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
Claims 2, 5 and 8-12 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/13/2026.
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.
Claim(s) 1, 3-4 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuessler (US 2019/0175332 A1).
Regarding claim 1, Schuessler teaches an artificial implant (20, breast implant, fig. 1) comprising:
a silicone shell (22, , fig. 1, ¶ [0023]) consisting of an upper portion (see annotated fig. 1, below), a lower portion (see annotated fig. 1, below), and a side portion (see annotated fig. 1, below); and
a filler injected into the silicone shell (24, fluid, fig. 1),
wherein the silicone shell includes one or more silicone layers (52, inner layer, fig. 7) and one or more reinforcing layers (54, intermediate layer, fig. 7) formed on at least a portion of a surface of the silicone layer (fig. 7), and
the reinforcing layer is provided in at least a portion of the lower portion and side portion of the silicone shell (fig. 1).
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Regarding claim 3, Schuessler further teaches at least a portion of the silicone shell is formed by continuously or alternately laminating the one or more silicone layers and the one or more reinforcing layers (¶ [0023] and ¶ [0040], fig. 7).
Claim 3 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a layered silicone shell. Manufacturing steps such as continuously or alternately laminating the silicon and reinforcing layers is not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process” (See MPEP 2113).
Regarding claim 4, Schuessler further teaches the silicone shell has a thickness of 0.4 to 1.2 mm (¶ [0032]), and the reinforcing layer has a thickness of 0.01 to 0.3 mm (¶ [0032]).
Regarding claim 7, Schuessler further teaches a cross-section of the artificial implant has one shape selected from a circular shape, an oval shape, and a teardrop shape (fig. 1, ¶ [0022]).
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuessler (US 2019/0175332 A1).
Regarding claim 6, Schuessler fails to explicitly state the silicone shell in which the reinforcing layer is provided has a rupture strength of 25 to 50 N and/or an elongation rate of 400 to 520%. The reinforced area of the implant of Schuessler increases rupture resistance in increase elongation (¶ [0060]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to the silicone shell in which the reinforcing layer is provided to have a rupture strength of 25 to 50 N and/or an elongation rate of 400 to 520%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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