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 Objections
Claim 23 is objected to because of the following informalities: In Line 35, the word “removes” should be replaced with the words --is configured to remove--. Appropriate correction is required.
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 9 & 23-30 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).
Claim 9 recites the limitation “wherein the at least one first engagement feature and the at least one second engagement feature engage with different portions of a bottom surface of a humeral head.” which seeks to positively recite the human body since the at least one first and second engagement features are recited as engaging with the humeral head. It is suggested that the claim be amended to only functionally recite the humeral head, i.e. “wherein the at least one first engagement feature and the at least one second engagement feature are configured to engage with different portions of a bottom surface of a humeral head”. Appropriate correction is required.
Claim 23 recites the limitation “wherein the body aperture receives the guide wire attached to the center of the humeral head” which seeks to positively recite the human body since the guide wire is recited as being attached to the humeral head. It is suggested that the claim be amended to only functionally recite the humeral head, i.e. “wherein the body aperture receives the guide wire which is configured to be attached to the center of the humeral head”. Appropriate correction is required.
Claim 25 recites the limitation “wherein the plurality of pins secure the cutting support member to the humeral head.” which seeks to positively recite the human body since the pins are recited as securing the cutting support member to the humeral head. It is suggested that the claim be amended to only functionally recite the humeral head, i.e. “wherein the plurality of pins are configured to secure the cutting support member to the humeral head.” Appropriate correction is required.
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 5-6 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.
Claim 5 recites “further comprising: a shaft defining a shaft aperture, the guide wire extending through the shaft aperture,”. The Applicant is required to clarify to what the claim is intended to be drawn to, i.e., either the subcombination of the surgical guide alone as recited in the preamble, or the combination of the surgical guide and the guide wire as stated in claim 5. The Applicant sets forth the combination of the surgical guide and the guide wire in Claim 5 when stating that the guide wire extends “through the shaft aperture”, which is inconsistent with the preamble and the limitations of Claim 4 (“wherein the guide body is configured to receive a guide wire extending through the guide aperture”) which sets forth the subcombination of the surgical guide with the guide wire only functionally recited. Applicant is required to make the language of the claims consistent with the intent of the claims. It should also be noted that in considering the claims on the merits, the Examiner will consider the claims as drawn to the subcombination where the guide wire is only functionally recited. If the guide wire is meant to be only functionally recited, it is suggested that Claim 5 be amended to say “the guide wire configured to extend through the shaft aperture”. Appropriate correction is required.
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(s) 1, 4 & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flett et al. (US PG Pub No. 2009/0163923) in view of Mercer et al. (US Patent No. 4,242,292).
Regarding Claim 1, Flett et al. discloses a humeral head surgical guide (jig 100, Figs. 1-5, Paragraphs [0056-0075]), comprising: a guide body (102, Fig. 1) (Paragraphs [0017-0019]) defining a guide aperture (vertical opening/hollow formed through 102, Fig. 1) extending along a first axis (central vertical longitudinal axis through 102, Fig. 1) at a center of the guide body; a first movable guide member (130, Figs. 1-4, Paragraphs [0060-0063]) coupled to the guide body (via 138, 140, Fig. 4, Paragraph [0065]), wherein the first movable guide member moves along a second axis (axis 332, Fig. 4) perpendicular to the first axis (Fig. 1, Paragraph [0067]); a first supporting member (134, Figs. 1, 3 & 4, Paragraph [0062]) comprising at least one first engagement feature (first bushing 304, Figs. 1 & 3, Paragraph [0065]), the first supporting member coupled to and extending from the first movable guide member (Figs. 3-4); a second movable guide member (180, Figs. 1, 2A-2B, Paragraph [0060, 0062-0063]) coupled to the guide body, wherein the second movable guide member moves along a third axis (axis 330, Fig. 4) perpendicular to the first axis and relative to the second axis (Fig. 1, Paragraph [0067]); and a second supporting member (184, Fig. 1, Paragraph [0062]) comprising at least one second engagement feature (bushing at end of 186, not labeled, Fig. 1), the second supporting member coupled to and extending from the second movable guide member (Figs. 3-4).
Flett et al. does not disclose that the guide body comprises a first and second marker, the first movable guide member comprising one or more first indicators, the second movable guide member comprising one or more second indicators, wherein the first marker is oriented relative to the one or more first indicators to indicate a first distance between the first axis and the at least one first engagement feature, and wherein the second marker is oriented relative to the one or more second indicators to indicate a second distance between the first axis and the at least one second engagement feature. Flett does disclose in Paragraphs [0017-0019] that “The jig can be adapted to be tracked. The jig can further include a first marker detectable by a tracking system. The first marker can be attached to the jig so that the position of the jig in a reference frame can be determined. [0018] The marker can be a wired or a wireless marker. The marker can reflect, or generate or transmit energy to a detector part of a tracking system. The energy can be electrical, electromagnetic or acoustic. The energy can be ultrasonic. The energy can be in the infrared, the radio frequency or microwave parts of the spectrum. [0019] The jig can further include a second marker detectable by a tracking system. The second marker can be attached to the second guide element and the first marker can be attached to the first guide element. In this way, the position of the guide elements can be determined and hence the position of the jig axis can be derived. The jig can further include an instrument passing through the first guide channel and second guide channel. The first marker can be attached to the instrument. The instrument can have a substantially straight part, sufficiently long to pass through the first guide channel and second guide channel when inserted between them.”
Mercer et al. discloses a surgical guide (Figs. 1-13) comprising a guide body, an upper/first mounting jig (40, Fig. 9) configured for sliding anterior-posterior and lateral movements, the upper mounting jig comprising scales for reading both the anterior-posterior and lateral movements (Col. 7, Lines 60-68, Fig. 9), and a lower/second mounting jig (10, Fig. 9) configured for sliding anterior-posterior and lateral movements, wherein “The lateral slide member 18 is superimposed on the vertical rise plate 24 where it is held in place by screws 26. As best shown in FIG. 7 the lateral slide member 18 is provided with two elongated slots 18a which permit lateral movement of slide member 18 relative to the vertical rise plate 24 when screws 26 are loosened. As best shown in FIG. 7 a convenient scale is scribed onto the vertical rise plate to indicate the right or left lateral displacement of screw 14 from the vertical axis of the articulator. An index line (not shown) is scribed on the edge of the lateral slide member adjacent to the scale, the index line being located to read 0 on the scale when the screw 14 is on the vertical axis of the articulator. Since the dental cast moves with the lateral slide member 18, moving the lateral slide member moves the lateral position of the dental cast in relation to the vertical axis of the articulator.” (Col. 5, Lines 47-65).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the surgical guide of Flett et al. to scribe a scale in the guide body adjacent each slot where the bushings slide and scribe an index line onto each guide member adjacent the respective engagement feature to indicate the amount of right or left lateral displacement of each bushing from the first/vertical axis of the guide body as taught by Mercer et al. in order to provide the guide with a visual means for indicating the position of and distance between each jig axis and the central/vertical axis through the guide body for subsequent placement of an instrument therethrough.
Regarding Claim 4, the combination of Flett et al. and Mercer et al. discloses the claimed invention as stated above in Claim 1, and Flett et al. further discloses wherein the guide body is capable of receiving a guide wire (442, Fig. 6-7, Paragraph [0087]) extending through the guide aperture, the guide wire capable of being attached to the center of a humeral head using at least the first movable guide member and the second movable guide member (The apertures 132 & 182 through 130 & 180 are fully and structurally capable of receiving a guide wire therethrough, with the guide wire being capable of being attached to a center of a humeral head, via 130 & 180. Paragraphs [0061, 0063, 0068]).
Regarding Claim 7, the combination of Flett et al. and Mercer et al. discloses the claimed invention as stated above in Claim 1, and Flett et al. further discloses wherein the first movable guide member and the second movable guide member are independently movable (via 140, 138 and 190, 188, Figs. 1-4, Paragraphs [0067-0068]).
Allowable Subject Matter
Claims 2-3, & 8-11 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 5-6 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
Claims 23-30 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 101, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The combination of Flett et al. and Mercer et al. discloses the claimed invention as stated above, except wherein the guide body comprises a third marker, the humeral head surgical guide further comprising: a third movable guide member coupled to the guide body comprising one or more third indicators, wherein the third movable guide member moves along the second axis; and a third supporting member comprising at least one third engagement feature, the third supporting member coupled to and extending from the third movable guide member, wherein the third marker is oriented relative to the one or more third indicators to indicate a third distance between the first axis and the at least one third engagement feature, a shaft defining a shaft aperture, the guide wire extending through the shaft aperture, the shaft comprising one or more fifth indicators, a first end, and a second end opposite the first end, wherein the one or more fifth indicators indicate a fifth distance between the second end and at least one of the at least one first engagement feature or the at least one second engagement feature, a gear coupled with the first movable guide member and the second movable guide member, wherein the gear maintains the at least one first engagement feature and the at least one second engagement feature at a same distance from the first axis, wherein the gear causes the first movable guide member and the second movable guide member to move at a same rate, and a first surgical apparatus, comprising: a first body defining a first aperture, wherein the guide wire extends through the first aperture; a first movable member extending around the first body, the first movable member movable along the first body; a cutting support member removably coupled with the first movable member, wherein the cutting support member guides a cutting member in cutting a humeral head; a second surgical apparatus, comprising: a body comprising a first portion and a second portion contiguous with the first portion, the first portion defining a track, the body defining a body aperture extending along a fourth axis through the first portion and the second portion, wherein the body aperture receives the guide wire attached to the center of the humeral head; and a coring member coupled to the second portion, the coring member comprising a plurality of cutting features, wherein the coring member removes at least a portion of the humeral head using the plurality of cutting features. Furthermore, no art was found which could have been used to reasonably modify Flett et al. or the combination with the claimed features without destroying the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
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