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 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, 6-7, 9-10, 13-14, 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Röhrig [US Pat. 5653731, hereinafter “Roehrig”].
Re. claim 1, Roehrig discloses a pacifier [Fig. 6] comprising:
a frame [“shield” 32] defining a frame rim [see Annotated Fig. 6], the frame rim defines a plurality of openings [11] extending across the frame from a first frame surface to a second frame surface [they are “smaller fixing holes 11” and described as through-holes in col. 4 lines 23-30, the first and second surfaces are the two major faces of the frame, one shown in Fig. 6. See also the through holes shown in Fig. 3, which represents the first embodiment but is the same as Fig. 6 in this respect as Fig. 6 differs only in the frame/shield shape]; and
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a mouth shield [39] defining a shield rim [the entirety of 39], the mouth shield secured to the frame at least partially by an overmold [see col. 4, lines 29-35. Note that this is a product-by-process limitation and there is no evidence that the object obtained by the claimed overmolding would differ from the molding method of Roehrig], wherein the shield rim is overmolded about the frame to contact both the first frame surface and the second frame surface [Fig. 3. See note above about embodiments], and wherein the shield rim integrally extends through the plurality of openings [Fig. 3],
wherein an interface between the mouth shield and the frame is continuous [because the mouth shield is overmolded onto the frame, the interface between them is continuous. See also Fig 6 which show an interface between the frame rim and element 39 being a continuous arc around the edge of the frame rim].
Re. claim 2, Roehrig discloses the shield rim is at least partially overmolded across at least a portion of the frame [Fig. 6. See note about overmolding in claim 1.].
Re. claim 3, Roehrig discloses wherein an entirety of the shield rim is overmolded along an entirety of the frame rim [Annotated Fig. 6 above.].
Re. claim 6, Roehrig discloses wherein the plurality of openings is distributed along the frame rim [Fig. 6].
Re. claim 7, Roehrig discloses the plurality of openings is distributed symmetrically along the frame rim [Fig. 6, where the line of symmetry is a vertical axis extending through the center].
Re. claim 9, Roehrig discloses the plurality of openings have respective circular cross-sections in a direction across the frame rim [Fig. 6].
Re. claim 10, Roehrig discloses the plurality of openings have a same diameter [Fig. 6].
Re. claim 13, Roehrig discloses the frame is formed of a rigid material [see Roehrig Claim 1].
Re. claim 14, Roehrig discloses the rigid material comprises one or more of a polymer and a thermoplastic [polypropylene, which is both; see Col. 3 lines 60-61].
Re. claim 16, Roehrig discloses the mouth shield is formed of a soft material [Col. 4 lines 6-8].
Re. claim 17, Roehrig discloses the soft material comprises silicone [col 4 line 11].
Re. claim 18, Roehrig discloses the rigid material of the frame comprises a thermoplastic chemically bonded to the silicone of the soft material of the mouth shield [see claims 14 and 17 above, and Col. 4 lines 53-55].
Re. claim 19, Roehrig discloses a handle [4] secured to the frame and opposing the mouth shield [Fig. 1. Note that these features of the first embodiment also apply to those of Fig 6].
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) 20-23, 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roehrig in view of Kliegman et al. [US 2009/0248074 A1, hereinafter “Kliegman”].
Re. claim 20, Roehrig fails to teach the nipple [3] being integral with the shield. However, Kliegman teaches forming a nipple to integrally extend from the mouth shield [Kliegman Par. 0029]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this amounts to making integral, and does not provide new or unexpected results but simplifies the manufacture of the device by reducing the number of elements [Kliegman Par. 0029]..
Re. claim 21, Roehrig discloses the apparatus as set forth with respect to claim 1 above, but fails to disclose the claimed details of manufacture.
However, Kliegman teaches, in a method of making a pacifier [Abstract], the method comprising:
securing a frame [105, Fig. 10] in a shield mold defining a mouth shield cavity [“The inner substrate layer 105 is inserted into a second mold,” the mold being that which defines the “mouth shield” 110, and thus inherently has a mouth shield cavity; Par. 0035];
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], wherein an interface between the mouth shield and the frame is continuous [Figs. 1 and 10 show the continuous interface, which is developed by overmolding as set forth above].
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 above because this method limits the amount of silicone used to make the manufacture cost effective [Kliegman Par. 0034] while producing a shield and nipple which are overmolded together reducing the number of parts [Kliegman Par. 0029].
Re. claim 22, 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 above because this method limits the amount of silicone used to make the manufacture cost effective [Kliegman Par. 0034] while producing a shield, nipple, and handle which are overmolded together reducing the number of parts [Kliegman Par. 0029].
Re. claim 23, Roehrig discloses securing the handle to the frame opposing the mouth shield [Fig. 1, handle 4, see col. 3 lines 49-51, which steps also apply to the frame shape of fig. 6]
Re. claim 26, Roehrig discloses the shield material comprises silicone [see claims 16-17 above]. (Note that Kliegman also teaches the shield [110] material comprises silicone [“The outer substrate layer 110 may be silicone,” Par. 0032]).
Re. claim 27, Roehrig discloses one or both of the frame material or the handle material comprises a polymer [at least the frame, see cls 13-14 above]. (Kliegman also teaches one or both of the frame material or the handle material comprises a polymer [Par. 0033].)
Re. claim 28, Roehrig discloses the polymer comprises a thermoplastic [see cl 14 above]. (Kliegman also teaches the polymer comprises a thermoplastic [polyamide or nylon, Par. 0033].)
Claim(s) 12, 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roehrig, or Roehrig in view of Kliegman as applied to claim 21/23, and further in view of Johansen et al. [US 6228105 B1, hereinafter “Johansen”].
Re. claim 12, Roehrig fails to teach the frame rim surrounding the shield rim. However, Johansen teaches a frame defines a frame rim [14, Fig. 2]and the frame rim circumferentially surrounds the shield rim [32, Fig. 3]. 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 Roehrig by forming the frame rim and shield rim such that the frame rim surrounds a shield rim because this “provides stiffness for the flexible base 22 of the nipple 12 to prevent an infant from collapsing the base 22” [Johansen Col. 3 lines 10-13].
Re. claim 24, Roehrig teaches gluing the handle, not 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.
Re. claim 25, Johansen further teaches introducing a handle material into a handle mold and allowing the handle material to set in the handle mold to form the handle [Col. 3, lines 45-48 describe how the handle is “integrally molded with the mounting ring 56”. Note that in order to be molded it must be introduced to a mold of some type and allowed to set]. 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 molding the handle as taught by Johansen because this amounts to selecting one from a limited list of ways known in the art of forming an element.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roehrig.
Re. claim 8, Roehrig fails to teach the openings being symmetrical around a center of the rim. However, 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 Roehrig by distributing the holes so they are symmetrical about a center because this amounts to a simple rearrangement of parts which does not modify the operation of the device. See MPEP 2144.04.Vi.C.
Response to Arguments
Applicant's arguments filed 3/27/26 have been fully considered but they are not persuasive. The amendments, which change the scope of the claims, have resulted in Roehrig being applied as the primary reference and thus references to Schofield are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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