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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 9, 2025 has been entered.
Information Disclosure Statement
The submitted information disclosure statement (IDS) was filed on 12/22/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. Please see the signed and attached forms 1449.
Status of Application
Applicants' arguments/remarks filed 12-09-2025 are acknowledged. Claims 1-4 and 6-8 are examined on the merits within and are currently pending.
Maintained Rejections
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 non-obviousness.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US 9,308,187 B2) or Takada et al. (EP 2865378 A1) in view of Nakajima et al. (Nakajima et al., Rheology, Composition, and Peel-Mechanism of Block Copolymer-Tackifier-Based Pressure Sensitive Adhesives. Journal of Applied Polymer Science, Vol. 44, 1437-1456, 1992).
Hatanaka et al. teach a patch comprising a support layer and an adhesive layer,
wherein the adhesive layer comprises diclofenac sodium (a drug) and dimethyl sulfoxide
(DMSO) (Abs). A styrene-isoprene-styrene triblock copolymer is used as the adhesive layer of a
patch (pg. 10, right column, 3rd last par.). The obtained patches were evaluated for the crystallization of diclofenac and diclofenac sodium; the results are shown in Table 2 together with the adhesive layer compositions. In addition, the value in a parenthesis represents the mass part of each component (dimethyl Sulfoxide or citric acid) when diclofenac sodium in the adhesive layer of each example or comparative example was made one mass part. Dimethyl sulfoxide, samples 1-4, 3-7%. The adhesive layers comprise diclofenac sodium, dimethyl sulfoxide and a mass ratio between the diclofenac sodium and the dimethyl sulfoxide (mass of
diclofenac sodium:mass of dimethyl sulfoxide) is 1:0.75 to 1:3. (Table 2, Col. 11 lines 30-Col. 12, lines 1-6). Or a mass ratio between the dimethyl sulfoxide and the diclofenac sodium (mass of dimethyl sulfoxide:sodium:mass of diclofenac) is 3:1 to 0.75:1 or 1:0.33 to 1:1.33.
Takada et al. teach skin patch comprising a support layer and an adhesive layer, wherein the adhesive layer comprises diclofenac sodium (a drug), dimethyl sulfoxide (DMSO) (57) and thermoplastic elastomer like rubber type adhesive, styrene-based block copolymers, which can be styrene-butadiene-styrene block copolymers (triblock), styrene-isoprene-styrene block copolymers (triblock), styrene-butadiene rubbers (diblock), and styrene-isoprene rubbers. One of these may be used alone, or a plurality of these may be used in combination. (0029) or acrylic type adhesive, silicone type adhesive. (0031).
Hatanaka et al. or Takada et al. do not teach the thermoplastic elastomer, a styrene-based block copolymer has a triblock content of 35%-65%.
Nakajima et al. teach three samples of styrene-isoprene-styrene (SIS) triblock copolymers, to determine pressure sensitive adhesives, tack, room-temperature peel-strength, and failure temperature under static shear. Three samples of styrene-isoprene-styrene ( S-I-S ) block copolymers were chosen; copolymer A had 25% styrene, and copolymers B and C had 14% styrene. (Synopsis). A and B contained 20% diblock and C contained 40% diblock polymer. (Abs). In shear adhesion failure temperature test, A, B and C have 44 or 52% SIS. (Table II, pg. 1439). Tack, Peel & Shear can define bond between two surfaces. For Polyken Probe Tack Test (to define bond between two surfaces) results were high tack for polymers A, B & C with 35-60%. (Figure 1, pg. & 1439). For Quick Stick test, polymer A, B & C with % SIS 40-65%. (Figure 2, pg. 1440).
Hatanaka et al. teach in patches that are on the market or are being developed is used
in the form of a pharmaceutically acceptable salt, particularly a sodium salt from the standpoints
of improving its stability, suppressing reduction in physical properties (intensity, elasticity,
durability, adhesiveness, and the like). (pg. 10, left col., lines 35-40). From the standpoint that
the attachability of a patch to the skin is more easily secured, one having elasticity such as a
woven fabric is preferable; from the standpoint of easy handling of the patch, one having self-supportability (such as a film or a sheet-like forming product) is preferable. (pg. 13, left col., line
35-50).
Takada et al. teach the adhesive layer is normally formed onto one surface of the support layer and allows for its attachment to the skin, and it is a layer comprising an adhesive having pressure-sensitive adhesiveness and diclofenac sodium to be absorbed percutaneously. (0018). From the standpoint that the attachability of a patch to the skin is more easily secured, one having elasticity such as a woven fabric is preferable; from the standpoint of easy handling of the patch. (0038). The adhesive force which is sufficient to make attachment easy and which does not allow for being peeled during the attachment is secured. (0040). A patch was evaluated in skin permutation test (0046), which is to test patch attachment of several possible variations, in which a set or number of things can be ordered or arranged.
Elasticity is the ability of a material to deform under an applied force and then return to its original shape once that force is removed and is the property that enables extending and contracting in response to motion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a transdermal patch comprising an adhesive layer on a backing, wherein the adhesive layer comprises a drug, DMSO, and an adhesive base, taught by Hatanaka et al. or Takada et al., wherein the adhesive base comprises a styrene-based thermoplastic elastomer having styrene-based thermoplastic elastomer with a triblock content of 35% to 65%, taught by Nakajima et al., and dimethyl sulfoxide and diclofenac sodium; where dimethyl sulfoxide mass % is 3-7%, a mass ratio between the dimethyl sulfoxide and the diclofenac sodium 1:0.33 to 1:1.33, taught by Hatanaka et al., and it prefers to have elasticity taught by Hatanaka et al. or Takada et al., since they have proven this range of triblock content would provide good adhesiveness for the transdermal patch.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US 9,308,187 B2) or Takada et al. (EP 2865378 A1) in view of Nakajima et al. (Nakajima et al., Rheology, Composition, and Peel-Mechanism of Block Copolymer-Tackifier-Based Pressure Sensitive Adhesives. Journal of Applied Polymer Science, Vol. 44, 1437-1456, 1992) and further in view of Wibaux et al. (WO 2009102933 Al).
The teachings of Hatanaka et al. or Takada et al. and Nakajima et al. are described in the claim 1 above.
Hatanaka et al. or Takada et al. and Nakajima et al. do not teach the adhesive layer has a viscosity of 450 Pa·s to 900 Pa·s at 60°C.
Wibaux et al. teach a thermoplastic elastomer comprising a blend of clear linear triblock
and deblock copolymer based on styrene and ethylene-butylene with a bound styrene of 14%
mass (0039). The liquid rubbers typically have a molecular weight of 25,000 to 50,000, and a
viscosity at 38°C of 50 to 10,000 Pa.s. A block copolymer of styrene and isoprene having a
styrene content of about 13% and an isoprene content of about 87%, a glass transition of about -
60°C., a melt viscosity of about 240 Pa.s at 50°C and which is commercially available from Shell
Chemical Company as LIR310, is particularly useful in the practice of the invention. Within the
adhesive material, in one embodiment, the weight ratio of solid rubber to liquid rubber is in the
range from about 100: 1 to about 1 :2, and is varied in order to obtain the desired degree of
adhesiveness and tackiness. In one embodiment, the weight ratio of solid rubber to liquid rubber
is in the range from about 50:1 to about 5:1, and in another embodiment, from about 20:1 to
about 10:1. (0040). The method of viscosity measurement would be provided by Shell Chemical Company.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to prepare a transdermal patch comprising an adhesive layer on a
backing, wherein the adhesive layer comprises a drug, DMSO, and an adhesive base, taught by Hatanaka et al. or Takada et al., wherein the adhesive base comprises a styrene-based thermoplastic elastomer having a triblock content of about 35% - 65%, taught by Nakajima et al. and to have the adhesive layer has a viscosity near the range of 450 Pa· s to 900 Pa· s at 60°C, taught by Wibaux et al., since they have proven that and since one of ordinary skill in the art knows that viscosity depends on temperature, method of measurement, molecular weights of polymers and percentage of styrene copolymer, so their results can be varied accordingly.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US 9,308,187 B2) or Takada et al. (EP 2865378 A1) in view of Nakajima et al. (Nakajima et al., Rheology, Composition, and Peel-Mechanism of Block Copolymer-Tackifier-Based Pressure Sensitive Adhesives. Journal of Applied Polymer Science, Vol. 44, 1437-1456, 1992) and further in view of Gu et al. (CN 107429036 A).
The teachings of Hatanaka et al. or Takada et al. and Nakajima et al. are described in the claim 1 above.
Hatanaka et al. or Takada et al. and Nakajima et al. do not teach the adhesive layer has a melt flow rate of 1.1 to 2 g/10 min at 60°C.
Gu et al. teach a thermoplastic elastomer mixture comprising polyisoprene containing
soft block of the hydrogenated styrene-based block copolymer, styrene-isobutylene-styrene
triblock copolymer (Abs). The report producer, HYBRAR KL-7125 copolymer of tangent 8 of
the peak temperature is -5°C, the melt flow rate (MFR) at 230°C, 2.16 kg load at 4g/10 minutes
(pg. 7, 3rd par.).
And Gu et al. teach that a styrenic block copolymer can have different molecular weights
from a relatively low to a relatively high average molecular weight of more than 75000,
preferably more than 200000, of about 75000 to about 1 million, or in the range of about 500000
to about 75000, a weight average molecular weight in the range of about 200000 to about 1
million, or in the range of about 500000 to about 200000 (pg. 6, 3rd last par.).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to prepare a transdermal patch comprising an adhesive layer on a
backing, wherein the adhesive layer comprises a drug, DMSO, and an adhesive base, taught by Hatanaka et al. or Takada et al., wherein the adhesive base comprises a styrene-based thermoplastic elastomer having a triblock content of 35% - 65%, taught by Nakajima et al. and to have the adhesive layer has a melt flow rate the melt flow rate (MFR) at 230°C, 2.16 kg load at 4g/10 minutes taught by Gu et al, since they prove that and since one of ordinary skill in the art knows that a melt flow rate depends on temperature, molecular weights of polymers and percentage of styrene copolymer so their results can be varied accordingly.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US 9,308,187 B2) or Takada et al. (EP 2865378 A1) in view of Nakajima et al. (Nakajima et al., Rheology, Composition, and Peel-Mechanism of Block Copolymer-Tackifier-Based Pressure Sensitive Adhesives. Journal of Applied Polymer Science, Vol. 44, 1437-1456, 1992) and further in view of Mckay et al. (Mckay et al., The Influence of Styrene Butadiene Diblock Copolymer on Styrene-Butadiene-Styrene Triblock Copolymer Viscoelastic Properties and Product Performance, Journal of Applied Polymer Science, vol. 56, Iss. 8, 23 May 1995, pg. 947-958).
The teachings of Hatanaka et al. or Takada et al. and Nakajima et al.are described in the claim 1 above.
Hatanaka et al. or Takada et al. and Nakajima et al. do not teach the adhesive layer has a loss tangent of 0.53 to 0.8 at 1 Hz.
McKay et al. teach quantitatively that the presence of the styrene-isoprene (SI) diblock
copolymer in the styrene-isoprene-styrene (SIS) triblock copolymer results in a linear increase in
the loss tangent and decrease in elasticity." (pg. 2, left col., 2nd par.). The influence of the diblock is quantitatively defined in the loss tangent and order-disorder transition of the neat copolymer. (pg. 2, right col., 3rd par.). Mckay et al. provided data of loss of tangent by different temperatures in the thermoplastic elastomer from about 1-0.1 (pg. 4, Fig. 1) and loss of elastic response by different composition in the thermoplastic elastomer. The loss of tangent increases from about 0.05-0.12 with decreasing of triblock copolymer (pg. 4, Fig. 2, pg. 5, left col., 1st par.). This loss in elastic response is described quantitatively in Figure 11 (pg. 10), where the loss tangent measured at 25°C and 1 rad/s is plotted vs. the diblock content in the triblock/diblock blends for both the neat polymers and the hot-melt adhesives. (pg. 9, right col., 2nd last par.). Tangent delta loss from around 0.1-0.3 or higher when the triblock percentage is decreased (Fig. 11, Pg. 10). With the extrapolation of Figure 11, it is obvious that with lower percentage of triblock copolymers, loss of tangent could be higher and up to 0.5 - 0.8 and especially with higher temperature than 25°C that the McKay's studies. The rheological measurements were performed on a Rheometrics dynamic mechanical spectrometer,
RDS-11. (pg. 949, left col. last par.).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to prepare a transdermal patch comprising an adhesive layer on a
backing, wherein the adhesive layer comprises a drug, DMSO, and an adhesive base, taught by Hatanaka et al. or Takada et al., wherein the adhesive base comprises a styrene-based thermoplastic elastomer having a triblock content of 35% - 65%, taught by Nakajima et al. and to have a loss tangent up to close to 0.5- 0.8, taught by Mckay et al, because they proved that and since one of ordinary skill in the art knows that tangent loss depends on working frequency, temperature, molecular weights of polymers and percentage of styrene copolymer and their results can be varied accordingly.
Claims 1, 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US 9,308,187 B2) or Takada et al. (EP 2865378 A1) in view of Nakajima et al. (Nakajima et al., Rheology, Composition, and Peel-Mechanism of Block Copolymer-Tackifier-Based Pressure Sensitive Adhesives. Journal of Applied Polymer Science, Vol. 44, 1437-1456, 1992) and further in view of Wibaux et al. (WO 2009102933 Al) and Gu et al. (CN 107429036 A).
The teachings of Hatanaka et al. or Takada et al. and Nakajima et al.are described in the claim 1 above.
The teaching of Wibaux et al. is described in claims 1 and 2 above.
The teaching of Gu et al. is described in claims 1 and 3 above.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to prepare a transdermal patch comprising an adhesive layer on a
backing, wherein the adhesive layer comprises a drug, DMSO, and an adhesive base, taught by Hatanaka et al. or Takada et al., wherein the adhesive base comprises a styrene-based thermoplastic elastomer having a triblock content of 35% - 65%, taught by Nakajima et al. and to have the adhesive layer has a viscosity near the range of 450 Pa·s to 900 Pa·s at 60°C, taught by Wibaux et al., and to have the adhesive layer has a melt flow rate close to 1.1 to 2 g/10 min at 60°C taught by Gu et al, since they prove that and since one of ordinary skill in the art knows that viscosity depends on temperature, method of measurement, molecular weights of polymers and percentage of styrene copolymer, so their results can be varied accordingly.
Claims 1, 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US 9,308,187 B2) or Takada et al. (EP 2865378 A1) in view of Nakajima et al. (Nakajima et al., Rheology, Composition, and Peel-Mechanism of Block Copolymer-Tackifier-Based Pressure Sensitive Adhesives. Journal of Applied Polymer Science, Vol. 44, 1437-1456, 1992) and further in view of Wibaux et al. (WO 2009102933 Al) and Mckay et al. (Mckay et al., The Influence of Styrene-Butadiene Diblock Copolymer on StyreneButadiene- Styrene Triblock Copolymer Viscoelastic Properties and Product Performance, Journal of Applied Polymer Science, Vol. 56, Iss. 8, 23 May 1995, Pg. 947-958).
The teachings of Hatanaka et al. or Takada et al. and Nakajima et al.are described in the claim 1 above.
The teaching of Wibaux et al. is described in claims 1 and 2 above.
The teaching of Mckay et al. is described in claims 1 and 4 above
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to prepare a transdermal patch comprising an adhesive layer on a
backing, wherein the adhesive layer comprises a drug, DMSO, and an adhesive base, taught by Hatanaka et al. or Takada et al., wherein the adhesive base comprises a styrene-based thermoplastic elastomer having a triblock content of 35% - 65%, taught by Nakajima et al. and to have the adhesive layer has a viscosity near the range of 450 Pa·s to 900 Pa·s at 60°C, taught by Wibaux et al., and a loss tangent of 0.5-0.8 at 1 Hz, taught by Mckay et al, because they have proven that and since also one of ordinary skill in the art can knows that a melt flow rate depends on the polymer composition, the molecular weights of the polymers and a loss tangent, which depends on working frequency, temperature, and the molecular weights of
the polymers so their results can be varied accordingly.
Claims 1, 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US 9,308,187 B2) or Takada et al. (EP 2865378 A1) in view of Nakajima et al. (Nakajima et al., Rheology, Composition, and Peel-Mechanism of Block Copolymer-Tackifier-Based Pressure Sensitive Adhesives. Journal of Applied Polymer Science, Vol. 44, 1437-1456, 1992) and further in view of Gu et al. (CN 107429036 A) and of Mckay et al. (Mckay et al., The Influence of Styrene-Butadiene Diblock Copolymer on Styrene-ButadieneStyrene Triblock Copolymer Viscoelastic Properties and Product Performance, Journal of Applied Polymer Science, Vol. 56, Iss. 8, 23 May 1995, Pg. 947-958).
The teachings of Hatanaka et al. or Takada et al. and Nakajima et al. are described in the claims 1 and 5 above.
The teaching of Gu et al. is described in the rejection of claims 1 and 3 above.
The teaching of Mckay et al. is described in the rejection of claims 1 and 4 above.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to prepare a transdermal patch comprising an adhesive layer on a
backing, wherein the adhesive layer comprises a drug, DMSO, and an adhesive base, taught by Hatanaka et al. or Takada et al., wherein the adhesive base comprises a styrene-based thermoplastic elastomer having a triblock content of 35% - 65%, taught by Nakajima et al. and to have the adhesive layer has a melt flow rate the melt flow rate (MFR) at 230°C, 2.16 kg load at 4g/10 minutes taught by Gu et al, and to have has a loss tangent of 0.53 to 0.8 at l Hz taught by Mckay et al. since they have proven those, and one of ordinary skill in the art knows that a melt flow rate depends on the polymer composition, the molecular weights of the polymers and a loss tangent depends on working frequency, temperature, and the molecular weights of the polymers, so their results can be varied accordingly.
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant argues that the test for obviousness under 35 U.S.C. § 103 is referred to as the "Graham Test", as laid out in Graham v. John Deere Co., 383 U.S. 1, 86 S. Ct. 684 (1966). Under the Graham Test, in order to determine whether an invention is obvious in light of the prior art, the following factors are considered: 1) the scope and content of the prior art; 2) the differences between the prior art and the claims at issue; 3) the level of ordinary skill in the pertinent art; and 4) secondary considerations of non-obviousness. See id. at 17-18. Subsequent to Graham, the court further refined the test for obviousness in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727 (2007).
Applicant's arguments have been fully considered but they are not persuasive, since the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things. The test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Applicant argues that the sample patches prepared according to Hatanaka et al. began to peel off almost immediately, with a significant portion of the patch peeling off after 24 hours. (REM, pg. 5, 2nd par.). It is believed that sufficient evidence has been submitted, in the originally-filed specification, in the Declaration filed on July 3, 2025, and in the Declaration filed concurrently herewith, to show, particularly via the measured adhesion and peeling distance of the presently claimed patches, that unexpected results not found in the cited art exist with regard to the presently claimed subject matter. (REM , pg. 6, 1st par.). Although Hatanaka et al. and Takada et al. may teach elasticity, the presently claimed subject matter has the unexpected result of exhibiting particularly good adhesion with specific regard to sites that stretch and contract during movement. The Declaration filed on July 3, 2025 showed the setup for the above-described Test Example 3 and discussed the results. (REM, pg. 6 last par.-pg. 7, 1st par.).
Applicant's arguments have been fully considered but they are not persuasive, as pointed out above that since the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. 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). Applicant provides unexpected results comparing to Hatanaka’s results (17433289-AF_D_132_2025-07-03/ Declaration filed on July 3, 2025), but in the office action of Final Rejection, 09/09/2025, Hatanaka and Takada do not teach the thermoplastic elastomer, a styrene-based block copolymer has a triblock content of 35%-65%. Nakajima et al. teach three samples of styrene-isoprene-styrene (SIS) triblock copolymers, to determine pressure sensitive adhesives, tack, room-temperature peel-strength, and failure temperature under static shear. Three samples of styrene-isoprene-styrene ( S-I-S ) block copolymers were chosen; For Polyken Probe Tack Test (to define bond between two surfaces) results were high tack for polymers A, B & C with 35-60%. (Figure 1, pg. & 1439). For Quick Stick test, polymer A, B & C with % SIS 40-65%. (Figure 2, pg. 1440). One with ordinary skill in the art can learn composition of the patch from both Hatanaka or Takada, and from Nakajima et al. and select has a triblock content of 35% to 65%, to achieve better outcome results. One with skill in the art could learn from. Applicant submitted the 1st Affidavit 17433289-AF_D_132_2025-07-03, comparing Hatanaka Example 1, 7 and 9 having longer peeling distances (pg. 4) than those of applicant’s Example 1, 2, and 3 (pg. 5), to prove applicant limitations in claim 1 of 35-65% of triblock styrene polymer provide better transdermal patch. However, i). as explained above that “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references”; ii). Hatanaka has adhesive force instead; iii) Nakajima provides high Polyken Probe Tack Test which have high adhesive force (Fig. 1, pg. 1439) and high Quick Stick Results, which show high ability of an adhesive to form and instantaneous bond with minimal pressure or high initial grab, (Fig. 2, pg. 1440) for SIS polymer with triblock % about 35%-60%,; iv) applicant provides shorter peeling distances, but also lower adhesive force (1st Affidavit 17433289-AF_D_132_2025-07-03): All of these do not prove applicant’s unexpected results.
Applicant argues that although the Examiner asserted that the pulling distance determines whether the bond will fail prematurely, this is not relevant with respect to the adhesive
force evaluated in the presently claimed subject matter. The adhesive force of the patch was
evaluated in Test Examples 4 and 5 of the originally-filed specification (paragraphs [0064] and
[0065]. In these tests, the resistance-to-peel strength of an adhesive was evaluated, rather than evaluating whether the bond will fail prematurely. (REM, pg. 7 last par.). Contrary to the Examiner's assertion, adhesion to sites that can stretch and contract during movement is not always positively correlated with the adhesive strength.
Applicant's arguments have been fully considered but they are persuasive. This statement “adhesion to sites that can stretch and contract during movement is not always positively correlated with the adhesive strength” is correct that adhesion to sites is not always positively correlated with adhesive strength. While initiating contact with a surface (adhesion/wetting) is necessary for a bond to form, the actual strength of that bond depends on multiple, often independent, factors, including cohesion, surface area, and mechanical, chemical, or viscoelastic properties. However, adhesive strength is not adhesive force. Adhesive strength generally refers to the stress (force per unit area) required to break a bond, whereas adhesive force refers to the intermolecular attraction between the adhesive and the substrate. However, in the 1st Affidavit 17433289-AF_D_132_2025-07-03 or same with the 2nd Affidavit 17433289-AF_D_132_2025-12-09, applicant’s Example 1, 2 and 3 have low Adhesive force (14.94, 8.17, and 8.76 (gF), while Hatanaka Example 7 and 9, has adhesive force 211.49 and 35.73 (gF), even though, Hatanaka does not provide triblock %.
Applicant argues that on elasticity, the unexpected results found in the presently claimed subject matter are not drawn to elasticity, peeling force or adhesive strength but, rather, the ability to remain adhered to skin despite stretching and contracting due to movement. Applicant submits the 2nd Affidavit 17433289-AF_D_132_2025-12-09 to show, particularly via the measured shortened peeling distance and the adhesion to actual human skin of the presently claimed patches, that unexpected results not found in the prior art exist with regard to the presently
claimed subject matter and noted that the peeling force is not relevant with regard to the superiority of the peeling distance of the presently claimed subject matter.
Applicant's arguments have been fully considered but they are not persuasive. Based on the principles of peel adhesion, the peeling force is highly relevant, but agreeing that it is not the only factor in determining the "superiority" of the peeling distance (the length of bonding maintained or the stability of the bond over time). In many applications, a higher peel force does not automatically equate to a superior, more stable bond over a longer distance, as factors like viscoelasticity, energy absorption, and failure mode are also critical. Even though applicant submits the measured shortened peeling distance and the adhesion to actual human skin of the presently claimed patches in the 2nd Affidavit 17433289-AF_D_132_2025-12-09, still applicant only shows its peeling distance are better than Hatanaka, but Hatanaka is not the prior art teaching 35-65% triblock styrene copolymers. As explained above that Nakajima et al. teach three samples of styrene-isoprene-styrene (SIS) triblock copolymers, have high tack for polymers A, B & C with 35-60%. (Figure 1, pg. & 1439). For Quick Stick test, polymer A, B & C with % SIS 40-65%. (Figure 2, pg. 1440). One with ordinary skill in the art can learn composition of the patch from both Hatanaka or Takada, and from Nakajima et al. and select has a triblock content of 35% to 65%, to achieve better outcome results.
Applicant argues that Nakajima does not include DMSO, it is clear that Nakajima et al. cannot effectively be used to address the specific problem caused by the inclusion of DMSO; i.e., the loss of adhesiveness due to the presence of DMSO. As discussed above, evidence of unexpected results, particularly with regard to solving the aforementioned problem of loss of adhesiveness, is amply provided in the Declaration filed on July 3, 2025 and in the Declaration filed concurrently herewith, thus overcoming the Examiner's combination of Hatanaka et al. or Takada et al. with Nakajima et al.
Applicant's arguments have been fully considered but they are not persuasive since Nakajima is the closet prior art teaching triblock Styrene-Isoprene-Styrene ( S-I-S ), with specific percentages, while Hatanaka and Takada do not. Also, Hatanaka has different percentages of tackifier Hydrogenated rosin glycerin ester, alicyclic saturated hydrocarbon resins and different percentages of plasticizer, paraffin-based processed oil, from applicant’s that they both significantly affect the pulling distances (often referred to as fibrillation, elongation, or stringiness) during the debonding or peeling of pressure-sensitive adhesives (PSAs) and adhesive forces. As explained above that idea to use triblock Styrene-Isoprene-Styrene to improve adhesive force are taught by Hatanaka and Takada and 35-65% of triblock Styrene-Isoprene-Styrene provides better adhesion is taught by Nakajima. No one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things.
Conclusion
No claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615