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 .
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a system or kit, classified in a61f2/4612.
II. Claims 18-20, drawn to a method, classified in a61b17/1739.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the system of invention I can be used in another and materially different process such as guiding drilling into Acetabulum .
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The groupings of patentably indistinct inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Jarrad Gunther on 9/4/26 a provisional election was made without traverse to prosecute the invention of group I, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 1-17 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 1 recites the limitation " a second arm" in line 6. It should read as “a second end”.
Claim 1 recites the limitation "the second end" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation " the second lateral side" in line 5. It should read as “the first lateral side”.
Claim 12 recites the limitation " the second lateral side" in line 5. 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)(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) 1, 5, 8-9, 11-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Keefer (US 20100082035 A1).
Keefer discloses a system fig. 2, comprising: a patient-specific guide including: a guide element 58 defining a lumen 60 that extends from a first side of the guide element to a second side of the guide element; a plurality of arms 56, each arm of the plurality of arms having a first end coupled to the guide element and extending to a second end such that each arm of the plurality of arms extends radially outward from the guide element fig. 2; and a plurality of peripheral pegs 54, each peripheral peg of the plurality of peripheral pegs coupled to the second end of a respective arm of the plurality of arms and extending from a lateral end to a medial end fig. 2, the medial end including an engagement surface 66, fig. 5 capable to conform to a three dimensional shape of a specific area of a border of a glenoid cavity of a scapula, wherein, when the patient-specific guide is coupled to the scapula such that each engagement surface of each peripheral peg of the plurality of peripheral pegs engages the specific area of the border of the glenoid cavity, the plurality of arms are spaced apart fig. 3 from a lateral surface of the glenoid cavity, wherein the patient-specific guide includes a handle (proximal portion of arm 56) coupled to and extend away from the guide element, wherein: the medial end of a first peripheral peg of the plurality of peripheral pegs capable to engage the specific area of a super-posterior border of the glenoid cavity; and the medial end of a second peripheral peg of the plurality of peripheral pegs is capable to engage of an anterior anatomical feature located at the specific area of the border of the glenoid cavity, wherein each peripheral peg of the plurality of peripheral pegs is capable to engage the specific area of the border of the glenoid cavity with a snap fit, wherein the guide element has a cylindrical shape fig. 2-3, wherein each arm of the plurality of arms 56 can be spaced from a lateral surface of the glenoid cavity of the patient when the patient-specific surface of each of the plurality of peripheral members engages the area of the border of the glenoid cavity of the patient, and wherein at least one peripheral member of the plurality of peripheral members is capable to engage a posterior border of the glenoid cavity of the patient.
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) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keefer in view of BOLLINGER (US 20140163564 A1).
Keefer fails to teach a pin guide sized and configured to be received within a portion of the lumen, wherein the pin guide defines a central aperture; and a pin sized and configured to be received within the central aperture defined by the pin guide, wherein the pin guide is configured to be coupled to the portion of the lumen via a friction fit, wherein pin guide is configured to be coupled to the portion of the lumen via locking conical tapers.
BOLLINGER teaches an insert 122, fig. 4 sized and configured to be received within a portion of lumen 127, wherein the insert 122 defines a central aperture 126; and a pin 230 sized and configured to be received within the central aperture 126 defined by the insert, wherein the insert is configured to be coupled to the portion of the lumen via a friction fit, wherein insert is configured to be coupled to the portion of the lumen 127 via locking conical tapers (para. 37).
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the guide element of Keefer with a tapered lumen to friction fit and receive an insert (pin guide) in view of BOLLINGER in order to enhance securing of the pin guide into the lumen of the guide element.
Claim(s) 6-7, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keefer in view of Iannotti (US 20120143267 A1).
Keefer fails to teach a strut having a first end coupled to the guide element, the strut extending radially outward from the guide element, wherein the strut defines a slot, the slot having a longitudinal axis that identifies the supero-inferior axis of the glenoid prosthesis and identifying a rotational position of the glenoid guide about an axis of the lumen.
Iannotti teaches a strut 428’, figs. 34-37 having a first end coupled to the guide element, the strut extending radially outward from the guide element, wherein the strut defines a slot figs. 34-37, the slot having a longitudinal axis that identifies the supero-inferior axis of the glenoid prosthesis and identifying a rotational position of the glenoid guide about an axis of the lumen.
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the guide element of Keefer with a strut in view of Iannotti in order to facilitate inserting a landmark in the secondary patient tissue area for securing and alignment purposes.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keefer in view of Iannotti, and further in view of BOLLINGER.
Keefer in view of Iannotti fail to teach a pin guide sized and configured to be received within a portion of the lumen, wherein the pin guide defines a central aperture; and a pin sized and configured to be received within the central aperture defined by the pin guide, wherein the pin guide is configured to be coupled to the portion of the lumen via a friction fit, wherein pin guide is configured to be coupled to the portion of the lumen via locking conical tapers.
BOLLINGER teaches an insert 122, fig. 4 sized and configured to be received within a portion of lumen 127, wherein the insert 122 defines a central aperture 126; and a pin 230 sized and configured to be received within the central aperture 126 defined by the insert, wherein the insert is configured to be coupled to the portion of the lumen via a friction fit, wherein insert is configured to be coupled to the portion of the lumen 127 via locking conical tapers (para. 37).
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the guide element of Keefer in view of Iannotti with a tapered lumen to friction fit and receive an insert (pin guide) further in view of BOLLINGER in order to enhance securing of the pin guide into the lumen of the guide element.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keefer in view of Frey (US 20130218163 A1).
Keefer fails to teach that the lateral end of at least one peripheral peg of the plurality of peripheral pegs includes an identifier.
Frey teach that the lateral end of at least one peripheral peg 354, fig. 42a of the plurality of peripheral pegs includes an identifier fig. 42a.
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the peripheral pegs of Keefer with identifiers in view of Frey in order to assisting the user in correctly placing the system with respect to the bone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775
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