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 .
Restriction/Election
Applicant’s election without traverse of Invention (claim 1-8) in the reply filed on 06/15/2026 is acknowledged. Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
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) 1-2 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shalon et al. US 20060069403 A1, herein referred to as Shalon.
Regarding claim 1, Shalon discloses a tissue expander (Fig 3A, 300) with a port (Fig 3D, 323) for implantation into a patient ([0002]). As noted in the present application, the term "low-Z" materials refers to chemical elements with a low atomic number (Z) of protons in the nucleus," and "low atomic number" is typically any element with an atomic number less than the atomic number of scandium (Sc)." Shalon discloses the device comprising aluminum [0208] which has an atomic number of 14, therefore, Shalon’s composition is considered a low z material.
Regarding claim 2, Shalon discloses wherein the low-z material comprises one or more materials selected from the group consisting of aluminum, magnesium, combinations thereof, and alloys thereof (aluminum; [0208].
Regarding claim 8, Shalon discloses wherein the tissue port is MRI and CT compatible (Teaches implant can be constructed from aluminum so that it does not interfere with radiation therapy [0208]).
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.
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) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shalon in view of Mueller 20190284670 A1, herein referred to as Mueller.
Regarding claim 3, Shalon disclose the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein the low-z material comprises an alloy of aluminum, magnesium, or a combination thereof.
However, in the same field of invention, Mueller teaches an expandable implant comprising a low z-material [0027], wherein the low-z material comprises an alloy of aluminum, magnesium, or a combination thereof ([0013]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Shalon to incorporate wherein the low-z material comprises an alloy of aluminum, magnesium, or a combination thereof, as taught and suggested by Mueller in order to impart pronounced mechanical asymmetry under load (Mueller [0017] and [0031]).
Regarding claim 4, Shalon as modified by Mueller discloses the invention substantially as claimed and as discussed above with respect to claim 3, and additionally teaches wherein the low-z material comprises an alloy of aluminum, magnesium, or a combination thereof (a magnesium alloy for use in implants that comprise a magnesium alloy having the composition of 0.2% by weight of Zn and 0.5% by weight of Ca, with the rest being formed by Mg with individual impurities, paragraphs [00154-157]).
Regarding claim 5, Shalon as modified by Mueller discloses the invention substantially as claimed and as discussed above with respect to claim 3, and additionally teaches wherein the alloy further comprises an additional material selected from the group consisting of Zn, Ca,Manganese, Silicon, Yttrium, Lithium, and combinations thereof (Mueller abstract and [0008]).
Regarding claim 6, Shalon as modified by Mueller discloses the invention substantially as claimed and as discussed above with respect to claim 5, and additionally teaches wherein the alloy further comprises from to about 5 % by weight of the additional material (Mueller discloses 0.2% by weight of Zn and 0.5% by weight of Ca, with the rest being formed by Mg with individual properties, paragraph [0154-157]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shalon in view of Yoon et al. Modeling of the metallic port in breast tissue expanders for photon radiotherapy. J Appl Clin Med Phys. 2018 May;19(3):205-214. doi: 10.1002/acm2.12320 (Enclosed in Applicant’s IDS), herein referred to as Yoon.
Regarding claim 7, Shalon explicitly disclose the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein the tissue port has a thickness of about 0.1 to about 3mm.
However, in the same field of endeavor, Yoon discloses wherein a port of an implant that has a thickness of about 1mm to about 3 mm (the diameter of the metallic port was 1.75cm and the thickness was 2.5 mm, see page 209 section 3 in Results and Discussion).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the filling date of the claimed invention to modify Shalon to have a thickness of about 1 mm to about 3 mm, as taught by Yoon for the advantages of providing improved accuracy of dose calculations (See Yoon abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Liu et al US 20130032962 A1 discloses an implant.
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/A.F./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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