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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-10, 13-17, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehouse (US-20100305280-A1) in view of Inoue et al. (US 20080200637 A1).
Regarding claim 1, Whitehouse teaches a multilayer film for packaging comprising a first resin layer (PHA blend) and a second resin layer (PHA film the blend is laminated onto) (Whitehouse, Abstract, Par. 0090-0093, and 0175-0177). Whitehouse teaches the first resin layer comprises a poly(3-hydroxyalkanoate resin (first PHA) (Whitehouse, Par. 0004 and 0017-0018). Whitehouse teaches the first resin layer has a thickness of at most 300 µm (Whitehouse, Par. 0164).
Whitehouse is silent regarding the second resin layer comprising a poly(3-hydroxyalkanoate) resin, a ratio of the thickness of the first resin layer to a thickness of the second resin layer being from 1.0:0.015 to 1.0:5.0, and wherein a heat quantity of the second resin layer is 25 J/g or less.
Inoue teaches a resin layer (sheet) for packaging wherein the resin layer comprises a poly(3-hydroxyalkanoate) resin (Inoue, Abstract, Par. 0002, 0015-0018, 0021-0026, and 0042). Inoue teaches the resin layer has a thickness of less than 1 mm (1000 µm) (Inoue, par. 0031, 0040, and 0046).
Whitehouse and Inoue are analogous art as they both teach packaging films comprising a layer of PHA. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used Inoue’s sheet as the second resin layer of Whitehouse. This would allow for an environmentally compatible, biodegradable film with good flexibility (Inoue, Abstract and Par. 0002). This further would result in a thickness ratio that overlaps the claimed range (i.e., a thickness of each film of 100 µm and thus a ratio of 1:1) and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I.
Regarding the limitation of the heat quantity of the first and second resin layer, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01. Modified Whitehouse teaches a first and second resin layer that are identical or substantially identical to the instant first and second resin layers. Modified Whitehouse teaches the first resin layer comprises a poly(3-hydroxyalkanoate) copolymer (first PHA) that comprises 3-hydroxybutyrate units and up to 7 mol% of 3-hydroxyhexanoate units (Whitehouse, Par. 0017-0019 and 0135-0138), which is the same units in an amount that overlaps that of the instant invention per the instant claims 3-5. Modified Whitehouse teaches the poly(3-hydroxyalkanoate) of the first resin layer has a weight average molecular weight of 200,000- 650,000 Daltons (g/mol) (Whitehouse, Par. 0022-0023), which lies within the range of the instant invention per the instant claim 17. Modified Whitehouse teaches the first resin layer comprises up to 10% of a nucleating agent (second PHA) that is a poly(3-hydroxybutyrate) (Whitehouse, Par. 0017-0021, 0049, 0055, 0135-0138), which overlaps the range of the instant invention per the instant claim 18. Modified Whitehouse’s poly(3-hydroxybutryate) satisfies a nucleating agent as it is given as an example of one per the instant claim 9. Modified Whitehouse teaches the first resin layer has a thickness of at most 300 µm (Whitehouse, Par. 0164), which overlaps the range of the instant invention per the instant claim 7. Modified Whitehouse teaches the poly(3-hydroxyalkanoate) of the first resin layer is formed from microbial production using Alcaligenes eutrophus (Whitehouse, Par. 0157), which is the same as the instant invention per the instant specification Par. 0031. Modified Whitehouse does not state that any other components are required in the first resin layer. Modified Whitehouse further teaches the second resin layer comprises a poly(3-hydroxyalkanoate) copolymer that comprises 3-hydroxybutyrate units and 8-20 mol.% of 3-hydroxyhexanoate units (Inoue, Par. 0017-0018), which is the same as the instant invention per the instant claims 3-5 and 16. Modified Whitehouse teaches the poly(3-hydroxyalkanoate) of the second resin layer has a weight average molecular weight of 500,000 to 2,000,000 g/mol (Inoue, Par. 0028), which overlaps the range of the instant invention per the instant claim 17. Modified Whitehouse teaches the second resin layer has a thickness of less than 1 mm (1000 µm) (Inoue, Par. 0031, 0040, and 0046), which overlaps the range of the instant invention per the instant claim 7. Modified Whitehouse teaches the poly(3-hydroxyalkanoate) of the second resin layer is formed from microbial production using Alcaligenes eutrophus (Inoue, Par. 0030), which is the same as the instant invention per the instant specification Par. 0031. Modified Whitehouse does not state that any other components are required in the second resin layer. Furthermore, the instant specification states that the heat quantity is controlled by the type and amounts of monomers in the poly(3-hydroxyalkanoates) (see the instant specification Par. 0046). Modified Whitehouse thus teaches a first and second resin layer that are identical or substantially identical to the instant invention. Therefore, absent objective evidence to the contrary, the first and second resin layers of modified Whitehouse would have inherently exhibited the claimed heat quantity, see MPEP 2112.01.
Regarding claims 2, 7, and 20, modified Whitehouse teaches the thickness of the first resin layer is at most 300 µm (Whitehouse, Par. 0164) and the thickness of the second resin layer is less than 1 mm (1000 µm) (Inoue, Par. 0031, 0040, and 0046), which overlap the claimed ranges of from 10 to 300 µm and from 5 to 70 µm respectively and therefore establish a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I. This further results in a thickness ratio range that overlaps the claimed range of 1.0:0.2 to 1.0:2.5 (see, i.e., both layers having a thickness of 50 µm and thus a ratio of 1:1), and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I.
Regarding claims 3-5 and 15-16, modified Whitehouse teaches the poly(3-hydroxyalkanoate) (first PHA) of the first resin layer is a copolymer comprising 3-hydroxybutyrate units and 3-hydroxyhexanoate units in an amount of up to 7 mol% (Whitehouse, Par. 0017-0019 and 0135-0138), which overlaps the claim 4 range of from 1 to 7 mol% and the claim 15 range of from 3 to 7 mol%, and therefore establishes a prima facie case of obviousness over the claimed ranges, see MPEP 2144.05, I. Modified Whitehouse teaches the poly(3-hydroxyalkanoate) of the second resin layer is a copolymer comprising 3-hydroxybutyrate units and 3-hydroxyhexanoate units in an amount of 8-20 mol% (Inoue, Par. 0017-0018), which lies within the claim 4 range of from 7 to 20 mol% and is the same as the claim 16 range of 8 to 20 mol% and therefore satisfies the claimed range, see MPEP 2131.03.
Regarding claim 6, modified Whitehouse teaches the first and second resin layer are laminated together and thus teaches that they are integral with each other (Whitehouse, Par. 0110-0111 and 0175-0177).
Regarding claims 8-9, modified Whitehouse teaches that the first resin layer comprises a nucleating agent (second PHA) that is poly(3-hydroxybutyrate) (Whitehouse, Par. 0017-0021, 0049, 0055, 0135-0138).
Regarding claim 10, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01. Modified Whitehouse teaches a first and second resin layer that are identical or substantially identical to the instant first and second resin layers as stated above for claim 1. Furthermore, the instant specification indicates that the first and second resin layers are adapted to be heat sealed (See the instant specification Par. 0014-0015). Therefore, absent objective evidence to the contrary, the first and second resin layer would have inherently been capable of being heat sealed and thus the multilayer film satisfies the limitation of being adapted for heat sealing, see MPEP 2112.01.
Regarding claim 13, modified Whitehouse teaches a packaging material comprising the multilayer film of claim 1 (Whitehouse, Par. 0091-0093).
Regarding claim 14, modified Whitehouse teaches a packaging material comprising the multilayer film of claim 1, wherein the packaging material can be in the form of a variety of different articles (Whitehouse, Par. 0091-0093). Modified Whitehouse further teaches the multilayer film is identical or substantially identical to the instant invention as stated above for claim 1. Regarding the limitation of the packaging material being in the form of a pillow pack, Applicant’s attention is drawn to MPEP 2106(II)(C) which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that modified Whitehouse discloses a packaging as presently claimed, it is clear that the package of modified Whitehouse would be capable of performing the intended use, i.e. being used to package a pillow, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
Regarding claim 17, modified Whitehouse teaches a weight average molecular weight of the poly(3-hydroxyalkanoate) resin of the first resin layer is 200,000- 650,000 Daltons (g/mol) (Whitehouse, Par. 0022-0023), which lies within the claimed range of from 20 x 104 to 250 x 104 and therefore satisfies the claimed range, see MPEP 2131.03. Modified Whitehouse teaches a weight average molecular weight of the poly(3-hydroxyalkanoate) resin of the first resin layer is 500,000 to 2,000,000 g/mol (Inoue, Par. 0028), which overlaps the claimed range of from 5 x 104 to 100 x 104 and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I.
Regarding claim 21, modified Whitehouse teaches the first resin layer comprises a nucleating agent that is talc (Whitehouse, Par. 0181 and Table 2).
Regarding claim 22, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01. Modified Whitehouse teaches a first and second resin layer that are identical or substantially identical to the instant first and second resin layers as stated above for claim 1. Therefore, absent objective evidence to the contrary, the peel strength between the first and second resin layer would have inherently exhibited the claimed peel strength, see MPEP 2112.01.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Whitehouse in view of Inoue et al. as applied to claim 13 above, further in view of Okada et al. (US 20150368022 A1).
To note, the following rejection is given as an alternative to the rejection to claim 14 above.
Regarding claim 14, modified Whitehouse teaches all of the elements of the claimed invention as stated above for claim 13. Modified Whitehouse further teaches the packaging material can be in the form of a variety of different articles (Whitehouse, Par. 0091-0093).
Modified Whitehouse is silent regarding the packaging material being in the form of a pillow pack.
Okada teaches a multilayer film comprising a polyhydroxyalkanoate wherein the multilayer film is formed into a pillow pack (Okada, Abstract, Par. 0134-0136, 0184-0186, 0205-0208, and Claim 1).
Modified Whitehouse and Okada are analogous art as they both teach multilayer films comprising polyhydroxyalkanoate that is formed into a package. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the package of modified Whitehouse into a pillow pack. This would allow for a flexible pillow packaging (Okada, Par. 0186; Whitehouse, Par. 0004).
Response to Arguments
Applicant’s remarks and amendments filed 12 March 2026 have been fully considered.
Applicant requests withdrawal of the rejection under 35 USC § 112 set forth in the previous office action.
The rejection under 35 USC § 112 set forth in the previous office action has been withdrawn due to the present claim amendments.
Regarding arguments directed to the rejections over prior art, on page 7 of the remarks, Applicant first argues that Whitehouse teaches an adhesive PHA blend and does not teach a multilayer laminate. This is not found persuasive for the following reasons:
Whitehouse specifically states that the PHA blend is used in laminates (Whitehouse, Par. 0093). Whitehouse further teaches the PHA blend is used in laminates which comprise substrates which can be other PHA films (Whitehouse, Par. 0174-0177). Whitehouse thus teaches a laminate which comprises a first layer comprising the PHA blend, and another layer that is a PHA film. Therefore, Whitehouse teaches a multilayer laminate and Applicant’s argument is unpersuasive.
Secondly, on page 8 of the remarks, Applicant argues that Whitehouse does not teach the nucleating agent of claim 21. This is not found persuasive for the following reason:
Whitehouse states that the composition of the first layer (i.e. the PHA blend) can comprise talc (Whitehouse, Par. 0181 and Table 2). Therefore, Whitehouse teaches a nucleating agent that is talc, satisfying the claim 21 limitations and Applicant’s argument is unpersuasive.
Thirdly, on pages 8-9 of the remarks, Applicant argues that one of ordinary skill in the art would not be motivated to combine Whitehouse and Inoue as there is no evidence that including additional layer would improve flexibility. This is not found persuasive for the following reasons:
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Inoue provides motivation for the combination such as allowing for an environmentally compatible, biodegradable film with good flexibility (Inoue, Abstract and Par. 0002). While flexibility is part of the motivation, the combination still allows for an environmentally compatible, biodegradable film as stated above. Furthermore, Inoue stating that the layer has good flexibility ensures that the resulting multilayer laminate of modified Whitehouse would have good flexibility.
Furthermore, regarding Applicant’s argument that including an additional layer would add material cost and complicate production, it is noted that Whitehouse already teaches including a PHA layer (substrate) in the multilayer laminate (Whitehouse, Par. 0174-0177). Therefore, Whitehouse does not teach away from including a PHA layer, such as the PHA layer of Inoue, in the multilayer laminate.
For the reasons stated above, Whitehouse in view of Inoue render obvious the second layer and Applicant’s argument is unpersuasive.
Fourthly, on pages 9-10 of the remarks, Applicant argues that the claimed invention with both layers instead of one layer and the specific thickness ratios results in superior and unexpected properties. This is not found persuasive for the following reasons:
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02(d). The nonobviousness of a broader claimed range [or genus] can be supported by evidence based on unexpected results from testing a narrower range [or species] if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979). See MPEP 716.02(d), I. Applicant only provides inventive and comparative data utilizing a specific P3HB3HH-1 and P3Hb3HH-4 as the poly(3-hydroxyalkanoate) resin of the first layer whereas the instant claims broadly recite a poly(3-hydroxyalkanoate) resin. Applicant only provides inventive data utilizing a specific P3HB3HH-2, P3HB3HH-3, and P3HB3HH-5 as the poly(3-hydroxyalkanoate) resin of the second layer whereas the instant claims broadly recite a poly(3-hydroxyalkanoate) resin. It is noted that the instant claim 1 does not claim any specific monomer amounts or ratios of the poly(3-hydroxyalkanoate) resin. One of ordinary skill in the art would be unable to determine a trend based upon this limited data to reasonably extend the probative data to the much more broadly claimed features as discussed above. Therefore, the inventive and comparative examples are not commensurate in scope with the claimed invention in view of MPEP 716.02(d), I.
Also, to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP 716.02(d), II.
Applying the required analysis noted above, it is clear that the data provided in the examples is not commensurate with the scope of the claims and does not show criticality in establishing unexpected results as follows. The inventive examples only utilize a content ratio of 3HB/3HH of 91/9 to 93/7 mol%/mol%, whereas the instant claim 1 does not recite any content ratio of monomers. The inventive examples only utilize a weight average molecular weight of the resins of 42 X 104 to 74 X 104 g/mol, whereas the instant claim 1 does not recite any weight average molecular weight. The inventive examples only utilize a first layer thickness of 30-100 µm, whereas the instant claim 1 does not recite any first layer thickness. The inventive examples only utilize a second layer thickness of 30-100 µm, whereas the instant claim 1 does not recite any second layer thickness. The inventive examples only utilize a ratio of thicknesses of the first layer to the second layer of 1 : 0.35 to 1 : 2.86, wherein the instant claim 1 recites a broad range of 1 : 0.015 to 1 : 5.0. No inventive examples are given at either endpoint of the claimed range. Furthermore, no comparative examples are given below the claimed range. One of ordinary skill in the art would not be able to reasonably conclude that all possible claimed content ranges/ratios would necessarily yield the asserted superior and unexpected results.
In view of the foregoing, the data provided is not commensurate in scope with the instant claims as required by MPEP 716.02(d).
Furthermore, Applicant “must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979)” see MPEP 716.02 (e). Applicant states that the laminate with two layers has superior properties over one layer. However, as stated above, Whitehouse teaches a laminate comprising a second PHA layer (PHA film substrate) (Whitehouse, Par. 0174-0177).
When all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. As such, Applicant’s argument that the instant invention has superior and unexpected results in unconvincing.
Fifthly, on pages 10-11 of the remarks, Applicant argues that Whitehouse teaches multiple ranges of the commoner 1-B and thus would not inherently exhibit the heat quantity. This is not found persuasive for the following reason:
Whitehouse specifically states that the commoner 1-B is present in the resin in an amount of at most 7 wt.% (Whitehouse, Par. 0017-0019 and 0135-0138). While Whitehouse teaches other possible weight ranges, this does not teach away from the specific disclosure of Whitehouse that teaches at most 7 wt.%. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Modified Whitehouse thus specifically teaches a content range of commoner 1-B of at most 7 wt.%, which overlaps the range of the instant invention per the instant claims 3-5. As stated above, Whitehouse teaches a first and second resin layer that is identical to the claimed invention, including having a content of commoner 1-B of at most 7 wt.%, and would thus inherently exhibit the claimed heat quantity.
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 THOMAS J KESSLER JR whose telephone number is (571)272-3075. The examiner can normally be reached 7:30-5:30 M-Th.
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/THOMAS J KESSLER/Examiner, Art Unit 1782
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