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 .
Status of the Claims and Previously Elected Subject Matter
Claims 1-8, 10, 12, and 14 have been canceled. Claims 9, 11, 13, and 15-28 are pending. Claims 21 and 26 are withdrawn. Claims 9, 11, 13, 15-20, 22-25, 27, and 28 are pending and under current examination.
As previously noted and detailed in the election dated 9/11/2024 in the file wrapper, Applicant elected without traverse Group A- leather; Group B- functional agent, antibacterial agent, aluminum salts; and Group C- cosmetic agent, repair agent, hyaluronic acid.
Withdrawn Rejections
All rejections of claim 12 are withdrawn in view of Applicant’s cancelation of this claim.
The rejections of claims 9, 11, 16-20, 22-25, and 27 under 35 U.S.C. 103 as being unpatentable over Waniek in view of Dehn and Leeper is withdrawn in view of Applicant’s amendments to the claims; subsequently, the rejection of claims 12, 13, 15, and 28 further in view of Kikuchi is withdrawn.
Response to Arguments
Applicant’s arguments filed 12/22/2025 (hereafter, “Remarks”) have been fully considered and are addressed as follows.
Applicant argues that the previously cited prior art does not teach the claimed subject matter as amended. Applicant’s argument is persuasive, and previously issued rejections have been withdrawn as detailed above. New grounds of rejection necessitated by amendment are presented below. The relevance of previously cited references is maintained as applied below.
New Grounds of Rejection Necessitated by Amendments
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 9, 11, 13, 15-20, 22-25, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over DE19847710A1 (“Waniek”) in view of EP2199447A1 (“Dehn”, previously enclosed), Leeper (US 4,435,180), and WO03093513A1 (“Minamiura”, newly cited).
The instant claims are drawn to a method for manufacturing a bracelet or strap, comprising at least one organic material, said organic material containing at least one functional agent and at least one cosmetic agent for the skin arranged to be able to be in contact with the user’s skin when the bracelet or strap is worn, the method comprising steps (a) preparing, (b) producing, (c) adding, and (d) making, each step further specified in the claims, and wherein the cosmetic agent content “is comprised” between 2 and 20 wt% and the functional agent “is comprised” between 0.2 and 0.4 wt%, each “with respect to the total weight of the formulation”. Applicant has elected leather, aluminum salts antibacterial agent, and hyaluronic acid repair compound in the requirements for elections of species as set forth 3/28/2024 and as elected 9/11/2024.
Waniek teaches the manufacturing of a composite continuous strip product especially a wrist watch strap (see title, in particular). Waniek teaches the combination of layers into a strip with multilayered structure including the inclusion of layers saturated with antibacterial agents, as well as additional functional additions (see abstract, in particular). Support and intermediate layers may be leather, among other materials named, (see abstract, in particular) with leather being known for watch strap materials (see “Description”, second paragraph, second sentence)(“leather” “organic material” as instantly elected and limitation of claims 9b and claim 10) and with alternate or additional layers being described as fabrics, polyurethane, latex, rubber, and synthetic resin, along with reinforcing layers (see abstract, in particular). Waniek teaches a moisture permeable layer containing an adsorber and an adsorbing layer is combined with a layer saturated with an antibacterial agent and anti-irritant layers and that the layers may be bonded in a mold; variants include the foam inserts for softness for instance; the support layer may be made of leather (see abstract, in particular). Waniek also teaches that leather materials may be combined with functional materials which will resolve or prevent skin irritation wherein the leather materials and functional materials are combined in an impregnation process (see page 18/28 of translation, second full paragraph “In addition to said materials for this anti-allergy layer…”). Waniek further recommends for instance antibacterial components to be included in one or two layers and particularly in absorbent components for instance (see third paragraph on page 14/28 of translation).
In Waniek’s embodiment in which leather is employed for instance as a support intermediate layer, Waniek’s support intermediate layer is considered “a formulation” as in claim 9b as amended and as an “only an element” as in claim 11 a; Waniek expressly teaches that the special properties of the object may be achieved by incorporating for instance an antimicrobial component by soaking a layer or parts of a layer with an antibacterial agent (see page 2, paragraph 7); to perform Waniek’s step of soaking a layer which is a leather layer with a functional agent is considered to meet the “incorporation” step as in claim 9c and 11b, in view of the substitution of functional agents detailed below.
As to the aluminum salt agent instantly elected (see claims 9, 17, and 18), Waniek teaches that aluminum oxide may be included (see “Description – Independent Claims” section of translation).
While Waniek teaches producing a leather impregnated with functional agents (constitutes steps “b” and “c” generally) as well as making of a bracelet or strap product, Waniek does not specify the functional agent antibacterial amount or the cosmetic agent hyaluronic acid (repair) agent or that the cosmetic agent is in encapsulated form as recited in step 9a. Moreover and regarding the claimed amount of functional agent, Waniek generally teaches for instance an antibacterial active to be between 0.5 and 5% of the dry weight of the object (see Waniek claim 11), but Waniek does not teach that this particular functional agent is limited to a range of 0.2 to 0.4% as recited for instance in claim 9 as amended or the cosmetic repair agent hyaluronic acid to be present in an amount between 2 and 20% as recited for example as in claim 9 as amended. It is the examiner’s position that this range is similar and functions as a starting point from which one would have been motivated to perform routine optimization procedures as motivated by Leeper, detailed below. Further regarding the cosmetic agent, Waniek suggests that additional layers may include anti-irritant layers thereby incorporating additional active agents, reasonably starting with an amount range similar to Waniek’s antibacterial active functional agent range of 0.5 to 5% (see page 16 of 28, paragraphs 3 and 4 for instance; see also Waniek claims 8 and 11 in particular as well as claims 19 and 28 which provides for an additional active ingredient). Based on Waniek, however, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Please see MPEP 2144.05
Dehn and Leeper cure this deficiency. Dehn teaches a superabsorbent polymer felt and methods for its manufacture (see title, in particular). The felt is provided in layers which may include several materials and/or functional materials combined into a layer so the felt layer is present as a composite (see page 7/31 of translation, paragraph 4), and encapsulated forms of active ingredients may be included (see page 7/31 of translation, paragraph 5). Encapsulated excipients may be included particularly in encapsulated form so they are gradually released from the material (see first partial paragraph page 8/31 of translation). Active agents which may be included include microbiocidally active substances (page 8/31 of translation, first full paragraph) or in a further embodiment skin care substances or would healing materials such as hyaluronic acid and antimicrobials (see page 8/31 of translation, second full paragraph)(limitations of claims 9, 17, 19, and 20). These may be added directly or in encapsulated form. Dehn further comprise felt materials to be useful particularly as watch straps (see page 25/31 of translation, 9 lines from the bottom of the page).
Waniek and Dehn are both directed to a process of providing products which may be for instance a watch strap comprising assembling layers which may include structural (i.e., leather in Waniek) and functional (active agents) components. It would have been prima facie obvious to one of ordinary skill in the art to add hyaluronic acid in encapsulated form as taught by Dehn to the functional material components of Waniek in Waniek’s leather product, with a reasonable expectation of success. One would have been motivated to do so in order to achieve good skin care properties and controlled release and/or stabilization effects from encapsulation thereof as taught by Dehn. One would have further been motivated to start with Waniek’s recommended active agent amounts for both Waniek’s antimicrobial agent as well as Dehn’s skin care substance, with a reasonable expectation of success. From here, one would have been motivated to perform routine optimization procedures with regard to the amounts of these functional and cosmetic agents based on Leeper’s teaching, detailed below.
Leeper teaches an active agent delivery system (see title) wherein an elastomeric material incorporates an active agent for use in products including bands adapted to encircle a body member such as a finger, leg, or arm, for instance in the form of a glove, sock, sleeve, cuff, or band (see abstract, in particular; see column 2, lines 6-8 “bracelet”, see paragraph bridging columns 3 and 4). Leeper specifies that the active agent is to be used in sufficient amount to be administered to and through the skin permitting the active agent to pass through the structure by diffusion or otherwise in an amount which, when taken in combination with the effective surface area of the device, is sufficient to produce the desired therapeutic or other beneficial effect (see column 3, lines 26-40, in particular).
Waniek and Leeper are both directed to body-encircling devices (i.e, a bracelet or an arm-encircling band) for transdermal delivery of active agents. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to adjust and increase the quantities of cosmetic and functional agents, including the values instantly claimed, in a device of Waniek and Dehn based on Leeper’s teaching that surface area and therapeutic/benefit agent concentration may be optimized to achieve the desired effect.
Further regarding the new claim language as to the impregnation method involving a cosmetic and functional agent being dissolved in a support liquid which is hexane, isopropanol, or d-limonene and subsequently impregnating the organic material with the solution by a fluid in supercritical conditions, the aforementioned references do not specify this process of impregnation. Minamiura cures this deficiency.
Regarding claims 9 and 11, Minamiura teaches leather products which are manufactured to include at least one effective component which may be a fragrant component, a deodorant component, a medical component, an antibacterial component, a mildew proofing component, or a moth proofing component, or an oil or fat component (see abstract, in particular) wherein in Embodiments 15 to 25 the fatliquoring agent is extracted with a high-pressure fluid such as a supercritical fluid and is made to permeate the raw material for the skin (see page 16 of 26, paragraph 6). Minamiura’s method uses high pressure fluid as a medium for said manufacturing (see abstract, in particular). Minamiura teaches that the “effective component(s)” may be a “fatliquoring agent” (comparable to the cosmetic and functional agents instantly claimed) and is extracted by supercritical carbon dioxide (“dissolved in a support liquid” as claimed) and then penetrates between the tissue of the skin material and the fibers (i.e., of a leather product, thereby achieving “impregnation” of the total leather product)(see last two paragraphs on page 11 of 26 of translation and first full paragraph on page 12 of 26 of translation). Minamiura specifies that the supercritical fluid can be carbon dioxide and may include an enhanced extraction effect when a solvent such as hexane is used as a co-solvent to form the supercritical fluid (see second full paragraph on page 16 of 26). Minamiura specifies that applicable leather products include leather accessories (fifth paragraph page 16 of 26).
Waniek and Minamiura are both directed to functionalized and impregnated leather products. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use Minamiura’s supercritical fluid impregnation method to compel functional agents into a solution and then leather structure, as enhanced by hexane cosolvent, in the leather-treating products and methods of Waniek. One would have been motivated to do so to facilitate functional activity from a functional benefit agent into a leather substrate as taught by Minamiura (see paragraph 7 on page 16 of 26 of Minamiura).
The limitations of claims 11, 16, and 22-25 have been addressed above in regard to claims 9 and 17-20.
Regarding claims 13 and 15 which further specify the order of steps, see MPEP 2144.04(IV)(c) regarding the obvious nature of changes in sequence of adding ingredients. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). As to the specific step of cutting, Minamiura for instance teaches applicable leather products to include those which one would have immediately envisaged to have been cut in order to fashion into the products detailed (wallets, business card holders, keychains, straps, hanging leather, toys, etc.)(page 16 of 26 of translation).
Conclusion
No claim is 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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/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617