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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 11 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The limitations “into the iliac crest” and “in close contact with the iliac crest” in claim 1; and “fixed to the iliac crest” and “a surface of the iliac crest” in claims 11 and 16 are claiming the human body which is considered non-statutory subject matter. The claims should be re-written with the term "adapted to" or “configured to” prior to the limitations to overcome positively citing human body.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Cohen et al. (2010/0217388) “Cohen”.
Regarding claims 1 and 8, as best understood, Cohen discloses an implant 10 (Fig. 3A) for pelvic and hip plasty for increasing pelvis and hip volumes of a human (Fig. 8 and par. 0081 disclose the implant is fully capable of being used for pelvic bone which is fully capable of performing this intended use), the implant 10 for pelvic and hip plasty (par. 0081) comprising: a first implant body 14 (Figs. 1A-1C discloses where body 14 is located which is similar to Figs. 3A-3C ) including an outer cover which has an interior space (inflatable compartments 16a-c and 30a-c have an outer inflatable/deflatable cover with an interior compartment; Fig. 3A; pars. 0065 and 0072-0073), includes an elastic material (par. 0072 discloses elastically deformable material), and is to be placed in hip tissues under an iliac crest of the human (Fig. 8 and par. 0081 disclose the implant is implanted in the pelvic bone and is fully capable of performing this intended use), a polymer gel including a silicone gel is filled in the interior space of the outer cover (par. 0030 discloses the interior space 16a-c is filled with silicone gel), and a flange portion 12 (Fig. 3A) projecting from an edge of the outer cover 14 and including an elastic-deformable material (par. 0066 discloses the flange portion 12 is integral with outer cover 14 and is formed of flexible material) to be in close contact with and fixed to the iliac crest of the human (Fig. 8 and par. 0081 disclose this intended use); and a fixing screw penetrating the flange portion and inserted into the iliac crest to fix the flange portion to the iliac crest (Figs. 1A, 3A and 8 and par. 0067 disclose screws are used to anchor the flange portion by penetrating holes 19 and 18), wherein, when the flange portion is in contact with the iliac crest, the flange portion deforms into a shape corresponding to an outer shape of the iliac crest and is in close contact with the iliac crest (par. 0066 and Fig. 8 disclose the flange portion 12 is made from a flexible material and is implanted in the pelvic bone where the structure of the flange portion is fully capable of performing this intended use when implanted in the pelvic bone).
Regarding claim 2, Cohen discloses wherein at least one first fastening hole is formed in the flange portion such that the fixing screw fixed to the iliac crest of the human passes through the at least one first fastening hole (Fig. 8 and par. 0067 disclose screws are used to anchor the flange portion by penetrating holes 19 and 18).
Regarding claims 3 and 7, Cohen discloses the flange portion 12 (Fig. 3A) is bendable to have a shape corresponding to a shape of the iliac crest and the flange portion has a shape corresponding to the iliac crest and is fixed to the iliac crest (par. 0066 and Fig. 8 disclose the flange portion 12 is made from a flexible material and is implanted in the pelvic bone where the structure of the flange portion is fully capable of performing this intended use when implanted in the pelvic bone).
Regarding claims 4-5, Cohen discloses wherein the flange portion 12 extends from an entire edge of the outer cover 14 and forms a ring; and wherein at least one flange portion extends from a part of the edge of the outer cover (as shown in Fig. 3B, the flange portion 12 extends entirely from outer cover 14 and has a circular/rounded ring like shape).
Regarding claim 6, Cohen discloses wherein the flange portion 12 includes a same material as the outer cover 14 and is integrated with the outer cover (par. 0066 discloses the flange portion 12 is integral with outer cover 14 and is formed of the same flexible material).
Regarding claim 9, Cohen discloses wherein the outer cover 14 includes at least one of silicon elastomer and polyurethane (par. 0066 discloses the outer cover 14 is formed as an integrated homogeneous unit formed from a flexible material and par. 0069 discloses the material is silicon).
Regarding claim 10, Cohen discloses the outer cover 14 consists of an upper surface and a lower surface with respect to the flange portion, and the upper surface and the lower surface have a convex shape (the convex shape of inflatable compartments 16a-c and 30a-c; Figs. 3A-3B).
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 11-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (2010/0217388) “Cohen” in view of White et al. (6416553) “White”.
As best understood, Cohen discloses an implant 10 (Fig. 3A) for pelvic and hip plasty for increasing pelvis and hip volumes of a human (Fig. 8 and par. 0081 disclose the implant is fully capable of being used for pelvic bone which is fully capable of performing this intended use), the implant 10 for pelvic and hip plasty (par. 0081) comprising: a first implant body 14 (Figs. 1A-1C discloses where body 14 is located which is similar to Figs. 3A-3C ) including an outer cover which has an interior space (inflatable compartments 16a-c and 30a-c have an outer inflatable/deflatable cover with an interior compartment; Fig. 3A; pars. 0065 and 0072-0073), includes an elastic material (par. 0072 discloses elastically deformable material), and is to be placed in hip tissues under an iliac crest of the human (Fig. 8 and par. 0081 disclose the implant is implanted in the pelvic bone and is fully capable of performing this intended use), a polymer gel filled in the interior space of the outer cover (par. 0030 discloses the interior space 16a-c is filled with silicone gel), and a flange portion 12 (Fig. 3A) which projects from an edge of the outer cover 14 (par. 0066 discloses the flange portion 12 is integral with outer cover 14 and is formed of flexible material) and is in close contact with and fixed to the iliac crest of the human (Fig. 8 and par. 0081 disclose this intended use); wherein the flange portion is in contact with the surface of the iliac crest (par. 0066 and Fig. 8 disclose the flange portion 12 is made from a flexible material and is implanted in the pelvic bone where the structure of the flange portion is fully capable of performing this intended use when implanted in the pelvic bone).
Cohen is silent regarding a second implant body fixed to the iliac crest to extend a lateral width of a pelvis of the human and including a close contact surface having a shape corresponding to the iliac crest, wherein the flange portion of the first implant body is inserted and fixed between the close contact surface of the second implant body and a surface of the iliac crest; wherein the second implant body includes: a base portion fixed onto the iliac crest of the pelvis and increasing a volume of the iliac crest, and an extension extending from an edge of the base portion; wherein a first fastening hole is formed in the flange portion, and a second fastening hole is formed in the base portion of the second implant body at a position corresponding to the first fastening hole such that the fixing screw penetrates the first fastening hole and the second fastening hole and is fixed to the iliac crest to fix the first implant body and the second implant body to the iliac crest; and the second implant body includes at least one material selected from a titanium alloy, a stainless alloy, polyethylene, and bio-ceramics.
However, White teaches a similar pelvic and hip implant 10 (Fig. 1) comprising a second implant body 80 (Fig. 1) fixed to the iliac crest to extend a lateral width of a pelvis of the human and including a close contact surface having a shape corresponding to the iliac crest (Fig. 17c and col. 1, lin. 50-53 disclose the implant is secured to the ilium region), wherein a flange portion 18 of a first implant body is inserted and fixed between the close contact surface of the second implant body and a surface of the iliac crest (Fig. 2 and col. 6, lin. 53-65 disclose the flange portion 18 is inserted in between the second implant body 80 and the ilium region); wherein the second implant body includes: a base portion (body of second implant 80; Fig. 6) fixed onto the iliac crest of the pelvis and increasing a volume of the iliac crest (the structure of second implant 80 is fully capable of performing this intended use; Fig. 17c), and an extension 92 extending from an edge of the base portion (as shown in Fig. 7); wherein a first fastening hole 130 (Fig. 8a) is formed in the flange portion 18, and a second fastening hole 98 (Fig. 6) is formed in the base portion of the second implant body 80 at a position corresponding to the first fastening hole such that the fixing screw 24 penetrates the first fastening hole and the second fastening hole and is fixed to the iliac crest to fix the first implant body and the second implant body to the iliac crest (col. 7, lin. 46-53 disclose the screws 24 penetrate through bores 94 and 130 to secure the second implant body to the ilium region; Figs. 5 and 17c); and the second implant body includes at least one material selected from a titanium alloy, a stainless alloy, polyethylene, and bio-ceramics (col. 5, lin. 34-37; col. 7, lin. 31-35 discloses the implant materials are titanium).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant and flange in Cohen to include a second implant body fixed to the iliac crest to extend a lateral width of a pelvis of the human and including a close contact surface having a shape corresponding to the iliac crest, wherein the flange portion of the first implant body is inserted and fixed between the close contact surface of the second implant body and a surface of the iliac crest; wherein the second implant body includes: a base portion fixed onto the iliac crest of the pelvis and increasing a volume of the iliac crest, and an extension extending from an edge of the base portion; wherein a first fastening hole is formed in the flange portion, and a second fastening hole is formed in the base portion of the second implant body at a position corresponding to the first fastening hole such that the fixing screw penetrates the first fastening hole and the second fastening hole and is fixed to the iliac crest to fix the first implant body and the second implant body to the iliac crest; and the second implant body includes at least one material selected from a titanium alloy, a stainless alloy, polyethylene, and bio-ceramics, as taught and suggested by White, for allowing the flange to be securely attached to the iliac crest using an additional second implant which is made of biocompatible materials and is contoured to closely match the shape of the anatomy (col. 7, lin. 34-36).
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “a third fastening hole through which the fixing screw passes is formed in the extension of the second implant body” as set forth in claim 14, which has not been found anticipated by or obvious over prior art. The closest prior art of record of Cohen et al. (2010/0217388) “Cohen” in view of White et al. (6416553) “White” fails to disclose a third fastening hole in the extension since the extension 92 in White does not have a fastening hole to anchor the second implant body to the iliac crest.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 4089187557. 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.
/YASHITA SHARMA/
Primary Examiner, Art Unit 3774