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 .
Election/Restrictions
Applicant’s election with traverse of Group 1 filed on 07/29/2026 is acknowledged.
The traversal to the restriction between species groups is on the ground(s) that Groups 1-4 reads on the elected invention Group 1. Groups 1-4 require “layers to be activatable by energy” and the restriction requirement acknowledges that “layers to be activatable by energy” is a special technical feature shared amongst Groups 1-4. This is found persuasive because the special technical features do not make contribution over Greg et al. (US 20170203043 A1).
Applicant has canceled claims 41-52 which are directed to Group 5.
Claim Objections
Claims 13, 14, 15, 23, 24, 27, 34 is/are objected to due to the following informalities:
In claim 13, lines 1 and 2, the term “a” should be inserted before “material” in both occurrences.
In claim 14, lines 1 and 2, the term “a” should be inserted before “material” in both occurrences.
In claim 15, lines 1-2, “the first layer includes a material configured to increase” should be corrected to “the material of the first layer is configured to increase” since these phrase was already introduced in claim 1.
In claim 16, lines 1-2, “the first layer includes a material configured to increase” should be corrected to “the material of the first layer is configured to increase” since these phrase was already introduced in claim 1.
In claim 16,
In claim 18, lines 1-2 should be corrected to recite “the micro groove and/or the micro rib”.
In claim 19, lines 1 should be corrected to recite “a porosity” due to lack of antecedent basis.
In claim 19, line 2 should be corrected to recite “the micro groove and/or the micro rib”.
In claim 23, line 1 “the micro feature” should be corrected to “theat least one micro feature”.
In claim 24, line 1 “the micro feature” should be corrected to “theat least one micro feature”.
In claim 26, the semi-colon on line 13 should be removed.
In claim 27, line 6, “the micro feature” should be corrected to “theat least one micro feature”.
In claim 33, line 2 should be corrected to recite “the micro groove and/or the micro rib”.
In claim 34, line 1, “a first layer” should be corrected to “the first layer”.
In claim 34, line 2 “at least one micro feature” should be corrected to “the at least one micro feature”.
In claim 34, line 4, the term “a” should be inserted before “linear movement” and “rotational movement”.
In claim 38, line 1, should be corrected to recite “theat least one micro feature”.
In claim 39, line 1 should be corrected to recite “theat least one micro feature”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-25, 26, 30, 33, 34 and 40 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the term “optionally” in line 10 renders the claim indefinite because it is unclear whether the limitations following the term “optionally” in lines 11-14 are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the limitation after the term “optionally” in lines 11-14 is not required. Therefore the “micro feature” and “micro groove” and/or “micro rib” in claims 9-16, 18, 19, 23 and 24, which depend on claim 1, is interpreted as not part of the claimed invention.
Claims 2-25 is/are rejected by virtue of their dependency on claim 1.
Regarding claim 5, the parenthesis in line 2 renders the claim indefinite because it is unclear whether the subject matter in the parenthesis is part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the subject matter in the parenthesis in line 5 is not required.
In claim 9, the term “optionally” in lines 2, 3, 4 and 5 renders the claim indefinite because it is unclear whether the limitations following the term “optionally” in lines 2, 3, 4 and 5 are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the limitation after the term “optionally” in lines 11-14 is not required. Therefore the limitations following the term “optionally” in lines 2, 3, 4 and 5, is interpreted as not part of the claimed invention.
Regarding claim 26, the phrase “optionally” in line 9 renders the claim indefinite because it is unclear whether the limitations following the phrase in lines 10-13 are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the limitation after the term “optionally” in lines 10-13 is not required.
In claim 26, lines 8-9 recites “the first zone configured to be less activatable by the energy source than the first zone”, however it is unclear how the first zone can be less activable than itself. For the sake of Examination, it is being interpreted that claim 26 is intended to recite “the first zone configured to be less activatable by the energy source than the second zone”. Applicant is therefore suggested to amend claim 26 to recite “the first zone configured to be less activatable by the energy source than the second zone” to overcome rejection.
In claim 30, line 2 recites “the second layer” however there is lack of antecedent basis for this limitation of the claim since claim 30 depends on claim 27. For the sake of Examination, it is being interpreted that claim 30 depends on claim 28, which introduces “a second layer”. Applicant is therefore suggested to amend claim 30 to depend on claim 28 to overcome rejection.
In claim 33, the term “optionally” in line 2 renders the claim indefinite because it is unclear whether the limitations following the term “optionally” in lines 2-3 are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the limitation after the term “optionally” in lines 2-3 is not required.
In claim 34, the term “optionally” in line 4 renders the claim indefinite because it is unclear whether the limitations following the term “optionally” in lines 4 are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, it is being interpreted that the limitation “including one or both of linear movement or rotational movement” after the term “optionally” in lines 4 is not required.
In claim 40, line 6 recites “a first zone”. However claim 40 previously introduced “a first layer” in line 4 and therefore it is unclear if the “first zone” of line 6 refers to the “first layer” of line 4 or is intended to introduce a new zone. For the sake of Examination it is being interpreted the “first zone” of line 6 refers to “first layer” of line 4. Therefore Applicant is suggested to amend claim 40 to recite “a first zone” in line 4 and “the first zone” in line 6 to overcome rejection.
In claim 40, lines 8-9 recites “the first zone configured to be less activatable by the energy source than the first zone”, however it is unclear how the first zone can be less activable than itself. For the sake of Examination, it is being interpreted that claim 26 is intended to recite “the first zone configured to be less activatable by the energy source than the second zone”. Applicant is therefore suggested to amend claim 26 to recite “the first zone configured to be less activatable by the energy source than the second zone” to overcome rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-5, 6, 8-15, 17-19, 20, 23-27, 29-30 and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rusch et al. (US 20170203043 A1).
Regarding claim 1, Rusch teaches a stopper (stopper 100 in Fig. 3) for use in an injector device (stopper 100 used in delivery device 10 in Fig. 1), the stopper having an outer side configured for engagement with an interior bore of an injector device barrel (a stopper attached to the distal end of the plunger rod and contacting at least a portion of the inner surface of the barrel [0006]), the stopper comprising:
an elastomer body (elastomeric body 125 in Fig. 3); and
a barrier coupled to the elastomer body (laminate layer 130 in Fig. 3 including layer 145 and layer 150), the barrier having an inner surface oriented toward the elastomer body (see Fig. 3 where inner surface of layer 150 faces towards the body 125) and an outer surface oriented away from the elastomer body (see Fig. 3 where outer surface of layer 145 faces away from the body 125), the barrier including a first layer (layer 145 in Fig. 3) of a first material (layer 145 include densified expanded fluoropolymer [0036]) and a second layer (layer 150 in Fig. 3) of a second material (layer 150 include fibrilizing fluoropolymers [0036]), the first layer being configured to be activatable by an energy source (layer 145 is heat treated [0036]; it is set forth in [0035] one of the sources for heat treatment for the layer of Fig. 1; which is a different embodiment, is plasma treatment and it is interpreted the layer 145 of Fig. 3 can be subjected to plasma treatment as well) and the second layer configured to be less activatable by the energy source than the first layer (it is interpreted layer 145 is more activable by heat since layer 150 is constructed to be thermally stable to allow heat treatment of layer 145 [0036]), and optionally wherein:
the barrier has at least one micro feature formed in the barrier by activating the first layer with the energy source, the at least one micro feature including one or both of: a micro groove and/or a micro rib (the micro feature and micro groove/rib are not part of the claimed invention as set forth above in the 112b rejection of claim 1).
Regarding claim 2, Rusch further disclose wherein the energy source includes at least one of a laser energy source, an RF energy source, a vibrational energy source, and a thermal energy source (it is set forth in the rejection of claim 1 the layer 145 is exposed to plasma treatment, which is interpreted as a thermal energy source).
Regarding claim 4, Rusch further discloses wherein the barrier has a thickness between 1 pm and 200 pm (the film is made with thicknesses of about 20 microns [0035]).
Regarding claim 5, Rusch further discloses wherein the first material and/or the second material includes a fluoropolymer (e.g., polytetrafluoroethylene (PTFE) or expanded PTFE (ePTFE)) (second layer 150 include ePTFE [0036]).
Regarding claim 6, Rusch disclosed all limitations of claim 1. Rusch further discloses wherein the first layer is microporous (layer 145 is interpreted as porous due to penetration 165 able to move between layer 145 and layer 150 in Fig. 5) and defines a first porosity (region of partial penetration 165 in Fig. 5) and the second layer has a lower porosity than the first layer (it is interpreted the material of layer 145 can be made more porous than layer 150 since both layers can comprise same material ePTFE [0036]).
Regarding claim 8, Rusch disclosed all limitations of claim 1. Rusch further discloses wherein the second layer is characterized by a higher dimensional stability than the first layer (region of partial penetration 165 may also provide support for the barrier layer 145 to impart strength, toughness, compliance and stability [0038]; it is interpreted dimensional stability is provided to layer 145 from layer 150 via penetration 165).
Regarding claim 9, Rusch as disclosed all limitations of claim 1. It is further set forth the micro groove of claim 9 is not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 10, Rusch disclosed all limitations of claim 1. It is further set forth the micro groove/rib of claim 10 are not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 11, Rusch disclosed all limitations of claim 1. It is further set forth the micro groove/rib of claim 11 are not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 12, Rusch disclosed all limitations of claim 1. It is further set forth the micro groove/rib of claim 12 are not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 13, Rusch disclosed all limitations of claim 1. It is further set forth the micro groove/rib of claim 13 are not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 14, Rusch disclosed all limitations of claim 1. It is further set forth the micro groove/rib of claim 14 are not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 15, Rusch disclosed all limitations of claim 1. Rusch further disclose wherein the first layer includes a material configured to increase in volume upon being activated by the energy source, and further wherein a portion of the first layer that has been increased in volume by being activated by the energy source (heat treatment of fluoropolymer layer 145 [0036] and the penetration of layer 145 into layer 150 [0038]; penetration of layer 145 into layer 150 is interpreted as an increase in volume of layer 145; the micro rib of claim 15 is not part of the claimed invention as set forth in the 112b rejection of claim 1 above).
Regarding claim 17, Rusch disclosed all limitations of claim 1. Rusch discloses wherein the barrier has been bonded to the elastomer body (penetration of the elastomer material of the elastomeric body 125 into the porous layer 150 may improve the bond between the elastomeric body 125 and the one or more laminate layers 130 [0037]) by activating the first layer with the energy source (layer 145 is heat treated [0036]).
Regarding claim 18, Rusch disclosed all limitations of claim 1. It is further set forth the micro groove/rib of claim 18 are not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 19, Rusch disclosed all limitations of claim 1. Rusch further discloses wherein the porosity of a portion of the first layer has been modified following the coupling of the barrier to the elastomer body (it is set forth in Fig. 4 the elastomer body bonds with second layer 150 via penetration 160, followed by in Fig. 5 the first layer interacts with the second layer by penetration 165, indicating a different penetration of material between Fig. 4 and 5; it is also set forth the micro groove and/or micro rib is not part of the claimed invention of claim 1)
Regarding claim 20, Rusch disclosed all limitations of claim 1. Rusch further discloses wherein at least one of the first material of the first layer and the second material of the second layer includes a thermoplastic material (second layer 150 comprises ePTFE and ePTFE support should be constructed to be thermally stable enough to allow heat treatment of deposited fluoropolymer [0036]; it is interpreted the first layer 145 performs as a thermoplastic).
Regarding claim 23, Rusch disclosed all limitations of claim 1. It is further set forth the micro groove/rib of claim 23 are not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 24, Rusch disclosed all limitations of claim 1. It is further set forth the micro groove/rib of claim 24 are not part of the claimed invention as set forth in the 112b rejection of claim 1 above.
Regarding claim 25, Rusch further discloses method of forming (forming process of the stopper [0022]) the injector device stopper of claim 1 (see rejection of claim 1), the method including forming at least one of the micro rib and/or the micro groove (see ribs 120 in Fig. 1; it is set forth in [0006] the ribs are formed on the fluoropolymer layer 145 [0006])) by activating the first layer with the energy source (see rejection of claim 1 for the activation of first layer with energy source;
Regarding claim 26, Rusch discloses a stopper (stopper 100 in Fig. 3) for use in an injector device (stopper 100 used in delivery device 10 in Fig. 1), the stopper having an outer side configured for engagement with an interior bore of an injector device barrel, the stopper comprising (a stopper attached to the distal end of the plunger rod and contacting at least a portion of the inner surface of the barrel [0006]):
an elastomer body (elastomeric body 125 in Fig. 3); and
a multi-zone barrier coupled to the elastomer body (laminate layer 130 in Fig. 3 including layer 145 and layer 150), the multi-zone barrier including a first zone (layer 150 in Fig. 3) having a first material property (layer 150 include fibrilizing fluoropolymers [0036]) and a second zone (layer 145 in Fig. 3) having a second material property (layer 145 include densified expanded fluoropolymer [0036]), the second zone being configured to be activatable by an energy source (layer 145 is heat treated [0036]; it is set forth in [0035] one of the sources for heat treatment for the layer of Fig. 1; which is a different embodiment, is plasma treatment and it is interpreted the layer 145 of Fig. 3 can be subjected to plasma treatment as well) and the first zone configured to be less activatable by the energy source than the first zone (it is set forth in the 112b rejection of claim 26 above that the claim is interpreted to read as the first zone configured to be less activable by the energy source than the second zone; it is interpreted layer 145 is more activable by heat since layer 150 is constructed to be thermally stable to allow heat treatment of layer 145 [0036]), and optionally wherein:
the multi-zone barrier has at least one micro feature formed by activating the second zone with the energy source, the at least one micro feature including one or both of: a micro groove; and/or a micro rib (the micro feature and micro groove/rib are not part of the claimed invention as set forth above in the 112b rejection of claim 1).
Regarding claim 27, Rusch discloses a method of making (forming process of the stopper [0022]) a stopper for use in an injector device (stopper 100 used in delivery device 10 in Fig. 1), the stopper having a seal surface configured for engagement with an interior bore of an injector device barrel (a stopper attached to the distal end of the plunger rod and contacting at least a portion of the inner surface of the barrel [0006]), the method comprising:
activating a first layer (barrier layer 140 in Fig. 2) of a barrier (laminate layer 130 in Fig. 1) of the stopper with an energy source (the layer 140 is treated with plasma treatment [0035]) to form at least one micro feature (see ribs 120 in Fig. 1; it is set forth in [0006] the ribs are formed on the fluoropolymer layer 140 [0006]), the barrier having an inner surface (see Fig. 1 where inner surface of barrier faces towards the body 125) and an outer surface (see Fig. 1 where inner surface of barrier faces opposite to the body 125), the micro feature including one or both of: a micro groove and/or a micro rib (it is set forth in [0029] the micro feature 120 are ribs); and
coupling the barrier to an elastomer body (bonding to the elastomeric body 125 [0035]).
Regarding claim 29, Rusch disclosed all limitations of claim 27. Rusch further discloses wherein the energy source includes at least one of a laser energy source, an RF energy source, a vibrational energy source, and a thermal energy source (it is set forth in the rejection of claim 27 the layer 140 is exposed to plasma treatment, which is interpreted as a thermal energy source).
Regarding claim 30, Rusch disclosed all limitations of claim 27. Rusch further discloses wherein first layer includes FEP (the one or more fluoropolymer layers include FEP [0012]) and the second layer includes PTFE (the one or more fluoropolymer layers include PTFE [0012]).
Regarding claim 38, Rusch disclosed all limitations of claim 27. Rusch further discloses wherein the micro feature is formed on the outer surface of the barrier (ribs 120 are located on the outer surface of barrier 130 in Fig. 1).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Rusch et al. (US 20170203043 A1) in Fig. 3, and further in view of the embodiment of Rusch in Fig 6.
Regarding claim 3, Rusch in Fig. 3 disclosed all limitations of claim 1. Rusch further discloses wherein the first layer is positioned under the second layer.
However Rusch teaches in Fig. 6 the barrier melt layer 175 is placed under layer 170.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the embodiment of Rusch in Fig. 3 to include wherein the first layer (as layer 175) is positioned under the second layer (as layer 170) since such a modification enables the device of Rusch to allow partial penetration of layer 175 towards an inner surface [Rusch, 0041].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusch et al. (US 20170203043 A1) in Fig. 3, and further in view of Muraki (US 6645635 B2).
Regarding claim 7, Rusch in the embodiment of Fig. 3 disclosed all limitations of claim 1. However, Rusch in the embodiment of Fig. 3 failed to explicitly disclose wherein the second layer is characterized by a higher melt temperature than the first layer.
However, Muraki teaches compositions with varying melting point temperatures in Table 5.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include wherein the second layer is characterized by a higher melt temperature than the first layer by selecting a material with higher melting point for second layer than the first layer as taught by Muraki since such a modification enables the second layer of Rusch to be transparent at high melting point [Col 5, lines 14-15].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusch et al. (US 20170203043 A1), and further in view of Nakano (US 20160235919 A1).
Regarding claim 16, Rusch disclosed all limitations of claim 1. Rusch however failed to explicitly disclose wherein the first layer includes a material configured to be removed upon being activated by the energy source, and further wherein a portion of the first layer that has been removed by being activated by the energy source. (the micro groove of claim 16 is not part of the claimed invention as set forth in the 112b rejection of claim 1 above).
However, Nakano teaches in Fig. 3 a groove 22 is cut on laminated film 15 [0049] by use of a laser beam [0050].
Nakano further teaches lamination film is made of PTFE [0040].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the device of Rusch as modified by Nakano and Krizan to include wherein the first layer includes a material configured to be removed upon being activated by the energy source, and further wherein a portion of the first layer that has been removed by being activated by the energy source taught by Nakano since such a modification enables the device of Rusch to have increased compressive stress in a portion of the stopper [Nakano, 0014].
Claim(s) 21, 22 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusch et al. (US 20170203043 A1), and further in view of Nakano (US 20160235919 A1) and Krizan et al. (US 20210330422 A1).
Regarding claim 21, Rusch disclosed all limitations of claim 1. However Rusch failed to explicitly disclose wherein the first material of the first layer includes a filler configured to increase absorption of light energy and/or radiofrequency energy of the first material.
However Nakano teaches lamination film 15 is made of a mixture of ETFE and other polymers [0041]. ETFE is interpreted as a filler in this composition.
Furthermore Krizan teaches film 14 is made of ETFE and has a high transmittance for laser [0035].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the device of Rusch include wherein the first material of the first layer includes a filler configured to increase absorption of light energy and/or radiofrequency energy of the first material taught by Nakano and Krizan since such a modification enables the device of Rusch to have a first layer with increased transmittance percentage to laser [Krizan, 0035].
Regarding claim 22, Rusch disclosed all limitations of claim 21. Rusch however failed to discloses wherein the filler includes at least one of fluorinated ethylene propylene (FEP) and ethylene tetrafluoroethylene (ETFE).
However Nakano teaches lamination film 15 is made of a mixture of ETFE and other polymers [0041].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the device of Rusch include wherein the filler includes at least one of fluorinated ethylene propylene (FEP) and ethylene tetrafluoroethylene (ETFE) by Nakano since such a modification enables the device of Rusch to have a first layer with increased transmittance percentage to laser [Krizan, 0035].
Regarding claim 40, Rusch discloses a method of making (forming process of the stopper [0022]) a stopper (stopper 100 in Fig. 3) for use in an injector device (stopper 100 used in delivery device 10 in Fig. 1), the stopper having a seal surface configured for engagement with an interior bore of an injector device barrel (a stopper attached to the distal end of the plunger rod and contacting at least a portion of the inner surface of the barrel [0006]), the method comprising:
activating a first layer (layer 145 in Fig. 3) of a multi-zone barrier of the stopper (laminate layer 130 in Fig. 3 including layer 145 and layer 150) with an energy source (heat treatment of the deposited fluoropolymer layer 145 [0036]; it is set forth in [0035] one of the sources for heat treatment for the layer of Fig. 1; which is a different embodiment, is plasma treatment and it is interpreted the layer 145 of Fig. 3 can be subjected to plasma treatment as well) to form at least one micro feature in the multi-zone barrier (see ribs 120 in Fig. 1; it is set forth in [0006] the ribs are formed on the fluoropolymer layer 145 [0006]), the multi-zone barrier including a first zone (it is set forth in the 112b rejection of claim 40 above the first zone is the first layer 145) having a first material property (layer 145 include densified expanded fluoropolymer [0036]) and a second zone (layer 150 in Fig. 3) having a second material propertylayer 150 include fibrilizing fluoropolymers [0036], and
coupling the multi-zone barrier to an elastomer body (bonding to the elastomeric body 125 [0035]).
But fails to explicitly disclose the second zone being configured to be activatable by the energy source and the first zone configured to be less activatable by the energy source than the first zone (it is set forth in the 112b rejection of claim 40 the first zone is configured to be less activable by the energy source than the second zone);
However, Nakano teaches gasket 13 of Fig. 2 with a laminate of film 15 that is plastically deformed by application of an external stress [0049], caused by irradiation with a laser beam [0050].
However, Krizan teaches a laser is used to form marks on body 12 on Fig. 1. Body 12 has a film 14 that allows radiation from laser to pass without causing damage thereto. Film 14 most preferably has at least 80% transmittance [0035].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the second layer of the device of Rusch to be activable by an energy source as taught by Nakano since such a modification enables the device of Rusch to form projections more easily [Nakano, 0049] and the first layer of Rusch to be less activable by an energy source as taught by Krizan by including a transmittance rate that is less than the second layer, since such a modification enables the device of Rusch to allow energy source to reach an inner layer through an upper layer without activation of upper layer [Krizan, 0035]
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Rusch et al. (US 20170203043 A1) in Fig. 2, and further in view of embodiment of Rusch in Fig. 3 and Krizan et al. (US 20210330422 A1).
Regarding claim 28, Rusch in Fig. 2 disclosed all limitations of claim 27. However Rusch in Fig. 2 failed to explicitly disclose wherein the barrier includes a second layer positioned over the first layer, and further wherein the first layer is activated through the second layer.
However Rusch in Fig. 3 teaches a layer 145 over layer 150.
Furthermore Krizan teaches Krizan teaches a laser is used to form marks on body 12 on Fig. 1. Body 12 has a film 14 that allows radiation from laser to pass without causing damage thereto. Film 14 most preferably has at least 80% transmittance. [0035].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the stopper of Rusch in the embodiment of Fig. 2 to include wherein the barrier includes a second layer positioned over the first layer, and further wherein the first layer is activated through the second layer as taught by Rusch in the embodiment of Fig.3 and Krizan since such a modification enables the device of Rusch to allow energy source to reach an inner layer through an upper layer without activation of upper layer [Krizan, 0035].
Claim(s) 31, 32, 35, 36 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusch et al. (US 20170203043 A1), and further in view of Sakashita (US 20180177951 A1).
Regarding claim 31, Rusch disclosed all limitations of claim 27. However Rusch failed to explicitly disclose wherein the barrier is coupled to the elastomer body during formation of the at least one micro feature.
However Sakashita teaches in production steps where annular projections are formed on the laminated film prior to the unvulcanized rubber stacked with the film of the laminated film via crosslink [0054].
Sakashita further teaches the molding of gasket 13 and formation of projection 22 can be achieved simultaneously [0045] (it is interpreted the film 15 is bonded to body 14 during the molding of gasket 13 since film 15 and body 14 together make up gasket 13).
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include wherein the barrier is coupled to the elastomer body during formation of the at least one micro feature as taught by Sakashita since such a modification enables the method of Rusch to eliminate problems that arise from forming annular projections [0016].
Regarding claim 32, Rusch disclosed all limitations of claim 27. However Rusch failed to explicitly disclose wherein forming the at least one micro feature includes cooling the barrier after activating the first layer.
However Sakashita teaches forming projection 22 from flouroresin by solidifying the material projection by cooling in Fig. 3A [0050].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include wherein forming the at least one micro feature includes cooling the barrier after activating the first layer as taught by Sakashita since such a modification enables the method of Rusch to eliminate problems that arise from forming annular projections [0016].
Regarding claim 35, Rusch disclosed all limitations of claim 27. However Rusch failed to explicitly disclose wherein the at least one micro feature is formed prior to coupling the barrier to the elastomer body.
However Sakashita teaches in production steps where annular projections are formed on the laminated film prior to the unvulcanized rubber stacked with the film of the laminated film via crosslink [0054].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include wherein the at least one micro feature is formed prior to coupling the barrier to the elastomer body as taught by Sakashita since such a modification enables the method of Rusch to eliminate problems that arise from forming annular projections [0016].
Regarding claim 36, Rusch disclosed all limitations of claim 27. However Rusch failed to explicitly disclose wherein the at least one micro feature is formed with the barrier in sheet form.
However Sakashita teaches in Fig. 3A projection 22 is formed on a sheet of laminate 15.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include wherein the at least one micro feature is formed with the barrier in sheet form as taught by Sakashita since such a modification enables the method of Rusch to eliminate problems that arise from forming annular projections [0016].
Regarding claim 39, Rusch disclosed all limitations of claim 27. However, Rusch failed to explicitly disclose wherein the micro feature is formed on the inner surface of the barrier.
However Sakashita teaches in Fig. 4B a projection disposed on the inner surface of film 15 opposite to the surface portion 23 but facing the main body 14.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include wherein the micro feature is formed on the inner surface of the barrier as taught by Sakashita since such a modification enables the method of Rusch to eliminate problems that arise from forming annular projections [Sakashita, 0016].
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusch et al. (US 20170203043 A1), and further in view of Nakano (US 20160235919 A1).
Regarding claim 33, Rusch disclosed all limitations of claim 27. However Rusch failed to explicitly disclose further comprising simultaneously forming the micro groove and micro rib, optionally by causing melted portions of the barrier to reflow and resolidify (it is set forth in the 112b rejection of claim 33 that the limitation following the term “optionally” is not part of the claimed invention).
However Nakano teaches the formation of groove 22 and projections 24 in Fig. 3 is simultaneously achieved [0055].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include further comprising simultaneously forming the micro groove and micro rib as taught by Nakano since such a modification enables the method of Rusch to form micro ribs relatively easily while forming micro grooves [Nakano, 0055].
Claim(s) 34 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rusch et al. (US 20170203043 A1), and further in view of Abrams et al. (US 20220040412 A1).
Regarding claim 34, Rusch disclosed all limitations of claim 27. However Rusch failed to explicitly disclose wherein activating a first layer of the barrier of the stopper with the energy source to form at least one micro feature includes inducing relative movement between the energy source and the stopper, the movement optionally including one or both of linear movement or rotational movement.
However Abrams teaches in Fig. 4A gasket 14 is rotated along the longitudinal axis to produce a continuous channel 20 in the film 16 residing on a circumferential outer portion of the gasket 14 while laser beam is applied obliquely to an outer portion of the film 16 [0045].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include wherein activating a first layer of the barrier of the stopper with the energy source to form at least one micro feature includes inducing relative movement between the energy source and the stopper, the movement optionally including one or both of linear movement or rotational movement as taught by Abrams since such a modification enables the method of Rusch to provide the stopper with improved prevention of liquid leakage [Abrams, 0012].
Regarding claim 37, Rusch disclosed all limitations of claim 27. However Rusch failed to explicitly disclose wherein the at least one micro feature is formed after coupling the barrier to the elastomer body.
However Abrams teaches gasket manufacturing and laser cut process [0076], wherein the film 16 is disposed over rubber base 18 in step (a) prior to the film being treated by laser to create channel 20 on the film in step (b).
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Rusch to include wherein the at least one micro feature is formed after coupling the barrier to the elastomer body as taught by Abrams since such a modification enables the method of Rusch to provide the stopper with improved prevention of liquid leakage [Abrams, 0012].
Conclusion
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
