DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claims 1 – 18 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.
There are many limitations in the claims that render the claims vague and unclear, and lacks antecedent basis, the office hereby group these limitations and requests to Applicant to revisit all the claims to make proper corrections to overcome these rejections. The claims are hereby interpreted as best understood as Applicant regards as the claimed invention.
In claim 1, the recitations of “the medial surface”, “the tibial head” don’t have antecedent basis.
In claim 1, the recitation of “the implant is attachable to the medial surface of a tibial corpus and the tibial head after circular-segment like cutting and rotating a caudal fragment by screws through screw holes that extend along a screw hole axis from a medial surface to a lateral surface” makes the claim unclear and vague, for not clarifying what Applicant regards as the claimed invention, clarification is requested. For the sake of examination, the office will take the interpretation that the preceding section of the preamble is referring to an implant capable of being used with a tibia, without specifying a specific structure for the implant.
In claim 3, the recitation of “at least largely parallel” makes the claim unclear and vague, for not specifying what Applicant regards as the claimed invention, clarification is requested. For the sake of examination, the preceding limitation is interpreted as referring to “substantially parallel”.
In claim 5, the recitation of “the caudal extension has a greater distal extension than the cranial extension” makes the claim unclear and vague for not specifying what Applicant regards as the claimed invention, clarification is requested. For the sake of examination, the preceding limitations is interpreted as referring to that the caudal extension extends distally above the cranial extension.
In claim 6, the recitation of “the Implant is produced using a 3-print process” makes the claim unclear and vague for not specifying what Applicant regards as the claimed invention, clarification is requested. For the sake of examination, the preceding limitations is interpreted as referring to “3D printing process”.
In claim 15, the recitation of “in the range of 91 – 105” makes the claim unclear and vague for not specifying if Applicant intends to refer to degrees, clarification is requested. For the sake of examination, the preceding limitation is interpreted as “in the range of 91 – 105°”.
In claim 18, the limitations directed to the implant, starting from line 11 till the end of the claim “wherein the implant … till line 23” makes the claim unclear and vague, wherein claim 18 depends from claim 17 which made a reference to the implant of claim 1, and therefore claim 18 does not need to relist the limitations of claim 1, clarification is requested. For the sake of examination, the limitations in claim 18 directed to the implant is interpreted as referring to claim 1, with the addition of the limitations directed to the screw holes from line 23 to 25.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 – 5, 7 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shenoy et al. (US Pub. 2015/0196325 A1).
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Claim 1, Shenoy discloses an implant [Abstract, Figs. 1 – 14, i.e. implant 40B, Fig. 11 above], for use in Tibial Plateau Leveling Osteotomy Surgery (TPLO) for a dog or a cat, wherein the implant is attachable to the medial surface of a tibial corpus and the tibial head after circular-segment like cutting and rotating a caudal fragment by screws through screw holes that extend along a screw hole axis from a medial surface to a lateral surface [the implant disclosed by Shenoy exhibits substantially identical structure to that claimed, and therefore inherently capable of performing the claimed functions], comprising:
(a) a proximal head portion attachable to the caudal fragment [at least a portion by 46],
(b) a cranial extension in distal and/or cranial direction is provided on a cranial side of the head portion [at least a portion by 42],
(c) a caudal extension in distal direction is provided on a caudal side of the head portion [at least a portion by 54],
wherein the cranial extension is attachable to at least one of a medial-cranial surface of the tibial corpus and a medial-cranial surface of a not cut cranial tibial head fragment, and wherein the caudal extension is attachable to the medial surface of the tibial corpus [the implant disclosed by Shenoy exhibits substantially identical structure to that claimed, and therefore inherently capable of performing the claimed functions to be attached to tibial portions, best shown in Fig. 11D].
Shenoy discloses the limitations of claim1, as above, and further, Shenoy discloses:
Claim 2, wherein the head portion has an arch-like configuration [Fig. 11 above], enclosing an angle of about 180° [this angle can be defined by imaginary axis extending along one of X, Y or Z axes] and comprising a first end portion and a second end portion [at least portions by 44 and 56 defining ends], wherein the cranial extension is adjoined to the first end portion and the caudal extension is adjoined to the second end portion [at least portion 42 is adjoined to at least a portion by 44, and at least a portion by 54 is adjoined to at least a portion by 56].
Claim 3, wherein the caudal extension has a first section being adjoined to the head portion and being at least largely parallel to the cranial extension [Fig. 11 above, the first extension is substantially parallel to at least a portion of 42].
Claim 4, wherein the caudal extension has a second section adjoining the first section and distant from the proximal head portion, wherein the first section and the second section are located along different straight lines, lying on a circular track and/or include an obtuse angle [Fig. 11 above, the sections are located along different straight lines].
Claim 5, wherein the caudal extension has a greater distal extension than the cranial extension [Fig. 11 above, wherein at least a portion of 42 extends above at least a portion of 42].
Claim 7, wherein a circular marking with a radius is provided on a medial surface of the implant, wherein the radius is the same as a radius of the circular segment-like cut [Fig. 11 above, defined by at least a portion of the arch-like configuration].
Claim 10, wherein at least one screw hole is provided in at least one of the cranial extension and the caudal extension, wherein at least one screw hole is provided with one of a thread structure or a ramp structure [¶76, at least two threaded holes 57, Fig.11B].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
Claim(s) 6 and 11 – 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shenoy et al. (US Pub. 2015/0196325 A1) in view of Hirata et al. (US Pub. 2017/0231673 A1).
Claim 6, Shenoy discloses the limitations of claim 1 as above, and further, Shenoy discloses wherein the at least two screw holes are provided with a thread structure [¶76, at least two threaded holes 57].
Shenoy does not disclose wherein the Implant is produced using a 3-print process and wherein at least two screw holes are provided with a thread structure and of a teardrop-like shape with a tip, wherein the tips of all screw holes are pointing in the same distal direction.
Hirata teaches an analogous surgical implant [Abstract, Figs. 33 - 34] having at least two screw holes [at least two threaded holes 56 or 57] are provided with a thread structure [¶15] and of a teardrop-like shape with a tip, wherein the tips of all screw holes are pointing in the same distal direction [Figs. 33 - 34].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Shenoy and Hirata, and construct the screw holes of the implant of Shenoy having the configuration of Hirata. A PHOSITA would have been motivated to do so in order to provide an implant with a screw hole that allows the screw head to sink in the hole and prevent irritating surrounding tissue [¶11, Hirata].
Moreover, Shenoy does not disclose wherein the Implant is produced using a 3-print process.
Hirata teaches an analogous surgical implant [Abstract, Figs. 33 - 34] produced using 3D printing technique [¶194].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Shenoy and Hirata, and construct the implant of Shenoy using the 3D printing technique of Hirata. A PHOSITA would have been motivated to do so in order to provide an implant shaped to correspond the a shape of the treated bone [¶11, Hirata].
Claims 11 – 13, Shenoy discloses the limitations of claims 1 and 10, as above, and further, Shenoy discloses wherein at least one of one screw hole in the cranial extension and one screw hole in the caudal extension are provided [¶76, at least two threaded holes 57, Fig.11B].
Shenoy does not disclose (as of claim 11) wherein at least one of one screw hole in the cranial extension and one screw hole in the caudal extension are provided with a ramp structure; (as of claim 12) wherein each ramp structure is provided with a slope extending along a slope axis, wherein the slope axis each is directed to an anatomical center point that is at an anatomical point of the center point of the circular segment-like cut with which the head of the tibia is cut, wherein the slope axis intersect at this anatomical center point; (as of claim 13) wherein the slopes of the ramps are configured in such a way that when a screw is inserted into the screw hole with the ramp and tightened, a screw head of the screw brought into contact by the tightening exerts a force with a force direction through the anatomical center point or through a mid-point axis that is directed through the anatomical center point from medial to lateral.
Hirata teaches an analogous surgical implant [Abstract, Figs. 33 - 34] having at least two screw holes [at least two threaded holes 56] are provided with a thread structure [¶15] and each of the holes is provided with a ramp structure provided with a slope extending along a slope axis [Figs. 33 – 34, wherein each of threaded holes 56 is formed to be intermittent, defining at least one ramp between threaded sections, that slope along a slope axis in the direction of the hole].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Shenoy and Hirata, and construct the screw holes of the implant of Shenoy having the configuration of Hirata. A PHOSITA would have been motivated to do so in order to provide an implant with a screw hole that allows the screw head to sink in the hole and prevent irritating surrounding tissue [¶11, Hirata].
Claim(s) 8 – 9, 14 – 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shenoy et al. (US Pub. 2015/0196325 A1).
Claims 8 – 9, Shenoy discloses the limitations of claim 1 as above, and further, Shenoy discloses at least one screw hole in each of the caudal extension and the cranial extension [¶76, at least two threaded holes 57, Fig.11B].
Shenoy does not disclose in the embodiment of Fig.11B wherein the head portion has a threaded screw hole.
Shenoy teaches in analogous embodiment of the same invention an implant having a screw hole [83, ¶86 - ¶87, Fig. 13D] in each of head portion, caudal extension and cranial extension [a portion by 82 define a head portion, and portions by 92a and 92b define caudal and cranial extensions].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of the embodiments of Shenoy, and construct the head portion of the implant of the embodiment of Fig.11B Shenoy having a screw hole. A PHOSITA would have been motivated to do so in order to allow the user securing the implant to different portions of the bone to stabilize the implant relative to the treated bone.
Claim 14, Shenoy discloses the limitations of claim 1 as above, and further, Shenoy discloses wherein one cranial screw hole, one caudal screw hole [¶76, at least two threaded holes 57, Fig.11B], wherein the cranial screw hole axis encloses an angle with the sagittal plane in proximal-distal direction [Fig.11B],wherein the caudal screw hole axis encloses an angle with the sagittal plane in proximal-distal direction [Fig.11B].
Shenoy does not disclose in the embodiment of Fig.11B wherein the head portion has a threaded screw hole between the cranial and caudal screw holes.
Shenoy teaches in analogous embodiment of the same invention an implant having a screw hole [83, ¶86 - ¶87, Fig. 13D] in each of head portion, caudal extension and cranial extension [a portion by 82 define a head portion, and portions by 92a and 92b define caudal and cranial extensions], and wherein the proximal screw axis encloses an angle with the sagittal plane in proximal-distal direction [Fig. 13D].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of the embodiments of Shenoy, and construct the head portion of the implant of the embodiment of Fig.11B Shenoy having a screw hole. A PHOSITA would have been motivated to do so in order to allow the user securing the implant to different portions of the bone to stabilize the implant relative to the treated bone.
Moreover, Shenoy does not explicitly disclose wherein the enclosed angle of the cranial screw hole in the range of 89-79°, and the enclosed angle of the caudal screw hole in the range of 92-82°, and the enclosed angle of the proximal portion in the range of 89-79°.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the current application to construct the enclosed angle of the cranial screw hole in the range of 89-79°, and the enclosed angle of the caudal screw hole in the range of 92-82°, and the enclosed angle of the proximal portion in the range of 89-79° for the sake of providing the implant with screw holes that directs the screws therethrough at a desired angle that enhances engagement of the implant to the treated bone, since it has been held that where the general conditions of a 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 233.
Claim 15, Shenoy discloses the limitations of claim 1 as above, and further, Shenoy discloses one cranial screw hole, and one caudal screw hole [¶76, at least two threaded holes 57, Fig.11B], wherein the cranial screw hole axis encloses an angle with the sagittal plane in caudal-cranial direction [Fig.11B], wherein the caudal screw hole axis encloses an angle with the sagittal plane in caudal-cranial direction [Fig.11B].
Shenoy does not disclose in the embodiment of Fig.11B wherein the head portion has a threaded screw hole between the cranial and caudal screw holes.
Shenoy teaches in analogous embodiment of the same invention an implant having a screw hole [83, ¶86 - ¶87, Fig. 13D] in each of head portion, caudal extension and cranial extension [a portion by 82 define a head portion, and portions by 92a and 92b define caudal and cranial extensions], and wherein the proximal screw axis encloses an angle with the sagittal plane in proximal-distal direction [Fig. 13D].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of the embodiments of Shenoy, and construct the head portion of the implant of the embodiment of Fig.11B Shenoy having a screw hole. A PHOSITA would have been motivated to do so in order to allow the user securing the implant to different portions of the bone to stabilize the implant relative to the treated bone.
Moreover, Shenoy does not explicitly disclose wherein the enclosed angle of the cranial screw hole in the range of 91-105°, and the enclosed angle of the caudal screw hole in the range of 82-67°, and the enclosed angle of the proximal portion in the range of 88-98°.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the current application to construct the enclosed angle of the cranial screw hole in the range of 91-105°, and the enclosed angle of the caudal screw hole in the range of 82-67°, and the enclosed angle of the proximal portion in the range of 88-98° for the sake of providing the implant with screw holes that directs the screws therethrough at a desired angle that enhances engagement of the implant to the treated bone, since it has been held that where the general conditions of a 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 233.
Claim 17, Shenoy discloses the limitations of claim 1, as above, except for explicitly discloses a system comprising a plurality of implants.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the current application to construct a system having a plurality of the implants of Shenoy, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shenoy et al. (US Pub. 2015/0196325 A1) in view of Lundquist et al. (US Pub. 2024/0390042 A1).
Shenoy discloses the limitations of claims 10 and 17, as above, and further, Shenoy discloses (as of claim 18) wherein at least one screw hole is provided in at least one of the cranial extension and the caudal extension, wherein at least one screw hole is provided with one of a thread structure or a ramp structure.
Shenoy does not disclose (as of claim 16) a drilling guide comprising a bolt with a thread section and an attachment section to be bolted into a screw hole provided with a thread structure located in the proximity of the screw hole with a ramp structure and a drill guide piece with a guiding section for a drill attachable to the bolt in that the drill is guided perpendicular to the screw hole with the ramp structure when the drill guide piece is attached to the bolt; (as of claim 18) a drilling guide for guiding and positioning a drill while drilling at the tibia for attaching an implant with a non- head locking screw through one of the screw holes provided with a ramp structure, comprising a bolt with a thread section and an attachment section to be bolted into a screw hole provided with a thread structure located in the proximity of the screw hole with a ramp structure and a drill guide piece with a guiding section for a drill attachable to the bolt in that the drill is guided perpendicular to the screw hole with the ramp structure when the drill guide piece is attached to the bolt, and wherein the caudal extension is attachable to the medial surface of the tibial corpus.
Lundquist teaches an analogous surgical system [abstract, Figs. 40 – 63] comprising an implant [at least a portion of 420] having threaded hole [at least one of apertures 420a or 420b], a drilling guide [at least a portion of 421] comprising a bolt [at least a proximal portion of 422 or 437] with a thread section [at least a distal portion of 422 or 437 intended to thread into hole 421a] and an attachment section to be bolted into a screw hole provided with a thread structure located in the proximity of the screw hole with a ramp structure [¶136] and a drill guide piece with a guiding section [at least another portion of 421] for a drill attachable to the bolt in that the drill is guided perpendicular to the screw hole with the ramp structure when the drill guide piece is attached to the bolt [¶136 - ¶159].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Shenoy and Lundquist, and construct the system of Shenoy having a drilling guide in view of Lundquist to correspond to the implant. A PHOSITA would have been motivated to do so in order to facilitate in proper placement and securement of the implant with minimal irritation to the surrounding tissues.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775
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