DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to claim(s) below have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New rejections were made in view of applicant’s amendments. Applicant is welcome to contact the examiner if they have any questions.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The limitations in claims 32, 38 regarding “spaced apart from all portions of the head above a greatest diameter” was not disclosed in the original specification. The limitation of claim 38 related to the width of the seat being greater than a maximum width of the pressure member was also not recited in the original specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “greatest diameter of the head measured in a direction perpendicular to the central axis” in claims 32, 38, and “a width (of the seat) that is wider than a maximum width of the pressure member” in claim 38. must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 38-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 38 recites “a seat configured to extend around the longitudinal axis to pivotably hold the head therein while remaining spaced apart from all portions of the head above a greatest diameter of the head measured in a direction perpendicular to the central axis” which was never previously recited in the claims or in the specification. Looking into the specification, it seems that the seat is feature #53 of the insert piece #5 as seen in Fig 5c-5d of the application, a seat #53 would be located below the greatest diameter of the head measured along a central axis of the anchoring element, see Fig 9a. But claim 38 further recites “wherein the seat is configured to assume a width that is wider than a maximum width of the pressure member” which was never disclosed in the specification and the drawings are not clear enough to say if the specification provides support for this limitation. Looking at the figures, the insert piece itself seems to be wider than the pressure member but not clear if the seat is. As such claims 38-43 recite new matter. As such Claim 38 has an effective filing date of the filing of the application March 1, 2024 (se MPEP 211.05). Should applicant claim an insert piece having a width larger than the pressure member, then Jackson US 2008/0154315 would read on the claim (see rejection for claim 32 below and see paragraph 50 where the insert piece #12 is flexible and is able to expand and have a width larger than the pressure member).
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 32-43 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 32 recites the limitation "the central axis" in line 9. There is insufficient antecedent basis for this limitation in the claim. The examiner will treat with art as best understood.
Claim 38 recites the limitation "the central axis" in line 9. There is insufficient antecedent basis for this limitation in the claim. The examiner will treat “central axis” as referring to a central axis of the anchoring element.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 28 is not further limiting because the seat and receiving part are physical objects and thus the seat will always form “an angle” relative to the receiving part and thus the longitudinal axis that extends through the receiving part. It is noted that a specific angle is not claimed. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,937,852 (hereinafter ‘852) in view of Farris US 2005/0080420.
Regarding Claim 1, ‘852 discloses a polyaxial bone anchoring device (preamble claim 10) comprising:
an anchoring element having a shaft for anchoring in a bone and a head (col 12 lines 33-34);
a receiving part configured to be pivotably connected to the head, the receiving part having a top end and a bottom end, a longitudinal axis extending through the top end and the bottom end, a channel transverse to the longitudinal axis for receiving a rod, and an accommodation space for accommodating the head (col 12 lines 35-40);
a seat configured to hold the head in the receiving part (col 12 lines 40-42),
a pressure member positionable at least partially in the accommodation space to exert pressure on the head (col 12 lines 43-44);
wherein when the head is held in the seat, the seat, and the pressure member are insertable together from the bottom end of the receiving part and securable in the receiving part while a rotational orientation of the seat relative to the longitudinal axis remains constant (col 12 line 45-52).
‘852 does not disclose a seat configured to extend uninterruptedly around a majority of a circumference around the longitudinal axis to hold the head in the receiving part.
Farris discloses a seat (#232, Fig 8) configured to extend uninterruptedly around a majority of a circumference (Fig 8) around the longitudinal axis (axis “L” in Fig 5) of a receiver part (#49) to hold a head (#47) of an anchoring element (#31) in the receiving part (paragraph 32, 36).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify the seat of ‘852 to extend uninterruptedly around a majority of a circumference around the longitudinal axis to hold the head in the receiving part in view of Farris above because this provides a known configuration for a seat to hold a head of a bone anchoring element.
Regarding Claim 27, ‘852 as modified discloses wherein the seat forms a closed ring that extends uninterruptedly entirely around the longitudinal axis (Fig 8 in Farris).
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,937,852 (hereinafter ‘852) in view of Jackson US 2008/0154315.
Regarding Claim 32, ‘852 discloses a polyaxial bone anchoring device (preamble claim 10) comprising:
an anchoring element having a shaft for anchoring in a bone and a head (col 12 lines 33-34);
a receiving part configured to be pivotably connected to the head, the receiving part having a top end and a bottom end, a longitudinal axis extending through the top end and the bottom end, a channel transverse to the longitudinal axis for receiving a rod, and an accommodation space for accommodating the head (col 12 lines 35-40);
a seat configured to extend around the longitudinal axis to pivotably hold the head therein (Col 12 lines 40-42); and
a pressure member positionable at least partially in the accommodation space to exert pressure on the head (col 12 lines 43-44);
wherein the seat is insertable from the bottom end of the receiving part into the receiving part and configured to be arranged at an angle relative to the longitudinal axis (Col 12 lines 45-52) and wherein when the seat held is in the receiving part, the head is restricted from being inserted from the bottom end of the receiving part into the accommodation space (examiner notes that this is intended use, and when the insert piece and seat of ‘852 are in the receiving part, they would at least partially block the bottom end and thus would at least restrict the head from being inserted from the bottom end).
‘852 does not disclose a seat configured to extend around the longitudinal axis to pivotably hold the head therein while remaining spaced apart from all portions of the head above a greatest diameter of the head measured in a direction perpendicular to the central axis.
Jackson discloses a polyaxial bone anchoring device (abstract, Fig 1) comprising:
an anchoring element having a shaft for anchoring in a bone and a head (see Fig below);
a receiving part (see Fig below) configured to be pivotably connected to the head (paragraph 39), the receiving part having a top end and a bottom end, a longitudinal axis extending through the top end and the bottom end (see Fig below), a channel transverse to the longitudinal axis for receiving a rod (see Fig below), and an accommodation space for accommodating the head (where head is located in Fig 3);
a seat (#94, see Fig below where insert #12 has a seat #94) configured to extend around the longitudinal axis to pivotably hold the head therein while remaining spaced apart from all portions of the head above a greatest diameter of the head measured in a direction perpendicular to the central axis (see Fig below, Fig 3 where the seat #94 is located below the greatest diameter of the head measured in a direction normal to the central axis and thus is it is spaced apart from all portions of the head above the greatest diameter); and
a pressure member (see Fig below) positionable at least partially in the accommodation space to exert pressure on the head (Fig 3);
wherein the seat is insertable from the bottom end of the receiving part into the receiving part and configured to be arranged at an angle relative to the longitudinal axis (paragraph 61, it is noted that the seat is part of insert #12 and would be inserted at an angle relative to the longitudinal axis, it also noted that the specific angle is not being claimed), and wherein when the seat held is in the receiving part, the head is restricted from being inserted from the bottom end of the receiving part into the accommodation space (examiner notes that this is intended use, and when the insert #12 and seat #94 are in the receiving part, they would at least partially block the bottom end and thus would at least restrict the head from being inserted from the bottom end).
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It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify ‘852 to have the seat be at a lower end of the insert piece such that it is located at the bottom of the head in view of Jackson above because this provides a known configuration for a seat to hold a head. With the modification, the seat would be at the bottom of the head and thus it is spaced apart from all portions of the head above the greatest diameter.
Claims 33-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,937,852 (hereinafter ‘852) and Jackson US 2008/0154315, as applied to claim 32 above and in further view of Farris US 2005/0080420.
‘852 as modified does not disclose the seat configured to extend uninterruptedly around a majority of a circumference around the longitudinal axis to hold the head in the receiving part, the seat forms a closed ring that extends uninterruptedly entirely around the longitudinal axis (Fig 8 in Farris).
Farris discloses an insert piece (#232, Fig 8) with a seat (lower edge adjacent to #258, #258a-b, see Fig below) configured to extend uninterruptedly around a majority of a circumference (Fig 8) around the longitudinal axis (axis “L” in Fig 5) of a receiver part (#49) to hold a head (#47) of an anchoring element (#31) in the receiving part (paragraph 32, 36).
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It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify the seat of ‘852 as modified to extend uninterruptedly around a majority of a circumference around the longitudinal axis to hold the head in the receiving part and form a closed ring in view of Farris above because this provides a known configuration for a seat to hold a head of a bone anchoring element.
Claim Rejections - 35 USC § 102
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1, 4-5, 28-31 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Jackson US 2008/0154315.
Regarding Claim 1, Jackson discloses a polyaxial bone anchoring device (abstract, Fig 1) comprising:
an anchoring element having a shaft for anchoring in a bone and a head (see Fig below);
a receiving part (see Fig below) configured to be pivotably connected to the head (paragraph 39), the receiving part having a top end and a bottom end, a longitudinal axis extending through the top end and the bottom end, a channel transverse to the longitudinal axis for receiving a rod (see Fig below), and an accommodation space for accommodating the head (where head is located in Fig 3);
a seat (see Fig below) configured to extend uninterruptedly around a majority of a circumference (see Fig below, Fig 8-10 where it extends over 180 degrees, nearly 360 degrees, about the longitudinal axis) around the longitudinal axis to hold the head in the receiving part (Fig 3),
a pressure member (see Fig below) positionable at least partially in the accommodation space to exert pressure on the head (see Fig 3);
wherein when the head is held in the seat, the seat, and the pressure member are insertable together from the bottom end of the receiving part and securable in the receiving part while a rotational orientation of the seat relative to the longitudinal axis remains constant (examiner notes that this is intended use, paragraph 61 where the head can be held in the seat and the pressure member placed over the head and seat and able to be placed through the bottom end while the orientation of the seat relative to the head remain constant).
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Regarding Claim 4, Jackson discloses the pressure member is configured to directly contact the head in the receiving part (as seen in Fig 3).
Regarding Claim 5, Jackson discloses wherein when the pressure member is in contact with the head in the receiving part, the pressure member and the seat are configured to be completely spaced apart from one another (as seen in Fig 3).
Regarding Claim 28, Jackson discloses the seat is configured to be arranged at an angle relative to the longitudinal axis (as seen in Fig 3, see also 112 rejection above, the seat will always form an angle relative to the longitudinal axis as the receiving part and seat are physical objects).
Regarding Claim 29, Jackson discloses the seat is tiltable in the receiving part (end of paragraph 61, “multi- or compound articulation..”).
Regarding Claim 30, Jackson discloses the seat and the anchoring element are independently tiltable in the receiving part (end of paragraph 61, “multi- or compound articulation..”).
Regarding Claim 31, Jackson discloses the seat is configured to directly engage the receiving part (as seen in Fig 3).
Claims 32-33, 35-37 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Jackson US 2008/0154315.
Regarding Claim 32, Jackson discloses a polyaxial bone anchoring device (abstract, Fig 1) comprising:
an anchoring element having a shaft for anchoring in a bone and a head (see Fig below);
a receiving part (see Fig below) configured to be pivotably connected to the head (paragraph 39), the receiving part having a top end and a bottom end, a longitudinal axis extending through the top end and the bottom end (see Fig below), a channel transverse to the longitudinal axis for receiving a rod (see Fig below), and an accommodation space for accommodating the head (where head is located in Fig 3);
a seat (#94, see Fig below where insert #12 has a seat #94) configured to extend around the longitudinal axis to pivotably hold the head therein while remaining spaced apart from all portions of the head above a greatest diameter of the head measured in a direction perpendicular to the central axis (see Fig below, Fig 3 where the seat #94 is located below the greatest diameter of the head measured in a direction normal to the central axis and thus is it is spaced apart from all portions of the head above the greatest diameter); and
a pressure member (see Fig below) positionable at least partially in the accommodation space to exert pressure on the head (Fig 3);
wherein the seat is insertable from the bottom end of the receiving part into the receiving part and configured to be arranged at an angle relative to the longitudinal axis (paragraph 61, it is noted that the seat is part of insert #12 and would be inserted at an angle relative to the longitudinal axis, it also noted that the specific angle is not being claimed), and wherein when the seat held is in the receiving part, the head is restricted from being inserted from the bottom end of the receiving part into the accommodation space (examiner notes that this is intended use, and when the insert #12 and seat #94 are in the receiving part, they would at least partially block the bottom end and thus would at least restrict the head from being inserted from the bottom end).
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Regarding Claim 33, Jackson discloses wherein the seat is configured to extend uninterruptedly around a majority of a circumference around the longitudinal axis (see Fig in claim 32, Fig 8-10 where it extends over 180 degrees, nearly 360 degrees, about the longitudinal axis).
Regarding Claim 35, Jackson discloses the seat is tiltable in the receiving part (end of paragraph 61, “multi- or compound articulation..”).
Regarding Claim 36, Jackson discloses the seat and the anchoring element are independently tiltable in the receiving part (end of paragraph 61, “multi- or compound articulation..”).
Regarding Claim 37, Jackson discloses the head is insertable from the bottom end of the receiving part into the accommodation space prior to inserting the seat into the receiving part (this limitation is intended use and see Fig 3, paragraph 50 the head is able to be inserted first while the seat is located in the neck area #26).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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, Eduardo Robert can be reached 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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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773