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 1 is objected to because of the following informalities: In Line 11, the word --and-- should be added after the semi-colon. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: In Line 12, the word --and-- should be added after the semi-colon. Appropriate correction is required.
Claim 20 is objected to because of the following informalities:
In Line 3, the word --first-- should be added before the word “circumferential”.
In Line 13, the word --and-- should be added after the semi-colon. 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 1-20 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 at Line 1 recites the limitation "a longitudinal axis" and Line 7 further recites “the lengthwise axis”, which renders the claim indefinite as it is unclear if the lengthwise axis is the same as the longitudinal axis previously recited in Line 1, or if two separate axes are being recited. It is noted that Claim 1 further recites “the longitudinal axis” in Line 15, and Claims 2, 5 & 8 also recite "said longitudinal axis", while Claims 2-6 further recite “the lengthwise axis”. For purposes of examination, Claim 1 is being interpreted as only having one recited longitudinal/lengthwise axis and thus all instances of “the lengthwise axis” will be interpreted as "the longitudinal axis", to include the instances in the dependent claims. Appropriate correction is required.
Claim 18 at Line 1 recites the limitation "a longitudinal axis" and Line 7 further recites “said lengthwise axis”, which renders the claim indefinite as it is unclear if the lengthwise axis is the same as the longitudinal axis previously recited in Line 1, or if two separate axes are being recited. It is noted that Claim 18 further recites “the longitudinal axis” in Line 16, and Claim 19 also recites "the longitudinal axis". For purposes of examination, Claim 18 is being interpreted as only having one recited longitudinal/lengthwise axis and thus all instances of “the lengthwise axis” will be interpreted as "the longitudinal axis". Appropriate correction is required.
Claim 20 at Line 1 recites the limitation "a longitudinal axis" and Line 7 further recites “said lengthwise axis”, which renders the claim indefinite as it is unclear if the lengthwise axis is the same as the longitudinal axis previously recited in Line 1, or if two separate axes are being recited. It is noted that Claim 20 further recites “the longitudinal axis” in Line 17. For purposes of examination, Claim 20 is being interpreted as only having one recited longitudinal/lengthwise axis and thus all instances of “the lengthwise axis” will be interpreted as "the longitudinal axis. Appropriate correction is required.
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.
Claim(s) 1-16 & 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glerum et al. (US PG Pub No. 2014/0180421).
Regarding Claim 1 as best understood, Glerum et al. discloses an expandable intervertebral spacer (10, Figs. 26-30, 1-9, 35-36, Paragraphs [0053-0122]) having a longitudinal axis (axis running centrally through length of 10), said expandable intervertebral spacer comprising: a main body (12, Fig. 26, Paragraph [0103]) defining a first opening (36, Fig. 2, Paragraph [0085]); a driving member (18, Fig. 26, Paragraph [0103]) defining a second opening (bore 63, Fig. 4) axially aligned with the first opening and a first plurality of steps (lower steps 60, 58, third step of 51 not numbered in Fig. 26 & Fig. 2, See examiner annotated Fig. 26 below), Paragraph [0063]) each including a surface that lies on a plane disposed at a non-parallel and non-perpendicular angle to the longitudinal axis (Fig. 26); a first endplate (lower endplate 16, Fig. 26, Paragraph [0103]) defining a first external surface (lower 50, Fig. 4, Paragraphs [0059, 0062]) of the spacer and a protrusion (extension 44 of 16, Fig. 2, Paragraphs [0059-0060]) defining a second plurality of steps (48, 46, and third step of extension 44 of 16 not depicted in Fig. 4, See examiner annotated Fig. 26 below) that structurally interfaces with the first plurality of steps (Figs. 5-6, Paragraph [0060]); a second endplate (upper endplate 14, Fig. 26, Paragraph [0103]) defining a second external surface of the spacer (upper 50, Fig. 4, Paragraphs [0059, 0062]); an actuation member (20, Fig. 26, Paragraph [0103]) extending through the first opening and in the second opening (Fig. 27); wherein rotational movement of the actuation member moves the driving member linearly along the longitudinal axis (Paragraphs [0076-0077]); and wherein linear movement of the driving member forces the first and second endplates to move away from the main body to transition the spacer from a first, unexpanded configuration to a second, expanded configuration (Paragraphs [0076-0077]).
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Regarding Claim 2, Glerum et al. discloses wherein the driving member defines a third plurality of steps opposite the first plurality of steps with respect to the longitudinal axis (See examiner annotated Fig. 26 above); wherein each step includes a surface that lies on a plane disposed at a non-parallel and non-perpendicular angle to the longitudinal axis (Figs. 2 & 26).
Regarding Claim 3, Glerum et al. discloses wherein the second endplate (14) defines a protrusion (extension 44 of 14, Figs. 2 & 26, Paragraphs [0059-0060]) defining a fourth plurality of steps that structurally interfaces with the third plurality of steps (48, 46, and third step of extension 44 of 14, not clearly depicted in Fig. 26, See Figs. 2, 4, 30 for similar arrangement with only two corresponding expansion portions instead of three, Paragraph [0063]); wherein at least one step of the fourth plurality of steps includes a surface that lies on a plane disposed at a non-parallel and non-perpendicular angle to the longitudinal axis (Fig. 4).
Regarding Claim 4, Glerum et al. discloses wherein each step of the first plurality of steps includes a surface that lies on a plane disposed at a non-parallel and non-perpendicular angle to the longitudinal axis (Fig. 26).
Regarding Claim 5, Glerum et al. discloses wherein the driving member (18) defines a third plurality of steps opposite the first plurality of steps with respect to the longitudinal axis (See examiner annotated Fig. 26 above); wherein each step of the third plurality of steps includes a surface that lies on a plane disposed at a non-parallel and non-perpendicular angle to the longitudinal axis (Fig. 26).
Regarding Claim 6, Glerum et al. discloses wherein the second endplate (14) defines a protrusion (extension 44 of 14, Figs. 2 & 26, Paragraphs [0059-0060]) defining a fourth plurality of steps (48, 46, and third step of extension 44 of 14, not clearly depicted in Fig. 26, See Figs. 2, 4, 30 for similar arrangement with only two corresponding expansion portions instead of three, Paragraph [0063]) that structurally interfaces with the third plurality of steps; wherein each step of the fourth plurality of steps includes a surface that lies on a plane disposed at a non-parallel and non-perpendicular angle to the longitudinal axis (Fig. 4).
Regarding Claim 7, Glerum et al. discloses wherein the main body defines a plurality of openings extending through a thickness of the main body (See examiner annotated Fig. 26 above).
Regarding Claim 8, Glerum et al. discloses wherein the main body includes first and second lateral surfaces on opposite sides of the longitudinal axis; and wherein at least one opening of the plurality of openings extends through a thickness of the first lateral surface (See examiner annotated Fig. 26 above).
Regarding Claim 9, Glerum et al. discloses wherein at least one opening of the plurality of openings extends through a thickness of the second lateral surface (See examiner annotated Fig. 26 above).
Regarding Claim 10, Glerum et al. discloses wherein the first endplate defines a second plurality of openings extending through a thickness of the first endplate (See examiner annotated Fig. 26 above showing openings in 14, which is identical to endplate 16).
Regarding Claim 11, Glerum et al. discloses wherein each opening of a first set of openings of the plurality of openings extends through a thickness of the first lateral surface of the main body (See examiner annotated Fig. 26 above).
Regarding Claim 12, Glerum et al. discloses wherein each opening of a second set of openings of the plurality of openings extends through a thickness of the second lateral surface of the main body (See examiner annotated Fig. 26 above).
Regarding Claim 13, Glerum et al. discloses wherein the second endplate defines a third plurality of openings extending through a thickness of the second endplate (See examiner annotated Fig. 26 above).
Regarding Claim 14, Glerum et al. discloses wherein the driving member defines a fourth plurality of openings (circular apertures formed through 52, Fig. 26) extending through a thickness of the driving member.
Regarding Claim 15, Glerum et al. discloses wherein the main body defines a circumferential channel (channel through 26, Figs. 26-27, Paragraph [0058]); and further comprising a retaining member (90 and ring 602, Fig. 26 & Paragraphs [0118-119]) captive within the circumferential channel (via 20, Fig. 27).
Regarding Claim 16, Glerum et al. discloses wherein the actuation member defines a second circumferential channel (bore 85, Fig. 3, Paragraph [0065]); and wherein the retaining member is disposed within the second circumferential channel (Figs. 26-30).
Regarding Claim 18 as best understood, Glerum et al. discloses an expandable intervertebral spacer (10, Figs. 26-30, 1-9, 35-36, Paragraphs [0053-0122]) having a longitudinal axis (axis running centrally through length of 10), said expandable intervertebral spacer comprising: a main body (12, Fig. 26, Paragraph [0103]) defining a first opening (36, Fig. 2, Paragraph [0085]) and a circumferential channel (channel through 26, Figs. 26-27, See examiner annotated Fig. 26 above, Paragraph [0058]); a driving member (18, Fig. 26, Paragraph [0103]) defining a second opening (bore 63, Fig. 4) axially aligned with the first opening and a first plurality of steps (lower steps 60, 58, third step of 51 not numbered in Fig. 26 & Fig. 2, See examiner annotated Fig. 26 above), Paragraph [0063]) each including a surface that lies on a plane disposed at a non-parallel and non-perpendicular angle to the longitudinal axis (Fig. 26); a first endplate (lower endplate 16, Fig. 26, Paragraph [0103]) defining a first external surface (lower 50, Fig. 4, Paragraphs [0059, 0062]) of the spacer and a protrusion (extension 44 of 16, Fig. 2, Paragraphs [0059-0060]) defining a second plurality of steps (48, 46, and third step of extension 44 of 16 not depicted in Fig. 4, See examiner annotated Fig. 26 above) that structurally interfaces with the first plurality of steps (Figs. 5-6, Paragraph [0060]); a second endplate (upper endplate 14, Fig. 26, Paragraph [0103]) defining a second external surface of the spacer (upper 50, Fig. 4, Paragraphs [0059, 0062]); a retaining member (90 and ring 602, Fig. 26 & Paragraphs [0118-119]) captive within the circumferential channel (via 20, Fig. 27); an actuation member (20, Fig. 26, Paragraph [0103]) extending through the first opening and in the second opening (Fig. 27); wherein rotational movement of the actuation member moves the driving member linearly along the longitudinal axis (Paragraphs [0076-0077]); and wherein linear movement of the driving member forces the first and second endplates to move away from the main body to transition the spacer from a first, unexpanded configuration to a second, expanded configuration (Paragraphs [0076-0077]).
Regarding Claim 19, Glerum et al. discloses wherein the main body includes first and second lateral surfaces on opposite sides of the longitudinal axis and defines a plurality of openings extending through a thickness of one of the first and second lateral surfaces (See examiner annotated Fig. 26 above).
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) 17 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glerum et al. (US PG Pub No. 2014/0180421) in view of Olmos et al. (US PG Pub. No. 2008/0140207).
Regarding Claim 17, Glerum et al. discloses the claimed invention as stated above, except wherein the retaining member comprises a c-shaped member. Glerum et al. does disclose in Paragraphs [0119-0120] that the ring member 602 can be formed of a material different from 18 or 20 such as a polymer like PEEK, and that the ring member 602 can have a different shape.
Olmos et al. discloses an intervertebral implant comprising a retaining member in the form of a ring, wherein the ring can be an annular ring without a gap (Paragraph [0094]), or a split ring with a c-shape (55, Fig. 9A, Paragraph [0093]), and can be formed from an elastic material.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the ring of the implant of Glerum et al. to be a split ring with a c-shape as taught by Olmos et al. in order to allow the ring to resiliently engage the components within the implant and be more easily removed as needed.
Regarding Claim 20 as best understood, Glerum et al. discloses an expandable intervertebral spacer (10, Figs. 26-30, 1-9, 35-36, Paragraphs [0053-0122]) having a longitudinal axis (axis running centrally through length of 10), said expandable intervertebral spacer comprising: a main body (12, Fig. 26, Paragraph [0103]) defining a first opening (36, Fig. 2, Paragraph [0085]) and a first circumferential channel (channel through 26, Figs. 26-27, See examiner annotated Fig. 26 above, Paragraph [0058]); a driving member (18, Fig. 26, Paragraph [0103]) defining a second opening (bore 63, Fig. 4) axially aligned with the first opening and a first plurality of steps (lower steps 60, 58, third step of 51 not numbered in Fig. 26 & Fig. 2, See examiner annotated Fig. 26 above), Paragraph [0063]) each including a surface that lies on a plane disposed at a non-parallel and non-perpendicular angle to the longitudinal axis (Fig. 26); a first endplate (lower endplate 16, Fig. 26, Paragraph [0103]) defining a first external surface (lower 50, Fig. 4, Paragraphs [0059, 0062]) of the spacer and a protrusion (extension 44 of 16, Fig. 2, Paragraphs [0059-0060]) defining a second plurality of steps (48, 46, and third step of extension 44 of 16 not depicted in Fig. 4, See examiner annotated Fig. 26 above) that structurally interfaces with the first plurality of steps (Figs. 5-6, Paragraph [0060]); a second endplate (upper endplate 14, Fig. 26, Paragraph [0103]) defining a second external surface of the spacer (upper 50, Fig. 4, Paragraphs [0059, 0062]); an actuation member (20, Fig. 26, Paragraph [0103]) extending through the first opening and in the second opening (Fig. 27) and defining a second circumferential channel (bore 85, Paragraph [0065]); and a retaining member (90 and ring 602, Fig. 26 & Paragraphs [0118-119]) captive within the first circumferential channel and disposed within the second circumferential channel (via 20, Fig. 27); wherein rotational movement of the actuation member moves the driving member linearly along the longitudinal axis (Paragraphs [0076-0077]); and wherein linear movement of the driving member forces the first and second endplates to move away from the main body to transition the spacer from a first, unexpanded configuration to a second, expanded configuration (Paragraphs [0076-0077]).
Glerum et al. does not disclose that the retaining member is c-shaped. Glerum et al. does disclose in Paragraphs [0119-0120] that the ring member 602 can be formed of a material different from 18 or 20 such as a polymer like PEEK, and that the ring member 602 can have a different shape.
Olmos et al. discloses an intervertebral implant comprising a retaining member in the form of a ring, wherein the ring can be an annular ring without a gap (Paragraph [0094]), or a split ring with a c-shape (55, Fig. 9A, Paragraph [0093]), and can be formed from an elastic material.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the ring of the implant of Glerum et al. to be a split ring with a c-shape as taught by Olmos et al. in order to allow the ring to resiliently engage the components within the implant and be more easily removed as needed.
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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