Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/6/26 has been entered.
This RCE enters the amendments dated 6/16/26, by which claims 1 and 21 have been amended.
Claim Interpretation
Claim 3 recites “an entirety of the shield rim is overmolded along an entirety of the frame rim.” Based on claim 1 and the specification, “along an entirety” is taken to mean throughout 360 degrees (rather than referring to an extent along the first or second surface).
Claim Rejections - 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.
Claim(s) 1-3, 6-8, 10, 13-14, 16, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duckstein [US Pat. 4195638, newly cited].
Re. claim 1, Duckstein discloses:
A pacifier [Figs. 1-3] comprising:
a frame [4] defining a frame rim [Annotated Fig. 3, the outer rim of the frame beginning at the location of holes 14],
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the frame rim defining a plurality of openings [14] extending across the frame from a first frame surface to a second frame surface [Fig. 2]; and
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a mouth shield [lower portion of 8, see Annotated Fig. 2] defining a shield rim [outer rim of 8, Annotated Fig. 2], the mouth shield secured to the frame at least partially by an overmold [Col. 2 lines 52-65], wherein the shield rim is overmolded about the frame to contact both the first frame surface and the second frame surface [Fig. 2], and wherein the shield rim integrally extends through the plurality of openings [Fig. 2 and Col. 2 lines 60-65];
wherein an interface between the mouth shield and the frame is continuous [Fig. 1],
and wherein the frame rim circumferentially surrounds the shield rim [Fig. 2].
Re. claim 2, Duckstein discloses: The pacifier of claim 1, wherein the shield rim is at least partially overmolded across at least a portion of the frame [Fig. 2].
Re. claim 3, Duckstein discloses: The pacifier of claim 2, wherein an entirety of the shield rim is overmolded along an entirety of the frame rim [Figs. 1-2 show the shield rim overmolded over 360 degrees of the frame rim. See Claim Interpretation, above].
Re. claim 6, Duckstein discloses: The pacifier of claim 1, wherein the plurality of openings is distributed along the frame rim [Fig. 3 shows the distribution of openings 14 on the rim of frame 4].
Re. claim 7, Duckstein discloses: The pacifier of claim 6, wherein the plurality of openings is distributed symmetrically along the frame rim [Fig. 3].
Re. claim 8, Duckstein discloses: The pacifier of claim 6, wherein the plurality of openings is distributed symmetrically along the frame rim about a geometric center of the frame rim [Fig. 3].
Re. claim 10, Duckstein discloses: The pacifier of claim 1, wherein the plurality of openings have a same diameter [they are the same shape and same width across. See Figs. 2-3].
Re. claim 13, Duckstein discloses: The pacifier of claim 1, wherein the frame is formed of a rigid material [Col. 2 lines 35-40].
Re. claim 14, Duckstein discloses: The pacifier of claim 13, wherein the rigid material comprises one or more of a polymer and a thermoplastic [polypropylene, Col. 2 line 40].
Re. claim 16, Duckstein discloses: The pacifier of claim 1, wherein the mouth shield is formed of a soft material [Col. 1 line s 59-61].
Re. claim 19, Duckstein discloses: The pacifier of claim 1, further comprising a handle [6] secured to the frame and opposing the mouth shield [Fig. 1].
Re. claim 20, Duckstein discloses: The pacifier of claim 1, wherein a nipple integrally extends from the mouth shield [Fig. 2].
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) 9, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duckstein in view of Röhrig [US Pat. 5653731, hereinafter "Roehrig”].
Re. claim 9, Duckstein discloses the pacifier of claim 1, but fails to teach the openings being circular. However, Roehrig teaches, in a pacifier with a frame rim defining a plurality of openings [11], wherein the plurality of openings have respective circular cross-sections in a direction across the frame rim [Fig. 6]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Duckstein by forming the holes to have circular cross sections as taught by Roehrig because this amounts to a change in shape of the holes which does not affect the function of the device [circular holes allow for the soft material to pass through the holes in the same manner as the holes of Duckstein].
Re. claim 17, Duckstein discloses the pacifier of claim 16, but fails to teach the soft material comprises silicone. However, Roehrig teaches, in a pacifier, the soft material comprises silicone [Col. 4 line 11]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Duckstein by forming the soft material of silicone because this amounts to a simple substation of one soft material known in the art for another, with predictable results [silicone is a soft and body-safe material].
Re. claim 18, Duckstein discloses the rigid material of the frame comprises a thermoplastic [Col. 2 line 40] but fails to teach a thermoplastic chemically bonded to a silicone of the mouth shield. However, Roehrig further teaches the frame comprising a thermoplastic chemically bonded to the silicone of the soft material of the mouth shield [Col. 4 lines 53-55]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Duckstein by chemically bonding the thermoplastic to the silicone of the mouth shield as taught by Roehrig because this allows for a stronger bond between the two materials.
Claim(s) 21-23, 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duckstein in view of Kliegman et al. [US 2009/0248074 A1, hereinafter "Kliegman”].
Re. claim 21, Duckstein discloses the pacifier as set forth with respect to claim 1 above. Duckstein further discloses a method of making the above pacifier, comprising:
securing a frame [4] in a shield mold defining a mouth shield cavity [20, Fig. 4], the frame defining a frame rim [see claim 1 above], the frame rim defining a plurality of openings extending across the frame from a first frame surface to a second frame surface [see claim 1 above];
introducing a material into the shield mold [Col. 2 lines 59-60];
overmolding at least a portion of the material across at least a portion of the frame in the mold, such that a shield rim of the curable material contacts both the first frame surface and the second frame surface and integrally extends through the plurality of openings [Col. 2 lines 52-65]; and
allowing the material to set in the mouth shield cavity into a mouth shield at least partially secured to the frame by an overmold,
wherein an interface between the mouth shield and the frame is continuous [see claim 1 above], and wherein the frame rim circumferentially surrounds the shield rim [see claim 1 above].
Regarding the curable precursor material, and the step of allowing the curable material to cure:
Duckstein fails to teach a process involving a curable precursor material, and allowing the curable material to cure. However, Kliegman teaches, in a method of making a pacifier [Abstract], introducing a curable precursor material into the shield [110] mold [Par. 0032 describes the curable precursor material which is injected into the mold]; overmolding at least a portion of the curable material across at least a portion of the frame in the mold [Pars 0032 and 0035]; and allowing the curable material to cure [Par. 0032 describes curing] in the mouth shield cavity into a mouth shield at least partially secured to the frame by an overmold ["The outer substrate layer 110 is overmolded onto inner substrate layer 105," Par. 0022].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of making the apparatus of Duckstein by using a curable material, and performing the steps as taught by Kliegman above because this method allows silicone to be used, which amounts to a simple substation of one soft material known in the art for another, with predictable results [silicone is a soft and body-safe material], while limiting the amount of silicone used to make the manufacture cost effective [Kliegman Par. 0034].
Re. claim 22, Duckstein fails to disclose the method of making the frame. However, Kliegman further teaches introducing a frame material into a frame mold and allowing the frame material to set in the frame mold to form the frame ["the inner substrate layer 105 may be molded in a first mold and ejected from the first mold," Par. 0035]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of making the apparatus of Roehrig by performing the steps as taught by Kliegman because this amounts to a simple substation of one method of producing a frame (molding) known in the art for another, with predictable results.
Re. claim 23, Duckstein discloses securing a handle to the frame opposing the mouth shield [Col. 2 lines 58-65].
Re. claim 25, Duckstein discloses introducing a handle material into a handle mold and allowing the handle material to set in the handle mold to form the handle[Col. 2 lines 58-65].
Re. claim 26, Duckstein fails to disclose the shield material comprising silicone. However, Kliegman the shield material comprises silicone [Par. 0032]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Duckstein such that the shield material comprises silicone because this amounts to a simple substation of one soft material known in the art for another, with predictable results [silicone is a soft and body-safe material].. (Previously Presented) The method of claim 21, wherein the shield material comprises silicone.
Re. claim 27, Duckstein discloses the frame material comprises a polymer [polypropylene, Col. 2 line 40].
Re. claim 28, Duckstein discloses the polymer comprises a thermoplastic [polypropylene, Col. 2 line 40]..
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duckstein in view of Kliegman, as applied to claim 23, and further in view of 21/23, and further in view of Johansen et al. [US 6228105 B1, hereinafter "Johansen"].
Re. claim 24, Duckstein fails to teach securing the handle by welding. Johansen teaches
securing a pacifier handle to a frame comprises welding the handle to the frame ["the mounting ring alternatively may be attached to the bond ring and/or the rim by an adhesive,
chemical welding, heat welding or the like," Col. 3 lines 55-60]. It would have been obvious to
one of ordinary skill in the art before the effective filing date of the invention to modify the
method of the modified Roehrig by welding the handle to the frame as taught by Johansen
because this amounts to selecting one from a limited list of ways known in the art of attaching
the handle to the frame, with welding having the advantage of allowing a different material (such as a more rigid material) to be used for the handle than for the nipple/shield.
Conclusion
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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