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 included in the prosecution are claims 1-17, 35 and 37-39.
Election/Restrictions
Applicant’s election of Group I and a medical device or implant in the reply filed on 12/15/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 18-34 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Objections
Claims 14 and 15 are objected to because of the following informalities: “mg/in 2” should be recited as --- mg/in2 ---. 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 1-17, 35 and 37-39 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 1 recites a surface subject to biofilm formation that is adapted to contact a liquid medium at least periodically. The claim is indefinite since the scope of the term “adapted” is unclear. It is not clear whether the term “adapted” means that the surface subject to biofilm formation is capable of being contacted with a liquid medium or means that the surface subject to biofilm formation needs to be modified to be capable of being contacted with a liquid medium.
Claim 2 recites a medical device or implant configured for implantation in vivo or application to an external tissue of a patient. The claim is indefinite since the scope of the term “configured” is unclear. A medical device or implant is inherently capable of being implanted or used on external tissue. It is unclear whether the term “configured” requires further modification to the medical device or implant. The Examiner recommends removing the term “configured” to obviate this issue.
Claim 4 recites associated with one another upon the surface. The claim is indefinite since the scope of the term “associated with” is unclear. It is unclear how the nanoparticles are associated with one another. For example, it is unclear if the nanoparticles are required to be bonded, close to one another, or the same chemical compound to be associated with one another.
Claim 9 recites the limitation "the metal nanoparticles.” There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the metal nanoparticles are referring to the metal nanoparticle agglomerates or to the individual nanoparticles of the agglomerates.
Claim 10 recites wherein at least a portion of the metal nanoparticles comprises metallic copper and a coating comprising Cu2O, CuO, or any combination thereof. The claim is indefinite since it is not clear that by reciting “at least a portion of the metal nanoparticles comprises metallic copper” and “Cu2O and/or CuO,” whether Cu2O and/or CuO are the other portion of the metal nanoparticles or is a separate entity within the coating.
Claim 17 recites wherein the article is adapted to contact a flowing liquid medium. The claim is indefinite since the scope of the term “adapted” in unclear. It is not clear whether the term “adapted” means that the article is capable of being contacted with a flowing liquid medium or means that the article needs to be modified to be capable of being contacted with a flowing liquid medium.
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.
1. Claims 1-5, 7-9, 13-17, 35 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Zinn (US 2016/0201183, Jul. 14, 2016) (IDS reference) in view of Cook et al. (US 2008/0063693, Mar. 13, 2008) (IDS reference) (hereinafter Cook).
Zinn discloses an article comprising an exposed surface coating containing a plurality of copper islands (i.e., agglomerates); and a substructure (i.e., surface) underlying the exposed surface coating (claim 1). The copper islands are formed from copper nanoparticles (abstract). The copper can remain in nanoparticle form in the surface coating as small copper nanoparticle “islands.” Optionally, a plurality of the copper nanoparticles can be agglomerated into larger copper islands while still individually remaining in nanoparticle form. Unfused copper nanoparticles can be more advantageous in the case of less thermally stable substructures such as polymers and textile fibers. Fusion of copper nanoparticles can be particularly desirable for articles having a metallic substructure (¶ [0025]). Fig. 3 shows an illustrative TEM image of individual copper nanoparticles and agglomerated copper nanoparticles of various sizes distributed on a substrate surface (¶ [0027]). Depending on whether the copper nanoparticles are fused or unfused, the copper islands can vary over a wide range of sizes. The copper islands can range between 1 µm to about 5 µm in size or between about 50 nm to about 250 nm in size (¶ [0029]). Cooper nanoparticles are effective toward forming articles having antiseptic activity (¶ [0021]). The copper nanoparticles can be used in combination with silver nanoparticles to broaden the range of microorganisms against which an article has antiseptic properties, thereby helping to mitigate the spread of infection. In addition to silver nanoparticles, copper nanoparticles can also be used in combination with rare earth metals to provide an even more heightened profile of antiseptic activity. Titanium can function similarly to a rare earth metal (¶ [0022]). In various embodiments, the surface coating can cover about 10% to about 90% of the surface area of the substructure of the article (¶ [0030]). To prevent surface movement, spreading and growth of microorganisms, the extent of coverage of the copper islands upon the underlying substructure of an article can be dictated, at least in part, by the size of the microorganisms against which the exposed surface coating is intended to convey antiseptic protection. The microorganism may be a virus (¶ [0031]). In some embodiments, a surface coating containing copper islands in the form of copper nanoparticles can be dispersed in a matrix material that is disposed upon the article’s substructure, where the matrix material itself provides for the adherence of the copper nanoparticles to the article. Suitable matrix materials include adhesives (¶ [0034]). The copper nanoparticle can be applied onto metals, polymers, rubber, textile fibers, ceramics, wood, paper, and the like (¶ [0021]). The type of articles on which a surface coating can be formed include medical equipment, such as implants (¶ [0065]). In some embodiments, the article can be configured to achieve timed release of the copper (¶ [0021]).
Zinn differs from the instant claims insofar as not disclosing wherein the substructure (i.e., surface) is subject to biofilm formation), wherein the coating comprises a metal salt, and wherein the coating provides activity against biofilm formation for a least 30 days.
However, Cook discloses antimicrobial coating for coating substrate surfaces, particularly medical devices, for preventing bacterial adhesion and biofilm formation by inhibiting microbial growth and proliferation on the coating surface (abstract). The antimicrobial coating may comprise a metal salt of silver as an antimicrobial metallic material (¶ [0029]). Medical devices may remain in patients for a long period of time (several days to weeks) (¶ [0009]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have applied the coating containing a plurality of copper islands of Zinn onto a surface subject to biofilm formation since Zinn discloses wherein the coating may be applied on a medical device and medical devices are known to be subjected to biofilm formation as taught by Cook.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated a silver salt into the coating of Zinn since Zinn discloses wherein the coating may comprise silver to treat more microorganisms and silver salt is a known and effective form of silver for treating microbes as taught by Cook.
Regarding instant claims 37-39, since the article of Zinn is a medical device and medical devices may remain in patient for a long period of time of several days to weeks as taught by Cook, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the days claimed based on the desired length of time the medical device is implanted. One of ordinary skill in the art would have had a reasonable expectation of success since Zinn discloses wherein the copper may be time release.
In regards to instant claim 1 reciting wherein the surface is adapted to contact a liquid medium at least periodically, Zinn discloses wherein the article may be an implant. An implant contacts blood (i.e., liquid medium) at least periodically.
In regards to instant claim 3 reciting wherein the surface is present upon a structure that is at least partially submersible, Zinn discloses wherein the article may be an implant. An implant is at least partially submersible within the body.
In regards to instant claim 14, Zinn discloses wherein extent of coverage of the copper islands is dictated by the size of the microorganism. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed coverage density through routine experimentation depending on the microorganism to be treated. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
In regards to instant claim 16 reciting wherein the adhesive is biologically compatible, Zinn discloses wherein the coating may comprise adhesives and wherein the article may be a medical implant. Therefore, it would have been obvious that the adhesive is biologically compatible.
In regards to instant claim 17 reciting wherein the article is adapted to contact a flowing liquid medium, Zinn discloses wherein the article may be an implant. An implant contacts blood (i.e., a flowing liquid medium).
2. Claims 6 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zinn (US 2016/0201183, Jul. 14, 2016) (IDS reference) in view of Cook et al. (US 2008/0063693, Mar. 13, 2008) (IDS reference) (hereinafter Cook), and further in view of Ren et al (US 2013/0091611, Apr. 18, 2013) (IDS reference) (hereinafter Ren).
The teachings of Zinn and Cook are discussed above. Zinn and Cook do not teach wherein the coating comprises TiO2 or a mixture of metallic copper, Cu2O, and CuO.
However, Ren discloses the use of nanoparticles for reducing and/or preventing virus transmission (claim 1). The nanoparticles may be a mixture of nanoparticles. The mixed composition of nanoparticle may be copper (Cu), copper(II) oxide (CuO), and copper(I) oxide (Cu2O) (¶ [0029]). The nanoparticle may further comprise titanium dioxide (TiO2) (¶ [0036]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Zinn discloses wherein the copper nanoparticles can be used in combination with titanium. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated titanium dioxide into the coating of Zinn since it is a known and effective form of titanium for treating microorganisms as taught by Ren.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated a mixture of copper (Cu), copper(II) oxide (CuO), and copper(I) oxide (Cu2O) as the copper nanoparticles because these copper compounds are known and effective copper compounds having antimicrobial properties which may be used together as taught by Ren.
In regards to instant claims 11 and 12, since it was known in the art that copper nanoparticles have antimicrobial activity, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts of each copper compound depending on the antimicrobial effect desired.
Conclusion
Claims 1-17, 35 and 37-39 are rejected.
Claims 18-34 and 36 are withdrawn.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614