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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al US20200172680A1 in view of Sinclair, R. US5180765A.
Regarding claims 1-3, Choi et al teaches a biodegradable polylactic acid-based copolymer with excellent mechanical properties, abstract. The copolymer is a block copolymer comprising a first block of polylactic acid (PLA) and a second block derived from polymerized 3-hydroxypropionic acid, ¶[0013], which reads on the poly(3-hydroxypropionic acid) repeat unit of claim 1.
Choi teaches the PLA unit is derived from any polylactic acid, used without limitation, including commercially available polylactic acid. The polylactic acid can be commonly prepared from an L-lactic acid-derived monomer and/or a D-lactic acid-derived monomer, such as L-lactide, D-lactide, or meso-lactide, where the crystallinity and melting point can be freely controlled according to the content, ¶[0015].
Choi is silent to the exact stereoisomers and their ratios in the PLA used in the examples. Choi, having disclosed the stereoisomers of the PLA in only a cursory fashion, is not especially forthcoming as to the stereoisomer content of the PLA. In instances such as these, one of ordinary skill would consult the related prior art to ascertain what is best suited in this capacity.
Sinclair discloses biodegradable compositions of poly(lactic acid) for use in packaging and pliable films, see abstract, which is the same field of use as the block copolymers of Choi. Sinclair discloses poly(lactic acid) derived from blends of L-lactide, D-lactide, and D,L-lactide and mixtures thereof, Col. 1 lines 10-11. In example 1, Sinclair exemplifies a polymer derived from an 80/20 blend of L-lactide and racemic D,L-lactide, Col. 16 lines 22-23. This blend produces clear, transparent, colorless thin films, that are flexible, Col. 16 lines 66-68. This blend reads on the percent ranges of claims 2 and 3 because this makes the L-lactide (formula 3 of claim 1) 90 wt.% and the D-lactide (formula 2 of claim 1) 10 wt.%, due to the racemic lactide being a 50:50 blend of D-lactide and L-lactide.
Choi and Sinclair are analogous to the claimed invention because both are in the field of poly(lactic acid) polymers and compositions thereof.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have practiced the invention of Choi but using a 90/10 blend of L-lactide and racemic D,L-lactide for the poly(lactic acid) repeat unit in the block copolymer because this blend is useful for producing flexible clear films as disclosed by Sinclair and the skilled artisan would be motivated to use such a blend to produce biodegradable block copolymers for packaging articles as taught by Choi.
Regarding claim 4, Choi teaches the weight average molecular weight of the block copolymer is 1,000-500,000 g/mol ¶[0022], which overlaps with the claimed range.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by Choi because selection of the overlapping portion of ranges has been held to be prima facie obvious. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claims 5-6, Choi teaches the block copolymers have tensile strengths 40-55 MPa, ¶[0025], which falls within the claimed range. The elongation of the block copolymer is 1.8%-540%, ¶[0022], which also falls within the claimed range of claim 6.
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al US20200172680A1 in view of Ramier, J. et al., “Microwave-Assisted Synthesis and Characterization of Biodegradable Block Copolyesters Based on Poly(3-hydroxyalkanoate)s and Poly(D,L-lactide)”, Journal of Polymer Sci., 2012, 50, 1445–1455, provided in applicant’s IDS dated 1/30/2024, as evidenced by the Sigma Aldrich D,L-Lactide datasheet.
Regarding claims 7, 9, and 11, Choi teaches a biodegradable block copolymer comprising a first block of polylactic acid (PLA) and a second block derived from polymerized 3-hydroxypropionic acid, ¶[0013]. The poly(3-hydroxypropionic acid), P(3HP), is prepared before reacting with the PLA and is added to the reactor in polymerized form, ¶¶[0026, 0039], which reads on step 1 of claim 7. Choi teaches the PLA unit is derived from any polylactic acid, used without limitation, including commercially available polylactic acid. The PLA can be commonly prepared from an L-lactic acid-derived monomer and/or a D-lactic acid-derived monomer, such as L-lactide, D-lactide, or meso-lactide, in a ring opening polymerization reaction, where the resulting crystallinity and melting point can be freely controlled according to the content, ¶[0015].
Choi is silent to the exact stereoisomers present in the exemplified PLA and further does not teach using the P(3HP) as a macroinitiator for the polymerization of the PLA in step 2. Choi uses small molecule (diisocyanate or hydroxy ethyl (meth)acrylate) as a linking compound, ¶¶[0013, 0017].
Ramier discloses microwave assisted ROP to form poly(3-hydroxyalkanoate)-b-poly(D,L-lactide) (PHA-b-PLA) diblock copolymers, where PHA block is represented by poly(3-hydroxybutyrate) (PHB) or poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBHV), see abstract and introduction, page 1445. Ramier uses the PHAs as macroinitiators in the ROP of the lactides, introduction and scheme 1, page 1447. The polymerization catalyst is SnOct2, which is the same catalyst utilized by applicant and reads on the ROP catalyst of claim 11. The D,L-lactide is obtained from Sigma Aldrich as 3,6-Dimethyl-1,4-dioxane-2,5-dione, listed under Experimental, Materials section page 1446. And as evidenced by page 4 of the D,L-lactide datasheet obtained from Sigma Aldrich, it is a racemic mixture of D-Lactide (applicant’s Formula 2 of claim 7) and L-lactide (applicant’s Formula 3 of claim 7) in a 50:50 ratio, which reads on the lactide mixture of claim 7 and the amount of Formula 2 in claim 9.
Ramier discloses the advantages of the reaction above includes very short reaction times (typically a few min) and comparatively low temperature associated with relatively high conversions (50–85%) (see page 1454, left column).
Choi and Ramier are analogous to the claimed invention because both are in the field of biodegradable block polymers comprising PLA and their methods of making.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of Choi but using Ramier’s direct polymerization method using racemic D,L-lactide monomers with the motivation of obtaining the PLA-P(3HP) block-copolymer with a high conversion rate and at very low reaction times.
Regarding claim 8, Choi exemplifies a P(3HP) with a molecular weight of 100,000 g/mol ¶[0039], and does not disclose a weight range for the poly(3HP) in the broader disclosure. The total molecular weight of the block copolymer is from 1,000-500,000 g/mol ¶[0022], therefore it follows it would be obvious that as long as the block copolymer is within this molecular weight, the P(3HP) can be less than 100,000 g/mol. Ramier forms block copolymers with molecular weights within the same range as Choi, see table 2 page 1451 where the Mn,NMR column shows the copolymer Mn results, the PDIs are also listed in the table. Then the Mw of the copolymers is calculated from Mn * PDI, which are all within Choi’s Mw range. The molecular weights Mn of the macroinitiators are also listed in Table 2, and are exemplified as ranging from 2,900-7,000 g/mol, which fall within the claimed range.
Therefore, it would be obvious to use the P(3HP) macroinitiator in a similar molecular weight range as exemplified by Ramier with the motivation of producing the predictable result of another biodegradable block copolymer because these molecular weights are suitable for the macroinitiators in the ROP of lactide monomers as disclosed by Ramier.
Regarding claim 10, Choi teaches the molar ratio of P(3HP) to PLA is 1:1 to 1:10 to adjust the glass transition temperature, ¶[0023], which falls within the claimed range.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 5, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 9, 11, and 13 of U.S. Patent No. 11359057B2 in view of Ramier, J. et al., “Microwave-Assisted Synthesis and Characterization of Biodegradable Block Copolyesters Based on Poly(3-hydroxyalkanoate)s and Poly(D,L-lactide)”, Journal of Polymer Sci., 2012, 50, 1445–1455, provided in applicant’s IDS dated 1/30/2024, as evidenced by the Sigma Aldrich D,L-Lactide datasheet.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent reference creates the claimed block copolymer having the same structural elements and possessing the same mechanical properties.
Reference claims 1, 5, and 6 claim a block copolymer, comprising a first block and a second block, wherein: the first block is a lactic acid-polymerized repeating unit; the second block is a 3-hydroxypropionic acid (3-HP)-polymerized repeating unit, which reads on the claimed block copolymer with a poly(3-hydroxypropionic acid) repeat unit and a poly(lactic acid) repeat unit. The difference is that the reference claim does not specify that the poly(lactic acid) is derived from the lactides shown in instant formulas 1, 2, and 3, which are known as meso-lactide, D-lactide, and L-lactide respectively. Although it is not explicitly disclosed in the claim, forming PLA from lactide monomers is common and well known in the art.
Ramier discloses poly(3-hydroxyalkanoate)-b-poly(D,L-lactide) (PHA-b-PLA) diblock copolymers, abstract. The block copolymers are used for making biodegradable articles, abstract and see Introduction. The D,L-lactide is obtained from Sigma Aldrich as 3,6-Dimethyl-1,4-dioxane-2,5-dione, listed under Experimental, Materials section, page 1446, and as evidenced by page 4 of the D,L-lactide datasheet obtained from Sigma Aldrich, it is a racemic mixture of D-Lactide (Formula 2 of instant claim 1) and L-lactide (Formula 3 of instant claim 1) in a 50:50 ratio, which reads on the presence of Formula 3 and either Formula 1 or 2 be present.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of patent ‘057 and use a racemic mixture of lactide monomers to form the PLA because the racemic blend of lactides is a commercially available product and is suitable for polymerizing to PLA which is then used in block copolymers for producing biodegradable products as disclosed by Ramier.
Reference claim 9 reads on the weight average molecular weight of instant claim 4.
Reference claim 11 reads on the tensile strength of instant claim 5.
Reference claim 13 reads on the elongation of instant claim 6.
Claims 1, 4, 5, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8-9 of U.S. Patent No. 11773223B2 in view of Ramier, J. et al., “Microwave-Assisted Synthesis and Characterization of Biodegradable Block Copolyesters Based on Poly(3-hydroxyalkanoate)s and Poly(D,L-lactide)”, Journal of Polymer Sci., 2012, 50, 1445–1455, provided in applicant’s IDS dated 1/30/2024, as evidenced by the Sigma Aldrich D,L-Lactide datasheet.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent reference creates the claimed block copolymer having the same structural elements and possessing the same mechanical properties.
Reference claim 1 claims a block copolymer, comprising a first block and a second block, wherein: the first block is a lactic acid-polymerized repeating unit; the second block is a 3-hydroxypropionic acid (3-HP)-polymerized repeating unit, which reads on the claimed block copolymer with a poly(3-hydroxypropionic acid) repeat unit and a poly(lactic acid) repeat unit. The difference is that the reference claim does not specify that the poly(lactic acid) is derived from the lactides shown in instant formulas 1, 2, and 3, which are known as meso-lactide, D-lactide, and L-lactide respectively. Although it is not explicitly disclosed in the claim, forming PLA from lactide monomers is common and well known in the art.
Ramier discloses poly(3-hydroxyalkanoate)-b-poly(D,L-lactide) (PHA-b-PLA) diblock copolymers, abstract. The block copolymers are used for making biodegradable articles, abstract and see Introduction. The D,L-lactide is obtained from Sigma Aldrich as 3,6-Dimethyl-1,4-dioxane-2,5-dione, listed under Experimental, Materials section, page 1446, and as evidenced by page 4 of the D,L-lactide datasheet obtained from Sigma Aldrich, it is a racemic mixture of D-Lactide (Formula 2 of instant claim 1) and L-lactide (Formula 3 of instant claim 1) in a 50:50 ratio, which reads on the presence of Formula 3 and either Formula 1 or 2 be present.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of patent ‘223 and use a racemic mixture of lactide monomers to form the PLA because the racemic blend of lactides is a commercially available product and is suitable for polymerizing to PLA which is then used in block copolymers for producing biodegradable products as disclosed by Ramier.
Reference claim 6 reads on the weight average molecular weight of instant claim 4.
Reference claim 8 reads on the elongation of instant claim 6.
Reference claim 9 reads on the tensile strength of instant claim 5.
Claims 1, 4, 5, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8 of U.S. Patent No. 12617888 B2 in view of Ramier, J. et al., “Microwave-Assisted Synthesis and Characterization of Biodegradable Block Copolyesters Based on Poly(3-hydroxyalkanoate)s and Poly(D,L-lactide)”, Journal of Polymer Sci., 2012, 50, 1445–1455, provided in applicant’s IDS dated 1/30/2024, as evidenced by the Sigma Aldrich D,L-Lactide datasheet.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent reference creates the claimed block copolymer having the same structural elements and possessing the same mechanical properties.
Reference claim 1 claims a poly (lactic acid-b-3-hydroxy propionic acid) block copolymer, which reads on the claimed block copolymer with a poly(3-hydroxypropionic acid) repeat unit and a poly(lactic acid) repeat unit. The difference is that the reference claim does not specify that the poly(lactic acid) is derived from the lactides shown in instant formulas 1, 2, and 3, which are known as meso-lactide, D-lactide, and L-lactide respectively. Although it is not explicitly disclosed in the claim, forming PLA from lactide monomers is common and well known in the art.
Ramier discloses poly(3-hydroxyalkanoate)-b-poly(D,L-lactide) (PHA-b-PLA) diblock copolymers, abstract. The block copolymers are used for making biodegradable articles, abstract and see Introduction. The D,L-lactide is obtained from Sigma Aldrich as 3,6-Dimethyl-1,4-dioxane-2,5-dione, listed under Experimental, Materials section, page 1446, and as evidenced by page 4 of the D,L-lactide datasheet obtained from Sigma Aldrich, it is a racemic mixture of D-Lactide (Formula 2 of instant claim 1) and L-lactide (Formula 3 of instant claim 1) in a 50:50 ratio, which reads on the presence of Formula 3 and either Formula 1 or 2 be present.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of patent ‘888 and use a racemic mixture of lactide monomers to form the PLA because the racemic blend of lactides is a commercially available product and is suitable for polymerizing to PLA which is then used in block copolymers for producing biodegradable products as disclosed by Ramier.
Reference claims 4 and 5 read on the elongation of instant claim 6.
Reference claim 6 reads on the tensile strength of instant claim 5.
Reference claim 8 overlaps with the weight average molecular weight of instant claim 4, therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by ‘888 because selection of the overlapping portion of ranges has been held to be prima facie obvious. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Claims 1, 4, 5, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7 of U.S. Patent No. 12698389B2 in view of Ramier, J. et al., “Microwave-Assisted Synthesis and Characterization of Biodegradable Block Copolyesters Based on Poly(3-hydroxyalkanoate)s and Poly(D,L-lactide)”, Journal of Polymer Sci., 2012, 50, 1445–1455, provided in applicant’s IDS dated 1/30/2024, as evidenced by the Sigma Aldrich D,L-Lactide datasheet.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent reference creates the claimed block copolymer having the same structural elements and possessing the same mechanical properties.
Reference claim 1 claims a poly (lactic acid-b-3-hydroxy propionic acid) block copolymer, which reads on the claimed block copolymer with a poly(3-hydroxypropionic acid) repeat unit and a poly(lactic acid) repeat unit. The difference is that the reference claim does not specify that the poly(lactic acid) is derived from the lactides shown in instant formulas 1, 2, and 3, which are known as meso-lactide, D-lactide, and L-lactide respectively. Although it is not explicitly disclosed in the claim, forming PLA from lactide monomers is common and well known in the art.
Ramier discloses poly(3-hydroxyalkanoate)-b-poly(D,L-lactide) (PHA-b-PLA) diblock copolymers, abstract. The block copolymers are used for making biodegradable articles, abstract and see Introduction. The D,L-lactide is obtained from Sigma Aldrich as 3,6-Dimethyl-1,4-dioxane-2,5-dione, listed under Experimental, Materials section, page 1446, and as evidenced by page 4 of the D,L-lactide datasheet obtained from Sigma Aldrich, it is a racemic mixture of D-Lactide (Formula 2 of instant claim 1) and L-lactide (Formula 3 of instant claim 1) in a 50:50 ratio, which reads on the presence of Formula 3 and either Formula 1 or 2 be present.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of patent ‘389 and use a racemic mixture of lactide monomers to form the PLA because the racemic blend of lactides is a commercially available product and is suitable for polymerizing to PLA which is then used in block copolymers for producing biodegradable products as disclosed by Ramier.
Reference claim 1 also reads on the tensile strength of instant claim 5.
Reference claim 4 also reads on the tensile strength of instant claim 5.
Reference claim 5 read on the elongation of instant claim 6.
Reference claim 6 overlaps with the weight average molecular weight of instant claim 4, therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by ‘389 because selection of the overlapping portion of ranges has been held to be prima facie obvious. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Reference claim 7 reads on the weight average molecular weight of instant claim 4.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/580,087 (reference application) in view of Ramier, J. et al., “Microwave-Assisted Synthesis and Characterization of Biodegradable Block Copolyesters Based on Poly(3-hydroxyalkanoate)s and Poly(D,L-lactide)”, Journal of Polymer Sci., 2012, 50, 1445–1455, provided in applicant’s IDS dated 1/30/2024, as evidenced by the Sigma Aldrich D,L-Lactide datasheet.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application makes the claimed block copolymer with the same structural units.
Reference claim 1 is directed to a poly(hydroxypropionic acid) block copolymer comprising a repeat unit of 3-hydroxypropionic acid, which reads on the same in instant claim 1, and a repeat unit of a lactone. Claim 1 does not require the poly(lactic acid) repeat unit, but in claim 2, which depends from claim 1, the block copolymer further comprises a repeat unit of a lactide, which reads on the poly(lactic acid) repeat unit of instant claim 1. Although the reference claims include a lactone repeat unit in the block copolymer which is not in the instant claims, the comprising language of the instant claims suggests other units are allowed in the block copolymer.
The reference claim 2 does not specify that the lactide repeat unit is derived from the lactides shown in instant formulas 1, 2, and 3, which are known as meso-lactide, D-lactide, and L-lactide respectively. Although it is not explicitly disclosed in the claim, these stereoisomers of lactide are common and well known in the art.
Ramier discloses poly(3-hydroxyalkanoate)-b-poly(D,L-lactide) (PHA-b-PLA) diblock copolymers, abstract. The block copolymers are used for making biodegradable articles, abstract and see Introduction. The D,L-lactide is obtained from Sigma Aldrich as 3,6-Dimethyl-1,4-dioxane-2,5-dione, listed under Experimental, Materials section, page 1446, and as evidenced by page 4 of the D,L-lactide datasheet obtained from Sigma Aldrich, it is a racemic mixture of D-Lactide (Formula 2 of instant claim 1) and L-lactide (Formula 3 of instant claim 1) in a 50:50 ratio, which reads on the presence of Formula 3 and either Formula 1 or 2 be present.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of 18/580,087 and use a racemic mixture of lactide monomers to form the lactide repeat unit because the racemic blend of lactides is a commercially available product and is suitable for polymerizing to PLA which is then used in block copolymers for producing biodegradable products as disclosed by Ramier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/681,562 (reference application) in view of Ramier, J. et al., “Microwave-Assisted Synthesis and Characterization of Biodegradable Block Copolyesters Based on Poly(3-hydroxyalkanoate)s and Poly(D,L-lactide)”, Journal of Polymer Sci., 2012, 50, 1445–1455, provided in applicant’s IDS dated 1/30/2024, as evidenced by the Sigma Aldrich D,L-Lactide datasheet.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application makes the claimed block copolymer with the same structural units.
Reference claim 1 is directed to a resin comprising a poly(lactic acid-b-3-hydroxypropionic acid) block copolymer which reads on the block copolymer of instant claim 1. The difference is that the reference claim does not specify that the poly(lactic acid) is derived from the lactides shown in instant formulas 1, 2, and 3, which are known as meso-lactide, D-lactide, and L-lactide respectively. Although it is not explicitly disclosed in the claim, forming PLA from lactide monomers is common and well known in the art.
Ramier discloses poly(3-hydroxyalkanoate)-b-poly(D,L-lactide) (PHA-b-PLA) diblock copolymers, abstract. The block copolymers are used for making biodegradable articles, abstract and see Introduction. The D,L-lactide is obtained from Sigma Aldrich as 3,6-Dimethyl-1,4-dioxane-2,5-dione, listed under Experimental, Materials section, page 1446, and as evidenced by page 4 of the D,L-lactide datasheet obtained from Sigma Aldrich, it is a racemic mixture of D-Lactide (Formula 2 of instant claim 1) and L-lactide (Formula 3 of instant claim 1) in a 50:50 ratio, which reads on the presence of Formula 3 and either Formula 1 or 2 be present.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of 18/681,562 and use a racemic mixture of lactide monomers to form the PLA repeat unit because the racemic blend of lactides is a commercially available product and is suitable for polymerizing to PLA which is then used in block copolymers for producing biodegradable products as disclosed by Ramier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 8, 15 of copending Application No. 18/996,000 (reference application) in view of Ramier, J. et al., “Microwave-Assisted Synthesis and Characterization of Biodegradable Block Copolyesters Based on Poly(3-hydroxyalkanoate)s and Poly(D,L-lactide)”, Journal of Polymer Sci., 2012, 50, 1445–1455, provided in applicant’s IDS dated 1/30/2024, as evidenced by the Sigma Aldrich D,L-Lactide datasheet.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application makes the claimed block copolymer with the same structural units.
Reference claim 1 is directed to a poly(lactic acid-b-3-hydroxypropionic acid) block copolymer composition comprising: poly(lactic acid-b-3-hydroxypropionic acid) block copolymer which reads on the block copolymer of instant claim 1. The difference is that the reference claim does not specify that the poly(lactic acid) is derived from the lactides shown in instant formulas 1, 2, and 3, which are known as meso-lactide, D-lactide, and L-lactide respectively. Although it is not explicitly disclosed in the claim, forming PLA from lactide monomers is common and well known in the art.
Ramier discloses poly(3-hydroxyalkanoate)-b-poly(D,L-lactide) (PHA-b-PLA) diblock copolymers, abstract. The block copolymers are used for making biodegradable articles, abstract and see Introduction. The D,L-lactide is obtained from Sigma Aldrich as 3,6-Dimethyl-1,4-dioxane-2,5-dione, listed under Experimental, Materials section, page 1446, and as evidenced by page 4 of the D,L-lactide datasheet obtained from Sigma Aldrich, it is a racemic mixture of D-Lactide (Formula 2 of instant claim 1) and L-lactide (Formula 3 of instant claim 1) in a 50:50 ratio, which reads on the presence of Formula 3 and either Formula 1 or 2 be present.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of 18/996,000 and use a racemic mixture of lactide monomers to form the PLA repeat unit because the racemic blend of lactides is a commercially available product and is suitable for polymerizing to PLA which is then used in block copolymers for producing biodegradable products as disclosed by Ramier.
Reference claim 4 recites the block copolymer is prepared by ring opening polymerization of lactide with the poly(3-hydroxypropionic acid), which reads on the method of instant claim 7.
Reference claims 6 and 15 overlaps with the number average molecular weight of the P(3HP) of instant claim 8, therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by ‘000 because selection of the overlapping portion of ranges has been held to be prima facie obvious. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Reference claim 8 overlaps with the weight average molecular weight of instant claim 4, therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by ‘000 because selection of the overlapping portion of ranges has been held to be prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/V.L.S./Examiner, Art Unit 1766
/RANDY P GULAKOWSKI/Supervisory Patent Examiner, Art Unit 1766
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