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 .
Response to Amendment
Applicant' s claim amendments and remarks filed 9/2/2025 are entered and have
been fully considered. Applicant has cancelled claim 3 and amended the claims to overcome the objections and §112b rejections, therefore they are withdrawn.
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.
Claims 1-2, 4, 7-12, 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al, US9931431 B2.
Regarding claims 1-2, 4, 8, 12, and 16 Wang teaches an article, an implantable medical device or stent, fabricated from a biodegradable polymer blend of a matrix polymer with star-block copolymers (which are multi-axial polymers) Col. 2 lines 54-67. The matrix polymer is Poly-L-lactic acid (PLLA) Col. 8 lines 24-28. Wang further teaches that traditional devices, such as stents, have shortcomings like lower toughness, and PLLA by itself is strong but brittle, Col. 6 lines 64-67. Blending with another polymer with high facture toughness increases the overall facture toughness of the blend, Col. 7 lines 10-12. PLLA is blended with a star-block copolymer for increased facture toughness, Col. 8 lines 59-62. The polymer blend is 5-20 wt.% star-block copolymer and 75-95 wt.% matrix polymer, Col. 8 lines 63-65.
Wang teaches a method of making a polylactide polymer blend composition by blending PLLA with a star copolymer in a blender and then extrude through a single or twin-screw extruder, Example 2, Col. 14 lines 23-36. Wang does not explicitly state there is partial transesterification during the blending. Applicant’s as filed spec teaches the melt blending in an extruder causes some transesterification, ¶[0046] of the instant specification. Therefore, one of ordinary skill in the art is reasonably suggested that blend of Example 2 of Wang must have some partial transesterification occurring to the overall blend because of the extrusion, it must be a melt blending process and Applicant’s as-filed spec teaches this is what is required for transesterification to occur.
Regarding claims 7, 9, 10, and 11 Wang further teaches that the star copolymers are polymerized from initiators of glycerol, Col. 11 line 27, and pentaerythritol Col. 11 line 38. Exemplified biodegradable star-block copolymers are P(CL-co-TMC)-b-PLLA and P(CL-co-TMC)-b-LPLG, Col. 11 lines 9-14. CL is caprolactone, TMC is tetramethyl carbonate, PLLA is poly L-lactic acid (a polyester), and LPLG is poly-L-lactide-co-glycolide. It is also taught that the discrete phases within the matrix polymer, the multi-arm polymers, are amorphous, Col. 8 lines 43-45.
Regarding claims 17-20, Wang teaches a method of making a polylactide polymer blend composition by blending PLLA with a star copolymer in a blender and then extrude through a single or twin-screw extruder, and then prepare a stent therefrom, Example 2, Col. 14 lines 23-36. Applicant’s as filed spec teaches the melt blending in an extruder causes some transesterification, ¶[0046] of the instant specification. Therefore, one of ordinary skill in the art is reasonably suggested that blend of Example 2 of Wang must have some partial transesterification occurring to the overall blend because of the extrusion, it must be a melt blending process and Applicant’s as-filed spec teaches this is what is required for transesterification to occur.
Claims 1-2, 4, 7-9, 11-12, 16, 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lindsey et al, US20180244840A1.
Regarding claims 1-2, 4, 7, 9, 12, 16, 17-20 Lindsey teaches medical devices such as stents (¶[0066]) comprised of biodegradable polymer blends of poly lactide and poly(ɛ-caprolactone), ¶[0073]. The exemplary blends comprise block co-polymers of PLLA-PCL-PLLA and a triaxial homopolymer of PLLA, ¶[0073]. Lindsey further teaches that the properties of the blend can be tuned based on the various parameters and reactants to achieve the desired properties, including impact resistance, ¶[0049].
The exemplary method for blending the polymers is an in-situ process, ¶[0006]. In Example 1, ¶[0080], 1,3-propanediol, ɛ-caprolactone, and tin(II)2-ethylhexanoate in toluene is reacted for 1 day at 140°C-180°C to form polycaprolactone. Then when cooled to 100°C-120°C, L-lactide and trimethylolpropane (the initiator) are added to the reaction vessel, mixed for 1-3 hours, then tin(II)2-ethylhexanoate in toluene is added, and the temperature increased to 121°C-180°C and heated for 3-5 days. This forms a blend composition comprised of 66 wt.% of the linear PLLA-PCL-PLLA copolymer and 34 wt.% of the triaxial PLLA homopolymer, ¶[0079].
Lindsey teaches the PLLA-PCL-PLLA copolymer with the triaxial PLLA homopolymer are mixed in a jar and then melt blended in an extruder at a temperature of 180 – 210 oC ¶[0115]. Lindsey does not explicitly state there is partial transesterification during the blending. Applicant’s as filed spec teaches the melt blending in an extruder causes some transesterification, ¶[0046] of the instant specification. Therefore, one of ordinary skill in the art is reasonably suggested that the blend of Example 14 of Lindsey must have some partial transesterification occurring to the overall blend because it is melt- blending in an extruder, and Applicant’s as-filed spec teaches this is what is required for transesterification to occur.
Regarding claims 8 and 11, Lindsey further teaches in example 8, ¶¶[0098-0099] that the triaxial block copolymer of PLLA-PCL-PLLA is prepared.
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.
Claims 1-2, 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Babcock et al, US8183321B2 in view of Wang et al, US9931431 B2.
Regarding claims 1 and 2, Babcock teaches a thermoformed article comprising a biodegradable (Col. 1 lines10-11) polylactide resin with impact modifier particles dispersed throughout, Col. 2 lines 23-28, 57. The impact modifier is a core-shell rubber which significantly increases the impact strength over the unmodified PLA resin, Col. 2 lines 38, 47-50. Babcock further teaches using an extruder for melt-blending, Col. 9 line 11.
Babcock does not teach blending a multi-axial polymer with the PLA or that partial transesterification occurs during blending.
Wang discloses a composition for medical devices comprising a biodegradable polymer blend of a matrix polymer with star-block copolymers (which are multi-axial polymers) Col. 2 lines 54-67. The matrix polymer is Poly-L-lactic acid (PLLA) Col. 8 lines 24-28. PLLA is blended with a star-block copolymer for increased facture toughness, Col. 8 lines 59-62. Wang also discloses a method of making a polylactide polymer blend composition by blending PLLA with a star copolymer in a blender and then extrude through a single or twin-screw extruder, Example 2, Col. 14 lines 23-36.
Wang nor Babcock explicitly state there is partial transesterification during the blending. Applicant’s as filed spec teaches the melt blending in an extruder causes some transesterification, ¶[0046] of the instant specification. Therefore, one of ordinary skill in the art is reasonably suggested that melt-blending must have some partial transesterification occurring to the overall blend during melt-blending and extrusion because Applicant’s as-filed spec teaches this is what is required for transesterification to occur.
Babcock and Wang are analogous to the claimed invention because both are in the field of polylactic acid compositions for the molding of articles.
Therefore it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the star-block copolymers of Wang with the invention of Babcock with the motivation to further improve the impact and fracture toughness of the PLA resin, and further melt-blending the star block copolymer with the invention of Babcock, as disclosed by Wang and Babcock, which inherently causes partial transesterification of the blend.
Regarding claim 4, Babcock teaches that the polymer matrix is at least 90 wt.% one or more polylactides, Col 2 lines 26-27. Similarly, Wang discloses the polymer blend is 5-20 wt.% star-block copolymer and 75-95 wt.% matrix polymer, Col. 8 lines 63-65.
Regarding claims 5 and 6, Babcock teaches adding the core shell rubber to PLA as an impact modifier, Col. 2 line 38, and that the crystallization of the PLA resin can be controlled by the presence of plasticizers and nucleating agents, Col. 4 line 38 and Col. 10 line 15.
Regarding claims 7-9, 10, and 11 Wang further teaches that the star copolymers are polymerized from initiators of glycerol, Col. 11 line 27, and pentaerythritol Col. 11 line 38. Exemplified biodegradable star-block copolymers are P(CL-co-TMC)-b-PLLA and P(CL-co-TMC)-b-LPLG, Col. 11 lines 9-14. CL is caprolactone, TMC is tetramethyl carbonate, PLLA is poly L-lactic acid (a polyester), and LPLG is poly-L-lactide-co-glycolide. It is also taught that the discrete phases within the matrix polymer, the multi-arm polymers, are amorphous, Col. 8 lines 43-45.
Regarding claims 12 and 13, Babcock teaches that the article is a sheet that is thermoformed to form containers such as cups, bottle, or dishes, Col. 10 lines 38-40.
Regarding claim 14, Babcock teaches a sheet is made of the polymer blend, Col. 9 line 14. An article of a sheet reads on the claimed mat of claim 14, and the limitation of it being an automobile component is a future intended use of the article, and therefore Babcock’s sheet is capable of being used in an automobile.
Regarding claim 15, Babcock teaches a sheet is made of the polymer blend, Col. 9 line 14. An article of a sheet reads on the claimed mulch film of claim 15, the limitation of it being an agricultural product is a future intended use, and therefore Babcock’s sheet is capable of being used as an agricultural product.
Regarding claims 12 and 16, Wang discloses the article is an implantable medical device such as a stent, Col. 2 lines 55 and 60.
Regarding claims 17-20, Babcock teaches a method of making a polymer blend composition comprising melt blending a masterbatch of the PLA resin with the core-shell rubber in a twin-screw extruder which is then pelletized, Col. 12 lines 18-24. The masterbatch is then dry blended with more PLA resin and then extruded through a twin-screw extruder to form a 15-mil thick amorphous sheet, Col. 12 lines 60-65. Babcock does not teach blending the multi-axial polymer with the impact modified PLA resin.
Wang discloses a method of making a polylactide polymer blend composition with increased fracture toughness (Col. 8 lines 59-62) by blending PLLA with a star copolymer in a blender and then extrude through a single or twin-screw extruder, and then prepare a stent therefrom, Example 2, Col. 14 lines 23-36.
Wang nor Babcock explicitly state there is partial transesterification during the blending. Applicant’s as filed spec teaches the melt blending in an extruder causes some transesterification, ¶[0046] of the instant specification. Therefore, one of ordinary skill in the art is reasonably suggested that melt-blending must have some partial transesterification occurring to the overall blend during melt-blending and extrusion because Applicant’s as-filed spec teaches this is what is required for transesterification to occur.
Babcock and Wang are analogous to the claimed invention because both are in the field of polylactic acid compositions for the molding of articles
Therefore it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the star-block copolymers of Wang with the invention of Babcock in a blender or mixer to form a polylactide polymer blend composition and melt-blending in an extruder, which inherently causes partial transesterification, because that is the known method of making a uniform blend composition in order to then form articles such as medical devices and sheets with increased fracture toughness, as disclosed by Wang.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al, US9931431 in view of Hong et al, US20110190448A1.
Regarding claim 14, Wang teaches the article of claim 12 as explained above. Wang does not teach that the article is an automotive component.
Hong discloses automotive components comprised of a polypropylene-polylactic acid composite with superior strength ¶[0003]. It is further disclosed that one of the problems with PLA resin is its low impact resistance, which limits its industrial applications, ¶[0006]. Hong explains that using the biomaterial, PLA, makes the composition renewable after use, and by improving the impact resistance, it is useful for automotive interiors/exteriors such as door pads, door trims, headliners, package trays, and trunk mats, ¶[0021].
Hong and Wang are analogous to the claimed invention because they are both in the field of biodegradable polylactide resin compositions.
Therefore it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the polylactide polymer blend composition of Wang to form automotive components for interiors/exteriors such as door pads, door trims, headliners, package trays, and trunk mats, with the motivation of improving the renewability and facture toughness of these articles.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al, US9931431 in view of Noda et al, US20030145518A1.
Regarding claim 15, Wang teaches the article of claim 12 as explained above. Wang does not teach that the article is an agricultural product.
Noda discloses agricultural items comprising a biodegradable polyhydroxyalkanoate copolymer, ¶[0027]. It is further disclosed that agricultural items such as mulches, nets, twines, pots, and stakes made from biodegradable polymers is advantageous because the items don’t require removal at the end of the growing season, ¶[0004]. Other agricultural items include erosion control covers, ground covers, fencing stakes, labels, and ropes, ¶[0045]. Noda discloses that many biodegradable items are brittle and there is a need for stronger biodegradable agricultural items, ¶¶[0017-0018].
Noda and Wang are analogous to the claimed invention because both are in the field of biodegradable resin compositions.
Therefore it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the polylactide polymer blend composition of Wang to form agricultural articles such as stakes, labels, ropes, and ground covers with the motivation of improving the biodegradability and facture toughness of these articles.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al, US9931431 in view of Rizk et al, US20070182041A1.
Regarding claims 5 and 6, Wang teaches the invention according to claim 1 as explained above. Wang is silent as to the addition of one or more additives, such as those claimed.
Rizk discloses compositions of toughened polylactic acid and copolymers thereof which are used for medical devices such as stents, abstract and ¶[0038]. It is further disclosed that the PLA compositions further comprise additives such as plasticizers, nucleants, and compatibilizers, as well as additives that impart benefits such as oxidative stability (antioxidant), brightness, color, flexibility, resiliency, workability, processability, viscosity, and odor control ¶[0034].
Wang is analogous to the claimed invention because it is the field of biodegradable PLA compositions.
Rizk is analogous to the claimed invention because it is in the field of polymer compositions using PLA. It is prima facie obvious to use a known combination of additives in PLA stents when they are used for the same purpose and do no more than yield predictable results for the skilled artisan.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of Wang and incorporate additives such as plasticizers, nucleants, compatibilizers and other additives to impart the benefits of oxidative stability, brightness, color, flexibility, resiliency, workability, processability, viscosity, and odor control as disclosed by Rizk.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lindsey et al, US20180244840A1 in view of Rizk et al, US20070182041A1.
Regarding claims 5 and 6, Lindsey teaches the invention according to claim 1 as explained above. Lindsey is silent as to the addition of one or more additives, such as those claimed.
Rizk discloses compositions of toughened polylactic acid and copolymers thereof which are used for medical devices such as stents, abstract and ¶[0038]. It is further disclosed that the PLA compositions further comprise additives such as plasticizers, nucleants, and compatibilizers, as well as additives that impart benefits such as oxidative stability (antioxidant), brightness, color, flexibility, resiliency, workability, processability, viscosity, and odor control ¶[0034].
Lindsey is analogous to the claimed invention because it is the field of biodegradable PLA compositions.
Rizk is analogous to the claimed invention because it is in the field of polymer compositions using PLA. It is prima facie obvious to use a known combination of additives in PLA stents when they are used for the same purpose and do no more than yield predictable results for the skilled artisan.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of Lindsey and incorporate additives such as plasticizers, nucleants, compatibilizers and other additives to impart the benefits of oxidative stability, brightness, color, flexibility, resiliency, workability, processability, viscosity, and odor control as disclosed by Rizk.
Response to Arguments
Applicant’s arguments, see page 2-3, filed 9/2/2025, with respect to the rejection(s) of claim(s) 1-4, 7-9, 11-12, 16, 17-20 under §102 over Lindsey as evidenced by Kricheldorf have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lindsey.
Examiner acknowledges that the evidentiary article Kricheldorf does not provide an inherent rationale for partial transesterification occurring in the blend of Lindsey. The grounds for rejection based on inherency has been modified based on the applicant’s requirements for transesterification. Applicant’s as filed spec teaches the melt blending in an extruder causes some transesterification, ¶[0046] of the instant specification. Therefore, one of ordinary skill in the art is reasonably suggested that the blend of Example 14 of Lindsey must have some partial transesterification occurring to the overall blend because it is melt- blending in an extruder, and Applicant’s as-filed spec teaches this is what is required for transesterification to occur.
Furthermore, this new ground for rejection based on inherency of partial transesterification is also applied to Wang and Babcock, because they also teach melt-blending in an extruder.
Applicant’s arguments regarding the §102 rejection over Wang and the §103 rejections of Babcock over Wang, Wang over Hong, and Wang over Noda are moot due to new grounds of rejection for each. And upon further examination, new rejections of claims 18 and 20 have been added to the §102 rejections over Wang; claims 14, 15, 18 and 20 added to the §103 rejection of Babcock over Wang; and §103 rejections of claims 5 and 6 over Wang in view of Rizk and also over Lindsey in view of Rizk have been added.
Conclusion
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/V.L.S./Examiner, Art Unit 1766
/RANDY P GULAKOWSKI/Supervisory Patent Examiner, Art Unit 1766