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 .
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)1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. CN114053481A, and in view of Yue et al. CN105288732A.
Regarding claim 1, Zhang teaches (para [0013]) teaches an antibacterial coating on a titanium surface which is derived from dopamine (where dopamine corresponds to the required catecholamine) polymerized in the presence of zinc ions and grafted with antibacterial peptides. Zhang is silent on the required antibacterial peptide bacitracin, but notes that various changes and modifications can be made to the invention (para [0057]).
Analogous reference Yue who also teaches antibacterial titanium surfaces, and discloses the required antibacterial bacitracin (Yue para [0013]). Advantageously, Yue provides the motivation to utilize bacitracin as the antibacterial peptide to provide both anti-inflammatory and anti-infective properties to the titanium surface (para [0037]).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to have modified Zhang’s polydopamine based coating composition with the bacitracin as taught by Yue for the same application of creating a titanium surface with improved anti-inflammatory and anti-infective properties.
Regarding claim 2 and 4, Zhang in view of Yue teach the required antibacterial polypeptide bacitracin, as discussed when addressing claim 1. Zhang teaches a method of creating an antibacterial coating where a Tris solution of dopamine (Zhang para [0032]), solution of antibacterial peptide (with bacitracin, per Yue’s disclosure), and a solution of metal ion are added to the titanium sheet surface in a step wise manner (Zhang Fig 1. and paras [0011] – [0013]).
Zhang (in view of Yue) teaches stepwise addition of the solutions of dopamine, antibacterial peptide (bacitracin) and the metal ion, to create the final antibacterial coating which differs from the required one step solution where all the ingredients are present together. It is noted that there is a finite list of immediately recognizable options
available to one of ordinary skill in the art, including a) where all the three solutions are combined together in a Tris solution of polydopamine, or b) step wise solution coating of the titanium surface (as presented by Zhang) or c) where two solutions are combined in one followed by impregnation of the titanium surface with the third solution.
With the presence of a finite number of options which are immediately recognizable to a person having ordinary skill in the art, and the options do not produce new or unexpected results, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try any of the immediately recognizable and finite options, including option a) with reasonable expectation of success of achieving the desired antibacterial coating, as taught above by Zhang and Yue (see MPEP 2143 I. E.).
Zhang recommends ambient temperatures (room temperature), and a time interval of 1-48 hours or 1-24 hours for the various reaction steps, which overlaps the claimed reaction time. Zhang teaches ultrasonic cleaning steps (para [0032] and [0033]). Zhang does not explicitly mention blow drying the final titanium surface, however notes performing scanning electron microscopy (para [0056]), which is conducted on a thoroughly dry surface to prevent instrument damage. Since Zhang does not highlight conducting the reaction in an inert atmosphere, the aerobic conditions in air would have been obvious to a skilled artisan (instant claim 4).
Regarding claim 3, Yue teaches (para [0018]) Tris solution with a pH of 8-9, meeting the claimed requirement.
Claim(s)5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. CN114053481A, and in view of Yue et al. CN105288732A, as applied to claims 1-4, further in view of Ding et al. US20150098976A1 and Gawande et al. US 11,103,433 B2.
Regarding claim 5, Zhang and Yue disclose dopamine which is a catecholamine, but do not address catecholamine, norepinephrine. Analogous reference Ding recognizes that dopamine and norepinephrine are equivalent catecholamines (reference claim 24). It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to have combined both dopamine and norepinephrine to generate the antibacterial coating, since combining equivalents known for the same purpose is prima facie obvious. See MPEP 2144.06.
Zhang notes the use of zinc ions however does not specify that they are derived from ZnCl2, however analogous reference Gawande (reference claim 2) discloses that the zinc salt can be zinc chloride, and advantageously provides the motivation to incorporate zinc chloride salt for the formation of an antimicrobial film since it adds to the anti-infective properties to the overall composition (col 2, lines 49-50).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to have modified Zhang and Yue’s polydopamine based coating composition with norepinephrine as taught by Ding and utilized ZnCl2 as taught by Gawande for the same application of creating an antibacterial coating composition with improved anti-inflammatory and anti-infective properties.
Regarding claim 6, reference Gawande discloses (col 3, line 21) ZnCl2 concentration of 1mg/ml, which meet the claimed requirement. Yue teaches (para [0019]) bacitracin concentration of 1-5mg/ml, overlapping the claimed requirement. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Yue discloses (para [0018]) dopamine concentration of 1-5mg/ml. As discussed when addressing claim 5, antibacterial composition comprising both catecholamines: dopamine and norepinephrine, is rendered obvious by the prior art. Similar range of norepinephrine of 1-5 mg/ml as that of dopamine, would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention.
Regarding claim 7, as discussed when addressing claim 6, prior art references disclose the required ZnCl2 concentration and render obvious an encompassing range of norepinephrine. Yue’s bacitracin concentration is higher than the required amount, however applicant’s attention is diverted to: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, in the absence of showing of new or unexpected results tied to the desired bacitracin concentration, in the process of routine optimization to minimize cost, decreasing the level of bacitracin to the required amount would have been obvious to one having ordinary skill in the art before the effective filing date of the invention.
Conclusion
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/S.M.D./
Examiner
Art Unit 1765
/JOHN M COONEY/Primary Examiner, Art Unit 1765
