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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/22/2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted and filed after the mailing date of the Notice of Allowance on 01/23/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 16-20 and 24-28, in the reply filed on 11/13/2025 is acknowledged. Election was made without traverse in the reply filed on 11/13/2025.
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 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.
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) 16-18 and 20 is/are rejected under 35 U.S.C. 103 as obvious over HUITEMA et al. (WO 2018229574 A1) in view of Scanlon et al. (US 20070207186 A1) in view of SHELTON IV et al. (WO 2015191219 A1) and further in view of D'AGOSTINO et al. (US 20220361928 A1).
Regarding claims 16-18 and 20, HUITEMA et al. discloses a method for embedding medical additives into a bioabsorbable material, the method comprising:chemically reacting one or more functional groups of a bioabsorbable material with one or more medical additives [0008, 0068, 0083], wherein the one or more functional groups comprise isocyanate groups and wherein the bioabsorbable material is configured to be placed inside a body of a human wherein the bioabsorbable material is configured to be used with a surgical staple cartridge configured to repair one or more parts of the body of the human (implantable staple cartridge 40, [0048], fig. 6), and wherein the one or more medical additives are configured to remain chemically bonded to a foam structure of the bioabsorbable material until a biodegradation of the bioabsorbable material (covalent bonded to polyurethane porous matrix [0067-0068].
HUITEMA et al. fails to disclose the one or more medical additives comprise one or more polydrugs wherein a polydrug is a single drug or a drug including multiple active pharmaceutical ingredients (APIs) in a single dosage form and the chemical reaction comprises end capping the isocyanate groups with the one or more polydrugs.
Scanlon et al. teaches a bioabsorbable material (12, polyurethane [0176, 0180, 0194-0195, 0260, 0271-0275, 0282]) with one or more medical additives (60/62, 90) that comprise one or more polydrugs wherein a polydrug is a single drug or a drug including multiple active pharmaceutical ingredients (APIs) in a single dosage form ([0137-0179, 0159, 0189, 0199, 0231-0232, 0270-0271, 0289, 0304], figs. 72-73) and the chemical reaction comprises end capping the isocyanate groups with the one or more polydrugs; the bioabsorbable material is a reaction product of a polyol and an isocyanate [0260, 0271-0275, 0282]
SHELTON IV et al. also teaches a bioabsorbable material (implantable staple cartridge 360/buttress 30/130 [93, 0116, 0540]) with one or more medical additives (therapeutic drug [117-122, 0153]) that comprise one or more polydrugs wherein a polydrug is a single drug or a drug including multiple active pharmaceutical ingredients (APIs) in a single dosage form and the bioabsorbable material is a reaction product of a polyol and an isocyanate wherein the polydrugs treat one or more of pain, wound healing, tissue growth, infection reduction, immunosuppression, radiotherapy, or combinations thereof [0128].
D'AGOSTINO et al. teaches an implant (5) having a isocyanate component is reacted with a polyol to produce a polyurethane or a prepolymer and endcapping the polyol with an isocyanate and having a foamed surface [0216, 0221-0222, 0426, 0466] and having one or more functional groups that comprise polyol hydroxyl groups [0028, 0212-0214, 0233, 0372, 0610], wherein chemically reacting the one or more functional groups of the bioabsorbable material with the one or more medical additives further comprises modifying the one or more functional groups via one or more reactive surfactants [0037].
Given the teachings of HUITEMA et al. to have a medical implant with medical additives, it 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 to modify medical implant with having the one or more medical additives comprise one or more polydrugs wherein a polydrug is a single drug or a drug including multiple active pharmaceutical ingredients (APIs) in a single dosage form and the chemical reaction comprises end capping the isocyanate groups with the one or more polydrugs to have better delivery of medicine via an implant, better sealing and absorption of the wound area, and/or strength of the material purposes as taught by Scanlon et al., SHELTON IV et al., and D'AGOSTINO et al.
Allowable Subject Matter
Claims 19 and 26-27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to teach or render obvious a method for embedding medical additives into a bioabsorbable material/buttress comprising all the structural and functional limitations and further comprising, amongst other limitations/features, hemically reacting one or more functional groups of a bioabsorbable material with one or more medical additives, wherein the one or more functional groups comprise isocyanate groups, the one or more medical additives comprise one or more polydrugs, and the chemical reaction comprises endcapping the isocyanate groups with the one or more polydrugs, wherein a polydrug is a single drug or a drug including multiple active pharmaceutical ingredients (APIs) in a single dosage form, wherein the bioabsorbable material is configured to be placed inside a body of a human, and wherein the one or more medical additives are configured to remain chemically bonded to a foam structure of the bioabsorbable material until a biodegradation of the bioabsorbable material, wherein the one or more medical additives react with the polyol. Though Schmid US 20140224857 A1 teaches a tissue thickness compensator that can involve reacting two or more precursors and embedding a biocompatible foam buttress with medicine to improve a biological effect, the buttress does not involve having the chemical reaction comprising endcapping the isocyanate groups with the one or more polydrugs, wherein a polydrug is a single drug or a drug including multiple active pharmaceutical ingredients (APIs) in a single dosage form, wherein the bioabsorbable material is configured to be placed inside a body of a human, and wherein the one or more medical additives are configured to remain chemically bonded to a foam structure of the bioabsorbable material until a biodegradation of the bioabsorbable material wherein the one or more medical additives react with the polyol and it would not be obvious to modify Schmid buttress without undue experimentation, hindsight reasoning to achieve the unexpected result of the bioabsorbable material configured to remain chemically bonded to a foam structure of the bioabsorptive material until the biodegradation of the material along with high rate of bioabsorption. Having the bioabsorbable material configured to remain chemically bonded to a foam structure of the bioabsorptive material until the biodegradation of the material along with high rate of bioabsorption provides an effective bioabsorbable material/buttress for healing the closure of a surgical area.
While various features of the claimed subject matter are found individually in the prior art, a skilled artisan would have to include knowledge gleaned only from the applicant's disclosure to combine or modify the teachings of the prior art to produce the claimed subject matter, and thus obviousness would not be proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). There is no teaching, suggestion, or motivation found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to combine or modify the teachings of the prior art to produce the claimed invention, and thus obviousness would not be proper. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Additional prior art considered pertinent: See references cited, form 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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/ROBERT F LONG/Primary Examiner, Art Unit 3731
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