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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 9/19/2024 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an attachable component” in claim 1, “a first component” and “a second component” in claim 11, “a complementary component” in claim 12, and “an attachable component” in claim 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-6, 10 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perego et al. (US 2020/0214846).
Perego discloses (see the stemless embodiment of Figs. 4; [0082]; [0201]) a stemless shoulder prosthesis (10) and method comprising the following claim limitations:
(claim 1) A stemless implant configured to be inserted into a bone of a patient (see Abstract), the stemless implant comprising: a bone anchor (13, see Figs. 4 and 6) configured to be mounted to the bone of the patient ([0200]-[0201]; humeral body 13 expressly for insertion into the humerus), the bone anchor (13) comprising: a central hub (133/134, Fig. 4) defining an aperture (as expressly shown in Figs. 5a-5b, 11 and 13; [0115]-[0118]; base 134 expressly disclosed and depicted as being cylindrical); and a plurality of fins (132, Fig. 4) extending radially from the central hub (134) (as shown in Figs. 4, 11 and 13), the plurality of fins (132) arranged in an asymmetric pattern (as shown in Fig. 13; see Abstract and claims 1 and 5; [0025]; [0112]-[0114]; [0120]; [0123]-[0124]), each fin (132) of the plurality of fins comprising: a proximal surface including a curvature (as shown in Figs. 4, 11 and 13; [0112]-[0114]; i.e., the proximal surface of each arm 132 is expressly depicted as curved forming a semispherical cage) such that a radial end of the respective fin (132) of the plurality of fins extends proximally beyond the central hub (134) (as shown in Figs. 4, 11 and 13); and an attachable component (14/15, Figs. 4-5a; 22, Figs. 6-7a) configured to be inserted into the aperture of the central hub (as shown in Figs. 4 and 6);
(claim 2) wherein the attachable component includes a humeral head (14/15) configured to be mounted to the bone anchor (13) (as expressly shown in Fig. 4-5b);
(claim 3) wherein the attachable component includes a concave recessed articulating component (22) including a humeral tray and bearing assembly (as shown in annotated Fig. 7a below);
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(claim 4) wherein the bone anchor (13) includes a porous metal ([0128]-[0130]; [0197]);
(claim 5) wherein the plurality of fins (132) are sized and positioned to conserve humeral bone (as shown in Figs. 4, 11 and 13; [0012]; [0017]; the stemless device expressly disclosed for beneficially maintaining the bone stock of the humerus);
(claim 6) wherein the attachable component is a humeral head (14/15, Figs. 4-5a) or a humeral tray (22, Figs. 6-7a), and wherein the bone anchor (13) is configured to selectively receive either the humeral head (14/15) or the humeral tray (22) (as expressly shown in Figs. 4-5a and/or Figs. 6-7a);
(claim 10) wherein one or more fins (132) of the plurality of fins include a T-shaped cross-section having a first portion extending from the central hub and a second portion perpendicular to the first portion (as shown in annotated Fig. 13 below); and
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(claim 20) A method of implanting an implant (10), the method comprising: installing a bone anchor (13, see Figs. 4 and 6) into a bone of a patient (see Abstract; [0200]-[0201]; humeral body 13 expressly inserted into the humerus), the bone anchor (13) comprising: a central hub (133/134, Fig. 4) defining an aperture (as expressly shown in Figs. 5a-5b, 11 and 13; [0115]-[0118]; base 134 expressly disclosed and depicted as being cylindrical); and a plurality of fins (132, Fig. 4) extending radially outward from the central hub (134) (as shown in Figs. 4, 11 and 13), the plurality of fins (132) arranged in an asymmetric pattern (as shown in Fig. 13; see Abstract and claims 1 and 5; [0025]; [0112]-[0114]; [0120]; [0123]-[0124]), each fin (132) of the plurality of fins comprising: a proximal surface including a curvature (as shown in Figs. 4, 11 and 13; [0112]-[0114]; i.e., the proximal surface of each arm 132 is expressly depicted as curved forming a semispherical cage) such that a radial end of the respective fin (132) of the plurality of fins is proximally above the central hub (134) (as shown in Figs. 4, 11 and 13); and installing an attachable component (14/15, Figs. 4-5a; 22, Figs. 6-7a) to the aperture of the bone anchor (as shown in Figs. 4 and 6).
Claim(s) 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone et al. (US 10,166,032).
Stone discloses (see Figs. 1-9) a system configured to be implanted into a patient comprising the following claim limitations:
(claim 11) A system configured to be implanted into a patient (as shown in exemplary Fig. 1), the system comprising: a first anchor (32, Figs. 1 and 3A) configured to be selectively mounted to a first bone (38, Fig. 1); a first component (33, Fig. 1; 30, Fig. 3B) configured to be mounted to the first anchor (32) such that the first component (33) is positioned proximal to a resected surface of a first bone (38) of the patient (as shown in Figs. 1 and 3A-3B; first anchor 32 in Fig. 3A comprises an onlay configuration wherein the first component 33 is positioned proximal to a resected surface of the first bone 38); a second anchor (as shown in Fig. 4; col. 4, lines 10-16; the system of Stone expressly comprises surgical kits containing numerous head members 33 and base members 32 having varying sizes, curvatures and configurations from which a surgeon may make a selection to optimize joint movement) configured to be selectively mounted to the first bone (38); and a second component (i.e., head member 33 complementary to base 32 of Fig. 4) configured to be mounted to the second anchor (32, of Fig. 4) such that the second component (33) is positioned distal to the resected surface of the first bone (3) (as shown in Fig. 4, second anchor 32 comprises an inlay configuration wherein the second component 33 is positioned distal to a resected surface of the first bone 38); wherein any one of the first anchor and the first component or the second anchor and the second component are selected intraoperatively to be inserted into the first bone (38) of the patient (see Fig. 1; col. 4, lines 10-16; the system of Stone expressly comprises surgical kits containing numerous head members 33 and base members 32 having varying sizes, curvatures and configurations from which a surgeon may make a selection to optimize joint movement during an operation); and
(claim 12) a complementary component (40, Fig. 1) configured to be mounted to a second bone (42, Fig. 1) of the patient, the second bone (42) forming a joint with the first bone (38) (i.e., shoulder joint); wherein the first component (33) and the second component (33) are both adapted to operate with the complementary component (40) (as shown in Fig. 1; humeral head member expressly configured to operate with the glenoid component 40).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-7, 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ball et al. (WO 2023/183283) in view of Sperling (US 2019/0105169).
Ball discloses (see Figs. 16B, 17B, 18B, 19B, 19D and 20A-20H) a stemless shoulder prosthesis and method comprising the following claim limitations:
(claim 1) A stemless implant configured to be inserted into a bone of a patient (see Abstract), the stemless implant comprising: a bone anchor (1650, Fig. 16B) configured to be mounted to the bone of the patient ([0100]; implant expressly for insertion into the humerus), the bone anchor (1650) comprising: a central hub (i.e., cylindrical central hub defining opening 1658 in Fig. 16B and cavities 1662/1664 in Figs. 18B and 20D-20E) defining an aperture (1658/1662, Figs. 16B and 18B); and a plurality of fins (1654/1656, Fig. 16B) extending radially from the central hub (as expressly shown in Figs. 16B and 20A-20C), each fin (1654/1656) of the plurality of fins comprising: a proximal surface (i.e., “upper” curved surface of fins 1654/1656, as shown in Figs. 16B, 17B, 18B and 20A-20H) including a curvature (as expressly shown in Figs. 16B, 17B, 18B and 20A-20H) such that a radial end of the respective fin (1654/1656) of the plurality of fins extends proximally beyond the central hub (as expressly shown in Figs. 16B, 17B, 18B and 20A-20H); and an attachable component (204/211, Figs. 12-15; 1700, Fig. 19B) configured to be inserted into the aperture (1658/1662) of the central hub (as expressly shown in Figs. 12-15, 18B and 20D-20E);
(claim 2) wherein the attachable component includes a humeral head (1700, Fig. 19B) configured to be mounted to the bone anchor (1650) (as expressly shown in Figs. 19B and 19D);
(claim 3) wherein the attachable component includes a concave recessed articulating component including a humeral tray (211, Figs. 12-15) and bearing assembly (204, Figs. 12-15);
(claim 4) wherein the bone anchor (1650) includes a porous metal ([0102]; inclusion of porous metal expressly disclosed);
(claim 5) wherein the plurality of fins (1654/1656) are sized and positioned to conserve humeral bone (as shown in Fig. 16B; [0088]; [0099]; the stemless device expressly disclosed for beneficially conserving native bone of the humerus);
(claim 6) wherein the attachable component is a humeral head (1700, Fig. 19B) or a humeral tray (211, Figs. 12-15), and wherein the bone anchor (1650) is configured to selectively receive either the humeral head (1700) or the humeral tray (211) (as expressly shown in Figs. 12-15, 19B and 19D); and
(claim 20) A method of implanting an implant, the method comprising: installing a bone anchor (1650, Fig. 16B) into a bone of a patient (see Abstract; [0100]; implant expressly for insertion into the humerus), the bone anchor (1650) comprising: a central hub (i.e., cylindrical central hub defining opening 1658 in Fig. 16B and cavities 1662/1664 in Figs. 18B and 20D-20E) defining an aperture (1658/1662, Figs. 16B and 18B); and a plurality of fins (1654/1656, Fig. 16B) extending radially outward from the central hub (as expressly shown in Figs. 16B and 20A-20C), each fin (1654/1656) of the plurality of fins comprising: a proximal surface (i.e., “upper” curved surface of fins 1654/1656, as shown in Figs. 16B, 17B, 18B and 20A-20H) including a curvature (as expressly shown in Figs. 16B, 17B, 18B and 20A-20H) such that a radial end of the respective fin (1654/1656) of the plurality of fins is proximally above the central hub (as expressly shown in Figs. 16B, 17B, 18B and 20A-20H); and installing an attachable component (204/211, Figs. 12-15; 1700, Fig. 19B) to the aperture (1658/1662) of the bone anchor (1650) (as expressly shown in Figs. 12-15, 18B and 20D-20E).
Ball discloses a stemless shoulder prosthesis and method comprising all the limitations of the claim except for the plurality of fins comprising six fins arranged in an asymmetric pattern wherein two or more fins of the plurality of fins include suture holes configured to receive a suture.
However, Sperling teaches a similar stemless humeral prosthesis and method comprising a plurality of fins comprising six fins (108/110/151/152/153/154) arranged in an asymmetric pattern (as shown in Figs. 3A-3C; [0008]; [0017]; [0019]; [0082]; [0187]-[0190]) in order to beneficially allow a surgeon to optimize joint arthroplasty component design using improved patient-specific asymmetrical implants while further facilitating intraoperative bone preparation and implantation ([0008]; [0017]; [0019]; [0082]; [0187]-[0191]), and wherein two or more fins of the plurality of fins include suture holes (236, Figs. 10A-10C) configured to (i.e., capable of) receive a suture ([0103]) in order to beneficially receive a stitch or suture to help hold portions of fractured bone together ([0103]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Ball to have a plurality of fins comprising six fins arranged in an asymmetric pattern in order to beneficially allow a surgeon to optimize joint arthroplasty component design using improved patient-specific asymmetrical implants while further facilitating intraoperative bone preparation and implantation, and wherein two or more fins of the plurality of fins include suture holes configured to receive a suture in order to beneficially receive a stitch or suture to help hold portions of fractured bone together, as taught by Sperling.
Claim(s) 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Perego as applied to claim 1 above, and further in view of Sperling (US 2019/0105169).
Perego, as applied above, discloses a stemless shoulder prosthesis comprising:
(claim 9) wherein two or more fins (132) of the plurality of fins include suture holes (131, Fig. 4) configured to receive a suture (as expressly shown in Fig. 4; holes 131 fully capable of receiving sutures therein if one so desires).
Perego discloses all of the limitations of the claim except for the plurality of fins including six fins.
However, Sperling teaches a similar stemless shoulder prosthesis comprising a bone anchor having a plurality of fins comprising any of four fins, five fins, or six fins ([0010]; [0082]; [0104]). Accordingly, Sperling teaches that it is known that four fins and six fins are elements that are functional equivalents for providing structures to implant and anchor the prosthetic device into a humerus of a patient. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the six fins taught by Sperling for the four fins of Perego because both elements were known equivalents for providing structures to implant and anchor the prosthetic device into a humerus of a patient within the prosthetic joint arts. The substitution would have resulted in the predictable results of providing structures to implant and anchor the prosthetic device into a humerus of a patient to the device of Perego.
Allowable Subject Matter
Claims 8 and 13-19 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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