DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 7/27/2026.
Status of the Claims
No claims are amended, cancelled or newly added. Accordingly, claims 1-17 remain pending in the application. Claims 2 and 3-17 stand withdrawn from further consideration, without traverse. Claims 1 and 3-12 are currently under examination.
Maintained Rejections
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.
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 and 10-12 stand rejected under 35 U.S.C. 103 as being unpatentable over Hamann (US 2004/0091557 A1, May 13, 2004, hereafter as “Hamann” in view of Silberstein et al. (WO 2017/191629 A1, Nov. 9, 2017, hereafter as “Silberstein”) and Liu (CN 111450023 A, Jul. 28, 2020, machine translation, hereafter as “Liu”).
The claimed invention is drawn to an elastomeric article (10) comprising: a substrate body (11) defining an inner surface (12) proximal to skin of a user and an outer surface (13) distal to the skin of the user, the substrate body (11) comprises an elastomer; an intermediate coating (15) overlying at least a portion of the inner surface (12), the intermediate coating (15) comprises a therapeutic agent; and an inner coating (14) overlying at least a portion of the intermediate coating (15), wherein the inner coating (14) comprises an extract of soapnuts for preserving the therapeutic agent.
Regarding instant claims 1, 3, 4 and 12, Hamman teaches elastomeric articles such as gloves having multiple layers (Abstract; [0010]; Figures 4, 6 and 22). In a particular embodiment, Hamman teaches an elastomeric glove having an elastomeric substrate layer, an intermediary layer on the substrate comprising a botanical extract, preferably Aloe vera, and a coating surface layer on the intermediary layer containing a non-Aloe vera material ([0156]; Fig. 9). It is noted that a glove is a substrate that has an inner surface proximal to the skin of a user and an outer surface distal to the skin of the user. Hamman also teaches that typically a 5% to 20% solution (water and/or ethanol) of the non-Aloe vera botanical extract is applied, but may range from 1% to 50% solution (based on a 100:1 powder of non-Aloe vera botanical extract) ([0148]).
Hamman is silent to an extract of soapnuts (instant claim 1) as well as a preservative (instant claim 6).
Silberstein teaches anti-bacterial compositions comprising saponins, which act as a preservative (page 2). The saponins include those derived from Sapindus mukorossi (Indian soapberry; Examples 7 and 9). Silberstein teaches that the compositions can contain between 0.01 and 2 wt.% saponin (page 4, 4th paragraph). Silberstein teaches said compositions are suitable for application to the skin (page 17, 5th paragraph).
Liu teaches a bath composition having skin care properties, comprising soapberry extract and Aloe vera extract in a ratio of 1:1 (Embodiment/Example 2).
The references are all drawn to compositions for application to the skin, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an extract of soapnuts, a known preservative, in the non-Aloe vera coating surface layer of Hamman, as suggested by Silberstein and Liu, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that saponins derived from Indian soapberry have antibacterial and preservative properties and the combination of Aloe vera and soapnut extracts has been demonstrated as an effective skin care composition.
Regarding instant claim 10, The references teach the elements discussed above. Hamman teaches that typically a 5% to 20% solution (water and/or ethanol) of the non-Aloe vera botanical extract is applied, but may range from 1% to 50% solution (based on a 100:1 powder of non-Aloe vera botanical extract) ([0148]). Silberstein teaches that the compositions can contain between 0.01 and 2 wt.% saponin (page 4, 4th paragraph).
While the references do not explicitly teaches the inner coating having 20-30% by volume of 1% (w/v) soapnuts extract, the references teach the general conditions of the claim and it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of extract of soapnuts by way of routine optimization with a reasonable expectation of success. MPEP 2144.05(II)(A) states, “[W]here 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”. A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed set of percentage ranges is the optimum combination of percentages (MPEP 2144.05).
Regarding instant claim 11, The references teach the elements discussed above.
Hamman also teaches the particular elastomer materials, natural rubber, a synthetic polyisoprene, a chloroprene, a polyurethane (PU), a polyvinyl chloride (PVC), a styrene butadiene styrene (SBS), a styrene isoprene styrene (SIS), a silicone, a butadiene methylmethacrylate, an acrylonitrile, a styrene ethylene butylene styrene (SEBS), an acrylate-based hydrogel ([0007]).
Thus, the combined teachings of Hamman, Silberstein and Liu render the instant claims prima facie obvious.
Response to Arguments
Applicants’ arguments have been fully considered but they are not persuasive.
Applicant argues that the Examiner fails to recognize that the key feature of the claimed invention is the use of soapnut extract particularly to prevent head degradation of plant based therapeutic agents. Remarks, page 6.
In response, it is respectfully submitted that applicant’s attention is directed to MPEP 2144 IV which recites “the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”… (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
In the instant case, the prior art recognizes the advantage of adding saponins derived from Indian soapberry (antibacterial and preservative properties), as well as the combination of aloe vera and said extracts as an effective skin care composition. The prior art need not recite the prevention of heat degradation, as alleged by Applicant.
Furthermore, the instant claims are drawn to a composition (article) of matter and not a process of preparing or product by process. The instant claims do not recite process steps regarding a temperature at which the extract is prepared. Thus, Applicant is arguing limitations which are not present in the claims.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
Claims 5, 8 and 9 stand rejected under 35 U.S.C. 103 as being unpatentable over Hamann (US 2004/0091557 A1, May 13, 2004, hereafter as “Hamann” in view of Silberstein et al. (WO 2017/191629 A1, Nov. 9, 2017, hereafter as “Silberstein”) and Liu (CN 111450023 A, Jul. 28, 2020, machine translation, hereafter as “Liu”), as applied claims 1 and 3 above, and further in view of Foo et al. (WO 2018/119491 A1, Jul. 5, 2018, hereafter as “Foo”).
The claimed invention is described above.
Hamman, Silberstein and Liu teach the elements discussed above.
Hamman, Silberstein and Liu are silent to the combination of Aloe vera and ginseng (instant claim 5).
Foo teaches elastomeric articles such as gloves comprising a coating having skin care properties (abstract; page 1, lines 4-7). Foo teaches that the coatings can contain skin care components such as Aloe vera and ginseng, and general amounts thereof (page 12, last paragraph - page 13, 2nd paragraph).
The references are all drawn to compositions for application to the skin, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include ginseng in a coating layer of Hamman/Silberstein/Liu, as suggested by Foo, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Foo teaches that ginseng and Aloe vera are suitable skin care components of a coating composition for an elastomeric article such as glove. MPEP 2144.06(I) states, “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”.
Hamman, Silberstein and Liu are silent to a first intermediate coating comprising Aloe vera and a second intermediate coating comprising ginseng (instant claim 8).
The references are all drawn to compositions for application to the skin, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include ginseng in a first intermediate coating layer and Aloe vera in a second intermediate coating layer of Hamman/Silberstein/Liu/Foo with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hamman teaches various multi-layer coating embodiments, wherein the surface coating layer is a non-Aloe coating layer and optimizing the number of layers and the arrangement of active ingredients in the layers by routine experimentation is within the normal desire of scientists or artisans to improve upon what is already generally known.
Hamman, Silberstein and Liu are silent to the claimed percentage of Aloe vera and ginseng (instant claim 9).
The references are all drawn to compositions for application to the skin, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amounts of ginseng and Aloe vera in Hamman/Silberstein/Liu/Foo by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the references teach various amounts of the active ingredients and it is within the normal desire of scientists or artisans to improve upon what is already generally known.
Thus, the combined teachings of Hamman, Silberstein, Liu and Foo render the instant claims prima facie obvious.
Response to Arguments
Applicants’ arguments have been fully considered but they are not persuasive.
Applicant argues that in the claimed invention, the extracts of aloe vera, ginseng, and soapnuts are selected because they have been observed to crosslink well with the elastomer. Most importantly, the extracts integrate well with each other to form a stabilized product with high efficacy. Remarks, pages 6-7.
In response, it is respectfully submitted that, as noted above, Foo teaches that ginseng and Aloe vera are suitable skin care components of a coating composition for an elastomeric article such as a glove.
Applicant’s attention is again directed to MPEP 2144 IV which recites “the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”… (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
Furthermore, the instant claims are drawn to a composition (article) of matter and not a process of preparing or product by process. The instant claims do not recite process steps regarding the crosslinking of the aloe vera, ginseng, and soapnuts with the elastomeric substrate or the temperature at which the coating step is performed. Thus, Applicant is arguing limitations which are not present in the claims.
For these reasons, applicant’s argument is unpersuasive.
Applicant also argues that the coating composition of Foo is encapsulated in a bilayer membrane, which is not disclosed in the claimed invention. Remarks, page 7.
In response, it is respectfully submitted that the claims utilize open-ended “comprising” language. Applicant’s attention is directed to MPEP 2111.03 I which discloses “the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)… ("Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948)”. Accordingly, the claims allow for additional unrecited elements such as the bilayer membrane of Foo.
For these reasons, applicant’s argument is unpersuasive.
The rejection is maintained.
Claims 6 and 7 stand rejected under 35 U.S.C. 103 as being unpatentable over Hamann (US 2004/0091557 A1, May 13, 2004, hereafter as “Hamann” in view of Silberstein et al. (WO 2017/191629 A1, Nov. 9, 2017, hereafter as “Silberstein”) and Liu (CN 111450023 A, Jul. 28, 2020, machine translation, hereafter as “Liu”), as applied claim 1 above, and further in view of Leong (US 2002/0114825 A1 Aug. 22, 2002, hereafter as “Leong”).
The claimed invention is described above.
Hamman, Silberstein and Liu teach the elements discussed above.
Hamman, Silberstein and Liu are silent to the particular preservatives, sodium benzoate or potassium benzoate.
Leong teaches an elastomeric article such as a glove comprising an Aloe vera coating (Abstract; [0001]). Said coating comprising Aloe vera extract and sodium benzoate as a preservative ([0011] and [0022]).
The references are all drawn to compositions for application to the skin, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the particular preservative, sodium benzoate in the invention of Hamman/Silberstein/Liu, as suggested by Leong, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Leong teaches that sodium benzoate is an effective preservative in a skin care composition comprising Aloe vera for coating an elastomeric article such as a glove.
Thus, the combined teachings of Hamman, Silberstein, Liu and Leong render the instant claims prima facie obvious.
Response to Arguments
Applicant relies on the same arguments as presented for the 103 rejection over Hamann, Silberstein and Liu. No further arguments regarding claims 6 and 7 are presented. Remarks, pages 5-7.
For the same reasons as discussed above, Applicant’s arguments are not persuasive. The rejection is, therefore, maintained for the reasons of record.
Conclusion
All claims have been rejected; no claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617
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