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 § 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) 1-2, 4-10, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lahteenkorva (2017/0095245A1) in view of Borck (2008/0033538A1).
In regard to claim 1, Lahteenkorva teaches a biocorrodible solid body 100 (abstract; [0037]),
with a base material 102 and a coating (130, 134) [0036: regulate the rate of degradation between sections; may utilize coatings; claim 14],
the coating (130, 134) being applied to the base material 102 so that different corrosion rates are established in different areas of the solid body 100 [0037: slow corrosion of one part of the body relative to another; 0036; claim 14], biodegradability of the coating is further correlated with biodegradability of the base material, (since the coating is applied to change the corrosion rate of the solid body, the corrosion rates are correlated. Correlated is defined as dependent upon one another and the coating affects the biodegradability of the base material and therefore meets the definition; [0003: reduce corrosion rate of the body])
the different areas (of the solid body 100) differing from one another with regard to at least one of property porosity, thickness [0005: area may be configured with dimensions such as thickness to manage corrosion or degradation; 0042; further thickness of the body is different along the length as shown in figure 7], hydrophilic/hydrophobic properties or composition [the applied coating will cause a difference in composition: 0036-0037].
However, Lahteenkorva does not teach the coating comprises silicon.
Borock teaches a coating for an implantable medical device (abstract: implant) the coating comprises silicon (abstract: organosilicon compound) to alter the corrosion rate [0013: cause a temporary inhibition of corrosion of the material in a physiological environment].
It would have been obvious to one of ordinary skill in the art of coatings and corrosion alterations at the time the invention was filed to use the coating of Borock in place of the coating of Lahteekorva because the coating is a functional equivalent coating to delay the rate of corrosion of the implant. MPEP 2144.06II Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed.
In regard to claim 2, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, and further teaches the solid body 100 is an implant. (abstract; fig 7; a suture anchor is an implant)
In regard to claim 4, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, and further teaches the base material 102 and the coating (130, 134) have a porous structure in the embodiment of figures 12-13. (see pores 133 in figures 12-13; [0047: penetrate through the body member; therefore also through the coating])
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the pores of the embodiment of figures 12-13 in the embodiment of figure 7 in order to decrease mass of the device and improve bone growth and absorption [0048].
In regard to claim 5, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, wherein biodegradability of the coating is positively correlated with a thickness of the base material. This claim is interpreted as best understood to mean that the coating is more biodegradable in thicker areas of the implant. As discussed in [0042] the thickness of the coating may be a gradient in order to control the rate of degradation [0042] and may vary between the ends (along the length [0044]) and vary between the ends decreasing from the distal to the proximal end [0049]. As shown for example in figure 6, the distal end is thinner than the proximal end.
In regard to claim 6, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, wherein biodegradability of the coating is negatively correlated with thickness of the base material. This claim is interpreted as best understood from the instant disclosure to mean that the biodegradability or corrosion rate is slower with a thinner implant thickness. As discussed in [0042] the thickness of the coating may be a gradient in order to control the rate of degradation [0042] and may vary between the ends (along the length [0044]) As shown for example in figure 6, the distal end is thinner than the proximal end.
In regard to claim 7, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, and further teaches the base material 102 contains magnesium as a main component (main is defined as influential; no clarification was provided in the instant disclosure to the intended definition). [0005: disposed on Mg-based material; 0004]
In regard to claim 8, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, and further teaches the base material 102 comprises a polymer. [0050: polymer construction of 114; 0004]
In regard to claim 9, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1 wherein the base material 102 has a uniform composition. [0004: Mg; 0036: magnesium alloy] Since only one material is listed, the composition is uniform. Uniform composition is interpreted as a single material.
In regard to claim 10, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, and further teaches a fiber (S; figure 7, the suture) or fabric.
In regard to claim 20, Lahteenkorva teaches a biocorrodible solid body, 100 (abstract; [0037]), with a base material 102 and a coating, (130, 134) [0036: regulate the rate of degradation between sections; may utilize coatings; claim 14],
the coating (130, 134) being applied to the base material 102 so that different corrosion rates are established in different areas of the solid body, [0037: slow corrosion of one part of the body relative to another; 0036; claim 14],
wherein biodegradability of the coating is correlated with biodegradability of the base material, (since the coating is applied to change the corrosion rate of the solid body, the corrosion rates are correlated. Correlated is defined as dependent upon one another and the coating affects the biodegradability of the base material and therefore meets the definition; [0003: reduce corrosion rate of the body])
and wherein biodegradability of the coating (130, 134) is correlated (dependent upon one another) with a thickness of the base material 102, (As discussed in [0042] the thickness of the coating may be a gradient in order to control the rate of degradation [0042] and may vary between the ends (along the length [0044]) and vary between the ends decreasing from the distal to the proximal end [0049]. As shown for example in figure 6, the distal end is thinner than the proximal end and therefore a gradient would result in the thickness of the coating correlating to the thickness of the implant)
the different areas (of base material 102) differing from one another with regard to at least one property of porosity, thickness, hydrophilic/hydrophobic properties or composition. [the applied coating will cause a difference in composition: 0036-0037].
It is noted that terms like “correlated with” appears to be a product by process limitation, patentable only based on the resulting end structure. It is suggested to claim the end structure. The instant disclosure does not provide any special definition for correlated, and correlated means “dependent upon one another.” Any coating will affect the biodegradability of the base structure underneath and will therefore be correlated with the biodegradability of the coating.
However, Lahteenkorva does not teach the coating comprises silicon.
Borock teaches a coating for an implantable medical device (abstract: implant) the coating comprises silicon (abstract: organosilicon compound) to alter the corrosion rate [0013: cause a temporary inhibition of corrosion of the material in a physiological environment].
It would have been obvious to one of ordinary skill in the art of coatings and corrosion alterations at the time the invention was filed to use the coating of Borock in place of the coating of Lahteekorva because the coating is a functional equivalent coating to delay the rate of corrosion of the implant. MPEP 2144.06II Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed.
It is recommended to amend the claim to further explain the correlation and positively recite the structure and explain its criticality.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lahteenkorva (20170095245A1) in view of Borck (2008/0033538A1) and further in view of Raad (WO2007/062306).
In regard to claim 3, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, but does not teach a biocidal substance.
Raad teaches a biocidal substance located between the base material and the coating. (abstract: coat or impregnant a surface of a medical device with an antimicrobial agent); [00092: the antimicrobial agent includes an imidazoline biocide].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to impregnate or coat the surface of the implant with the biocide of Raad because this reduces the risk of infection (abstract). If the surface of the base material of the suture anchor of Lahteenkorva is impregnated with the biocide of Raad, the biocide will be between an inner portion of the base material (suture anchor) and the coating due to the location it is applied.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lahteenkorva (20170095245A1) in view of Borck (2008/0033538A1) and further in view of Krebs (6165203A).
In regard to claim 11, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, but does not teach a biological material.
Krebs teaches the solid body comprises a biological material (claim 15: composite comprises a polymer and a growth factor)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the growth factor Krebs in the suture anchor polymer material of Lahteenkorva because the growth factor promotes healing (Col 7, lines 28-35).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lahteenkorva (20170095245A1) in view of Borck (2008/0033538A1) and further in view of Mayer (2012/0078300A1).
In regard to claim 18, Lahteenkorva meets the claim limitations as discussed in the rejection of claim 1, and further teaches the base material 102 may comprise polymers [0004] but does not specifically teach the polymers as claimed.
Mayer teaches the base material comprises a polylactide, polysaccharide, polyamide, polyester, PLGA or PCL. [0012: PLGA, PCL, polyamides]
It would have been obvious to one of ordinary skill in the art of suture anchors at the time the invention was filed to use the suture anchor polymer material of Mayer in place of the suture anchor polymer material of Lahteenkorva through functional equivalents because both are degradable polymers used in a suture anchor MPEP 2144.06II and it appears either would work equally well. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed.
Response to Arguments
In regard to the objection to claim 1, the amendment overcomes the objection.
In regard to the 112b rejection of claims 5-6, 9, 18, the amendments to claims 9 and 18 overcome the rejections. In regard to claims 5-6, the applicant’s arguments have been fully considered.
The applicant argues that positive correlation refers to both the coating and base material have the same rapid degradability. The applicant asserts that this is explained in [017-018, and 033]. It appears from the instant disclosure that this is referring to the thickest portions of the implant degrading the fastest. See [017]. The instant disclosure does not actually state equal degradability, only that both the coating and base have more rapid degradation. The applicant states that negative correlation refers to providing the thinnest section of the solid body with the slowest degrading coating and refers to [018] and [037]. In response to these explanations, the rejection is withdrawn and the applicant’s interpretations will be used.
In regard to the 103(a) rejection of claims 1-2 and 4-10 as unpatentable over Lahteenkorva (2017/0095245A1) and in view of Borck (2008/0033538A1), the applicant’s arguments have been fully considered but are directed towards new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim 3 as unpatentable over Lahteenkorva (2017/0095245A1) and in view of Borck (2008/0033538A1) and further in view of Raad (WO2007/062306), no further arguments have been presented.
In regard to the 103(a) rejection of claim 11 as unpatentable over Lahteenkorva (2017/0095245A1) and in view of Borck (2008/0033538A1) and further in view of Krebs (6165203A), no further arguments have been presented.
In regard to the 103(a) rejection of claim 18 as unpatentable over Lahteenkorva (2017/0095245A1) and in view of Borck (2008/0033538A1) and further in view of Mayer (2012/0078300A1), no further arguments have been presented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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