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 1-3, 6-17, 35 and 37-42.
Applicants' arguments, filed 04/14/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 1-3, 6-17, 35 and 37-42 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.
Response to Arguments
Applicant argues that what is required is that the article is designed or constructed to achieve the recited function.
The Examiner submits that there is a misunderstanding. The claim is indefinite since it is unclear whether the term “adapted” requires there to be a modification to the surface subject to biofilm formation. Any surface can make contact with a liquid medium. Thus, it is not clear how the term “adapted” modifies the claimed surface. As such, the rejection is maintained.
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.
Response to Arguments
Applicant argues that what is required is that the article is designed or constructed to achieve the recited function.
The Examiner does not find Applicant’s argument to be persuasive. It is unclear whether the article has to be further modified to achieve the recited function. Applicant has not addressed this. Therefore, the rejection is maintained.
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.
Response to Arguments
Applicant argues that the skilled artisan would understand that the subject matter of claim 9 describes features of the individual metal nanoparticles, as the metal nanoparticles agglomerates are described with different size ranges.
The Examiner does not find Applicant’s argument to be persuasive. Claim 1 does not recite the size range of the metal nanoparticle agglomerates. Although the specification discloses size ranges for the agglomerates, the claimed agglomerates are not limited to the disclosed size ranges. Therefore, it is unclear whether the metal nanoparticles are referring to the metal nanoparticle agglomerates or to the individual nanoparticles of the agglomerates. As such, the rejection is maintained.
Claim 10 recites wherein at least a portion of the copper 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.
Response to Arguments
Applicant argues that the other copper nanoparticles may include any type of copper nanoparticle as defined in the disclosure.
The Examiner does not find Applicant’s argument to be persuasive. Applicant saying in their arguments that the other copper nanoparticles may include any type of copper nanoparticle as defined in the disclosure does not cure the claim of its indefiniteness.
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.
Response to Arguments
Applicant argues that what is required is that the article is designed or constructed to achieve the recited function.
The Examiner submits that there is a misunderstanding. The claim is indefinite since it is unclear whether the term “adapted” requires there to be a modification to the article. Any article can make contact with a flowing liquid medium. Thus, it is not clear how the term “adapted” modifies the claimed article. As such, the rejection is maintained.
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.
Claims 1-3, 6-17, 35 and 37-42 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; 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. In some embodiments. The copper islands can contain platelets (¶ [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]). The metal nanoparticles can have a surfactant coating on their exterior surface, which can further tailor the properties of the metal nanoparticles (¶ [0038]). 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]). A surfactant coating upon the copper nanoparticles can help promote dispersion within the matrix material (¶ [0035]). 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.
The combined teachings of Zinn and Cook do not teach wherein the coating comprises TiO2 and 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 claim 1 reciting Cu2O formed from at least partial oxidation of the copper nanoparticles, this is a product-by-process limitation. Even 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. Accordingly, since Ren teaches substantially the same Cu2O as claimed, the claimed Cu2O is obvious even though the prior art does not disclose formulating Cu2O from at least partial oxidation of the copper nanoparticles.
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 1 reciting wherein the metal nanoparticles are associated with one another upon the surface, claim 40 defines associated with one another to include non-covalent interactions and covalent interactions. The copper nanoparticles are agglomerated either by non-covalent interactions or covalent interactions. Therefore, the claim limitation is met.
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 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.
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).
In regards to instant claim 41 reciting a surfactant-stabilized metal salt compound, as discussed above, Zinn discloses wherein the metal nanoparticles can have a surfactant coating on their exterior surface, which can further tailor the properties of the metal nanoparticles. Accordingly, it would have been obvious to one of ordinary skill in the art to have coated the silver salt of Cook with surfactant motivated by the desire to tailor its properties.
Response to Arguments
Applicant argues that titanium and TiO2 are very different compounds that exhibit different properties and are used for different purposes. TiO2 may catalyze the formation of hydroxyl radicals. Atmospheric moisture or water in contact with the biofilm-resistant article may supply the source of water for producing the hydroxyl radicals. There is no teaching or suggestion that titanium performs a similar function.
The Examiner does not find Applicant’s argument to be persuasive. It is not necessary for the prior art to teach using TiO2 for the same reason as Applicant. See MPEP 2144(IV). As discussed in the rejection, Zinn discloses wherein titanium is added to function as a rare earth metal. Applicant has not shown wherein TIO2 would not function like titanium as a rare earth metal. Therefore, Applicant has not shown wherein one of ordinary skill in the art would not substitute titanium with TiO2. As such, Applicant’s argument is unpersuasive.
Applicant argues that Zinn does not describe or suggest the size of the metal nanoparticles as claimed because, while nanoparticles are defined as less than 100 nm in size, only nanoparticles 20 nm less in size are used in an antiseptic substrate (only copper island agglomerates are larger than 20 nm in size).
The Examiner does not find Applicant’s argument to be persuasive. Zinn discloses in paragraph [0029] wherein when the copper nanoparticles are dispersed as individuals in the surface coating, the copper islands can mirror the size of the copper nanoparticles themselves. Thus, the about 50 nm to about 250 nm in size for the copper islands also applies to the copper nanoparticles. As such, Applicant’s argument is unpersuasive.
Applicant argues that there is no teaching or suggestion that an already formed copper nanoparticle can partially oxidized to form a Cu2O coating surrounding the copper nanoparticles. Ren does not cure the deficiencies of Zinn and Cook.
The Examiner does not find Applicant’s argument to be persuasive. The instant claims as currently recited do not require a Cu2O coating surrounding the copper nanoparticles. The instant claims as currently recited requires metal nanoparticles comprising copper nanoparticles and Cu2O. In regards to the instant claims reciting Cu2O formed from at least partial oxidation of the copper nanoparticles, this is a product-by-process limitation. Even 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. Accordingly, since Ren teaches substantially the same Cu2O as claimed, the claimed Cu2O is obvious even though the prior art does not disclose formulating Cu2O from at least partial oxidation of the copper nanoparticles. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1-3, 6-17, 35 and 37-42 are rejected.
Claims 18, 21-34 and 36 have been withdrawn.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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