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 . Claims 1-11 are pending and examined below.
Claim Objections
Claims 3 and 9 are objected to because of the following informalities:
Regarding claims 3 and 9, the claim recites, “wherein the metal oxide into the thermoplastic material”. For examination purposing, the examiner is interpreting the following, “the metal oxide particles in the thermoplastic material”. Appropriate correction is required.
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 3 and 7-11 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.
Claim 3 recites the limitation "the metal oxide" in line. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7 and , the phrase "an amount effect to cause oxidative stress" renders the claim indefinite because it is unclear what amount is required to achieve the desired effect. The dependent claims are likewise rejected.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 7—8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Michael et al (WO 2007/003361 A2).
Regarding claim 7, Michael et al discloses an antimicrobial prosthetic liner (abstract) comprising: an open upper end (see annotated fig. 1c below, also see paragraph 0013); a closed distal end (see annotated fig. 1c below, also see paragraph 0013); and sidewalls between the closed distal end and the open upper end (see annotated fig. 1c below, also see paragraph 0013); and an inner layer of a thermoplastic material wherein the thermoplastic material is infused with metal oxide particles in an amount effective to cause oxidative stress on bacteria when donned on a residual limb (silver is used in the form of particles in the nanometer range to act as an antibacterial and/or fungicidal active ingredient, paragraphs 0007 and 0016).
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Regarding claim 8, Michael et al discloses the antimicrobial prosthetic liner of Claim 7 wherein the metal oxide is selected from the group consisting of silver nanoparticles (silver used in the form of particles in the nanometer range, paragraphs 0016), copper(I) oxide, copper(II) oxide, magnesium oxide, titanium dioxide, and zinc oxide.
Regarding claim 10, Michael et al discloses the antimicrobial prosthetic liner of Claim 7 wherein the sidewalls have a thickness between 1-9 millimeters (6 mm thick, paragraph 0013).
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.
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.
Claims 1-6, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Michael et al (WO 2007/003361 A2), in view of Kanovsky (US 2020/0100503 A1).
Regarding claim 1, Michael et al discloses an antimicrobial prosthetic liner (abstract) comprising: an open upper end (see annotated fig. 1a below, also see paragraph 0013); a closed distal end (see annotated fig. 1a below, also see paragraph 0013); and sidewalls between the closed distal end and the open upper end (see annotated fig. 1a below, also see paragraph 0013); and an inner layer of a thermoplastic material (inner liner, paragraph 0017) wherein the thermoplastic material is infused with metal oxide particles which are distributed evenly throughout the thermoplastic material (silver is added to the thermoplastic material during production, paragraphs 0007 and 0016-0019), however doesn’t specifically disclose metal oxide particles in an amount between 2-10% by weight.
Kanovsky discloses materials with antimicrobial properties by using metal oxide powers (abstract), which can have various application, such as for medical textiles (paragraph 0042). Kanovsky discloses metal oxide particles in an amount between 2-10% by weight ( about 1% -about 5% wt., paragraph 0135).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the concentration of metal oxide particles taught by Michael et al with the concentration of the metal oxide particles as taught by Kanovsky in order to maximize antimicrobial effects (paragraphs 0077 and 0095).
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Regarding claim 2, Michael et al discloses wherein the metal oxide is selected from the group consisting of silver nanoparticles (silver used in the form of particles in the nanometer range, paragraphs 0016), copper(I) oxide, copper(II) oxide, magnesium oxide, titanium dioxide, and zinc oxide.
Regarding claim 3, Michael et al doesn’t specifically disclose wherein the metal oxide into the thermoplastic material is a mixture of metal oxide particles.
Kanovsky discloses wherein the metal oxide into the thermoplastic material is a mixture of metal oxide particles (a polymer and a synergistic combination of a least two metal oxide powered incorporated into the polymer, paragraph 0015).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the silver metal oxide particles taught by Michael et al to include at least one other metal oxide particle as taught by Kanovsky in order to maximize antimicrobial effects (paragraphs 0077 and 0095).
Regarding claim 4, Michael et al discloses wherein the sidewalls have a thickness between 1-9 millimeters (6 mm thick, paragraph 0013).
Regarding claim 5, Michael et al doesn’t specifically disclose wherein the metal oxide particles have a diameter between 5-100 nanometers.
Kanovsky discloses wherein the metal oxide particles have a diameter between 5-100 nanometers (about 1nanometer to about 10 nanometers, paragraph 0015).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify single metal oxide particles taught by Michael et al to include at least two metal oxide particles as taught by Kanovsky in order to maximize antimicrobial effects (paragraphs 0026, 0077, and 0095).
Regarding claim 6, Michael et al discloses an antimicrobial prosthetic liner (abstract) comprising: an open upper end (see annotated fig. 1b below, also see paragraph 0013); a closed distal end (see annotated fig. 1b below, also see paragraph 0013); and sidewalls between the closed distal end and the open upper end (see annotated fig. 1b below, also see paragraph 0013) and having a thickness between 1-9 millimeters (6 mm thick, paragraph 0013); and an inner layer of a thermoplastic material wherein the thermoplastic material is infused with metal oxide particles (silver is added to the thermoplastic material during production, paragraphs 0007 and 0016-0019) selected from the group consisting of silver nanoparticles (silver used in the form of particles in the nanometer range, paragraphs 0016), copper(I) oxide, copper(II) oxide, magnesium oxide, titanium dioxide, and zinc oxide which are distributed evenly throughout the thermoplastic material (silver is added to the thermoplastic material during production, paragraphs 0007 and 0016-0019); however doesn’t specifically disclose the metal oxide particles having a diameter between 5-100 nanometers and metal oxide particles in the amount between 2- 10% by weight.
Kanovsky discloses materials with antimicrobial properties by using metal oxide powers (abstract), which can have various application, such as for medical textiles (paragraph 0042). Kanovsky discloses metal oxide particles in an amount between 2-10% by weight ( about 1% -about 5% wt., paragraph 0135). Kanovsky further discloses wherein the metal oxide particles have a diameter between 5-100 nanometers (about 1nanometer to about 10 nanometers, paragraph 0015).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the concentration and size of metal oxide particles taught by Michael et al with the concentration and size of the metal oxide particles as taught by Kanovsky in order to maximize antimicrobial effects (paragraphs 0077 and 0095).
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Regarding claim 9, Michael et al doesn’t specifically disclose wherein the metal oxide into the thermoplastic material is a mixture of metal oxide particles.
Kanovsky discloses materials with antimicrobial properties by using metal oxide powers (abstract), which can have various application, such as for medical textiles (paragraph 0042). Kanovsky discloses further wherein the metal oxide into the thermoplastic material is a mixture of metal oxide particles (a polymer and a synergistic combination of a least two metal oxide powered incorporated into the polymer, paragraph 0015).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the silver metal oxide particles taught by Michael et al to include at least one other metal oxide particle as taught by Kanovsky in order to maximize antimicrobial effects (paragraphs 0077 and 0095).
Regarding claim 11, Michael et al doesn’t specifically disclose wherein the metal oxide particles have a diameter between 5-100 nanometers.
Kanovsky discloses wherein the metal oxide particles have a diameter between 5-100 nanometers (about 1nanometer to about 10 nanometers, paragraph 0015).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify single metal oxide particles taught by Michael et al to include at least two metal oxide particles as taught by Kanovsky in order to maximize antimicrobial effects (paragraphs 0026, 0077, and 0095).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE H TREVINO III whose telephone number is (703)756-4678. The examiner can normally be reached Monday - Friday: 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.T./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774