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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/22/2025, 02/26/2025, and 09/17/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim preamble should be amended to better convey the invention as follows - - A manufacturing method used to make a stopper for medical containers - -. The language provided is only suggested; other language that conveys the same idea would be considered when formally presented to the Office.
Claims 2 – 16 are objected to because of the following informalities: the claims recite “method of Claim”, the claims should be amended to change the capital letter in the phrase e.g., “method of claim”.
Claim 7 is objected to because of the following informalities: claim 7 recites in lines 2 – 3, “the upper mold having a upper cavity to accommodate an expansion of the septum”, this seems to be a typographical error. The claim should be amended to - - the upper mold having an upper cavity to accommodate an expansion of the septum - -.
Claim 7 is objected to because of the following informalities: claim 7 recites in lines 3-4, “and the common lower mold further comprising an moving pin”, this seems to be a typographical error. The claim should be amended to - - and the common lower mold further comprising a moving pin - -.
Claim 11 is objected to because of the following informalities: claim 11 line 4 recites “derived from from”. The claim should be amended to eliminate the repeated word.
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 4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “high modulus thermoplastic polyurethane elastomer” in claim 4 lines 3 – 4, is a relative term which renders the claim indefinite. The term “high modulus” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, the term renders the claim indefinite since what could be considered by the Applicant as a thermoplastic polyurethane elastomer having “high modulus” is subjective to Applicant’s interpretation and/or desired application, and a thermoplastic polyurethane elastomer having the same modulus might not necessarily be consider “a high modulus thermoplastic polyurethane elastomer” by one having ordinary skill in the art.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 – 2, 4 – 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over KEHNE et al. (US 2021/0177699 A1), in view of Belley et al. (US 2008/0091173 A1), and GIANNI (IT-TO20050276-A1).
Regarding claim 1, KEHNE et al. teaches a manufacturing method used in a stopper for medical containers [0002], [0006-0009], the stopper (see FIG. 2) having a septum (5) and a housing (7) supporting the septum [0024-0028], the manufacturing method comprising firstly creating the septum (5) using a first molding process with a thermoplastic elastomer [0041] composition (see FIG. 7 and [0056]);
then creating the housing (7) using a second molding process (see FIG. 8 and [0057]) with a plastic composition [0046], by the second molding process the septum being pre-compressed in a radial direction perpendicular to a needle penetration direction of the septum [0045]; and
subjecting the stopper to a steam sterilization (e.g., KEHNE et al. [0004] discloses that when the molded stopper has air spaces, there is then the need for a sterilization procedure of the assembled part).
KEHNE et al. did not disclose, wherein after the septum experiences the steam sterilization, the septum exhibits a residual pre-compression level of 12% to 30% in the radial direction compared to when the septum is uncompressed, and the residual pre-compression level is measured based on a thickness or average diameter of the septum.
KEHNE et al., however, discloses at [0045], “As one option in the present invention, the cap presses the septum against at least the inner sidewall of the barrel. Thus, the septum, as a result, can be compressed, to some extent, against at least part of or a portion of the inner sidewall of the injection site end of the barrel. The amount of compression can be such that the septum is compressed in a uniaxial or biaxial direction by less than 3%, such as 0.01% to 1% (comparing a non-compressed septum to a compress septum with respect to total surface area) or amounts below or above this range. This compression can be a uniaxial compression or a biaxial compression. The compression can result in the septum being squeezed or compressed so as to exhibit only from 90% to 99.99% (e.g. 98% to 99.99%) of its original, non-compressed height and/or non-compressed diameter”, “This compression can contribute or provide a ‘self-sealing’ feature to the septum once an injection needle or cannula has been removed from the septum. This compression can impart a pre-load to the septum and improve the sealing ability of the septum after a needle or cannula is removed from the septum.”
Belley et al., in the field of endeavor of methods of manufacturing an over-the-needle IV catheter including an in-line valve and having a re-sealable septum compressed by a collar [0003], discloses and embodiment, wherein the axial width of the collar 475 [analogous to the claimed “housing”] is longer than the axial width of the septum 316 such that the entire septum 316 is uniformly compressed, as the septum expands axially due to the radial compression. The compression member 475 may be composed of a rigid bio-compatible material such as stainless steel, plastic (e.g. polycarbonate) or like material to lend circumferential rigidity and strength to the septum [0104].
Therefore, Belley et al. recognizes that radial compression applied to the septum results in axial expansion (i.e., radially compressing the septum reducing its diameter results in an expansion of it thickness axially, e.g., bulging/protruding).
Gianni, in the same field of invention of methods of manufacturing a stopper with septum by an over-molding process in which a molded elastomer septum (e.g., using a thermoplastic elastomer composition) (lines 44 – 91), teaches a method, wherein “the elastic sealing body 6 [septum] overmoulded on the end 3 of the tubular element 2 has an internal axial portion 11 which is thickened and protrudes axially within the tubular element 3 and whose end surface 12 has a convex, typically spherical, configuration. Thanks to this configuration, in use, when the needle (or cannula) inserted through the elastic sealing body 6 is extracted and removed from the device, any fluid pressure within the tubular element 2 creates a prompt and complete hermetic closure of the relative hole made through the elastic sealing body 6. This effect is due to the radial components of this pressure acting on the convex surface 12 of the portion 11.” (see FIG. 6 and lines 105 – 111).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized, by routine experimentation, the septum residual pre-compression level in the radial direction compared to when the septum is uncompressed in the method of KENHE et al., to obtain the desired balance between the self-healing feature of the septum and the amount of compression needed to expand the septum axially, as suggested by the prior art of Belley et al. [0104], for the purpose of creating a convex bulge (e.g., Gianni’s internal axial portion 11), as suggested by the prior art, since Gianni teaches that thanks to this convex bulged configuration, in use, any fluid pressure within the tubular element creates a prompt and complete hermetic closure of the relative hole made through the septum e.g., when in use, when a needle is extracted from it, due to the radial components of this pressure acting on the convex bulged surface (see Gianni FIG. 6 and lines 105 – 111) (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claim 2, KEHNE/Belley/Gianni teaches the manufacturing method of claim 1, wherein the thermoplastic elastomer composition comprises one or any combination of the following: thermoplastic vulcanizate (TPV) (KEHNE [0041]), styrenic block copolymer (SBC) (e.g., KEHNE [0041] discloses “The thermoplastic elastomer can be a homopolymer or copolymer of any one or more of these thermoplastic elastomers”), thermoplastic polyurethane elastomer (TPU) (KEHNE [0041]), thermoplastic olefin elastomer (TPO) (KEHNE [0041]), thermoplastic polyester elastomer (TPE-E) (KEHNE [0041]; Gianni lines 68-73), or thermoplastic polyamide elastomer (TPEA) (KEHNE [0041]).
Regarding claim 4, KEHNE/Belley/Gianni teaches the manufacturing method of claim 1, wherein the plastic composition comprises one or any combination of the following: polyolefin, polycarbonate (KEHNE [0029]; Belley et al. [0104]), polycarbonate alloy, polypropylene/styrene-ethylene-butylene-styrene block copolymer alloy (PP/SEBS alloy), high modulus thermoplastic polyurethane elastomer, or high modulus thermoplastic polyester elastomer. (Note that KEHNE et al. [0046] discloses that the material of the housing (cap 7), can be the same or different from the disclosed materials as the barrel 3, and at [0029] “The thermoplastic material can be or include one or more thermoplastics such as, but not limited to, a polymer that is polycarbonate, polystyrene, polypropylene, polyethylene, and/or acrylonitrate butadiene, or a copolymer of or having one or more of these polymers, and the like.”).
Regarding claim 5, KEHNE/Belley/Gianni teaches the manufacturing method of claim 1, wherein the first molding process and second molding process is implemented by selecting one of the following methods: co-injection molding process, insert-molding process, over-molding process, or multi-shot injection molding process (e.g., see KEHNE et al. [0002], [0011], [0013], [0048], [0051 – 0056]; Gianni lines 68 – 91, 105 – 114).
Regarding claim 6, KEHNE/Belley/Gianni teaches the manufacturing method of claim 1, wherein the second molding process comprises extruding a melt of the plastic composition to radially compress the septum and expand the septum along a direction perpendicular the radial direction (see KEHNE et al. FIG. 8 and the discussion of claim 1 above).
Regarding claim 16, KEHNE/Belley/Gianni discloses a stopper manufactured using any one of the manufacturing methods of claim 1 (see claim 1 above).
Applicant is respectfully reminded that "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over KEHNE et al. (US 2021/0177699 A1), in view of Belley et al. (US 2008/0091173 A1), and GIANNI (IT-TO20050276-A1), as applied to claim 1, and as evidenced by the non-patent literature of HLC “What Is TPU Material? Properties, Types & Applications” (NPL_1).
Regarding claim 3, KEHNE/Belley/Gianni teaches the manufacturing method of claim 1, wherein the thermoplastic elastomer composition has a Shore A hardness of Shore A 30 to Shore A 50 (e.g., KEHNE et al. [0042] “ The material used to form the septum can have a Shore A hardness of from about 30 to about 70, such as from 35 to 50 (based on the Shore A durometer scale following ASTM D2240 type A)” – overlapping with the claimed range of from 30 to 50 Shore A), except for explicitly disclosing, an elongation at break equal to or greater than 250%.
However, KEHNE teaches the use of TPU as the elastomer composition, and said elastomer composition having an overlapping Shore A hardness with the Applicant’s. Therefore, KEHNE’s TPU would comprise a Shore A hardness at least greater than 250% as evidenced by NPL_1, which discloses TPUs combine several desirable properties1, such as, among others, a wide Hardness Range - TPU can be formulated from soft and gel-like (~Shore 60A) up to stiff and rigid (~Shore 75D) while maintaining Elasticity, and a high Elasticity and Toughness - TPU can often stretch 300–600% before breaking and will rebound without permanent deformation. It has high tensile strength and tear resistance, especially in formulations designed for mechanical stress.
Therefore, the claimed physical properties implicitly would have been achieved by the thermoplastic elastomer composition as claimed and rendered obvious (MPEP 2112.01(I,II)).
Claim(s) 7 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over KEHNE et al. (US 2021/0177699 A1), in view of Belley et al. (US 2008/0091173 A1), and GIANNI (IT-TO20050276-A1), as applied to claim 1, and further in view of Tanaka et al. (JP 2003175090 A).
Regarding claim 7, KEHNE/Belley/Gianni teaches the method of claim 1, wherein the second molding process (KEHNE FIG. 8, [0059]) comprises placing the septum between an upper mold (128) and a common lower mold (110), and the common lower mold (110) further comprising a moving pin (core pin 108), the moving pin supporting and retaining the septum during the first molding process (see FIG. 8), except for specifically disclosing, the upper mold (110) having a upper cavity to accommodate an expansion of the septum (see FIG. 8); and during the second molding process, the moving pin moving downward to form a lower cavity to accommodate an expansion of the septum as the upper mold and the common lower mold are closed.
Tanaka et al., in the same field of endeavor of a stopper with a septum (rubber plug) for a medical container and a method for manufacturing the stopper (lines 28 – 33, lines 123-275), teaches an upper mold (mold A combined with mold B in FIG. 12, and H in FIG. 13) having an upper cavity (Bb in FIG. 12, and Ha in FG. 13) to accommodate an expansion of the septum (e.g., see FIG. 12 and lines 476 – 484 “Since the mold B is not in contact with the surface, a flat recessed space Bb is formed on the top surface side of the rubber plug, and the bulging deformation of the top surface can be received.”, see lines 505 – 511), and
a moving pin (mold D in FIG. 12, and mold G in FIG. 13) moving downward to form a lower cavity to accommodate an expansion of the septum as the upper mold and the common lower mold are closed (e.g., see FIGs. 12-13 and lines 485 – 492 “so that when the side surface of the rubber stopper body is subjected to compressive stress, it can slide and move when the bottom surface of the rubber stopper is reduced in diameter.”; see lines 512 – 521).
Tanaka further discloses that “By adopting such a molding method, the top surface and the bottom surface of the rubber plug are reduced in diameter, and the top surface and the bottom surface are bulged and deformed.” (lines 519 – 521), and that “It was found that by applying compressive stress from the side to the center direction to reduce the diameter of the rubber plug, the needle tightening force during needle penetration and the strong closing force of the hole after needle withdrawal increase.” (Lines 123 – 129).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the upper mold and the lower mold’s core pin in the method of KEHNE/Belley/Gianni so that the upper mold comprises an upper cavity (e.g., Tanaka Bb or Ha) to accommodate an expansion of the septum, as suggested ant taught by Tanaka, and during the second molding process, the moving pin (e.g., KEHNE 108) moving downward to form a lower cavity to accommodate an expansion of the septum as the upper mold and the common lower mold are closed, as suggested and taught by Tanaka (lines 485 – 492), for the purpose of reducing the diameter of the septum, since Tanaka teaches that “It was found that by applying compressive stress from the side to the center direction to reduce the diameter of the rubber plug, the needle tightening force during needle penetration and the strong closing force of the hole after needle withdrawal increase.” (Lines 123 – 129). See MPEP 2143 (I) (G).
Regarding claim 8, KEHNE/Belley/Gianni teaches the manufacturing method of claim 1, wherein the septum is not subjected to any stress-relieving pretreatment prior to the pre-compression (see KEHNE [0054 – 0059] the septum is formed and fused in a single step, with no pretreatment disclosed between the septum forming step and the housing forming step).
Regarding claim 9, KEHNE/Belley/Gianni teaches the manufacturing method of claim 2, wherein the styrenic block copolymer comprises one or any combination of the following: styrene-ethylene-butylene-styrene block copolymer (SEBS) (see KEHNE [0041]).
Claim(s) 10 – 11, 13 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over KEHNE et al. (US 2021/0177699 A1), in view of Belley et al. (US 2008/0091173 A1), and GIANNI (IT-TO20050276-A1), as applied to claim 1, and further in view of Hisasue et al. (JP 2002143270 A), and as evidenced by the non-patent literature of Jesús E. Ibarra R. and Jessica N. Santiago, “Hydrogenated Styrenic Block Copolymers for Adhesives and Sealants,” ASI ADHESIVES & SEALANTS INDUSTRY, 2024, “NPL_2”)2.
Regarding claim 10, KEHNE/Belley/Gianni teaches the manufacturing method of claim 1, wherein the thermoplastic elastomer composition comprises: (a) 100 parts by weight of a block copolymer of formula A-B-A (e.g., styrene-ethylene-butadiene-styrene (SEBS), KEHNE [0041], [0042] “the septum contains at least 90 wt. % elastic, elastomeric, or thermoelastic polymer(s), such as from 90 wt. % to 100 wt. %”), where A is a vinyl aromatic block (e.g., styrene), and B is a hydrogenated conjugated diene block (e.g., ethylene-butadiene) with more than 90% hydrogenation rate (as evidenced by the NPL_2 page 3, “In SEBS, the level of hydrogenation of butadiene unsaturation is greater than 99%”), except for specifically disclosing, (b) 50-250 parts by weight of a plasticizer, and (c) 5-100 parts by weight of a polyolefin homopolymer.
KEHNE, however, discloses the use of one or more elastomeric or thermoplastic materials examples including homopolymers and/or copolymers, which discloses as not limited to this examples, that can be styrene-ethylene-butadiene-styrene (SEBS), thermoplastic olefin, thermoplastic vulcanizate, thermoplastic polyurethane, melt processible rubber, co-polyester-ether, polyether block amide, polyisoprene and the like, a silicone or include a silicone, and can contain, in addition to the thermoelastic material, one or more additives e.g., such additives, include, but are not limited to, fillers, nanobarcodes, RFIDs, electrically conductive particles, thermally conductive particles, anti-microbial agent(s), colorant(s), and the like, that can be present in any amount, such as from 0.01 wt. % to 5 wt. % or more based on the total weight of the material forming the septum [0041].
Hisasue, in the same field of endeavor of a stopper with a septum, teaches a plug (septum) for an infusion container which is excellent in balance of physical properties such as resealability of a hole afterward, excellent in sanitary properties, and excellent in productivity such as moldability and recyclability characteristic of thermoplastic elastomers and excellent in productivity (lines 76 – 91). Hisasue discloses the used a thermoplastic elastomer composition containing a styrene-based hydrogenated block copolymer as a main raw material and having a molecular weight and a molecular weight distribution within a specific range (lines 84 – 91), the composition of the thermoplastic elastomer is (a) at least two polymer blocks A mainly composed of a vinyl aromatic compound, and at least one conjugated polymer block. The weight average molecular weight obtained by hydrogenating a block copolymer comprising a polymer block B mainly composed of a diene compound is 100,000 to 250,000 in terms of polystyrene, and the main peak in the molecular weight distribution shown in FIG. 1, B/(A + B + C) × 100 (%) (1) (where A, B, and C indicate the area of each part) is 80% or more of the hydrogenated block copolymer 100
parts by weight, (b) 50 to 250 parts by weight of a softener for non-aromatic rubber, (c) 5 to 50 parts by weight of a polyolefin-based hydrocarbon resin, and a sealed body comprising (a), (b) and (c). (Lines 92 – 116).
Hisasue discloses the use of polyolefin homopolymers e.g., “polyethylene”, (lines 210 – 215 “the polyolefin-based hydrocarbon resin used as the component (c) of the present invention is useful for improving the processability and/or heat resistance of the obtained plug, and for example, polyethylene, isotactic polypropylene, propylene and the like.”), in a compounding amount of from 5 to 50 parts by weight – overlapping the claimed range of from 5-100 parts by weight of a polyolefin homopolymer. (Lines 92 – 116).
Hisasue further discloses that the component (b) is a softener useful for adjusting the hardness of the obtained plug and imparting flexibility [under the broadest reasonable interpretation, analogous to the claimed plasticizer], with a compounding amount of the softener of the component (b) is 50 to 250 parts by weight (overlapping the claimed plasticizer range of from 50-250 parts by weight). (Lines 196 – 209).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the thermoplastic elastomer composition in the manufacturing method of KEHNE/Belley/Gianni with a plasticizer, and a polyolefin homopolymer, as suggested by the prior art, since it have held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP § 2144.07. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the portion of Hisasue' plasticizer and polyolefin homopolymer ranges that corresponds to the claimed range. In re Malagari, 184 USPQ 549 (CCPA 1974).
One would have been motivated to pursue the modification for the purpose of e.g., for adjusting the hardness of the obtained plug and imparting flexibility by adding the plasticizer taught and suggested by Hisasue, and/or for the purpose of e.g., improving the processability and/or heat resistance of the obtained septum by adding the polyolefin homopolymers taught and suggested by Hisasue. See MPEP 2143 (I) (G).
Regarding claim 11, KEHNE/Belley/Gianni/Hisasue teaches the manufacturing method of claim 10, wherein block A is derived from one or any combination of the following: styrene (KEHNE [0041]), methylstyrene and isomers thereof (see Hisasue lines 156 – 159), and block B is derived from one or any combination of the following: 1,3-butadiene, 2,3-dimethyl-1,3-butadiene, 3-butyl-1,3-octadiene, isoprene, 1-methylbutadiene, and 2-phenyl-1,3-butadiene (e.g., KEHNE [0041], see Hisasue lines 156 – 194).
Regarding claim 13, KEHNE/Belley/Gianni/Hisasue teaches the manufacturing method of claim 10, except for specifically disclosing, wherein the thermoplastic elastomer composition has a melt flow index (MFI) of 2 g/10 min to 60 g/10 min at 230°C and 5 kg.
However, KEHNE/Belley/Gianni/Hisasue’s thermoplastic elastomer composition is similar to the applicant’s thermoplastic elastomer composition (e.g., NPL_2 discloses similar thermoplastic elastomer composition (e.g., SEBS, SEBS/SEB, TABLE 2), with a melt flow ratio of from <1 g/10 min to 25 g/10 at 190°C and 5 kg.) and thus, has similar properties. Therefore, the claimed physical properties implicitly would have been achieved by thermoplastic elastomer composition as claimed and rendered obvious (MPEP 2112.01(I,II)). It has been held that when the claimed and prior art products are at least substantially identical, claimed properties are presumed to be inherent. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP § 2112.01.
Regarding claim 14, KEHNE/Belley/Gianni/Hisasue teaches the manufacturing method of claim 10, wherein the weight-average molecular weight of the block copolymer is from 200,000 to 500,000, and the weight-average molecular weight of the block A is from 5,000 to 100,000 (e.g., see Hisasue lines 92 – 116 “The weight average molecular weight obtained by hydrogenating a block copolymer comprising a polymer block B mainly composed of a diene compound is 100,000 to 250,000 in terms of polystyrene, and the main peak in the molecular weight distribution shown in FIG. 1, B/(A + B + C) × 100 (%) (1) (where A, B, and C indicate the area of each part) is 80% or more of the hydrogenated block copolymer 100 parts by weight, (b) 50 to 250 parts by weight of a softener for non-aromatic rubber, (c) 5 to 50 parts by weight of a polyolefin-based hydrocarbon resin, and a sealed body comprising (a), (b) and (c).”).
Regarding claim 15, KEHNE/Belley/Gianni/Hisasue teaches the manufacturing method of claim 10, wherein the block copolymer has a bonded vinyl aromatic content e.g., 31% by weight (Hisasue lines 310 – 312), overlapping with the claimed range of from 20% to 50% by weight of the block copolymer, and has a vinyl bond content e.g., 337% by weight (Hisasue lines 315 – 317), overlapping with the claimed range of from 32% to 42% by weight of block B of the block copolymer. Overlapping ranges are prima facie evidence of obviousness.
It would have been obvious to one having ordinary skill in the art to have selected the portion of Hisasue' bonded vinyl aromatic content range and vinyl bond content range that corresponds to the claimed range. In re Malagari, 184 USPQ 549 (CCPA 1974). See MPEP 2144.05 (I).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over KEHNE et al. (US 2021/0177699 A1), in view of Belley et al. (US 2008/0091173 A1), and GIANNI (IT-TO20050276-A1), Hisasue et al. (JP 2002143270 A), and as evidenced by NPL_2, as applied to claim 10 above, and further in view of Thomas (EP 2688542 B1).
Regarding claim 12, KEHNE/Belley/Gianni/Hisasue teaches the manufacturing method of claim 10, wherein the thermoplastic elastomer composition further comprises: (d) greater than 0 but not more than 150 parts by weight of fillers (e.g., KEHNE [0041] “fillers”, “can be present in any amount, such as from 0.01 wt. % to 5 wt. % or more based on the total weight of the material forming the septum.”), except for specifically disclosing, and (e) greater than 0 but not more than 50 parts by weight of polyphenylene oxide.
KEHNE, however, discloses the use of one or more elastomeric or thermoplastic materials examples including homopolymers and/or copolymers, which discloses as not limited to this examples, that can be styrene-ethylene-butadiene-styrene (SEBS), thermoplastic olefin, thermoplastic vulcanizate, thermoplastic polyurethane, melt processible rubber, co-polyester-ether, polyether block amide, polyisoprene and the like, a silicone or include a silicone. [0041].
Thomas, teaches a method for producing a medical bag, in particular an infusion or transfusion bag, for receiving medical fluids, comprising the steps of: a) providing a plastic strand and providing bag film, b) joining the bag film and the strand to form a bag, and c) forming the strand as a one-piece port system (see lines 40 – 71, lines 99 - 119, and FIG. 1, the port system 12 comprising a “strand” in the form of a “separation region” 22 and a “calibration flap” 24, analogous to the claimed stopper for medical container comprising a septum, see lines 146 – 153).
Thomas further discloses that the material for the strand comprises a plastic mixture with high recovery, the polymer mixture polymers selected from polyphenylene oxide, polyethylene copolymers, ethylene vinyl acetate (EVA), styrene / ethylene butylene block copolymer (SEB), styrene / ethylene / butylene / styrene block Copolymer (SEBS), styrene / ethylene / propylene copolymer (SEP), polypropylene (PP), styrene-butadiene / styrene copolymer (SBS), polybutylene (PB), ethylene / propylene / diene rubber (EPDM), ethylene / propylene Plastic and styrene / butadiene / styrene block polymer (SBS), styrene / isoprene / styrene block copolymer (SIS). Preferably, the plastic mixture comprises a combination of PP, SEB and / or SIS. (lines 112 – 119), and that these materials are selected for the strand since they offer high resilience (property of a sealant to resume all or part of the original dimensions after the forces that caused the deformation have been removed”), such that the strand still seals tightly even after repeated piercing and pulling out of a transfer element (lines 120 – 130).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected polyphenylene oxide as an additive for the thermoplastic elastomer composition in the method of KEHNE/Belley/Gianni/Hisasue, since Thomas teaches that polyphenylene oxide offer high resilience, such that the septum still seals tightly even after repeated piercing and pulling out of a transfer element, as suggested and taught by Thomas lines 120 – 130, since it have held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP § 2144.07:
Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
As the penetration resiliency of a septum is a variable that can be modified, among others, by adjusting said amount of additive such as polyphenylene oxide in in the thermoplastic elastomer composition, with said penetration resiliency increasing with the addition of the polyphenylene oxide, as suggested by the prior art, the precise content of the additive would have been considered a result effective variable by one having ordinary skill in the art before the time the invention was effectively filed. As such, without showing unexpected results, the claimed polyphenylene oxide content cannot be considered critical. Accordingly, one of ordinary skill in the art at time the invention was effectively filed would have optimized, by routine experimentation, the polyphenylene oxide content in the method of KEHNE/Belley/Gianni/Hisasue to obtain a septum that still seals tightly even after repeated piercing and pulling out of a transfer element, as taught and suggested by Thomas lines 120 – 130 (see MPEP 2143 (I)(G)), (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Pat. No. 5,147,483 Col. 4 lines 8 – 21: Where the septum retaining arrangement includes the notched and contoured interior housing surface, the septum is installed by shoehorning the septum into place in the housing, which entails resiliently compressing the septum laterally with an installation tool while driving the septum downward into its seat at the housing interior surface. When seated, the septum resiliently engages and interfits with the housing interior surface due to the elastic restoring forces generated within the septum material itself. In this way, the septum is preloaded with radial force components so that it is very securely retained in its seat, able to more securely engage a syringe needle that penetrates it, and better able to reseal itself after needle puncture.
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/EDGAREDMANUEL TROCHE/Examiner, Art Unit 1744
/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742
1 NPL_1 “What id TPU Material? Properties, Types & Applications”, retrieved from https://www.hlc-metalparts.com/news/what-is-tpu-material-85135316.html
2 Retrieved from https://www.adhesivesmag.com/articles/101453-hydrogenated-styrenic-block-copolymers-for-adhesives-and-sealants