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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19-22, 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemello (U.S. Patent 6,077,264, hereinafter “Chemello”).
Chemello discloses, regarding claim 19, a humeral head support (9 and 91, see Fig. 4a) for use in an implant (1) for repairing a multipart fracture of a proximal end of a humerus of a human (see Fig. 4a, note multipart fracture shown in long bone, see lines 5-12 of column 1, “treatment of fractures, especially fractures of long bone”, note that since the humerus is a long bone the implant would be capable of repairing a fracture in humerus), the humeral head support comprising: a base portion (9) configured for attachment (via 2) to a proximal end of the implant (11); and a support portion (91) configured to support a humeral head of the humerus during a repair of a four-part fracture of the humerus (see Fig. 4a, device is shown supporting the head of a long bone with 4 fractures in the long bone), wherein the support portion extends from the base portion in a direction such that the base portion is configured to extend from the base portion diagonally in a medial and distal direction when the base portion is attached to the proximal end of the implant (see annotated Fig. 4a below) and when the implant is implanted so as to be surrounded by bone within a proximal volume of the humerus (see Fig. 4a, note that 9 and 91 are surrounded with bone in a proximal portion of a long bone), and wherein the support portion is positioned with respect to the base portion so as to be positioned between the humeral head of the humerus and a lesser tuberosity of the humerus so as to support the humeral head of the humerus when the implant is implanted so as to be surrounded by bone during a repair of a four-part fracture of the humerus (see Fig. 4a, note that the support portion is capable of being positioned between a humeral head and a lesser tuberosity when the implant is surrounded by a four-part fracture, since the support portion is shown to be between a head and the neck of a long bone).
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Regarding claim 20, wherein the humeral head support has a medial surface (see annotated Fig. 4a below), a lateral surface opposite the medial surface of the humeral head support (e.g. opposite side of 91 from annotated medial surface), a proximal end (see annotated Fig. 4a below), a distal end opposite the distal end of the humeral head support (see annotated Fig. 4a above), and at least one anchoring point (see annotated Fig. 4a above) configured to engage an anchoring device (2), and wherein the base portion configured for attachment to the proximal end of the implant includes the proximal end of the humeral head support having a profile that is complementary to a surface of the proximal portion of the implant when the lateral surface of the humeral head support is positioned adjacent the surface of the proximal portion of the implant (see lines 4-8 of column 3).
Regarding claim 21, further comprising at least one anchoring point (see annotated Fig. 4a above).
Regarding claim 22, wherein the at least one anchoring point includes at least one threaded hole (12) configured to receive at least one screw (2, see lines 4-8 of column 3).
Regarding claim 26, wherein the base portion is configured to be coupled to a cylindrical intramedullary nail (see Fig. 4A, note that 9 is coupled to 1 via 11 and 2, and that 1 is cylindrical).
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.
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.
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chemello, as applied to claim 19 above.
Chemello discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 23, wherein the humeral head support has a length that is in a range of from 10 millimeters to 60 millimeters; and regarding claim 24, wherein the humeral head support has a width that is in a range of from 5 millimeters to 35 millimeters.
It is evident, that the width and length of the support is a result effective variable, since changes to the width and length result in the more engagement with the bone / better fit within the bone for enabling compressing the multi-fragmented fracture will occur. With regard to claims 23 and 24, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the humeral head support of Chemello to have a length in the range of from 10 millimeters to 60 millimeters and a width that is in a range of from 5 millimeters to 35 millimeters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chemello, as applied to claim 19 above.
Chemello discloses all of the features of the claimed invention, as previously set forth above, Chemello further discloses that the base portion is shaped to engage the non-circular / octagonal proximal end of the implant (11, see lines 4-8 of column 3). Chemello however fails to explicitly disclose, regarding claim 25, wherein the base portion is configured to be coupled to a triangular surface of the proximal end of the implant.
It would have been an obvious matter of design choice to one skilled in the art at the time the invention was made to construct non-circular / octagonal proximal end of the implant and the base portion that is shaped to engage it of Chemello with a triangular surface, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an additional shape that would also provide non-rotational engagement between the proximal end of the implant and the base portion. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claim(s) 27-28, 30-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chemello (U.S. Patent 6,077,264, hereinafter “Chemello”) in view of Vargas et al. (U.S. Pub. No. 2014/0052192 A1, hereinafter “Vargas”).
Chemello discloses, regarding claim 27, a humeral head support (9 and 91, see Fig. 4a) configured for use in an implant (1) for repairing a multipart fracture of a proximal end of a humerus of a human (see Fig. 4a, note multipart fracture shown in long bone, see lines 5-12 of column 1, “treatment of fractures, especially fractures of long bone”, note that since the humerus is a long bone the implant would be capable of repairing a fracture in humerus), wherein the humeral head support comprises: a base portion (9) configured for attachment (via 2) to a proximal end of the implant (11); and a support portion (91) configured to support a humeral head of the humerus during a repair of a four-part fracture of the humerus (see Fig. 4a, device is shown supporting the head of a long bone with 4 fractures in the long bone), wherein the support portion extends from the base portion in a direction such that the base portion is configured to extend from the base portion diagonally in a medial and distal direction when the base portion is attached to the proximal end of the implant (see annotated Fig. 4a below) and when the implant is implanted so as to be surrounded by bone within a proximal volume of the humerus (see Fig. 4a, note that 9 and 91 are surrounded with bone in a proximal portion of a long bone), and wherein the support portion is positioned with respect to the base portion so as to be positioned between the humeral head of the humerus and a lesser tuberosity of the humerus so as to support the humeral head of the humerus when the implant is implanted so as to be surrounded by bone during a repair of a four-part fracture of the humerus (see Fig. 4a, note that the support portion is capable of being positioned between a humeral head and a lesser tuberosity when the implant is surrounded by a four-part fracture, since the support portion is shown to be between a head and the neck of a long bone).
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Regarding claim 33, wherein each humeral head support has a medial surface (see annotated Fig. 4a above), a lateral surface opposite the medial surface of the humeral head support (e.g. opposite side of 91 from annotated medial surface), a proximal end (see annotated Fig. 4a above), a distal end opposite the distal end of the humeral head support (see annotated Fig. 4a above), and at least one anchoring point (see annotated Fig. 4a above) configured to engage an anchoring device (2), and wherein the base portion of each humeral head support of the plurality of humeral head supports configured for attachment to the proximal end of the implant includes the proximal end of the humeral head support having a profile that is complementary to a surface of the proximal portion of the implant when the lateral surface of the humeral head support is positioned adjacent the surface of the proximal portion of the implant (see lines 4-8 of column 3).
Regarding claim 34, wherein the humeral head support further comprises at least one anchoring point (see annotated Fig. 4a above).
Regarding claim 35, wherein the at least one anchoring point includes at least one threaded hole (12, see lines4-8 of column 3) configured to receive at least one screw (2).
Chemello fails to disclose, regarding claim 27, a kit, comprising: a plurality of humeral head supports, wherein each humeral head support of the plurality of humeral head supports comprises: a base portion and a support portion; regarding claim 28, wherein a first humeral head support of the plurality of humeral head supports and a second humeral head support of the plurality of humeral head supports are shaped differently from one another; regarding claim 30, wherein a first humeral head support of the plurality of humeral head supports and a second humeral head support of the plurality of humeral head supports are sized differently from one another; regarding claim 31, wherein the first humeral head support and the second humeral head support have different lengths from one another; regarding claim 32, wherein the first humeral head support and the second humeral head support have different widths from one another.
Vargas discloses a head support device (209), wherein the device is provided in a kit (see para. [0066]) with a plurality of support devices (see para. [0066]), wherein the supports are shaped / sized differently from each other (see para. [0066]) with different widths (see para. [0066]) in order to provide various sizes and shapes available to the user to select a particular support device to best fit the patient specific anatomy (see para. [0066]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the support device in Chemello to include a plurality of differently sized / shaped supports in a kit in view of Vargas in order to provide various sizes and shapes available to the user to select a particular support device to best fit the patient specific anatomy.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chemello in view of Vargas, as applied to claims 27 and 28.
Chemello in view of Vargas, discloses all of the features of the claimed invention, as previously set forth above, Chemello further discloses that the base portion is shaped to engage the non-circular / octagonal proximal end of the implant (11, see lines 4-8 of column 3). Chemello however fails to explicitly disclose, regarding claim 29, wherein the base portion of the first humeral head support is configured to be coupled to a triangular surface of the proximal end of the implant, and wherein the base portion of the second humeral head support is configured to be coupled to a cylindrical intramedullary nail.
It would have been an obvious matter of design choice to one skilled in the art at the time the invention was made to construct non-circular / octagonal proximal end of the implant and the base portion that is shaped to engage it of Chemello in view of Vargas with a triangular surface, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an additional shape that would also provide non-rotational engagement between the proximal end of the implant and the base portion. In re Dailey and Eilers, 149 USPQ 47 (1966).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose support devices for bone fractures:
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773