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 .
Claim Objections
Claims 1-3, 5, 8-12 and 17 are objected to because of the following informalities:
In claims 1-3, 5, 8-12: “the earplug body” should read as “the elongated compressible earplug body”.
In claim 5, line 2 should be amended to recite: “the young’s modulus of the elastically deformable material…”.
In claim 17, lines 2-3 should be amended to recite: “the internal portion is disposed within the earplug body and the external portion is disposed external to a back end…”.
Appropriate correction is required.
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, 3, 6, 8-9, 11-15, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falco (US 20100300460 A1).
Regarding claim 1, Falco discloses an earplug (earplug 10), comprising:
an elongated compressible earplug body (tip 20) formed from an elastically deformable material ([0030-0032]- discusses the “polymer foam” material of the tip 20 and how it deforms and recovers when inserted into the ear canal); and
a planar insert (stem 30) partially disposed within the earplug body (Figure 1- stem 30 includes a portion that is embedded within the earplug 10, specifically, member 50 is the component of stem 30 that is inserted into cavity 26 of the earplug 10 – see para [0039]; see also para [0045, 0047]), the planar insert (30) having oppositely facing planar surfaces (as shown in figure 3, faces 36 and 37 are oppositely facing planar surfaces of the stem 30) and a thickness less than a height and a length (annotated Figure 8- indicated length and height dimensions are shown to be greater than an indicated thickness dimension);
wherein the earplug body (20) is configured to be temporarily compressed into a flattened shape by application of force against the oppositely facing planar surface (para [0031-0032]- describes the deformation of the tip 20 when compressed and how it rebounds following the deformation, thus rendering the compression “temporary”, the tip 20 is inherently capable of having a flattened shape in a compressed state because it’s made of a deformable polymer foam).
ANNOTATED FIG 8 OF Falco US 20100300460 A1 :
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Regarding claim 3, Falco discloses the earplug as claimed (see rejection of claim 1) and Falco further discloses an external portion (base section 32 and tapered section 33), extending beyond a rear end of the earplug body to form a handle (Figure 1- external portion of stem 30 is shown to extend from the back end of the tip 20, [0036]- these sections allow the stem 30 to be easily gripped by the user and thus are interpreted as forming a “handle” – see para [0036]).
Regarding claim 6, Falco discloses the earplug as claimed (see rejection of claim 1) and Falco further discloses that the planar insert (30) is configured to provide rigidity in a direction perpendicular to the oppositely facing planar surfaces (it is inherent that the biaxial stiffness of the stem 30 will provide rigidity in a direction perpendicular to the oppositely facing planar surface in order to provide structural support to the earplug when compressed) and flexibility in a direction parallel to the oppositely facing planar surfaces (the stem 30 will bend in the normal direction, DN, which is parallel to the oppositely facing planar surfaces, such that injury to the inner ear of the user is prevented – see para [0038] and fig 2).
Regarding claim 8, Falco discloses the earplug as claimed (see rejection of claim 1) and Falco further discloses that the planar insert (30) defines an opening within an internal portion of the planar insert ([0044]- “Channels 75 are defined along the longitudinal length of the member 50, although they may have various shapes and sizes as discussed above, and positioned generally within a central portion of each of the faces 71 and 72”) embedded within the earplug body (member 50 is the component of stem 30 that is inserted into cavity 26 of the earplug 10 – see para [0039]; see also para [0045, 0047]) to facilitate retention within the earplug body (para [0042]- “the member 50 is formed with a shape and length that complement the shape/length of the cavity 26 such that the tip 20 and the stem 30 can be axially and circumferentially aligned with one another when the member 50 is inserted into the cavity 26 – thus the shape of member 50, including the channels 75 disposed therein, complement the shape of cavity 26 and thus assist in retaining member 50 within cavity 26).
Regarding claim 9, Falco discloses the earplug as claimed (see rejection of claim 1) and Falco further discloses that the planar insert (30) is adhesively bonded within the earplug body (surface 51 of member 50 (which is part of stem 30) is adhered to the sound attenuating material of the tip 20 that is located at the interior facing surface of the cavity 26 when the member 50 is inserted therein – para [0039]).
Regarding claim 11, Falco discloses the earplug as claimed (see rejection of claim 1) and Falco further discloses that the earplug body (tip 20) has a bell shape (Figures 1, 13 & 14- tip 20 is shown to be bell shaped), or a generally symmetrical cross section (Figure 6- shows an axial view of the tip 20 that would form a symmetrical cross section).
Regarding claim 12, Falco discloses the earplug as claimed (see rejection of claim 1) and Falco further discloses that the planar insert (30) is disposed substantially symmetrically about a center axis of the earplug body (as shown in the view in figure 5).
Regarding claim 13, Falco discloses a method of making an earplug (para [0052-0053]) comprising: forming an elongated planar insert (para [0052] - forming a stem 30 with a biaxial stiffness including an elongate portion 31, and a member 50), the planar insert having a length and height dimension greater than a thickness dimension (annotated fig 8 – indicated length and height dimensions are shown to be greater than an indicated thickness dimension), the elongated planar insert (30) including oppositely facing planar surfaces (as shown in figure 3, faces 36 and 37 are oppositely facing planar surfaces of the stem 30); disposing the planar insert within an earplug body (para [0052] - inserting the member 50 into the cavity 26 of foam tip 20) that is elongated, compressible, and formed from an elastically deformable material ([0030-0032]- discusses the “polymer foam” material of the tip 20 and how it deforms and recovers when inserted into the ear canal), the planar insert (30) extending centrally along a center axis of the earplug body (annotated Figure 1- stem 30 extends along the indicated center axis in relation to the tip 20 of earplug 10); and wherein the earplug body 20 (tip 20) has a symmetrical or near- symmetrical cross-section perpendicular to the center axis when the earplug body is in an uncompressed state (Figure 6- shows an axial view of the tip 20 that would form a symmetrical cross section that would be perpendicular to the indicated center axis, see annotated Figure 1, [0030]- describes the tip 20 in a non-deformed state) and a flattened cross-section when the earplug body 20 is in a compressed state against the oppositely facing planar surfaces ([0031-0032]- describes the deformation of the tip 20 when compressed, the tip 20 is inherently capable of having a flattened cross section in a compressed state because it’s made of a deformable polymer foam).
ANNOTATED FIG 1 OF Falco US 20100300460 A1 :
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Regarding claim 14, Falco discloses the method as claimed (see rejection of claim 13) and Falco further discloses that disposing the planar insert within a compressible earplug body comprises forming the earplug body around the planar insert (para [0053]).
Regarding claim 15, Falco discloses the method as claimed (see rejection of claim 13) and Falco further discloses that disposing the planar insert within a compressible earplug body comprises inserting the planar insert into the earplug body (para [0052] – inserting the member 50 of stem 30 into the cavity 26 of tip 20).
Regarding claim 17, Falco discloses the method as claimed (see rejection of claim 13) and Falco further discloses wherein the planar insert 30 comprises an internal portion 50 (member 50, [0042]- “the member 50 is formed with a shape and length that complement the shape/length of the cavity 26 such that the tip 20 and the stem 30 can be axially and circumferentially aligned with one another when the member 50 is inserted into the cavity 26) and an external portion 32, 33 (base section 32 and tapered section 33), wherein the internal portion 50 (member 50) is disposed within the earplug body (Figure 1- member 50 is disposed within the cavity 26 of the tip 26, [0044-0045]) and the external portion 32,33 (base section 32 and tapered section 33) is disposed to extend externally to a back end of the earplug body (Figure 1- external portion of stem 30 is shown to extend from the back end of the tip 20, [0036]- these portions of the stem 30 are to be easily gripped by the user).
Regarding claim 19, Falco discloses the method as claimed (see rejection of claim 13) and Falco further discloses that the internal portion 50 (member 50) has a slot 75 (channels 75) extending lengthwise ([0044]- “Channels 75 are defined along the longitudinal length of the member 50, although they may have various shapes and sizes as discussed above, and positioned generally within a central portion of each of the faces 71 and 72”).
Claim Rejections - 35 USC § 102/103
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.
35 USC 102:
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.
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.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Falco (US 20100300460 A1).
Regarding claim 10, Falco discloses the earplug as claimed (see rejection of claim 1) and Falco further discloses that the earplug body is formed around the planar insert (para [0053]). Falco does not explicitly disclose that the earplug body is formed around the planar insert during a molding process but this phrase is being treated as a product by process limitation; that is, that the earplug body is made by molding. As set forth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Thus, even though Falco is silent as to the specific process used to form the earplug body, it appears that the product in Falco would be the same or similar as that claimed; especially since both applicant's product and the prior art product is made of a foam material (see instant spec at para [0051-0052]; Falco para [0030]).
Claim Rejections - 35 USC § 103
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 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Falco (US 20100300460 A1) in view of Hamer et al (US 2014/0017492).
Regarding claim 2, Falco discloses the earplug as claimed (see rejection of claim 1) but Falco does not disclose that the planar insert is positioned such that a minimum distance between the planar insert and an external surface of the earplug body is at least 10% of a maximum cross-sectional dimension of the earplug body.
Hamer teaches an earplug that includes an elongate core including a first material and an outer layer including a second material wherein the outer layer has an outer diameter between 2.5 mm and 6.5 mm and the elongate core has an outer diameter between 1.5 mm and 3.5 mm (para [0011]). Thus, in Hamer, the maximum cross section dimension is 2.5-6.5mm and the minimum distance between the planar insert and an external surface of the earplug body is 1-3mm ((2.5-1.5mm) and (6.5-3.5mm)) which is at least 10% of the maximum cross-sectional dimension of the earplug body (1mm/6.5mm = 15.4% which is at least 10%). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the earplug of Falco so that the planar insert is positioned such that a minimum distance between the planar insert and an external surface of the earplug body is at least 10% of a maximum cross-sectional dimension of the earplug body, like in Hamer, in order to provide sufficient cushioning between the insert and the ear and, furthermore, because discovering an optimum value of a result effective variable involves only routine skill in the art.
Claim(s) 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Falco (US 20100300460 A1) in view of Grozil (US 5074375 A).
Regarding claim 4, Falco discloses the earplug as claimed (see rejection of claim 3) but Falco does not disclose that the external portion of the planar insert defines at least one aperture configured to receive a cord, string, or other connector.
Grozil teaches an analogous earplug with a planar insert 26,28,30 (Figure 4- insert is formed by stem portion 26, stop portion 28, and connecting portion 30) wherein there are one or more holes in the insert (Figure 4- connecting portion 30 of insert is shown to have an aperture 38), configured to receive a cord, string or other connector (strap 40 such as a lanyard) to allow the earplug device to be attachable to an attachable element, such as glasses, via the strap - Abstract, Figures 1-2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the planar insert of Falco to have at least one aperture configured to receive a cord, string, or other connector as taught by Grozil, allowing the earplug device to be attachable to an attachable element such as glasses (Abstract, Figures 1-2).
Regarding claim 18, Falco discloses the method as claimed (see rejection of claim 17) but Falco does not disclose that the external portion of the planar insert defines one or more holes,
Grozil teaches an analogous earplug with a planar insert 26,28,30 (Figure 4- insert is formed by stem portion 26, stop portion 28, and connecting portion 30) wherein there are one or more holes in the insert (Figure 4- connecting portion 30 of insert is shown to have an aperture 38), configured to receive a cord, string or other connector (strap 40 such as a lanyard) to allow the earplug device to be attachable to an attachable element, such as glasses, via the strap - Abstract, Figures 1-2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the planar insert used in the method of Falco to have at least one hole configured to receive a cord, string, or other connector as taught by Grozil, allowing the earplug device to be attachable to an attachable element such as glasses (Abstract, Figures 1-2).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Falco (US 20100300460 A1), as evidenced by Property Information- Young’s Modulus (see attached NPL reference).
Regarding claim 5, Falco discloses the earplug as claimed (see rejection of claim 1) and Falco further discloses wherein the planar insert 30 (stem 30) is comprised of a stiff material ([0038, 0051-0052]- discusses that there is biaxial stiffness of the elongate portion 31 of the stem 30 to prevent injury when inserting the stem 30 into the tip 20 and then the earplug 10 into the ear canal of the user) and wherein the earplug body 20 tip 20) is a deformable material ([0031]- “Thus, the polymer foam is easily deformable by the user and tends to rebound following the deformation. In this way, the tip 20 may be inserted with appropriate force into the ear canal whereupon the polymer foam adaptively responds to the shape and the size of the ear canal interior and freely articulates with respect to the stem 30”).
Falco does not explicitly disclose wherein the planar insert comprises a material with a higher Young’s modulus than a material of the earplug body. However, Falco teaches that the material of the planar insert is stiffer than the deformable material of the tip as discussed above. A person of ordinary skill in the art would recognize that the stiffer material of planar insert 30 would have an inherently higher Young’s modulus compared to that of the material of the deformable tip 20, as is further evidenced by Property Information- Young’s Modulus (page 1- “A stiff material has a high Young's modulus and changes its shape only slightly under elastic loads (e.g. diamond). A flexible material has a low Young's modulus and changes its shape considerably (e.g. rubbers).”), providing that the stiff material of the insert prevents injury to the user when the earplug is inserted (Falco- [0038]). Falco and the instant invention are analogous because they both teach earplugs with an insert. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to recognize that the stiffer planar insert of Falco has a higher Young’s modulus than the deformable earplug body of Falco so that the stiff material of the insert prevents injury to the user when the earplug is inserted (Falco- [0038]).
Claim(s) 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Falco (US 20100300460 A1) in view of Jenkins, Jr. et al (US 7192544).
Regarding claim 7, Falco discloses the earplug as claimed (see rejection of claim 1) but Falco does not disclose that the planar insert comprises a barbed structure with one or more barbs extending outwardly from a central axis of the planar insert.
Jenkins, however, teaches an earplug which includes an insert (251; fig 17) that comprises a barbed structure with one or more barbs extending outwardly from a central axis of the insert (Fig 17 – insert 251 includes barbs 252, 254 and 256 extending outwardly from a central axis 260 of the insert). Jenkins further teaches that the barb elements function to increase the blockage of noise because when noise encounters an interface between materials of different densities, such as the stiff material of the insert 251/barbs 252-256 compared to the soft foam of the earplug body 262, more of the noise is blocked (col 5 lines 13-38). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the planar insert of Falco so that it comprises a barbed structure with one or more barbs extending outwardly from a central axis of the planar insert, like the insert of Jenkins, in order to increase the blockage of noise.
Regarding claim 16, Falco discloses the method as claimed (see rejection of claim 13) but Falco does not disclose that the planar insert comprises a barbed insert.
Jenkins, however, teaches an earplug which includes an insert (251; fig 17) that comprises a barbed structure with one or more barbs extending outwardly from a central axis of the insert (Fig 17 – insert 251 includes barbs 252, 254 and 256 extending outwardly from a central axis 260 of the insert). Jenkins further teaches that the barb elements function to increase the blockage of noise because when noise encounters an interface between materials of different densities, such as the stiff material of the insert 251/barbs 252-256 compared to the soft foam of the earplug body 262, more of the noise is blocked (col 5 lines 13-38). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the planar insert used in the method of Falco so that it comprises a barbed structure, like the insert of Jenkins, in order to increase the blockage of noise.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Falco (US 20100300460 A1) in view of Falco et al (US 7464786) (hereinafter “Falco ‘786”).
Regarding claim 20, Falco discloses the method as claimed (see rejection of claim 17) but Falco does not disclose that the external portion comprises a planar structure disposed generally perpendicular to the center axis and generally parallel to the back end of the earplug body.
Falco ‘786, however, teaches an analogous earplug and method of forming the earplug wherein the device includes an insert (stem 14; fig 8-10) that has an internal portion (portion 46 is described as the “inserted portion”) and external portion (handle portion 48) wherein the external portion (48) comprises a planar structure (lowermost surface at stem end 44 is shown being flat and thus comprising a planar structure as shown in figs 9-10) disposed generally perpendicular to the center axis and generally parallel to the back end of the earplug body (as shown in figs 9-10, the flat lower surface at stem end 44 is parallel to the collar 62 which is provided along the back end of the earplug body during use and perpendicular to the center axis which runs from ends 42 to 44; see also fig 1 which shows stem 14 in use with the earplug body and illustrates how the lower surface of stem 14 is parallel to the back end of body 12 at end 18). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the external portion of the insert used in the method of Falco so that the external portion comprises a planar structure disposed generally perpendicular to the center axis and generally parallel to the back end of the earplug body, like the insert of Falco ‘786, in order to allow the planar structure of the device to be placed on a surface so that the earplug stands upright so the tip does not contact the surface, thereby preventing contamination of the earplug tip from the surface.
Double Patenting
NON-STATUTORY DOUBLE PATENTING
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12364624 (“the ‘624 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application. Specifically, claims 1 and 13 of the present application and claim 1 of the ‘624 patent differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claim 1 of the ‘624 Patent is in effect a “species” of the broader, “generic” invention recited in claims 1 and 13 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claims 1 and 13 of the present application are anticipated by claim 1 of the ‘624 patent and, therefore, are not patentably distinct from claim 1 of the ‘624 patent.
Conclusion
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786