FINAL 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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/19/2025, 07/31/2025, and 09/23/2025 have been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 09/22/2025 in which claims 1-18 and 21-22, 24, 26-27, 32, and 34-35 were canceled; claims 19, 25, 28, and 33 were amended; and claim 36 was newly added. All the amendments have been thoroughly reviewed and entered.
Claims 19-20, 23, 25, 28-31, 33 and 36 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Maintained-Modified Rejections
Modification Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-20, 23, 25, 28-31, 33 and 36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 19 and 28 introduce new matter as the claims recite the limitation: a thermoset polyurethane SMP foam that includes an amide linkage. There is no support in the specification for the thermoset polyurethane SMP foam to contain an amide linkage.
Nowhere in the specification does it disclose that the thermoset polyurethane SMP foam contains “an amide linkage” as recited in claims 19 and 28. There is no disclosure in the original claims or the specification including the drawings that pertains to amide linkage.
Applicant alleges that support for “a thermoset polyurethane SMP foam that includes an amide linkage” as recited in claims 19 and 28, can be found in Figure 1 in which “the HDI and CA (cinnamic acid includes a carboxylic acid) in step 1 of Route A” (Remarks filed 09/22/2025, page 7, 2nd paragraph). However, contrary to Applicant’s allegation, there is no disclosure in Figure 1 that disclose the thermoset polyurethane SMP foam contains an amide linkage. Nothing in the Figure 1 describes or states there is amide linkage in the synthesis shown in Route A or Route B.
Claims 20, 23, 25, 29-31, 33, and 36 are also rejected as they depend directly or indirectly from conflicting claims 19 and 28, respectively.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of claims 19 and 28 as amended at the time of filing of the instant application.
Response to Arguments
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive.
Applicant argues “amide linkages are created via direct reactions between isocyanates and carboxylic acids, such as, for example, the HDI and CA (cinnamic acid includes a carboxylic acid) in Step 1 of Route A of Figure 1. Nothing in Step 2 of Route A would remove the amide linkage. If anything, the isocyanates of the prepolymer in Step 2 would react with the CA of Step 2 to produce even more amide linkages.” (Remarks, page 7, 2nd paragraph).
In response, the Examiner disagrees. As discussed above in the pending new matter rejection, there is no disclosure in Figure 1 that disclose the thermoset polyurethane SMP foam contains an amide linkage. Nothing in the Figure 1 describes or states there is amide linkage in the synthesis shown in Route A or Route B.
Thus, it is maintained that the disclosure does not reasonably convey that the inventor had possession of the subject matter of claims 19 and 28 as amended at the time of filing of the instant application.
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(s) 19, 23, 25, 28, 30-31, and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singhal et al (US 2013/0317541 A1), as evidenced by Boon et al (US 2010/0093860 A1).
Regarding claims 19 and 28, Singhal teaches a thermoset polyurethane shape memory polymer (SMP) foam prepared by: i) reacting trifunctional triethanolamine (TEA) (a polyol with three hydroxyl (OH-) portions) with hydroxybutyrate (HB) and hexamethylene diisocyanate to form a prepolymer first reaction product; and ii) mixing the prepolymer with another HB-TEA to form a second reaction product; and iii) mixing the second reaction product with a blowing agent to form the polyurethane SMP foam, wherein the prepolymer is formed before mixing the second reaction product with the blowing agent to form the SMP foam ([0030]-[0081]; Figs. 4-5; claims 1-22). As evidenced by Boon, hydroxybutyrate is an antimicrobial agent (Boon: Abstract; [0007], [0009], [0012], [0089]-[0090], [0108]; claim 41).
As discussed above, Singhal teaches the SMP foam is fabricated by first forming a prepolymer made by mixing HDI (an isocyanate) with HB-TEA polyol ([0068]-[0069]). The “first reaction product” is the prepolymer made by mixing the mixing HDI (an isocyanate) with HB-TEA polyol, in which the HDI is the isocyanate and the HB-TEA polymer is the first polyol portion with a first antimicrobial agent (HB – hydroxybutyrate), thereby the first polyol portion include triethanolamine (the TEA of HB-TEA polyol).
After the prepolymer is formed, said prepolymer is reacted with another HB-TEA ([0069]). Thus, the “second polyol portion” is the TEA from the HB-TEA that is reacted with the prepolymer.
As explained above, the prepolymer is reacted with HB-TEA ([0069]). Thus, the “second antimicrobial agent portion” is the HB from the HB-TEA that is reacted with the prepolymer.
As explained above, the prepolymer is reacted with HB-TEA ([0069]). Thus, the “second reaction product” is the reaction product from the reaction of the prepolymer with HB-TEA.
With respect to the claimed “the SMP foam is a thermoset polyurethane SMP foam that includes an amide linkage” as recited in claims 19 and 28, as depicted below in Fig. 5 of Singhal, the prepolymer (that is mixed with blowing agent to form the resultant thermoset polyurethane SMP foam) contains amide linkage:
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Regarding claim 23, as discussed above, the prepolymer of Singhal is reacted with HB-TEA ([0069]). Thus, the “second polyol portion” is the triethanolamine (TEA) from the HB-TEA that is reacted with the prepolymer.
Regarding claim 25 and 33, Fig. 5 of Singhal (depicted below), the prepolymer (that is mixed with blowing agent to form the resultant thermoset polyurethane SMP foam), contains urethane linkage and amide linkage:
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Regarding claim 30, as discussed above, Singhal teaches the SMP foam is fabricated by first forming a prepolymer made by mixing HDI (an isocyanate) with HB-TEA polyol ([0068]-[0069]). The “first reaction product” is the prepolymer made by mixing the mixing HDI (an isocyanate) with HB-TEA polyol, in which the HDI is the isocyanate and the HB-TEA polymer is the first polyol portion with a first antimicrobial agent (HB – hydroxybutyrate), thereby the first polyol portion include triethanolamine (the TEA of HB-TEA polyol).
Regarding claim 31, as discussed above, after the prepolymer is formed, said prepolymer is reacted with another HB-TEA ([0069]). Thus, the “second polyol portion” is the TEA from the HB-TEA that is reacted with the prepolymer.
As a result, the aforementioned teachings from Singhal are anticipatory to claims 19, 23, 25, 28, 30-31, and 33 of the instant invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19-20, 23, 25, 28-31, 33, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singhal et al (US 2013/0317541 A1), as evidenced by Boon et al (US 2010/0093860 A1), and further in view of Lendlein et al (US 2006/0257629 A1).
The methods of claims 19, 23, 25, 28, 30-31, and 33 are discussed above, said discussion being incorporated herein in its entirety.
Singhal teaches that the hydroxybutyrate molecule is a pendant group chemically bonded to a polyurethane polymer chain of the SMP foam via ester bond formation (Singhal: [0059]-[0069]; Figs. 4-5; claims 20-22). Singhal teaches a preferred SMP is based on hexamethylene diisocyanate (HDI), tetrakis (2-hydroxypropyl)ethylene diamine (HPED), and triethanolamine (TEA) ([0059]). Singhal teaches hydroxyalkanoate (e.g. 3-hydroxybutyrate) modified TEA and HPED are preferred as the branched polyols with tri- and tetra functional molecules because they give the dual benefit of high functionality with biocompatible end products ([0060]).
However, Singhal does not teach the antimicrobial agent of claims 20, 29 and 36.
Regarding the antimicrobial agent of claims 20, 29 and 36, Lendlein teaches formation of a shape memory polymer (SMP) by functionalizing a cinnamic acid to a star shaped branched polymers or oligomers having terminal OH-groups via esterification, wherein the resultant polymer formed with the cinnamic acid group have shape memory properties, and the shape memory polymer have high elasticity that enables a simple deformation of material for programming of a temporary shape and the shape memory polymer have high degree of recovery (abstract; [0009], [0010], [0019], [0022], [0026]-[0041], [0043]-[0046], [0053]-[0058], [0064]; claims 10-14). The shape memory polymer is a crosslinked shape memory polymer ([0019], [0020], [0022] and [0068]).
It would have been obvious to one of ordinary skill in the art in art to modify the polyurethane SMP foam of Singhal such that the polyurethane polymer chain is functionalized with cinnamic acid (instead of 3-hydroxybutyrate) via esterification, per guidance from Lendlein, and produce the claimed invention. One of ordinary skill in the in the art would have been motivated to do so because Maitland and Lendlein are commonly drawn to polyurethane SMP foams which has an agent containing a carboxylic acid group as pendant group chemically bonded to the polyurethane polymer chain via an ester, and are both use for medical purposes. Lendlein provided the guidance for modifying the polymer that forms the SMP foam such that the polymer is functionalized with a cinnamic acid via esterification, and such resultant SMP foam containing functionalized cinnamic acid has high mechanical strength and stability, high elasticity and high degree of recovery (Lendlein: [0009], [0022] and [0056]). Thus, an ordinary artisan provided the guidance for the prior art would have looked to modifying the SMP foam of Singhal such that the polyurethane polymer is functionalized with cinnamic acid so as to obtain resultant polyurethane SMP foam that can be used for the same medical purpose, yet have superior properties with respect to high mechanical strength and stability, high elasticity and high degree of recovery, and achieve Applicant’s claimed invention with reasonable expectation of success.
With respect to the first polyol portion includes the HPED and the second polyol portion includes the TEA of claim 36, as discussed above, Singhal provided the direct guidance for using TEA and HPED as the polyol, thereby the first and second polyol portions in the reaction products of Singhal (as described in claim 19 supra) would contain TEA and HPED.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive.
Applicant argues that Singhal’s squiggly line in the drawing from Figure 5 was defined by the UCLA article (cited by Applicant) as meaning (1) “molecular structure beyond this point unspecified or unimportant,” or (2) a mixture of isomers at this point” and thus, alleged that Singhal’s squiggly line does not include a carbon, and therefore Singhal does not include an amide linkage. Applicant further requested the Examiner to answer the streamline questions on page 6 of the Remarks to record for appeal. (Remarks, pages 5-7).
In response, the Examiner disagrees. Applicant’s analysis of the “squiggly line” in Figure 5 of Singhal as having an oxygen and does not include a carbon, is a far-stretched interpretation of Singhal because Singhal does not identify the “squiggly line” in the disclosure of Singhal and thus, such “squiggly line” as per Applicant’s UCLA article is unspecified or unimportant in Singhal, and thereby not pertinent to the 102 and 103 rejections as they pertain to the Singhal reference. Unless the Singhal reference disclose the “squiggly line” as a critical component and further identify the “squiggly line,” one does not need to focus on the “squiggly line,” as per Applicant’s UCLA article, this “squiggly line” is unimportant. The focus should be on the actual structure/components that are shown in the SMP product of Figure 5, which as discussed above in the pending 102 and 103 rejections, clearly showed that the SMP of Figure 5 contains an amide linkage (a carbonyl group (C=O) bonded to a nitrogen atom (—NH—) (Figure 5 is reproduced below to show the amide linkage). Therefore, the “squiggly line” has nothing to do with the already present amide linkage as depicted below.
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Applicant is noted that claims 19 and 28 recites “the SMP foam is a thermoset polyurethan SMP that includes an amide linkage.” Indeed, Singhal does teach said limitation of “the SMP foam is a thermoset polyurethan SPM that includes an amide linkage” because it can be clearly seen in Figure 5 of Singhal, the SMP product include an amide linkage. To this end, the Examiner does not need to answer Applicant’s streamline questions on page 6 of Applicant’s Remarks because the gist of Applicant’s argument and of the streamline questions are drawn to one main focus of the Singhal does not include an amide linkage. As discussed above, the Examiner had adequately rebutted Applicant’s argument drawn to “Singhal does not include an amide linkage” by showing that Figure 5 of Singhal does in fact show the SMP product included an amide linkage, thereby meeting the claimed “the SMP foam is a thermoset polyurethan SPM that includes an amide linkage.”
If Applicant’s disagrees with the Examiner’s position above and to move this case forward, Applicant is invited to proceed with Applicant’s intention of filing a Notice of Appeal.
As a result, for at least the reason discussed above, claims 19, 23, 25, 28, 30-31, and 33 remain rejected as being anticipated by Singhal (and as evidenced by Boon); and claims 20, 29 and 36 remain rejected as being obvious and unpatentable over the combined teachings of Singhal and Lendlein in the pending 102 and 103 rejections, respectively, as set forth in this office action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 19-20, 23, 25, 28-31, 33 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11090408.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘408 significantly overlap with the subject matter of the instant claims i.e., the claims of the instant application being a product-by-process type claim, yet process produces the same thermoset polyurethane SMP foam as that of Patent ‘408, in which the thermoset polyurethane SMP foam includes an antimicrobial agent that is a phenolic acid selected from benzoic acid, gentisic acid, 4-hydroxy benzoic acid, p-coumaric acid, vanillic acid, syringic acid, protocatechuic acid, gallic acid, ferulic acid, sinapic acid, caffeic acid, or combinations thereof, wherein the phenolic acid is a pendant group chemically bonded, via an ester, to a polyurethane polymer chain of the SMP foam, and wherein the SMP foam includes a reaction product of hexamethylene diisocyanate (HDI) with one or more of trimethanolamine (TEA), N,N,N′,N′ tetrakis (hydroxyl propylene) ethylenediamine (HPED), or combinations thereof. The thermoset of Patent ‘408 would contain an amide linkage and urethane linkage, as the thermoset SMP foam of the Patent ‘408 contains the same structural components as the instant claims.
The dry and wet glass transition temperatures as recited in the claims of the Patent ‘408 would be inherent features of the thermoset polyurethane SMP foam produced in the method of the instant claims, as thermoset polyurethane SMP foams of the instant application and that of Patent ‘408 are structurally identical.
Because the subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, and if the claims of the instant application are allowed, would improperly extend the "right to exclude" already granted in the patent. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11090408.
Response to Arguments
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive.
Applicant argues by requesting reconsideration of the double patent rejection in light of the present amendments (Remarks, page 7, last paragraph).
In response, in light of the present amendments, the double patenting rejection is maintained for the reasons discussed above in the pending double patenting rejection, and pending filing of a terminal disclaimer.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613