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 Objections
As amended, claim 2 fails to comply with 37 CFR 1.121(c)(2), which requires that the text of any deleted subject matter must be shown by strike-through script (except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters). In this case, the term “Mayo®” was simply deleted from the claim.
Despite non-compliance, the amended claim set is being entered and examined on the merits in the interest of compact prosecution.
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 1-5 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over LaPray (US 2017/0210889 A1) in view of Neuman (WO 2013/088443).
Regarding claim 1, LaPray teaches articles, including films (Abstract), formed from a combination of petrochemical plastic(s) and carbohydrate-based polymers (Abstract). LaPray specifies that the petrochemical plastics may include polyethylene and polypropylene ([0052]) in amounts ranging from 10 to 99 wt% of the formulation ([0088]), and indicates that the carbohydrate-based materials may comprise one or more starches mixed together ([0053]), and teaches that the first starch may comprise between about 50 and 95 wt% of the overall starch composition ([0056]). The degradable starch mixture therefore may be incorporated in amounts ranging from 1.0 to 50 wt%. In each case, the compositional amounts taught by LaPray overlap their respectively claimed ranges, establishing prima facie cases of obviousness.
The degradable mixture therefore may be incorporated in amounts ranging from 1.0 to 50 wt%. In each case, the compositional amounts taught by LaPray as modified by Neuman and Govan overlap their respectively claimed ranges, establishing prima facie cases of obviousness.
LaPray differs from claim 1 because, while it teaches a composition containing non-degradable polymers (including at least polyethylene and polypropylene, which the instant disclosure indicates as non-degradable, c.f. claim 17) and a blend of other polymers, it is silent with regard to said polymers being those of the claimed list.
In the same field of endeavor, Neuman teaches a biodegradable sheet prepared from biodegradable materials (Abstract), and teaches a series of biodegradable polymers suitable therein, including Poly(lactic acid) (PLA), Polyhydroxyalkanoates (PHA), and Poly(butylene adipate-co-terephthalate) (PBAT) in addition to starch ([0043]). Meanwhile, as described above, LaPray is directed towards biodegradable films (e.g., [0003] and [0047]). It is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose (see MPEP 2144.06). Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to substitute the biodegradable polymers (including PLA, PHA, and/or PBAT) in place of the starches within the formulation of LaPray, as taught by Neuman, as Neuman recognizes them as alternatives to starch within biodegradable film formulations. In doing so, LaPray as modified by Neuman teaches a formulation containing a non-degradable polymer (optionally including polyethylene and/or polypropylene) and a mixture of degradable polymers (optionally including PLA and/or PHA and PBAT, which is a poly-terephthalate according to the instant Specification at [0072]). The formulation of LaPray as modified by Neuman therefore reads on the claimed composition.
As described above, LaPray and Neuman both teach the formation of sheets, which read on the claimed “drape.”
Regarding the claimed limitation requiring biodegradation of at least 10% within 90 days according to ASTM D5511, LaPray teaches percentage biodegradation of the inventive composition under ASTM D5511 conditions ([0118], [0121], and [0144]), and specifically emphasizes the importance of biodegradability according to the claimed standard. Futhermore, it is prima facie obvious to perform routine optimization to discover optimum or workable ranges (see MPEP 2144.05.II.A.). It therefore would have been obvious to one having ordinary skill in the art at the time of filing to optimize the biodegradation rates of the composition of LaPray to meet the claimed range, as doing so would meet the desired degree of degradation discussed in LaPray at [0144]).
Assuming arguendo that LaPray fails to render obvious the claimed biodegradation rate at the specifically claimed degradable material concentration, the combined prior art teaches a composition which is compositionally identical to the claimed composition, containing all of the same components in all of the claimed amounts. Furthermore, the instant Specification teaches the mere blending and injection molding of the inventive composition (e.g., [0077]), which is mirrored within LaPray ([0004] and [0086] of LaPray). The composition of LaPray as modified is therefore formed by a process which is substantially similar to the one as claimed.
Products of identical chemical compositions cannot have mutually exclusive properties. Where the claimed and prior art products are identical or substantially identical in structure or composition and have been produced by an identical or substantially identical process, a prima facie case of obviousness has been established. See MPEP 2112.01. The claimed biodegradation characteristics will therefore necessarily be present in LaPray as modified, and as applied above.
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. "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See MPEP 2112 and 2112.01.
Regarding claim 2, the recited list is directed towards intended uses of the claimed “drape.” The intended use limitations do not require steps to be performed or limit the claims to a particular structure. These limitations do not limit the scope of the instant claims and need not be taught by the prior art in order to read on the claims. See MPEP 2111.02. Therefore, LaPray as modified by Neuman as applied to claim 1, above, also reads on claim 2.
Regarding claims 3-5, the claims are directed towards alternate “biodegradable disposable” products as required by claim 1. As described above, LaPray as modified by Neuman reads on the biodegradable disposable drape within the list of claim 1. LaPray as modified by Neuman therefore reads on claims 3-5 as the additional limitations on alternative “biodegradable disposable” products do not affect the way in which LaPray as modified by Neuman reads on the claimed “biodegradable disposable.”
Regarding claims 8-10, as described above, LaPray as modified teaches the incorporation of between 50 and 99.0 wt% of a non-degradable polymer such as polyethylene or polypropylene ([0088]). The degradable mixture therefore may be incorporated in amounts ranging from 1.0 to 50 wt%. In each case, the compositional amounts taught by LaPray as modified by Neuman and Govan overlap their respectively claimed ranges, establishing prima facie cases of obviousness.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over LaPray (US 2017/0210889 A1) in view of Neuman (WO 2013/088443) and further in view of Mishler (US 2006/0252326 A1).
Regarding claims 6 and 7, LaPray as modified by Neuman teaches all of the limitations of claim 1, as described above. LaPray as modified differs from claim 6 because it is silent with regard to the incorporation of an antimicrobial agent.
In the same field of endeavor, Mishler teaches an antimicrobial fabrics (Abstract, [0002]) optionally formed from polyethylene or polypropylene ([0021]), which possesses an antimicrobial effect derived from the incorporation of silver or compounds including silver ([0028]). Mishler teaches that the inventive curtain is useful for reducing the level of microbes present in the product ([0002]). Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to incorporate silver and/or silver-containing compounds into the sheet of LaPray as modified by Neuman and Govan for the purpose of reducing the level of microbes present therein.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over LaPray (US 2017/0210889 A1) in view of Neuman (WO 2013/088443) and further in view of Herrera (Journal of Polymer Science: Part A: Polymer Chemistry, 2002, vol. 40, pp. 4141-4157).
Regarding claims 11-14, LaPray as modified by Neuman teaches all of the limitations of claim 1, as described above. LaPray as modified by Neuman further teaches the use of poly(butylene-adipiate-co-terepthalate) (e.g., [0043] of Neuman), which reads on the claimed chemical structures wherein “a” and “c” are 4 (butylene monomer units) and “b” is 6 (adipate monomer units). However, LaPray as modified by Neuman differs from claims 11-14 because it is silent with regard to the limitation wherein “m” and “n” are within the claimed percentages of one another. It is recognized that the values of “m” and “n,” respectively, refer to the molar amounts of butylene terephthalate and butylene adipate repeat units within the claimed polymer.
In the same field of endeavor, Herrera investigates the properties of random PBAT copolymers having differing ratios of butylene terephthalate and butylene adipate subunits (Abstract), and specifically teaches copolymers containing a 50/50 split between the two (c.f. Table 1, wherein PBAT (50/50) is indicated). Furthermore, Herrera reports high degradation rates of PBAT (50/50) in lipase media (c.f. p. 4155, Table 7). It is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose, and LaPray as modified by Neuman is directed towards biodegradable compositions including PBAT. It therefore would have been obvious to one of ordinary skill in the art at the time of filing to select a PBAT having a 50/50 composition of butylene adipate and butylene terephthalate subunits within the formulation of LaPray as modified by Neuman, as Herrera teaches that it is a biodegradable PBAT copolymer. A PBAT copolymer having the aforementioned 50/50 (even) compositional breakdown whould have values of m and n which are essentially equal to one-another; therefore the PBAT polymer having a 50/50 (even) compositional breakdown reads on the claimed limitations wherein “m” and “n” are “within 30% of one another,” “within 20% of one another,” “within 10% of one another,” and “within 5% of one another.”
Finally, as described above, Neuman contemplates blends involving two or more biodegradable polymers, and teaches the specific use of PBAT and PLA. Furthermore, Neuman specifies that the PLA polymer may be poly-L-lactide (p. 9, line 31). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to utilize a mixture of PLLA and PBAT, as required by claim 12.
Response to Arguments
As an initial matter, the Applicant has stated that the Examiner has not approved nor objected to the drawings and has requested approval thereof. The drawings are approved.
Applicant’s arguments, see Applicant’s Remarks, filed February 20, 2026, with respect to 35 USC 112(b) have been fully considered and are persuasive. The 35 USC 112(b) rejection of claim 2 has been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive.
Applicant argues that the prior art fails to contemplate circumstances where the claimed biodegradation rate is achieved given the relatively small concentration of degradable material. However, LaPray explicitly teaches this circumstance (see [0179], where LaPray specifically points out a biodegradation rate which exceeds the degradable polymer content, and Figure 16 where inventive compositions are shown to rapidly degrade under anaerobic conditions according to ASTM D5511).
Applicant argues that the examiner has not provided evidence of inherency. As an initial matter, the claimed biodegradation amounts were not required in the previous claim set, and thus an argument of inherency was not required at that time. In the rejection above, an inherency rejection has been supplied in addition to the teachings of LaPray which specifically read on the claimed biodegradation rate.
Applicant argues that biodegradation is not an inherent structural property of the composition, stating that biodegradation depends on “additive concentration, dispersion morphology, crystallinity, molecular weight, crosslink density, glass transition temperature, and microbial accessibility.” However, additive concentration, molecular weight, and glass transition temperature are inherently linked to the composition – an additive’s concentration is dictated by how much is included in a composition, a molecular weight will depend on the materials themselves (i.e., what molecular weight of polymer was used), and glass transition temperature is a characteristic of each polymer material/blend. The remaining factors are determined by processing characteristics and, while some of these factors may be controlled by both composition and processing conditions, as described above LaPray as modified teaches both a composition and a production process which mirror those as claimed. The biodegradation characteristics as claimed will therefore necessarily be present.
Applicant argues that the Examiner has failed to meet the burden of proof of regarding inherency; however, the burden of proof is that of the Applicant, to show that the reasoning for inherency (provided by the Examiner, in this case provided herein) is inaccurate (see MPEP 2112.V.).
Conclusion
THIS ACTION IS MADE FINAL. 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 JOSHUA CALEB BLEDSOE whose telephone number is (703)756-5376. The examiner can normally be reached Monday-Friday 8:00 a.m. - 5:00 p.m. EST.
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/JOSHUA CALEB BLEDSOE/Examiner, Art Unit 1762
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762
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