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 10/14/2025. As directed by the amendment: claims 1, 2, 5-7, 9, 13-15 and 17-19 have been amended, no additional claims have been cancelled and no new claims have been added. Thus, claims 1-9 and 11-19 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 prosthesis wherein the second attachment member is configured to be secured directly to a side of os metacarpale II on a surface of the os metacarpale II, and also being an intramedullary rod configured for intramedullary insertion into the medullary cavity of os metacarpale II (claim 6), the prosthesis wherein the second attachment member is configured to be secured directly to a side of os metacarpale II on a surface of the os metacarpale II, and also being a curved intramedullary rod, with a curvature corresponding with the curvature of a medullary cavity of os metacarpale II, and configured for intramedullary insertion into the medullary cavity of os metacarpale II (claim 7), and the prosthesis wherein the second attachment member is configured to be secured directly to a side of os metacarpale II on a surface of the os metacarpale II, and also being an intramedullary rod configured for intramedullary insertion into the medullary cavity of os metacarpale I, wherein the intramedullary rod comprises at least two fixing holes arranged at right angles relative to a longitudinal axis of the intramedullary rod, and respective axes of the fixing holes being arranged at an angle greater than 5° but not greater than 135° relative to each other (claims 9, 17 and 18) 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-9 and 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 6, which depends from independent claim | which sets forth the parameter of “the second attachment member is configured to be secured directly to a side of os metacarpale II on a surface of the os metacarpale II” (emphasis added), and claim 6 further sets forth the parameter(s) of “wherein the second attachment member comprises an intramedullary rod” and that the intramedullary rod is configured for intramedullary insertion into the medullary cavity of os metacarpale II’; however this parameter was never mentioned before in the originally filed disclosure. Specifically, the originally filed disclosure does not mention, suggest or show a prosthesis wherein the second attachment member is configured to be secured directly to a side of os metacarpale II on a surface of the os metacarpale II (which according to the originally filed disclosure equates to the second attachment member having a plate like shape), and also being an intramedullary rod configured for intramedullary insertion into the medullary cavity of os metacarpale II.
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 1-9 and 11-19 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 claim 1, the last two lines set forth the parameter of the second attachment member being configured “to be secured directly to a side of the os metacarpale II on a surface of the os metacarpale II radial to the axis”; however, this parameter is found to confusing. Specifically, it is not clear what exactly, structurally/location- wise, is meant by the term “radial to the axis” since “the axis” is a plane that runs along the length of the os metacarpale II; thus, it is not clear where/at what location radial to a plane would specifically be. It is noted that Applicant argues, in the response dated 10/14/2025, that the above mentioned parameter is not indefinite by giving a definition of the term “radial”; however, the word “radial” is not the issue with the term “radial to the axis”, the word/term “axis” is actually the issue. Specifically, the axis is a plane that runs longitudinally/length-wise alone the os metacarpale II, however, it is not clear where this plane is positioned in the medial-lateral plane along the os metacarpale II, thereby making it unclear/indefinite to know where/what location would be radial to “the axis”. For the purpose of examination, as can be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as “the second attachment member is configured to be secured directly onto a radial side surface of the os metacarpale II”; and it is suggested the parameter be amended as such, or similarly.
Regarding claim 6, which depends from independent claim 1, which sets forth the parameter of “the second attachment member is configured to be secured directly to a side of os metacarpale II on a surface of the os metacarpale II”, and claim 6 further sets forth the parameter(s) of “wherein the second attachment member comprises an intramedullary rod” and that the intramedullary rod is configured for intramedullary insertion into the medullary cavity of os metacarpale IT’; however this parameter is found to be confusing since it is not clear how exactly, structurally, the second attachment member can be secured directly to a radial surface side of the os metacarpale II (which according to the originally filed disclosure equates to the second attachment member having a plate like shape), and also be an intramedullary rod configured for intramedullary insertion into the medullary cavity of os metacarpale II. Additionally, the originally filed disclosure does not aid in clarify and/or explaining the above mentioned parameter, since 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, and all claims that depend from it, 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, 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 § 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.
Claims 1, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Oster et al. (US PG Pub. 2016/0302935), as previously disclose, hereinafter Oster’935, in view of Oster (US PG Pub. 2016/00374817), as previously disclose, hereinafter Oster’817.
Regarding claims 1 and 11, Oster’935 discloses a prosthesis (1), illustrated in Figures 1-6, for movably coupling of os metacarpale I (1M) of a hand to a second metacarpal bone of the hand, specifically an os metacarpale II (2M) with an axis extending along a length of os metacarpale II, wherein the prosthesis (1) comprises a first element (3) and a second element (2), wherein the first element (3) comprises a first attachment member (5) configured for attachment to os metacarpale I (1M), and the second element (2) comprises a second attachment member (4) configured for attachment to the second metacarpal bone/os metacarpale II (2M), wherein the first and second elements (3&2) are coupled, and movable relative, to each other by a ball-and-socket joint, illustrated in Figures 1-6 and 10 ([0021] & [033]); but does not specifically teach the second attachment member is configured to be secured directly to/onto a radial side surface of the os metacarpale II.
However, Oster’817 teaches multiple embodiment of a prosthesis having first and second elements to movable connect bones of a hand, wherein one embodiment includes a prosthesis (1b) comprising a first element (2b), having a first attachment member (4b), and a second element (3b), having a second attachment member (5b), wherein the second attachment member (5b) is at plate-like member, configured to be secured directly onto a side surface of a metacarpal, illustrated in Figures 16-19; and in another embodiment the second element (3a) has a second attachment member (5a) which is a conical shaped member configured to be secure within a bone, illustrated in Figures 9 and 10; the two embodiments are considered alternatives of each other ([0063], Lines 3-5; [0071], Lines 1-3 & [0074]).
In view of the teachings of Oster’817, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the conically shaped second attachment member, of the prosthesis of Oster’935, with a plate-like shaped second attachment member, such that the second attachment member is configured to be secured directly onto a radial side surface of the os metacarpale II, since both types/shapes of second attachment members are art equivalent means/alternatives for securing the attachment member to bone, as taught by Oster’817.
Regarding claim 12, Oster’935 in view of Oster’817 disclose the prosthesis according to claim 11, wherein Oster’935 further teaches the ball- and-socket joint comprises a first part (7), comprising an at least partially cup-shaped cavity (31), and a second part (6), comprising an at least partially spherical ball (32), wherein the spherical part of the ball (32) is arranged rotatably in the cavity (31), illustrated in Figures 1-6 (Oster’935: [0033]); and though it is not specifically disclosed the first part is arranged on the first element, and the second part is arranged on the second element, instead Oster’935 teaching the opposite, i.e. the first part is arranged on the second element and the second part is arranged on the first element, it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate location/placement of the first and second parts of the ball and socket joint of the prosthesis of Oster’935 in view of Oster’817, including the first part is arranged on the first element, and the second part is arranged on the second element, since doing so amounts to a matter of reversing working parts of a device, and it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art (see MPEP 2144.04).
Claims 2-4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Oster’935 in view of Oster’817 as applied to claim 1 above, and further in view of Hashmi et al. (US PG Pub. 2015/0374423), as previously disclosed, hereinafter Hashmi.
Regarding claim 2, Oster’935 in view of Oster’817 disclose the prosthesis according to claim 1, wherein Oster’817 teaches the second attachment member (5b) comprises a plate, illustrated in Figures 17-19 (Oster’817: [0074], Lines 4-10); but does not specifically disclose the plate corresponds on a first side with a curved shape of the radial outer side of the os metacarpale II of the hand.
However, Hashmi teaches a bone plate, illustrated in Figures 1-4, wherein a first/bone contacting side of the plate has a curved shape corresponding to a target portion of a bone which the plate will be seated on, the curved shape ensures the plate is seated flush over the bone ([0018]).
In view of the teachings of Hashmi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the plate, of the prosthesis of Oster’935 in view of Oster’817, to have a curved shape first side which corresponds to the radial outer side of the os metacarpale II, in order to ensure the plate is seated flush over the os metacarpale II, as taught by Hashmi.
Regarding claim 3, Oster’935 in view of Oster’817 and Hashmi disclose the prosthesis according to claim 2, wherein Oster’817 further teaches the plate (5b) comprises at least one fastening hole (35b) for receiving a fastening means (36b) and wherein the at least one fastening hole (35b) is continuous and extends to the first side, illustrated in Figures 17-19 (Oster’817: [0074]).
Regarding claim 4, Oster’935 in view of Oster’817 and Hashmi disclose the prosthesis according to claim 3, wherein Oster’817 further teaches at least one of the at least one fastening hole (35b) is provided with first locking means, i.e. a countersink relief structure, for the purpose of anchoring a fastening means (36b) to the plate (5b) with angular stability relative to the plate, illustrated in Figures 17-19.
Regarding claim 13, Oster’935 in view of Oster’817 and Hashmi disclose a combination of a prosthesis according to claim 4, and Oster’817 further teaches at least one fastening means (36b), which is elongate and is provided on or close to a first outer end with second locking means, i.e. screw threads, for the purpose of anchoring the at least one fastening means (36b) with angular stability in at least one of the at least one fastening hole (35b) provided with first locking means, i.e. a countersink relief structure, and is configured at a second outer end for attachment of the plate (5b) to os metacarpale II by means of a form-fitting connection, illustrated in Figures 17-19 (Oster’817: [0074]).
Claims 5, 14, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Oster’935 in view of Oster’817 and Hashmi as applied to claims 2-4 above, and further in view of Scheker (US Patent No. 9,962,261), as previously disclosed.
Regarding claims 5, 14 and 15, Oster’935 in view of Oster’817 and Hashmi disclose the prosthesis according to claims 2, 3 and 4, but do not specifically disclose the plate comprising at least one fastening pin extending from the first/bone facing side.
However, Scheker teaches an orthopedic plate device (50*), in the same field of endeavor, comprising at least one fastening pin (68) extending from a first/bone facing side and configured to attach the plate device to bone, illustrated in Figure 6; the fastening pin (68) aids in positioning the plate device (50*) relative to the bone (Column 3, Lines 18-9 & 52-54).
In view of the teachings of Scheker, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the plate, of the prosthesis of Oster’935 in view of Oster’817 and Hashmi, to further comprise at least one fastening pin extending from the first/bone facing side, configured to attach the plate to the os metacarpale II, wherein the fastening pin aids in proper positioning of the plate relative to the bone/os metacarpale II.
Regarding claim 19, Oster’935 in view of Oster’817, Hashmi and Scheker disclose a combination of a prosthesis according to claim 5, and Oster’817 further teaches at least one fastening means (36b), which is elongate and is provided on or close to a first outer end with second locking means, i.e. screw threads, for the purpose of anchoring the at least one fastening means (36b) with angular stability in at least one of the at least one fastening hole (35b) provided with first locking means, i.e. a countersink relief structure, and is configured at a second outer end for attachment of the plate (5b) to os metacarpale II by means of a form-fitting connection, illustrated in Figures 17-19 (Oster’817: [0074]).
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive. Applicant argues the objections to the drawings and the new matter rejections stating, specifically regarding claim 6, that “the requisite claim language is “configured for intramedullary insertion” (claim 6) and “configured to be secured directly to a side” not that both are required to be performed at the same time”. However, claim 6 depends from claim 1 (which sets forth the second attachment member is configured to be secured directly to a side surface of the os metacarpale II), and that essentially means claim 6 includes all the parameters set forth in claim 1 and also all the parameters set forth in claim 6 (which sets forth the second attachment member is configured for intramedullary insertion). Thus, claim 6 is, in fact, actually setting forth that the second attachment member is required to perform both functions at the same time. Furthermore, the originally filed specification clarifies that a structural limitation is imparted to the second attachment member based on the function/functional language. Specifically, the function/functional language of configured to be secured/fixed to a radial side of the os metacarpale II equates to the second attachment member having a plate like structure, as illustrated in Figures 1-3 and described in paragraphs [0056] - [0058] (of the PG Pub. 2022/0401223 – Pg. 9, Line 21 – Pg. 10, Line 12 of clean copy specification submitted 04/27/2022). Figures 4 and 5 are clearly stated as being another, different, embodiment, this embodiment describing the function/functional language of being arranged in an intramedullary/medullary cavity of the os metacarpale II, and equating to the second attachment member having an intramedullary rod shape, as illustrated in Figures 4 and 5 and described in paragraphs [0060] and [0061] (of the PG Pub. 2022/0401223 – Pg. 10, Line 22 – Pg. 11, Line 10 of clean copy specification submitted 04/27/2022). There is nothing in the originally filed disclosure that mentions or illustrates an embodiment which is configured to be secured/fixed to a radial side of the os metacarpale II and also having a intramedullary rod shape. Thus, the drawing objections and new matter rejections are deemed to be proper and stand.
Applicant goes on to argue the combination of the prior art of Oster’935 in view of Oster’817, in the rejection of independent claim 1, stating that nothing suggests the elements of Oster’817 as being “useful as a prosthesis for movably coupling os metacarpale I to os metacarpale II as is required by independent claim 1. Thus, there is no recorded evidence to support the conclusion that the “second attachment member” of Oster 817 would be interchangable with the second attachment member of Oster 935”. Examiner respectfully disagrees with Applicant’s assertion. It is important to keep in mind that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references; rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art (see MPEP 2145 III). In the instant case, Oster’935 teaches all the structural limitations set forth in independent claim 1 except that the second attachment member is configured to be secured directly to/onto a radial side surface of the os metacarpale II (which according to the originally filed disclosure equates to the second attachment member having a plate like shape). The secondary reference of Oster ‘817 is used not only to teach that a structure of a plate-like shape is known, as illustrated in Figures 16-17 of Oster ‘817, but also that it is known that a plate-like shape is considered to be an art equivalate alternative to a intramedullary rod shape, as illustrated in Figures 9 and 10 of Oster ‘817. Furthermore, Oster ‘817 also states “the prosthesis members may be used at other smaller joints than wrists, e.g. at finger and toe or interphalangeal joints…” (Oster ‘817: [0103], Lines 5-6). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the conically shaped second attachment member, of the prosthesis of Oster’935, with a plate-like shaped second attachment member, such that the second attachment member is configured to be secured directly onto a radial side surface of the os metacarpale II, since both types/shapes of second attachment members are art equivalent means/alternatives for securing the attachment member to bone of a joint, as taught by Oster’817. Hence, the rejection of independent claim 1 as being unpatentable over the prior art of Oster’935 in view of Oster’817 is deemed to be proper; therefore, the rejection stands.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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