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 § 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 1,5-6, 10-12, and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipted by Hochbaum et al. (“Inhibitory Effects of D-Amino Acids on Staphylococcus aureus Biofilm Development” 2011.)
Regarding claim 1 Hochbaum et al. discloses method of reducing or preventing the adsorption of a polypeptide on a surface comprising the steps of: a) providing a composition comprising the polypeptide and at least two amino acids; b) contacting the composition with the surface. (See Hochbaum Abstract and PG. 5616 Materials and Methods and Results and Pg. 5618 Para 1 and Figs. 1-2 wherein a composition comprising amino acids and cells, i.e. cells are comprised of polypeptides, are placed contact with a substrate surface and prevent formation of a biofilm, i.e. adsorption of polypeptides within the cells on the surface.)
wherein the two different amino acids comprise at least one amino acid with an aromatic R group and at least one amino acid with a non-polar aliphatic R group; and wherein the amino acids are free amino acids which are not bound to each other to form oligo- or polymers. (See Hochbaum Abstract and PG. 5616 Materials and Methods and Results and Pg. 5618 Para 1 and Figs. 1-2 wherein the at least two amino acids comprise the free and unbound amino acids proline and phenylalanine.)
Regarding claim 5 it is noted that Hochbaum discloses all the claim limitations as set forth above as well as the method wherein the composition is an aqueous solution. (See Hochbaum Pg. 5616 Materials and Methods wherein the composition is an aqueous solution.)
Regarding claim 6 it is noted that Hochbaum discloses all the claim limitations as set forth above as well as the method wherein the composition is free or substantially free of at least one stabilising protein and/or wherein the composition is free or substantially free of at least one surfactant. (See Hochbaum Pg. 5616 Materials and Methods wherein the composition is free of stabilizing protein and/or surfactant.)
Regarding claims 10 and 24-25 it is noted that Hochbaum discloses all the claim limitations as set forth above as well as the method wherein the surface comprises or consists of a metal, a glass or a polymer material, (See Hochbaum Fig. 2 Abstract wherein the surface comprises glass or polystyrene, i.e. a polymer) In regards to claims 24-25 the glass is chosen as the surface and are thus not further limited by claims 24 and 25 which further limit the polymer option.
Regarding claim 11 it is noted that Hochbaum discloses all the claim limitations as set forth above as well as the method the surface is a hydrophobic surface. (See Hochbaum Fig. 2 wherein the surface comprises polystyrene which is inherently hydrophobic.)
Regarding claim 12 it is noted that Hochbaum discloses all the claim limitations as set forth above as well as the method wherein the surface is part of a medical device. (See Hochbaum Fig. 1 wherien the surface may be a petri dish, i.e. devices used in medical procedures and testing, i.e. they are medical devices.)
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hochbaum et al. (“Inhibitory Effects of D-Amino Acids on Staphylococcus aureus Biofilm Development” 2011.)
Regarding claim 7-8 it is noted that Hochbaum discloses all the claim limitations as set forth above but does not specifically disclose polypeptides being at least 100 mg/ml or not higher than 20mg/ml.
As the cost of adsorbing amino acids and range of environments of operation are variables that can be modified, among others, by adjusting the amount of polypeptides to be adsorbed, with said costs and range of environments increasing as the amount of polypeptide to be adsorbed increases the precise concentration of polypeptides would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed concentration of polypeptides cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the concentration of polypeptides in the method of Hochbaum to obtain the desired balance between the adsorbing amino acid cost and the operation environment (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hochbaum et al. (“Inhibitory Effects of D-Amino Acids on Staphylococcus aureus Biofilm Development” 2011.) as applied to claims above, and further in view of Tong et al. (“An In Vitro Study on the Effect of Free Amino Acids Alone or in Combination with Nisin on Biofilms as well as on Planktonic Bacteria of Streptococcus mutans” 2014.)
Regarding claims 3 and 4 it is noted that Hochbaum discloses that amino acids of different groups but does not specify combining 5 different groups of amino acids.
Tong discloses a method of reducing biofilm formation on a surface, i.e. adsorption of proteins comprising polypeptides by utilizing amino acid compositions comprising amino acids from groups consisting of: (a) amino acids with non-polar, aliphatic R groups; (b) amino acids with polar, uncharged R groups; (c) amino acids with positively charged R groups; (d) amino acids with negatively charged R groups; and (e) amino acids with aromatic R groups. (See Tong Abstract and Table 1)
It would have been obvious to one of ordinary skill in the art at the time of invention to utilize compositions comprising amino acids of Tong in the method of Hochbaum because such amino acid compositions are known to effectively reduce the adsorption of proteins and other biological fouling molecules on surfaces of medical devices as would be desirable in the method of Hochbaum.
In regards to providing five different amino acids in the composition it is noted that modified Hochbaum discloses at least 5 types of amino acids are known to be useful for the purpose of protein adsorption and thus combining five different amino acids groups so known would have been obvious to one of ordinary skill in the art at the time of filing because it has been held that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (See MPEP 2144.06
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hochbaum et al. (“Inhibitory Effects of D-Amino Acids on Staphylococcus aureus Biofilm Development” 2011.) as applied to claims above, and further in view of Reches (WO 2014/118779)
Regarding claim 9 Hochbaum discloses all the claim limitations as set forth above but does not specifically disclose polypeptides being part of a virus.
Reches discloses a method of reducing adsorption of proteins on surfaces wherein the proteins may be part of a virus, i.e. attached to a capsid or envelope of a virus or viral vector. (See Reches Pg. 23 Para 2-3 wherein viral adhesion including polypeptides so attached is desirable)
One of ordinary skill in the art would have been motivated to prevent polypeptides attached to a virus capsid or envelope from adsorbing to a surface in the composition of Hochbaum because virus’s are known in the art to foul surfaces and the prevention of such adherence would have been desirable in the method of Hochbaum.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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