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 .
Claims 1-20 are pending.
Applicants have amended the claims:
See in independent claims 1, 8, and 17; and
dependent claims 7 and 10.
Response to Arguments
Applicant’s arguments, based upon the latest amendment, filed 8/10/2026, with respect to the rejection(s) of claim(s) 1-20 under KAWASAKI, along with secondary references of YAMADA, STROPPOLO, or POOLE and BLASZCZYKIEWICZ have been fully considered and are persuasive. Therefore, the previous rejections have been withdrawn based upon features of the amended claims. The amended features primarily are directed to the shape of the axial opening and the corresponding end of the elongated member that engages said opening. After further search and consideration based upon the latest features, a new ground(s) of rejection is made with the additional reference of BLASZCZYKIEWICZ (US 11225704 B2) that is applied to the rejections. The reference teaching of the claimed features regarding the non-curved portions of the side walls of the axial opening and the corresponding portion on the elongated portion.
Further, the rejection of claim 7 based upon 35 USC 112 due to an antecedent basis issue is now withdrawn as this particular issue have been resolved in the latest amendment.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-6, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over JPH08192295 A (KAWASAKI, see attached ESPACENET NPL document for english translation) in view of BLASZCZYKIEWICZ (US 11225704 B2, henceforth referred as BLAS’704).
Re 1, the KAWASAKI reference a tooling assembly (see Fig. 1), comprising:
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an elongated base portion (see shaft portions 22, 32) having a distal end and a proximal end, the proximal end having an axial opening (recess 23, 33; concave portion 23, see [0022]) therein; and
an elongated ceramic rod portion (ceramic heads 24, 34) having a distal end and a proximal end, the proximal end being inserted into the axial opening (recess 23, 33) in the proximal end of the elongated base portion;
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(Above are marked up copies of Fig. 1 showing particular regions)
wherein the proximal end of the elongated ceramic rod is secured to the proximal end of the elongated base portion by an interference fit.
(see insertion of the convex portion 25 of head 24 into concave portion 23 of the shaft portion, see [0022]).
The KAWASAKI reference does not teach of the axial opening having a non-curved portion, and of the end of the elongated ceramic rod portion having a non-curved portion, and lastly, of “wherein the non-curved portions of the axial opening and the proximal end of the elongated ceramic rod portion prevent rotation of the ceramic rod portion relative to the elongated base portion.”
See BLAS’704, see Figs. 2A-3, wherein, see the center pin 60 which would correspond to the claimed base, and the housing center 50 which corresponds to the claimed elongated rod portion, wherein, the bore of the center pin having a non-curved portion, see close up portion of Fig. 2A below. Wherein, the axial opening is of a hexagonal shape, which would have the non-curved portions.
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The BLAS’704 reference being relevant to the KAWASAKI reference in regards to known assembly of adjacent elements, particularly of formation of rod/pin/mandrel type assemblies from multiple elements.
It would have been obvious for one of ordinary skill in the art to have modified KAWASAKI with the non curved portions to the axial opening and the rod portion end as taught by BLAS’704 as known assembly of the rod portions in forming a tooling assembly, see KRS rationale, MPEP2143, as a use of known technique to improve similar devices (methods or products) in the same way.
Re 2 (upon 1), wherein the distal end of the elongated ceramic rod portion is a metal-detectable ceramic tip.
(see KAWASAKI reference [0019].)
Re 3 (upon 2), wherein the ceramic tip is configured as a compaction punch for producing pharmacological pill bodies.
(see MPEP 2114 and 2115 regarding the KAWASAKI reference being capable of operation, intended use.)
Re 5 (upon 1), wherein the elongated ceramic rod portion is selected from the group consisting of alumina, mullite, zirconia, yttria stabilized zirconia (YSZ), combinations thereof.
(see teaching of partially stabilized zirconia and alumina, see [0019].)
Re 6 (upon 1), wherein the tooling assembly is a punch in a rig for manufacturing pharmaceutical tablets.
(see MPEP 2114 and 2115 regarding the KAWASAKI reference being capable of placement into a rig, intended use, the KAWASAKI reference teaches of punches for pressing and molding raw material such as ceramic powder in a press machine, [0001])
Re 17, the KAWASAKI reference (as shown in teaching for claim 1 above) also teaches of a tooling assembly (see Fig. 1, see punches 20, 30 of a press die, see [0005]), comprising:
a metallic base portion (see shaft portions 22, 32) having a distal end and a proximal end, the distal end being configured for attachment to a press machine and the proximal end having an axial opening therein (see teaching of metallic base via tool steel [0020]); and
a ceramic rod portion (ceramic heads 24, 34) having a distal end and a proximal end, the proximal end being inserted into the axial opening (see recess 23, 33) in the proximal end of the elongated base portion, the distal end being a ceramic tip (see [0019]);
wherein the proximal end of the elongated ceramic rod is secured to the proximal end of the elongated base portion by an interference fit.
(see insertion of the convex portion 25 of head 24 into concave portion 23 of the shaft portion, see [0022]).
The KAWASAKI reference does not teach of: “therein, the axial opening including a sidewall having at least one non-curved surface”.
See BLAS’704, see Figs. 2A-3, wherein, see the center pin 60 which would correspond to the claimed base, and the housing center 50 which corresponds to the claimed elongated rod portion, wherein, the bore of the center pin having a non-curved portion, see modified portion of Fig. 2A, see below.
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The BLAS’704 reference being relevant to the KAWASAKI reference in regards to known assembly of adjacent elements, particularly of formation of rod/pin/mandrel type assemblies from multiple elements.
It would have been obvious for one of ordinary skill in the art to have modified KAWASAKI with the non-curved portions to the axial opening and the rod portion end as taught by BLAS’704 as known assembly of the rod portions in forming a tooling assembly, see KRS rationale, MPEP2143, as a use of known technique to improve similar devices (methods or products) in the same way.
Re 18 (upon 17), wherein the press machine produces pharmaceutical pill bodies.
(see MPEP 2114 and 2115 regarding the KAWASAKI reference being capable of capable of working upon such materials, seen as intended use, the KAWASAKI reference teaches of punches for pressing and molding raw material such as ceramic powder in a press machine, [0001].)
Re 19 (upon 17), wherein the ceramic tip is configured as a compaction punch for producing pharmacological pharmaceutical pill bodies.
(see MPEP 2114 and 2115 regarding the KAWASAKI reference being capable of working upon such materials, seen as intended use, the KAWASAKI reference teaches of punches for pressing and molding raw material such as ceramic powder in a press machine, [0001].)
Claim(s) 7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over KAWASAKI in view of BLAS’704 as applied to claims 1 and 19 above, and further in view of US 6245439 B1 (YAMADA), and further by the “Permeability” NPL document (from Engineer’s Toolbox for evidentiary teaching regarding inherent material properties of permeability).
Re 7 (upon 1), KAWASAKI fails to teach wherein at least one respective elongated member further comprises a plurality of metallic particles dispersed therein; wherein the metallic particles are selected from the group consisting of Ni, Fe, Co, permalloy, Mu-metal, and combinations thereof; and wherein the at least one respective elongated member has a high magnetic permeability μ of at least about 2.5×10−2 H/m with a relative permeability μ/μo of at least about 20000.
(this assuming that the elongated member is referring to the elongated ceramic rod portion.)
Regarding the claimed particles, this can be seen in other terminology of such dispersion material such as metallic fibers, or metallic whiskers. Here, the YAMADA reference teaches of the concept of ceramic and whisker comprising of ceramic and metal that are impregnated within the ceramic, see Col 1, lines 44-65 , which are to be able to form high fracture strength and high quality and which are strong against thermal shock. See also by YAMADA in Col 30, line 17-38 that teaches of magnetic properties including magnetic permeability, with the teaching of terms of particles, whiskers, fibers, or the like, see Col. 30, lines 29-30, and of high hardness and heat resistance. The material includes teaching of the claimed materials including steel, nickel, iron, and other types of material, see Col. 19, lines 41-56 with additive materials include nickel and iron.
It would have been obvious for one of ordinary skill in the art to have further modify the ceramic of the modified KAWASAKI with the additional metal particles such as iron or nickel alloy whiskers as taught by YAMADA allowing for improved properties such as it allows for improving the mechanical properties including heat resistance, hardness, and other properties, see YAMADA, Col. 8, lines 39-55.
Regarding the particular magnetic permeability properties, the teaching by the particular material by YAMADA that includes magnetic permeability that would encompass the claimed ranges. Wherein, the amount of the particles within the elongated member and YAMADA includes changing the size of the dispersion material that also affects the dispersion density, see Col. 8, line 56 to Col. 9, line 25, and dispersion can be 0.01-70 precent by volume, see Col. 10, lines 40-52 . Wherein iron (99.95 % pure Fe annealed in H, seen from the “Permeability” NPL document regarding permeability from engineering toolbox) having a permeability of 2.5 x 10-1 and relative permeability of 200000.
Wherein, one skilled in the art would recognize the amount of proportion range by YAMADA of the dispersion material as incorporated into the modified KAWASAKI would affect the permeability properties of the elongated rod member and encompass the claimed ranges of the properties of the elongated rod member of the modified KAWASAKI teaching.
(Re 20 (upon 19), KAWASAKI fails to teach wherein the ceramic tip is a metal-detectable ceramic.
In claim 20, the KAWASAKI reference does not teach of a ceramic having metals within. However, this feature is a known in the art as seen in the teaching by YAMADA above for claim 7 regarding the ceramic with metals within.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over KAWASAKI in view of BLAS’704 as applied to claim 1 above, and further in view of STROPPOLO (US 2006/0216347 A1).
Re 4 (upon 2), KAWASAKI does not teach wherein the ceramic tip includes a polymer wear layer.
See teaching of the STROPPOLO that includes the tablet punch (which would correspond to the ceramic rod portions) that includes a non-stick polymer layer, see [0009, 0022], with the polymer layer that includes a coating to the surface/head and allows for wear resistance, durability, and/or strength, see [0022]. See teaching of PTFE by STROPPOLO which corresponds to the same material stated in the specification in the instant application.
It would have been obvious for one of ordinary skill in the art to have further modified the ceramic rod portion of the modified KAWASAKI with additional polymer wear layer as taught by STROPPOLO allowing additional properties including wear resistance, STROPPOLO [0022].
Claim(s) 8-12, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over JPH08192295 A (KAWASAKI, see attached ESPACENET NPL document for english translation) in view of US 4205423 A (POOLE) and BLASZCZYKIEWICZ (US 11225704 B2, henceforth referred as BLAS’704).
Re 8, KAWASAKI teaches of a method of forming a tooling assembly (see teachings above by the KAWASAKI reference for claims 1 and 17), comprising the steps of:
a) providing tooling assembly (see Fig. 1) having:
an elongated base portion (22, 32) having a distal end and a proximal end, the proximal end having an axial opening (recess 23, 33) therein;
a first elongated ceramic rod portion (see 24, 34) having a worn distal end and a proximal end, the proximal end being inserted into the axial opening (recess 23, 33) in the proximal end of the elongated base portion;
d) inserting the proximal end of the second elongated ceramic rod portion into the axial opening of the elongated base portion.
(the KAWASAKI reference teaches of the formation of the device with the insertion of the head into the shaft portion, see insertion of the convex portion 25 of head 24 into concave portion 23 of the shaft portion, see [0022]).
Wherein, the KAWASAKI reference does not teach of refurbishing, that includes steps of:
“b) removing the first elongated ceramic rod portion from the elongated base portion;
c) providing a second elongated ceramic rod portion having a distal end and a proximal end”;
and further does not teach of the non-curved side wall portion of the axial opening, and of the rod having a non-curved sidewall portion.
However, as seen in the POOLE reference, the concept of refurbishing (in this case re-tipping) of a similar elongated tooling assembly is known in the art. Wherein, the POOLE reference teaches of the reworking that includes cutting off the old tip and subsequently butt welding a new tip on, rehardening, and then grinding, see Col. 1, lines 47-59. Further, see in POOLE of the various manner of fit including interference fit, see Fig. 4, Col. 3, lines 52-62, and threaded engagement, see Fig. 6, Col. 4, lines 60-68, between the base portion 15, 25 to rod portion 22, 32.
It would have been obvious for one of ordinary skill in the art to have modified KAWASAKI with the refurbishing step as taught by POOLE as it allows for accepting new tips particularly when the existing one becomes worn out, see POOLE, Col. 2, lines 36-43.
Regarding the opening and rod having non-curved shape, see in BLAS’704, see Figs. 2A-3, wherein, see the center pin 60 which would correspond to the claimed base, and the housing center 50 which corresponds to the claimed elongated rod portion, wherein, the bore of the center pin having a non-curved portion, see modified portion of Fig. 2A, see below.
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The BLAS’704 reference being relevant to the KAWASAKI reference in regards to known assembly of adjacent elements, particularly of formation of rod/pin/mandrel type assemblies from multiple elements.
It would have been obvious for one of ordinary skill in the art to have further modify the process of the modified KAWASAKI with the non-curved sidewall portions to the axial opening and the rod portion end as taught by BLAS’704 as known assembly of the rod portions in forming a tooling assembly, see KRS rationale, MPEP2143, as a use of known technique to improve similar devices (methods or products) in the same way.
Regarding the second elongated rod portion, the combined teaching with POOLE would have been obvious for this shape for the refurbishment with the piece that would readily fit into a similar shape of the axial opening of the teaching by BLAS’704.
Re 9 (upon 8), wherein the proximal ends of the first and second elongated ceramic rod portion are secured to proximal end of the elongated base portion by an interference fit.
(see KAWASAKI reference [0022].)
Re 10 (upon 8), wherein the sidewall of the axial opening of the base portion further includes at least one groove, the KAWASAKI teaches the further as shown in the rejection above, and further, the BLAS’704 reference also teaches wherein the proximal ends of the first and second elongated ceramic rod portion are secured to proximal end of the elongated base portion by a threaded engagement.
(See teaching by BLAS’704, see Figs, of the axial opening having the non-arcuate regions which corresponds to the claimed grooves.)
Re 11 (upon 8), further comprising:
between step c) and step d) the proximal end of the elongated base portion is heated.
(See teaching of heated, KAWASAKI reference [0022].)
Re 12 (upon 8), wherein step b) includes heating the proximal end of the elongated base portion.
(See teaching by KAWASAKI including heating, see [0022].)
Re 13 (upon 8), the KAWASAKI reference teaches of wherein the distal end of the elongated ceramic rod portion is a ceramic tip configured as a compaction punch, but does not teach of the punch being “for producing pharmacological pill bodies”.
However, such punch structures are known also for producing such pill bodies. See teaching by BLAS’704 of use of the tooling for pharmaceutical manufacturing, Col. 1, lines 38-57.
Wherein, it would have been obvious for one of ordinary skill in the art to have further modify the use of the modified KAWASAKI with the for producing in the pharmaceutical manufacturing as taught by BLAS’704 as a known manner of manufacturing utilizing the powder compacting and molding devices, see KSR rationale, MPEP 2143, as this is applying a known technique to a known device (method or product) ready for improvement to yield predictable results. .
Re 14 (upon 8), wherein the first elongated ceramic rod is destroyed during step b).
(See teaching by POOLE regarding destroying the original that includes cutting, see above in claim 1 teaching.)
Re 16 (upon 8), wherein the elongated ceramic rod portions are selected from the group consisting of alumina, mullite, zirconia, yttria stabilized zirconia (YSZ), combinations thereof.
(see teaching of partially stabilized zirconia and alumina, see [0019].)
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over KAWASAKI in view of POOLE and BLAS’704 as applied to claim 8 above, and further in view of STROPPOLO (US 2006/0216347 A1).
Re 15 (upon 8), the KAWASAKI reference does not teach wherein the first and second elongated ceramic rod portion are over molded with a polymer wear layer.
See teaching of the STROPOLLO that includes the tablet punch (which would correspond to the ceramic rod portions) that includes a non-stick polymer layer, see [0009, 0022], with the polymer layer that includes a coating to the surface/head and allows for wear resistance, durability, and/or strength, see [0022]. See teaching of PTFE by STROPPOLO which corresponds to the same material stated in the specification in the instant application.
It would have been obvious for one of ordinary skill in the art to have further modify the ceramic rod portion of the modified KAWASAKI with additional polymer wear layer as taught by STROPPOLO allowing additional properties including wear resistance, STROPPOLO [0022].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892 form, wherein, the features of the references are directed to tooling pin structures, of particular note:
The MANETTA (US 5774971 A) reference teaches of a pin with tip that is fastened which corresponds to the claimed base portion and elongated portion, and wherein, as seen in Figs. 2-3, see flat 22 that is provided upon the body (or plug/stud 16), wherein, which is a non-curved portion, allowing for air to escape the plug as it is advanced in the bore 14.
ALIBERTI (US 2837796 A) teaches of a pin that is secured within a base, wherein, the concept of the non-curved portions are taught as seen in prongs 23 with edges 25 that allows to maintain the pins in the proper aligned position, and the pins “will not accidently rotate”, see Col. 1, lines 50-62.
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 EMMANUEL S LUK whose telephone number is (571)272-1134. The examiner can normally be reached Monday-Friday 9 to 5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao S Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL S LUK/Primary Examiner, Art Unit 1744
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