Detailed Action
This is the first office action on the merits for US application number 19/076,602.
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 .
Election/Restrictions
Applicant’s election of the product of invention I, of claims 1-15, in the reply filed on July 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1332” has been used to designate both a surface on Fig. 13A and an opposing surface on Fig. 13B. Examiner suggests amending the label on Fig. 13A to 1330 consistent with the disclosure of ¶124.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 and 10 is/are objected to because of the following informalities:
Claim 1 line 13 should read “a portion of the hand grip of the movable guide tool assembly”.
Claim 10 lines 13-16 should read “from a first position to a second position, the first position comprising the keel rasp head [[is ]]spaced apart at a first distance from the guide head, .
Appropriate correction is required.
Applicant is advised that should claim 8 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 1-15 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 recites/recite the limitation "the superior direction" in line 5. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the first one or more protrusions extending towards a superior direction;”.
Claim(s) 1 recites/recite the limitation "the inferior direction" in line 10. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the second one or more protrusions extending towards [[the]]an inferior direction,”.
Claim(s) 10 recites/recite the limitation "the superior direction" in line 5. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the first one or more protrusions extending towards a superior direction,”.
Claim(s) 10 recites/recite the limitation "the inferior direction" in line 9. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the second one or more protrusions extending towards [[the]]an inferior direction,”.
Claim(s) 2-9 and 11-15 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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 8 and 9 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). Claims 8 and 9 lines 2-3 “at least a portion of the first contact surface may contact or engage a bone surface” appears to claim the human body as a bone surface. Examiner suggests amending as “at least a portion of the first contact surface may be configured to contact or engage a bone surface” to address this rejection and will interpret these limitations as meaning that at least a portion of the first contact surface capable of contacting or engaging a bone surface.
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) 1, 2, 5, 6, 8, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schneid et al. (US 2008/0312705, hereinafter “Schneid”).
As to claim 1, Schneid discloses a keel alignment system (Figs. 1-5) comprising: a handle (56); a fixed keel rasp (12) disposed substantially in a first orientation or plane (Figs. 1-5), the fixed keel rasp comprising a keel rasp head (96), the keel rasp head comprising a first one or more protrusions (¶59 discloses that 96 is a rotatable milling head, ¶s 61 and 62 disclose using 96 for machining a groove in vertebral bodies for receiving a fin-like projection on a vertebral implant; thus, 96 comprises at least one protrusion to cut the bone when rotated), the first one or more protrusions extending towards a superior direction (Fig. 2, where ¶s 59, 61, and 62 disclose that 96 is a rotatable milling head used for machining a groove in vertebral bodies; thus, for the setup shown in Fig. 2, at least one of the one or more protrusions must extend upwardly/superiorly in order to contact the bone); and a movable guide tool assembly (12) disposed substantially in a second orientation or plane (Figs. 1-5), the movable guide arm removably coupled to the handle (via 54, 66, Figs. 2, 4, and 5, ¶53), the movable guide tool assembly comprising a guide arm (Figs. 2, 4, and 5), the guide arm including a guide head (84, 70, Figs. 1-3, ¶s 55 and 57) and a hand grip (22, Figs. 2, 4, and 5, ¶51), the guide head comprising a second one or more protrusions (88s), the second one or more protrusions extending towards an inferior direction (¶57 discloses that projections 88s form stops for vertebral bodies 16; thus, in order to contact the lower/inferior vertebral body, 88s must also extend downward/inferiorly), the movable guide tool assembly moves relative to the fixed keel rasp from the second orientation towards the first orientation until a portion of the hand grip contacts or engages at least a portion of the handle when compressing or squeezing a portion of the hand grip of the movable guide tool assembly to create a spacing between the guide head and the keel rasp head (Figs. 2, 4, and 5, ¶54 discloses that body 58 includes pins 68 that slide within grooves 44 and 46 so that 54 slides along a path defined by grooves 44 and 46 while holding rasp 14 which can therefore be moved in such manner relative to 20/12).
As to claim 2, Schneid discloses that the handle comprises a manual handle (Fig. 2).
As to claim 5, Schneid discloses that the first one or more protrusions comprise a plurality of sharp teeth (¶s 59, 61, and 62 disclose that 96 is a rotatable milling head used for machining a groove in vertebral bodies; thus, such are sufficiently sharp to cut vertebral bone).
As to claim 6, Schneid discloses that the first one or more protrusions comprise a plurality of sharp teeth (¶s 59, 61, and 62 disclose that 96 is a rotatable milling head used for machining a groove in vertebral bodies; thus, such are sufficiently sharp to cut vertebral bone) and the second one or more protrusions comprise a plurality of flat and smooth surfaces (Figs. 1-3).
As to claims 8 and 9, Schneid discloses that the guide head comprises a first contacting surface (72) and a second contact surface (74), at least a portion of the first contact surface may be capable of contacting or engaging a bone surface (¶55).
Allowable Subject Matter
Claims 3, 4, and 7 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 if rewritten as suggested or consistent with the interpretation set forth in this Office action 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 for the base claim and any intervening claims.
Claim 10 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, as suggested or consistent with the interpretation set forth in this Office action.
Claims 11-15 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 if rewritten as suggested or consistent with the interpretation set forth in this Office action 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 for the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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 or telephone the Examiner.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (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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/AMY R SIPP/Primary Examiner, Art Unit 3775
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