EXAMINER'S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
The application has been amended as follows:
CANCEL Claim 1.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/17/2026 has been entered.
Election/Restrictions
This application is in condition for allowance except for the presence of claim 1 directed to an invention, non-elected without traverse. Accordingly, claim 1 is cancelled.
Response to Amendment
The previous rejection of Claim 2 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in light of the Applicant’s amendments.
The previous rejections of Claims 4-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in light of the Applicant’s amendments.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. §101 because the claimed recitation of a use, without setting forth any steps involved in the process results in an improper definition of a process under 35 U.S.C. § 100(b); i.e., the claim language results in a claim which is not a proper process claim under 35 U.S.C. § 101. See MPEP 2173.05(q).
Claim 15 provides for "use of 3D printed parts of claim 10…” This is an improper method claim because the claims do not set forth any steps involved in the method and/or process and as a result, would not be a proper process claim under the definition of a “process” under 35 U.S.C. § 100(b); i.e., the claim language results in a claim which is not a proper process claim under 35 U.S.C. § 101. See MPEP 2173.05(q).
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.
Claim 15 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 15 provides for "use of 3D printed parts of claim 10…” This is an improper method claim because the claims do not set forth any steps involved in the method and/or process and as a result, would not be a proper process claim under the definition of a “process” under 35 U.S.C. § 100(b); i.e., the claim language results in a claim which is not a proper process claim under 35 U.S.C. § 101. See MPEP 2173.05(q).
Claim 15 provides for "use of 3D printed parts of claim 10…” It is unclear if the “use of” is an actual step or not. See MPEP 2173.05(q).
It is suggested the claim be amended to “The 3D printed part of claim 10, wherein the 3D printed part is a bone filler, a vascular closure device, or a hemostasis device, for aneurysms applications, mastectomy applications, and/or stent applications, or a scaffold for regenerative medicine.”
Allowable Subject Matter
Claim 15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. §101 and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 2, and 4-14, are allowed.
The following is an examiner’s statement of reasons for allowance:
The first closest prior art is Shuying et al. (hereinafter Shuying). 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). 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).
Shuying does not 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.
Shuying further does not teach that the polymer is “multi-block” polymer and also does not teach “wherein the shape changes in a temperature range of −60 to 60° C.”
The second closest prior art is 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). 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). 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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. 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).
Peponi does not teach wherein the glycolide portion of the polymer.
Peponi further does not teach that the polymer is “multi-block” polymer and also does not teach “wherein the shape changes in a temperature range of −60 to 60° C.”
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
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-4:00pm.
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/HA S NGUYEN/Primary Examiner, Art Unit 1766
