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 § 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.
Claims 1-16 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.
The parentheses and quotation marks in Claim 1 around “poly(lactic-co-glycolic acid)-containing resin composition” render the claim indefinite because it is unclear if this limitation is intended to be a part of the claim and if it is different from the resin composition and/or the poly(lactic-co-glycolic acid) recited in line 1. For the purpose of further examination, it is taken to not further limit the claim and is simply a repetition of the “resin composition containing poly(lactic-co-glycolic acid)” in the preamble. It is suggested to delete the parentheses and the text therein.
Claims 2-16 are indefinite due to dependence on indefinite claim 1.
The parentheses in Claim 14 around “in Equation 1, Wᵢ is an initial mass (g) of the film, and Wf is a mass (g) of the film measured after the film is left in soil under composting conditions according to ISO 20200 for 6 months” render the claim indefinite and must be removed. It is unclear if the text within the parentheses is included in the claim and further limits the subject matter of the claim, or whether it is an aside to the claim and is not further limiting. For the purpose of further examination, it is taken that the text within the parentheses further limits the claim. Appropriate correction is required. It is suggested to delete the parentheses.
The parentheses in Claim 15 around “in Equation 2, OTR (PLGA-Poly) is the oxygen transmittance rate of the film formed from the poly(lactic-co-glycolic acid)-containing resin composition, OTR (PLGA) is an oxygen transmittance rate of a film including only poly(lactic-co-glycolic acid), OTR (Poly) is an oxygen transmittance rate of a film including only a resin including a zinc-containing ionomer or an ethylene terpolymer, and X is in a range of 0.65≤x < 1” render the claim indefinite and must be removed. It is unclear if the text within the parentheses is included in the claim and further limits the subject matter of the claim, or whether it is an aside to the claim and is not further limiting. For the purpose of further examination, it is taken that the text within the parentheses further limits the claim. Appropriate correction is required. It is suggested to delete the parentheses.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 and 3-16 are rejected under 35 U.S.C. 103 as being unpatentable over Plimmer et al (US 2012/0259028 A1).
Regarding Claims 1, 3-4, and 7: Plimmer teaches a composition comprising a polyhydroxyalkanoic acid such as poly(lactic-co-glycolic acid)/PLGA (para. 0017-18, copolymers of lactic acid and glycolic acid), an ethylene terpolymer that is a copolymer of ethylene, glycidyl methacrylate, and n-butyl acrylate (para. 0074), and a zinc-containing ionomer (para. 0075).
Plimmer further teaches embodiments having 60-95wt% of polylactic acid and 5-40wt% of ethylene copolymers (para. 0027), wherein the ethylene copolymers are the combination of the ethylene terpolymer containing glycidyl methacrylate (para. 0024) and an ethylene copolymer having an organic acid group (para. 0025), reading on the zinc ionomer (para. 0075). Although Plimmer teaches 60-95wt% of PLA, rather than PLGA, the usage of PLA is a preferred embodiment of the polyhydroxyalkanoic acid (para. 0016); one could easily envision substituting the PLA with 60-95wt% of a different disclosed polyhydroxyalkanoic acid such as poly(lactic-co-glycolic acid) and would find it obvious to do so because Plimmer teaches that they are functional equivalents. See MPEP 2144.06(II).
Regarding Claims 5-6: The sum of the ethylene terpolymer and the zinc ionomer is 5-40wt%, as set forth above (para. 0027). Plimmer teaches a specific embodiment comprising 12wt% of the zinc ionomer and 8wt% of the ethylene terpolymer (p.9, Table 1, Mix #50).
Regarding Claim 8: The sum of the ethylene terpolymer and the zinc ionomer is 5-40wt%, as set forth above (para. 0027). When using a mixture of two ingredients, one of ordinary skill in the art would find it obvious to use an equal amount of each as a starting point.
Regarding Claim 9: Not disclosed is the melt viscosity of the composition. However, Plimmer teaches all of the claimed ingredients in the claimed amounts made by a substantially similar process. The original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amount. Therefore, the claimed effects and physical properties, i.e. a melt viscosity of 200-10,000 Pa·s, would naturally arise and be achieved by a composition with all the claimed ingredients. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties with only the claimed ingredients.
Regarding Claim 10: Not disclosed is the melt flow index of the composition. However, Plimmer teaches all of the claimed ingredients in the claimed amounts made by a substantially similar process. The original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amount. Therefore, the claimed effects and physical properties, i.e. a melt viscosity of 1-200 g/10 min, would naturally arise and be achieved by a composition with all the claimed ingredients. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties with only the claimed ingredients.
Regarding Claim 11: Plimmer teaches a film formed from the composition (para. 0046).
Regarding Claim 12: Plimmer further teaches the production of films having a thickness of 10-100 microns (para. 0009). This overlaps the claimed range. In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. MPEP 2144.05 (I). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a film having a thickness of 100 microns, and they would be easily able to envision doing so because the disclosure of Plimmer indicates that the composition is suitable for use in a film of that thickness.
Regarding Claim 13: Not disclosed is the oxygen permeability of the composition. However, Plimmer teaches all of the claimed ingredients in the claimed amounts made by a substantially similar process. The original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amount. Therefore, the claimed effects and physical properties would naturally arise and be achieved by a composition with all the claimed ingredients. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties with only the claimed ingredients.
Regarding Claim 14: Not disclosed is the mass reduction rate of the film. However, Plimmer teaches all of the claimed ingredients in the claimed amounts made by a substantially similar process. The original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amount. Therefore, the claimed effects and physical properties, i.e. a mass reduction rate of 5-85%, would naturally arise and be achieved by a composition with all the claimed ingredients. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties with only the claimed ingredients.
Regarding Claim 15: Not disclosed is the relative oxygen permeability compared to a film comprising only PLGA or PLGA and one of the copolymers. However, Plimmer teaches all of the claimed ingredients in the claimed amounts made by a substantially similar process. The original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amount. Therefore, the claimed effects and physical properties would naturally arise and be achieved by a composition with all the claimed ingredients. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching as to how to obtain the claimed properties with only the claimed ingredients.
Regarding Claim 16: “Wherein the film is formed using a press…” is a product-by-process limitation. MPEP § 2113 states that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. Therefore, the structure implied by the process step of the press conditions will be considered when assessing patentability of Claim 16. However, the Applicant should note that “the Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP § 2113(II).
Plimmer teaches that the mixture may be molded into articles using any suitable melt-processing technique (para. 0044). The film formed this way is taken to read on claim 16.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Plimmer et al (US 2012/0259028 A1) in view of Maki et al (JP 2011/219588 A, using the machine translation for the citations below).
Plimmer teaches the limitations of claim 1, as set forth above. Plimmer further teaches that the zinc-containing ionomer is a copolymer of ethylene, methacrylic acid, and n-butyl acrylate, wherein a portion of the methacrylic acid has been neutralized with zinc, forming zinc methacrylate (para. 0075). Although this copolymer contain the repeat units set forth in instant claim 2, it is not a terpolymer due to the presence of n-butyl acrylate.
Maki teaches a PLA composition (para. 0001) containing an ionomer of an ethylene-unsaturated carboxylic acid copolymer, such as a partially neutralized zinc ionomer of ethylene and methacrylic acid, i.e. a terpolymer of ethylene, methacrylic acid, and zinc methacrylate (para. 0017, 0026), as well as copolymers containing ethylene, (meth)acrylic acid, and n-butyl acrylate, wherein the (meth)acrylic acid is partially neutralized with zinc (para. 0017), wherein the ionomer imparts the resin composition with higher melt tension (para. 0019). Plimmer also teaches that the zinc ionomer/organic acid-containing copolymer is used for the purpose of improving melt strength of the composition (para. 0032). Maki and Plimmer are analogous art because they are directed toward the same field of endeavor, namely polyhydroxyalkanoic acid compositions containing zinc ionomers of carboxylic acid-ethylene copolymers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the n-butyl acrylate-containing zinc ionomer of Plimmer with the terpolymer of ethylene, methacrylic acid, and zinc methacrylate as taught by Maki, and they would have been motivated to do so because Maki teaches that they are equivalents known for the same purpose (improving melt strength in polyhydroxyalkanoic acid compositions). MPEP 2144.06.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 18/601,180 in view of Plimmer et al (US 2012/0259028 A1).
Reference claim 4 teaches a composition containing poly(glycolic acid), a zinc-containing ionomer, and an ethylene-based terpolymer, wherein the PGA is present at 60-98wt%.
Although the reference application does not particularly teach PLGA, PLGA is a copolymer of glycolic acid and lactic acid, which falls into the genus of PGA polymers. Furthermore, Plimmer teaches PGA homopolymers and copolymers, such as PLGA, as functional equivalents for the same purpose (para. 0015-0018). One could easily envision adding poly(lactic-co-glycolic acid) to the claimed composition of the reference application as the PGA component and would find it obvious to do so because Plimmer teaches that they are functional equivalents. See MPEP 2144.06(II).
This is a provisional nonstatutory double patenting rejection.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN N ILLING whose telephone number is (571)270-1940. The examiner can normally be reached Monday-Friday 8AM-4PM.
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/C.N.I./Examiner, Art Unit 1767
/MARK EASHOO/Supervisory Patent Examiner, Art Unit 1767
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