DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This Office action is in response to the amendment filed 11/03/2025. Claims 1, 2, 5, 9-10, 12-13 and 15-26 are pending.
Election/Restrictions
Applicant’s election without traverse of Species 2 in the reply filed on 11/03/2025 is acknowledged.
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 2 is 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 2 includes the recitation of “a first end of the first elongated element.” It is noted that claim 1 previously recites “a first enlarged end at an end of the first elongated element.” It is unclear if Applicant is referring back to the previously recited first enlarged end or trying to identify a separate structure with the reference to “a first end” in claim 2. For purposes of examination the recited first end of claim 2 will be interpreted as the first enlarged end.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 2, 5, 9, 10, 12, 13, 15, 16 and 21-26 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Abdou (U.S. 2008/0243186 A1).
Concerning claim 1, Abdou discloses an adjustable articulating spinal rod assembly (see Fig. 3), the assembly comprising: a first elongated element (see below) for attachment to a first anatomical region, wherein the first elongated element comprises: a first enlarged end (see below) at an end of the first elongated element; a second elongated element (see below) for attachment to a second anatomical region, wherein the second elongated element comprises: a second enlarged end (see below) at an end of the second elongated element; and at least one coupling member see below) connecting the first elongated element with the second elongated element, the at least one coupling member comprising:
a body (see below) having a first opening (see below), a second opening (see below), and two third openings (see below), wherein the first opening is at a first end of the body, the second opening is at a second end of the body, and the two third openings are positioned on a side of the body between the first end and the second end and extends through the body into at least one socket (see below); and
two locking mechanisms (see element 125 below) received within the two third openings; wherein the first elongated element extends through the first opening to position the first enlarged end in the at least one socket; wherein the second elongated element extends through the second opening to position the second enlarged end in the at least one socket; and wherein the two locking mechanisms (125) are inserted into the two third openings to engage a portion of at least one of the first enlarged end of the first elongated element and a portion of the second enlarged end of the second elongated element.
[AltContent: connector][AltContent: textbox (Threaded)][AltContent: arrow][AltContent: textbox (Socket)][AltContent: arrow][AltContent: textbox (Socket)][AltContent: textbox (Coupling Member)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Two Third Openings)][AltContent: connector][AltContent: textbox (Second Opening)][AltContent: connector][AltContent: textbox (First Opening)][AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (Second enlarged end)][AltContent: textbox (Second elongated Element)][AltContent: textbox (First enlarged end)][AltContent: textbox (First elongated Element)]
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Concerning claim 2, as best understood, wherein the first enlarged end (see Fig. 4 above) of the first elongated element is arcuate shaped.
Concerning claim 5, wherein the socket (see above) of the at least one socket at the first end of the body and the first end of the first elongated element is configured as a ball and socket joint (see pars. 0080 and 0088) and, wherein the socket of the at least one socket at the second end of the body and the first end of the second elongated element is configured as a ball and socket joint (see pars. 0080 and 0088).
Concerning claim 9, wherein the two locking mechanisms are threaded set screws (see Fig. 4, element 125).
Concerning claim 10, wherein at least one of the two threaded set screws comprises a tapered wedge portion ((305), wherein the tapered wedge portion of the threaded set screws pressingly engage at least one of the first enlarged end of the first elongated element and the second enlarged end of the second elongated element when at least one of the two locking mechanisms are in a locked position.
Concerning claim 12, wherein the two third openings of the body are threaded (see above) on at least a portion between an outer surface of the body into the at least one socket.
Concerning claim 13, wherein the threads (see above) of the two third openings are configured to engage two threaded set screws (125).
Concerning claim 15, wherein the body comprises an outer surface and is generally cylindrically shaped (see Fig. 3 below – generally the form of a cylinder) and wherein the outer surface has one or more tabs (see Fig. 3 below) extending outward from the outer surface.
[AltContent: arrow][AltContent: textbox (Marking)][AltContent: arrow][AltContent: textbox (Tab)]
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Concerning claim 16, wherein the body comprises an outer surface and is generally cylindrically shaped and wherein the outer surface has at least one marking or indicia (see Fig. 3 above) for measuring angular adjustments between the first elongated element and the second elongated element.
Concerning claim 21, wherein a first of the two third openings receives a first locking mechanism of the two locking mechanisms to engage at least a portion of the first enlarged end of the first elongated element, and wherein a second of the two third openings receives a second locking mechanism of the two locking mechanisms to engage at least a portion of the second enlarged end of the second elongated element (see Fig. 4 above).
Concerning claim 22, wherein the first opening is at an opposite end of the body from the second opening (see above).
Concerning claim 23, wherein at least one of the first opening and the second opening are generally elliptical (see Fig 3 above).
Concerning claim 24, wherein the two locking mechanisms are operable in an unlocked condition to allow polyaxial movement of the first elongated element and the second elongated element with respect to the at least one coupling member and wherein the two locking mechanisms are operable in a locked condition to fix the position of the first elongated element and the second elongated element with respect to the at least one coupling member (see par. 0081).
Concerning claim 25, wherein the body of the at least one coupling member comprises: a cylindrical portion (see Fig. 3 – noting that the body is shaped cylindrically); a first socket (see Fig. 4 above) at a first end of the cylindrical portion, wherein the first enlarged end of the first elongated element is received within the first spherical socket; and a second socket (see Fig. 4 above) at a second end of the cylindrical portion, wherein the second enlarged end of the second elongated element is received within the second spherical socket.
Concerning claim 26, wherein the first spherical socket (see Fig. 3 below) comprises one third opening (see Fig. 3 below) of the two third openings for receiving a first locking mechanism (set screw) of the at least one two locking mechanisms and wherein the second spherical socket (opposite side) comprises another third opening of the at least one two third openings for receiving a second locking mechanism of the at least one two locking mechanisms (set screw).
[AltContent: arrow][AltContent: textbox (One third opening)][AltContent: arrow][AltContent: textbox (1st spherical socket)]
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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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 17-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Abdou 2 (U.S. 2005/0288669 A1) in view of Abdou (U.S. 2008/0243186 A1).
Concerning claim 17, Abdou 2 discloses a first elongated element (see below), a second elongated element (see below), a third elongated element (see below) and a fourth elongated element (see below), wherein the third elongated element and the fourth elongated element are parallel to the first elongated element and second elongated element when the assembly is implanted in a spine.
[AltContent: arrow][AltContent: arrow][AltContent: textbox (4th elongated element)][AltContent: textbox (3rd elongated element)][AltContent: arrow][AltContent: arrow][AltContent: textbox (2nd elongated element)][AltContent: textbox (1st elongated element)]
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However, Abdou 2’s body includes a single third opening and locking mechanism – not two separate openings and locking mechanism received within the separate openings.
It would have been obvious to modify Abdou 2’s body by forming two separate third openings and two locking mechanisms, the concept of which is disclosed above by Abdou (see claim 1 above), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Furthermore, the ability to lock each rod section individually could be beneficial during implantation based on the particular anatomy of the patient.
Concerning claim 18, it is noted that the use of polyaxial pedicle screws to attach elongated supports to the spine is well known in the art. For example, Abdou discloses a screw assembly (see Fig. 15 below) comprising a bone screw; a rod receiver; and a securing element, wherein the rod receiver has a channel through which the elongated element passes.
[AltContent: connector][AltContent: textbox (Securing Element)][AltContent: connector][AltContent: textbox (Rod Receiver)][AltContent: arrow][AltContent: textbox (Bone screw)]
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It would have been obvious to one having ordinary skill in the art to utilize polyaxial pedicle screws to secure the free ends of the elongated elements to the spine, the concept of which is disclosed by Abdou, in order to provide proper support and attachment to various regions in an adjustable manner.
Concerning claim 19, wherein the at least one screw assembly is moveable along a length of the elongated element. It is noted that the polyaxial screw can be secured to the free end of the elongated element at various points along its length to attach to various anatomical regions.
Concerning claim 20, wherein the first elongated element and the third elongated element are connected to a plate member (see element 105 of Abdou 2 above), wherein the plate member is configured to be attached to a human skull.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Relating the concept of connecting elongated elements that support spinal segments. It is noted that the art further supports the concept of running spinal rod down a spine in a parallel fashion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
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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/ELLEN C HAMMOND/ Primary Examiner, Art Unit 3773