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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/3/2024 and 6/19/2025 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "164" (in Figs. 1 and 15) and "168" (in Figs. 17-20 and 22) have both been used to designate the shaft “tip”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 6 is 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.
Claim 6 recites the limitation "the insert-receiving space" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 7-8, 12 and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McCue (US 5,788,701).
McCue discloses (see Figs. 2 and 7) a system for knee arthroplasty comprising the following claim limitations:
(claim 1) A system for a knee arthroplasty (see Abstract), the system comprising: a tibial tray (56, Fig. 7) having a pair of posterior notches (i.e., lip of rim 57 shown engaged at both prongs 55) and an anterior notch (i.e., lip of rim 57 shown engaged at groove 49) (as expressly shown in Fig. 7); and an inserter (11, Fig. 2) having a main body (54, Fig. 7) with a pair of posterior tabs (55, Fig. 7), a moveable anterior tab body (59, Fig. 7) having an anterior tab (49, Fig. 7), and a rotatable shaft (53, Fig. 7) for controlling movement of the anterior tab body (59) (as shown in Fig. 7; col. 4, line 64-col. 5, line 30), wherein the posterior tabs (55) are receivable in the posterior notches (at 57) of the tibial tray (56) and the anterior tab (49) is receivable in the anterior notch (at 49) of the tibial tray (56) when the shaft (53) is rotated (as shown in Fig. 7; col. 4, line 64-col. 5, line 30);
(claim 2) wherein the tibial tray (56) has a kidney-bean shape with an anterior side forming an outer convex side (i.e., adjacent lower groove 49) and a posterior side including an inner concave side separating two lobes (i.e., two lobes shown adjacent the two prongs 55) (as shown in Fig. 7);
(claim 7) An inserter instrument (11, Fig. 2) for implanting a tibial tray (56, Fig. 7), the instrument comprising: a main body (54, Fig. 7) coupled to a handle (11, Fig. 2) (col. 4, line 64-col. 5, line 30), the main body (54) including a pair of posterior tabs (55, Fig. 7); a moveable anterior tab body (59, Fig. 7), the anterior tab body (59) including an anterior tab (49, Fig. 7); and a rotatable shaft (53) for controlling movement of the anterior tab body (59) (as shown in Fig. 7; col. 4, line 64-col. 5, line 30), wherein when the shaft (53) is rotated, the anterior tab body (59) is translated outside the main body (54) into a locked position (as shown in Fig 7; col. 4, line 64-col. 5, line 30; rotation of shaft 53 expressly moves anterior tab body 59 outside of and away from the main body 54 to lock the tibial tray 56);
(claim 8) wherein the main body (54) includes a foot with a neck protruding upwardly and an arm protruding anteriorly (as shown in annotated Fig. 7 below);
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(claim 12) wherein the anterior tab body (59) includes a base (i.e., bottom surface) with an upwardly projecting tongue (i.e., frame extending upward from the bottom base surface), and the tongue defines a threaded opening (i.e., for receiving shaft 53) (as expressly shown in annotated Fig. 7 below); and
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(claim 14) wherein the anterior tab (49) is positioned along an anterior portion of the base, wherein the anterior tab (49) extends along the entire width of the anterior tab body (59) (as shown in annotated Fig. 7 under claim 12 above).
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zappacosta et al. (US 2022/0061998).
Zappacosta discloses (see Figs. 1-3 and 18-19) a system for knee arthroplasty comprising the following claim limitations:
(claim 1) A system for a knee arthroplasty (see Abstract), the system comprising: a tibial tray (10, Fig. 1) having a pair of posterior notches (at 24, Fig. 1) and an anterior notch (at convex portion of wall 20 shown adjacent edge 18 and recess 26 in Fig. 1 for mating with mounting insert 1228 of Fig. 18; [0064]) (as shown in annotated Fig. 1 below); and an inserter (1200, Fig. 18) having a main body (1212, Fig. 18) with a pair of posterior tabs (see annotated Fig. 19 below), a moveable anterior tab body (1226/1228, Fig. 19) having an anterior tab (1228, Fig. 19), and a rotatable shaft (1230, Fig. 18) for controlling movement of the anterior tab body (1226/1228) (as shown in Fig. 18; [0064]-[0065]; shaft 1230 expressly rotates about axis of rotation AR which moves the anterior tab body since it is attached to shaft 1230), wherein the posterior tabs are receivable in the posterior notches (24) of the tibial tray (10) and the anterior tab (1228) is receivable in the anterior notch of the tibial tray (10) when the shaft (1230) is rotated (as shown in Figs. 18-19; [0064]-[0065]; mounting inserts 1226/1228 are expressly resiliently biased away from each other to resiliently engage the perimeter wall 20 of the implant 10 at the posterior and anterior notches);
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(claim 2) wherein the tibial tray (10) has a kidney-bean shape with an anterior side forming an outer convex side and a posterior side including an inner concave side separating two lobes (i.e., two lobes at two posterior notches 24) (as shown in annotated Fig. 1 below);
(claim 3) wherein the tibial tray (10) includes a keel (28, Fig. 1) attached to a distal surface of the tibial tray (10) (as shown in Figs. 1-3), and the keel (28) includes a pair of coronal fins (30, Figs. 2-3) and at least one sagittal fin (32, Figs. 2-3); and
(claim 4) wherein the main body (1212) of the inserter (1200) includes a foot (1216, Fig. 19) with a neck (1224, Fig. 19) protruding upwardly and an arm (1230, Fig. 19) protruding anteriorly, wherein the foot (1216) is bifurcated by a keyway (i.e., the gap depicted between 1226 and 1228 in Fig. 19), and the anterior tab body (1228) is receivable in the keyway (i.e., the gap depicted between 1226 and 1228 in Fig. 19) ([0064]-[0065]; anterior tab body 1228 and insert 1226 are both resilient and deformable towards each other into the keyway during insertion into the receiving space 22 and recesses 24, and then resiliently biased away from each other out of the keyway to engage the outer wall 20).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over McCue as applied to claim 1 above, and further in view of Zappacosta et al. (US 2022/0061998).
McCue, as applied above, discloses a system for knee arthroplasty comprising all the limitations of the claim except for the tibial tray including a keel attached to a distal surface of the tibial tray, and the keel includes a pair of coronal fins and at least one sagittal fin.
However, Zappacosta teaches (see Figs. 16-17) a similar system for knee arthroplasty comprising a tibial tray (12) including a keel (128) attached to a distal surface of the tibial tray (12), and the keel (128) includes a pair of coronal fins (130) and at least one sagittal fin (132) (as shown in Figs. 16-17) in order to beneficially improve and facilitate insertion of the tibial implant without any or minimal prior bone preparation ([0061]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of McCue to have a tibial tray including a keel attached to a distal surface of the tibial tray, and the keel includes a pair of coronal fins and at least one sagittal fin in order to beneficially improve and facilitate insertion of the tibial implant without any or minimal prior bone preparation, as taught by Zappacosta.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over McCue as applied to claim 7 above, and further in view of Overes et al. (US 2017/0266015).
McCue, as applied above, discloses a system for knee arthroplasty comprising all the limitations of the claim except for wherein the threaded opening is a triple lead threaded hole, and the shaft includes a triple lead shaft configured to interface with the triple lead threaded hole to increase translation speed of the anterior tab body.
However, Overes teaches (see Figs. 8a-8b) an implant inserter instrument (1) wherein the threaded opening (18) is a triple lead threaded hole ([0104]; [0111]), and the shaft (70) includes a triple lead shaft ([0111]) configured to interface with the triple lead threaded hole (18) to increase translation speed of the anterior tab body 40 ([0104]; [0111]) in order to beneficially provide a more efficient configuration that facilitates a larger translation per turn ([0104]; [0111]; triple lead configuration expressly taught to facilitate a larger translation per turn). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inserter of McCue to incorporate the threaded opening being a triple lead threaded hole, and the shaft includes a triple lead shaft configured to interface with the triple lead threaded hole to increase translation speed of the anterior tab body in order to beneficially provide a more efficient configuration that facilitates a larger translation per turn.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over McCue as applied to claim 7 above, and further in view of Maudlin (US 5,732,992).
McCue, as applied above, discloses a system for knee arthroplasty comprising all the limitations of the claim except for wherein the handle includes an elongate body that terminates distally at a threaded end, wherein the threaded end mates with corresponding threads in the main body.
However, Mauldin teaches (see Figs. 3-5) an inserter for a knee prosthesis wherein the handle (60) includes an elongate body that terminates distally at a threaded end (as best seen in Fig. 5), wherein the threaded end mates with corresponding threads in the main body (46) (as shown in Fig. 3) in order to beneficially provide for simplicity of manufacture and assembly wherein a practitioner’s hand never needs to move to effect the grasping and release motions (col. 6, lines 9-29; col. 7, lines 39-45). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle of the inserter of McCue to incorporate the handle including an elongate body that terminates distally at a threaded end, wherein the threaded end mates with corresponding threads in the main body in order to beneficially provide for simplicity of manufacture and assembly wherein a practitioner’s hand never needs to move to effect the grasping and release motions.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zappacosta as applied to claim 1 above, and further in view of Metzger et al. (US 2019/0269422) and Ghijselings (US 2010/0241126).
Zappacosta, as applied above, discloses a system for knee arthroplasty comprising all the limitations of the claim except for wherein the inserter includes a plurality of plugs press fit into the main body, wherein the plurality of plugs protrude from a bottom of the main body, thereby ensuring the main body does not contact the insert receiving space of the tibial tray.
However, Metzger discloses (see Figs. 47-48B) instrumentation and implants for knee surgery ([0002]) and teaches wherein the inserter (530) includes a plurality of plugs (532) in the main body (534), wherein the plurality of plugs (532) protrude from a bottom of the main body (534), thereby ensuring the main body (534) does not contact the insert receiving space of the tibial tray (as shown in Fig. 47; [0103]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the main body of the inserter of Zappacosta to incorporate the inserter including a plurality of plugs, wherein the plurality of plugs protrude from a bottom of the main body, thereby ensuring the main body does not contact the insert receiving space of the tibial tray, in order for the inserter to only contact the tibial tray at the contact surface of the plugs ([0103]).
Metzger fails to teach wherein the plugs are press-fit to the main body and instead discloses where the plugs and main body are integral (as shown in Fig. 47). While Metzger teaches that the plugs and main body are integral, it would have been obvious to one having ordinary skill in the art at the time the invention was made to design the plugs as press fit into the main body, since it has been held that designing a feature of an apparatus to be integral or modular is ordinary routine practice (MPEP (2141(I))).
Zappacosta also fails to disclose wherein the inserter includes a plurality of plugs press fit into the anterior tab body. However, Ghijselings discloses (see Figs. 7-8) devices for knee arthroplasty (see Abstract) and teaches wherein the inserter (26) includes a plurality of plugs (23/23’) press fit into the anterior tab body (as shown in Figs. 7-8). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inserter of Zappacosta to incorporate the inserter including a plurality of plugs press-fit into the anterior tab body, in order to fix the position and orientation of the inserter relative to the tibial plate ([0047]).
Claims 7-10, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zappacosta et al. (US 2022/0061998) in view of McCue (US 5,788,701).
Zappacosta discloses (see Figs. 1-3 and 18-19) a system for knee arthroplasty comprising the following claim limitations:
(claim 7) An inserter instrument (1200, Fig. 18) for implanting a tibial tray (1010, Fig. 18), the instrument comprising: a main body (1212, Fig. 18) coupled to a handle (1202, Fig. 18), the main body (1212) including a pair of posterior tabs (see annotated Fig. 19 under claim 1 above); a moveable anterior tab body (1226/1228, Fig. 19), the anterior tab body including an anterior tab (1228, Fig. 19) (as shown in Figs. 18-19; [0064]-[0065]; mounting inserts 1226/1228 are expressly resiliently biased away from each other to resiliently engage the perimeter wall 20 of the implant 10 at the posterior and anterior notches);
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(claim 8) wherein the main body (1212) includes a foot (1216, Fig. 19) with a neck (1224, Fig. 19) protruding upwardly and an arm (1230, Fig. 19) protruding anteriorly (inserter 1200 is free to be held with the neck extending upward and the arm extending anteriorly);
(claim 9) wherein the foot (1216) has an outer kidney-bean shape (as shown in Fig. 19);
(claim 10) wherein the foot (1216) is bifurcated by a keyway (i.e., the gap depicted between 1226 and 1228 in Fig. 19), and the anterior tab body (1226/1228) is receivable in the keyway (i.e., the gap depicted between 1226 and 1228 in Fig. 19) ([0064]-[0065]; anterior tab body 1228 and insert 1226 are both resilient and deformable towards each other into the keyway during insertion into the receiving space 22 and recesses 24, and then resiliently biased away from each other out of the keyway to engage the outer wall 20);
(claim 12) wherein the anterior tab body (1226/1228) includes a base with an upwardly projecting tongue (at 1216) (as shown in Fig. 19, portion/tongue 1216 projects upward from the anterior tab body 1226/1228); and
(claim 14) wherein the anterior tab (1228) is positioned along an anterior portion of the base (as expressly shown in Fig. 19), wherein the anterior tab (1228) extends along the entire width of the anterior tab body (1226/1228) (as shown in Fig. 19; [0064]-[0065]; mounting insert 1228 is expressly resiliently biased away from opposed mounting insert 1226 to resiliently engage the perimeter wall 20 of the implant 10).
Zappacosta, as applied above, discloses a system for knee arthroplasty comprising all the limitations of the claim except for a rotatable shaft for controlling movement of the anterior tab body, wherein when the shaft is rotated, the anterior tab body is translated outside the main body into a locked position.
However, McCue teaches (see Figs. 2 and 7) a similar knee arthroplasty inserter comprising a rotatable shaft (53, Fig. 7) for controlling movement of the anterior tab body (59, Fig. 7), wherein when the shaft (53) is rotated, the anterior tab body (59) is translated outside the main body (54, Fig. 7) into a locked position (as shown in Fig 7; col. 4, line 64-col. 5, line 30; rotation of shaft 53 expressly moves anterior tab body 59 outside of and away from the main body 54 to lock the tibial tray 56). Accordingly, McCue teaches that it is known that translating an anterior tab body to engage the perimeter of a tibial tray via either a resilient tab material having an outward resilient bias or a threaded shaft providing incremental rotational translation are elements that are functional equivalents for providing translation of an anterior tab body to engage the perimeter of a tibial tray. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the threaded shaft taught by McCue for the resilient tab material of Zappacosta because both elements were known equivalents for providing translation of an anterior tab body to engage the perimeter of a tibial tray within the knee arthroplasty art. The substitution would have resulted in the predictable results of providing translation of an anterior tab body to engage the perimeter of a tibial tray to the device of Zappacosta.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zappacosta as applied to claim 7 above, and further in view of Overes et al. (US 2017/0266015).
Zappacosta, as applied above, discloses a system for knee arthroplasty comprising all the limitations of the claim except for wherein the threaded opening is a triple lead threaded hole, and the shaft includes a triple lead shaft configured to interface with the triple lead threaded hole to increase translation speed of the anterior tab body.
However, Overes teaches (see Figs. 8a-8b) an implant inserter instrument (1) wherein the threaded opening (18) is a triple lead threaded hole ([0104]; [0111]), and the shaft (70) includes a triple lead shaft ([0111]) configured to interface with the triple lead threaded hole (18) to increase translation speed of the anterior tab body 40 ([0104]; [0111]) in order to beneficially provide a more efficient configuration that facilitates a larger translation per turn ([0104]; [0111]; triple lead configuration expressly taught to facilitate a larger translation per turn). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inserter of Zappacosta to incorporate a threaded opening in the form of a triple lead threaded hole, and the shaft includes a triple lead shaft configured to interface with the triple lead threaded hole to increase translation speed of the anterior tab body in order to beneficially provide a more efficient configuration that facilitates a larger translation per turn.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Zappacosta as applied to claim 7 above, and further in view of Maudlin (US 5,732,992).
Zappacosta, as applied above, discloses a system for knee arthroplasty comprising all the limitations of the claim except for wherein the handle includes an elongate body that terminates distally at a threaded end, wherein the threaded end mates with corresponding threads in the main body.
However, Mauldin teaches (see Figs. 3-5) an inserter for a knee prosthesis wherein the handle (60) includes an elongate body that terminates distally at a threaded end (as best seen in Fig. 5), wherein the threaded end mates with corresponding threads in the main body (46) (as shown in Fig. 3) in order to beneficially provide for simplicity of manufacture and assembly wherein a practitioner’s hand never needs to move to effect the grasping and release motions (col. 6, lines 9-29; col. 7, lines 39-45). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle of the inserter of Zappacosta to incorporate the handle including an elongate body that terminates distally at a threaded end, wherein the threaded end mates with corresponding threads in the main body in order to beneficially provide for simplicity of manufacture and assembly wherein a practitioner’s hand never needs to move to effect the grasping and release motions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,903,845. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 11,903,845
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5-10
9
6
10
5-10
11
5-10
12
7-9
13
8
14
9
15
10
Allowable Subject Matter
Claims 5 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is noted that claims 5 and 11 remain subject to double patenting rejections, as set forth above, that must be resolved before these claims can be rewritten into independent form for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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