 0.1 wt% would have been nothing more than routine optimization of a result-effective variable. Pursuant to MPEP 2144.05, “in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Although Takayama et al. does not expressly define the molecular weight of the hyaluronic acid employed in the exemplary formulation, hyaluronic acid for topical cosmetic use and in the pharmaceutical arts was well known before the effective filing date to be available in all weight grades (e.g., low, medium, and high molecular weight). A person of ordinary skill in the art would have understood that any of these conventional grades, alone or in combination, could be employed in the probiotic formulations of Gueniche and Takayama et al. to achieve routine adjustments in viscosity, skin feel, and penetration, without altering the fundamental properties of the composition. In the absence of evidence of criticality or unexpected results associated with selecting low molecular weight with medium/high molecular weight hyaluronic acid, the recited selection represents nothing more than a matter of design choice. Accordingly, the selection of one or more molecular weight forms of hyaluronic acid would have been an obvious variation of the hyaluronic acid taught by Takayama et al. (and Gueniche above).
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to formulate the composition taught by Gueniche using hyaluronic acid in an amount of 0.1%, as taught by Takayama et al., and to select any combination of the conventional molecular weight forms (low, medium, and/or high) of hyaluronic acid for use in said composition. Said practitioner would have been motivated to optimize the known hyaluronic acid containing L. paracasei skin formulations of Gueniche by using a routine cosmetic hyaluronic acid level (0.1%) as specifically exemplified by Takayama et al., with a reasonable expectation of achieving the claimed formulation. There is a reasonable expectation of success because Takayama et al. successfully demonstrates the inclusion of such amounts of hyaluronic acid in a probiotic formulation, comprising L. paracasei, for skin application. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments for Rejections under 35 USC § 103
In the response filed on 11/07/2025, Applicant argues that the claimed composition is non-obvious based on experimental data allegedly demonstrating enhanced effects arising from the combination of viable Lactobacillus paracasei LPC-S01 and hyaluronic acid. Applicant further contends that the cited prior art does not teach or suggest the claimed composition, including the claimed concentrations and forms of hyaluronic acid. These arguments are not persuasive for the reasons outlines below.
Regarding the allegation of unexpected results, Applicant relies on an in vitro 3D skin model (P3 mixture) in which approximately 8×10⁹ CFU of LPC‑SO1 are resuspended in “a hyaluronic acid‑based aqueous solution.” However, the alleged results do not represent a property or effect that would have been unexpected in view of the prior art. Gueniche teaches that L. paracasei strains modulate NF‑κB‑mediated inflammatory pathways and are useful for preventing and/or treating skin irritation and disorders when administered in topical formulations, and further suggests inclusion of hydrating agents such as hyaluronic acid in such compositions. Balzaretti et al. teaches that LPC-S01 exhibits probiotic and immunomodulatory properties comparable to other L. paracasei strains , and Jeong et al. teaches that L. paracasei improves skin barrier function, accelerates recovery of skin barrier function, and inhibits inflammatory mediators such as substance P‑induced TNF‑α expression. Additionally, hyaluronic acid is well known in the cosmetic and pharmaceutical arts to improve skin hydration and support skin structure. In view of these teachings, a person of ordinary skill would have reasonably expected that combining a known anti‑inflammatory, barrier‑supporting probiotic, L. paracasei, with hyaluronic acid in a topical formulation for UV‑stressed skin would provide improved protection of skin structure relative to either component alone. Pursuant to MPEP 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Applicant’s data showing that one particular combination preserves the dermal‑epidermal junction morphology better than either component alone therefore reflect, at most, an expected enhancement in the same direction taught by the prior art (improved skin barrier integrity and reduced inflammation), i.e., a difference in degree rather than a difference in kind. Such results are insufficient to outweigh the prima facie case of obviousness.
Applicant’s arguments are therefore unpersuasive and the rejections are maintained.
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 1, 15, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In view of the 2019 PEG (“The 2019 Revised Patent Subject Matter Eligibility Guidance” (2019 PEG) found at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf ), based upon an analysis with respect to the claims as a whole, claims 1-2 and 15 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
Claim 1 does not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “Subject Matter Eligibility” found at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility ; as well as Subject Matter Eligibility Examples: Life Sciences at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf ).
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ), the claims are directed to an ineligible product as further detailed below.
In this case, the claims are directed to a composition of matter (Step 1) and recite natural phenomenon (in this case, naturally occurring bacteria) that is directed to a judicial exception (Step 2A).
Claim 1 recites “a composition comprising: (a) a mixture M comprising viable bacterial strain Lactobacillus paracasei LPC-S01…(b) hyaluronic acid or a salt thereof; wherein the composition is formulated as a cream, ointment, mask or lotion…”. Claim 19 recites the composition according to claim 1, in specific amounts. Lactobacillus paracasei LPC-S01 is a naturally occurring bacteria and hyaluronic acid (HA) is a natural substance, a glycosaminoglycan, found in the human body. Although claim 1 recites a combination of the L. paracasei strain and HA, the combination of natural products is not markedly different from the natural counterparts. The claimed composition does not result in a structural change to either component, nor is there evidence that the combination imparts a new or markedly different functional characteristic to either the bacterial strain or the hyaluronic acid. Rather, each component appears to person its known, conventional biological activity as it would in nature. In particular, the strain is alleged to exhibit anti-inflammatory benefits, while hyaluronic acid functions as a moisturizing or protective agent. These activities are consistent with the known properties of the individual components. As such, the combination of these components amounts to a mere aggregation of natural products that would not render the composition “markedly different” from its natural components or amount to significantly more thana judicial exception.
Thus, claims 1 and 19 read upon a composition of matter, as recited in Step 1, and a naturally occurring bacterium, i.e., a natural phenomenon as recited in Step 2A. The claim thus recites a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart, or is directed to a “product of nature” exception.
As to Prong 2 of Step 2A, the claims do not recite additional elements that integrate the judicial exception (natural phenomenon according to MPEP 2106.04(b)) into a practical application. “Integration into a practical application’ requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html )
Further, in view of Step 2B, the claims do not recite additional elements that amount to significantly more than the judicial exception. Claims 1 and 15 recite the additional limitations of the composition being formulated as a cream, ointment, mask or lotion. However, merely integrating products of nature into a formulation, such as a cream, ointment, mask or lotion, does not add meaningful limitation, as there is no indication that the combination of these components changes the structure or function of the bacterium itself. Creams, ointments, masks and lotions are conventional means of formulation that are routinely used for delivering cosmetic or therapeutic agents to the skin. The recited formulation thus represents well understood, routine, and conventional activity in the field and does not amount to tan inventive concept that would render the claims patent-eligible under Step 2B.
As such, the added limitations and elements discussed above are merely nominal components of the claims, and therefore the claims are directed to a product of nature. The claims do not include additional elements that are sufficient to amount to significantly more because the additional limitations are recited at a high level of generality, and as such cannot provide an inventive concept.
Therefore, claims 1, 15 and 19 do not recite eligible subject matter under 35 U.S.C.101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter.
Response to Arguments for Rejections under 35 USC § 101
In the response filed on 11/07/2025, Applicant argues that claim 1 should be found patent eligible in view of claim 4 of Example 28 in the 2014 101 guidelines. Applicant asserts that the use of a cream, emulsion, gel, liposome, nanoparticle, or ointment alters the properties of the natural product and that a parallel analysis may be performed for the present claims to arrive at the same conclusion. Applicant has also add claim 19 which recites the bacterial strain and different weight grades of hyaluronic acid, in a range of CFUs and weight percentages, respectively. Applicant’s arguments have been considered in full, and have not been found to be persuasive for the following reasons below.
The claims are directed to a composition comprising two nature‑based products—Lactobacillus paracasei LPC‑SO1 and hyaluronic acid or a salt thereof—formulated as a cream, ointment, mask, or lotion. Under the markedly different characteristics analysis of MPEP 2106.04(c), the relevant question is whether the claimed combination exhibits structural, functional, or other properties that are markedly different from the closest naturally occurring counterparts, i.e., the bacterium and hyaluronic acid individually. Example 28, claim 4, is found eligible because, under its broadest reasonable interpretation, the claim is directed to a vaccine composition comprising Peptide F in a pharmaceutically acceptable carrier in amounts sufficient to produce an immunogenic response and provide a dosage form suitable for administration. The example explains that the claim as a whole is focused on that man-made vaccine composition rather than on Peptide F per se. By contrast, claim 1 here merely recites a composition comprising a naturally occurring bacterial strain and hyaluronic acid in a cream, ointment, mask, or lotion vehicle, without reciting that the composition as a whole exhibits any markedly different characteristics compared to the natural bacterium and hyaluronic acid individually. In the absence of persuasive evidence that the claimed combination in a topical vehicle yields such markedly different characteristics, claim 1 remains directed to a nature-based product and thus to a judicial exception, and does not parallel the eligible vaccine claim of Example 28.
With respect to claim 19, absent evidence to the contrary, merely providing a naturally occurring product of nature at a higher concentration does not impose any meaningful characteristics to the actual structure or function of the strain. Acknowledgement is made of Applicant’s in vitro 3D model, (P3 mixture) in which approximately 8×10⁹ CFU of LPC‑SO1 are resuspended in “a hyaluronic acid‑based aqueous solution.” However, the specification does not disclose the concentration, percentage by weight, or molecular weight distribution of the hyaluronic acid present in that solution. Thus, the experiment does not establish that the particular hyaluronic acid concentration ranges or low‑ and medium/high‑molecular‑weight limitations recited in claim 19 are critical to achieving the reported effect. Evidence of unexpected results must be commensurate in scope with the claims and should demonstrate criticality of the claimed ranges. See MPEP 716.02(d) and 2145. Moreover, the claims encompass any cream, ointment, mask, or lotion comprising the recited strain and hyaluronic acid, across the full breadth of the recited bacterial CFU range and hyaluronic‑acid ranges and molecular‑weight forms. Applicant’s single 3D in vitro experiment, carried out with one formulation of unspecified hyaluronic acid content and distribution, does not provide a reasonable basis for concluding that all compositions within the scope of the claims exhibit the alleged synergistic reduction of UV‑induced structural damage. Accordingly, the evidence is not commensurate in scope with the claimed invention.
The argument is therefore unpersuasive and the rejection is maintained.
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 1 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims, 1, 3, 6 and 8 of copending Application No. 17/798,052 (reference application) in view of Gueniche, A. (US2010/0226892A1, cited in a pervious office action).
It is noted that the instant claims are directed to a composition for the intended use of treating skin, whereas the ‘052 claims are directed to a composition for the intended use of treating a viral infection. Pursuant to MPEP 2111.02 II: The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
With respect to the limitation wherein the composition is formulated as a cream, ointment, mask or lotion, Gueniche teaches compositions comprising L. paracasei and hyaluronic acid, formulated as creams and lotions (Specification, para 0165). Therefore, it would be obvious to a person of ordinary skill in the art to formulate the composition of ‘052 into a cream or lotion, as taught by Gueniche. Such formulations are well-known in the art and provide a predictable means of delivering compositions comprising a probiotic and hyaluronic acid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 19 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims, 1, 3, 6 and 8 of copending Application No. 17/798,052 (reference application) in view of Gueniche, A. (US2010/0226892A1, cited in a pervious office action) and Takayama et al. (WO2018216744, English translation relied upon, cited in a previous office action).
With respect to the claimed bacterial CFU and hyaluronic acid weight grades and weight percentages, Gueniche teaches that a composition for topical application, as described above, may comprise 10³-10¹²cfu/g of microorganism (para 0097), which may be in live (viable) form (para 0100). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (see MPEP 2144.05).
Takayama et al. teaches topical cosmetic compositions comprising Lactobacillus paracasei (Specification, pg. 2-3), further comprising hyaluronic acid, or a salt thereof (pg. 7). Takayama et al. specifically discloses an exemplary cream formulation wherein hyaluronic acid sodium is present in an amount of 0.1% (pg. 21). It is noted that 0.1% lies within the claimed 0.01-2 wt% range for low molecular weight hyaluronic acid and within the 0.005-1 wt% range for medium/high molecular weight hyaluronic acid. In the absence of evidence of criticality or unexpected results associated with the endpoints or subranges, selecting 0.1 wt% would have been nothing more than routine optimization of a result-effective variable. Although Takayama et al. does not expressly define the molecular weight of the hyaluronic acid employed in the exemplary formulation, hyaluronic acid for topical cosmetic use and in the pharmaceutical arts was well known before the effective filing date to be available in all weight grades (e.g., low, medium, and high molecular weight). A person of ordinary skill in the art would have understood that any of these conventional grades, alone or in combination, could be employed in the probiotic formulations of Gueniche and Takayama et al. to achieve routine adjustments in viscosity, skin feel, and penetration, without altering the fundamental properties of the composition. In the absence of evidence of criticality or unexpected results associated with selecting low molecular weight with medium/high molecular weight hyaluronic acid, the recited selection represents nothing more than a matter of design choice. Accordingly, the selection of one or more molecular weight forms of hyaluronic acid would have been an obvious variation of the hyaluronic acid taught by Takayama et al. (and Gueniche above).
Response to Double Patenting Rejections
In the response filed on 11/07/2025, Applicant asserts that the double patenting rejections have been addressed by the amendments to the claims and arguments presented above. Applicant’s arguments are not persuasive, as Applicant has not identified any amendment or argument that renders the instant claims patentably distinct from the claims of the reference application. The arguments presented above relate to alleged unexpected results and patentability over the prior art, which are not relevant to the issue of obviousness-type double patenting. Additionally, the claims have not been amended to overcome the rejection, rather claim 1 has been amended to incorporate a limitation from claim 2 (no cancelled), which was previously rejected over the reference application in view of Gueniche.
Applicant’s arguments have been considered in full, and it stands that the claims of the reference application and the instant claims are directed to compositions comprising L. paracasei strains, including LPC-S01, and hyaluronic acid. Differences in intended use recited in the claims do not impart patentable distinction. With respect to claim 19, the recited bacterial concentrations and hyaluronic acid amounts have been taken into consideration. It is noted that the rejection above has been modified in order to consider the required limitations related to the concentration and amounts, which are disclosed by Takayama et al.
Conclusion
No claim is in condition for allowance.
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 CFR 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAGHMEH NINA MOAZZAMI/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652