DETAILED ACTION
Claim Status
Claim(s) 1-12, 14, 17-23, 27-33, 35, 41-51 is/are pending.
Claim(s) 1-9, 14, 17-23, 27-33, 35, 41-51 is/are rejected.
Claim(s) 10-12 is/are withdrawn from consideration.
Claim(s) 13, 15-16, 24-26, 34, 36-40 is/are cancelled by Applicant.
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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of species A(ii), two or more dicarboxylic acids, and B(iv), starch or thermoplastic starch, in the reply filed on June 21, 2022 is acknowledged.
Claims 1-9, 13-14, 17-23, 27-33, 35, 41-49 encompass the elected species.
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.
Claim(s) 44, 49 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 44, 49 are vague and indefinite because there is insufficient antecedent basis for the limitation “the at least one additional polymer” in the claim.
Double Patenting
The rejections based on the ground of nonstatutory double patenting based on U.S. Patent No. 11,358,378 (HACKFORT ET AL) in the previous Office Action mailed 09/08/2025 in view of the Claim Amendments filed 09/18/2025.
Claim Rejections - 35 USC § 103 (AIA )
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.
Claim(s) 1, 3-9, 14, 21-23, 27-33, 35, 35, 41-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• KRISHNASWAMY ET AL (US 2012/0108743),
in view of STEINKE ET AL (US 2011/0178196),
and in view of LAPRAY ET AL (US 2017/0362418).
KRISHNASWAMY ET AL ‘743 discloses films formed from a biodegradable polymer composition, wherein the biodegradable polymer composition comprises:
(i) polyhydroxyalkanoate (PHA) (co)polymer resins (corresponding to the recited “component A”) (e.g., poly 3-hydroxybutyrate (hereinafter referred to as PHB); poly 3-hydroxyvalerate (P3HV); poly 3-hydroxybutyrate-co-3-hydroxyvalerate (PHB-3HV), poly 3-hydroxybutyrate-co-3-hydroxyhexanoate (PHB-3HH); etc.)(corresponding to the recited “component A”), wherein the PHA resins can have weight average molecular weights of 500 to 2,000,000 (preferably 100,000 to 700,000) and can, but is not required to have a polydispersity index of about 2.5-8.0;
(ii) polybutylene succinate (PBS) (e.g., BIONOLLE 1001, etc.) or polybutylene succinate adipate (PBSA) (e.g., BIONOLLE 3001, etc.) (corresponding to the recited “component B” and the recited “aliphatic copolyester composed of at least one diol component and at least one dicarboxylic acid component”);
(iii) 0.05-20 wt% (based on the total polymer composition) of various additives which are “any compound known in the art to those of skill in the art to be useful in the production of thermoplastics” (e.g., fillers, crosslinking agents, nucleating agents, pigments, etc.), wherein “It is well within the skilled practitioner's abilities to determine whether an additive should be included in a thermoplastic composition and, if so, what additive and the amount that should be added to the composition”;
wherein the biodegradable polymer composition can be primarily PHA-based or primarily PBS(A)-based compositions, wherein in certain embodiments, the ratio of PHA to PBS(A) can be, but is not limited to: 75/25, 70/30, 65/35, etc., while in other embodiments, the ratio of PHA to PBS(A) can 79/21 to 63/36, or alternatively 33/67 to 18/82.
The films have a typical thickness of 10-200 microns, and is capable of exhibiting superior mechanical properties (e.g., tear resistance, greater puncture resistance, tensile strength, etc.) compared to a corresponding PHA film made without PBS and/or PBSA (e.g., but not limited to, machine direction break strength (corresponding to the recited “tensile strength... in the machine direction”) of 17.2 MPa or more; etc.) in addition to having good, controllable biodegradability. The biodegradable polymer compositions can be used as bags (e.g., grocery bags, food bags, compost bags, etc.) and other numerous packaging or wrapping applications. The films are typically formed by melt-blending components (i) and (ii) and (iii) together, followed by film formation (e.g., by extrusion, etc.). (entire document, e.g., paragraph 0004, 0028, 0030, 0032, 0040-0047, 0092-0094, 0101-0102, 0130-0138, 0156, etc.; Table 1-2, 5-6, etc.) However, the reference does not specially disclose the recited “at least one additional polymer”).
STEINKE ET AL ‘196 discloses that it is well known in the art to incorporate additives known to a person skilled in the art such as organic filler (e.g., native or thermoplasticized starch) in typical amounts of 1-60 wt% in biodegradable polymer compositions. The reference further discloses that it is well known in the art to utilize biodegradable polymer compositions to make film for bags (e.g., fruit and vegetable bags; carrier bags, shopping bags, etc.) and other numerous packaging or wrapping applications. (e.g., paragraph 0056, 0068-0069, 0074, 0105, 0108-0111, etc.)
LAPRAY ET AL ‘418 discloses that it is well known in the art to incorporate biodegradation-promoting starch-based additives into plastic material compositions (e.g., comprising polymers which already exhibit biodegradability, such as PHA, PBS, etc.) in order to enhance or control the biodegradation rate (e.g., allowing biodegradation in marine environments, etc.) which can be measured using established test standards (e.g., ASTM D6691, ASTM D6400, etc.) and can be as high as 95% in 180 days. The reference further discloses that the biodegradation-promoting starch-based additives comprise mostly (e.g., but not limited to, 65-90 wt%, etc.) of at least one type of starch (e.g., thermoplastic starch or derivatives thereof, etc.), wherein: (i) the biodegradation-promoting starch-based additives is present in amounts sufficient to lend a predetermined degree of biodegradability to the plastic material -- e.g., amounts of at least 0.5 wt% (e.g., at least 2 wt%, at least 5 wt%, at least 10 wt%, etc.) and no more than 99 wt% (e.g., no more than 80 wt%, no more than 50 wt%, no more than 30 wt%, etc.) of the plastic material. (paragraph 0006-0007, 0049, 0051-0053, 0057, 0062, 0066-0067, 0070-0071, 0075-0076, 0084-0085, 0105-0106, 0109-0110, etc.)
Regarding claims 1, 4-8, 14, 27-28, 30, 33, 35, 41-51 it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention incorporate effective amounts (e.g., up to 20 wt%, as disclosed in KRISHNASWAMY ET AL ‘743) of known organic filler (e.g., starch, as disclosed in STEINKE ET AL ‘196) as a filler additive which promotes biodegradation (as suggested by LAPRAY ET AL ‘418) in the biodegradable polymer compositions of KRISHNASWAMY ET AL ‘743 to produce useful biodegradable films with readily modified or enhanced mechanical properties (e.g., tensile strength, etc.), combined with good processibility and excellent biodegradation characteristics which can be readily tailored for specific applications.
Further regarding claims 1, 35, 41-49, the phrase “percentages of PHA to PBS or PBSA are 5% to 95% by weight” in KRISHNASWAMY ET AL ‘743 appears to be a confusing misstatement, given that the working Examples utilize both predominantly PHA-based (i.e., the PHA is the major component) and predominantly PBS(A)-based (i.e., the PBS(A) is the major component) compositions.
Further regarding claims 1, 35, 41-49, since KRISHNASWAMY ET AL ‘743: (i) discloses certain embodiments in which the ratio of PHA to PBS(A) can be, but is not limited to: 75/25, 70/30, 65/35 (corresponding to a range of A/(A+B) values of 65-75 wt% and B/(A+B) values of 25-35 wt%); and (ii) discloses working Example compositions containing:
• composition 4: 77 wt% PHA and 20 wt% PBS(A), which corresponds to a A/(A+B) value of 79 wt% and a B/(A+B) value of about 21 wt%;
• composition 5: 62 wt% PHA and 35 wt% PBS(A), which corresponds to a A/(A+B) value of 63 wt% and a B/(A+B) value of about 36 wt%;
• composition 7: 32 wt% PHA and 65 wt% PBS(A), which corresponds to a A/(A+B) value of 33 wt% and a B/(A+B) value of about 67 wt%;
• composition 8: 17 wt% PHA and 80 wt% PBS(A), which corresponds to a A/(A+B) value of 18 wt% and a B/(A+B) value of about 82 wt%;
KRISHNASWAMY ET AL ‘743 discloses (or at least reasonably suggests) biodegradable polymer compositions in which: (i) the content of PHA (corresponding to recited “component A”) can be 63-79 wt% and the content of PBS(A) (corresponding to recited “component B”) is 21-36 wt%; or alternatively, (ii) the content of PHA (corresponding to recited “component A”) can be 18-33 wt% and the content of PBS(A) (corresponding to recited “component B”) is 67-82 wt%.
Further regarding claims 1, 35, 47, 50-51, one of ordinary skill in the art would have selected the amount of biodegradation-promoting starch-based additives (and therefore, the amount of starch) incorporated into the biodegradable films of KRISHNASWAMY ET AL ‘743 based on the composition of the plastic material and the desired rate of biodegradation under specified biodegradation conditions. For example, for plastic materials containing polymers which already exhibit some degree of biodegradability (e.g., PHA, PBS, etc.), lower amounts (e.g., 40 wt% or less) of biodegradation-promoting starch-based additives (and therefore starch) would be required to provide a predetermined degree of biodegradation under specific conditions (e.g., aqueous or marine environments, etc.) -- e.g.:
• 5 wt% of starch-based additive, of which 75 wt% constitutes starch, resulting in a plastic composition with a starch content of about 3.75 wt%;
• 30 wt% or less of starch-based additive, of which 65 wt% constitutes starch, resulting in a plastic composition with a starch content of about 19.5 wt%;
• 16 wt% or less of starch-based additive, of which 80 wt% constitutes starch, resulting in a plastic material with a starch content of about 12.8 wt%;
• 10 wt% or less of starch-based additive, of which 90 wt% constitutes starch, resulting in a plastic material starch content of about 9 wt%; etc.
Regarding claims 3, 21-23, it would have been obvious to one of ordinary skill in the art to incorporate effective amounts of known biodegradation-promoting starch-based additives (as suggested by LAPRAY ET AL ‘418) in the biodegradable films of KRISHNASWAMY ET AL ‘743 in order to form films and articles (e.g., bags, etc.) which achieve desired or predetermined rapid biodegradation degrees and rates (e.g., carbon reduction to carbon dioxide as recited in claims 3, 21, 23; specific residual particle sizes as recited in claims 3, 22; etc.) under specified conditions after disposal and/or standard test conditions (e.g., more than 60% after 100 days in a marine environment, as measured using ASTM D6691; etc.) using routine experimentation since the rate of biodegradation is generally expected to increase as a function of the amount of biodegradation-promoting starch-based additive present (e.g., the more biodegradation promoter is present in an article, the faster said article typically degrades under the predetermined test conditions, etc.).
Regarding claim 6, since: (i) KRISHNASWAMY ET AL ‘743 discloses PHA resins with preferred weight average molecular weights of 100,000 to 700,000 which can, but are not required to, have polydispersity indexes of 2.5-8.0; (ii) the polydispersity index is (Mw/Mn), which is the ratio of weight average molecular weight to number average molecular weight; the Examiner has reason to believe that the PHA (co)polymers as disclosed in KRISHNASWAMY ET AL ‘743 can have number-average molecular weight (Mn) values that at least partially read on the number-average molecular weights recited in claim 6, therefore the Examiner has basis for shifting the burden of proof to applicant as in In re Fitzgerald et al., 205 USPQ 594.
Regarding claim 9, one of ordinary skill in the art would have utilized commercially available aliphatic polyesters with number-average molecular weights which at least partially read on the number-average molecular weights recited in claim 9 as component (ii) in the biodegradable polymer compositions of KRISHNASWAMY ET AL ‘743, in order to obtain films with the required mechanical properties (e.g., tensile strength, elongation, etc.) for specific applications.
Regarding claim 29, one of ordinary skill in the art would have selected the thickness (and thereby the weight) of the films of KRISHNASWAMY ET AL ‘743 used to produce disposable bags (e.g., carrier bags, etc.) based on the intended usage (e.g., thin, lighter weight bags for light loads and single short-term usage; thicker, heavier weight bags for heavy loads, loads with a tendency to penetrate, extended usage and/or storage; etc.).
Regarding claims 31-32, one of ordinary skill in the art would have used well known methods of forming multilayer films (e.g., coextrusion, lamination, etc.) to combine the biodegradable films of KRISHNASWAMY ET AL ‘743 with other biodegradable layers in order to form biodegradable multilayer packaging or carrying articles with specific performance properties.
The Examiner cautions that if Applicant chooses to argue that the physical properties recited in claims 2-3, 17-23 cannot be obtained by one of ordinary skill in the art using known improvement and/or modification techniques or methods (e.g., as mentioned above) using routine experimentation, this may raise significant issues under 35 U.S.C. 112(a) with respect to scope of enablement, and that Applicant’s arguments and/or assertions may be used as admissions or supporting evidence with respect to rejections under 35 U.S.C. 112(a) with respect to scope of enablement.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• KRISHNASWAMY ET AL (US 2012/0108743), in view of STEINKE ET AL (US 2011/0178196), and in view of LAPRAY ET AL (US 2017/0362418),
as applied to claims 1, 3-9, 14, 21-23, 27-33, 35, 35, 41-51 above,
and further in view of KATAYAMA ET AL (US 2004/0068059).
KATAYAMA ET AL ‘059 discloses that: (i) the polybutylene succinate (PBS) resin BIONOLLE 1001 is known to have a number average molecular weight (Mn) of 70,000; and (ii) the polybutylene succinate adipate (PBSA) resin BIONOLLE 3001 is known to have a Mn of about 70,000. (paragraph 1063-1064, etc.)
Regarding claims 7-9, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize commercially available PBS(A) resins as disclosed in KATAYAMA ET AL ‘059 as component (ii) in the biodegradable polymer compositions of KRISHNASWAMY ET AL ‘743.
Claim(s) 2, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• KRISHNASWAMY ET AL (US 2012/0108743), in view of STEINKE ET AL (US 2011/0178196), and in view of LAPRAY ET AL (US 2017/0362418),
as applied to claims 1, 3-9, 14, 21-23, 27-33, 35, 35, 41-51 above,
and further in view of SCHMIDT ET AL (US 2010/0249268).
SCHMIDT ET AL ‘268 discloses that it is well known in the art to incorporate 0.01-7 wt% of an epoxy-containing polymer (e.g., based on styrene, (meth)acrylic easters, etc.) into biodegradable film compositions containing biodegradable polyester (e.g., aliphatic polyesters such as polybutylene succinate (PBS), polybutylene succinate adipate (PBSA), polyhydroxyalkanoate (PHA), etc.) and starch in order to improve mechanical properties (e.g., tensile strength, elongation at break, etc.). The reference further discloses that the modified biodegradable film compositions are capable of exhibiting a tensile strength of 5-60 N/mm2 (5-60 MPa) and an elongation at break of at least 200 %. (paragraph 0005-0010, 0015, 0021, 0024-0025, 0040, 0045, etc.)
Regarding claims 2, 17-20, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize effective amounts of a known epoxy-containing polymer as disclosed in SCHMIDT ET AL ‘268 as a crosslinking additive in the biodegradable polymer compositions of KRISHNASWAMY ET AL ‘743 in order to produce biodegradable films with sufficiently high tensile strength and sufficiently high elongation at break in at least one film direction (e.g., machine direction and/or transverse direction) to meet the performance requirements for specific packaging, wrapping, and/or bag applications.
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• KRISHNASWAMY ET AL (US 2012/0108743), in view of STEINKE ET AL (US 2011/0178196), and in view of LAPRAY ET AL (US 2017/0362418),
as applied to claims 1, 3-9, 14, 21-23, 27-33, 35, 35, 41-51 above,
and further in view of WNUK ET AL (US 5,391,423).
WNUK ET AL ‘423 discloses that it is well known in the art to combine biodegradable film layers of different composition in order to produce multilayer biodegradable films with performance properties which cannot be readily attained by a single-layer film. The reference further discloses that it is well known in the art to utilize coextrusion or lamination to form said multilayer biodegradable films. (line 33-44, col. 2; line 56, col. 4 to line 5, col. 5; line 50-55, col. 5; etc.)
Regarding claims 31-32, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use well known methods of forming multilayer films (e.g., coextrusion, lamination, etc. as suggested by WNUK ET AL ‘423) to combine the biodegradable films of KRISHNASWAMY ET AL ‘743 with other layers in order to form biodegradable multilayer packaging or carrying articles with specific performance properties which cannot be readily attained by a single-layer film.
Response to Arguments
Applicant's arguments filed 03/03/2026 have been fully considered but they are not persuasive.
(A) Applicant argues that Applicant “again respectfully submits that this very broad disclosure of Steinke-in an amount of 1% to 60% by weight or 5% to 40% by weight-lacks the required sufficient specificity to either anticipate or render obvious the film according to claim 1.” Applicant further argues that “Steinke fails to provide sufficient specificity or indeed any specific example or embodiment that would fall within the claimed ranges of the film according to claim 1” and that “the disclosure of Steinke lacks the required specificity to be considered to anticipate or make obvious the claimed range of components of the film of claim 1, and particularly "starch in an amount of 2 to 18 wt. % based on a total weight of the film, wherein the starch includes thermoplastic starch, denatured starch, and/or starch derivatives," as required by amended claim 1.” Applicant further argues that “Krishnaswamy or the combination of Krishnaswamy and Steinke fails to consider or describe the significance or the criticality of the recited proportional relationship of the components A and B as has been found by the inventors of the present application.” Applicant further argues that “one of ordinary skill in the art would not be motivated to modify the Examples and teachings of Steinke to arrive at the features of claim 1 as a whole.”
Applicant’s arguments have been considered but are moot in view of the new grounds of rejection necessitated by the Claim Amendments filed 03/03/2026. In particular,
KRISHNASWAMY ET AL ‘743 explicitly states that “It is well within the skilled practitioner's abilities to determine whether an additive should be included in a thermoplastic composition and, if so, what additive and the amount that should be added to the composition” (KRISHNASWAMY ET AL ‘743, paragraph 0102), while LAPRAY ET AL ‘418 discloses that the amount of starch-based additive should be selected to obtain the degree and rate of biodegradation desired for specific product usage and specific biodegradation conditions (e.g., composting; in marine conditions; etc.). Applicant has not provided evidence of unexpected results and/or criticality commensurate in scope with the present claims from the recited amount of starch.
(B) Applicant argues that “ ‘None of the films described solves the problem of the particular challenge of biodegradation in seawater whilst simultaneously having satisfactory mechanical properties’... ‘Proceeding from the prior art described above, the object of the invention is to provide a film which has a very good biodegradability in seawater and at the same time has excellent mechanical properties.’ ” Applicant further argues that “Applicant's disclosure states: "Surprisingly, it has been found that the films according to the invention have both outstanding mechanical properties such as high tensile strength and/or high elongation at tear and very good biodegradability in natural seawater." Applicant further argues that “Krishnaswamy or the combination of Krishnaswamy and Steinke fails to consider or describe the significance or the criticality of the recited proportional relationship of the components A and B as has been found by the inventors of the present application.” Applicant further argues that “one of ordinary skill in the art would not be motivated to modify the Examples and teachings of Steinke to arrive at the features of claim 1 as a whole.”
In response to applicant's above arguments that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., films which simultaneously exhibit both “outstanding mechanical properties” and “very good biodegradability”; etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). KRISHNASWAMY ET AL ‘743 explicitly states that the disclosed biodegradable films can contain additives (i.e., “any compound known in the art to those of skill in the art to be useful in the production of thermoplastics” (e.g., fillers, crosslinking agents, nucleating agents, pigments, etc.), wherein “It is well within the skilled practitioner's abilities to determine whether an additive should be included in a thermoplastic composition and, if so, what additive and the amount that should be added to the composition”; (KRISHNASWAMY ET AL ‘743, paragraph 0102), while STEINKE ET AL ‘196 identifies starch (e.g., native or thermoplasticized starch) as an organic filler suitable for biodegradable polymer compositions in additive which promotes biodegradation, and LAPRAY ET AL ‘418 suggests the use of starch-based additives in amounts of 20 wt% or less as effective biodegradation-promoting additives for plastic materials, including polymers which already exhibit biodegradability (e.g., PHA, PBS, etc.). Applicant has not provided evidence of unexpected results and/or criticality commensurate in scope with the present claims -- for example, but not limited to:
• the type and amount of PHA (A)
• the type and amount of aliphatic copolyester (B);
• the amount of starch; etc.
While Applicant is not required to provide evidence of unexpected results and/or criticality for every possible embodiment encompassed by the present claims, any showings of criticality and/or unexpected results provided by the specification or Applicant should be reasonably representative of the full scope of the claimed invention and/or provide sufficient evidence that can be reasonably extended by one of ordinary skill in the art over the scope of the present claims.
MPEP 716.02(d) Unexpected Results Commensurate in Scope With Claimed Invention [R-08.2012]
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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) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110C and 130C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).
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I. NONOBVIOUSNESS OF A GENUS OR CLAIMED RANGE MAY BE SUPPORTED BY DATA SHOWING UNEXPECTED RESULTS OF A SPECIES OR NARROWER RANGE UNDER CERTAIN CIRCUMSTANCES
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The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range 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) (Claims directed to mixtures of an herbicide known as "FENAC" with a diphenyl ether herbicide in certain relative proportions were rejected as prima facie obvious. Applicant presented evidence alleging unexpected results testing three species of diphenyl ether herbicides over limited relative proportion ranges. The court held that the limited number of species exemplified did not provide an adequate basis for concluding that similar results would be obtained for the other diphenyl ether herbicides within the scope of the generic claims. Claims 6-8 recited a FENAC:diphenyl ether ratio of 1:1 to 4:1 for the three specific ethers tested. For two of the claimed ethers, unexpected results were demonstrated over a ratio of 16:1 to 2:1, and the effectiveness increased as the ratio approached the untested region of the claimed range. The court held these tests were commensurate in scope with the claims and supported the nonobviousness thereof. However, for a third ether, data was only provided over the range of 1:1 to 2:1 where the effectiveness decreased to the "expected level" as it approached the untested region. This evidence was not sufficient to overcome the obviousness rejection.); In re Lindner, 457 F.2d 506, 509, 173 USPQ 356, 359 (CCPA 1972) (Evidence of nonobviousness consisted of comparing a single composition within the broad scope of the claims with the prior art. The court did not find the evidence sufficient to rebut the prima facie case of obviousness because there was "no adequate basis for reasonably concluding that the great number and variety of compositions included in the claims would behave in the same manner as the tested composition.").
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II. DEMONSTRATING CRITICALITY OF A CLAIMED RANGE
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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).
In the present instance, the Examples in the specification only utilize:
(A) 29.7 wt% or 69.3 wt% of a single type of PHA resin -- i.e., poly(hydroxybutyrate-co-hexanoate) (PHBH) (i.e., AONILEX 151N) -- of unspecified composition (e.g., percentage of hexanoate comonomer units; molecular weight; etc.);
(B) 69.3 wt% or 29.7 wt% of a single type of aliphatic polyester (i.e., poly(butylene succinate-co-adipate) copolyester) (PBSA) (i.e., BioPBS FD92PM) of unspecified composition (e.g., ratio of succinate units and adipate units; molecular weight; etc.);
(C) 0 wt% starch.
Applicant has not provided objective evidence that the relied upon unexpected and/or surprising combination of mechanical properties and biodegradation in seawater characteristics would be present using compositions which fall within the scope of the present claims, but differ materially from the two inventive Examples in the specification, particularly with respect to the amount of starch.
(C) Applicant argues that secondary references SCHMIDT ET AL ‘268 and WNUK ET AL ‘423 fail to remedy the alleged deficiencies of KRISHNASWAMY ET AL ‘743 in combination of STEINKE ET AL ‘196. However, since Applicant’s arguments with respect to the alleged deficiencies of KRISHNASWAMY ET AL ‘743 and STEINKE ET AL ‘196 are deemed unpersuasive, Applicant’s arguments regarding the above secondary references are similarly deemed unpersuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
BOND ET AL (US 2003/010870) and CHAPMAN ET AL (US 2019/0309147) and MATSUSHITA ET AL (US 6,515,054) and ZHAO ET AL (US 2004/0225269) and PONTI ET AL (US 2023/0311460) and KHEMANI ET AL (US 2005/0182196) and SARAZIN ET AL (US 2012/0283364) disclose biodegradable PHA-containing compositions containing starch as a modifier.
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 Vivian Chen (Vivian.chen@uspto.gov) whose telephone number is (571) 272-1506. The examiner can normally be reached on Monday through Thursday from 8:30 AM to 6 PM. The examiner can also be reached on alternate Fridays.
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May 28, 2026
/Vivian Chen/
Primary Examiner, Art Unit 1787
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