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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because
Reference character “103” has been used to designate both valve (¶ [0024]) and size of small valve (¶ [0025]).
Reference character “104” has been used to designate both filling (¶ [0025]) and size of large valve (¶ [0025]).
They include the following reference character(s) not mentioned in the description: 100, 105, and 206.
It appears reference characters 207 and 208 are swapped. Examiner believes 207 is the filling and 208 is the shell.
Reference character 102 is stated to be the shell but it appears to be pointed at the valve.
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. 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 and 17-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 17, the valve is described as larger than a first valve type configured for introducing saline and smaller than a second valve type configured for introducing silicone, no quantifiable description of those sizes is given. For the purpose of examination, if the valve can introduce silicone and saline, it is understood to be able to introduce hyaluronic acid. Dependent claims 2-7, 18 and 19 are likewise rejected.
Regarding claim 8, the tube is described as larger than a first tube type configured to transfer saline and smaller than a second tube type configured to transfer silicone, no quantifiable description of those sizes is given. For the purpose of examination, if the tube can transfer silicone and saline, it is understood to be able to transfer hyaluronic acid. Dependent claims 9-14 are likewise rejected.
Claim Rejections - 35 USC § 102
Claim(s) 1-5, 7-8, 10-11, 13-18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Becker (US 2010/0114311 A1).
Regarding claim 1, Becker discloses
an implant (40, implant, fig. 7), comprising:
a shell (44, outer envelope, fig.7); and
a valve (52, valve, fig. 7, seen in fig. 5) larger than a first type of valve configured for introducing saline into the shell and smaller than a second type of valve configured for introducing silicone into the shell (as described in the 112(a) rejection above, since the valve is intended to be used with both saline and silicone it is understood to be compatible with hyaluronic acid).
Regarding claim 2, Becker further discloses a filling for the shell (hyaluronic acid, ¶ [0038]), the filing comprising a material other than saline or silicone (hyaluronic acid, ¶ [0038]).
Regarding claim 3, Becker further discloses the filing comprises hyaluronic acid (¶ [0038]).
Regarding claim 4, Becker further discloses the valve is configured for introducing hyaluronic acid into the shell (52, valve, fig. 7, seen in fig. 5). The valve can introduce both saline and silicone, examiner takes the position the valve is configured to introduce hyaluronic acid. The phrase “the valve is configured for introducing hyaluronic acid into the shell” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the valve is considered to be capable of introducing hyaluronic acid into the shell.
Regarding claim 5, Becker further discloses the valve comprises a single-use valve (fig. 5, due to the flange on plug 34 and the barbs 36 once the valve is sealed it will not be able to be re-opened) resistant against leakage of the hyaluronic acid after use (as the valve is not intended to leak, ¶ [0035], and made to be used with saline which has a lower viscosity than hyaluronic acid, examiner takes the position hyaluronic acid would also not leak).
Regarding claim 7, Becker further discloses the shell comprises silicone (¶ [0038]).
Regarding claim 8, Becker discloses
a system (fig. 1) for filling an implant after implantation (¶ [0036]), comprising:
a tube (27, filling tube, fig. 2A) configured for attaching to a valve of the breast implant (¶ [0033]), the tube larger than a first type of tube used to transfer saline and smaller than a second type of tube used to transfer silicone (as described in the 112(a) rejection above, since the tube is intended to be used with both saline and silicone it is understood to be compatible with hyaluronic acid); and
a delivery device configured to fill the breast implant through the tube and the valve (hypodermic needle, ¶ [0033])with a filling comprising a material other than saline or silicone (hyaluronic acid, ¶ [0038]).
Regarding claim 10, Becker further discloses the filling comprises hyaluronic acid (¶ [0038]).
Regarding claim 11, Becker further discloses the valve comprises a single-use valve (fig. 5, due to the flange on plug 34 and the barbs 36 once the valve is sealed it will not be able to be re-opened) resistant against leakage of the hyaluronic acid after use (as the valve is not intended to leak, ¶ [0035], and made to be used with saline which has a lower viscosity than hyaluronic acid, examiner takes the position hyaluronic acid would also not leak).
Regarding claim 13, Becker further discloses the breast implant further comprises a shell (44, outer envelope, fig. 7).
Regarding claim 14, Becker further discloses the shell comprises silicone (¶ [0038]).
Regarding claim 15, Becker discloses
an implant (40, implant, fig. 7), comprising:
a shell (44, outer envelope, fig. 7); and
a filling for the shell comprising a material other than saline or silicone (hyaluronic acid, ¶ [0038]).
Regarding claim 16, Becker further discloses the filling comprises hyaluronic acid (hyaluronic acid, ¶ [0038]).
Regarding claim 17, Becker further discloses a valve (52, valve, fig. 7, seen in fig. 5) for introducing the material other than saline or silicone into the shell, the valve larger than a first type of valve configured for introducing saline into the shell and smaller than a second type of valve configured for introducing silicone into the shell (as described in the 112(a) rejection above, since the valve is intended to be used with both saline and silicone it is understood to be compatible with hyaluronic acid).
Regarding claim 18, Becker further discloses the valve comprises a single-use valve (fig. 5, due to the flange on plug 34 and the barbs 36 once the valve is sealed it will not be able to be re-opened) resistant against leakage of the hyaluronic acid after use (as the valve is not intended to leak, ¶ [0035], and made to be used with saline which has a lower viscosity than hyaluronic acid, examiner takes the position hyaluronic acid would also not leak).
Regarding claim 20, Becker further discloses the shell comprises silicone (¶ [0038]).
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.
Claim(s) 6, 12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Becker in view of Alejandro (US 2012/0123535 A1).
Regarding claims 6, 12, and 19 Becker fails to teach a multi-use valve. However, Alejandro discloses a breast implant that includes the valve comprises a multi-use valve (10, port, fig. 8A, ¶ [0022]) resistant against leakage of the hyaluronic acid after each use. The valve is not intended to leak and made to be used with both silicone and saline which respectively have greater and lower viscosities than hyaluronic acid, examiner takes the position hyaluronic acid would also not leak. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Becker to include a multi-use valve as taught by Alejandro in order to inflate and deflate the implant any time after insertion (¶ [0022], Alejandro).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Becker (US 2010/0114311 A1) in view of Sforza (US 2019/0083234 A1).
Regarding claim 9, Becker fails to teach the delivery device comprises an infusion pump. However, Sforza discloses a device for implantation of filler into the body that includes the delivery device comprises an infusion pump (¶ [0039]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Becker to include the delivery device comprises an infusion pump as taught by Sforza since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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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/T.M.D./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774