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 .
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered. The amendments have overcome the 35 U.S.C. 102(a)(1) rejections of claims as being anticipated by Fockens and Martin but not O’Gara. Applicant argues the examiner agreed that the amendments to claim 1 would overcome the rejections in view of the prior art. The examiner does not recall such an agreement and the interview summary does not reflect this. While the amendments to claim 1 overcome the embodiment of image 3 of O’Gara, claim 1 is still anticipated by the embodiment of image 1 of O’Gara. Applicant argues the addition of two through channels would render the implant of O’Gara useless because in order to transfer the forces into the intramedullary portion, the femoral neck must be secured into the intramedullary portion of the implant. This is not persuasive because the embodiment of image 1 of O’Gara shows the neck 3 extending through a through channel in 4 as well as a through channel in 1. O’Gara states “Image 1 and 2 demonstrates a potential press fit articulation of the femoral neck 3 with the intramedullary rod 1” (par.13) and images 1 and 2 show the neck 3 extending completely through and beyond the rod 1. Such an arrangement allows for transfer of forces into the intramedullary portion since the neck 3 is secured into the intramedullary portion 1 by a press-fit. Accordingly, O’Gara image 1 anticipates claim 1. See the annotated images 1 and 2 below for the neck 3 extending completely through the rod 1.
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Claim Objections
Claim 18 is objected to because of the following informalities: In claim 18, line 2, “including” is believed to be in error for --includes--. Appropriate correction is required.
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.
Claim 4 is 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. Claim 1 was amended to be directed to only figs. 3A-3D and 5A-5B of the instant application. Claim 1 cannot be directed to figs. 4A-4C since this embodiment does not have a void area as claimed in claim 1 and cannot be directed to figs. 6A-6B since this embodiment does not have first and second through channels. The limitation of claim 4 is only supported by the embodiment of figs. 4A-4C, therefore claim 4 is directed to new matter since there is no disclosure of the combination of a void area between the first anchor and the proximal portion of the base and a recessed portion in the second anchor that is in fluid communication with an aperture. Note, claims 2 and 3 are interpreted broadly to read on the embodiments of figs. 5A-5B wherein the aperture is considered an opening portion of the first through channel.
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 4 and 21-24 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 4, based on the specification, it is unclear how the embodiment of figs. 4A-4C wherein the second anchor includes a recessed portion that is in fluid communication with an aperture in the proximal portion of the base can be combined with the embodiment of figs. 5A-5B comprising a void area between the distal portion of the first anchor and the proximal portion of the base.
Claim 21 recites the limitation "the pathway" in lines 11 and 15. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 5-7, 15, 17, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Gara US 2007/0038306 (hereafter referred to as O’Gara).
Regarding claim 1, O’Gara discloses a prosthetic implant system (Image 1) comprising a first articulation component (ball head 6 shown in image 1), a base having a proximal portion 4 and a first anchor 1 extending in a distal direction along a longitudinal first anchor axis (the vertical longitudinal axis of the rod 1), the proximal portion of the base configured to couple to the first articulation component (image 1 shows the head coupled to the proximal portion of the base), and a second anchor 3 formed separately from the base (image 1; par.13), the second anchor extending along a longitudinal second anchor axis (longitudinal axis of neck 3 shown in image 1), wherein the base includes a pathway extending from a first through channel in the proximal portion of the base through a second through channel in a distal portion of the first anchor 1 (see the annotated image 1 below), the pathway sized and shaped to receive the second anchor 3 therethrough (par.13 discloses a press-fit connection between the neck 3 and the rod 1; images 1 and 2 shows the neck 3 extending completely through the proximal portion of the base at 4 and the first anchor 1), wherein the distal portion of the first anchor is spaced from the proximal portion of the base so that a void area is formed therebetween, the pathway extending across the void area (see annotated image 1 below), wherein when the second anchor is received within the pathway, the longitudinal first anchor axis is oblique to the longitudinal second anchor axis (image 1 shows the first anchor 1 and the second anchor 3 forming an oblique angle).
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Regarding claim 2, see image 1 which shows a connector of the ball head (considered the proximal portion of 3) extending through the aperture in 4.
Regarding claim 3, the top of the opening in 4 opens to and is in fluid communication with the pathway (image 1).
Regarding claims 5-7, see par.4 for the second anchor 3 being cylindrical (therefore circular in cross-section), oval (oblong), or triangular (regular polygon), and see par.10 for a matching cavity 7.
Regarding claims 15 and 17, see image 1 for the top opening of the first through channel in the proximal portion 4 being coaxial with the second anchor axis and therefore oblique to the first anchor axis.
Regarding claim 19, see a proximal end of second anchor 3 being within the first through channel in the proximal portion of the base and a distal end of the second anchor being within the second through channel in the distal portion of the first anchor in image 1.
Regarding claim 20, the device of O’Gara is capable of being used in a total shoulder arthroplasty and the first articulation component can be used as a prosthetic humeral head (image 1). Note that claim 20 is directed to an intended use of the prosthetic implant system. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since O’Gara has the claimed structure, it is capable of performing the intended use.
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over O’Gara as applied to claim 17 above, and further in view of Papadonikolakis US 2015/0223940 (hereafter referred to as Papadonikolakis). O’Gara discloses the prosthetic implant system of claim 17 as discussed above. However, O’Gara discloses a single piece head and anchor 3 and does not disclose a separate connector and anchor such that the proximal end of the second anchor includes an opening therein, the first articulation component includes a connector, and the opening in the proximal end of the second anchor is sized and shaped to receive the connector therein.
Papadonikolakis teaches a prosthetic implant system, in the same field of endeavor, wherein a head 12 comprises a connector 3, and a rod 5 comprises an opening in a proximal end 7 thereof, wherein the opening in the proximal end is sized and shaped to receive the connector therein (fig.2) for the purpose of connecting a head to an anchor (par.25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single piece head and second anchor of O’Gara to include a proximal opening in the second anchor which receives a connector on the head as taught by Papadonikolakis in order to allow for a modular head and anchor. It would have been obvious to make the head and anchor of O’Gara modular and separable since it has been held that making parts separable for any desirable reason is an obvious extension of prior art teachings (In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) MPEP V C). In this case a modular head and anchor allows for replacing a damaged head or modifying the size of the head which would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Allowable Subject Matter
Claims 13 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 21-24 are would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774