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 .
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are:
The use of the terms “fastener, “fastener element” and “fixing element” throughout the specification appears to be interchangeably used to describe the active element 1-2 as shown in the drawings. This creates confusion in the specification as well as the claims. A single term should be used throughout the specification/claims for any particular element of the device. The specification should be revised so that all terms throughout are consistent.
Additionally, the specification is unclear regarding the embodiment disclosed on page 12, lines 28-35. This particular disclosure states that the “fixing element”/”fastening element” may be formed integral with the internal body (from the same material) via the SLM method disclosed. It is unclear how this process will result in the differing thermal expansion coefficients disclosed in this paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 4 and 6 recite the limitation of the “outer member” (claim 4) and the “fastener” (claim 6) (these terms are considered to be the same element) formed of a material having a coefficient of thermal expansion greater than 15 to 40% of the body (claim 4) or forming it from a second material. However, claim 1 recites in lines 16 and 17 that the body and the outer member are formed in one piece from the same material. The specification does not clearly disclose how the SLM process disclosed, can result in the embodiments recited in claims 4 and 6, while forming both elements from “the same material”.
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.
Claims 1-7 are 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.
In claim 1, line 3, “the intended implant” has no prior antecedent basis.
In claim 1, lines 5-6, the parentheses should be removed.
In claim 1, line 7, “and/or non-metallic” is unclear and indefinite. It appears that “powders” should be inserted after “non-metallic” and the claim will be assumed to read as such, for purposes of this action.
In claim 1, lines 8 and 9, “the fastener” has no prior antecedent basis. This term is also confusing because it appears that “the fastener” is the same element as the “outer member” that is recited in subsequent claims. For purposes of this action, “the fastener” and “outer member” will be considered to be the same element.
In claim 1, line 9, “the inner body” has no prior antecedent basis. This term is also confusing because it appears that “the inner body” is the same element as “elongated body” that is recited in subsequent claims. For purposes of this action, “the inner body” and “elongated body” will be considered to be the same element.
In claim 1, line 16, “said body” should be –said elongated body--.
In claim 4, line 1, “claims” should be –claim--.
In claim 5, line 4, “the assembly forming the fastener” has no prior antecedent basis.
In claim 6, line 2, “the assembly forming the fastener” has no prior antecedent basis.
In claim 6, line 2, “a second material” is unclear. Specifically claim 1, from which claim 6 depends, recites that the body and the outer member are formed in “one piece from the same material” (lines 16-17). It is unclear how the body and outer member can be formed in one piece from the same material, while at the same time the fastener (outer member) being formed of a second material.
In claim 6, line 4, “the body” should be –the elongated body--.
In claim 6, line 7, “the internal body” should be –the elongated body--.
In claim 6, line 7, “with temperature body” is unclear. It appears that this should read –at body temperature—and will be treated as such for purposes of this action.
In claim 7, line 3, “the portion of the assembly forming the inner body” has no prior antecedent basis.
In claim 7, line 4, “the portion of the assembly forming the fixing element” has no prior antecedent basis. Furthermore, “fixing element” has no prior antecedent basis and will be treated as “outer member” for purposes of this action.
In claim 7, lines 4 and 5 are unclear, specifically “without a bridge of material between them” is unclear. This claim will be interpreted to read –wherein the outer member is detached from the elongated body so as to eliminate any bridge of material between them--.
In claim 7, line 6, “the part of the assembly forming the fastening element” has no prior antecedent basis, and “fastening element” will be interpreted to mean “outer member”.
In claim 7, line 8, “the effect” is unclear, and will be interpreted to mean “when it moves between the passive position and the active position”.
Double Patenting
Applicant is advised that should claim 3 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 4, while not completely identical to claim 3, appears to recite the same limitations as claim 3. The only difference is that claim 4, recites “the material constituting said outer member”, while claim 3, recites “said outer member”. However, these two limitations appear to be of the same breadth, and therefore claim 4 appears to be claiming the same thing as claim 3.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al 20110111367 in view of Miller et al 20150093283.
With regard to claim 1, Arnold et al discloses a dental implant assembly 1 (fig. 8) comprising an elongated inner body 80 which substantially resembles a tooth root, and an outer member 82 for fixing (capable of fixing) a heterogenous porous structure to a patient’s bone structure, the outer member 82 adapted to provide bone growth (the outer member 82 encourages bone growth (see paragraph 107, the outer member 82 is formed of resorbable material). The outer member 82 is comprised of a heterogeneous porous structure (resorbable material) movable between a stored passive position and an extended active position (see paragraph 107).
Arnold et al does not disclose the implant assembly being formed from an additive manufacturing process using only dry powder materials, the method comprising using a three-dimensional computer model of the intended implant to control a selective laser melting (SLM) system that selectively melts layers of powders; said powders comprised of a mixture of nanometric particles of zirconia or similar ceramics and particles of micrometric titanium (or any other metal); and
stacking layers of metal powders and/ or non-metallic fused powders selectively by concentration of an energy source comprising a step of preparing the mobility of the fastener relative to the inner body until the three-dimensional computer model of the intended implant is finished.
Miller et al disclose methods of forming medical implants. Miller et al disclose the steps of using a three dimensional computer model of an intended implant (see paragraphs 34 and 35, which disclose the use of CAD files) to control an SLM system that selectively melts layers of powders (see paragraphs 39 and 44). Note in paragraph 74 that Miller et al disclose that the powder used may be a mixture of ceramic and metal materials, and that the process can be used to form an implant in a single pice. Miller et al also disclose that a concentration of an energy source (a laser) is used during the SLM process.
It would have been obvious to one skilled in the art to form the implant of Arnold et al using the SLM method as disclosed by Miller et al, in view of the teaching of Miller et al that the disclosed SLM method may be used to form medical implants.
With further regard to claim 1, while Miller et al do not disclose the ceramic/metal powder mixture to comprise micrometric sized metal particles and nanometric sized ceramic particles, Miller et al disclose that varying size particles may be used. See paragraph 42.
It would have been obvious to one skilled in the art to utilize nanometric particles of ceramic material mixed with micrometric particles of metal material in the method of Arnold et al /Miller et al, in view of the teaching of Miller et al that the powder used in the SLM method may have varying particle sizes.
With regard to claim 2, Arnold et al discloses that the inner body may be formed with external threads. See paragraph 32. Such threads would define the recesses for the shape memory material. Arnold et al do not disclose the shape memory material within such recesses to deploy to an active position by a distance equal to or greater than the thread height. It would have been obvious to one skilled in the art to form the shape memory material of the outer member of the implant formed by the method of Arnold et al/Miller et al such that it would deploy from the recesses of the threaded body to an active position by a distance equal to or greater than the thread height, if one wished for a certain desired expansion of the outer member at a specific implant site.
With regard to claims 3 and 4, Arnold et al do not specifically disclose the outer member 82 (fastening element) to have a coefficient of thermal expansion greater than 15 to 40% of that of the body 80 of the implant at body temperature, allowing the implant assembly a greater lateral deployment.
It would have been obvious to one skilled in the art to form the outer member (fastening element) of the implant formed by the method of Arnold et al/Miller et al, to have a coefficient of thermal expansion greater than 15 to 40% of that of the body 80 of the implant at body temperature, allowing the implant assembly a greater lateral deployment, in view of the teaching of Arnold et al that the outer member is designed to expand, while the body is not. It appears that one skilled in the art would have had a reasonable expectation of success in selecting the outer member to have a thermal expansion that falls within this claimed range, as it only involves adjusting amount of expansion of the outer member to provide the stated desired property of engagement of the implant. Therefore, it would have been obvious to one skilled in the art to provide the claimed range as a matter of routine optimization, 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955).
With regard to claim 6, note that Arnold et al discloses that the fastener may be formed of a second material having a coefficient of thermal expansion greater than the body of the implant. See paragraph 107 of Arnold et al that discloses the outer member 82 (fastening element) to be formed of a polymeric shape memory material. Arnold et al also disclose that the body 80 may be formed of a non resorbable material, such as a metal (paragraph 61). Thus, it is clear that the outer member 82 of Arnold et al has a coefficient of thermal expansion greater than the body 80 of the implant. However, Arnold et al do not specifically disclose the second material of the outer member 82 (fastening element) to have a coefficient of thermal expansion greater than the body, such that lateral deployment is 15 to 40% greater of the body of the implant at body temperature, allowing the implant assembly a greater lateral deployment.
It would have been obvious to one skilled in the art to form the outer member (fastening element) of the implant formed by the method of Arnold et al/Miller et al, of a second material that has a coefficient of thermal expansion greater than the body, such that lateral deployment is 15 to 40% greater of the body of the implant at body temperature, allowing the implant assembly a greater lateral deployment, in view of the teaching of Arnold et al that the outer member is designed to expand, while the body is not. It appears that one skilled in the art would have had a reasonable expectation of success in selecting the outer member to have a lateral deployment that falls within this claimed range, as it only involves adjusting amount of expansion of the outer member to provide the stated desired property of lateral deployment of the fastener. Therefore, it would have been obvious to one skilled in the art to provide the claimed range as a matter of routine optimization, 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955).
With regard to claim 5, the method of Arnold/Miller et al does not explicitly disclose the step of preparing the mobility of the fastener comprises a step of forming a bridge of breakable material between a portion of the assembly forming the inner body and a portion of the assembly forming the fastener during manufacture by stacking layers.
However, Miller et al does disclose that a breakable area can be formed on an implant formed by the disclosed SLM process, so that it can be released from other structures. See paragraph 57.
It would have been obvious to one skilled in the art to prepare the mobility of the fastener of the implant formed by the method of Arnold/Miller et al to comprise a step of forming a bridge of breakable material between a portion of the assembly forming the inner body and a portion of the assembly forming the fastener during manufacture by stacking layers, in view of the teaching of Miller et al that a step of forming a breakable material during a SLM implant forming process allows the implant to be separated at desired points.
With regard to claim 7, note that the method of manufacturing the dental implant assembly of Arnold et al/Miller et al further disclosed the step of preparing the mobility of the fastener comprises a step of forming a portion of the assembly forming the inner body (inherent in forming the body 80 of Arnold et al), wherein the portion of the assembly forming the fixing element 82 of Arnold et al is without a bridge of material between the body 80 and fixing element 82 (the final product (implant) of Arnold et al comprises separate body 80 and fixing element 82 portions), wherein the part of the assembly forming the fastening element 82 ( spiral portion 82, fig. 10) is manufactured with an internal recess (the spiral portion 82itself has an inherent recess within it, which allows it to circumscribe the body 80), allowing it to be radially deployable under a thermal expansion effect.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430.
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/NICHOLAS D LUCCHESI/ Primary Examiner, Art Unit 3772