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 .
Response to Amendment
This office action is in response to the amendment filed June 4, 2026. As directed by the amendment, claims 10-12, 14-15 have been amended and claims 33-39 were previously withdrawn. As such, claims 1-3, 5-12, 14-25 remain under consideration in the instant application.
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 14, 16, 17 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 14, 16, 17 recite “the first end section and “the second end section” or similar. There is insufficient antecedent basis for this limitation in the claim. Examiner evaluated the claims as reciting “the first end” and “the second end” in its place.
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.
Claim(s) 1-3, 6, 10-12, 14-15, 19, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ledet et al. (US 2014/0257395), hereinafter “Ledet”.
Regarding claim 1, Ledet discloses a resorbable material activated device (340, FIG. 23) comprising: a support (340) including a first end section (102), an opposing second end section (104), and a center section (346) intermediate the first end section and the second end section; a first resorbable material (at 344) positioned intermediate the first end section and the center section of the support; a second resorbable material (at 348) positioned intermediate the second end section and the center section of the support (¶93); and wherein the shape of the support changes in response to dissolving of the first and second resorbable materials (¶92).
Regarding claim 2, Ledet discloses the device of claim 1, wherein the center section moves from a first position to a second position in response to dissolving of the first and second resorbable materials (movement will occur as stiffness changes, ¶92).
Regarding claim 3, Ledet discloses the device of claim 1, wherein the support comprises a biocompatible material (¶98).
Regarding claim 6, Ledet discloses the device of claim 1, wherein the support is capable of being inserted within the rib cage of a human for repairing pectus excavatum (implantable device).
Regarding claim 10, Ledet discloses a resorbable material activated device (150, FIG. 10) comprising: a compliant segment (162) including opposing first (102) and second (104) ends; first and second bioresorbable materials operably coupled (“reinforced with” ¶87) to the compliant segment intermediate the first and second ends, respectively; and wherein at least one of the shape, position or configuration of the compliant segment changes in response to dissolving of the bioresorbable materials (¶87).
Regarding claim 11, Ledet discloses the device of claim 10, wherein the compliant segment is capable of moving from a first position to a second position in response to dissolving of the first and second bioresorbable materials (¶98).
Regarding claim 12, Ledet discloses the device of claim 10, wherein the compliant segment comprises a biocompatible material (¶98).
Regarding claim 14, Ledet discloses the device of claim 10, wherein the compliant segment has greater elasticity than the first and second end sections (¶98).
Regarding claim 15, Ledet discloses the device of claim 10, wherein the compliant segment is capable of being inserted within the rib cage of a human for repairing pectus excavatum (implantable device).
Regarding claim 19, Ledet discloses a device (340, FIG. 23) capable of repairing pectus excavatum in a human body, the device comprising: a support (340) including a first end section (102), an opposing second end section (104), and a center section (346) intermediate the first end section and the second end section, the support formed of a biocompatible material (¶98); a first bioresorbable material (at 344) positioned intermediate the first end section and the center section of the support; a second bioresorbable material (at 348) positioned intermediate the second end section and the center section of the support (¶93); and wherein the center section moves from a first position to a second position in response to dissolving of the first and second bioresorbable materials to exert a force against a sternum of the human body (movement will occur as stiffness changes, ¶92).
Regarding claim 22, Ledet discloses the device of claim 19, wherein the support is capable of being inserted within the rib cage of a human for repairing pectus excavatum (implantable device).
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.
Claim(s) 9, 18, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ledet in view of Steger et al. (US 2002/0128654), hereinafter “Steger”.
Ledet discloses the device of claims 1, 10 and 19, but is silent regarding the specific resorbable material used. Steger teaches a device (28) comprising a resorbable material, wherein the resorbable material includes at least one of polyglycolide (PGA), polylactic acid (PLA), tricalcium phosphate (TCP) or calcium carbonate (¶45). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to use at least one of polyglycolide (PGA), polylactic acid (PLA), tricalcium phosphate (TCP) or calcium carbonate as the resorbable material in the Ledet device.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ledet.
Ledet discloses the device of claim 19, wherein the biocompatible material “may be comprised of a metallic material” (¶98), but is silent regarding the metallic material being at least one of titanium or stainless steel. Titanium and stainless steel are well known in the art as biocompatible materials for forming implantable devices. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to form the device of Ledet with at least one of titanium or stainless steel.
Allowable Subject Matter
Claims 5, 7-8, 16-17, 21, 23-24 are 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:
Regarding claims 7-8, 16-17, 23-24, Ledet discloses a resorbable material activated device (340, FIG. 23) comprising: a support (340) including a first end section (102), an opposing second end section (104), and a center section (346) intermediate the first end section and the second end section; a first resorbable material (at 344) positioned intermediate the first end section and the center section of the support; a second resorbable material (at 348) positioned intermediate the second end section and the center section of the support (¶93); and wherein the shape of the support changes in response to dissolving of the first and second resorbable materials (¶92). However, Ledet is silent regarding wherein: the first end section includes a first cutout; a first top plate is supported in the first cutout and includes a first channel receiving the resorbable material; the second end section includes a second cutout; and a second top plate is supported in the second cutout and includes a second channel receiving the resorbable material.
Regarding claims 5 and 21, Ledet discloses a resorbable material activated device (340, FIG. 23) comprising: a support (340) including a first end section (102), an opposing second end section (104), and a center section (346) intermediate the first end section and the second end section; a first resorbable material (at 344) positioned intermediate the first end section and the center section of the support; a second resorbable material (at 348) positioned intermediate the second end section and the center section of the support (¶93); and wherein the shape of the support changes in response to dissolving of the first and second resorbable materials (¶92). However, Ledet is silent regarding wherein the center section has greater elasticity than the first and second end sections.
Response to Arguments
In response to Applicant's argument that Ledet fails to disclose the shape of the support changing in response to dissolving of the first and second resorbable materials, Examiner respectfully disagrees. The limitation pertains to a method step in an apparatus claim “wherein the shape of the support changes in response to dissolving of the first and second resorbable materials” (or its equivalent in claims 10 and 19). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the resorption of the biomaterial and the subsequent changing in stiffness is capable of causing the shape of the support to change.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN TRUONG, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571 -273-8300.
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/OLIVIA C CHANG/Primary Examiner, Art Unit 3775
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