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 .
Response to Amendment
The preliminary amendment filed on May 22, 2024 has been entered. It is noted that the amendment both cancels claim 32 and amends claim 32 (see page 8 of the amendment). It is apparent that there was no intention to cancel claim 32, especially in view of the remarks on page 11 of this amendment. Accordingly, this Office action is treating claim 32 as amended in the May 22, 2024 amendment. Additionally, it is noted that there are two claims numbered as claim 8 and no claim 9. For purposes of this Office action, the second claim 8 will be treated as claim 9; however, the Applicant is required to correct this in the next response.
Claim Objections
Claims 23-27 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim shall refer to other claims in the alternative only. Specifically, claim 23 is dependent upon “claim 19” in line 1 and “any preceding claim” in line 3. Claims 24-27 are objected to due to their dependence upon claim 23. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claims 2, 5, 9, 14, 16-18, 30, and 34 are objected to because of the following informalities:
In claim 2, line 1, the term “of Formula (I)” should be inserted after the term “compound” to provide clear antecedent basis. Similar changes should be made in claims 9, 16, and 34.
In claim 5, line 2, the term “formula (II)” should be capitalized to be consistent with the naming convention used for “Formula (I)” in the claims.
Claim 5 refers to independent claim 1 two times, i.e., line 1 and line 7. This unconventional dependence should be corrected via amendment such that claim 1 is only referenced a single time in this dependent claim.
In claims 14, 17, and 18, the preamble should be changed to “A polyurethane…”.
In claim 16, the preamble should be changed to “A method of producing a polyurethane…”.
In claim 30, line 2, the term “Comprises” should be changed to “comprises”.
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 14, 16-22, 28-30, 32-37, 39, 41-44, 48, and 50 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 14 is indefinite as to scope. Specifically, claim 14 recites that it is directed to an impregnated polyurethane and is dependent upon claim 1, which is also directed to an impregnated polyurethane. Thus, it is unclear how claim 14 further limits claim 1. Additionally, the term “a compound” in line 1 should be changed to “the compound of Formula (I)”, since the compound has antecedent basis in claim 1. Claims 41 and 42 are rejected due to their dependence upon rejected claim 14.
In claim 16, line 2, the term “a compound” in line 1 should be changed to “the compound of Formula (I)”, since the compound has antecedent basis in claim 1. Additionally, claim 16 is indefinite in that it is unclear if a second polyurethane is being claimed and required by this claim. That is, the preamble recites a polyurethane (line 1) and the claim further references claim 1 (line 2), which requires a polyurethane. Thus, it is unclear which polyurethane is being referenced in line 3, or if there is only a single polyurethane. Claims 17 and 18 are indefinite for these same reasons.
Claim 19 is indefinite for the following reasons. First, the preamble states that it is directed to a composition but it is dependent upon claim 1, which is directed to an impregnated polyurethane. Thus, the scope is not clear as to which statutory class of invention this claim is directed to. Second, in line 2, the term “a compound” in line 1 should be changed to “the compound of Formula (I)”, since the compound has antecedent basis in claim 1. Third, it is unclear if a second polyurethane is being claimed and required by this claim. That is, line 2 recites a thermoplastic polyurethane and the claim further references claim 1 (line 3), which requires a polyurethane. Thus, it is unclear if the TPU is a second polyurethane or further limits the polyurethane that is provided for in independent claim 1. This claim is being treated as an article claim, i.e., impregnated polyurethane, that further defines the polyurethane as a TPU. Claims 20-22, 28-30, and 32 are rejected due to their dependence upon rejected claim 19.
Claims 28 and 30 are further indefinite in that the term “a compound of Formula I” in line 3 and line 2, respectively, should be changed to “the compound of Formula (I)”, since the compound has antecedent basis in claim 1.
Claim 32 is further indefinite in that the term “a composition of claim 19” should be changed to “the composition of claim 19”, since the composition has antecedent basis in claim 19. Claim 37 is indefinite for this same reason.
Claims 33, 35 and 48 are indefinite in that the terms “a compound of Formula I” and “a compound should be changed to “the compound of Formula (I)”, since the compound has antecedent basis in claim 1.
Claims 34, 36, 39, 43, 44, and 50 are rejected due to their dependence upon rejected claim(s).
Claims 33 and 34 are further indefinite in that the preliminary amendment deleted the claim dependency, which is needed for antecedent basis for Formula (I).
Claim 35 is additionally indefinite in that the term “an antimicrobial” in lines 1-2 should be changed to “the antimicrobial”, since the antimicrobial coating has antecedent basis in claim 1.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-14, 16-22, 28-30, 32-37, 39, 41-44, 48, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Lytix Biopharma (WO2010/038040) in view of Hunter et al. (US 2009/0060973).
Regarding claims 1-6, 8, and 10-14, WO ‘040 discloses a cationic antimicrobial peptide which is identical to Formula (I), Formula (II), and the structure of claim 6 (pg 16, line 30 et seq, Compound 2 (pg 19)). WO ‘040 discloses that the peptide can be attached to a solid support that can be a medical device (pg 14, lines 3-25), such as a catheter, in-dwelling device, or a wound dressing (pg 28, lines 5-7). WO ‘040 does not disclose using the peptide with a polyurethane material. US ‘973 discloses a medical device having an antimicrobial coating [0025] which is formed from a polyurethane [0016]. That is, WO ‘040 discloses that it is known in the art to coat polyurethane medical devices with antimicrobial coatings. Thus, it would have been obvious to one of ordinary skill in the art to have used the antimicrobial peptide of WO ‘040 with a polyurethane, as disclosed in US ‘973, motivated by the desire to obtain desired antimicrobial properties on a known polyurethane-based medical device.
Regarding claim limitation that the polyurethane is a thermoplastic polyurethane (TPU), i.e., claims 7, 19-22, 28-30, 32-37, and 39, US ‘973 discloses the use of a thermoplastic polyurethane [0162].
Regarding the limitation that the polyurethane is not a foam, i.e., claims 8 and 16, US ‘973 discloses the use of non-foam polyurethane medical devices [0162].
Regarding the limitation of the use of organic solvents in the antimicrobial coating, such as THF, i.e., claims 16, 19-22, 28-30, 32, 34-37, US ‘973 discloses the use a THF as the organic solvent in the antimicrobial coating [0122].
Regarding the process steps, such as the impregnation steps of the coating onto the polyurethane material, US ‘973 discloses the claimed process steps and alternatives ([0171]-[0175]), i.e., claims 16, 28-29, 32, and 35. US ‘973 further discloses that the coating process can be a spot-coating process [0140], a pit-coating process [0141], a dip coating process [0172], i.e., claim 36, or can be partially coated (claim 2), i.e. claim 18.
Regarding claims 41-43, US ‘973 discloses the claimed polyurethane that is produced by the reaction of a polyether polyol [0104] with an aliphatic diisocyanate [0101].
Regarding claim 44, WO ‘040 as modified by US ‘973 does not specifically disclose a process wherein the compound of Formula (I) is provided in a two-step coating process, i.e., applying a second coating containing Formula (1) to an article that has been coated with a coating containing a compound of Formula (I). However, it would have been obvious to one having ordinary skill in the art to have provided multiple coatings comprising the compound of Formula (I) motivated by the desire to ensure that thorough coating coverage of the antimicrobial coating is achieved on the surface of the medical device.
Regarding claims 48 and 50, both WO ‘040 and US ‘973 are directed to coated medical devices that prevent bacterial infection during use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Blaine Copenheaver whose telephone number is (571)272-1156. The examiner can normally be reached M-F 8-5.
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/BLAINE COPENHEAVER/Primary Examiner, Art Unit 1781