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 .
Response to Amendment
The Amendments filed 08/08/2025 responsive to the Office Action filed 05/08/2025 has been entered. Claim 1 has been amended. Claims 1-7, 9-12, 14, 15 and 20 are pending in this application.
Response to Arguments
Applicant arguments, see Amendments pages 5-7 filed 08/08/2025, with respect to the rejection of the claim 1 under 103 have been fully considered but are not persuasive.
Applicant argues that “Neither Kousai nor Quackenbush teach or suggest a die that gives a unitary wall. Instead, the entire purpose of the dies in Kousai and Quackenbush are to create cannulas that have a splittable line or portion along the length of the cannula. See, e.g., Kousai at Abstract ("This cannula is removed after use from the medical instrument by being splitted."); Quackenbush at Abstract ("This invention relates to 'peel-away' tubing . .. ."). Kousai creates its splittable feature by creating a weld line with the extrusion die. See, Kousai at 2:24-30 ("a portion of the hollow tubular body is composed of a strip member of a material different from the main portion of the hollow tubular body ... and a weld line is longitudinally formed in the strip member."). Kousai then explains that, "[i]n this specification, weld line means a portion where fusion bonding of the coupled portion is incomplete, and a mechanical strength is decreased" (Kousai at 2:60-63). So, according to Kousai, its tubular body is sectioned into one material for part of the distance around the tube and is sectioned into a different, second material for theremainder of the distance around the tube. Further, because the weld line is, by definition, a different strength, the actual weld line along the tube is different from the rest of the tube. Accordingly, Kousai expressly teaches that its hollow tubular body is not unitary- it instead requires a non-unitary tube to create its splittable feature (pages 6-7)
Applicant’s arguments are found to be unpersuasive because:
The written specification does not explicitly mention that “an extruded parison from the extrusion die has a unitary wall”, but merely discloses “a uniform wall thickness of the extruded parison” in Pa [0033] which is the support for the amendment that Applicant recites in the argument (Remarks, page 5). Examiner has interpreted “a unitary wall” according to the lexical meaning thereof as “a wall forming a single or uniform entirety” (See the definition of “unitary” in Google Dictionary) and the support in the written description as “a uniform wall thickness”. In view of them, Examiner has maintained the current rejection because Kousai teaches the extrusion die forming the extruded parison having a unitary wall and a substantially uniform wall thickness around a diameter of the extruded parison. Kousai teaches that “molding resin flows for forming the strip member are divided by at least one buffer plate arranged near a die outlet port of a molding resin flow path of an extruder and are subsequently joined to be extruded from the die outlet port…Note that a melted resin flow is once divided in a cylinder, and the divided flows are joined and coupled again. In this specification, the weld line means a portion where fusion bonding of the coupled portion is incomplete, and a mechanical strength is decreased.” (co 2 li 50-54 and 58-53). Namely, Kousai teaches at least one buffer plate to form the weld line at which the divided flows are joined and coupled again and fusion bonding of the coupled portion is incomplete, and a mechanical strength is decreased, but does not teach that the weld line has a different thickness. Furthermore, according to the teachings by Kousai, the wall of the extruded product is unitary, i.e., a single unit. If Applicant tries to use “unitary wall” to specifically mean “non-splittable feature” or “uniform strength” as Applicant recites, the specification does not explicitly disclose this limitation and thus it might be rejected under 112(a) rejection.
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.
Claims 1-7, 9, 11, 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kousai et al. (US 4,874,374) in view of Quackenbush (US 5,104,388) (All of record).
With respect to claim 1, Kousai teaches an extrusion device comprising:
an extrusion die (“two-color extruder 15 having two cylinders 15a and 15b”, co 5 li 5-6 and Figs. 5 and 7) comprising:
a die bushing (“die 17” and “outer mold 20”, co 5 li 9, 23) comprising:
a channel (“resin path 21”, co 5 li 24) extending to an opening of the die bushing; and
a first section having a cylindrical shape and a length L1 (the cylindrical portion in the die 17 and the outer mold 20, Figs. 5 and 7); and
a second section having a frusto-conical shape (the frusto-conical portion in the outer mold 20), wherein the length L1 of the first section extends from the opening of the die bushing to the second section (Figs. 5 and 7);
a die pin (“inner mold 19”) positioned in the channel; and
at least one continuous die pin support feature (“buffer plate 18”) disposed in the first section of the die bushing and extending between the die pin and the die bushing (“buffer plate 18 projects from the inner surface of inner mold 19 near an outlet portion of die 17.”, co 5 li 7-9).
Kousai does not explicitly teach that the at least one continuous die pin support feature has a length LF that is greater than about 50% of L1.
However, in Fig. 7, Kousai shows that the length of the buffer plate 18 is greater than about 50% of the cylindrical portion. Thus, one would have found it obvious to provide the buffer plate having the length greater than about 50% of the cylindrical portion in order to form a weld line 14, since it has been held that While patent drawings are not to scale, relationships clearly shown in the drawings of a reference patent cannot be disregarded in determining the patentability of claims. See In re Mraz, 173 USPQ 25 (CCPA 1972).
Furthermore, Kousai teaches that the tear strength of weld line 14 can be adjusted by adjusting the position, height, width (length, thickness), and the like of buffer plate 18, or by adjusting types of resins or a blend of two or more resins constituting strip member 13 (co 5 li 32-36). Thus, in addition or alternatively, one would have found it obvious to select the optimum length of the buffer plate by routine experimentation for the purpose of forming the weld line having a desired tear strength, since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Besides, even though Kousai does not specifically mention the at least one continuous die pin support feature is positioned to retain the die pin in its position such that an extruded parison from the extrusion die has a unitary wall and a substantially uniform wall thickness around a diameter of the extruded parison, since Kousai teaches that distance h between the upper end of buffer plate 18 and the inner wall of outer mold 20 is 0 to a half of H (“a ratio of distance h between the upper end of buffer plate 18 and the inner wall of outer mold 20 to interval H of resin path 21 is set to be h:H=0 to 1/2:1”, co 5 li 21-24), the buffer plate inherently retains the die pin in its position and it results in an extruded parison from the extrusion die having a unitary wall and a substantially uniform wall thickness around a diameter of the extruded parison.
Kousai teaches providing a medical tool introduction cannula (co 2 li 13), but does not explicitly teach that the die pin has a diameter of between 0.025 inches and 0.085 inches in the first section.
In the same field of endeavor, a peel-away sleeve for a cannula for medical usage, Quackenbush teaches that splittable tubes of the type disclosed herein can be made by conventional extrusion equipment (co 3 li 37-38) and the typical inside diameter (ID) of the inner layer 11 of a cannula for medical use is 0.060" (co 2 li 32-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Kousai with the teaching of Quackenbush provide the die pin having a diameter of 0.060" for the purpose of forming a typical cannula for medical use.
With respect to claim 2, Kousai as applied to claim 1 above further teaches that the at least one continuous die pin support feature comprises a first end attached to the die bushing and a second end attached to the die pin (“a ratio of distance h between the upper end of buffer plate 18 and the inner wall of outer mold 20 to interval H of resin path 21 is set to be h:H=0 to 1/2:1”, co 5 li 21-24; In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I))).
With respect to claim 3, Kousai as applied to claim 1 above further teaches that the at least one continuous die pin support feature is integrally formed on a surface of the die bushing (“the same buffer plate 18 as in FIGS. 4 and 5 may be provided to an outer mold of die 17”, co 5 li 42-44, Fig. 7).
With respect to claim 4, Kousai as applied to claim 1 above further teaches that the at least one continuous die pin support feature is integrally formed on a surface of the die pin (“buffer plate 18 projects from the inner surface of inner mold 19 near an outlet portion of die 17.”, co 5 li 7-9, Fig. 5).
With respect to claim 5, Kousai as applied to claim 1 above does not explicitly teach at least one discrete die pin support feature, but further teaches that the tear strength of weld line 14 can be adjusted by adjusting the position, height, width (length, thickness), and the like of buffer plate 18 (co 5 li 32-34). Thus, one would have found it obvious to select the optimum length of the buffer plate by routine experimentation for the purpose of forming the weld line having a desired tear strength, since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With respect to claim 6, Kousai as applied to claim 1 above does not explicitly teach a plurality of discrete die pin support features, but further teaches that the tear strength of weld line 14 can be adjusted by adjusting the position, height, width (length, thickness), and the like of buffer plate 18 (co 5 li 32-34) and the same buffer plates may be provided to two or more portions of the outer or inner mold, or may be provided to both the outer and inner molds to oppose each other (co 5 li 46-48). Thus, one would have found it obvious to select the optimum length of the buffer plates by routine experimentation for the purpose of forming the weld line(s) having a desired tear strength, since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With respect to claim 7, Kousai as applied to claim 1 above further teaches at least two continuous die pin support features (“the same buffer plates may be provided to two or more portions of the outer or inner mold, or may be provided to both the outer and inner molds to oppose each other.”, co 5 li 46-48).
With respect to claim 9, Kousai as applied to claim 1 above further teaches a clearance fit between die pin support feature and the die pin (Figs. 6-7; “a ratio of distance h between the upper end of buffer plate 18 and the inner wall of outer mold 20 to interval H of resin path 21 is set to be h:H=0 to 1/2:1”, co 5 li 21-24; In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I))).
With respect to claim 11, Kousai as applied to claim 1 above further teaches a clearance fit between the die pin support feature and the die bushing (Figs. 4-5; “a ratio of distance h between the upper end of buffer plate 18 and the inner wall of outer mold 20 to interval H of resin path 21 is set to be h:H=0 to 1/2:1”, co 5 li 21-24; In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
With respect to claim 14, Kousai as applied to claim 1 above does not explicitly teach a plurality of discrete die pin support features having curved surfaces, wherein a curved surface of one of the plurality of discrete die pin support features interacts with a curved surface of another of the plurality of discrete die pin support features to form the boundaries a hole, but further teaches that the tear strength of weld line 14 can be adjusted by adjusting the position, height, width (length, thickness), and the like of buffer plate 18 (co 5 li 32-34) and the same buffer plates may be provided to two or more portions of the outer or inner mold, or may be provided to both the outer and inner molds to oppose each other (co 5 li 46-48). Thus, one would have found it obvious to select the optimum length and number of the buffer plates by routine experimentation for the purpose of forming the weld line(s) having a desired tear strength, since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this modification, a hole would inherently be formed between two adjacent discrete die pin support features. Even though Kousai shows the buffer plate 18 in a cuboid shape in Figs. 4-7, one would have found it obvious to change the shape of the buffer plates having curved corners, since it has been held that the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1976) (see MPEP § 2144.04).
With respect to claim 20, Kousai as applied to claim 1 above further teaches that the first section of the die bushing further comprises a gap having a length L extending from the opening of the die bushing to the at least one continuous die pin support feature (“distance L between the distal end position of buffer plate 18 and the distal end of die 17 is set to be 0 to 5 mm”, co 5 li 19-21).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kousai et al. (US 4,874,374) in view of Quackenbush (US 5,104,388) as applied to claim 1 above, and further in view of Palmer (US 5,580,405) (All of record).
With respect to claims 10 and 12, Kousai as applied to claim 1 above teaches the extruder in which buffer plate 18 projects from the inner mold 19, as shown in FIGS. 4 and 5 or as shown in FIGS. 6 and 7 the same buffer plate 18 as in FIGS. 4 and 5 provided to an outer mold of die 17 (co 5 li 37-44), but does not explicitly teach an interference fit between the at least one continuous die pin support feature and the die pin or an interference fit between the at least one continuous die pin support feature and the die bushing.
In the same field of endeavor, extrusion apparatus, Palmer teaches an extrusion apparatus comprising a die bushing (“extrusion sleeve 302”) comprising a channel extending to an opening of the die bushing, a die pin (“extrusion die 304”) positioned in the channel and at least one die pin support feature (“spider 360”) extending between the die pin and the die bushing (Fig. 3). Palmer further teaches that the sleeve 362 carries a plurality, preferably four, fins 364 which extend longitudinally along the sleeve 362 and radially outwardly so as to terminate in an interference fit with the internal periphery of extrusion sleeve 302, thus, firstly, the spider 360 provides support for the die 304 at a distal axial end additional to that provided by the extrusion sleeve 302 in contact with opposite axial end region 308 of the die and centres the die 304 within the extrusion sleeve 302, and moreover, it is found surprisingly that such a spider has not only a supporting function but also acts as a polymer flow stability enhancer to enable higher extrusion speeds to be employed and also providing an accurate adjustment of the pressure of the plastics material passing through the exit orifice 322 between frusto-conical part 316 of extrusion die 304 and frusto-conical end part 318 of extrusion sleeve 302 (co 14 li 59- co 15 li 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to provide the spider with the extrusion die in order to support and center the die pin within the die bushing and enhance a polymer flow stability.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kousai et al. (US 4,874,374) in view of Quackenbush (US 5,104,388) as applied to claim 1 above, and further in view of Uhlig (US 4,305,902) (All of record).
With respect to claim 15, Kousai as applied to claim 1 above does not explicitly teach that the at least one continuous die pin support feature comprises a spiral groove member.
In the same field of endeavor, an extruder, Uhlig teaches that in the extruder 21 the orifice mandrel 70 is provided with a series of axially spaced, separate, annular, peripheral rib 72 which project radially from the orifice mandrel 70 toward the orifice bore 38. Similarly, the orifice bore 38 is provided with a plurality of radially inwardly projecting, annular peripheral protuberances 73 which project inwardly toward the mandrel extension 70 (co 6 li 4-11) as seen in Figs. 2-4, one function of the support features is to provide shear forces on the material passing therethrough (col 7 ln 1-10), and teaches alternative structural elements such as threads 182 or threads 194 (Figs. 10-12) that can also provide such shear forces (col 11 ln 28-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to provide the helical threads with the inner mold 19 and/or the outer mold of die 17 in order to provide shear forces on the material passing therethrough.
Conclusion
THIS ACTION IS MADE FINAL. 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 YUNJU KIM whose telephone number is (571)270-1146. The examiner can normally be reached on 8:00-4:00 EST M-Th; Flexing Fri.
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/YUNJU KIM/Primary Examiner, Art Unit 1742