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 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 3-4 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 3 Applicant uses the claim phrase “in particular defining a honeycomb structure”. It is unclear if the honeycomb structure is required or optional as “in particular” does not ascertain the necessity of the following limitation.
For the purpose of examination, the claim has been interpreted that the “in particular” is purely optional”.
Claim 4 is rejected under 35 U.S.C. 112(b) as it depends from a rejected base claim and does not rectify the issue at hand.
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.
Claims 1-12 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Unger et al. (US 2020/00261243).
Regarding claim 1, Unger et al. disclose an element for augment or bone filler,
Comprising at least one first outer-layer portion (102) having a trabecular lattice (110) of metallic material (¶35), and at least one reinforcing inner layer (130) of said metallic material, said at least one reinforcing inner layer having a plurality of channel structures (140’s) arrayed with respective channel openings delimited by edges in structural contact with said at least one first outer-layer portion (figures 5, 7, 14 and 16-24), wherein said metallic material is made entirely and simultaneously by additive manufacturing and has structural continuity at least between said at least one first outer-layer portion and said at least one reinforcing inner layer (¶34, ¶52).
Regarding claim 2, Unger et al. disclose the trabecular lattice has a cell porosity with a first dimension, and wherein said channel structures have channel equivalent diameter with a second dimension greater than said first dimension (figures 5, 7, 14, 16-24). Regarding claim 3, Unger et al. disclose the channel structures are adjoining and substantially aligned (the structures are all connected to one another and are aligned in both an array and in layers on top of one another), in particular defining a honeycomb structure. Regarding claim 4, Unger et al. disclose the channel structures are partially diverging from each other, to follow a slanted contour surface of said element (figures 11-12, 14). Regarding claim 5, Unger et al. disclose the channel structures are arrayed along a prevalent stress direction of said element (vertical direction), and wherein said element is configured to be subject to a prevalent stress in said direction (via the stress applied from the adjacent vertebral bodies). Regarding claim 6, Unger et al. disclose the channel structures comprise respective through channel cavities (figure 14).
Regarding claim 7, Unger et al. disclose the at least one reinforcing inner layer further comprises a bulk reinforcement (190, figure s13-14) transversal to said channel structures, thus defining non-through channel cavities (figures 13-14). Regarding claim 8, Unger et al. disclose at least one second outer-layer portion (101) having said trabecular lattice of metallic material and positioned opposite said at least one first outer-layer portion with respect to said reinforcing inner layer (figures 9-14), wherein respective second channel openings of said plurality of channel structures are further delimited by second edges in structural contact with said at least one second outer-layer portion (figures 5, 7, 14, 16-24).
Regarding claim 9, Unger et al. disclose at least one third outer-layer portion (104) with bulk thin shell of metallic material (¶34, ¶52) configured to at least partially surround said element laterally to said reinforcing inner layer (figures 9, 11, 18, 20, 22). Regarding claim 10, Unger et al. disclose at least one fourth outer-layer portion (104) of trabecular metallic material configured to at least partially surround said element laterally to said reinforcing inner layer (figures 9, 11, 18, 20, 22).
Regarding claim 11, Unger et al. disclose a bulk protruding profile (190) of metallic material on a surface opposite said at least one first outer-layer portion (figures 13-14), said bulk protruding profile being configured for a positive-locking fit with a further prosthesis component (if one so chooses).
Regarding claim 12, Unger et al. disclose at least one hole (105, figures 11, 14, 18, 20, 22-23) configured for inserting a connecting screw to connect to a further prosthesis component or directly to a bone (¶27, ¶50).
Regarding claim 14, Unger et al. disclose the at least one first outer-layer portion having said trabecular lattice of metallic material occupies at least 45% of a surface of a respective side of said element (figures 1-25). Regarding claim 15, Unger et al. disclose the metallic material comprises titanium (¶28, ¶34, ¶52).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
