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 .
Status of Claims
This office action is responsive to the amendment filed on 05/30/2024. As directed by the amendment, claims 1-28 have been cancelled and new claims 29-48 have been added; thus, claims 29-48 are presently pending in this application, and currently examined in the Office Action.
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, the cap component having a recess designed to protect zones with critical blood supply during preparation and/or implantation (claim 39), and the endoprosthesis comprising an insert component having an anti-rotation and/or anti-translation element arranged on a facing surface which faces the first bone joint part, wherein the an anti-rotation and/or anti-translation element has the form of a tooth (claim 48) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claim 46 sets forth that the second metal of the insert component (which is the base material of the insert component according to claim 44, from which claim 46 depends; specifically claim 44 sets forth “a second base material of the insert component includes a second metal”) “comprises titanium particles, and wherein the titanium particles are applied using titanium plasma spray coating process”; however this parameter was never disclosed or suggesting in the originally filed specification. Specifically, the originally filed specification never sets forth that a second base material of the insert component includes a second metal which comprises titanium particles, and wherein the titanium particles are applied using titanium plasma spray coating process.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29-48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 29 and 43, which set forth the parameter of “the cap component and/or a first base material of the cap component having a modulus of elasticity that is about equal to bone material of the associated bone joint part”, on lines 4-5 of claim 29 and lines 9-11 of claim 43; however, this parameter is found to be confusing for a couple reasons. Firstly, the term “about” is a relative term which renders the claims indefinite since the term is not defined by the claims, and the specification does not provide a standard for ascertaining the requisite degree. Therefore, it is unclear what exactly the metes and bounds of the limitation of “about equal” would be. Secondly, it is unclear what exactly is meant by the modulus of elasticity of associated bone material, specifically, which part/type of bone, i.e. cancellous or cortical, and/or the modulus measure in what direction/form, compression, bending, in an axial direction, or a lateral direction; and since there is no clarification, a modulus of elasticity of associated bone material can be very broad/vary greatly. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claims indefinite.
Regarding claim 31, the parameter(s) set forth in the claim are found to be confusing for multiple reasons. Firstly, will all the optionality, i.e. recitation of “and/or”, it is unclear what exact structure/material would be needed in order to meet the claim. Secondly, line 2 sets forth the limitation of “a second material”, however does not give any clarity and/or detail as to what exact structure this second material belongs to, and/or how it relates to the claimed invention of “a cap component”. Thirdly, it is not clear what additional structural limitation(s) is/are imparted, on the final structure of claimed invention of “a cap component”, by the parameters of “a metal alloy of a second base material of an insert component slidingly cooperating with the cap component” and “wherein the metal alloy includes titanium, iron, chromium, cobalt, or any combination thereof”, since they are directed to a non-claimed invention/device, and do not hold patentable weight. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination, as can best be gleaned from the originally filed disclosure, claim 31 shall be interpreted as “the first base material of the cap component is softer than titanium, iron, chromium, cobalt, or any combination thereof”.
Regarding claim 38, it is unclear what, if any, additional structural limitation(s) is/are imparted by the parameter of this claim on the final structure of the claimed invention/cap component. The parameter set forth in the claim seems to merely recite functional language, however, neither the claim nor the originally filed specification, disclose/set forth any additional structure which would be needed in order to meet said functional language. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 39, which sets forth the parameter of “the cap component has a recess designed to protect zones with critical blood supply during preparation and/or implantation”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the cap component having “recess designed”. Does “a recess designed” mean there is a recess in one, or both, of the surfaces of the cap component, or is there a recess that goes entirely through from one surface to the other surface of the cap component, or is it a term for the overall shape/form of the cap component, and if so, what exact shape/from would this be; and it is to be noted that the originally filed disclosure does not aid in defining or clarifying what exactly, structurally, is meant by the cap component having “a recess designed”. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 45, which recites the limitation “the metal oxide”, on line 2; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what exactly this “metal oxide” is, and/or how it relates to the final structure of the claimed invention. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 46, which depends from claim 44 which sets forth the parameter of “a second base material of the insert component includes a second metal”, and claim 46 further sets forth the parameter of “wherein the second metal of the insert component comprises titanium particles, and wherein the titanium particles are applied using titanium plasma spray coating process”; however, this parameter is found to be confusing since it is not clear how exactly the base material of the second insert could comprise titanium particles which are applied using titanium plasma spray coating process. Additionally, the originally filed disclosure does not aid in clarifying, illustrating, or explaining said parameter; in fact, the originally filed specification is completely silent regarding such a parameter. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
It is also to be noted that the invention of claims 29-42 is “A cap component”, and only the claimed final structure of the cap component bears patentable weight; any limitation(s) directed towards other structure(s)/devices shall be considered to the extent that it/they further define(s) the claimed final structure of the invention, i.e. the “cap component”.
It is further to be noted that many of the claims have optionality language, i.e. “and/or” language, which can be found to be confusing as to what exact structure is being claimed/would be needed in order to meet the claim.
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 29-31, 33-35 and 42-45 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Zhu et al. (US PG Pub. 2018/0028321), as disclosed in the IDS dated 09/09/2024, hereinafter Zhu, or, in the alternative, under 35 U.S.C. 103 as obvious over Liao et al. (Polyetheretherketone and Its Composites for Bone Replacement and Regeneration; Polymers; 2020; pgs.1-48), hereinafter Liao, and Wu et al. (Young's modulus of trabecular bone at the tissue level: A review; Acta Materialia Inc. Published by Elsevier Ltd.; 2018; pgs.1-12), hereinafter Wu.
Regarding claims 29, 30 and 33-35, Zhu discloses a cap component (100), illustrated in Figures 2-4, comprising a convex sliding surface (111); the cap component (100) being designed to enclose part or all of an associated bone joint part; a first base material (113), of the cap component, comprising a plastic, specifically PEEK, having a modulus of elasticity that is about equal to bone material of the associated bone joint part, specifically less than 10 GPa; a facing surface (112) of the cap component facing the associated bone joint part being at least partially coated with a first metal (116); and the cap component (100) having an anti-rotation element (120), in the form of a bar/bollard/anchoring pin, arranged on the facing surface (112) facing the associated bone joint part, illustrated in Figures 2-4 (Zhu:[0028]; [0032]; [0035] & [0036]). It is to be noted that it is known in the art, and iterated by Liao, that PEEK has an modulus of elasticity less than 10 GPa, specifically 3.7-4GPa (Liao: Abstract); and further known in the art, and iterated by Wu, that that the modulus of elasticity of bone material of the associated bone joint part, i.e. a femoral head, is about equal to that of PEEK, i.e. modulus of elasticity of a femoral head is 3.47±0.41 (Wu: Table 2), which is about equal to that of PEEK, as taught by Liao.
Regarding claim 31, Zhu in view of Liao and Wu disclose the cap component of claim 29, wherein Zhu and Liao further teach the first base material (113)/PEEK of the cap component is softer than a second metal, specifically titanium, iron, chromium, cobalt, and/or alloys of them (Zhu: [0028]; [0036] & Liao: Pg.2, Lines 12-13).
Regarding claim 42, Zhu in view of Liao and Wu disclose the cap component of claim 29, wherein Zhu further teaches the facing surface (112) of the cap component (100) is spherical on a first side of an equator of the cap component, and deviates from being spherical on a second side of the equator of the cap component, illustrated in Figures 1-3.
Regarding claims 43 and 44, Zhu discloses an endoprosthesis, illustrated in Figure 1, comprising an insert component (200) designed to be inserted into/replace a first bone joint part of a first bone, having a sliding surface (201), illustrated in Figure 5, and a cap component (100), illustrated in Figures 2-4, for a second bone joint part of a second bone, including a sliding surface (111); the cap component (100) being designed to enclose part or all of the second bone joint part; a first base material (113)/PEEK, of the cap component, having a modulus of elasticity that is about equal to bone material of the second bone joint part; and a facing surface (112) of the cap component facing the second bone joint part being at least partially coated (116) with a first metal, a facing surface (203) of the insert component (200) facing the first bone joint part is coated (204) with the first metal, and wherein the sliding surface (201) of the insert component (200) is in sliding contact with the sliding surface (111) of the cap component (100), illustrated in Figures 1-5 (Zhu:[0028]; [0032]; [0035]; [0036] & [0039]). It is to be noted that it is known in the art, and iterated by Liao, that PEEK has an modulus of elasticity of 3.7-4GPa (Liao: Abstract); and further known in the art, and iterated by Wu, that that the modulus of elasticity of bone material of the second bone joint part, i.e. a femoral head, is about equal to that of PEEK, i.e. modulus of elasticity of a femoral head is 3.47±0.41 (Wu: Table 2), which is about equal to that of PEEK, as taught by Liao.
Regarding claim 45, Zhu in view of Liao and Wu disclose the endoprosthesis according to claim 43, wherein Zhu and Liao further teach the first base material (113)/PEEK, of the cap component, is softer than a second metal/metal alloy of the insert component, i.e. Ti/Ti alloy (Zhu: [0028]; [0036]; [0039] & Liao: Pg.2, Lines 12-13).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Liao and Wu as applied to claim 29 above, and further in view of Fonte et al. (US Patent No. 9,155,819), hereinafter Fonte.
Regarding claim 32, Zhu in view of Liao and Wu disclose the cap component of claim 29, wherein Zhu teaches the first metal includes titanium, used to fix the implant by facilitating integration between the implant and bone (Zhu: [0035]); but does not specifically disclose the titanium includes particles applied using a titanium plasma spray coating process.
However, Fonte teaches that it is well known in the art to form porous coatings, on an orthopedic device surface, of titanium particles by a plasma spray coating process, in order to improve performance/osteointegration of the implant (Column 2, Lines 23-30 & 49-53).
In view of the teachings of Fonte, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first metal titanium, of the cap component of Zhu in view of Liao and Wu, to comprise titanium particles applied by a plasma spray coating process, since such a process is well known in the art as a way to coat surfaces of orthopeic implants, in order to improve performance/osteointegration of the implant, as taught by Fonte.
Claims 36, 37, 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Liao and Wu as applied to claims 34 and 43 above, and further in view of Steinberg (US PG Pub. 2005/0085915).
Regarding claims 36 and 37, Zhu in view of Liao and Wu disclose the cap component of claim 34, but do not specifically teach the cap component having an anti-translation element on the facing surface.
However, Steinberg teaches a cap component (1900), in the same field of endeavor, having an anti-translation element (1906), in the form of a groove/recess, arranged on a facing surface (1904) to face associated bone/femoral head, illustrated in Figures 9A-9C; the anti-translation element (1906) allowing for a snap-fit engagement with the associated bone/femoral head ([0396]).
In view of the teachings of Steinberg, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the facing surface, of the cap component of Zhu in view of Liao and Wu, to have an anti-translation element, in the form of a groove/recess, arranged on the facing surface to face associated bone/femoral head, in order to provide a snap-fit engagement with the associated bone/femoral head, as taught by Steinberg.
Regarding claims 47 and 48, Zhu in view of Liao and Wu disclose the endoprosthesis according to claim 43, but do not specifically teach the insert component having an anti-rotation/anti-translation element arranged on a facing surface of the insert component facing the first bone joint part.
However, Steinberg teaches an insert component (1500), in the same field of endeavor, having an anti-rotation/anti-translation element (1507), in the form of a cavity/recess, arranged on a facing surface (1504) to face bone, illustrated in Figures 5A-5C; the anti-rotation/anti-translation element (1507) allowing for a snap-fit engagement with associated bone ([0377]).
In view of the teachings of Steinberg, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for a facing surface, of the insert component of Zhu in view of Liao and Wu, to have an anti-rotation/anti-translation element, in the form of a cavity/recess, arranged thereon to face the first bone joint part, in order to provide a snap-fit engagement with the first bone joint part, as taught by Steinberg.
Claims 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Liao and Wu as applied to claim 29 above, and further in view of Muratoglu et al. (US PG Pub. 2014/0128988), hereinafter Muratoglu.
Regarding claim 39, Zhu in view of Liao and Wu disclose the cap component of claim 29, but do not specifically disclose the cap component has a recess designed to protect zones with critical blood supply during preparation and/or implantation.
However, Muratoglu teaches a cap component (64), in the same field of endeavor, having a recess design/contoured geometry to protect zones with critical blood supply during preparation/implantation, and thereby avoiding tissue impingement, illustrated in Figure 10 ([0206]).
In view of the teachings of Muratoglu, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the cap component, of Zhu in view of Liao and Wu, to have a recess design/contoured geometry to protect zones with critical blood supply during preparation/implantation, and thereby avoiding tissue impingement, as taught by Muratoglu.
Regarding claims 40 and 41, Zhu in view of Liao and Wu disclose the cap component of claim 29, wherein Zhu teaches the sliding surface (111) of the cap component (100) is spherical on a first side of an equator of the cap component, illustrated in Figures 2-4; but does not teach the sliding surface of the cap component deviating/tapering from being spherical on a second side of the equator, such that the sliding surface has two different radii.
However, Muratoglu teaches a cap component (64), in the same field of endeavor, having a sliding surface which is spherical on a first side of an equator of the cap component and deviated/tapered from being spherical on a second side of the equator, such that the sliding surface has two different radii (R on the first side & r on the second side), illustrated in Figure 10, such a shape/geometry minimizes overhang of the cap component (64) beyond native articular surface, thereby reducing the potential for soft-tissue impingement ([0206]).
In view of the teachings of Muratoglu, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the sliding surface, of the cap component of Zhu in view of Liao and Wu, to be spherical on a first side of an equator of the cap component and deviated/tapered from being spherical on a second side of the equator, such that the sliding surface has two different radii, in order to minimize overhang of the cap component beyond native articular surface, thereby reducing the potential for soft-tissue impingement, as taught by Muratoglu.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DINAH BARIA/Primary Examiner, Art Unit 3774 07/09/2026
Prosecution Insights