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 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, line 11, “sidewalls” lacks consistent antecedent basis.
Claim 11, line 14, “sidewalls” lacks consistent antecedent basis.
Claim 11, line 15, “an undulating outer surface” is unclear as “an undulating outer surface” was previously set forth, making unclear whether it is the same surface or a different surface.
Dependent claims are also rejected because they include the limitations of their respective parent claim(s).
Appropriate correction is required.
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.
Claims 1-11, 14-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wickham (2016/0022431).
Regarding claim 1, Wickham discloses a 3-D printed (i.e., using additive manufacturing techniques) intervertebral implant 14 (cf. Fig. 1; para. 0010) for implantation in an intervertebral space between vertebrae (paras. 0001 and 0009), the implant comprising:
a solid upper outer rim defined at the edge between the outer side wall 24 and the upper surface 18 and a solid upper inner rim defined at the edge between the inner side wall 22 and the upper surface 18, the upper outer and inner rims defining an upper surface 18;
a solid lower outer rim defined at the edge between the outer side wall 24 and the lower surface 20 and a solid lower inner rim defined at the edge between the inner side wall 22 and the lower surface 20, the lower outer and inner rims defining a lower surface 20;
a front end, an opposite rear end 64 and the opposed side walls 22, 24 extending between the ends and between the upper inner and outer rims (supra) and lower inner and outer rims (supra; cf. Fig. 1; para. 0022 and claim 17);
each of the side walls 22, 24 include a corrugated (i.e., undulating) wall (paras. 0023-0024) extending between the upper surface 18 and the lower surface 20 (para. 0022 and claim 17); and
a porous structure (supra; paras. 0019 and 0039) integrally formed (i.e., monolithically formed; para. 0019) in the side walls with the corrugated walls (supra), the implant being formed as a single 3-D printed structure (para. 0010, i.e., using additive manufacturing techniques).
It is noted that the side walls are clearly defined by Wickham as extending between the upper and lower surfaces 18, 20 (para. 0022 and claim 17). The size of the window in some embodiments (para. 0013 and claim 11) is not given, and the implant explicitly includes the side walls defined as extending between the upper and lower surfaces. Thus, a window in a wall does not change that the side walls extend between the upper and lower surfaces (e.g., at least about the window).
Regarding claim 2, the porous structure includes at least a repeating pattern (para. 0012 and cf. Fig. 1) of open pores (id.), and the porous structure is greater than 50% open (supra).
Regarding claim 3, the porous structure has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm.
Regarding claim 4, the porous structure has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm.
Regarding claim 5, the porous structure has a higher porosity along the inner rims than at least at the outer rims at the solid outer wall 64 (cf. Fig. 1) thereof. Note also that the modulus is defined as being low for ossification and high for mechanical robustness in a manner similar to bone (i.e., more porous central cancellous bone and more dense outer cortical bone) (e.g., paras. 0011, 0013).
Regarding claim 6, the porous structure has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm, and has a higher porosity along the inner rims than at least at the outer rims at the solid outer wall 64 (cf. Fig. 1) thereof. Note also that the modulus is defined as being low for ossification and high for mechanical robustness in a manner similar to bone (i.e., more porous central cancellous bone and more dense outer cortical bone) (e.g., paras. 0011, 0013).
Regarding claim 7, the porous structure has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm, and has a different porosity along the inner rims than at least at the outer rims at the solid outer wall 64 (cf. Fig. 1) thereof. Note also that the modulus is defined as being low for ossification and high for mechanical robustness in a manner similar to bone (i.e., more porous central cancellous bone and more dense outer cortical bone) (e.g., paras. 0011, 0013).
Regarding claim 8, the porous structure is greater than 50% open (supra) and has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm, and has a different porosity along the inner rims than at least at the outer rims at the solid outer wall 64 (cf. Fig. 1) thereof. Note also that the modulus is defined as being low for ossification and high for mechanical robustness in a manner similar to bone (i.e., more porous central cancellous bone and more dense outer cortical bone) (e.g., paras. 0011, 0013).
Regarding claim 9, a plurality of cross struts 30 extend between the upper outer rim (supra) and the upper inner rim (id.), and between the lower outer rim (id.) and the lower inner rim (id.), wherein each of the cross struts 30 defines a portion of a surface serration (cf. Fig. 1).
Regarding claim 10, an additional solid vertical structure, e.g., solid wall 64 and/or the solid rounded corners at the rear end (cf. Fig. 1), extend between the upper rims (supra) and the lower rims (id.) at the rear end, wherein the corrugated walls (i.e., undulating) walls (paras. 0023-0024) extend from the additional solid vertical structure (id.).
Regarding claim 11, Wickham discloses a 3-D printed (i.e., using additive manufacturing techniques) cervical intervertebral implant 14 for implantation in a cervical intervertebral space between vertebrae (cf. Fig. 1; paras. 0001 and 0009), the implant comprising:
a solid upper outer rim defined at the edge between the outer side wall 24 and the upper surface 18 and a solid upper inner rim defined at the edge between the inner side wall 22 and the upper surface 18, the upper outer and inner rims defining an upper surface 18;
a solid lower outer rim defined at the edge between the outer side wall 24 and the lower surface 20 and a solid lower inner rim defined at the edge between the inner side wall 22 and the lower surface 20, the lower outer and inner rims defining a lower surface 20;
a front end, an opposite rear end 64 and opposed side walls 22, 24 extending between the ends and between the upper inner and outer rims and lower inner and outer rims (supra);
a plurality of cross struts 30 extending between the upper outer rim (supra) and the upper inner rim (id.), and between the lower outer rim (id.) and the lower inner rim (id.);
each of the side walls 22, 24 including a corrugated (i.e., undulating) wall (paras. 0023-0024) extending between the upper surface 18 and the lower surface 20, and defining an undulating inner surface (id.) and an undulating outer surface (id.); and
a porous structure (supra; paras. 0019 and 0039) integrally formed (i.e., monolithically formed; para. 0019) in the sidewalls with the corrugated walls (supra) to cover both the undulating inner surface and an undulating outer surface of the corrugated walls (paras. 0019 and 0039), the implant 14 being formed as a single 3-D printed structure (para. 0010, i.e., using additive manufacturing techniques; para. 0019, i.e., monolithically formed) and the porous structure being greater than 50% open (the volume of a three-dimensional shape is at least greater than the volume of the shell/frame enclosing the volume; therefore, the total volume of the openings is greater than 50% of the total implant volume, i.e., at least 50% open).
Regarding claim 14, the porous structure has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm.
Regarding claim 15, the porous structure has a higher porosity along the inner rims than at least at the outer rims at the solid outer wall 64 (cf. Fig. 1) thereof. Note also that the modulus is defined as being low for ossification and high for mechanical robustness in a manner similar to bone (i.e., more porous central cancellous bone and more dense outer cortical bone) (e.g., paras. 0011, 0013).
Regarding claim 16, the porous structure has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm, and has a higher porosity along the inner rims than at least at the outer rims at the solid outer wall 64 (cf. Fig. 1) thereof. Note also that the modulus is defined as being low for ossification and high for mechanical robustness in a manner similar to bone (i.e., more porous central cancellous bone and more dense outer cortical bone) (e.g., paras. 0011, 0013).
Regarding claim 17, the porous structure has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm, and has a different porosity along the inner rims than at least at the outer rims at the solid outer wall 64 (cf. Fig. 1) thereof. Note also that the modulus is defined as being low for ossification and high for mechanical robustness in a manner similar to bone (i.e., more porous central cancellous bone and more dense outer cortical bone) (e.g., paras. 0011, 0013).
Regarding claim 19, a plurality of cross struts 30 extend between the upper outer rim (supra) and the upper inner rim (id.), and between the lower outer rim (id.) and the lower inner rim (id.), wherein each of the cross struts 30 defines a portion of a surface serration (cf. Fig. 1).
Regarding claim 20, an additional solid vertical structure, e.g., solid wall 64 and/or the solid rounded corners at the rear end (cf. Fig. 1), extend between the upper rims (supra) and the lower rims (id.) at the rear end, wherein the corrugated walls (i.e., undulating) walls (paras. 0023-0024) extend from the additional solid vertical structure (id.).
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 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 12, 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wickham (2016/0022431).
Regarding claim 12, the porous structure includes at least a repeating pattern of open pores, and the porous structure is at least 50% open (supra; cf. Fig. 1, paras. 0010-0014). Wickham teaches modifying the pores and modulus to approximate the modulus of bone and provide for bone ingrowth (id.), but does not explicitly recite the porous structure being greater than 60% open.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date to select a porosity such that the porous structure is greater than 60% open, e.g., to promote bone ingrowth and/or approximate the modulus of bone. It is further noted that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 13, the porous structure of the implant of Wickham has an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm.
Regarding claim 18, the porous is at least 50% open (supra; cf. Fig. 1, paras. 0010-0014). In addition, Wickham teaches modifying the pores and modulus to approximate the modulus of bone and provide for bone ingrowth (id.), but does not explicitly recite the porous structure being greater than 60% open.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date to select a porosity such that the porous structure is greater than 60% open, e.g., to promote bone ingrowth and/or approximate the modulus of bone. It is further noted that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
It is noted that Wickham teaches an average pore size of .75 mm (750 µm; para. 0014), which is between 200 µm and 900 µm, and a different porosity along the inner rims than outer rims; e.g., the porosity is greater along the inner rims than at least at the outer rims at the solid outer wall 64 (cf. Fig. 1) thereof. Note also that the modulus is defined as being low for ossification and high for mechanical robustness in a manner similar to bone (i.e., more porous central cancellous bone and more dense outer cortical bone) (e.g., paras. 0011, 0013).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
It is noted that Halverson et al. (2017/0156880) also teaches pore size in the approximate claimed range for a 3-D printed (additive manufactured) implant (e.g., paras. 0054 and 0062).
It is noted that Wooley (2012/0185047) also teaches pore size in the approximate claimed range and porosity greater than 50% (e.g., para. 0047) for a 3-D printed implant (e.g., para. 0115).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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