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 .
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 10/20/2025 . As directed by the amendment: claim(s) 1, 14, and 20 have been amended. Thus, claims 1-4, 6-14, and 16-20 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 5/20/2025 have been fully considered but they are not fully persuasive.
Applicant’s arguments, see pages 7-10 of remarks, filed 5/20/2025, with respect to the rejection(s) of the independent claim(s) under US 7129389 B1, particularly with regard to the new amendments to the claims “wherein in the second position at least one elongated tab is folded over the aperture to completely seal the cavity closed by the at least one elongated tab”, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20030194426 A1 with regard to the amended limitation of the claimed elongated tab completely sealing the claimed cavity. The office action still relies upon US 7129389 B1, however it is not being relied upon for certain claim limitations addressed in applicant’s arguments which are taught by US 20030194426 A1, as discussed below.
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable. See examiner’s discussion of the independent claims above, and see examiner's rejection as necessitated by the amendment, below, detailing the prior art relied upon which discloses/teaches the dependent claims.
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.
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.
Claim 1, 4, 6, 8-9, 11, 14, 17, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 7129389 B1, henceforth written as Watson, in view of US 20030194426 A1, henceforth written as Wendel.
Regarding Claim 1
Watson discloses:
A puncture site patch, comprising:
(patch 10; fig 1)
an elastomeric, self-sealing membrane, wherein the elastomeric, self-sealing membrane further including an exterior face and an interior face;
(membrane 12 has exterior face 11 and interior face 13 ; fig 2)
a spacer including an outer face and an inner face, wherein the outer face of the spacer is coupled to the interior face of the elastomeric, self-sealing membrane;
(spacer 14 has outer face 15 and inner face 17; fig 2)
wherein the spacer further includes an aperture, the aperture forming a cavity defined by the interior face of the elastomeric, self-sealing membrane, spacer, and skin when applied to a user;
(col 4 line 4-24; aperture 16 forms a cavity 20; fig 3)
an adhesive film configured to adhere to skin, the adhesive film on the inner face of the spacer;
(col 3 line 37 - col 4 line 3; adhesive film (not enumerated/illustrated) is coated on spacer 14)
at least one elongated tab moveable between a first position and a second position; --
(pull tab 24; fig 2)
--wherein in the first position the at least one elongated tab extends outward from a periphery of the spacer;
(see fig 3a for claimed first position of tab 24)
and wherein in the second position at least one elongated tab is folded --
(the elongated tab must be "moveable between a first position and a second position", such claim language of “moveable between” implies a functional language and the prior art must at least be capable of performing the recited function; accordingly in light of col 4 line 32-35, since the pull tab 24 is loose relative to the spacer 14 such that it may be bent/held by an operator for removal it accordingly would be functionally capable of bending/folding over the aperture 16; further col 3 line 37-42 and col 4 line 44-63 detailing the material of spacer 14, and therein a material of its unitary component of tab 24, and fig 4 illustrating the manufacturing process of the invention which demonstrates that the material of tab 24/spacer 14 is a bendable material initially wrapped on a “1st roll of [material]”)
Watson discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the at least one elongated tab includes: a length greater than a length from a point on a perimeter defining the aperture farthest away in an extending direction from the elongated tab to a base end of the elongated tab, and a width greater than a width of the aperture--
and wherein in the second position at least one elongated tab is folded over the aperture to completely seal the cavity closed by the at least one elongated tab
However, Wendel teaches a folding dermatological medical device:
wherein the at least one elongated tab includes: a length greater than a length from a point on a perimeter defining the [surface of the invention impregnated with a disinfecting/healing agent] farthest away in an extending direction from the elongated tab to a base end of the elongated tab, and a width greater than a width of the [surface of the invention impregnated with a disinfecting/healing agent] —
(tongue 7 on laminate strip 1, where impregnated absorptive support 2 is disposed underneath, is folded about the anti-breakup means 5 so as to cover the entire underside of tongue 6 on laminate strip 1 with the underside of tongue 7; fig 1-2; examiner notes that the portion of laminate strip 1 on the right side of means 5 in fig 2 & tongue 7 are to be interpreted as the claimed elongated tab, such that the claimed elongated tab has a length and width greater than the impregnated support 2)
and wherein in the second position at least one elongated tab is folded over the [surface of the invention impregnated with a disinfecting/healing agent] to completely seal the [dermatologically exposed area] closed by the at least one elongated tab
(paragraph 14+29; after use, tongue 7 is folded about anti-breakup means 5 to cover and prohibit access to the underside of strip 1 and the impregnated absorptive support 2 to avoid inadvertent subsequent application of the remainder of the agent of the impregnated absorptive support 2, therein completely sealing the dermatologically exposed area and impregnated absorptive support 2; fig 1-2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Wendel’s teachings of folding an elongated tab about a hinge on a dermatological medical device to prohibit access to a medical agent/dermatologically exposed area after use to the elongated tab disclosed by Watson, such that Wendel’s anti-breakup means 5 is disposed between Watson’s medical agent impregnated absorptive & dermatologically exposed area(s), the inner face of spacer 14 including spanning cavity 20, and Watson’s elongated tab, pull tab 24, and further Watson’s pull tab 24, is modified so as to resemble Wendel’s elongated tab in that it has an area and shape sufficient to cover & prohibit access to Watson’s medical agent impregnated absorptive & dermatologically exposed area(s) after Watson’s modified elongated tab has been folded about Wendel’s anti-breakup means 5, in order to advantageously arrive at an invention which can prohibit inadvertent access to an area which has been exposed to a potentially contaminated biological surface and which is impregnated with a medical agent product, see paragraph 14+29 of Wendel, therein reducing the risks associated with medical agent/contaminant exposure to a user manipulating the invention after use.
Regarding claim 4, Watson in view of Wendel teaches:
The puncture site patch of claim 1 further comprising an axis running through a center of the aperture defining a first side of the spacer and a second side of the spacer,
Watson: (fig 2-3)
and wherein in the second position the puncture site patch is folded along the axis such that the first side of the spacer and second side of the spacer substantially overlap each other and the at least one elongated tab is folded over the substantially overlapping first and second sides of the spacer to seal the first and second sides of the spacer closed.
Watson: (such claim language of “folded along” implies a functional language and the prior art must at least be capable of performing the recited function of the patch folding/bending along the axis; accordingly in light of col 3 line 37-42 detailing that the spacer 14 is formed of foldable materials (e.g. linen) and fig 4 illustrating the manufacturing process of the invention which demonstrates that the material of spacer 14 is a bendable material initially wrapped on a “1st roll of [material]”), the spacer accordingly would be functionally capable of the claimed bending/folding to overlap the claimed first and second sides of the spacer to seal the first and second sides of the spacer closed.; examiner notes that in light of the modification of Watson in view of Wendel above, the claimed elongated tab is of a size larger than the unfolded spacer 14, such that when the modified invention’s spacer 14 has been folded about the claimed axis running through the center of the aperture 16 the claimed elongated tab folds about Wendel’s anti-breakup means 5 and is capable of completely sealing the folded spacer 14 in the claimed configuration)
Regarding claim 6, Watson in view of Wendel discloses:
The puncture site patch of claim 1 further comprising a release paper in contact with and completely covering the adhesive film, wherein the release paper is configured to be removed prior to application to skin.
Watson: (col 3 line 62 - col 4 line 3; release paper 18 protects adhesive coating and can be removed prior to application to the skin 90; fig 3)
Regarding claim 8, Watson in view of Wendel discloses:
The puncture site patch of claim 1, wherein the elastomeric, self-sealing membrane is substantially transparent.
Watson: (col 3 line 21-24; membrane 12 is transparent)
Regarding Claim 9,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
wherein the spacer further includes an antimicrobial agent.
Watson: (col 4 line 40-43; antimicrobial agents implemented on the spacer 14 adjacent the membrane 12)
However, Watson in view of Wendel is silent regarding:
wherein the elastomeric, self-sealing membrane further includes an antimicrobial agent.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the antimicrobial agent application disclosed on Watson's spacer and apply it to the claimed elastomeric, self-sealing membrane in order to improve the antimicrobial resilience of the invention as a whole, see MPEP 2144.04(VI)(B).
Regarding claim 11, Watson in view of Wendel teaches:
The puncture site patch of claim 9, wherein the antimicrobial agent is a coating applied to the elastomeric, self-sealing membrane.
(col 4 line 18-22 + 40-43; antimicrobial agents are applied to the spacer, as originally cited from Watson, in the same manner as the coagulating agent applied to the spacer, and therein in light of the combination made in claim 9 above the antimicrobial agent would likewise be coated on the elastomeric, self-sealing membrane)
Regarding Claim 14,
Watson discloses:
A puncture site patch, comprising:
(patch 10; fig 1)
a substantially transparent elastomeric, self-sealing membrane, wherein the substantially transparent elastomeric, self-sealing membrane further including an exterior face and an interior face;
(membrane 12 has exterior face 11 and interior face 13 ; fig 2; col 3 line 21-24; membrane 12 is transparent)
a spacer including an outer face and an inner face;
(spacer 14 has outer face 15 and inner face 17; fig 2)
wherein the outer face of the spacer is coupled to the interior face of the substantially transparent elastomeric, self-sealing membrane;
(see fig 2)
wherein the spacer further includes an aperture, the aperture forming a cavity defined by the interior face of the substantially transparent elastomeric, self-sealing membrane, the spacer, and skin when applied to a user;
(col 4 line 4-24; aperture 16 forms a cavity 20; fig 3)
an adhesive film configured to adhere to skin, the adhesive film on the inner face of the spacer;
(col 3 line 37 - col 4 line 3; adhesive film (not enumerated/illustrated) is coated on spacer 14)
an axis running through a center of the aperture defining a first side of the spacer and a second side of the spacer
(fig 2-3; spacer 14 has multiple sides has defined by an axis running through aperture 16)
an elongated tab moveable between a first position and a second position; --
(pull tab 24; fig 2; the elongated tab must be "moveable between a first position and a second position", such claim language of “moveable between” implies a functional language and the prior art must at least be capable of performing the recited function; accordingly in light of col 4 line 32-35, since the pull tab 24 is loose relative to the spacer 14 such that it may be bent/held by an operator for removal it accordingly would be functionally capable of bending/folding between first and second positions; further col 3 line 37-42 and col 4 line 44-63 detailing the material of spacer 14, and therein a material of its unitary component of tab 24, and fig 4 illustrating the manufacturing process of the invention which demonstrates that the material of tab 24/spacer 14 is a bendable material initially wrapped on a “1st roll of [material]”))
--wherein in the first position the elongated tab extends outward from a periphery of the spacer;
(see fig 3a for claimed first position of tab 24)
and wherein in the second position the puncture site patch is folded over the axis and over the aperture--
(such claim language of “folded over” implies a functional language and the prior art must at least be capable of performing the recited function of the patch folding/bending along the axis; accordingly in light of col 3 line 37-42 detailing that the spacer 14 is formed of foldable materials (e.g. linen) and fig 4 illustrating the manufacturing process of the invention which demonstrates that the material of spacer 14 is a bendable material initially wrapped on a “1st roll of [material]”), the spacer accordingly would be functionally capable of the claimed bending/folding to overlap the claimed first and second sides of the spacer to seal the first and second sides of the spacer closed.)
Watson discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the at least one elongated tab includes: a length greater than a length from a point on a perimeter defining the aperture farthest away in an extending direction from the elongated tab to a base end of the elongated tab, and a width greater than a width of the aperture –
and wherein in the second position [the elongated tab] completely seal the cavity closed by the at least one elongated tab
However, Wendel teaches a folding dermatological medical device:
wherein the at least one elongated tab includes: a length greater than a length from a point on a perimeter defining the [surface of the invention impregnated with a disinfecting/healing agent] farthest away in an extending direction from the elongated tab to a base end of the elongated tab, and a width greater than a width of the [surface of the invention impregnated with a disinfecting/healing agent] —
(tongue 7 on laminate strip 1, where impregnated absorptive support 2 is disposed underneath, is folded about the anti-breakup means 5 so as to cover the entire underside of tongue 6 on laminate strip 1 with the underside of tongue 7; fig 1-2; examiner notes that the portion of laminate strip 1 on the right side of means 5 in fig 2 & tongue 7 are to be interpreted as the claimed elongated tab, such that the claimed elongated tab has a length and width greater than the impregnated support 2)
and wherein in the second position at least one elongated tab is folded over the [surface of the invention impregnated with a disinfecting/healing agent] to completely seal the [dermatologically exposed area] closed by the at least one elongated tab
(paragraph 14+29; after use, tongue 7 is folded about anti-breakup means 5 to cover and prohibit access to the underside of strip 1 and the impregnated absorptive support 2 to avoid inadvertent subsequent application of the remainder of the agent of the impregnated absorptive support 2, therein completely sealing the dermatologically exposed area and impregnated absorptive support 2; fig 1-2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Wendel’s teachings of folding an elongated tab about a hinge on a dermatological medical device to prohibit access to a medical agent/dermatologically exposed area after use to the elongated tab disclosed by Watson, such that Wendel’s anti-breakup means 5 is disposed between Watson’s medical agent impregnated absorptive & dermatologically exposed area(s), the inner face of spacer 14 including spanning cavity 20, and Watson’s elongated tab, pull tab 24, and further Watson’s pull tab 24, is modified so as to resemble Wendel’s elongated tab in that it has an area and shape sufficient to cover & prohibit access to Watson’s medical agent impregnated absorptive & dermatologically exposed area(s) after Watson’s modified elongated tab has been folded about Wendel’s anti-breakup means 5, in order to advantageously arrive at an invention which can prohibit inadvertent access to an area which has been exposed to a potentially contaminated biological surface and which is impregnated with a medical agent product, see paragraph 14+29 of Wendel, therein reducing the risks associated with medical agent/contaminant exposure to a user manipulating the invention after use.
Regarding Claim 17,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
wherein the spacer further includes an antimicrobial agent.
Watson: (col 4 line 40-43; antimicrobial agents implemented on the spacer 14 adjacent the membrane 12)
However, Watson in view of Wendel is silent regarding:
wherein the elastomeric, self-sealing membrane further includes an antimicrobial agent.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the antimicrobial agent application disclosed on Watson's spacer and apply it to the claimed elastomeric, self-sealing membrane in order to improve the antimicrobial resilience of the invention as a whole, see MPEP 2144.04(VI)(B).
Regarding claim 19, Watson in view of Wendel teaches:
The puncture site patch of claim 9, wherein the antimicrobial agent is a coating applied to the elastomeric, self-sealing membrane.
Watson: (col 4 line 18-22 + 40-43; antimicrobial agents are applied to the spacer, as originally cited from Watson, in the same manner as the coagulating agent applied to the spacer, and therein in light of the combination made in claim 9 above the antimicrobial agent would likewise be coated on the elastomeric, self-sealing membrane)
Regarding Claim 20,
Watson discloses:
A puncture site patch, comprising:
(patch 10; fig 1)
a substantially transparent elastomeric, self-sealing membrane, wherein the substantially transparent elastomeric, self-sealing membrane further including: an exterior face; an interior face; --
(membrane 12 has exterior face 11 and interior face 13 ; fig 2; col 3 line 21-24; membrane 12 is transparent)
--a spacer including an outer face and an inner face;
(spacer 14 has outer face 15 and inner face 17; fig 2)
wherein the outer face of the spacer is coupled to the interior face of the substantially transparent elastomeric, self-sealing membrane;
(see fig 2)
wherein the spacer further includes an aperture, the aperture forming a cavity defined by the interior face of the substantially transparent elastomeric, self-sealing membrane, the spacer, and skin when applied to a user;
(col 4 line 4-24; aperture 16 forms a cavity 20; fig 3)
an adhesive film configured to adhere to skin, the adhesive film on the inner face of the spacer;
(col 3 line 37 - col 4 line 3; adhesive film (not enumerated/illustrated) is coated on spacer 14)
an axis running through a center of the aperture defining a first side of the spacer and a second side of the spacer
(fig 2-3; spacer 14 has multiple sides has defined by an axis running through aperture 16)
an elongated tab moveable between a first position and a second position; --
(pull tab 24; fig 2; the elongated tab must be "moveable between a first position and a second position", such claim language of “moveable between” implies a functional language and the prior art must at least be capable of performing the recited function; accordingly in light of col 4 line 32-35, since the pull tab 24 is loose relative to the spacer 14 such that it may be bent/held by an operator for removal it accordingly would be functionally capable of bending/folding over the aperture 16; further col 3 line 37-42 and col 4 line 44-63 detailing the material of spacer 14, and therein a material of its unitary component of tab 24, and fig 4 illustrating the manufacturing process of the invention which demonstrates that the material of tab 24/spacer 14 is a bendable material initially wrapped on a “1st roll of [material]”, thus the pull tab 24 is moveable between a first position and a second position)
--wherein in the first position the elongated tab extends outward from a periphery of the spacer;
(see fig 3a for claimed first position of tab 24)
and wherein in the second position the puncture site patch is folded over the axis -and over the aperture
such claim language of “folded over” implies a functional language and the prior art must at least be capable of performing the recited function of the patch folding/bending along the axis; accordingly in light of col 3 line 37-42 detailing that the spacer 14 is formed of foldable materials (e.g. linen) and fig 4 illustrating the manufacturing process of the invention which demonstrates that the material of spacer 14 is a bendable material initially wrapped on a “1st roll of [material]”), the spacer accordingly would be functionally capable of the claimed bending/folding to overlap the claimed first and second sides of the spacer to seal the first and second sides of the spacer closed.)
Watson discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the substantially transparent elastomeric, self-sealing membrane further including an antimicrobial agent;
However, Watson does disclose:
wherein the spacer further includes an antimicrobial agent.
Watson: (col 4 line 40-43; antimicrobial agents implemented on the spacer 14 adjacent the membrane 12)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the antimicrobial agent application disclosed on Watson's spacer and apply it to the claimed elastomeric, self-sealing membrane in order to improve the antimicrobial resilience of the invention as a whole, see MPEP 2144.04(VI)(B).
The modified invention of Watson discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the at least one elongated tab includes: a length greater than a length from a point on a perimeter defining the aperture farthest away in an extending direction from the elongated tab to a base end of the elongated tab, and a width greater than a width of the aperture
--and wherein in the second position [the elongated tab] completely seal the cavity with the elongated tab.
However, Wendel teaches a folding dermatological medical device:
wherein the at least one elongated tab includes: a length greater than a length from a point on a perimeter defining the [surface of the invention impregnated with a disinfecting/healing agent] farthest away in an extending direction from the elongated tab to a base end of the elongated tab, and a width greater than a width of the [surface of the invention impregnated with a disinfecting/healing agent] —
(tongue 7 on laminate strip 1, where impregnated absorptive support 2 is disposed underneath, is folded about the anti-breakup means 5 so as to cover the entire underside of tongue 6 on laminate strip 1 with the underside of tongue 7; fig 1-2; examiner notes that the portion of laminate strip 1 on the right side of means 5 in fig 2 & tongue 7 are to be interpreted as the claimed elongated tab, such that the claimed elongated tab has a length and width greater than the impregnated support 2)
and wherein in the second position at least one elongated tab is folded over the [surface of the invention impregnated with a disinfecting/healing agent] to completely seal the [dermatologically exposed area] closed by the at least one elongated tab
(paragraph 14+29; after use, tongue 7 is folded about anti-breakup means 5 to cover and prohibit access to the underside of strip 1 and the impregnated absorptive support 2 to avoid inadvertent subsequent application of the remainder of the agent of the impregnated absorptive support 2, therein completely sealing the dermatologically exposed area and impregnated absorptive support 2; fig 1-2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Wendel’s teachings of folding an elongated tab about a hinge on a dermatological medical device to prohibit access to a medical agent/dermatologically exposed area after use to the elongated tab disclosed by Watson, such that Wendel’s anti-breakup means 5 is disposed between Watson’s medical agent impregnated absorptive & dermatologically exposed area(s), the inner face of spacer 14 including spanning cavity 20, and Watson’s elongated tab, pull tab 24, and further Watson’s pull tab 24, is modified so as to resemble Wendel’s elongated tab in that it has an area and shape sufficient to cover & prohibit access to Watson’s medical agent impregnated absorptive & dermatologically exposed area(s) after Watson’s modified elongated tab has been folded about Wendel’s anti-breakup means 5, in order to advantageously arrive at an invention which can prohibit inadvertent access to an area which has been exposed to a potentially contaminated biological surface and which is impregnated with a medical agent product, see paragraph 14+29 of Wendel, therein reducing the risks associated with medical agent/contaminant exposure to a user manipulating the invention after use.
Claims 2-3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Watson in view of Wendel, as applied to claim 1 above, in view of US 4781712 A, henceforth written as Barabino.
Regarding Claim 2,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The puncture site patch of claim 1, wherein the at least one elongated tab is a first elongated tab
Watson: (modified pull tab 24; fig 2)
wherein the first -- elongated tabs each extend outward from the periphery of the spacer
Examiner notes that in light of the modification of Watson in view of Wendel made above, the modified pull tab 24 of Watson extends outward from the periphery of the claimed spacer.
However Watson is silent regarding:
-- and the puncture site patch further includes a second elongated tab, wherein the first and second elongated tabs each extend outward from the periphery of the spacer and are disposed directly opposing each other.
However, Barabino teaches a folded absorptive dermatological medical device:
and [the invention] further includes a second elongated tab, wherein the first and second elongated tabs each extend outward from the periphery of the [center of the invention] and are disposed directly opposing each other.
(col 4 line 57 to col 5 line 38; absorbent pad 10 can have its opposingly disposed elongate tabs panel 20 & liner 22 and wrapper panel 16 & wrapper panel 18, folded to overlap with eachother and provide an improved seal of the used inner contents of pad 10; fig 1-4)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the multiple opposing tab teachings of Barabino to the modified puncture site patch disclosed by Watson in view of Wendel, such that Barabino’s second elongated tab is disposed opposite Watson’s modified pull tab 24 as well as subsequent elongate tabs of Barabino are disposed perpendicular to Watson’s elongated tab, in order to advantageously arrive at an invention with improved sealing means for protecting a user from contamination during the disposal of a used medical product, see col 4 line 57 to col 5 line 38 of Barabino.
Regarding claim 3, Watson in view of Wendell and Barabino teaches:
The puncture site patch of claim 2, wherein in the second position the first and second elongated tabs substantially overlap each other.
Examiner notes that in light of the modification of Watson in view of Wendell and Barabino above, the incorporated multitude of elongated tabs overlap with one another so as to improve the sealing of the contaminated underside of Watson’s spacer 14 when the modified invention is in the claimed second position.
Regarding Claim 16,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The puncture site patch of claim 14, wherein the at least one elongated tab is a first elongated tab
Watson: (modified pull tab 24; fig 2)
wherein the first -- elongated tabs each extend outward from the periphery of the spacer
Examiner notes that in light of the modification of Watson in view of Wendel made above, the modified pull tab 24 of Watson extends outward from the periphery of the claimed spacer.
However Watson is silent regarding:
-- and the puncture site patch further includes a second elongated tab, wherein the first and second elongated tabs each extend outward from the periphery of the spacer and are disposed directly opposing each other.
However, Barabino teaches a folded absorptive dermatological medical device:
and [the invention] further includes a second elongated tab, wherein the first and second elongated tabs each extend outward from the periphery of the [center of the invention] and are disposed directly opposing each other.
(col 4 line 57 to col 5 line 38; absorbent pad 10 can have its opposingly disposed elongate tabs panel 20 & liner 22 and wrapper panel 16 & wrapper panel 18, folded to overlap with eachother and provide an improved seal of the used inner contents of pad 10; fig 1-4)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the multiple opposing tab teachings of Barabino to the modified puncture site patch disclosed by Watson in view of Wendel, such that Barabino’s second elongated tab is disposed opposite Watson’s modified pull tab 24 as well as subsequent elongate tabs of Barabino are disposed perpendicular to Watson’s elongated tab, in order to advantageously arrive at an invention with improved sealing means for protecting a user from contamination during the disposal of a used medical product, see col 4 line 57 to col 5 line 38 of Barabino.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Watson in view of Wendel, as applied to claim 1 above, in view of US 20120082815 A1, henceforth written as Dehlinger.
Regarding Claim 7,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Watson in view of Wendel is silent regarding:
wherein the at least one elongated tab further included deadened adhesive.
However, Dehlinger teaches a dressing patch:
wherein the at least one elongated tab further included deadened adhesive.
(paragraph 30; deadened adhesive is provided to promote removal of a protective release layer)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the deadened adhesive teachings of Dehlinger to the surface of the elongated tab disclosed by Watson in order to arrive at an invention which advantageously promotes removal of the protective release layer, see paragraph 30 of Dehlinger
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Watson in view of Wendel, as applied to claim 9 and 17 above, in view of WO 2011022023 A1, henceforth written as Llinas.
Regarding Claim 10,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Watson in view of Wendel is silent regarding:
wherein the antimicrobial agent is incorporated into the elastomeric, self-sealing membrane during extrusion.
However, Llinas teaches a dressing
wherein the antimicrobial agent is incorporated into the elastomeric, self-sealing membrane during extrusion.
(page 19 line 16-18 + page 20 line 18-32; a stress-distributing, or antimicrobial agent, can be applied in a coating or by extruding during manufacturing)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Llinas extrusion teachings to the antimicrobial agent disclosed by Watson as coating and extruding an antimicrobial agent are have art recognized suitability for the intended purpose of applying an antimicrobial agent, see page 19 line 16-18 of Llinas.
Regarding Claim 18,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Watson in view of Wendel is silent regarding:
wherein the antimicrobial agent is incorporated into the elastomeric, self-sealing membrane during extrusion.
However, Llinas teaches a dressing
wherein the antimicrobial agent is incorporated into the elastomeric, self-sealing membrane during extrusion.
(page 19 line 16-18 + page 20 line 18-32; a stress-distributing, or antimicrobial agent, can be applied in a coating or by extruding during manufacturing)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Llinas extrusion teachings to the antimicrobial agent disclosed by Watson as coating and extruding an antimicrobial agent are have art recognized suitability for the intended purpose of applying an antimicrobial agent, see page 19 line 16-18 of Llinas.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Watson in view of Wendel, as applied to claim 9 above, in view of WO 2005049101 A1, henceforth written as Addison.
Regarding Claim 12,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Watson in view of Wendel is silent regarding:
wherein the antimicrobial agent is a plurality of silver nanoparticles.
However, Addison teaches a dressing
wherein the antimicrobial agent is a plurality of silver nanoparticles.
( page 1 line 16-19; it is well known to use silver nanoparticles as a form of antimicrobial compound)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Addison's teachings of specific antimicrobial agents to the antimicrobial agent disclosed by Watson as it has art recognized suitability for the intended purpose of deterring microbes, see MPEP 2144.07.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Watson in view of Wendel, as applied to claim 9 above, in view of US 20110034887 A1, henceforth written as Forden.
Regarding Claim 13,
Watson in view of Wendel discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Watson in view of Wendel is silent regarding:
wherein the antimicrobial agent is a carvacrol agent incorporated into the elastomeric, self-sealing, membrane at a concentration of about 0.01% to about 0.001%.
However, Forden teaches an antimicrobial agent
wherein the antimicrobial agent is a carvacrol agent incorporated into the elastomeric, self-sealing, membrane at a concentration of about 0.01% to about 0.001%.
(paragraph 78; any concentration of a blend of thymol and carvacrol is an effective antimicrobial agent, therein encompassing a concentration of “about 0.01% to about 0.001%”)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the specific antimicrobial agent teachings to the antimicrobial agent disclosed by Watson as it has art recognized suitability for the intended purpose of deterring microbes, see MPEP 2144.07.
Conclusion
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783