DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Acknowledgment
Claim 17 is amended and filed on 12/4/2025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 13, 17 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kyvik et al. (US.20080065022A1) (“Kyvik”).
Re Claim 1, Kyvik discloses a securement device (10, Figs. 1-5) for securing medical devices (catheter body 21) of different shapes and sizes (¶0014, the securement device is capable can accommodated several tube sizes such as from a tube has a tapered portion with diameters range, ¶0014-¶0015), comprising: a flexible body member (11, Fig. 3, ¶0015) including a first surface (right surface close to 12) and a second surface (left surface) opposite the first surface (Fig. 3), the first surface including an adhesive thereon (12, ¶0015) configured to adhere the body member to a patient (¶0015); a pad (14 and 26) coupled to the first surface of the body member (Fig. 3); and a channel (31, Fig. 5)extending longitudinally through the pad (Fig. 5) and encircling a portion of a medical device extending therethrough (Fig. 3), wherein the securement device is configured to conform to both a shape and size of the medical device and the patient when adhered to the patient over the medical device ( ¶0015, the soft material can be compressible and resilient over the catheter will conform the shape and the side of the catheter) and mitigate lateral and longitudinal motion of the medical device disposed in the channel (¶0015, ¶0016).
Re Claim 13, Kyvik discloses a securement device (10, Figs. 1-5) for securing medical devices (catheter body 21) of different shapes and sizes (¶0014, the securement device is capable can accommodated several tube sizes such as from a tube has a tapered portion with diameters range, ¶0014-¶0015), comprising: a flexible body member (11, Fig. 3, ¶0015) including a first surface (right surface close to 12) and a second surface (left surface) opposite the first surface (Fig. 3), the first surface including an adhesive thereon (12, ¶0015) configured to adhere the body member to skin of a patient (¶0015); a pad (14 and 26) disposed on the first surface of the body member (Fig. 3); and a channel (31, Fig. 5) disposed in the pad to retain a portion of a medical device (catheter 21, ¶0015) disposed between the medical device and the flexible body a long an entire length of the channel (Fig. 5), wherein the securement device is configured to conform to both a shape and size of the medical device and the patient when adhered to the patient over the medical device ( ¶0015, the soft material can be compressible and resilient over the catheter will conform the shape and the side of the catheter) and mitigate lateral and longitudinal motion of the medical device disposed in the channel (¶0015, ¶0016).
Re Claim 17, Kyvik discloses a securement device (10, Figs. 1-5) for securing medical devices (catheter body 21) of different shapes and sizes (¶0014, the securement device is capable can accommodated several tube sizes such as from a tube has a tapered portion with diameters range, ¶0014-¶0015), comprising: a flexible body member (11, Fig. 3, ¶0015) including a first surface (right surface close to 12) and a second surface (left surface) opposite the first surface (Fig. 3), the first surface including an adhesive thereon (12, ¶0015) configured to adhere the body member to a patient (¶0015); a pad (14 and 26) coupled to the first surface of the body member (Fig. 3); and a channel ( channel between 31 and 26, Fig. 2, 5) disposed in the pad (Fig. 5) extending longitudinally between a proximal end and a distal end of the pad ( left end of 31 and right end of 31, Fig. 5), the pad configured to press against a portion of a medical device (11, Fig. 1, ¶0018, wherein the 26 and 31 are capable to be pressed against the 22) when the securement device is lowered onto the patient and adhere to the patient (Fig. 3, ¶0015), wherein the securement device is configured to conform to both a shape and size of the medical device and the patient when adhered to the patient over the medical device ( ¶0015, the soft material can be compressible and resilient over the catheter will conform the shape and the side of the catheter) and mitigate lateral and longitudinal motion of the medical device disposed in the channel (¶0015, ¶0016).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-12, 14-16, 18-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kyvik in view of Bracken et al. (US. 20090137962A1) (“Bracken”).
Re Claim 2, Kyvik fails to disclose wherein the pad is formed of an organopolysiloxane composition.
However, Bracken discloses a catheter securement device (Fig 10) and wherein the pad (12) is formed of an organopolysiloxane composition (¶0062-¶0064).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the pad is formed of an organopolysiloxane composition as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 3, Kyvik fails to disclose wherein the organopolysiloxane of the organopolysiloxane composition is of formula
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where R is a monovalent hydrocarbon radical , R1 is selected from alkyl, alkenyl, and aryl radicals, R2 is selected from alkyl and aryl radicals, R4 and R5 are independently selected from alkyl and vinyl radicals, x varies from 0-3000, and y varies from 0-300, wherein at least one of R or R1 includes the alkenyl radical or at least one of R4 or R5 includes the vinyl radical and wherein about 30-90% of the alkenyl radicals or vinyl radicals are crosslinked in the organopolysiloxane composition.
However, Bracken discloses wherein the organopolysiloxane of the organopolysiloxane composition is of formula I (¶0062)
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(Formula 1, ¶0062), where R is a monovalent hydrocarbon radical (¶0035, ¶0062), R1 is selected from alkyl, alkenyl, and aryl radicals (¶0035, ¶0062), R2 is selected from alkyl and aryl radicals, R4 and R5 are independently selected from alkyl and vinyl radicals (¶0035, ¶0062), x varies from 0-3000 (¶0035, ¶0062), and y varies from 0-300 (¶0035, ¶0062), wherein at least one of R or R1 includes the alkenyl radical or at least one of R4 or R5 includes the vinyl radical (¶0035, ¶0062), and wherein about 30-90% of the alkenyl radicals or vinyl radicals are crosslinked in the organopolysiloxane composition (¶0072).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane of the organopolysiloxane composition is of formula
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where R is a monovalent hydrocarbon radical , R1 is selected from alkyl, alkenyl, and aryl radicals, R2 is selected from alkyl and aryl radicals, R4 and R5 are independently selected from alkyl and vinyl radicals, x varies from 0-3000, and y varies from 0-300, wherein at least one of R or R1 includes the alkenyl radical or at least one of R4 or R5 includes the vinyl radical and wherein about 30-90% of the alkenyl radicals or vinyl radicals are crosslinked in the organopolysiloxane composition as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 4, Kyvik fails to disclose wherein the organopolysiloxane of the
organopolysiloxane composition is of formula II
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where R is a monovalent hydrocarbon radical, R1 and R6 are independently selected from alkyl, alkenyl, and aryl radicals, R2 is a monovalent hydrocarbon radical, R3 is selected from alkyl, alkenyl, and aryl radicals, w varies from 0-500, and z varies from 0-200, wherein at least one of R, R1, R2, or R3 includes the alkenyl radical, and wherein about 30-90% of the alkenyl radicals are crosslinked in the organopolysiloxane composition.
However, Bracken discloses wherein the organopolysiloxane of the
organopolysiloxane composition is of formula II (¶0062-¶0064)
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where R is a monovalent hydrocarbon radical (¶0035, ¶0062-¶0064), R1 and R6 are independently selected from alkyl, alkenyl, and aryl radicals (¶0035, ¶0062-¶0064), R2 is a monovalent hydrocarbon radical (¶0035, ¶0062-¶0064), R3 is selected from alkyl, alkenyl, and aryl radicals (¶0035, ¶0062-¶0064), w varies from 0-500 (¶0062-¶0064), and z varies from 0-200 (¶0062-¶0064), wherein at least one of R, R1, R2, or R3 includes the alkenyl radical, and wherein about 30-90% of the alkenyl radicals are crosslinked in the organopolysiloxane composition (¶0072).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane of the organopolysiloxane composition is of formula II
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where R is a monovalent hydrocarbon radical, R1 and R6 are independently selected from alkyl, alkenyl, and aryl radicals, R2 is a monovalent hydrocarbon radical, R3 is selected from alkyl, alkenyl, and aryl radicals, w varies from 0-500, and z varies from 0-200, wherein at least one of R, R1, R2, or R3 includes the alkenyl radical, and wherein about 30-90% of the alkenyl radicals are crosslinked in the organopolysiloxane composition as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 5, Kyvik fails to disclose wherein the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane)
However, Bracken discloses wherein the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane) (¶0066).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane) as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 6, Kyvik fails to disclose wherein the organopolysiloxane composition includes a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane- treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay
However, Bracken discloses wherein the organopolysiloxane composition includes a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane- treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay (¶0065).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition includes a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane- treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 7, Kyvik fails to disclose wherein the reinforcing agent is about 10-30% by weight of the organopolysiloxane composition.
However, Bracken discloses wherein the reinforcing agent is about 10-30% by weight of the organopolysiloxane composition (¶0066).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the reinforcing agent is about 10-30% by weight of the organopolysiloxane composition as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 8, Kyvik fails to disclose wherein the organopolysiloxane composition has a tackiness of about 10-450 g as determined by a probe tack tester.
However, Bracken discloses wherein the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane) (¶0070).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition has a tackiness of about 10-450 g as determined by a probe tack tester as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 9, Kyvik fails to disclose wherein the organopolysiloxane composition has a hardness of about 5-55 units (Shore 00).
However, Bracken discloses wherein the organopolysiloxane composition has a hardness of about 5-55 units (Shore 00) (¶0070).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition has a hardness of about 5-55 units (Shore 00) as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 10, Kyvik fails to disclose wherein the organopolysiloxane composition has a tensile strength of about 20-800 psi.
However, Bracken discloses wherein the organopolysiloxane composition has a tensile strength of about 20-800 psi (¶0070).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition has a tensile strength of about 20-800 psi as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 11, Kyvik fails to disclose wherein the organopolysiloxane composition has a tear strength of about 5-200 lbs/in.
However, Bracken discloses wherein the organopolysiloxane composition has a tear strength of about 5-200 lbs/in (¶0070).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition has a tear strength of about 5-200 lbs/in as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 12, Kyvik fails to disclose wherein the organopolysiloxane composition has a minimum elongation of about 250-1100%.
However, Bracken discloses wherein the organopolysiloxane composition has a minimum elongation of about 250-1100%. (¶0070).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition has a minimum elongation of about 250-1100%. as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 21, Kyvik fails to disclose wherein the pad is formed of an organopolysiloxane composition, the organopolysiloxane of the organopolysiloxane composition of formula I
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where R is a monovalent hydrocarbon radical, R1 is selected from alkyl, alkenyl, and aryl radicals, R2 is selected from alkyl and aryl radicals, R4 and R5 are independently selected from alkyl and vinyl radicals, x varies from 0-3000, and y varies from 0-300, where at least one of R or R1 includes the alkenyl radical or at least one of R4 or R5 includes the vinyl and about 30-60% of the alkenyl radicals or vinyl radicals are crosslinked in the organopolysiloxane composition.
However, Bracken discloses a securement device (Fig. 1-13) comprises a pad (12) is formed of an organopolysiloxane composition, the organopolysiloxane of the organopolysiloxane composition of formula I (¶0062)
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where R is a monovalent hydrocarbon radical, R1 is selected from alkyl, alkenyl, and aryl radicals (¶0035, ¶0062- ¶0064), R2 is selected from alkyl and aryl radicals, R4 and R5 are independently selected from alkyl and vinyl radicals (¶0035, ¶0062- ¶0064), x varies from 0-3000 (¶0035, ¶0062- ¶0064), and y varies from 0-300 (¶0035, ¶0062- ¶0064), where at least one of R or R1 includes the alkenyl radical (¶0035, ¶0062- ¶0064) or at least one of R4 or R5 includes the vinyl and about 30-60% of the alkenyl radicals (¶0035, ¶0062- ¶0064) or vinyl radicals are crosslinked in the organopolysiloxane composition (¶0072).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the pad is formed of an organopolysiloxane composition, the organopolysiloxane of the organopolysiloxane composition of formula I
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where R is a monovalent hydrocarbon radical, R1 is selected from alkyl, alkenyl, and aryl radicals, R2 is selected from alkyl and aryl radicals, R4 and R5 are independently selected from alkyl and vinyl radicals, x varies from 0-3000, and y varies from 0-300, where at least one of R or R1 includes the alkenyl radical or at least one of R4 or R5 includes the vinyl and about 30-60% of the alkenyl radicals or vinyl radicals are crosslinked in the organopolysiloxane composition as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 14, Kyvik fails to disclose wherein the organopolysiloxane composition includes about 10-30% by weight of a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane-treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay.
However, Bracken discloses wherein the organopolysiloxane composition includes about 10-30% by weight of a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane-treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay (¶0065).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition includes about 10-30% by weight of a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane-treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 15, Kyvik fails to disclose wherein the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane)
However, Bracken discloses wherein the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane) (¶0066).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane) as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 16, Kyvik fails to disclose wherein the organopolysiloxane composition has a tackiness of about 10-450 g as determined by a probe tack tester, a hardness of about 5-55 units (Shore 00), a tensile strength of about 20-800 psi, a tear strength of about 5-200 lbs/in, and a minimum elongation of about 250-1100%..
However, Bracken discloses wherein the organopolysiloxane composition has a tackiness of about 10-450 g as determined by a probe tack tester (¶0070), a hardness of about 5-55 units (Shore 00) (¶0070), a tensile strength of about 20-800 psi (¶0070), a tear strength of about 5- 200 lbs/in (¶0070), and a minimum elongation of about 250-1100% (¶0070).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition has a tackiness of about 10-450 g as determined by a probe tack tester, a hardness of about 5-55 units (Shore 00), a tensile strength of about 20-800 psi, a tear strength of about 5-200 lbs/in, and a minimum elongation of about 250-1100%. as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 22, Kyvik fails to disclose wherein the organopolysiloxane of the
organopolysiloxane composition is of formula II
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where R is a monovalent hydrocarbon radical, R1 and R6 are independently selected from alkyl, alkenyl, and aryl radicals, R2 is a monovalent hydrocarbon radical, R3 is selected from alkyl, alkenyl, and aryl radicals, w varies from 0-500, and z varies from 0-200, wherein at least one of R, R1, R2, or R3 includes the alkenyl radical, and wherein about 30-90% of the alkenyl radicals are crosslinked in the organopolysiloxane composition.
However, Bracken discloses wherein the organopolysiloxane of the
organopolysiloxane composition is of formula II (¶0062-¶0064)
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where R is a monovalent hydrocarbon radical (¶0035, ¶0062-¶0064), R1 and R6 are independently selected from alkyl, alkenyl, and aryl radicals (¶0035, ¶0062-¶0064), R2 is a monovalent hydrocarbon radical (¶0035, ¶0062-¶0064), R3 is selected from alkyl, alkenyl, and aryl radicals (¶0035, ¶0062-¶0064), w varies from 0-500 (¶0062-¶0064), and z varies from 0-200 (¶0062-¶0064), wherein at least one of R, R1, R2, or R3 includes the alkenyl radical, and wherein about 30-90% of the alkenyl radicals are crosslinked in the organopolysiloxane composition (¶0072).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane of the organopolysiloxane composition is of formula II
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where R is a monovalent hydrocarbon radical, R1 and R6 are independently selected from alkyl, alkenyl, and aryl radicals, R2 is a monovalent hydrocarbon radical, R3 is selected from alkyl, alkenyl, and aryl radicals, w varies from 0-500, and z varies from 0-200, wherein at least one of R, R1, R2, or R3 includes the alkenyl radical, and wherein about 30-90% of the alkenyl radicals are crosslinked in the organopolysiloxane composition as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 18, Kyvik fails to disclose wherein the organopolysiloxane composition includes about 10-30% by weight of a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane-treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay
However, Bracken discloses wherein the organopolysiloxane composition includes about 10-30% by weight of a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane-treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay (¶0065).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition includes about 10-30% by weight of a reinforcing agent selected from titanium dioxide, calcium carbonate, lithopone, zinc oxide, zirconium silicate, silica aerogel, iron oxide, diatomaceous earth, silazane-treated silica, precipitated silica, fumed silica, mined silica, glass fibers, magnesium oxide, chromic oxide, zirconium oxide, aluminum oxide, alpha quartz, and calcined clay as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 19, Kyvik fails to disclose wherein the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane).
However, Bracken discloses wherein the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane) (¶0066).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition includes polydimethylsiloxane or poly(methyl hydrogen siloxane) as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Re Claim 20, Kyvik fails to disclose the organopolysiloxane composition has a tackiness of about 10-450 g as determined by a probe tack tester, a hardness of about 5-55 units (Shore 00), a tensile strength of about 20-800 psi, a tear strength of about 5- 200 lbs/in, and a minimum elongation of about 250-1100%.
However, Bracken discloses wherein the organopolysiloxane composition has a tackiness of about 10-450 g as determined by a probe tack tester (¶0070), a hardness of about 5-55 units (Shore 00) (¶0070), a tensile strength of about 20-800 psi (¶0070), a tear strength of about 5- 200 lbs/in, and a minimum elongation of about 250-1100% (¶0070).
Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify the material of the pad of Kyvik so that the organopolysiloxane composition has a tackiness of about 10-450 g as determined by a probe tack tester, a hardness of about 5-55 units (Shore 00), a tensile strength of about 20-800 psi, a tear strength of about 5- 200 lbs/in, and a minimum elongation of about 250-1100%.as taught by Bracken for the purpose of having a high coefficient of friction, tacky, gel-like elastomer that firmly secure the catheter (Bracken, ¶0009).
Response to Arguments
Applicant’s arguments field on 12/4/2025 with respect to claim(s) 1, 13, 17 have been considered but are not persuasive. The applicant argues with regards to the limitation“ the pad is configured to press a portion of a medical device wherein the devices is lowered onto the patient and adhered to the patient” and art Kyvik fails discloses such limitation and at least there is no pad on back of the catheter. This is found not persuasive as 26 and 14 is considered to be the pad and 26 is in the back of the catheter. Also, as claimed “press” does not means that a pressing force is applied from back. It can means that the pad can squeeze the catheter between the sides of the pad 14 and or pressed on the back as 26 can be pressed on the catheter.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783