DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/15/2025 has been entered.
Election/Restrictions
Applicant’s election of Group II: Claims 2 and 3 in the reply filed on 02/11/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, and 4-15, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2025.
Response to Amendment
The previous rejections are maintained and modified in light of the Applicant’s arguments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 103254595 A to Shuying et al. (hereinafter Shuying) and in further view of Peponi et al., “Synthesis and characterization of PCL-PLLA polyurethane with shape memory behavior,” European Polymer Journal, vol. 49, pp. 893-903, 2013. (hereinafter Peponi).
Regarding claims 2 and 3, Shuying teaches a shape memory function degradable stent obtained from a degradable low-weight-average molecular weight polymer with a Mw of 10,000-30,000 by ring-opening polymerization of lactide, glycolide and polycaprolactone with a diol, (para 5, 8, 13 and 15), and then chain extending the degradable polymer to obtain a polymer having an Mw of 80,000-110,000 (para 8 and 17), with a glass transition temperature is 30-35 deg C (para 18), and shape memory is restored (i.e. changes) at temperatures above the glass transition temperature (para 33), which meets the claimed shape changes of claim 3. Shuying also teaches degradable polymer having a Mw of 25,000 is first obtained by reacting L-lactide, glycolide and caprolactone in a molar ratio of 3:5:2 (para 50), and is then chain extended by reacting with hexamethylene diisocyanate (HDI) at a 1:1 molar ratio to form a degradable polymer product with a Mw of 105,000 with a shape memory function and a Tg of 34 deg C (para 50). The above L-lactide meets the claimed
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99
134
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x unit, the above glycolide meets the claimed
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100
140
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y unit, and the HDI (168 g/mol) meets the claimed
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60
138
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unit.
Using the above molar ratio of 3:5:2 polymer (30 mol% lactide, 50 mol% glycolide, 20 mol% PCL) with a Mw of 25,000 and the chain extended by hexamethylene diisocyanate (HDI, Mw 168 g/mol) at a 1:1 molar ratio to form a degradable polymer product with a Mw of 105,000, this correlates to the claimed lactide x of about 52, the claimed glycolide y of about 107, the polyurethane n = 4.1 (105000/25168), which meets the claimed x, y, x+y, and n.
Shuying does not explicitly teach wherein the above polycaprolactone with a diol has the claimed formula
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111
461
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(i.e. PCL-diol) portion of the polymer.
However, Peponi teaches a shape-memory polyurethane that are biocompatible and biodegradable for the biomedical field (page 893) composes of a hard segment and a soft segment obtained from polylactic acid (PLLA) and poly(caprolactone) (page 894), which is the same field of use of shape memory biodegradable polyurethanes as the Applicant’s invention. Peponi teaches the polyurethane is obtained by a ring-opening polymerizing L-Lactide with a polycaprolactone diol (PCL-diol) with a Mw of 4000 with a stannous octoate (SnOct2) catalyst to form a polymer that is then chain extended by reacting it with 1,6-hexamethylene diisocyanate in a 1:1 molar ratio to form the final polymer. (page 894, 2.1 Synthesis of the polyurethane). Peponi teaches the PCL-diol at Mw of 4000 has the formula
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38
687
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, wherein the n correlates to about a total of 34, and meets the claimed z and
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unit of polymer B. Peponi also teaches that the PCL-diol is used to initiate the ring-opening polymerization, (page 894), the PCL a tough polymer with a lower elastic modulus and has a much higher strain at break (page 897), and would act as a “switching segment” for shape-memory behavior (page 897), where the melting temperature can be used as transition temperature between 37-47 deg C, (page 902), and such good properties would give potential use in bio-medical applications. (page 902).
It would have been obvious to one ordinarily skilled in the art before the effective date of the claimed invention to use the PCL-diol of Peponi for the polycaprolactone/diol segment in the degradable polymer of Shuying because Peponi teaches the same field of use of shape memory biodegradable polyurethanes as the Applicant’s invention and Peponi also teaches that the PCL-diol monomer will initiate the ring-opening polymerization, (page 894), the PCL-diol is a tough polymer with a lower elastic modulus and higher strain at break (page 897), and would act as a “switching segment” for shape-memory behavior (page 897), where the melting temperature can be used as transition temperature between 37-47 deg C. (page 902), and such good properties would give potential use in bio-medical applications. (page 902).
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., multi-block-copolymers, shape retention properties without SiO2, higher molecular weight of PLLA/PGA segment than PCL-diol segment) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On page 5-6, the Applicant argues that Shuying does not teach a block copolymer and does not teach shape retention properties without SiO2. This is not persuasive because, as cited above, claim 2 only requires for a “bioresorbable polymer” and does not claim a “block” polymer and does not claim “without SiO2.”
On page 6-8, the Applicant appears to be making an argument that Peponi does not teach the Applicant’s unexpected good properties of a glass transition between 28-47 deg C for handling in medical devices, as well as the good memory shape properties due to the rigid crystallinity from the higher molecular weight of the PLLA/PGA segment that is 5 times that of the PCL segment. Although the unexpected properties is persuasive, the claims do not commensurate in scope to the Applicant’s evidence. For example, the claims are directed to a “polymer” while the good properties are to a triblock and/or multi-block copolymer. The claims also do not teach a higher molecular weight ratio of PLLA/PGA segment to PCL-diol segment. Therefore, for the above reasons, the Applicant has not met their burden in establishing unexpected results. See MPEP 716.02 (a-e).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HA S NGUYEN whose telephone number is (571)270-7395. The examiner can normally be reached Mon-Fri, Flex schedule 7:30am-3:45pm.
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/HA S NGUYEN/Primary Examiner, Art Unit 1766