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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-10) in the reply filed on 10/21/2025 is acknowledged. Claims 11-17 are withdrawn from prosecution.
Regarding the Election of Species requirement, applicant's election with traverse in the reply filed on 10/21/2025 is acknowledged. The examiner agrees to withdraw the election of species requirement.
Specification
The disclosure is objected to because of the following informalities: PDMS, believed to be polydimethylsiloxane, is not spelled out in the specification.
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 1-4 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wawro et al (2009/0093879).
Wawro et al teaches an artificial prosthesis (implant) comprising a surface having a pattern formed thereon; see at least par. 0007 and figure 3 below.
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The pattern having a straight shape and being aligned in parallel as shown in figure 3 above.
Claim 2, the pattern is formed by alternate repeated parallel alignment of straight embossed portions 135 and engraved portions 125. Further, see par. 0040.
Claim 3, see par. 0040 stating, “the pattern may be replicated at intervals to form a periodic or repeating pattern”. The width of the engraved portion (grooved) equals the intervals of the embossed portions which are 5 microns in the range of 5-35 micron. Also, see par. 0013.
Claim 4, the width of the embossed portions and the width of the engraved portion have the same length as described in par. 0040 teaching a period of 10 micron. See par. 0041 the embossed portion and the engraved portion are the same, 50 percent and 50 percent. Therefore, the width of the embossed portions is also 5 microns.
Claims 7-8, at least par. 0006 teaches a silicone breast prosthesis.
Claim 9, the prosthesis of Wawro et al is constructed at least according to applicant’s claim 1 and, therefore, inherently inhibits capsular contracture when implanted. This is relative terminology.
Claim 10, the prosthesis of Wawro et al is constructed at least according to applicant’s claim 1 and, therefore, inherently inhibits an inflammatory response when implanted. This is relative terminology.
Claims 1, 2, 4, 6, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berman et al (2003/0204270).
Referring to included figure 7 below, Berman et al teaches an artificial prosthesis comprising a surface having a pattern formed thereon, the pattern having a straight shape and being aligned in parallel as shown, see par. 0036 teaching linear
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Claim 2, wherein the pattern is formed by alternate repeated parallel alignment of straight embossed portions 39 and engraved portions 38.
Claim 4, figure 2 clearly shows the width of the embossed portions is greater than the width of the engraved portions. See MPEP 2125 Drawing as Prior Art.
Claim 6, wherein a height difference between the highest point of the embossed portions and the lowest point of the engraved portions is best shown in figure 2. Said height difference is generally equal to the thickness of the first sheet layer 70 which is 0.05 to 0.4 mm (par. 0054) fulfilling the claimed range of 0.01 to 1.5 mm.
Claim 9, the prosthesis (surface having a pattern) is fully capable of inhibiting capsular contracture. This is relative terminology.
Claim 10, the prosthesis is fully capable of inhibiting an inflammatory response. This is relative terminology.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wawro et al (2009/0093879).
Wawro et al teaches an artificial prosthesis (implant) comprising a surface having a pattern formed thereon as described above, however, is unclear as to teaching the width of the embossed portions is greater than the width of the engrave portions by 1 to 5 microns.
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Figure 1 clearly shows the width of the embossed portion 135 is greater than the width of the engraved portion 120. See MPEP 2125 Drawing as Prior Art. See par. 0011 and 0038 teaching the equation for the engraved portions (groove valley width). The width of the embossed portion is the fill factor multiplied by the period. The width of the engraved portion is 1 minus the fill factor (par. 0038). Par. 0040-0041 teach two examples: (1) a fill factor of 50 percent on a 10 micron periodic pattern producing a 5 micron embossed portion width and 5 micron engrave portion width, and, (2) an 80 percent fill faction on a 10 micron periodic pattern producing a 8 micron embossed portion and 2 micron engraved portion (only a 6 micron difference).
It would have been obvious to one having ordinary skill in the art to have tried various fill factors at least between 50-80 percent on at least a 10 micron periodic pattern to have produced a width of the embossed portions which is greater than the width of the engraved portions by 1 to 5 micron to control and/or modify micro-organisms or fibroblast adhesion to the implant surfaces. Fill factors examples of fulfilling the claim include 60 to 70.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774