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 .
Applicant’s election without traverse of Group I, claims 1-23 in the reply filed on 09/23/2025 is acknowledged. Claims 24-26 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 4 and 17-19 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.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In claims 17-19, the phrase “the sacral bone” lacks proper antecedent basis.
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.
(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, 7, 9-13, 15-16 and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Folger et al. (2020/0197149; hereinafter Folger). Folger discloses a surgical sytem/rod shape visualisation device (20) which is inherently capable for providing information on the desired shape of a posterior spinal rod during a bending process whilst being arranged in a sterile operation area, the rod shape visualisation device comprising a sterile case (22, 50) including a housing portion (24, 26) having an entrance aperture (Fig. 5) and a cover (50) to seal the entrance aperture, the sterile case including an inner lumen (44) configured to come in contact with non-sterile or sterile object, and a non-sterile or sterile visualisation template (39) including a displaying side (a top side or bottom side as shown in Fig. 5) which is inherently capable of providing information on the desired shape of a posterior rod. The rod shape visualisation device of Folger defines a first, open state in which the cover is open (Fig. 5), and a second, closed state in which the cover is closed (Figs. 1-4), and in the closed state the displaying side of the visualization template is visibly arranged in the inner lumen (Folger discloses both sides of the sterile case may be fully made from clear or transparent material to provide access to the template disposed within the inner lumen [0048]).
As to claim 7, Folger discloses at least one side of the housing portion and/or the cover is transparent [0048].
As to claim 9, Folger further discloses the cover is coupled to the housing by a hinge coupling [0048].
As to claim 10, Folger discloses the housing is shaped as a box.
As to claim 11, Folger further discloses the housing and/or the cover has/have at least one handle defined by two cut-outs (25) to facilitate grasping which is considered equivalent to at least one handle as claimed [0059].
As to claim 12, Folger discloses the visualization template (39) is captured in a stable shell or covering (Fig. 5).
As to claim 13, Folger discloses the shell or covering comprises at least one handheld (see claim 11 above).
As to claim 15, Folger discloses the rod shape visualisation device comprises a rod holder (44, W1; Fig. 5) to hold the spinal rod (39) and the rod holder is placed on the housing portion.
As to claim 16, Folger discloses the rod holder is an integral part of the rod shape visualisation device.
As to claim 20, Folger further discloses the visualisation template is built of a plurality of smaller visualisation sub-templates ([0048]; Folger discloses the visualisation template comprises to long rods/sub-templates).
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.
Claim(s) 1-3, 5-7, 9-17 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powers et al. (2005/0033430; hereinafter Powers) in view of The Official Notice and/or Jacobson (2014/0346072).
As to claim 1, Powers discloses a surgical kit/rod shape visualisation device which is capable for providing information on the desired shape of a posterior rod during a bending process whilst being arranged in a sterile operation area, the rod shape visualisation device comprising an outer enclosure such as an outer box/sterile case ([0020], lines 14-19), it is old and conventional that the outer box comprising an entrance aperture and a cover to seal the entrance aperture, the outer box/sterile case comprising an inner lumen configured to come in contact with a packaging/non-sterile or sterile objects (14, 30, 32; [0024]); and a non-sterile or sterile visualisation template (50; Fig. 3) comprising a displaying side which is capable of providing information of the desired shape of a posterior rod. Powers discloses the rod shape visualisation device defines a first, open state in which the cover is open, and a second, closed state in which the cover is closed, and in the closed state the displaying side of the visualisation template is visibly arranged in the inner lumen (Powers discloses the visualisation template is attached to the exterior of an outer packaging container (32) while the outer packaging container disposed within the outer box, the visualisation template can be accessed by a surgeon or other medical personnel without having to open the outer box/sterile case ([0029] & [0050]). Powers also discloses the other claimed limitations. To the extent that Powers fails to disclose in the closed state the displaying side of the visualisation template is visibly arranged in the inner lumen while the visualisation template is attached to the exterior of the outer packaging container (32) while the outer packaging container disposed within the outer box, The Official Notice is taken of an old and conventional practice of providing an outer box for containing an object and the outer box formed from a transparent material to allow visual access to the object disposed within the outer box in a closed state. Jacobson, is cited by way of example only, teaches a sterile container (10) comprising an outer box (100), an inner box (200) for containing various surgical objects and the inner box disposed within the outer box. Jacobson further teaches the outer box and the inner box are formed from a transparent material [0088] for allowing a user to access to the various surgical objects without opening the boxes. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention in view of The Official Notice and/or Jacobson to modify the outer box/sterile case of Powers so the surgical kit/rod shape visualisation device is constructed with the outer box/sterile case from a transparent material to provide visual access to the non-sterile or sterile visualisation template in the closed state to provide more convenience for a user and also to prevent the objects from contamination.
As to claim 2, Powers discloses the visualisation template is a thin single-use object (50) including a graphical image (52) as claimed.
As to claim 3, it appears that the visualisation template of Powers is made of a medium or material selected from paper, cardboard, foil, plastic, steel, aluminum or any combination thereof as claimed. To the extent that Powers fails to disclose the visualisation template is made of a medium or material selected from paper, cardboard, foil, plastic, steel, aluminum or any combination thereof, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical kit/rod shape visualisation device of Powers as modified so the visualisation template is made of a medium or material selected from paper, cardboard, foil, plastic, steel, aluminum or any combination thereof since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
As to claim 5, to the extent that the rod shape visualisation device of Powers as modified further fails to disclose the length of the inner lumen is at least 60 cm, more preferably at least 70 cm as claimed, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rod shape visualisation device of Powers as modified so the sterile case is constructed with the length of the inner lumen is at least 60 cm, more preferably at least 70 cm the selection of the specific length of the inner lumen such as the length as claimed or as shown by Powers or Jacobson would have been an obvious matter of design choice for accommodating various types of objects.
As to claim 6, the rod shape visualisation device of Powers as modified comprises most of the limitations of the claim except for at least one of the sidewalls and/or the periphery comprises at least one marking or different colour as claimed. The Official Notice is taken of an old and conventional practice of providing a box comprising at least one of sidewalls having at least one marking or different colour. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention in view of The Official Notice to modify the rod shape visualisation device of Powers as modified so the sterile case is constructed with at least one of the sidewalls and/or the periphery comprises at least one marking or different colour to provide more convenience for a user. The at least one marking or different colour of the housing portion of Powers as modified is capable for allowing a non-sterile object or persons to contact.
As to claim 7, Jacobson discloses at least one side of the housing portion and/or the cover is transparent [0088].
As to claims 9 and 10, see Fig. 3 of Jacobson.
As to claim 11, Jacobson further teaches the inner box (300) comprises a handle (350; Fig. 61).
As to claim 12, Powers discloses the visualisation template is captured in a stable shell or covering (Powers discloses the visualisation template attached to the packaging 14).
As to claim 13, Jacobson teaches the covering comprises at least one handhold (350; Fig. 61).
As to claim 14, Powers further discloses the visualisation template comprises at least one first placement reference (Fig. 3 shows at least one size of bone anchors matches with complementarily bone anchors (22) disposed within the packaging (14)).
As to claim 15, Powers further discloses the rod shape visualisation device comprises a rod holder (34d) and the rod holder is placed on the housing portion (Fig. 2).
As to claim 16, Powers discloses the rod holder is an integral part of the rod shape visualisation device.
As to claim 17, Powers discloses the rod shape visualisation device comprises a rod holder (34d) is capable to hold a spinal rod as claimed.
As to claims 20 and 21, Powers further discloses the visualisation template comprises three rows of images. However, Powers fails to show the visualisation template is built of a plurality of smaller visualisation sub-templates in lieu of one large visualisation template. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rod shape visualisation device of Powers as modified so the visualisation template is constructed from a plurality of smaller visualisation sub-templates instead of one large visualisation template to facilitate separating from one size of images to another size of images to provide more convenience for a user.
Allowable Subject Matter
Claims 7, 8, 18-19 and 22-23 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 LUAN K BUI whose telephone number is (571)272-4552. The examiner can normally be reached Generally M-F, 7-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Avilés can be reached on 571-270-5531 or orlando.aviles-bosques@uspto.gov. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUAN K BUI/
Primary Examiner, Art Unit 3736