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 Arguments
Applicant's arguments filed 10/24/25 have been fully considered but they are not persuasive.
On pages 6-7 regarding prior art rejections, Applicant argues the opening 32 of Jones’ sleeve 10 could not have a depression across the proximal end, since there is no surface across Jones’ opening for a depression. Applicant argues Jones teaches a “closed arrangement”, and neither end could support having a depression across the proximal end as is required by the claims.
The Examiner respectfully disagrees, noting it is unclear what a “closed arrangement” is and what it has to do with the language of the claims. As regards the suggestion that the proximal surface of the Combination could not include a depression since “there is no surface”, the Examiner points out that the modification to include said depression is the modification which creates the surface, making this argument unclear. A change in shape is considered an obvious modification.
On page 8 Applicant argues further that Ganey discloses a sheet of DBF which would not be capable of performing the intended use of “screw fixation”.
The Examiner respectfully notes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. See MPEP 2145(IV). In this case, the rejection is not made over Ganey’s sheet-shaped implant alone, but rather the Combination of Ganey in view of Jones, or over Ganey in view of Schlachter, Jones, and Kale. Accordingly, arguments against Ganey’s implant, as it is shaped without modification, are not persuasive. Further, the Examiner notes that claim language requires the implant to be capable of enhancing fixation of a screw, as opposed to “performing…screw fixation” as is being argued. Further, the statement appears to be unsupported by evidence in the record and the Examiner reminds Applicant that the arguments of counsel cannot take the place of evidence in the record. See MPEP 716.01(c).
On page 8, Applicant argues the references used in the rejection itself do not provide the motivation to modify or combine.
The Examiner respectfully notes that motivation to combine reference or modify reference does not need to come from a reference itself, but rather, it can come from market forces, design incentives, interrelated teachings of multiple patents, any need or problem known in the field of endeavor, etc. Please see MPEP 2143.01.
On page 8, Applicant argues Schlachter does not teach using a DBF for screw fixation and does not teach an implant with a depression across the proximal end to receive a screw.
The Examiner again reminds Applicant that finding one lacking feature in Schlachter does not render Schlachter completely ineligible as prior art. As the rejection of record notes, Schlachter is used to teach only that it was known at the time the invention was filed to utilize injection molding to form bone implants made of DBFs.
On pages 8-9 Applicant argues Jones’ sleeve 10 is made of “flaccid fibers” or “woven fibers” that allow adjustment of the sleeve diameter, and argues the sleeve 10 also could not have a depression across the proximal end, since there is no surface across Jones’ opening 32 for a depression. Applicant argues Jones is dynamic, and adjusts from being an “open arrangement” to a “closed arrangement”.
The Examiner respectfully points out that it appears Applicant is again arguing against Jones alone, as opposed to the Combination of Ganey in view of (Schlachter and) Jones. Arguments that Jones’ fibers are “flaccid” appear unsupported by evidence from Jones, but the Examiner also notes that the material composition of the fiber of the Combination is actually the DBF fibers of Ganey, which further renders this argument unpersuasive. Further, arguments that Jones’ proximal end could not include a depression because “there is no surface” fails to take into account the modification made in light of Kale, who teaches the inclusion of a surface with a depression. This again appears to be an argument against one reference individually as opposed to the Combination of record. The shape of the implant being modified in light of Kale is understood to be a suitable modification.
On page 9 Applicant argues again that DBF implants from Ganey and Schlachter “do not provide the…motivation to form the claimed truncated cone implant from DBF fibers with a depression across the proximal end for receiving a screw”. Applicant then admits Jones’ device does disclose screw fixation, but argues Jones’ device doesn’t support having a depression across the proximal end.
The Examiner respectfully reiterates that motivation to combine reference or modify a reference does not need to come from a reference itself, but rather, it can come from market forces, design incentives, interrelated teachings of multiple patents, any need or problem known in the field of endeavor, etc. Please see MPEP 2143.01. As regards Jones not teaching a depression across the proximal end, the Examiner agrees, as does the rejection of record, which relies on Kale to teach such a modification in order to assist in screw lead-in.
On page 10, regarding the modification in light of Kale, Applicant argues Kale’s beveled edge 31 could not have a depression across the proximal end, since there is no surface across Kale’s opening on which to form the depression.
The Examiner respectfully disagrees, noting the modification on the record in light of Kale provides part of the proximal end, where a bevel or depression is added to the implant of the Ganey (Schlachter) Jones Combination. It is unclear if Applicant is arguing the depression within Kale does not extend at least partially across the implant’s end, since the Examiner understands this to be the case.
On pages 10-12, Applicant argues further regarding Kale that while they discuss their implant being made of demineralized bone, the material is not in the form of fibers. Applicant concludes Kale’s screw fixation device is made of a hard monolithic material, meaning a person of ordinary skill wouldn’t have considered a fibrous form of the same material as being useful as a screw fixation device (and accordingly would also not find it obvious to include a depression). Applicant also concludes that the materials of Kale would prevent a screw from penetrating therethrough.
The Examiner respectfully points out that since Ganey already discloses DBF and this is the composition required by the claims, it is unclear why Applicant is discussing the material of Kale, when it is only used to provide teachings of why a person of ordinary skill would include a depression on a bone-filling implant. Further, Kale’s implant structure being monolithic or not is also not relevant to the rejection of record, since Ganey also teaches this construction modified to be in the shape of Jones. Arguments stating tha ta person of ordinary skill would not have found a fibrous material to be “useful” as a screw fixation device as not persuasive since they fail to point to evidence in the record supporting the statement, and also since it goes against express teachings of Jones, whose fibrous implant is for screw fixation.
Claim Objections
Claims 21 and 36 are objected to because of the following informalities:
Claims 21 and 36 are objected to for referring to “the surface” of the bone with improper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-40 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 21 and 36 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claims positively recite that the “flared proximal end” of the implant contacts “the surface of the bone”.
Remaining claims are rejected for depending on a claim which positively recites part of a human organism.
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 21-37 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21 and 36 are rejected for having new matter for claiming the proximal end contacts the surface of the bone, but there is no support for this in the originally filed disclosure.
Remaining claims are rejected for depending on a claim with new matter.
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.
Claims 21-32, 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganey et al. (US 20200054789 A1) hereinafter known as Ganey in view of Jones (US 5984926 A), or in the alternative, over Ganey in view of Schlachter et al. (US 20170216491 A1) hereinafter known as Schalchter, further in view of Jones and Kale et al. (US 20110144766 A1), hereinafter known as Kale.
Regarding claim 21 Ganey discloses a bone-defect space filling structure ([0002]) capable of swelling from hydration ([0011] the demineralized bone fibers are lyophilized, or freeze dried, which inherently renders them capable of swelling if hydrated) comprising:
a plurality of cut demineralized bone fibers (DBFs) (Abstract; [0007]) having a fiber length of or between 1-30 cm ([0010]),
wherein the cut DBFs are combed together to form a mass of cut DBFs entangled with each other and arranged into a shape (Figure 9-10), and
wherein the mass of cut DBFs is processed by a fluid-assisted injection molding into a shape (The applicant is advised that this part of the claim is recited as a “product-by-process” claim. Even 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.” See MPEP 2113. In this case, the cited limitations failed to distinguish the claimed structure from Ganey, since all the structural limitations of the claim appear to be met. See additionally Ganey [0011] formation by molding, or Ganey [0098] fluid. As regards whether or not the fluid-assisted molding occurs via injection or not, the Examiner understands the final structure of Ganey is not changed whether the molding occurs via injection molding or not. Alternatively the person of ordinary skill in the art would have found it obvious to utilize any known type of molding for manufacture of the implant, including injection molding (see for example Schlachter [0170] who teaches it is known to utilize injection molding to form bone implants made of DBFs), wherein the proximal end contacts the surface of the bone (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Ganey was considered capable of performing the cited intended use of having a proximal end contact a surface of a bone.). Ganey and Schlachter are involved in the same field of endeavor, namely the processing of DBFs. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the structure of Ganey so that the fibers were formed by injection molding as is taught by Schlachter since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C).) with a ratio of fluid to DBF in a range of or between 3-20 mL fluid to 1 gram DBF (This remains part of the product-by-process limitation, and the ratio of fluid to DBFs is not understood to effect the final structure of the implant. However/alternatively, see also Ganey [0098] which teaches a ratio of 3 mL fluid to 1g bone, which indicates a known ratio of fluid to bone for injection);
but is silent with regards to the shape of the bone-defect filling structure,
and the proximal end is flared, and comprises a depression thereacross for receiving the screw.
However, regarding claim 21 Jones teaches a fibrous implant (Column 7 lines 48-50, Column 8 lines 58-60) configured for enhancing fixation of a screw for placement in a hole a bone in need of repair (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the apparatus of Jones discloses (as detailed above) all the structural limitations required to perform the recited functional language of “enhancing fixation of a screw into a hole of a bone in need of repair”, therefore was considered to anticipate the claimed apparatus. See, for example the Abstract and Column 1 line 12.), the implant being space-filling (it is inherent that all structures that exist in the world fill the space they occupy; see also the Abstract which states the sleeve will fill space between the screw any hole into which it is placed, and Figure 8 showing the implant for filling a defect in bone), the implant comprising:
a proximal and distal end with the distal end outer diameter being less than the outer diameter of the proximal end so the proximal end is flared (Figure 5 item 10a) and is capable of contacting a surface of a bone (as was noted above, this is an “intended use” of the proximal end, which the flared proximal end of Jones is capable of doing if positioned thereadjacent),
the shape being a truncated cone or cannulated truncated cone (Figure 5 item 10a). Ganey and Jones are involved in the same field of endeavor, namely space filling bone growth promoting implant structures. It would have been obvious to one of ordinary skill at the time the invention was filed to modify the material of Ganey by forming it into any shape required by a bone defect or bone implant, including that as is disclosed by Jones, in order to apply the novel inventive DBFs of Ganey towards bone-defect filling structures to help enhance their bone growth (Ganey [0005]-[0006]).
Further, regarding claim 21 Kale teaches a bone implant which includes a proximal end having depression across the proximal end for receiving a screw ([0074] Figure 1a item 31; the depression (beveled edge/chamfer) is an indent in the proximal end edge/diameter which receives the screw, acts as a lead in, helps in locating the screw and assists in starting the screw). Ganey and Kale are involved in the same field of endeavor, namely bone repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of the Ganey Jones Combination (or the Ganey Schlachter Jones Combination) so that the proximal end of the implant comprises an depression as is taught by Kale in order to have the depression act as a lead in, help in locating the screw, and assists in starting the screw.
Regarding claims 22 and 27 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Combination) teaches the implant of claim 21 substantially as is claimed,
wherein Kale further teaches that bone screw implants can have a length between 3-10 cm ([0008] 10-60 mm (1-6 cm). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the dimensions of the implant of the Ganey Jones Kale (or the Ganey Schlachter Jones Kale) Combination so that it has a length between 3-10 cm as is taught by Kale since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art. The obviousness of tailoring the dimensions of the implant towards a particular desired size to work with a screw is considered within the grasp of the person of ordinary skill.
Regarding claims 23-24 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) teaches the implant of claim 21 substantially as is claimed,
wherein Ganey further discloses the cut fibers have a fiber length between 3-4 cm ([0010]).
Regarding claims 25-26 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) teaches the implant of claim 21 substantially as is claimed,
wherein Kale further teaches an implant has a diameter of or between 2-5 mm ([0050]-[0051], [0057] tube with a diameter of 2 mm). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the dimensions of the implant of the Ganey Jones Kale (or Ganey Schlachter Jones Kale) Combination so that it has a diameter of 2-5 mm as is taught by Kale since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art. The obviousness of tailoring the dimensions of the implant towards a particular desired size to work with a screw is considered within the grasp of the person of ordinary skill.
Regarding claims 28-29 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) teaches the implant of claim 21 substantially as is claimed,
wherein Kale further teaches an implant which includes a volume of or between about 0.15 cm3 up to 2 cm3 (see at least [0008], [0050]-[0051], [0055], [0057], [0059], etc. Tube volume equals length of the implant times pi times (outer radius - inner radius)2 and the values given for the implant dimensions fall within the claimed ranges). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the volume of the implant of the Combination so that it occupies the volume taught by Kale since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art. In this case, the Examiner understands the volume of the implant (and any of its dimensions) can be modified based on the intended location of implantation and desired intended use.
Regarding claim 30 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) teaches the implant of claim 21 substantially as is claimed,
but is silent with regards to the volume of the cut DBFs.
However, regarding claim 30 Kale teaches an implant which includes a volume of or between about 0.15 cm3 up to 2 cm3 (see at least [0008], [0050]-[0051], [0055], [0057], [0059], etc. Tube volume equals length of the implant times pi times (outer radius - inner radius)2 and the values given for the implant dimensions fall within the claimed ranges). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the volume of the implant of the Combination so that it occupies the volume taught by Kale since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art. In this case, the Examiner understands the volume of the implant (and any of its dimensions) can be modified based on the intended location of implantation and desired intended use.
Regarding claim 31 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) teaches the implant of claim 30 substantially as is claimed,
wherein Kale further teaches an outer flared diameter of one end of the implant being of or between 2-7 mm ([0050]-[0051], [0057] tube with a diameter of 2 mm and flare that is 5 mm (e.g. flare diameter of 7 mm)).
Regarding claim 32 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) teaches the implant of claim 21 substantially as is claimed,
wherein Ganey further discloses the implant further comprises mineralized bone fibers added to the plurality of cut DBF ([0009]).
Regarding claims 34-35 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) teaches the implant of claim 21 substantially as is claimed,
wherein Ganey further discloses the implant includes hydroxyapatite added to the cut DBFs (Ganey claims 24-25).
Claim 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganey, (Schlachter,) Jones, and Kale as is applied above, further in view of Scarborough et al. (US 20180263779 A1) hereinafter known as Scarborough.
Regarding claim 33 the Ganey Jones Combination (or the Ganey Schlachter Jones Combination) teaches the implant of claim 21 substantially as is claimed,
but is silent with regards to including bone chips to the cut DBF.
However, regarding claim 33 Scarborough teaches a bone implant comprising cancellous or cortical bone chips and/or demineralized cancellous or cortical bone chips added to a plurality of cut demineralized bone fibers ([0005]). Ganey and Scarborough are involved in the same field of endeavor, namely bone implant compositions. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the material of the composition of the Ganey Jones Combination (or the Ganey Schlachter Jones Combination) so that it includes cancellous/cortical bone such as is taught by Scarborough since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07.
Claims 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganey, Jones, and Kale as is applied above.
Regarding claim 36 Ganey discloses a bone-defect space filling ([0002]) structure capable of swelling from hydration ([0011] the demineralized bone fibers are lyophilized, or freeze dried, which inherently renders them capable of swelling if hydrated) comprising:
a plurality of cut demineralized bone fibers (DBFs) having a fiber length of or between 1-30 cm,
wherein the cut DBFs are combed together to form a mass of cut DBFs entangled with each other and arranged into a shape (see the rejection to claim 21 above), and
wherein the mass of cut DBFs is processed by a molding process or wet lay process into a shape (this is stated as a product-by-process limitation. See the explanation in the rejection to claim 21 above. See also [0079] molding) with a ratio of fluid to DBF in a range of or between 3-20 mL fluid to 1 gram DBF (This remains part of the product-by-process limitation, and the ratio of fluid to DBFs is not understood to effect the final structure of the implant. However/alternatively, see also Ganey [0098] which teaches a ratio of 3 mL fluid to 1g bone, which indicates a known ratio of fluid to bone for injection), and a proximal end contacting the surface of the bone (this appears to be an intended location Applicant intends the proximal end to be located, as opposed to structurally affecting the implant itself. Please see the rejection in claim 21 above related to “intended use” statements.);
but is silent with regards to the shape of the bone-defect filling structure and whether or not it includes a depression.
However, regarding claim 36 Jones teaches an implant for enhancing fixation of a screw in repair of a bone (this is stated as a functional limitation (see the explanation in the rejection to claim 21 above). See also Jones’s Abstract, Column 3 lines 41-44) the implant comprising:
a flared proximal and distal end, with the distal end outer diameter being less than the outer diameter of the flared proximal end (Figure 5 item 10a) to form a truncated cone or cannulated truncated cone (Figure 5 item 10a) and the proximal end is capable of contacting a surface of a bone (as was noted above, this is an “intended use” of the proximal end, which the flared proximal end of Jones is capable of doing if positioned thereadjacent). Ganey and Jones are involved in the same field of endeavor, namely space filling bone growth promoting implant structures. It would have been obvious to one of ordinary skill at the time the invention was filed to modify the material of Ganey by forming it into any shape required by a bone defect or bone implant, including that as is disclosed by Jones, in order to apply the novel inventive DBFs of Ganey towards bone-defect filling structures to help enhance their bone growth (Ganey [0005]-[0006]).
Further, regarding claim 36 Kale teaches a bone implant which includes a proximal end having a depression for receiving a screw ([0074] Figure 1a item 31; the depression (beveled edge/chamfer) is an indent in the proximal end edge/diameter which receives the screw, acts as a lead in, helps in locating the screw and assists in starting the screw), and the implant having an implant which includes a volume of or between about 0.15 cm3 up to 10 cm3 (see at least [0008], [0050]-[0051], [0055], [0057], [0059], etc. Tube volume equals length of the implant times pi times (outer radius - inner radius)2 and the values given for the implant dimensions fall within the claimed ranges). Ganey and Kale are involved in the same field of endeavor, namely bone implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of the Ganey Jones Combination so that the proximal end of the implant comprises an indent as is taught by Kale in order to have the indent act as a lead in, help in locating the screw, and assists in starting the screw. Further, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the volume of the implant of the Combination so that it occupies the volume taught by Kale since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art. In this case, the Examiner understands the volume of the implant (and any of its dimensions) can be modified based on the intended location of implantation and desired intended use.
Regarding claim 37 the Ganey Jones Kale Combination teaches the implant of claim 36 substantially as is claimed,
wherein Ganey further discloses each of the plurality of cut DBFs have a fiber length of or between 1-4 cm ([0010]),
and wherein Kale further teaches a bone implant which includes an outer flared diameter of one end of the implant being of or between 2-7 mm ([0050]-[0051], [0057] tube with a diameter of 2 mm and flare that is 5 mm (e.g. flare diameter of 7 mm)). Ganey and Kale are involved in the same field of endeavor, namely bone repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of the Ganey Jones Kale Combination so that the proximal end of the implant comprises dimensions as is taught by Kale since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art.
Claim 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganey, (Schlachter,) Jones, and Kale as is applied above, further in view of Castro (US 20090177239 A1).
Regarding claim 38 the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) teaches the implant of claim 21 substantially as is claimed (see the rejection above),
but is silent with regards to a kit including the implant and an awl.
However, regarding claim 38 Castro teaches wherein surgical kits for orthopedic bone repair include awls ([0030]). Ganey and Castro are involved in the same field of endeavor, namely bone repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of the Ganey Jones Kale Combination (or the Ganey Schlachter Jones Kale Combination) so that it is a kit including an awl as is taught by Castro in order to provide a tool which enables preparation of the bone into which the implant is being implanted, thus ensuring all required tools are available at the time surgery starts.
Regarding claims 39-40 the Ganey Jones Kale Castro Combination (or the Ganey Schlachter Jones Kale Castro Combination) teaches the kit of claim 38 substantially as is claimed,
wherein Jones further teaches a screw (Figure 6 item 16),
and wherein the Combination further teaches the guide wire or awl are disposable (the Examiner notes anything is disposable if it is thrown out).
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 11/05/25