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
The claims contain minor informalities.
In claim 13, the language “… to a portion of the applicator housing [[at]] that ends before the applicator housing base … from the tip of the [[housing of the]] applicator housing and a lower modulus of elasticity from the base of the [[housing of the]] applicator housing.” should be changed for clarity and consistent style.
In claim 14, the language “… to a portion of the applicator housing [[at]] that ends before the applicator housing base, and the portion is visually distinct with a visual distinction [[as]] selected from a wave …” should be changed for clarity.
Specification
The disclosure is objected to because of the following informalities.
The specification compares the elasticities of two materials with a modulus of elasticity (¶ [0021] The sidewall of the housing (“barrel”) can be comprised of a first material and the projections of the housing (“barrel”) can be comprised at least in part of a second material that is different from the first material with the second material having a modulus of elasticity that is greater than that of the first material; ¶ [0081], The material of the applicator may have a modulus of elasticity less than a modulus of elasticity of an overmolded portion of a softer material at the tip of the applicator).
However, as known in the art, the modulus of elasticity includes measures such as Young’s modulus, where hard materials such as diamond have high values, and soft materials such as rubber have low values.
Material
Young's modulus
(GPa)
Polystyrene, foam
0.0025–0.007
Rubber, small strain
0.01–0.1
Low-density polyethylene (LDPE), molded
0.228
Polytetrafluoroethylene (PTFE), molded
0.564
Polypropylene (PP), molded
1.68
Polycarbonate (PC)
2.2
Examiner suggests to revise the specification to describe soft materials as having a low elastic modulus, and hard materials has having a high elastic modulus.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 13 is 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 pre-AIA the applicant regards as the invention.
Claim 13 calls for “… and wherein said portion comprises two different materials having a greater modulus of elasticity from the tip of the housing of the applicator and a lower modulus of elasticity from the base of the housing of the applicator.”
This language is ambiguous because the specification calls for a softer tip and harder base (¶ [0021] The sidewall of the housing (“barrel”) can be comprised of a first material and the projections of the housing (“barrel”) can be comprised at least in part of a second material that is different from the first material with the second material having a modulus of elasticity that is greater than that of the first material; ¶ [0081], The material of the applicator may have a modulus of elasticity less than a modulus of elasticity of an overmolded portion of a softer material at the tip of the applicator). As known in the art, the modulus of elasticity includes measures such as Young’s modulus, where hard materials such as diamond have high values, and soft materials such as rubber have low values.
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 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) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(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; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 6-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by VanDenBogart; Tom William et al. (US 20100016780 A1).
Regarding claim 1, VanDenBogart discloses an applicator (¶ [0006], tampon applicators; ¶ [0006], [0018], FIG. 1, one embodiment of a tampon applicator is generally designated by reference numeral 21);
comprising: an applicator housing including a sidewall that is delimited at a first end by a tip and a second end by an applicator housing base (¶ [0018] FIG. 1 … The tampon applicator comprises a barrel, indicated generally at 23); and
has a first surface and a second surface with the second surface defining a cavity that extends within the housing from the applicator housing base to the tip of the applicator housing (¶ [0018], FIG. 1 …The tampon applicator comprises a barrel, indicated generally at 23, housing a tampon 25 (FIG. 5), and a plunger, indicated generally at 27);
a plunger that is arrangeable within the cavity of the applicator housing (¶ [0019] The tampon applicator 21 has a longitudinal axis X, with the barrel 23 and plunger 27 being in coaxial relationship with each other on this axis. The plunger 27 is thus moveable telescopically along the longitudinal axis X from an extended position as illustrated in FIG. 1 to a delivery position (not shown)); and
wherein at least a portion of the applicator housing is coated with a lubricious coating (¶ [0033] In other embodiments the barrel 23 may instead, or additionally, be coated with a friction reducing, or slip agent such as, without limitation, wax, polyethylene, silicone, cellophane, clay and combinations thereof. In still other suitable embodiments the barrel 23 may comprise a polymer blend melted together and co-extruded to provide a low coefficient of friction).
Regarding claim 6, VanDenBogart discloses all features of claim 1 as discussed above. VanDenBogart further discloses that at least a portion of the plunger is coated with a lubricious coating (¶ [0043] The applicator plunger 27 is, in one particularly suitable embodiment, constructed of the same material (e.g., polymer or polymer blend) as at least the first layer 81 (FIG. 2, e.g., the central region 43 and/or tip region 45) of the barrel to provide a relatively low coefficient of friction to plunger for sliding within the guide channel 63. While not shown in the drawings, it is contemplated that the plunger 27 may also be formed by a coinjection process similar to that used to form the barrel 23).
Regarding claim 10, VanDenBogart discloses an applicator (¶ [0006], tampon applicators; ¶ [0006], [0018], FIG. 1, one embodiment of a tampon applicator is generally designated by reference numeral 21);
comprising: an applicator housing including a sidewall that is delimited at a first end by a tip and a second end by an applicator housing base (¶ [0018] FIG. 1 … The tampon applicator comprises a barrel, indicated generally at 23); and
has a first surface and a second surface with the second surface defining a cavity that extends within the applicator housing from the base of the applicator housing to the tip of the applicator housing (¶ [0018], FIG. 1 …The tampon applicator comprises a barrel, indicated generally at 23, housing a tampon 25 (FIG. 5), and a plunger, indicated generally at 27);
a plunger that is arrangeable within the cavity of the applicator housing (¶ [0019] The tampon applicator 21 has a longitudinal axis X, with the barrel 23 and plunger 27 being in coaxial relationship with each other on this axis. The plunger 27 is thus moveable telescopically along the longitudinal axis X from an extended position as illustrated in FIG. 1 to a delivery position (not shown)); and
wherein at least a portion of the applicator housing is overmolded (¶ [0036] In a sequential coinjection process, the material injected first (e.g., the material from which the tip region 45 is formed) flows to the wall near the entrance to the mold, and the second material (e.g., the material from which the central region 43--and underlying portion of the grip region 41 is formed) then enters the mold and continues to flow in the center of the channel and fan out to the wall further down the part. In this way the far end of the part, e.g., the tip region 45, can be comprised solely of the first material, while the portion of the barrel 23 forming the grip region 41 and central region 43, will contain the stiffer second material).
Regarding claims 2, 3, 7 and 8, VanDenBogart discloses an applicator wherein the lubricious coating is added during manufacturing (¶ [0036] In a sequential coinjection process; ¶ [0043] The applicator plunger 27 is, in one particularly suitable embodiment, constructed of the same material (e.g., polymer or polymer blend) as at least the first layer 81 (FIG. 2, e.g., the central region 43 and/or tip region 45) of the barrel … the plunger 27 may also be formed by a coinjection process similar to that used to form the barrel 23);
wherein the lubricious coating prevents sticking of a menstrual collection device when a menstrual collection device is placed in the applicator housing (¶ [0033] One or more additives may be added to the polymeric first layer 81 of the barrel 23 (prior to molding) to enhance the slip characteristic (e.g., to provide a low coefficient of friction) of the barrel outer surface at least at the central region 43 of the barrel and more suitably at the central region and tip region 45 of the barrel).
Regarding claims 4 and 9, VanDenBogart discloses a lubricious coating (¶ [0036], [0043]).
VanDenBogart does not explicitly disclose that the lubricious coating is medical grade. However, the phrase “medical grade” does not distinguish VanDenBogart’s various coating materials from the claimed coating material. Instead, this phrase only describes that the coating is intended for medical uses. Therefore, VanDenBogart anticipates these claims.
Regarding claims 11-13 and 15, VanDenBogart discloses an applicator wherein the applicator housing is overmolded with a material selected from the group consisting of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), and combinations thereof (¶ [0032], For example, the barrel 23 may be constructed along its full length … of a polymeric first or core layer 81 comprising a polyolefin such as, without limitation, polypropylene, polyethylene … polyvinyl chloride, polymethyl methacrylate, polyolefin elastomer, copolymers of alfa-olefines, and combinations thereof; ¶ [0039], the second, or skin layer 83 forming the grip region 41 may comprise a thermoplastic elastomer (TPE));
wherein the applicator is overmolded from the tip of the applicator housing to a portion of the applicator housing at ends before the applicator housing base (¶ [0036] In a sequential coinjection process, the material injected first (e.g., the material from which the tip region 45 is formed) flows to the wall near the entrance to the mold … In this way the far end of the part, e.g., the tip region 45, can be comprised solely of the first material);
wherein the applicator is overmolded from the tip of the applicator housing to a portion of the applicator housing at ends before the applicator housing base, and wherein said portion comprises two different materials having a greater modulus of elasticity from the tip of the housing of the applicator and a lower modulus of elasticity from the base of the housing of the applicator; wherein the applicator housing is overmolded in its entirety (¶ [0036] In this way the far end of the part, e.g., the tip region 45, can be comprised solely of the first material, while the portion of the barrel 23 forming the grip region 41 and central region 43, will contain the stiffer second material).
Regarding claim 14, VanDenBogart discloses that applicator is overmolded from the tip of the applicator housing to a portion of the applicator housing at ends before the applicator housing base (¶ [0036] In a sequential coinjection process … the tip region 45, can be comprised solely of the first material, while the portion of the barrel 23 forming the grip region 41 and central region 43, will contain the stiffer second material); and
the portion is visually distinct with a visual distinction as selected from a wave, a straight line, a double wave pattern, different shapes, different patterns, two different pigments, two different colors, and combinations thereof (Fig. 1 shows a wave pattern at an interface between tip region 45 and central region 43).
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961
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Greyscale
Claims 1, 3, 4, 6, 8 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jarmon, George S. et al. (US 20030105421 A1).
Regarding claims 1 and 6, Jarmon discloses an applicator (¶ [0002], an insertion device, such as a catamenial or tampon applicator; ¶ [0016], [0022], FIG. 1 … Tampon applicator 10);
comprising: an applicator housing including a sidewall that is delimited at a first end by a tip and a second end by an applicator housing base (¶ [0022], Preferably, barrel 12 has a plunger receiving end or portion 18 and a fingergrip area 20 preferably adjacent end 18); and
has a first surface and a second surface with the second surface defining a cavity that extends within the housing from the applicator housing base to the tip of the applicator housing (¶ [0022], Tampon applicator 10 has a barrel 12 that can house a pledget 14 therein);
a plunger that is arrangeable within the cavity of the applicator housing (¶ [0022], a plunger 16 that can be connected to the barrel to engage, telescopically, the pledget housed in the barrel); and
wherein at least a portion of the applicator housing or plunger is coated with a lubricious coating (¶ [0025] Additionally, any surface of barrel 12 and/or plunger 16 may be coated with any-suitable material to enhance strength and/or reduce surface friction. Suitable coating materials include, for example, plastic, wax, silicone, epoxy, polyester, cellulose, lacquer, polyolefin, nylon, polyvinyl chloride, polyvinyl alcohol, nitrocellulose, cellophane, polylactide, or any combinations thereof).
Jarmon applies a lubricious coating to both the applicator housing and plunger (¶ [0025]). Therefore, Jarmon’s applicator anticipates both claims 1 and 6.
Regarding claims 3 and 8, Jarmon discloses that the lubricious coating prevents sticking of a menstrual collection device when a menstrual collection device is placed in the applicator housing (¶ [0006] Therefore, there is a need for a tampon applicator that exhibits surfaces having smooth and virtually frictionless characteristics; ¶ [0009] It is still another object of the present invention to provide such a tampon applicator with a barrel having a smooth interior and/or exterior surface with a low coefficient of friction; ¶ [0024], The resulting reduction in friction between the plunger surface and the barrel surface, as well as between pledget 14 and the barrel's inner surface, allows the user to expel the pledget from barrel 12 with greater ease; ¶ [0025] Additionally, any surface of barrel 12 and/or plunger 16 may be coated with any-suitable material to enhance strength and/or reduce surface friction);
Regarding claims 4 and 9, Jarmon discloses a lubricious coating (¶ [0025], any surface of barrel 12 and/or plunger 16 may be coated … reduce surface friction … plastic, wax, silicone, epoxy, polyester, cellulose, lacquer, polyolefin, nylon, polyvinyl chloride, polyvinyl alcohol, nitrocellulose, cellophane, polylactide, or any combinations thereof).
Jarmon does not explicitly disclose that the lubricious coating is medical grade. However, the phrase “medical grade” does not distinguish Jarmon’s various coating materials from the claimed coating material. Instead, this phrase only describes that the coating is intended for medical uses. Therefore, Jarmon anticipates these claims.
Claim Rejections - 35 USC § 102 / 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 2 and 7 are 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 Jarmon, George S. et al. (US 20030105421 A1).
Regarding claims 2 and 7, Jarmon suggests that the lubricious coating is added during manufacturing (¶ [0025] Additionally, any surface of barrel 12 and/or plunger 16 may be coated with any-suitable material to enhance strength and/or reduce surface friction. Suitable coating materials include, for example, plastic, wax, silicone, epoxy, polyester, cellulose, lacquer, polyolefin, nylon, polyvinyl chloride, polyvinyl alcohol, nitrocellulose, cellophane, polylactide, or any combinations thereof).
This claim is interpreted as a product-by-process claim, since it claims an apparatus and describes the process used to make or construct the apparatus. In spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established (MPEP 2113).
Jarmon does not explicitly recite that the various coating materials are added during manufacture. However, Jarmon’s coating materials comprise polymers that require specialized equipment to apply or incorporate in the applicator’s surfaces. This suggests that the coating materials are added during manufacture and not by a user.
Alternatively, applying Jarmon’s various coating materials during manufacture would have been obvious, since these materials have high melting points that a user cannot consistently regulate, or require handling irritating chemical precursors. For example, Jarmon enumerates epoxy, polyester, polyolefin, nylon and polyvinyl chloride (¶ [0025]). Uncured epoxy irritates skin, and the other polymers require high temperatures to apply as a coating. Therefore, it would have been obvious to apply the coating during manufacture in order for the end-user to avoid handling skin irritants or applying high temperatures.
Claim Rejections - 35 USC § 103
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Jarmon, George S. et al. (US 20030105421 A1) in view of Brown; Shawn W. et al. (US 20160296379 A1).
Regarding claim 5, Jarmon discloses a plunger (¶ [0022], plunger 16).
Jarmon is silent whether the top of the plunger comprises a cavity. Brown discloses a tampon applicator (¶ [0001] The present invention is directed to a tampon applicator; ¶ [0004], [0040] FIG. 1 … Tampon applicator assembly 100);
comprising: an applicator housing (¶ [0040] FIG. 1 … Tampon applicator assembly 100 includes a barrel 10);
a plunger that is arrangeable within the cavity of the applicator housing (¶ [0040] FIG. 1 … plunger 30);
wherein the plunger further comprises a cavity at the top of the plunger capable of accommodating a stem of a menstrual collection device (¶ [0049] Referring to FIG. 2, plunger 30 is an elongate member that includes a stem 30b having a proximal flared end portion 30a and a distal flared end portion 30c … proximal flared end portion 30a, stem 30b, and distal flared end portion 30c together define a passage 32 extending through plunger 30; ¶ [0056] Referring to FIG. 9B, a user exerts a force F on plunger 30 so that the distal flared end portion 30c of plunger 30 urges the tampon T toward the distal end 11b of barrel 10).
Brown accommodates a tampon string inside the plunger, distributes force across the tampon’s surface and also retains the plunger against displacing out of the applicator housing (¶ [0053], proximal flared end portion 30a undergoes radial deformation such that proximal flared end portion 30a defines a smaller, deformed diameter D.sub.5′ to pass through the proximal end 10a of barrel 10). One would be motivated to modify Jarmon with Brown’s plunger cavity since Jarmon relies on the plunger to dispense a tampon or other device, but discloses only general features of the plunger’s shape. In another embodiment, Jarmon suggests to widen the plunger’s top end (Fig. 5, applicator 10 has a widened fingergrip 32). Therefore, it would have been obvious to modify Jarmon with Brown’s plunger cavity in order to provide more details about a plunger that advances a tampon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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