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 .
Priority
This application claims priority to a plurality of applications and provisional applications. The earliest support for the claimed subject matter is within provisional application 62619260, but there is a break in the chain of priority to this application. This application is CIP of both applications 15876695 and 15941193, but neither application has support for the claimed upper and lower anchors. Therefore, the chain of priority is broken. Additionally, it is noted that our system shows this application as a continuation of application 16/251,383, but this application has been left off of the current priority. Therefore, the priority for this application is the filing date of 04/24/2023.
Status of Claims
Claims 1-20 are pending.
Claims 6, 12-14, 17, and 20 have been withdrawn from consideration.
Election/Restrictions
Applicant elected with traverse Species 1 (Figures 1-6), Species 5U (Figures 24-25), and Species 8L (Figures 24-25) in the reply filed on 06/27/2025 is acknowledged. The applicant argues that their species are patentable indistinct, but this is not persuasive because each configuration comprises a variety of different shapes and configurations which would each require a separate search and considerations causing undue burden upon the examiner. The applicant has withdrawn claims 6, 12, and 17. Upon further review claims 13, 14, and 20 have also been withdrawn as being directed at a non- elected embodiment. Claims 13-14 require the circumferential thread matching the helix of the upper bone anchor, which is not disclosed as part of the elected embodiment. Claim 20 depends upon withdrawn claim 6. Therefore these claims have been withdrawn from consideration. The requirement is deemed proper and is therefore made FINAL.
Information Disclosure Statement
The Information Disclosure Statements filed on 08/09/2024 (x2) have been considered by the examiner.
Additionally the information disclosure statement has numerous citations stricken through. The applicant has cited whole US applications instead of individual documents and references from prosecution of these applications. This is the equivalent to citing an author or the entire work of an author rather than an individual book.
They are also stricken through because the office actions and other correspondence within those applications are not documents relevant to the patentability of the current claims. These documents may have citations to relevant documents, but the documents themselves are not relevant. They are not addressing the same claim language and were not drafted with the current claims in mind.
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 cylindrical cross-section (Claims 1, 2, 18, see 112 rejections for more details), an upper bone anchors with a metallic repeating unit cell lattice structure (Claim 9), and an irregular/irregular-cylindrical cross-section (Claims 18 and 19 see 112 rejections for more details) 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.
Specification
The abstract of the disclosure is objected to because it is over the 150 word limit and is not limited to a single paragraph. Correction is required. See MPEP § 608.01 (b).
The disclosure is objected to because of the following informalities: missing/outdated priority information. Since the filing of this application at least one of the parent applications have been issued patent numbers. The priority information within the first line of the specification must be amended to disclose these patent numbers.
Additionally the specification is objected to because it describes the details of Figures 21A and B but describes them as being Figures 20A and B. ([0128] of the published application.) Appropriate correction is required.
Additionally, the specification is objected to because it fails to disclose the requirements of claim 7. Claim 7 is an original claim so it is not considered to include new matter. The applicant is advised to add the exact language of claim 7 into the specification to avoid introduction of any new matter.
Claim Objection
Claim 1 is objected to for the following minor issue. Specifically lines 4 says “along entire circumferential surface thereof”, but should recite “along an entire circumferential surface thereof”.
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 1-5, 7-11, 15, 16, 18, and 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.
Claims 1-5, 7-11, 15, 16, 18, and 19 are rendered indefinite because the preamble of the independent claim clearly defines the invention as a single bone anchor, but then immediately defines upper and lower anchors. It is unclear how the two claimed anchors can be part of a single bone anchor. The applicant is advised to define the two anchors as portions or components of the single bone anchor.
Claims 1 and 2 are rendered indefinite by requiring cylindrical cross-sections. A cross-section is a 2D area so it cannot be cylindrical. The applicant is advised to define the overall shape as cylindrical not the cross-section.
Claim 9 is rendered indefinite for antecedent basis issues. Lines 2-3 recite “a the metallic repeating unit cell lattice structure”. The applicant is advised to delete “the” so that the claim defines the structure for the upper bone anchor and doesn’t refer back to the previously defined structure of claim 1 associated with the lower bone anchor.
Claim 15 is rendered indefinite for lack of antecedent basis. Claim 15 recited upper bone segment in lines 1-2 instead of upper bone anchor. The applicant is advised to amend the claim to say upper bone anchor.
Claim 16 is rendered indefinite because it has been amended to depend upon itself. The applicant is advised to amend claim 16 to depend upon claim 15.
Claim 16 is rendered indefinite for lack of antecedent basis. Claim 16 refers to “the substantially resorbable material” but the only material previously defined is the non-resorbable material of the upper bone anchor. The applicant is advised to amend claim 16 to introduce the non-resorbable material of the lower bone anchor.
Claim 18 is rendered indefinite by the requirement for an irregular cylindrical cross-section. As explained above a cross-section cannot be a 3D shape. Additionally, it is unclear how a cylindrical shape can be irregular when a cylindrical shape is inherently regular. Therefore, it is unclear what would and would not qualify as cylindrical shaped while being irregular. At some point there must be a shape too irregular that is no longer cylindrical, but a person of ordinary skill in the art would not be able to determine the scope of this phrase without further explanation.
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.
Claim(s) 1-5, 7-10, 15, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu US 2009/0287214 A1.
Yu discloses the invention substantially as claimed being bone anchor (Figure 1) for medical implants comprising a upper bone anchor 1 comprising a first attachment area (smaller threaded protrusion) and a lower bone anchor 2 comprising a second attachment area (internal threaded opening [0019]), wherein the upper and lower bone anchors are attached via a removable coupling of the first and second attachment areas (the threaded protrusion and opening are attachable and removable in the same manner as the applicant’s elected embodiment)
wherein the upper bone anchor comprises a cylindrical cross section (see 112 rejection above, but as best understood the cylindrical body of 1 reads upon this limitation as much as the applicant’s own invention) a helix shaped protrusion extending along an entire circumferential surface thereof (enlarged thread is shown extending multiple times around the circumference in Figure 1); lower bone anchor comprises a body having a metallic ([0019] discloses the entire device is made from metal) repeating unit cell lattice structure (figure 1 shows repeating cells within a mesh).
2. Yu as explained above discloses both anchors comprising as much of a cylindrical cross-section as the applicant’s invention. The lower anchor of Yu further discloses a first end comprising the second attachment area (right side of 2 in Figure 1 and described in [0019]). Yu does not specifically disclose the volumetric density of the porous network of the second end of the lower bone anchor. However, the claims define this as a region not the entire end or component. A region of the porous lattice structure of Yu can be identified to comprise a variety of shapes including only enough openings and solid structure to achieve a volumetric density of greater than 85%.
3. Yu discloses the second end of the lower bone anchor comprises a region that enhances tissue distraction (the second end has a bulbous volume that enhances distraction by occupying a large space).
4. and 5. Yu discloses the first attachment area comprises a threaded extension and the first second attachment area comprises a threaded opening that receives the threaded extension of the first attachment area (shown in Figure 1 and described in detail in [0019]).
7 and 8, Yu discloses the upper bone anchor 1 as a solid structure [0019] meaning it inherently has a 100% volumetric density.
9. Yu discloses the upper bone anchor the metallic repeating unit cell lattice structure (Figure 3 shows the upper bone anchor can also include the unit cell lattice structure).
10. Yu discloses the second elongate segment further lower bone anchor comprises a bone ingrowth enhancing surface treatment (the porous unit cell lattice structure on the surface of the lower bone anchor is considered to be a surface treatment which enhances ingrowth by providing space for the growth).
15. Yu discloses the upper bone anchor comprises a substantially non-resorbable material ([0019] discloses the use of titanium which is non-resorbable).
18. Yu discloses the upper bone anchor has an irregular cylindrical cross-section (see 112 rejection above, but as best understood, the upper bone anchor of Yu has external threads resulting in an irregular cylindrical cross-section).
19. Yu discloses the lower bone anchor comprises an irregular cross section (the lower bone anchor comprises a threaded inner opening which will result in an irregular cross-section).
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.
Claims 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yu US 2009/0287214 A1 in view of Biscup et al (Biscup) US 2005/0059972 A1.
Yu discloses the upper bone anchor with a smooth solid outer surface, but does not specifically state that it has a growth inhibiting coating
Biscup teaches the use of a bone screws comprising a coating for inhibiting bone growth [0020] in the same field of endeavor for the purpose of enabling the upper portion to be modified and adjusted without affecting the attachment to the implant site.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide a coating for inhibiting bone growth of Biscup to the upper bone anchor of Yu in order to enable the upper portion to be modified and adjusted without affecting the attachment of the lower bone anchor to the implant site.
Claim 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Trieu et al (Trieu) US 2007/0270858 A1.
Yu discloses the invention substantially as claimed being described above. However, Yu does not disclose of a resorbable material for further promoting ingrowth.
Trieu teaches the use of a bone screw comprising a solid first portion 1 and an open lattice second portion 40 comprising a degradable material [0025] in the same field of endeavor for the purpose of enabling complete ingrowth throughout the second portion.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to combine the degradable materials of Trieu with the lower bone anchor of Yu in order to promote gradual ingrowth throughout the entire area initially occupied by the second segment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached on Monday-Friday 10 am - 6 pm (HST).
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, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774