DETAILED ACTION
Response to Amendment
The amendment and response filed on May 20, 2026 has been entered. Claims 1-14, 16-30, 32-37, 39, 41-44, 48, and 50 are pending.
Claim Objections
Claims 4, 23, and 28 are objected to because of the following informalities:
In claim 4, line 4, the term “and” should be insert after “Bip (4-T-Bu);”.
In claim 23, the recitation in line 1 of “composition of claim 19” and “Formula (I)…” in lines 4-20 is redundant.
In claim 23, line 3, the term “a thermoplastic polyurethane (TPU)” should be changed to “the thermoplastic polyurethane (TPU)” since this term has antecedent basis in claim 19.
In claim 23, line 3, the term “an organic solvent” should be changed to “the organic solvent” since this term has antecedent basis in claim 19.
In claim 23, line 4, the term “a compound of Formula (I)” should be changed to “the compound of Formula (I)” since this term has antecedent basis in claim 19.
In claim 23, the recitation in line 1 of “composition of claim 19” and “Formula (I)…” in lines 4-21 is redundant.
In claim 23, lines 2-3, the term “a thermoplastic polyurethane (TPU)” should be changed to “the thermoplastic polyurethane (TPU)” since this term has antecedent basis in claim 19.
In claim 23, line 3, the term “an organic solvent” should be changed to “the organic solvent” since this term has antecedent basis in claim 19.
In claim 23, lines 3-4, the term “a compound of Formula (I)” should be changed to “the compound of Formula (I)” since this term has antecedent basis in claim 19.
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.
Claims 33-36 and 39 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 33 is indefinite in that it is unclear if (A) a coating comprising a composition of a polyurethane and a compound of Formula (I) is being claimed, i.e., similar to the embodiment claimed in claim 19, or (B) a polyurethane impregnated with a compound of Formula (I) is being claimed, i.e., similar to the embodiment claimed in claim 14. Specifically, it appears as though this claim is mixing these embodiments as an impregnated polyurethane would be considered by the skilled artisan to be a formed article rather than a coating material.
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.
Claims 1-14, 16-18, 33-36, 39, 41-42, 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 Pub 2009/0060973) and Fatora et al. (US Pub 2009/0053278).
Regarding claims 1-6, 9-14, and 18, 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.
With respect to the newly added limitation that “the compound of Formula (I) is releasably associated with the polyurethane”, WO ‘040 discloses that the administration of the peptide can be incorporated into transdermal patches and the like and can be designed to control the release of the active agent from the matrix (pg 28, lines 3-34). Further, WO ‘040 discloses that the peptide can be applied directly or indirectly to a solid support and can be attached to solid supports by any means known in the art (pg 14, line 26+). US ‘278 discloses a polyurethane medical device that is coated with an antimicrobial peptide such that the peptide is not chemically reacted with the polymer matrix so that the peptide can be diffused out of the matrix and work as a bactericide in the vicinity of the surface [0124]. It would have been obvious to the skilled artisan to have provided the active material to be releasably associated with the polyurethane in order for the active material, i.e., peptide, to be releasable to ensure effective treatment, as taught by US ‘278.
Regarding claim limitation that the polyurethane is a thermoplastic polyurethane (TPU), i.e., claims 7, 33-36, 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 16-17, 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 and 34-36, 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 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 41-42, US ‘973 discloses the claimed polyurethane that is produced by the reaction of a polyether polyol [0104] with an aliphatic diisocyanate [0101].
Regarding claims 48 and 50, both WO ‘040 and US ‘973 are directed to coated medical devices that prevent bacterial infection during use.
Allowable Subject Matter
Claims 19-30, 32, 37, 43, and 44 are allowed.
None of the prior art of record disclose or suggests the claimed composition formed from a thermoplastic polyurethane and a compound of Formula (I) dissolved in an organic solvent.
Response to Arguments
Applicant’s arguments with respect to the 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.
The previous objections to the claims and rejections under 35 U.S.C. 112(b) have been overcome by the present amendment.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, WO ‘040 is relied on for the disclosure of an antimicrobial peptide coating on a medical device, such as an implant (pg 14, lines 14-25). US ‘973 is relied upon to teach a polyurethane medical device.
The arguments with respect to the newly added limitation that “the compound of Formula (I) is releasably associated with the polyurethane”. The obviousness rejection has been modified to include Fatora et al. (US Pub 2009/0053278). See paragraph #9 above.
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 Blaine Copenheaver whose telephone number is (571)272-1156. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frank Vineis can be reached at (571)270-1547. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLAINE COPENHEAVER/Primary Examiner, Art Unit 1781
Prosecution Insights