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 .
Response to Amendment
The Amendment filed 10/30/2025 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 07/31/2025. Applicant’s claims have been amended in the following manner: independent claim 1 now specifies the preservative (previously found in claim 4, which is now cancelled) and viscosity (previously found in claim 9, which is now cancelled) to prompt a new ground of rejection, although the thrust of the current rejection remains essentially the same as before, relying on the same Art. The following objections/rejections are withdrawn: the 112b rejections.
The Examiner further acknowledges the following:
Claims 1-2, 5-8, 10, and 12-19 are pending.
Claims 12-14 and 19 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-2, 5-8, 10, and 15-18 are presented for examination and rejected as set forth below.
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.
Claim 16 is 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 16 recites “the adhesive composition” of claim 4 for which there is insufficient antecedent basis and is indefinite, because claim 4 has been cancelled. See MPEP 2173.05(e). The Examiner assumes that Applicant intendeds to refer claim 16 back to claim 1 and addresses the office action accordingly.
New 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.
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 1-2, 5-8, 10, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kruse (US20050281869), and in further view of Hughes (US 5223592), Hartnett (US20170239155A1), Sugai (US 2009/0126753), and Master Bond (2011).
Applicant’s claims are directed to an adhesive composition comprising: 2.5 to 12% by weight of sodium polyitaconate, 0.5 to 1.5% by weight of a preservative (which is specified), and at least 10% by weight of water, wherein the adhesive composition has a viscosity of 60,000 to 90,000 centipoise. The phrase “for adhering…to human skin” is an intended use, and for compositions: a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003).
Kruse teaches a self-adhesive polymer matrix (abstract) that allows matrices of defined consistency and bond strength for skin cosmetic application [0183, 0186]. Kruse further teaches polyacrylates as polymers for general use in adhesives [0175-0180] and teaches the polymeric matrix to be made of a polyacrylic acid [0188].
Regarding claims 1-2 and 15: Kruse teaches an adhesive composition that serves as an attachment point on skin [0185], comprising at least 20 wt% water ([0352], Examples), chelating agents in 0-15 wt% [0256-0258], and 0.01-2.0 wt% disinfecting agent (reads on preservatives) [0329-0330, 0335-0336, 0343]. For the amounts, "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Furthermore, citric acid (reads on a preservative of instant claim 1) is named for incorporation in 0.02-2 wt% [0256-0258].
Regarding claims 7-8 and 18: Kruse teaches glycerin and propanediol [0191-0192, 0251-0252].
In summary, Kruse teaches an adhesive composition, comprising water, a chelating agent, and a preservative. However, Kruse does not teach sodium polyitaconate (instant claim 1), the specific preservative (instant claim 16), the thickening agent in the adhesive (instant claims 5-6 and 17), the pH (instant claim 10), and the viscosity of the adhesive (instant claim 1).
Hughes teaches polyitaconate as a sequestrant (reads on chelating agent) (abstract) (including fully neutralized sodium polyitaconate at pH 7 in Example 2) in compositions (reads on instant claim 1).
Hartnett teaches a personal care composition that can be applied to the skin (abstract). Hartnett describes the importance of thickening agents such as guar gum, xanthan gum and hydroxyethylcellulose (Hartnett – claim 2) to achieve desired viscosities [0001-0002] (reads on instant claims 5-6 and 17). Harnett also discloses pHs of 5-7 as a desired range for compositions that are compatible with exposure to the body [0107]. Hartnett also teaches the diol preservative 2-bromo-2-nitropropane-1,3-diol (reads on diol preservative of claims 1 and 16) among many other preservatives (Hartnett – claim 8).
Sugai teaches adhesives for wigs (abstract), and that the tackiness (or adhesiveness) to the head (or skin) can be altered by adjustment of the applying viscosity [0073]. Although Sugai’s adhesive is set at 2000-3000 cps [0111], a person skilled in the art would modify the viscosity in order to improve tackiness for an improved skin binding product. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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). A PHOSITA would understand that Sugai’s preferred viscosity is based on the objectives that Sugai sets for the disclosure and is optimized based on the particular ingredients in the composition of the disclosure.
Master Bond indicates that adhesives can have a wide range of suitable viscosities of 100-1,500,000 cps, depending on application (pg 2-3). Note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Thus, the viscosity range disclosed by Master Bond as useful for adhesive formulations encompasses the instant range (instant claim 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add polyitaconate as a chelating agent to Kruse’s adhesive composition because Hughes teaches sodium polyitaconate as a chelating agent, in which chelating agents are allowed in Kruse’s adhesive composition in an amount of 0-15 wt% [0256-0257], such that the amount sodium polyitaconate to be incorporated encompasses the instant range of polyitaconate amount. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art by adding thickening agents such as guar gum, xanthan gum and hydroxyethylcellulose because that achieves desired viscosities, which is deemed important by Kruse for adhesives [0178, 0181]; select preservatives such as the diol preservative 2-bromo-2-nitropropane-1,3-diol taught by Hartnett, because preservatives are useful in aqueous adhesive compositions as taught by Kruse [0336]; and use the pH range taught by Hartnett that is desirable as not harmful to the body, because Kruse discusses appropriate pH ranges for cosmetic products [0044]. Collectively, the cosmetic formulation teachings of Hartnett as directed to topical application to skin have relevance in the teachings of adhesives taught by Kruse that are applied topically to the skin.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art by optimizing the viscosity to within a range of 60,000 to 90,000 cps because that would improve tackiness of the final adhesive and that these viscosities are generally suitable for adhesives, as taught by Sugai and Master Bond. Furthermore, Master Bond indicates that adhesives can have a wide range of suitable viscosities of 100-1,500,000 cps, depending on application (pg 2-3), which encompasses the instant range, rendering the instant range prima facie obvious.
Response to Arguments
Applicants arguments, see pg 5-8, filed 10/30/2025, with respect to the 103 rejection of claims 1-2, 4-10, and 15-18 under rejection have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set and new added claims. The thrust of the rejection remains the same as before, relying on the same references.
On page 5, Applicant discusses amendments to address the 112 rejections, in which the 112 rejections are now withdrawn based on the amendments.
On page 6, Applicant argues that there is a long list of possible materials to be used, as taught by the Prior Art (i.e., Kruse at [0257]). It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Thus, the number of available ingredients the art teaches as desirable for selection does not impact an obviousness rejection.
Applicant also suggest Hughes is directed to laundry applications. However, the Examiner points to neutralized polyitaconate, according to Hughes, as suitable for a wide variety of uses such as detergent additives, scale inhibitors and removers, sequestrants, yarn sizers, deflocculating agents, de-inking agents, suspending agents and dispersing agents (abstract), and not just laundry applications. Note that specific embodiments do not define the teachings: “Applicants erroneously point to specific embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).” Thus, Hughes is relevant to the instant application as analogous art (i.e. by not only naming the species of the invention, but describing functional roles of sodium polyitaconate that could benefit adhesive formulations).
As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). The Examiner has pointed to nothing other than what the art available at the time the instant application was filed to teach or suggest each and every limitation of the invention claimed, and relied on nothing other than the art to rationalize their combination in the manner you put forth. Applicants have provided no evidence that the rejection is not based on anything other than the knowledge available to those of ordinary skill in the art as taught by the references the examiner has relied on. The 103 rejection is based on the Prior Art on record.
Applicant also claims Kruse has no desire for an alternative chelator, because Kruse lists a plurality of chelators. Note that an express suggestion for substitution is not required to render a substitution obvious: “Furthermore, as noted by the court in In re Fout, 675 F.2d 297 (CCPA 1982), an express suggestion to substitute one equivalent component (e.g., an equivalent viscosity modifier) for another is not necessary to render such substitution obvious.” Furthermore, Kruse teaches general use of chelating agents in 0-15 wt% [0256-0258]. The selection of Hughes’s polyitaconate ingredient is simply the selection of a component known to be useful as the generic component taught by the primary reference Hughes. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Because Hughes teaches generically these chelator ingredients [0256-0258], it would be obvious to a PHOSITA to substitute/add polyitaconate into Kruse’s compositions, based on the sequestrant/chelating function of sodium polyitaconate taught by Hughes.
Applicant claims amendment of claim 1 by inclusion of claims 4 and 9 has resolved the issues. However, further narrowing the independent claim 1 by specifying the preservative and viscosity that were previously found in now-cancelled dependent claims does not impact the obviousness of the combination, as described in the amended obvious rejection above.
On page 6-8, Applicant argues that the specific viscosity of 60000 to 90000 centipoise is not taught by the Prior Art on record. Applicant argues that Sugai’s preferred viscosity of 2000-3000 cps [0111] is a preferred viscosity that does not relate to the instant viscosity. The fact that Sugai has a preferred viscosity does not teach away from the larger teaching of such that Master Bond indicates that adhesives can have a wide range of suitable viscosities of 100-1,500,000 cps, depending on application (pg 2-3), and that Sugai provides a motivation for a PHOSITA working in the field of wig adhesives such that a PHOSITA would want to optimize tackiness (or adhesiveness) to the head (or skin) by adjustment of the applying viscosity [0073]. Note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)). Furthermore, this establishes formulation viscosity as a result-effective variable that a person of ordinary skill in the art would routinely optimize in order to adjust tackiness of the adhesive. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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). Because Sugai discloses a preferred viscosity of 2000-3000 cps [0111] for that particular system, does not discredit the larger teaching that a PHOSITA would want to optimize tackiness (or adhesiveness) to the head (or skin) by adjustment of the applying viscosity [0073]. Applicant has not argued for the specific advantage of the instant viscosity range based on evidence of unexpected results of the instant viscosity range as a demonstration of non-obviousness, such that the data would be commensurate in scope with the claim set.
On page 8, Applicant concludes. The Examiner notes no discussion of unexpected results (as supported by data/evidence in the Specification or by Affidavit/Declaration) to demonstrate non-obviousness of the invention with respect to the 103 rejection above. To establish unexpected results over a claimed range (e.g., ingredient amount or viscosity), applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
Correspondence
Applicant's amendment necessitated the new ground 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 extension fee 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 date of this final action.
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/R.P./Examiner, Art Unit 1614 12/1/2025
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614