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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 12/12/2025. As directed by the amendment: claim 60 has been amended, no additional claims have been cancelled, no new claims have been added, and claims 69 and 71 remain withdrawn from consideration as being drawn to a nonelected species. Thus, claims 60-68, 70 and 72-78 are presently examined in the current Office Action.
Priority
It is to be noted that, according to the current most Filing Receipt dated 04/19/2024, this application has a priority date of 02/18/2021, which is the filing date of application 17/178,271 (US Patent No. 11,877,932), from which this current application is a continuation of. If there is an error in this current Filing Receipt, dated 04/19/2024, Applicant is advised to submit a written request for a corrected Filing Receipt, including a properly marked-up ADS showing the changes with strike-through for deletions and underlining for additions; when the request has been processes, the USPTO will generate another Filing Receipt incorporating the requested corrections provided that the request is grantable.
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 medical device comprising an artificial caput femur surface, having first and second sections; a fixating member; a fixed stabilizing member, extending from said fixating member perpendicular to a longitudinal extension of said medical device; wherein said fixating member is adapted to be positioned on the collum femur (claim 65), the medical device as described in claim 60, wherein said stabilizing part of the collum femur is the proximal half of the collum femur (claim 66), the medical device comprising an artificial caput femur surface, having first and second sections; a fixating member; a fixed stabilizing member, extending from said fixating member perpendicular to a longitudinal extension of said medical device; and a material, specifically comprising a bone cement, an at least partly elastic material, glue, adhesive, antibiotic, biocompatible plastic material, biocompatible ceramics, and/or biocompatible metal, placed between the fixating member and said cortical bone of said stabilizing part of the collum femur (claims 72 and 73), the medical device as described in claim 60, wherein said stabilizing part, of the collum femur, being adapted to connect to the outside of collum femur surface least on two opposite sides thereof (claim 74), the medical device comprising an artificial caput femur surface, having first and second sections; a fixating member; a fixed stabilizing member, extending from said fixating member perpendicular to a longitudinal extension of said medical device; wherein the artificial caput femur comprises a caput femur surface area, and said artificial caput femur surface comprises an artificial caput femur surface area, and wherein said artificial caput femur surface area is smaller than the caput femur surface area (claim 75), the medical device comprising an artificial caput femur surface, having first and second sections; a fixating member; a fixed stabilizing member, extending from said fixating member perpendicular to a longitudinal extension of said medical device; and said fixating member further comprises a mechanical connection adapted to mechanically connect to said cortical bone of said stabilizing part of the collum femur on the inside thereof (claim 76), the medical device comprising an artificial caput femur surface, having first and second sections; a fixating member; a fixed stabilizing member, extending from said fixating member perpendicular to a longitudinal extension of said medical device; and said fixating member further comprises a mechanical connection adapted to mechanically, and indirectly, connect to said cortical bone of said stabilizing part of the collum femur on the inside thereof (claim 77), and the medical device comprising an artificial caput femur surface, having first and second sections; a fixating member; a fixed stabilizing member, extending from said fixating member perpendicular to a longitudinal extension of said medical device; and said fixating member further comprises a mechanical connection adapted to mechanically connect to said cortical bone of said stabilizing part of the collum femur on the outside thereof (claim 78) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
*** It is to be noted that in the response dated 12/12/2025, Applicant states that “Each element recited in the claims is illustrated and corresponds directly to the described embodiments”; however, does not point to any specific figures, and/or to specific structure in the figure of the current embodiment to support the assertion; thus, the drawing objections still stand.
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.
Examiner’s Notes
Applicant is reminded that the currently pending claims are device/apparatus claims; thus, only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
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 § 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 61-65 and 72-78 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 61-64, it is unclear what additional structural limitations are imparted by the parameters of these claims to the final structure of the claimed medical device; the parameters of all the claims merely seem to be reciting intended use/functional language and/or limitations directed towards the body, however, none of the claims actually set forth any additional limitations (structural limitations) directed toward the final structure of the claimed invention of “the medical device”. Furthermore, the intended use/functional language seems to be directed towards the body, i.e. the collum femur, and does not seem to directly, or indirectly, impart any additional structure/structural limitations towards 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 claims indefinite.
Regarding claim 65, it is unclear what additional structural limitation is imparted by the parameter of this claim to the final structure of the claimed medical device; the parameter merely seems to be reciting intended use/functional language, however does not include any structural limitation(s) to the final structure of the claimed invention which would be needed in order to mee the intended use/functional language. Additionally, the actual the intended use/function is found to be confusing, since it is not clear how exactly the fixating member can be “positioned on the collum femur”. 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 66, it is unclear what additional structural limitation is imparted by the parameter of this claim to the final structure of the claimed medical device; in fact, the parameter is only directed towards the body, i.e. structure of the collum femur, and does not directly, or indirectly, impart any additional structure/structural limitations towards 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 claims indefinite.
Regarding claim 72, it is unclear if the parameter of this claim relates to/is part of the final structure of the claimed invention of the “medical device”; specifically, is “a material” part of the final structure of the medical device, or is it just a random material which is used with, but not part of, the final structure of the claimed invention. It is to be noted that judging from the parameter(s) of claim 73, which depends from claim 72, it seems the “material” is not a structure which is part of the final structure of the claimed medical device. Applicant is reminded that only the claimed structure of the final device bears patentable weight; additional components/materials which are able to be used with the claimed final device are not part of the claimed invention, and are given consideration to the extent that they may further define the claimed structure of the final device. 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 74, it is unclear what additional structural limitation is imparted by the parameter of this claim to the final structure of the claimed medical device; in fact, the parameter is only directed towards the body, i.e. structure of the collum femur, and does not directly, or indirectly, impart any additional structure/structural limitations towards 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 claims indefinite.
Regarding claim 75, which recites the limitation “the artificial caput femur”, on lines 1-2; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is also unclear what exactly the structure of “the artificial caput femur” is, and/or how exactly it relates to the final structure of the claimed medical device. Furthermore, the parameter set forth in this claim is found to be confusing and doesn't seem to make sense; firstly it is not clear what exactly the structural difference is between the caput femur surface area (which is the surface area of the artificial caput femur, as set forth on lines 1-2 of this claim) and the artificial caput femur surface area, both these limitations/terms seem to be directed towards the same structure. Secondly, it is unclear how the same structure/surface area can be smaller, have any type of different size/area, than itself. 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 76, which sets forth the parameter of “said fixating member further comprises a mechanical connection adapted to mechanically connect to said cortical bone of said stabilizing part of the collum femur on the inside thereof” (emphasis added); however, this parameter is found to be confusing for a few reasons. Firstly, it is unclear what exact structure “a mechanical connection” entails, secondly, it is unclear how exactly the structure of the “mechanical connection” relates to the final structure of the claimed invention/the medical device, and thirdly, it is unclear if the structure of the “mechanical connection” even actually relates to the final structure of the claimed invention, or if it is merely a material/structure which is used with the claimed invention, to connect to the inside of the collum femur, but is not actually part of the final structure if the claimed invention/the medical device. Moreover, the originally filed disclosure does not aid in clarifying, either by detail/explanation in the specification or by illustration in any of the figures, what exactly the structure of “a mechanical connection” is, and/or how it relates to the claimed invention. Additionally, it is also unclear how exactly this parameter would lead to a different final structure of the claimed medical device than the parameter set forth in claim 78. 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 77, which sets forth the parameter of “said mechanical connection is adapted to indirectly connect to said cortical bone of said stabilizing part of the collum femur on the inside thereof” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by “adapted to indirectly connect”. Specifically, it is unclear how a structure could/would be able to “indirectly” connect something, not to mention it is unclear what said structure is. Furthermore, the originally filed specification does not aid in explaining, or clarifying, what kind/type of mechanical connection would be capable of indirectly connecting the medical device/fixating member to the inside of the collum femur, and/or what exact structure this type of mechanical connection would have. 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 78, which sets forth the parameter of “said fixating member further comprises a mechanical connection adapted to mechanically connect to said cortical bone of said stabilizing part of the collum femur on the outside thereof” (emphasis added); however, this parameter is found to be confusing for a few reasons. Firstly, it is unclear what exact structure “a mechanical connection” entails, secondly, it is unclear how exactly the structure of the “mechanical connection” relates to the final structure of the claimed invention/the medical device, and thirdly, it is unclear if the structure of the “mechanical connection” even actually relates to the final structure of the claimed invention, or if it is merely a material/structure which is used with the claimed invention, to connect to the inside of the collum femur, but is not actually part of the final structure if the claimed invention/the medical device. Moreover, the originally filed disclosure does not aid in clarifying, either by detail/explanation in the specification or by illustration in any of the figures, what exactly the structure of “a mechanical connection” is, and/or how it relates to the claimed invention. Additionally, it is also unclear how exactly this parameter would lead to a different final structure of the claimed medical device than the parameter set forth in claim 76. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 66 and 74 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Both claims 66 and 74 only recite structure/limitations directed towards the body, i.e. “wherein said stabilizing part of the collum femur is the proximal half of the collum femur” (claim 66), and “wherein said stabilizing part is adapted to connect to the outside of collum femur surface at least on tow opposite sides thereof” (claim 74).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 60-68, 70,72, 73 and 76-78 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tarabishy (US PG Pub. 2003/0060889), as previously disclosed.
Regarding claims 60-68 and 70, Tarabishy discloses a medical device (10), illustrated in Figures 1,2 and 6-11, for implantation in a hip joint for providing a joint surface ([0052], Lines 1-7), wherein said medical device (10) comprises an artificial caput femur surface (70) adapted to be in contact with an artificial acetabulum surface (16), and a fixating member (114) adapted to be positioned in/on a collum femur to at least partly be stabilized by a cortical bone of a proximal half of the collum femur, illustrated in Figure 26, and a fixed stabilizing member (142) extending from said fixating member (114) perpendicular to a longitudinal extension of said medical device configured to stabilize the medical device from movement when implanted, illustrated in Figures 2, 23 and 26 ([0069]), and wherein the medical device/artificial caput femur surface (70) comprises a first section and a second section (72a-e) being displaceable, in situ, in relation to each other so as to allow the artificial caput femur surface to be inserted through a smaller hole in a femoral bone than if it was not divided into said first and second sections, wherein said first and second sections (72a-e) of the artificial caput femur surface (70) are structured to enable a sliding relation to each other, wherein in a locking position, are substantially locked at least in all directions except the sliding direction, and are positioned in a functional/predefined position inside of the hip joint such that said medical device can function as a hip joint surface, illustrated in Figures 6-11 and 26 ([0054]; [0062]; [0065]; [0080]; [0081] & [0082]).
Regarding claims 72, 73, 76 and 77, Tarabishy discloses the medical device according to claim 60, wherein said fixating member (114) further comprises a mechanical connection/material adapted to indirectly connect to said cortical bone of the collum femur on the inside thereof, wherein said mechanical connection/material is bone cement ([0068], Lines 30-39).
Regarding claim 78, Tarabishy discloses the medical device according to claim 60, wherein said fixating member (114) further comprises a mechanical connection (138) adapted to mechanically connect to said cortical bone of the collum femur on the outside thereof, illustrated in Figures 1, 2 and 26 (it is to be noted the mechanical connection/screw 138 is inserted from the outside of the collum femur through cortical bone).
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive. Applicant argues the rejection of claim 60 as being unpatentable over the prior art of Tarabishy stating that the limitation of a fixed stabilizing member configured to stabilize the medical device from movement when implanted is not taught since Tarabishy discloses that surgical screws (138) are used to stabilize the device, and further also states that the “artificial caput femur part of the device does not comprise a first and a second section adapted to be displaceable in relation to each other”. Examiner respectfully disagrees with Applicant’s assertions. The fixed stabilizing member (142), of the device of Tarabishy, clearly meets the structural and intended use/functional limitations of “a fixed stabilizing member” as set forth in the claim. Specifically, Tarabishy teaches a fixed stabilizing member (142) extending from said fixating member (114) perpendicular to a longitudinal extension of said medical device, illustrated in Figures 2, 23 and 26; additionally, Tarabishy states that the fixed stabilizing member/shield (142) has legs (144) which, once the device is implanted, “engage the corner of the cortical bone” at the edge of the thru-hole which the device/fixating member is placed through, illustrated in Figures 23 and 26 ([0069]). Thus, the fixed stabilizing member/shield (142) is “configured to”, i.e. has the physical/structural ability to, meet the intended use/functional language of “stabilize the medical device from movement when implanted”, and therefore meets the claimed limitation. Additionally, Tarabishy also teaches the artificial caput femur (70) comprising a first section and a second section (72a-e) being displaceable in relation to each other, as illustrated in Figures 6-11 and detailed at least in paragraphs [0062], [0065] and [0081]. Hence, the rejection of independent claim 60 as being unpatentable over the prior art of Tarabishy is deemed to be proper since all the structural limitations set forth in the claim are taught; therefore, the rejection stands.
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.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/18/2026