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 .
Applicant’s amendment and reply filed November 26, 2025 have been received and entered into the case. Claim 18 is canceled; claims 1 – 17 and 19 – 24 are pending and have been considered on the merits. All arguments have been fully considered.
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 – 17 and 19 – 24 remain 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.
Claim 1 and its dependents remain confusing for reciting “is configured to activate” because it is unclear if the phrase intends active steps to be carried out, as in a method, or if the phrase intends to define a characteristic of the microorganism product. Moreover, it is unclear how the phrase intends to limit the inactivated microorganism product. Clarification is required.
In claim 7, the phrase “is selected” renders the claim indefinite as it is unclear if steps are carried out to meet the limitation or if the phrase intends to confer a particular trait of the microorganism. Moreover, the metes and bounds of the claim are unclear.
Claim 21 remains indefinite for reciting a method “of disposing” an article because the step that follows appears to be drawn to degrading the article rather than disposing the article. Clarification is required.
Response to Arguments
Regarding claim 1, applicant argues that “configured to” defines a characteristic of the inactivated microorganism and is therefore clear. However, this argument fails to persuade since the phrase implies an unrecited step must occur to define the argued and undefined characteristic. Applicant may overcome this rejection by replacing “is configured to activate” with “activates” to more clearly define the claimed product.
Regarding claim 7, applicant argues the claim is clear in that the phrase “is selected” intends to confer a particular trait to the microorganism. However, this argument fails to persuade because the phrase fails to clearly delineate the metes and bounds of the composition. Applicant may overcome this rejection by deleting “selected to be” to more clearly define the claimed product.
Regarding claim 21, applicant argues that one in the art would know that disposal and degradation are related and is therefore clear. However, this argument fails to persuade because while the disposal of products may involve degradation, the processes are not mutually reliant on each other. In the context of the claimed method, the preamble states the purpose of the method, which is disposing of a biodegradable article. However, no steps are recited to dispose of the article when considering the plain meaning of disposing, e.g., to get rid of, per Merriam Webster (see attached).
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.
Claims 1 – 17, 19 and 21 – 23 remain rejected under 35 U.S.C. 103 as being unpatentable over Gustafson et al. (GB 2484511) in view of Noda (US 6160199), as evidenced by Mir et al. (2018).
Regarding claim 1, Gustafson teaches biodegradable articles with absorbent cores (absorbent article) (abstract, p.4), comprising at least one layer of polyolefin polyesters (p.4) and inactive microorganisms (abstract, p.3), wherein the microbe activates upon contact with a predetermined amount of moisture and begins to degrade the polyester layers (p.9).
Gustafson does not teach the polyester is a polyhydroxyalkanoate (PHA). However, at the time the claims were filed, PHA was a commonly used polyester used in absorbent articles. In support, Noda teaches biodegradable PHA as the primary component in the polyester layers wherein they are more biodegradable than polyesters such as polyolefin (abstract, col.24 line 55 – col.27 line 15). Thus, at the time the claims were filed, one of ordinary skill in the art would have been motivated by Noda to use PHA as the biodegradable polyester in Gustafson for the advantages of being more biodegradable and compostable than polyolefin (col.27 line 1-15) and with a reasonable expectation for successfully obtaining a biodegradable article.
Gustafson does not specifically teach the microorganism activates upon contact with a salt containing liquid as claimed. However, the reference does teach the microbes activate upon contact with moisture, such as wetting during the course of use (p.9). Moreover, Gustafson teaches that upon using the articles such as diapers and incontinence pads (abstract), the microbes will activate (p.9). Since it is known that urine typically contains 40 – 220 mmol sodium (including 50 mmol or more of a salt) (see attached Mir et al.), the microbes of Gustafson are considered to be “configured to activate” upon contacting a salt containing liquid having 50 mmol salt or greater. The activated microbes are disclosed as biotic degradation using enzyme catalyzed pathways to break down the polymers (p.6-7), which is interpreted to mean the microbes increase the rate at which the polymer would break down without it as claimed.
Regarding claim 2, the combined references do not suggest including a microorganism that secretes poly[R-3-hydroxybutyrate] depolymerase. However, in following the combined teachings of Gustafson and Noda, one of ordinary skill in the art would have been motivated to select such a microbe so as to degrade the PHA used in the article obtained by the combined teachings with a reasonable expectation for successfully obtaining a biodegradable absorbent article.
Regarding claim 3, Gustafson teaches the microbe can be freeze dried (p.9).
Regarding claims 4 and 5, Gustafson teaches the microbes can be naturally occurring or genetically modified to secrete the enzymes (p.7).
Regarding claims 6, 7, 12 and 13, Gustafson teaches the microbe can be Bacillus or Pseudomonas (p.9). Although the reference does not indicate the bacteria have a resistance to salt levels as claimed, the reference teaches using the same genus of bacteria under the same conditions of exposure to urine (diapers, incontinence pads), menses (sanitary napkins) and/or feces (diapers) (abstract, p.9). In this regard, the microbes would also necessarily be tolerant to the claimed levels.
Regarding claims 8 and 9, Gustafson teaches the article has at least one film or nonwoven layer, at least two layers having one liquid pervious layer, a top sheet (outer cover), and an absorbent core (between the layers) wherein the liners and outer layers are made from the polyester (p.4); and Noda teaches the same (col.4 line 10 – 17).
Regarding claims 10 and 11, the references do not teach the claimed ratio of microbes to polymer or percent of microorganism. However, since the microbe is indicated as the active biodegrading component, it is a recognized result effective variable included in the article at 103 CFU per gram of polymer (p.8). In this regard, it would have been well within the purview of one of ordinary skill in the art to optimize the amount thereof, and the resulting ratio of microbe to polymer, as a matter of routine practice and experimentation, and with a reasonable expectation for successfully obtaining an effective absorbent article.
Regarding claims 14 and 15, since the limitations are recited in the alternative to freeze drying, they are not specifically required by the claim language.
Regarding claims 16 and 17, Gustafson teaches the microbes can be sprinkled as a powder (p.10) indicating forms such as particles, fibers or flakes.
Regarding claim 19, Gustafson teaches the microbes are viable, indicating at least 90% would be viable (p.9).
Regarding claims 21 – 23, Gustafson teaches the articles are contacted with moisture, such as wetting during the course of use, to include contact with urine (wearable diapers and incontinence pads) (abstract, p.9), which contains sodium or is a salt containing liquid (see Mir et al. for support). Although the urine is not disclosed to contain the claimed salt concentration, it is known that urine typically contains 40 – 220 mmol sodium (including 50 mmol or more of a salt) (see attached Mir et al.).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues that Gustafson does not teach using PHA polymer or activating microbes upon contact with a salt containing liquid and that Noda does not cure this deficiency. Specifically, applicant argues that one in the art would not be motivated to use a PHA polymer or a PHA polymer with inactivated microbe absent hindsight. More specifically, applicant argues that Gustafson requires a polyolefin in combination with microbes that cleave carbon-carbon bonds under specific temperatures; that PHA has a different structure and function than polyolefin making it unsuitable for the microorganism used in Gustafson; and that the claimed microbe produces enzymes to degrade PHA not break carbon-carbon bonds in the polymer required by Gustafson. Applicant additionally argues that Noda fails to motivate one in the art to use PHA in combination with a microbe for a biodegradable article.
However, these arguments fail to persuade.
Applicant essentially argues limitations and cited reference individually in that one would not be motivated to substitute only the polymer or only the microbe in the biodegradable article disclosed by Gustafson. However, the rejection of record does not suggest that one in the art would have been motivated to substitute these parameters in the alternative. Rather the rejection is based on the teachings of the combined prior art as a whole. Gustafson teaches the concept of biodegradable absorbent articles wherein they comprise a polymer (polyolefin) and microorganism (e.g., Bacillus or Pseudomonas) wherein the microorganism degrades the polymer. As stated above, while Gustafson does not teach the polymer is PHA, Noda teaches PHA was a known biodegradable polymer used in biodegradable articles, which was also a well-known alternative to polyolefin (col. 24 – 27). In this regard, it is maintained that one of ordinary skill in the art would have been motivated by Noda to use PHA in place of polyolefin for its known advantage for being more biodegradable and compostable than polyolefin. Regarding the microorganism, Gustafson teaches Bacillus and Pseudomonas can be used as the preferred microorganism (p.2), which is the same used by applicant (claims 12, 13 and paragraph 0035 of the published application). Moreover, Gustafson teaches a microbe that activates upon contacting a salt containing liquid (e.g. urine, p.9, abstract); and one that produces an enzyme that degrades PHA, as evidenced by applicant’s specification at paragraph 0035 of the published application. Further support of this quality can be found in Di et al. and Wang et al., attached hereto.
Regarding the arguments that Gustafson requires a microbe that cleaves carbon-carbon bonds and not one that produces enzymes to degrade the polymer, it is maintained that since Gustafson teaches the claimed microbes in the biodegradable articles, the microbes must also produce enzymes to degrade the polymer. Notwithstanding, Gustafson teaches including microorganisms that break down more polar polymers, such as polyesters (e.g., PHA), in order to accelerate their degradation (p.6 - 7).
Regarding the argument that PHA has a different structure and function than polyolefin making it unsuitable for the microorganism used in Gustafson, it is iterated that Gustafson teaches the same bacteria used by applicant, e.g., Bacillus and Pseudomonas, which produce the claimed enzyme (see Di, Wang and paragraph 0035 of the published application).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699