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 .
Election/Restrictions
Claim 2 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), Claims 4-15, directed to the process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claim 1, directed to the invention(s) of a biosorbable polymer of Formula A does NOT require all the limitations of an allowable product claim, and has NOT been rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement of groups III-VIII as set forth in the Office action mailed on 12/11/2024 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Response to Amendment
The previous rejections of Claim(s) 2 and 3 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with shape memory behavior,” European Polymer Journal, vol. 49, pp. 893-903, 2013, (hereinafter Peponi), are withdrawn in light of the Applicant’s amendments.
Claim Rejections - 35 USC § 112
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.
Claim 2 is 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.
Claim 2 recites, the limitations of “without SiO2” and “wherein the molecular weight of PLLA/PGA segment is higher than PCL segment,” in line 10-11.
In regard to “without SiO2,” the Applicant’s specification only mentions “an inorganic particle,” but is merely silent regarding SiO2. In this case, because SiO2 is not explicitly mentioned in the specification, there is no support to explicitly exclude it, and thus, the limitation is considered as new matter. (“Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claim…and [t]he mere absence of a positive recitation is not basis for an exclusion.” See MPEP 2173.05(i).)
In regard to “wherein the molecular weight of PLLA/PGA segment is higher than PCL segment,” the Applicant’s specification only states that the PLLA segment has a “segment length of 10 k, and a PCL segment chain length of 2 k,” but does not have support for the broader range of PLLA/PGA segment as “higher than” the PCL segment. Thus, there is no support and the limitation is considered as new matter.
It is suggested the limitations of “without SiO2,”and “wherein the molecular weight of PLLA/PGA segment is higher than PCL segment,” be deleted to alleviate the issues above.
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.
Claims 4-15 are 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.
Claims 4, and 6, depends from claims 1 and/or claim 3, which has been canceled.
Claims 11-13, depends from claims 1 and/or claim 3, which has been canceled, and appears to also be improper multiple dependent claims. See MPEP § 608.01(n).
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 is also unclear if “use of” is an actual step or not. See MPEP 2173.05(q). It is suggested the claim be amended to “The 3D part of claim 10, wherein the 3D printed part is a bone filler, a vascular closure device, or a hemostasis device, in aneurysms applications, mastectomy application, and stent applications, or a scaffold for regenerative medicine.”
Claims 5, 7-10, and 14, are dependent claims which fail to alleviate the issues above.
Allowable Subject Matter
Claim 2 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as set forth in this Office action.
Claims 4-15 would be allowable and if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, canceling claim 1, and if the issues of Claim 2 are alleviated, as cited above,
The following is a statement of reasons for the indication of allowable subject matter:
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.”
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 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
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