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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-3) in the reply filed on 17 August 2026 is acknowledged.
Examiner notes that the remaining claims (Claims 4-25) subject to the restriction requirement dated 14 July 2026 have been cancelled by applicant, and that new claims 26-45 have been added to further define the methods associated with claim 1.
Information Disclosure Statement
The information disclosure statement(s) (IDS) was/were filed on 26 November 2026. The submissions are in compliance with the provisions of 37 CFR 1.97, and therefore are considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, recitations of the placement of alignment members relative to a patient must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. This is applicable to claim 1 (“… second alignment member in a second plane and relative to a patient”), claim 26 (at least “placing a first component…supporting a first alignment member relative to a patient”), and claim 38 (at least “…supporting a second alignment member relative to a patient”).
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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.
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.
Claims 1-3 and 26-45 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0190722 A1 by David L. Windt (herein after “Windt”) in view of US 2022/0304750 A1 by Shaw P. Wan (herein after “Wan”).
Regarding claim 1, Windt discloses a method (Windt title – alignment method), comprising:
placing a first component supporting a first alignment member in a first plane (Windt fig. 3c and [0032] discloses an attenuating metal grid 313 [first component] located at a particular position in the xy plane [first plane], where the first metal grid 313 has a pattern of open spaces 403 [first alignment member] seen in fig. 4 [first component supports first alignment member in a first plane]) and a second component supporting a second alignment member in a second plane (Windt fig. 3c and [0032] discloses a second attenuating metal grid 314 [second component] located at a particular position in the xy plane but separated at a distance in the z-axis from the first metal grid 313 [second plane], where the second metal grid 314 has a separate pattern of open spaces 404 [second alignment member], also seen in fig. 4 [second component supports second alignment member in second plane]); and
aligning a fluoroscopic device with an anatomical plane using the first and second alignment members to thereby locate and communicate a position in 3D space when viewed under fluoroscopy so that the first and second alignment members appear as a single alignment member when the fluoroscopic device is aligned with the anatomical plane (Windt [0034] discloses a method of alignment of the grids with an X-ray beam [aligning a fluoroscopic device]; [0036] discloses the presence of an imaging plane of the X-ray imaging system, as is well known to one of ordinary skill – as the X-ray imaging device is used in a variety of human medical environments (i.e. mammography), the imaging plane of the x-ray imaging system is considered “an anatomical plane”; [0035] discloses positional information of the grids relative to one another is obtainable by detecting at least the X-ray beam, and each grid has a known position [communicate a position in 3D space when viewed under fluoroscopy]; [0032] recites equations for the length and width requirements for the slots in the bottom and top grids with respect to the distance of each grid to the X-ray focal spot, in order for the alignment grids to appear as a single alignment member – as the image plane of the X-ray imaging device serves as the anatomical plane, a successful alignment would result in the first and second alignment members appearing as a single element so long as the members are being aligned with respect to the X-ray imaging device).
Windt is silent to a component supporting an alignment member in a plane relative to a patient.
However, Wan does address this limitation. Windt and Wan are considered to be analogous to the present invention because they relate to alignment devices and methods for radiography or fluorography imaging systems.
Wan discloses “a component supporting an alignment member in a plane relative to a patient” (Wan [0058] and figs. 19-20 disclose an alignment device and method where two grids are aligned with one another (in the case of [0058] a proximal grid 20 and distal grid 30) via fluoroscopic radiography, where the grids are aligned to guide placement of a needle within a patient; [0042] recites that grid 80 is alternatively used to facilitate placement of introductory needle into the patient; figs 19-20 show the grid 80 supporting [0051] one or more radiopaque grid lines 89 [alignment members]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate a component supporting an alignment member in a plane relative to a patient as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 2, Windt when modified by Wan discloses the method of claim 1, and Windt further teaches the method wherein aligning the fluoroscopic device with the anatomical plane includes viewing the first and second alignment members under fluoroscopy (Windt [0034] recites the alignment of the first and second metal attenuation grids 313 and 314 with respect to the X-ray beam [viewing first and second alignment members under fluoroscopy – i.e. under X-ray beam emission]; [0036] also recites a similar alignment method with respect to both an X-ray source and a visible source, but recites explicitly taking X-ray images and translating the metal attenuation grids 313/314 to align the grids successfully).
Regarding claim 3, Windt when modified by Wan discloses the method of claim 1, and Windt further teaches the method wherein the first and second alignment members have a complementary shape when the fluoroscopic device is aligned with the anatomical plane (Windt fig. 4 shows the patterns within the metal attenuation grids 313 and 314 with pattern 403 [first alignment member] and pattern 404 [second alignment member] which have complementary shapes, and thus would also have complementary shapes when the fluoroscopic device is aligned with the anatomical plane).
Regarding claim 26, Windt discloses a method for aligning a fluoroscopic device with an anatomical plane (Windt title and abstract discloses a method and device for an X-ray optical alignment system for an X-ray imaging device [method for aligning a fluoroscopic device]; [0036] discloses the presence of an imaging plane of the X-ray imaging system, as is well known to one of ordinary skill, where the imaging plane here is considered “an anatomical plane”), comprising:
placing a first component having a first body supporting a first alignment member (Windt fig. 3c and [0032] discloses an attenuating metal grid 313 comprising a square body [first component, having a first body] located at a particular position, where the first metal grid 313 has a pattern of open spaces 403 [first alignment member] seen in fig. 4 [first component having a first body supports first alignment member]);
placing a second component having a second body supporting a second alignment member, the first alignment member separated from the second alignment member (Windt fig. 3c and [0032] discloses a second attenuating metal grid 314 comprising a square body [second component, having a second body] located at a particular position separated at a distance in the z-axis from the first metal grid 313, where the second metal grid 314 has a separate pattern of open spaces 404 [second alignment member], also seen in fig. 4 [second component having a second body supports a second alignment member]);
viewing the first and second alignment members under fluoroscopy (Windt [0034] and [0036] discloses the alignment of the first and second metal attenuation grids 313 and 314 with respect to X-ray beam, and recites taking X-ray images of the metal attenuation grids 313/314 [viewing the first and second alignment members under fluoroscopy]); and
aligning the fluoroscopic device with the anatomical plane based on an appearance of the first and second alignment members when viewed under fluoroscopy (Windt [0036] recites translating the grids 313/314 to align the grids successfully based on the obtained X-ray images of the grids 313/314 based on their appearance in the images, where the fluoroscopic device is aligned with the anatomical plane, as defined above [aligning the fluoroscopic device based on an appearance of the first and second alignment members when viewed under fluoroscopy]).
Windt is silent to placing a first component relative to a patient, and placing a second component relative to a patient.
However, Wan does address this limitation. Windt and Wan are considered to be analogous to the present invention because they relate to alignment devices and methods for radiography or fluorography imaging systems.
Wan discloses “placing a first component relative to a patient, and placing a second component relative to a patient” (Wan [0058] and figs. 19-20 disclose an alignment device and method where two grids are aligned with one another (in the case of [0058] a proximal grid 20 and distal grid 30) via fluoroscopic radiography, where the grids are aligned to guide placement of a needle within a patient; [0042] recites that grid 80 is alternatively used to facilitate placement of introductory needle into the patient; figs 19-20 show the grid 80 supporting [0051] one or more radiopaque grid lines 89 [alignment members])).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate placing a first component relative to a patient, and placing a second component relative to a patient as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 27, Windt when modified by Wan discloses the method of claim 26, and Windt further teaches the method wherein the fluoroscopic device is properly aligned with the anatomical plane when the first and second alignment members appear as a single alignment member when viewed under fluoroscopy (Windt [0032] recites equations for the length and width requirements for the slots in the bottom and top grids with respect to the distance of each grid to the X-ray focal spot, in order for the alignment grids to appear as a single alignment member).
Regarding claim 28, Windt when modified by Wan discloses the method of claim 26. Windt is silent to the method of claim 26, wherein the first and second alignment members are formed from radiopaque material.
However, Wan does address this limitation.
Wan discloses the method of claim 26, “wherein the first and second alignment members are formed from radiopaque material” (Wan [0051] and figs. 19-20 disclose that the grid lines 89, seen both in each grid 80 where the grid lines 89 are perpendicular to each other [first and second alignment members] are radiopaque grid lines [formed from radiopaque material]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate wherein the first and second alignment members are formed from radiopaque material as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 29, Windt when modified by Wan discloses the method of claim 28. Windt is silent to the method of claim 28, wherein the first body and the second body are formed from a radiolucent material such that the first body and the second body are at least partially invisible when viewed under fluoroscopy.
However, Wan does address this limitation.
Wan discloses the method of claim 28, “wherein the first body and the second body are formed from a radiolucent material such that the first body and the second body are at least partially invisible when viewed under fluoroscopy” (Wan [0050] discloses that in addition to the radiopaque markings within distal grid 30 (or alternatively the grid 80, shown in figs 19-20), there are adjustable radiolucent grooves distributed between; [0044] also discloses that grids 20 and 30 (alternatively grid 80) are formed from soft rubber or rigid plastic – one of ordinary skill recognizes that plastics and rubbers are inherently radiolucent and would thereby appear at least partially invisible when viewed under fluoroscopy [first body and second body, which support the first/second alignment members at least partially formed from a radiolucent material]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate wherein the first body and the second body are formed from a radiolucent material such that the first body and the second body are at least partially invisible when viewed under fluoroscopy as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 30, Windt when modified by Wan discloses the method of claim 29. Windt is silent to the method of claim 29 wherein the radiolucent material includes at least one of a polymer, PEEK, ABS, or nylon.
However, Wan does address this limitation.
Wan discloses the method of claim 29 wherein the radiolucent material includes at least one of a polymer, PEEK, ABS, or nylon (Wan [0044] discloses the use of soft rubber and/or rigid plastic for construction materials of the grids 20 and 30 (or alternatively grid 80, see figs. 19-20) [soft rubber and rigid plastics being examples of polymers]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate wherein the radiolucent material includes at least one of a polymer, PEEK, ABS, or nylon as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 31, Windt when modified by Wan discloses the method of claim 28, and Windt further teaches the method wherein the radiopaque material includes at least one of titanium or tantalum (Windt [0033] discloses the metal attenuation grids [first and second components] are made of a tantalum sheet – as the attenuation grids of Windt are x-ray attenuating as are the radiopaque grids of Wan, it would be obvious to construct the radiopaque material of Wan consistent with that of Windt, namely tantulum).
Regarding claim 32, Windt when modified by Wan discloses the method of claim 26, and Windt further teaches the method wherein a shape of the first alignment member is the same as a shape of the second alignment member (Windt fig. 4 shows the X-ray attenuation grids 313 and 314 having a grid shape, which are substantially the same shape).
Regarding claim 33, Windt when modified by Wan discloses the method of claim 32, and Windt further teaches the method wherein the first alignment member and the second alignment member each have a circular shape (Windt [0032] discloses alternatives for the grid patterns shown in fig. 4, including concentric circular shapes).
Regarding claim 34, Windt when modified by Wan discloses the method of claim 32, and Windt further teaches the method wherein a dimension of the first alignment member is the same as a dimension of the second alignment member (Windt [0033] discloses that the patterned alignment grids are fabricated into tantalum sheets of 0.5mm in thickness – this indicates that the thickness of the sheets and therefore the thickness of the first/second alignment members are equal, and therefore a dimension of the first alignment member is the same as a dimension of the second alignment member).
Regarding claim 35, Windt when modified by Wan discloses the method of claim 26, and Windt further teaches the method wherein the first and second alignment members have different complementary shapes (Windt [0032] discloses alternatives for the grid patterns shown in fig. 4, including a bulls eye with concentric circular slot, i.e. a crosshair pattern within a circular slot forming the bulls eye [first and second alignment members have different complementary shapes]).
Regarding claim 36, Windt when modified by Wan discloses the method of claim 35, and Windt further teaches the method wherein the first alignment member has a circular shape and the second alignment member includes a crosshair dimensioned to correspond to the circular shape of the first alignment member (as with claim 35 above, Windt [0032] discloses alternatives for the grid patterns shown in fig. 4, including a bulls eye with concentric circular slot, i.e. a crosshair pattern within a circular slot forming the bulls eye [first alignment member has circular shape with second alignment member comprising a crosshair corresponding to the circular shape of the first alignment member]).
Regarding claim 37, Windt when modified by Wan discloses the method of claim 35, and Windt further teaches the method wherein the first alignment member has a circular shape and the second alignment member is a dot sized to fill an opening of the circular shape of the first alignment member (Windt [0032], consistent with the above claims 35-36 which have disclosed alternatives to the grid patterns shown in fig. 4 comprising at least concentric circular slots, a prima facie case of obviousness exists for the second alignment member being a dot sized to fill the opening of the first alignment member under MPEP §2144.04 IV. A. Changes in Shape, as the function of the grids for alignment is unchanged by the shape of the pattern, so long as the features between the first and second alignment members correspond to one another – Windt discloses such that there is “great flexibility in the choice of the pattern of openings formed in the grids”).
Regarding claim 38, Windt discloses a method for verifying alignment of a fluoroscopic device relative to an anatomical plane (Windt title and abstract discloses a method and device for an X-ray optical alignment system for an X-ray imaging device [method for aligning a fluoroscopic device – a “verification of alignment” is inherent within a method for alignment]; [0036] discloses the presence of an imaging plane of the X-ray imaging system, as is well known to one of ordinary skill, where the imaging plane here is considered “an anatomical plane”), comprising:
placing a first component supporting a first alignment member (Windt fig. 3c and [0032] discloses an attenuating metal grid 313 [first component] located at a particular position, where the first metal grid 313 has a pattern of open spaces 403 [first alignment member] seen in fig. 4 [first component having a first body supports first alignment member]) and a second component supporting a second alignment member (Windt fig. 3c and [0032] discloses a second attenuating metal grid 314 [second component] located at a particular position separated at a distance in the z-axis from the first metal grid 313, where the second metal grid 314 has a separate pattern of open spaces 404 [second alignment member], also seen in fig. 4 [second component supports a second alignment member]), the first alignment member separated from the second alignment member (Windt fig. 3c and [0032], as disclosed above, the first/second metal grids 313/314 are separated by a distance in the z-axis);
viewing the first and second alignment members under fluoroscopy (Windt [0034] and [0036] discloses the alignment of the first and second metal attenuation grids 313 and 314 with respect to X-ray beam, and recites taking X-ray images of the metal attenuation grids 313/314 [viewing the first and second alignment members under fluoroscopy]); and
identifying a misalignment between the fluoroscopic device and the anatomical plane when both the first alignment member and the second alignment member are separately visible under fluoroscopy (Windt [0036] recites translating the grids 313/314 to align the grids successfully based on the obtained X-ray images of the grids 313/314 based on their appearance in the images, where the fluoroscopic device is aligned with the anatomical plane, as defined above [aligning the fluoroscopic device based on an appearance of the first and second alignment members when viewed under fluoroscopy]; the alignment apparatus and method require the grids satisfy dimensional requirements relative to one another so that the pattern is sensitive to misalignments in orthogonal directions x and y [identifying a misalignment between the fluoroscopic device and anatomical plane]; one of ordinary skill recognizes the result of misalignment between the grids 313/314 being the patterns being separately visible under fluoroscopy (and not appearing as a single alignment member)).
Windt is silent to a method for verifying alignment of a fluoroscopic device relative to an anatomical plane of a patient, comprising:
positioning a first component and a second component relative to a patient, and the first and second alignment members formed from a radiopaque material.
However, Wan does address this limitation. Windt and Wan are considered to be analogous to the present invention because they relate to alignment devices and methods for radiography or fluorography imaging systems.
Wan discloses “a method for verifying alignment of a fluoroscopic device relative to an anatomical plane of a patient, comprising:
positioning a first component and a second component relative to a patient” (Wan [0058] and figs. 19-20 disclose an alignment device and method where two grids are aligned with one another (in the case of [0058] a proximal grid 20 and distal grid 30) via fluoroscopic radiography, where the grids are aligned to guide placement of a needle within a patient; [0042] recites that grid 80 is alternatively used to facilitate placement of introductory needle into the patient; figs 19-20 show the grid 80 supporting [0051] one or more radiopaque grid lines 89 [alignment members]), “and the first and second alignment members formed from a radiopaque material” (Wan [0051] and figs. 19-20 disclose that the grid lines 89, seen both in each grid 80 where the grid lines 89 are perpendicular to each other [first and second alignment members] are radiopaque grid lines [formed from radiopaque material]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate a method for verifying alignment of a fluoroscopic device relative to an anatomical plane of a patient, comprising: positioning a first component and a second component relative to a patient, and the first and second alignment members formed from a radiopaque material as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 39, Windt when modified by Wan discloses the method of claim 38, and Windt further teaches the method further comprising determining that the fluoroscopic device is aligned with the anatomical plane when the first and second alignment members appear as a single alignment member when viewed through fluoroscopy (Windt [0032] recites equations for the length and width requirements for the slots in the bottom and top grids with respect to the distance of each grid to the X-ray focal spot, in order for the alignment grids to appear as a single alignment member).
Regarding claim 40, Windt when modified by Wan discloses the method of claim 38, and Windt further teaches the method wherein the first component includes a first body and the second component includes a second body (Windt fig. 3c and [0032] discloses attenuating metal grid 313 comprising a square body [first component having a first body] and attenuating metal grid 314 comprising a square body [second component having a second body]).
Windt is silent to the method of claim 38, wherein the first component includes a first body formed from a radiolucent material and the second component includes a second body formed from a radiolucent material such that the first and second bodies are at least partially invisible when viewed under fluoroscopy.
However, Wan does address this limitation.
Wan discloses the method of claim 38 “wherein the first component includes a first body formed from a radiolucent material and the second component includes a second body formed from a radiolucent material such that the first and second bodies are at least partially invisible when viewed under fluoroscopy” (Wan [0050] discloses that in addition to the radiopaque markings within distal grid 30 (or alternatively the grid 80, shown in figs 19-20), there are adjustable radiolucent grooves distributed between; [0044] also discloses that grids 20 and 30 (alternatively grid 80) are formed from soft rubber or rigid plastic – one of ordinary skill recognizes that plastics and rubbers are inherently radiolucent and would thereby appear at least partially invisible when viewed under fluoroscopy [first body and second body, which support the first/second alignment members at least partially formed from a radiolucent material]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate wherein the first component includes a first body formed from a radiolucent material and the second component includes a second body formed from a radiolucent material such that the first and second bodies are at least partially invisible when viewed under fluoroscopy as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 41, Windt when modified by Wan discloses the method of claim 38, and Windt further teaches the method wherein a radiopacity of the first alignment member is different from a radiopacity of the second alignment member (Windt within claim 38 has disclosed the grids 313/314 being constructed by radiopaque materials – while Windt does not disclose a difference in radiopacity between the first and second alignment members, the radiopacity of the first and second alignment members being different from one another is obvious in light of MPEP §2143 I. E. “Obvious to Try”; for a case where the radiopacity of the first and second alignment members is the same, deviations in the alignment of the first and second components may not be easily recognizable, but in a case where the radiopacity differs, the amount of deviation from alignment may be viewable in the obtained fluoroscopic images, thereby yielding a predicable solution for fluoroscopic alignment with a reasonable expectation of success).
Regarding claim 42, Windt when modified by Wan discloses the method of claim 38, and Windt further teaches the method wherein the first component and the second component are respective portions of a common device selected from a prosthesis, a fixture, or a jig (Windt figs. 3c, 5, and [0034] disclose the grids 313/314 [first and second components] being fixed to an alignment grid mounting bracket assembly [common device] comprising mounting bracket side plate 310 [a fixture]).
Regarding claim 43, Windt when modified by Lalena discloses the method of claim 38. Windt is silent to the method of claim 38, wherein at least one of the first alignment member and the second alignment member is embedded within a body of the respective first or second component.
However, Wan does address this limitation.
Wan discloses the method of claim 38, “wherein at least one of the first alignment member and the second alignment member is embedded within a body of the respective first or second component” (Wan [0051] discloses that the radiopaque grid lines 89 are located within the body of each grid 80 [first and second alignment members embedded within their respective components]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate wherein at least one of the first alignment member and the second alignment member is embedded within a body of the respective first or second component as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 44, Windt when modified by Wan discloses the method of claim 38. Windt is silent to the method of claim 38, wherein at least one of the first alignment member and the second alignment member is affixed to a surface of the respective first or second component using an adhesive or a mechanical coupling.
However, Wan does address this limitation.
Wan discloses the method of claim 38, “wherein at least one of the first alignment member and the second alignment member is affixed to a surface of the respective first or second component using an adhesive or a mechanical coupling” (Wan [0051] discloses that the radiopaque grid lines 89 [first/second alignment members corresponding to the respective grids 80] are formed on the body of each grid; while an explicit recitation of mechanical or adhesive coupling is not recited within Wan, the limitation is found obvious in light of MPEP §2143 I. D, as the application of a mechanical or adhesive coupling is well known in the art to achieve coupling (i.e. applying a known technique to yield predictable results); examiner notes that a method for attaching the grid 30 (alternatively 80) itself to a surface via adhesive is disclosed by Wan, providing further evidence for the yielding of a predictable result).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Windt to incorporate wherein at least one of the first alignment member and the second alignment member is affixed to a surface of the respective first or second component using an adhesive or a mechanical coupling as suggested by Wan for the advantage of utilizing radiopaque markings to improve placement accuracy of any surgical interventions with respect to the patient (Wan [0003], [0054]), (i.e. prosthesis alignment in the case of the claimed invention).
Regarding claim 45, Windt when modified by Wan discloses the method of claim 38, and Windt further teaches the method wherein the first and second components each include plural alignment members (Windt fig. 3c shows that each attenuation grid 313/314 has a grid pattern supported by the square body; a single alignment member here is considered as a single rectangle of length L and width W, where any other rectangle which makes up the grid is indicative of the first and second components including plural alignment members), and wherein at least one alignment member is disposed in a first plane and at least one alignment member is disposed in a second plane different from the first plane (Windt fig. 3c, and addressed in claim 38, discloses that the attenuation grids 313/314 are separated by a distance in the z-direction; therefore, at least one alignment member is disposed in a first plane within 313 and a second alignment member is disposed in a second plane within 314).
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 1-3, 26-28, 32-34, 37-38, 41, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-8, and 10-14 of U.S. Patent No. 12,196,856 B2 (herein after “ ‘856 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, all the limitations of claim 1 are taught by claims 1 and 11 of the ‘856 patent.
Regarding claim 2, all the limitations of claim 2 are taught by claims 1 and 12 of the ‘856 patent.
Regarding claim 3, all the limitations of claim 3 are taught by claims 7 and 14 of the ‘856 patent.
Regarding claim 26, all the limitations of claim 26 are taught by claims 1 and 11 of the ‘856 patent. Examiner notes that the recitation of “a first component having a first body” and “a second component having a second body” does not result in the claims being patentably distinct given the entirety of claim 11.
Regarding claim 27, all the limitations of claim 27 are taught by claim 13 of the ‘856 patent.
Regarding claim 28, all the limitations of claim 28 are taught by claim 5 of the ‘856 patent. The recitation within claim 5 of the “radiopacity of the two or more first alignment members [being] different from a radiopacity of the two or more second alignment members” inherently contains the “first and second alignment members [being] formed from a radiopaque material”, as instantly claimed.
Regarding claim 32, all the limitations of claim 32 are taught by claim 3 of the ‘856 patent.
Regarding claim 33, all the limitations of claim 33 are taught by claim 8 of the ‘856 patent.
Regarding claim 34, all the limitations of claim 34 are taught by claim 4 of the ‘856 patent.
Regarding claim 37, all the limitations of claim 37 are taught by claim 10 of the ‘856 patent.
Regarding claim 38, all the limitations of claim 38 are taught by claim 5 of the ‘856 patent. While instant claim 38 recites differences including “identifying a misalignment between the fluoroscopic device and the anatomical plane when both the first alignment member and the second alignment member are separately visible”, examiner notes that the alignment system of claim 5 inherently contains the ability to identify a misalignment, as the system of ‘856 patent claim 5 is configured to “provide an indication that a fluoroscopic device is properly aligned”. Regarding the “radiopaque material”, the same reasoning applies as described with respect to claim 28.
Regarding claim 41, all the limitations of claim 41 are taught by claim 5 of the ‘856 patent. See discussion of claim 28 with respect to “radiopacity”.
Regarding claim 45, all the limitations of claim 45 are taught by claim 1 of the ‘856 patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA M CARLSON whose telephone number is (571)270-0065. The examiner can normally be reached Mon-Fri. 8:00AM - 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur R Chowdhury can be reached at (571) 272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA M CARLSON/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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