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 .
DETAILED ACTION
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-14 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 claims, “an outer surface of the shell has a concave-convex surface in contact with tissue” positively claims the human organism.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s):
Claim 1, “the surface has an arithmetic mean waviness (Wa) value of 3.00 pm or more in a waviness curve filtered under a measurement condition with a cut-off value of 0.08”. Please include in the drawing support for these limitations according to page 4, lines 14 et seq.
“The term "waviness 111" as used in the present specification refers to a surface curvature with a relatively long period compared to a roughness curve of the surface of the breast implant 100, and is commonly used interchangeably with "W" or "Wmax". The waviness 111 is also defined by a distance between two parallel lines that are parallel to the centerline of the cross-sectional curve and that touch the highest peak and the deepest valley, by taking as much as the standard length of waviness from the cross-sectional curve. In detail, under a measurement condition with a cut-off value of 0.08 mm, a cross-sectional curve, i.e., a height profile curve, recorded by enlarging the contour appearing in a cross-section perpendicular to the measurement plane of the breast implant 100 in the vertical and horizontal directions, is obtained, and then, the waviness 111 can be calculated from a curve filtered by passing only a frequency less than the cut- off frequency. In addition, the waviness parameter may be related to the adhesive strength throughout target tissue among the surrounding tissue into which the breast implant100 is inserted.”
In summary, add the distance between two parallel lines that are parallel to the centerline of the cross-sectional curve and that touch the highest peak and the deepest valley and a cut-off value of 0.08 mm to the drawing.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-14 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 1, 2, 4, 6, 8, 10, 11, should cut-off value of 0.08 be 0.08 mm?
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 1 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bayat et al (2020/0170771). Claims 10-11 are further evidenced by Munhoz et al (Breast Implant Surfaces and Their Impact on Current Practices: Where We are No and Where Are We Going)
Bayat et al teaches: [0251] Implant material according to the invention may optionally also comprise surface waviness (111), gradients or contours at a comparatively large-scale perspective on which the surface roughness features (112) discussed herein are superimposed.
This teaching is what applicant shows in figure 1 reproduced below.
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Said implant is a breast implant comprising a shell constituting an outer skin (par. 0010) and a filler material accommodated inside the shell (inherent or at least obvious to one skilled in the art).
Said waviness of the outer surface of the shell inherently forms a concave-convex surface. Figures 16C, 20C, 21B are believed to show a Wa greater than 3.00 microns measured along the Y-axis. However, it is unclear if Bayat et al teaches the surface having an arithmetic mean waviness (Wa) value of 3.00 microns or more in a waviness curve filtered under a measurement condition with a cut-off value of 0.08.
A cut-off value of 0.08 appears to be arbitrary value and it would have been obvious to one having ordinary skill in the art to have tried any value, including 0.08, that is larger than that of the arithmetic mean waviness (Wa) value with a reasonable expectation of success.
Claim 12, wherein the shell is formed of silicone material; see claim 1.
Claim 13, the breast implant is fully capable of being implanted in tissue which is one or more selected from the group consisting of thin fascia, muscular fascia, breast fascia, supportive fiber, and transverse fibrolamella.
Claim 14, “wherein the breast implant suppresses breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)” is interpreted as functional language which the breast implant of Bayat et al is fully capable of. The SUMMARY OF INVENTION
[0027] teaches, “The inventors propose new biomimetic textured surface topographies for implants, particularly breast implants. The inventors have found in particular that by controlling aspects of the surface texture, for example the surface roughness at macro, micro and/or nano scale to resemble corresponding features of the general surface topography of the basement membrane and/or papillary dermis of human skin, desirable and indeed improved cellular response, reduced capsular contraction and appropriate cellular anchoring/in-growth could be achieved compared to conventional smooth and textured implants.” This reduces BIA-ALCL.
Allowable Subject Matter
Claims 2-11 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 closes prior art of record is Bayat et al which fails to teach the combination of claim and:
Claim 2, wherein the surface has an arithmetic mean waviness (Wa) value in a range of 3.07 pm to 7.00 microns in the waviness curve filtered under a measurement condition with a cut-off value of 0.08.
Claim 10, Bayat et al teaches wherein the surface has a skewness (Wsk) value in a range of -0.48 microns to 0.41 pm (see claim 31), however, fails to teach a kurtosis (Wku) value in a range of 2.62 pm to 5.28 microns (see claim 32) in a waviness curve filtered under a measurement condition with a cut-off value of 0.08.
Claim 11, Bayat et al teaches wherein the surface has a skewness (Rsk) value in a range of -0.21 pm to 0.22 microns (see claim 31), however, fails to teach a kurtosis (Rku) value in a range of 2.72 pm to 3.86 mircons in a roughness curve filtered under a measurement condition with a cut-off value of 0.08.
Examiner’s Comment
The examiner finds that the arithmetic mean waviness (Wa) value (including all of claim 1) is not a typical value found in describing a breast implant. Applicant is invited to point out any particular reference(s) which they believe is relevant to the claimed invention and why they are relevant to claim 1. Further, applicant is invited for an interview.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774