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 .
The amendment filed July 27, 2026, has been received and entered.
Claims 1-10 are pending and examined on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Italy on June 28, 2023. It is noted, however, that applicant has not filed a certified copy of the IT 102023000013428 application as required by 37 CFR 1.55.
A certified translation of the foreign priority application was filed on July 10, 2024, but a certified copy of the foreign priority application itself has not been filed.
Specification
The disclosure is objected to because of the following informalities:
The formulas (Formula 1 and Formula 2) of the amendment to the specification filed July 27, 2026, with respect to page 3, lines 9 and 25 of the specification, are not completely legible. Regarding Formula 1 of the amendment, the second structure is blurry, with the functional groups and the character for repeating units being unclear. Regarding Formula 2 of the amendment, the character for repeating units is unclear.
Appropriate correction is required.
Claim Objections
Claims 4 and 6-8 are objected to because of the following informalities:
Claim 4 is objected to because the recitation “the fatty ethoxylated dimeric urethanes contains” is not grammatically correct. The recitation “contains” should be substituted with “contain.”
Claim 6 is objected to because of the recitation “range from 70 and 80% by weight.” The word “and” in the recitation should be substituted with “to” for proper recitation of a range.
Claim 7 is objected to because of the recitation “range from 5 and 15% by weight.” The word “and” in the recitation should be substituted with “to” for proper recitation of a range.
Claim 8 is objected to because it recites “2.5-3.6 Pa.s”. The recitation incorrectly includes a period for the known SI units for viscosity. The recitation “Pa.s” should be substituted with “Pa·s”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 9 and 10 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.
Claim 9 is rendered indefinite by the recitation “A cleansing wet wipe and/or a medicated pimple patch.” The recitation includes the embodiment of a cleansing wet wipe and a medicated pimple patch. For that embodiment, it is unclear whether it is referring to a product comprising both a cleansing wet wipe and a medicated pimple patch, or two distinct products (a first product being a cleansing wet wipe, a second product being a medicated pimple patch.” For examination purposes, the latter interpretation (two distinct products) is being taken.
Claim 10 recites the limitation "the gel formulations according to claim 1” in line 3. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 does not recite multiple gel formulations, and instead recites a single gel formulation. This rejection can be overcome by amending line 3 to recite “the gel formulation according to claim 1” (accordingly, this would require substituting the recitation “formulations” in line 4 with “formulation”).
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.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it recites a plurality of products as the invention, thus not reciting a single invention (single product). Claim 9 recites “A cleansing wet wipe and/or a medicated pimple patch,” which includes the embodiment of a cleansing wet wipe and a medicated pimple patch. That embodiment is directed to two products (see rejection under 35 U.S.C. 112(b) above for the interpretation of that embodiment). This rejection can be overcome by amending claim 9 to recite a single product (i.e. “A cleansing wet wipe or a medicated pimple patch”).
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 (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.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrari (US 9,757,328. Listed on IDS filed 5/28/24) in view of van den Berg (WO 01/89540. Listed on IDS filed 5/28/24) and Zofchak (US 2005/0106193. Previously cited), as evidenced by Charter (US 2002/0001582. Previously cited) and Fares (US 2010/0120645).
Ferrari discloses formulations of gelled lysozyme (abstract). The lysozyme gels can be useful for therapeutic use, such as a topical treatment of various conditions including sores, wounds, pimples, acne, etc. (column 3, line 62 through column 4, line 3). Therefore, the formulations of Ferrari are directed to a ‘gel formulation for topical use,’ meeting a limitation of instant claim 1.
The compositions comprise gelled lysozyme, water, and a solvent (column 2, lines 35-38). Furthermore, Ferrari teaches that natural and synthetic excipients can be added to their lysozyme gels, examples of which include glycols, gelling and suspending agents, thickeners, and preservatives (column 4, lines 42-48). Given this teaching, Ferrari teaches the embodiment of their formulation (directed to the claimed ‘gel formulation for topical use’) comprising a preservative.
In sum, Ferrari meets limitations of the claimed invention by disclosing a gel formulation for topical use containing lysozyme, a preservative, and water.
Ferrari differs from the claimed invention in that Ferrari does not expressly disclose that their formulation further comprises:
Ovotransferrin; and
Fatty ethoxylated dimeric urethanes.
Regarding difference (1) (the formulation of Ferrari does not comprise ovotransferrin):
As pointed out above, the lysozyme gels of Ferrari can be useful in the topical treatment of wounds (column 3, lines 62-66). Further still, Ferrari teaches that their lysozyme gels are particularly useful as a body sanitizer and disinfectant, like, for example, in the disinfection of the skin and in the hygiene of hands and of the oral cavity (column 4, lines 13-18). Additionally, Ferrari teaches, to the lysozyme gels embodied in their invention, adding complimentary active compounds, either synthetic or natural, as long as they are compatible, such as cicatrizing compounds, disinfectants, and antibiotics (column 4, lines 32-35).
van den Berg discloses whole egg white or egg white fractions enriched with conalbumin and/or lysozyme (page 6, lines 1-2). As evidenced by Charter, conalbumin is also known as egg white ovotransferrin (paragraph [0082]). van den Berg also teaches topical preparations such as a gel containing egg white and/or a fraction thereof, and these preparations further contain excipients and additives suitable for the specific type of preparation (page 6, lines 6-9). Experiments were performed to determine the antibacterial activity of egg white constituents in order to examine the potential of egg white to prevent and/or treat bacterial wound infections (page 9, lines 8-19, particularly lines 8-11). Microbial infections often complicate and inhibit the wound healing process (page 11, lines 27-28). From the experiments, it was determined that conalbumin (i.e. ovotransferrin) inhibits the growth of several pathogens in vitro (page 11, line 29). Also, lysozyme was found to exhibit antibacterial properties, mainly against Gram-positive species (page 11, lines 29-30). Moreover, van den Berg found that the combination of conalbumin (i.e. ovotransferrin) and lysozyme acts synergistically against some pathogens (page 11, line 30 through page 12, line 2).
Also, a study was performed in van den Berg on the effect of individual egg white components on wound healing in a skin fibroblast cell model (page 11, lines 19-20). As shown in Figure 5, conalbumin and lysozyme each have a healing index above zero, with conalbumin having a greater healing index than lysozyme. See page 11, lines 19-25 for describing Figure 5.
As such, van den Berg demonstrates that ovotransferrin is directed to a disinfectant and an antibiotic since ovotransferrin was found to have antibacterial activity. Additionally, van den Berg demonstrates that ovotransferrin is directed to a cicatrizing compound through the results of its experiment investigating its effect on wound healing in a skin fibroblast cell model.
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to add ovotransferrin as a complimentary active compound to the formulation containing lysozyme, a preservative, and water of Ferrari. It would have been an obvious matter of simple substitution of a complimentary active compound that is a cicatrizing compound, disinfectant, and/or antibiotic (as taught in Ferrari for addition to their lysozyme gels) for another; ovotransferrin is directed to each based on the teachings of van den Berg. Additionally, one of ordinary skill in the art would have been motivated to include ovotransferrin in the formulation of Ferrari because the combination of ovotransferrin and lysozyme acts synergistically against some pathogens, as indicated in van den Berg. The synergism against pathogens would have been desired in Ferrari since Ferrari discloses their lysozyme gels for uses as a body sanitizer and disinfectant for skin. There would have been a reasonable expectation of success in preparing the formulation of Ferrari for its uses (topical treatment of wounds, body sanitizer, and skin disinfectant) through addition of ovotransferrin to the lysozyme gels because Ferrari teaches that complementary active compounds can be added to their lysozyme gels, and van den Berg teaches the inclusion of egg white fractions, including ovotransferrin and lysozyme, in a topical preparation such as gel, with wound healing and antibacterial properties.
Regarding difference (2) (the formulation of Ferrari does not comprise fatty ethoxylated dimeric urethanes):
As discussed above, Ferrari teaches that natural and synthetic excipients can be added to their lysozyme gels, examples of which include gelling and suspending agents and thickeners (column 4, lines 42-48).
Zofchak discloses personal care products comprising fatty ethoxylated dimeric urethane compounds that enhance the viscosity of constituent water based surfactant systems (abstract). When incorporated into personal care products such as lotions, the fatty ethoxylated dimeric urethane compounds serve as thickeners and provide exceptional viscosity control (paragraph [0016]). The personal care products include creams, lotions, skin care products, and protective skin formulations (paragraph [0022]). Dermothix 75 and Dermothix 100 are disclosed as examples of the fatty ethoxylated dimeric urethane (paragraph [0040] and claim 9 of Zofchak). Moreover, these two fatty ethoxylated dimeric urethanes are described as thickeners (paragraphs [0040] and [0045]).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to add Dermothix 75 and Dermothix 100 (directed to ‘fatty ethoxylated dimeric urethanes’) as a thickener to the formulation comprising lysozyme, ovotransferrin, a preservative, and water rendered obvious by Ferrari in view of van den Berg. It would have been an obvious matter of simple substitution of an excipient that is a thickener (as taught in Ferrari for addition to their lysozyme gels) for another. There would have been a reasonable expectation of success in obtaining the formulation of Ferrari in view of van den Berg for topical treatment because Ferrari teaches that excipients such as thickeners can be added to their lysozyme gels, and Dermothix 75 and Dermothix 100 are suitable for inclusion in skin care products, as indicated in Zofchak.
Therefore, Ferrari in view of van den Berg and Zofchak renders obvious instant claim 1.
Regarding instant claim 2, Ferrari teaches the lysozyme as being free-base or in a hydrochloride form (column 2, lines 23-25; claims 5 and 9 of Ferrari). Also, Ferrari teaches that in some embodiments of their invention, the amount of lysozyme comprises between 0.1% w/w and 50% w/w of the total gel, more preferably between 1.5% w/w and 8% w/w, and more preferably between 1% w/w and 5% w/w (column 3, lines 31-39). The first range fully encompasses the claimed range, and the other two ranges overlap the claimed range. Thus, instant claim 2 is rendered obvious.
Regarding instant claim 3, the references differ from the claimed invention in that they do not expressly disclose that ovotransferrin is present in a range from 0.007 to 15.8% by weight of the gel formulation. However, van den Berg discloses that conalbumin (i.e. ovotransferrin) inhibits bacterial growth at concentrations of 1 mg/mL and 2 mg/mL, with the greater concentration having greater inhibitory effects (Table 2 on page 12). These two concentrations convert to 0.1% w/w and 0.2% w/w, respectively (see calculation below). It would have been a matter of routine optimization to have varied the concentration of ovotransferrin in the formulation rendered obvious by Ferrari, van den Berg, and Zofchak, including to a concentration in a range from 0.0007 to 15.8% by weight, since the skilled artisan would have recognized that the concentration of ovotransferrin is a results-effective parameter that affects its antibacterial property, based on van den Berg. Moreover, the person of ordinary skill in the art would have been motivated to include the ovotransferrin in a concentration in that range because ovotransferrin in two concentrations in that range (0.1% and 0.2% by weight) were shown in van den Berg to inhibit bacterial growth. Thus, instant claim 3 is rendered obvious.
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Regarding instant claim 4, Zofchak discloses that Dermothix 75 is a 75 mole ethoxylate, and Dermothix 100 is a 100 mole ethoxylate (paragraph [0040]). As evidenced by Fares, Dermothix 75 and Dermothix 100 are polyurethanes based on an ethoxylated stearyl alcohol, and are compounds having 75 and 100 moles of ethoxylation, respectively (paragraph [0012] of Fares). Therefore, in comprising Dermothix 75 and Dermothix 100, then the formulation rendered obvious by Ferrari, van den Berg, and Zofchak comprises fatty ethoxylated dimeric urethanes containing 100 mole ethoxylated stearyl alcohol and 75 mole ethoxylated stearyl alcohol, meeting a limitation of instant claim 4. The references differ from the claimed invention in that they do not expressly disclose that Dermothix 75 and Dermothix 100, directed to the claimed fatty ethoxylated dimeric urethanes containing 100 mole ethoxylated stearyl alcohol and 75 mole ethoxylated stearyl alcohol, are present in a range from 2 to 8% by weight of the gel formulation. However, Zofchak discloses that the fatty ethoxylated dimeric urethane compounds are included in personal care products/formulations in effective amounts, i.e., amounts which produce an intended effect (paragraph [0029]). The amount generally ranges from about 0.5% to about 10% by weight or more of personal care formulations, preferably in amounts ranging from about 0.5% to about 5% by weight (paragraph [0029]). The first range encompasses the claimed range, and the second range overlaps the claimed range. It would have been a matter of routine optimization to have varied the concentration of Dermothix 75 and Dermothix 100 in the formulation rendered obvious by Ferrari, van den Berg, and Zofchak, including to a concentration in a range from 2 to 8% by weight, since the skilled artisan would have recognized that the concentration of Dermothix 75 and Dermothix 100 is a results-effective parameter that affects its thickening property, based on Zofchak that used fatty ethoxylated dimeric urethane compounds for viscosity control and its teaching that the fatty ethoxylated dimeric is included in an effective amount for its intended effect (viscosity control). Moreover, the person of ordinary skill in the art would have been motivated to include Dermothix 75 and Dermothix 100 in a concentration in that range because Zofchak teaches concentration ranges that include or overlap the claimed range for inclusion in personal care products/formulations such as skin care products to serve as thickeners. Thus, instant claim 4 is rendered obvious.
Regarding instant claim 6, Ferrari discloses that in some embodiments of their invention, the amount of water comprises between 1% w/w and 95% w/w of the total gel, more preferably between 2% w/w and 80% w/w (column 3, lines 45-48). These two ranges fully encompass the claimed range. Thus, instant claim 6 is rendered obvious.
Regarding instant claim 7, the references differ from the claimed invention in that they do not expressly disclose that the formulation contains humectants (optional limitation of parent claim 1) which are glycerol and propylene glycol, each present in a range from 5 to 15% by weight. However, Zofchak discloses humectants for their personal care products (paragraph [0027]), wherein the personal care products include skin care products (paragraphs [0016] and [0022]). Examples of suitable humectants include propylene glycol and glycerin (i.e. glycerol, as well known in the art) (paragraph [0027]). As a general rule, Zofchak teaches that humectants are used in a weight percentage range of from about 1% to about 20%, preferably from about 4% to about 10% (paragraph [0027]). The first range encompasses the claimed range, and the second range overlaps with the claimed range. It would have been obvious to the person of ordinary skill in the art to include humectants that are glycerol and propylene glycol in the formulation rendered obvious by Ferrari, van den Berg, and Zofchak, at a concentration of about 1% to about 20% wt, or about 4% to about 10% wt, because Ferrari teaches that natural and synthetic excipients can be added to their lysozyme gels (column 4, lines 42-43) (humectants are directed to excipients) and because Zofchak teaches inclusion of humectants such as glycerol and propylene glycol at those concentrations for personal care products that include skin care products. There would have been a reasonable expectation of success in obtaining the formulation of Ferrari in view of van den Berg and Zofchak for topical treatment by this modification because Ferrari teaches that excipients, examples of which include a wide range of products, can be added to their lysozyme gels, and humectants are suitable for inclusion in personal care products such as skin care products, as indicated in Zofchak. Thus, instant claim 7 is rendered obvious.
Regarding instant claim 8, the references differ from the claimed invention in that they do not expressly disclose that their formulation has a viscosity at time zero of 2.5-3.6 Pa·s at 25ºC. However, Zofchak discloses a personal care product comprising fatty ethoxylated dimeric urethane, wherein the viscosity of the personal care product ranges from about 500 to about 500,000 cps (claim 1 of Zofchak). That converts to about 0.500 Pa·s to about 500 Pa·s. It would have been obvious to the person of ordinary skill in the art to have included Dermothix 75 and Dermothix 100 (the fatty ethoxylated dimeric urethanes) at a concentration such that viscosity of the formulation rendered obvious by Ferrari in view of van den Berg and Zofchak at time zero at room temperature (standard at 25ºC) is from about 0.500 to about 500 Pa·s. One of ordinary skill in the art would have been motivated to do this because Zofchak teaches that viscosity range as being suitable for personal care products, wherein a fatty ethoxylated dimeric urethane is used for producing viscosity control (paragraph [0016]). Since the range of about 0.500 to about 500 Pa·s includes the claimed range, then the claimed viscosity is rendered obvious. Also, it would have been an obvious matter of routine optimization to have varied the viscosity of the formulation rendered obvious by Ferrari in view of van den Berg and Zofchak, including to a viscosity at time zero of 2.5-3.6 Pa·s at room temperature (standard at 25ºC), because Zofchak teaches that viscosity control is necessary in personal care products to ensure stability, consistent dispensing, and desirable aesthetic properties (paragraph [0002]), thus indicating that viscosity is a parameter that is optimizable for achieving those properties. The skilled artisan would have recognized the viscosity of 2.5-3.6 Pa·s at time zero at room temperature as being suitable for the formulation rendered obvious by Ferrari, van den Berg, and Zofchak, because Zofchak teaches a wide range of viscosities for their personal care products that include skin care products. Therefore, instant claim 8 is rendered obvious.
Regarding instant claim 10, as pointed out above, Ferrari teaches that their lysozyme gels can be useful for therapeutic use, such as a topical treatment of pimples and acne (column 3, line 62 through column 4, line 3). Also, Ferrari teaches that their lysozyme gels are particularly useful as a body sanitizer and disinfectant, like, for example, in the disinfection of the skin and in the hygiene of hands (column 4, lines 13-18). Given these uses, then Ferrari teaches a method for treating acne vulgaris and for reducing the number of bacteria on the surface of the skin of individuals in need thereof with their lysozyme gels. Therefore, it would have been obvious to the person of ordinary skill in the art to practice that method by applying a pharmaceutically effective amount of the formulation rendered obvious by Ferrari, van den Berg, and Zofchak to the surface of the skin of subjects in need of acne treatment (any subject is necessarily additionally in need of skin disinfection). In applying that pharmaceutically effective amount of the formulation rendered obvious by the references to the surface of the skin of those subjects, it also would have been obvious that acne vulgaris is prevented since the formulations treat acne (see Example 7 of Ferrari at column 8, lines 33-39 in which the acne disappeared completely) and disinfect the skin. Therefore, instant claim 10 is rendered obvious.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ferrari, van den Berg, and Zofchak, as evidenced by Charter and Fares as applied to claims 1-4, 6-8, and 10 above, and further in view of Luck (CA 1322162. Previously cited).
As discussed above, Ferrari in view of van den Berg and Zofchak (as evidenced by Charter and Fares) renders obvious claims 1-4, 6-8, and 10. However, the references differ from claim 5 in that they do not expressly disclose that their formulation contains a preservative selected from sodium benzoate, phenoxyethanol, caprylyl glycol, benzoic acid, sorbic acid, levulinic acid, and anisic acid. As pointed out above, Ferrari teaches that excipients can be added to their lysozyme gels, such as preservatives (column 4, lines 42-47).
Luck discloses that combining non-enzymatic preservatives with enzymes having N-acetylmuramidase activity results in a synergism of action, allowing for medicaments and cosmetic products to being preserved for comparatively longer than by using the individual components (abstract). Enzymes having N-acetylmuramidase activity include lysozyme (page 1, lines 25-26). Examples of suitable preservatives as active substances in the formulation of Luck include sorbic acid and benzoic acid (page 2, last paragraph). Luck teaches in Example 7 a moisturizing cream comprising lysozyme and sorbic acid (page 9, lines 7-30, particularly lines 26-27). Compared to a moisturizing cream comprising lysozyme, a moisturizing cream comprising lysozyme and sorbic acid had a longer shelf life (page 10, lines 1-5).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to include sorbic acid or benzoic acid as a preservative in the formulation rendered obvious by Ferrari in view of van den Berg and Zofchak (as evidenced by Charter and Fares). One of ordinary skill in the art would have been motivated to do this because the combination of each of these preservatives with lysozyme has a synergistic effect of extending the shelf life of cosmetic products such as moisturizing cream, as taught by Luck. Also, it would have been an obvious matter of simple substitution of the preservative with a known preservative that is compatible with lysozyme. There would have been a reasonable expectation of success in preparing a formulation suitable for topical treatment as sought by Ferrari by including sorbic acid or benzoic acid in the formulation rendered obvious by Ferrari in view of van den Berg and Zofchak because Ferrari teaches adding preservatives to their lysozyme gels and because Luck teaches that they are preservatives suitable for inclusion with lysozyme for cosmetic products such as moisturizing cream. Therefore, instant claim 5 is rendered obvious.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ferrari, van den Berg, and Zofchak, as evidenced by Charter and Fares as applied to claims 1-4, 6-8, and 10 above, and further in view of Lunsmann (US 2002/0031486. Previously cited) and/or Buseman (US 6,495,158. Previously cited).
As discussed above, Ferrari in view of van den Berg and Zofchak (as evidenced by Charter and Fares) renders obvious claims 1-4, 6-8, and 10. However, the references differ from claim 9 in that they do not expressly disclose a cleansing wet wipe and/or a medicated pimple patch comprising the formulation rendered obvious by the references.
As pointed out above, Ferrari teaches that their lysozyme gels can be useful for therapeutic use, such as a topical treatment of pimples and acne (column 3, line 62 through column 4, line 3). Also, Ferrari teaches that their lysozyme gels are particularly useful as a body sanitizer and disinfectant, like, for example, in the disinfection of the skin and in the hygiene of hands (column 4, lines 13-18).
Lunsmann discloses an antimicrobial, cleansing wet wipe (paragraph [0018]). The wet wipes can advantageously be used for various wipes including hand wipes, face wipes, and cosmetic wipes (paragraph [0018]). The wipe can contain a benefit agent, wherein the benefit agent can be selected from anti-acne compounds (claims 20 and 21 of Lunsmann).
Buseman discloses an adhesive patch useful for treating or preventing acne or a pimple (column 4, lines 32-34). The patch administers to the skin an effective and known amount of a topical acne drug (column 4, lines 35-36). The patch includes an ointment or gel that includes an effective, known, and safe amount of a medicament that is useful for treating acne (column 28-31).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to include the formulation rendered obvious by Ferrari in view of van den Berg and Zofchak (as evidenced by Charter and Fares) in an antimicrobial, cleansing wet wipe as taught by Lunsmann and/or an adhesive patch of Buseman. One of ordinary skill in the art would have been motivated to do this in order to deliver the formulation rendered obvious by Ferrari, van den Berg, and Zofchak (as evidenced by Charter and Fares) to the skin of subjects to treat or prevent acne or pimples. There would have been a reasonable expectation of treating or preventing acne or pimples by including the formulation rendered obvious by Ferrari, van den Berg, and Zofchak (as evidenced by Charter) in an antimicrobial, cleansing wet wipe and/or an adhesive patch because Lunsmann teaches including anti-acne compounds in their wipes that can be used as face and cosmetic wipes, and because Buseman teaches that their patch includes a gel that includes a medicament for treating acne (which the formulation rendered obvious by Ferrari, van den Berg, and Zofchak (as evidenced by Charter and Fares) is directed to). Therefore, instant claim 9 is rendered obvious.
Response to Arguments
Applicant’s arguments, filed July 27, 2026, with respect to the objections to claims 2 and 10, the rejection under 35 U.S.C. 101 of claims 1 and 3-8, and the rejections under 35 U.S.C. 112(b) of claims 1-8 and 10, have been fully considered and are persuasive. In particular, the claim objections have been overcome by the amendments to claims 2 and 10. The rejection under 35 U.S.C. 101 has been overcome by the amendments to claims 1 and 3-8. The rejections under 35 U.S.C. 112(b) have been overcome by the amendments to claims 1, 4, 5, and 7. Therefore, these objections and rejections have been withdrawn.
However, Applicant’s arguments are unpersuasive with respect to the foreign priority document issue, the objection to the specification, the objection to claim 8, the rejection under 35 U.S.C. 101 of claim 9, the rejection under 35 U.S.C. 112(b) of claim 9, the rejection under 35 U.S.C. 103 of claims 1-4, 6-8, and 10 as being unpatentable over Ferrari in view of van den Berg and Zofchak (as evidenced by Charter), the rejection under 35 U.S.C. 103 of claim 5 as being unpatentable over Ferrari, van den Berg, and Zofchak (as evidenced by Charter) in further view of Luck, and the rejection under 35 U.S.C. 103 of claim 9 as being unpatentable over Ferrari, van den Berg, and Zofchak (as evidenced by Charter) in further view of Lunsmann and Buseman. The objections and the rejections have been modified as necessitated by the amendments to the claims, including relying on the newly cited reference Fares as evidence in light of the amendment to claim 4.
Regarding the foreign priority document issue, Applicant cites the updated Application Data Sheet filed June 13, 2024, asserting that acknowledgement of the filing has never been provided, and requesting that the USPTO update the filing receipt in that respect. However, as set forth in the Application Data Sheet, under the PDX program, Applicant bears the ultimate responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual property office, or a certified copy of the foreign priority application is filed, within the time period specified in 37 CFR 1.55(g)(1).
Regarding the objection to the specification, the amendment to the specification filed July 27, 2026, still includes structures which are not completely legible.
Regarding the objection to claim 8, though claim 8 has been amended to correct the recitation of “2,5-3,6,” claim 8 has not been amended to correct the recitation of “Pa.s.” Therefore, the objection has been maintained.
Regarding the rejection under 35 U.S.C. 101 and the rejection under 35 U.S.C. 112(b) of claim 9, claim 9 has been amended to recite “A cleaning wet wipe and/or a medicated pimple patch.” Because of the use of “and/or” in the recitation which includes the embodiment of a cleaning wet wipe and a medicated pimple patch, claim 9 is rejected under 35 U.S.C. 101 and 35 U.S.C. 112(b).
With respect to the rejections under 35 U.S.C. 103, Applicant points out that Ferrari teaches that lysozyme itself is a gelling substance (self-gel) and therefore, it can be advantageously formulated into topical compositions without the addition of other gelling substances such as cellulose starch, or other polysaccharides, citing the abstract. Applicant also cites teachings in Ferrari, specifically column 2, lines 24-29 and column 3, lines 52-58 (Applicant cites paragraphs of the corresponding patent publication), for indicating that the lysozyme acts as a self-gelling substance in mixtures of a solvent, the advantageous properties of their lysozyme gels, and the statement “In particular, it should be emphasized that the invented formulations do not require the presence of preservatives, gelling agents, thickeners, sequestering agents, etc.” (column 3, lines 55-58). However, in the next column of the reference, as pointed out in the rejection, Ferrari discloses that natural and synthetic excipients can be added to the lysozyme gels, examples of which include glycols, gelling and suspending agents, thickeners, preservatives, and sequestering agents (column 4, lines 42-48). It is clear that though preservatives, gelling agents, and sequestering agents are not necessary for their formulations, Ferrari indeed also recognizes that such excipients can be added to their lysozyme gels. In adding an excipient, e.g. a thickener, to the lysozyme gel, then the lysozyme gel contains the excipient. According to MPEP 2123(I), “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments,” further citing Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component). Therefore, the invention of Ferrari provides the inclusion of gelling agents in a formulation, contrary to Applicant’s assertions. Though Ferrari does not specifically disclose inclusion of ovotransferrin (note that humectants are an optional limitation of claim 1), that limitation of the claimed invention is rendered obvious in view of van den Berg.
Additionally, Applicant asserts that Examples 1-4 described by Ferrari clarify that methods of obtaining lysozyme gels described therein occur only using ethanol/water or isopropanol/water. However, Applicant appears to attempt to differentiate the invention of Ferrari with the claimed invention, both products, according to the process by which they are made. However, the claims do not recite the process by which the product made, and even if the process were recited in the product claims, the patentability of a product does not depend on its method of production, as set forth in MPEP 2113(I). Moreover, as pointed out above, Ferrari teaches inclusion of excipients such as gelling agents and thickeners (column 4, lines 42-48). As indicated in MPEP 2123(II), “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” Therefore, Examples 1-4 do not constitute a teaching away from column 4, lines 42-48 of Ferrari.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Though Ferrari is silent with regard to ovotransferrin and fatty ethoxylated dimeric urethanes, as set forth in the rejection, it would have been obvious to the skilled artisan to include ovotransferrin and fatty ethoxylated dimeric urethanes in view of van den Berg and Zofchak.
With respect to van den Berg, Applicant disagrees with the Examiner’s position that one of ordinary skill in the art would have been motivated to include ovotransferrin in the formulations of Ferrari because the combination of ovotransferrin and lysozyme acts synergistically against some pathogens, as indicated in van den Berg, because (1) Applicant asserts that the gel formulations of Ferrari are made only of lysozyme/water/alcohol, and are different from the presently claimed gel formulations; and (2) the synergy described by van den Berg does not include description of the known microorganisms responsible for acne infections and tested by Applicants’ (e.g., Cutibacterium acnes, etc.). Regarding (1), Ferrari teaches that the lysozyme gels can further include additional complementary active compounds (column 4, lines 32-35) and excipients (column 4, lines 42-48), so the lyzoyme gels of Ferrari (directed to gel formulations) are not limited to gel formulations comprising only lysozyme, water, and a solvent (e.g., alcohol). Regarding (2), in response to applicant's argument that van den Berg does not describe synergism against bacteria responsible for acne infections, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The synergism against pathogens still would have motivated the skilled artisan to include ovotransferrin in the formulation of Ferrari since Ferrari discloses using their lysozyme gels for uses as a body sanitizer and disinfectant for skin (column 4, lines 13-18 and 32-35).
Regarding Zofchak, Applicant asserts that Zofchak does not expressly disclose that the claimed fatty ethoxylated dimeric urethanes are present in a range from 2 to 8% by weight of the formulations. However, only claim 4 recites the argued content range. Even with respect to claim 4, Zofchak discloses that the amount of the fatty ethoxylated dimeric urethane compounds generally ranges from about 0.5% to about 10% by weight or more of personal care formulations, preferably from about 0.5% to about 5% by weight (paragraph [0029]). The first range encompasses the range of claim 4, and the second range overlaps the range of claim 4. Therefore, Applicant’s arguments are unpersuasive.
Conclusion
No claims are allowed.
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.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
