DETAILED ACTION
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 (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.
Status of the Claims
Claims 1-15 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 requires a smoking article filter comprising lyocell tow including lyocell fibers wherein biodegradation of the smoking article filter within 6 months according to the American Society for Testing and Materials (ASTM) D6691 is 90% or higher under marine conditions at 30 °C. However, Applicant’s Specification states that the “biodegradation under marine conditions for 182 days [i.e., 6 months]”, ¶ 0055 of Applicant’s Specification as originally filed 5/30/2024, “at 30 °C”, ¶ 0049, of lyocell filter is only 79.4% and of lyocell tow is only 79.9% (Table 2 of Applicant’s Specification, see also Applicant’s Fig. 4). The Examiner notes that Applicant’s Specification sets forth lyocell filters and lyocell tow “having 90% or higher biodegradation relative to the standard product”, ¶ 0051, the standard product being “cellulose powder”, ¶ 0049. That is, the biodegradation percentage of lyocell filters or lyocell tow divided by the biodegradation percentage of cellulose powder may be 90% or higher (see Applicant’s Table 2 which lists the relative biodegradation of lyocell filter as the biodegradation percentage of lyocell filter (79.4%) divided by the biodegradation percentage of cellulose (83.1%) which equals 95.5% and of lyocell tow as the biodegradation percentage of lyocell tow (79.9%) divided by the biodegradation percentage of cellulose (83.1%) which equals 96.1%). However, claim 1 did not recite that the ratio (i.e., relative percentage) of the biodegradation percentage of the lyocell tow smoking article filter to the biodegradation percentage of cellulose powder is 90% or higher but, instead, that the biodegradation of the smoking article filter itself is 90% or higher. Because Applicant’s Specification did not set forth that the biodegradation percentage of lyocell tow smoking article filters can be 90% or higher (to the contrary, Applicant’s Specification and Drawings are evidence that the biodegradation of lyocell tow smoking article filters is less than 80% as discussed above), the subject matter of claim 1 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Similarly, claim 11 requires a smoking article comprising a smoking article filter which includes lyocell tow including lyocell fibers wherein biodegradation of the smoking article filter within 6 months according to the American Society for Testing and Materials (ASTM) D6691 is 90% or higher under marine conditions at 30 °C. However, Applicant’s Specification states that the “biodegradation under marine conditions for 182 days [i.e., 6 months]”, ¶ 0055, “at 30 °C”, ¶ 0049, of lyocell filter is only 79.4% and of lyocell tow is only 79.9% (Table 2 of Applicant’s Specification, see also Applicant’s Fig. 4). The Examiner notes that Applicant’s Specification sets forth lyocell filters and lyocell tow “having 90% or higher biodegradation relative to the standard product”, ¶ 0051, the standard product being “cellulose powder”, ¶ 0049. That is, the biodegradation percentage of lyocell filters or lyocell tow divided by the biodegradation percentage of cellulose powder may be 90% or higher (see Applicant’s Table 2 which lists the relative biodegradation of lyocell filter (79.4%) divided by the biodegradation percentage of cellulose (83.1%) which equals 95.5% and of lyocell tow as the biodegradation percentage of lyocell tow (79.9%) divided by the biodegradation percentage of cellulose (83.1%) which equals 96.1%). However, claim 11 did not recite that the ratio (i.e., relative percentage) of the biodegradation percentage of the lyocell tow smoking article filter to the biodegradation percentage of cellulose powder is 90% or higher but, instead, that the biodegradation of the smoking article filter itself is 90% or higher. Because Applicant’s Specification did not set forth that the biodegradation percentage of lyocell tow smoking article filters can be 90% or higher (to the contrary, Applicant’s Specification and Drawings are evidence that the biodegradation of lyocell tow smoking article filters is less than 80% as discussed above), the subject matter of claim 11 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 2-10 depend from claim 1 and, therefore, require the subject matter of claim 1, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. As such, claims 2-10 are also rejected.
Similarly, claims 12-15 depend from claim 11 and, therefore, require the subject matter of claim 11, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. As such, claims 12-15 are also rejected.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 and 11 require a smoking article filter (claim 1 is directed to a smoking article filter and claim 11 is directed to a smoking article comprising a smoking article filter) comprising lyocell tow including lyocell fibers wherein biodegradation of the smoking article filter within 6 months according to the American Society for Testing and Materials (ASTM) D6691 is 90% or higher under marine conditions at 30 °C.
This limitation is construed as a metric for the biodegradation of the smoking article filter itself and not a relative biodegradation made in comparison with some other material because Applicant set forth that the terminology “Biodegradation (%)” refers to the biodegradation of the material itself (see, e.g., Applicant’s Fig. 4 which labels the short axis as “Biodegradation (%)” and uses the values of the “Biodegradation(%)” – “AVG” column of Applicant’s Table 2), which is distinct from the “relative biodegradation” of a smoking article filter, which is the ratio of the biodegradation percentage of the smoking article filter to the biodegradation percentage of another material (¶ 0050, see also the “Biodegradation(%)” – “REL” column of Applicant’s Table 2, which lists the ratio of a particular article’s biodegradation percentage to that of a standard product that is cellulose powder).
Determination of compliance with the enablement requirement of 35 U.S.C. 112(a) is made with the framework of factors developed in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
With respect to the breadth of the claims (Wands factor (A)), claims 1 and 11 limit the biodegradation to be “90% or higher”. The entire breadth of this range is outside the values of biodegradation of lyocell tow filters set forth in the evidence of record (see Applicant’s Fig. 4 and Table 2 which show the biodegradation of lyocell tow filters as less than 80%). In fact, Applicant’s Specification notes that even something as highly biodegradable as pure cellulose in powder form (“standard cellulose powder”, ¶ 0049) only achieves a biodegradation percentage of 83.1% under the testing conditions, which is less than the claimed biodegradation of 90% or higher (see Applicant’s Fig. 4 and Table 2).
With respect to the nature of the invention (Wands factor (B)), the subject matter of claims 1 and 11 is a smoking article filter and a smoking article comprising a smoking article filter, respectively, that is intended to have a high percentage of biodegradation. Although biodegradation can be measured in a plurality of ways, some of which may even result in a biodegradation of the lyocell tow filter which is 90% or higher, claims 1 and 11 limit the biodegradation to be determined by ASTM D6691. The evidence of record indicates that lyocell tow filters cannot achieve a biodegradation of 90% or higher under ASTM D6691 (see Applicant’s Fig. 4 and Table 2 which show the biodegradation of lyocell tow filters as less than 80%).
With respect to the state of the prior art (Wands factor (C)), Applicant has noted that prior smoking article filters utilize cellulose acetate tow (“Cellulose acetate (CA) tow . . . . used in manufacturing conventional cigarette filters”, ¶ 0002) have a low biodegradation percentage (11.6 % at 28 days and 73.5 % at 182 days as seen in Applicant’s Tables 1 and 2 and Figs. 3 and 4) and that lyocell tow filters have improved biodegradation percentages (see Applicant’s Tables 1 and 2 and Figs. 3 and 4). As such, the evidence of record indicates that, in terms of biodegradation percentages, lyocell tow filters such as those in claims 1 and 11 are an improvement over the prior art, but the evidence of record does not indicate that this improvement reaches a biodegradation of 90% or higher (see Applicant’s Fig. 4 and Table 2 which show the biodegradation of lyocell tow filters as less than 80%).
With respect to the level of one of ordinary skill (Wands factor (D)), there is no evidence in the record indicating that a person of ordinary skill in the art has a level of skill which could achieve the required biodegradation percentage of lyocell tow smoking article filters of 90% or higher. The evidence of record, instead, indicates that one of ordinary skill will only achieve a biodegradation percentage of lyocell tow smoking article filters of less than 80% (see Applicant’s Fig. 4 and Table 2 which show the biodegradation of lyocell tow filters as less than 80%).
With respect to the level of predictability in the art (Wands factor (E)), claims 1 and 11 require that the biodegradation percentage be determined according to the American Society for Testing and Materials (ASTM) D6691 test. This test sets forth specific sets of requirements and procedures (said requirements and procedures available for purchase or via subscription at https://store.astm.org/d6691-24.html). As the requirements and procedures are clearly set forth, the evidence of record indicates a high level of predictability in the art. However, it is not predictability for achieving a biodegradation percentage of 90% or higher, as required by claims 1 and 11 but, instead, a biodegradation percentage of less than 80% (see Applicant’s Fig. 4 and Table 2 which show the biodegradation of lyocell tow filters as less than 80%).
With respect to the amount of direction provided by the inventor (Wands factor (F)), the inventor directs one of ordinary skill to measure the biodegradation percentage using the American Society for Testing and Materials (ASTM) D6691 test. This test sets forth specific sets of requirements and procedures (said requirements and procedures available for purchase or via subscription at https://store.astm.org/d6691-24.html). As the requirements and procedures are clearly set forth, the evidence of record indicates a high amount of direction provided by the inventor. However, it is not direction for achieving a biodegradation percentage of 90% or higher, as required by claims 1 and 11, but, instead, a biodegradation percentage of less than 80% (see Applicant’s Fig. 4 and Table 2 which show the biodegradation of lyocell tow filters as less than 80%).
With respect to the existence of working examples (Wands factor (G)), the evidence of record presents no working examples for achieving a biodegradation percentage of smoking article filters formed of lyocell tow within 6 months according to the American Society for Testing and Materials (ASTM) D6691 of 90% or higher under marine conditions at 30 °C. Further, the evidence of record presents examples wherein the biodegradation percentage of smoking article filters formed of lyocell tow within 6 months according to the American Society for Testing and Materials (ASTM) D6691 under marine conditions at 30 °C does not reach 90% or higher (see Applicant’s Fig. 4 and Table 2 which show the biodegradation of lyocell tow filters as less than 80%).
With respect to the quantity of experimentation needed to make or use the invention based on the content of the disclosure (Wands factor (H)), the Application does not disclose or suggest any parameters for the smoking article filter of claims 1 and 11 which may be varied as a matter of routine experimentation in order to achieve a biodegradation percentage of 90% or higher (see Applicant’s Fig. 4 and Table 2 which show the biodegradation of lyocell tow filters as less than 80%). As such, one having ordinary skill in the art would not know how to achieve a biodegradation percentage of smoking article filters formed of lyocell tow within 6 months according to the American Society for Testing and Materials (ASTM) D6691 under marine conditions at 30 °C of 90% or higher, if it is even possible, without an undue amount of experimentation.
With respect to other factors, the evidence of record suggests that it may not be possible for smoking article filters of lyocell tow to achieve a biodegradation percentage within 6 months according to the American Society for Testing and Materials (ASTM) D6691 under marine conditions at 30 °C of 90% or higher, as Applicant’s Specification notes that even something as highly biodegradable as pure cellulose in powder form (“standard cellulose powder”, ¶ 0049) only achieves a biodegradation percentage of 83.1% under the testing conditions (see Applicant’s Fig. 4 and Table 2).
As such, based on the evidence of record as a whole, the specification, at the time the application was filed, would not have enabled one skilled in the art to make the inventions in claims 1 and 11 without undue experimentation.
Claims 2-10 depend from claim 1 and, therefore, require the subject matter of claim 1 which was not described in the specification in such a way as to enable one skilled in the art to make the invention without undue experimentation. As such, claims 2-10 are also rejected.
Claims 12-15 depend from claim 11 and, therefore, require the subject matter of claim 11 which was not described in the specification in such a way as to enable one skilled in the art to make the invention without undue experimentation. As such, claims 12-15 are also rejected.
In an effort to promote compact prosecution, the Examiner notes that if claims 1 and 11 were amended to require A) a smoking article filter (or a smoking article comprising a smoking article filter) comprising lyocell tow including lyocell fibers wherein biodegradation of the smoking article filter within 6 months according to the American Society for Testing and Materials (ASTM) D6691 is 79% or higher under marine conditions at 30 °C or B) a smoking article filter (or a smoking article comprising a smoking article filter) comprising lyocell tow including lyocell fibers wherein the biodegradation of the smoking article filter within 6 months according to the American Society for Testing and Materials (ASTM) D6691 under marine conditions at 30 °C divided by the biodegradation of cellulose powder within 6 months according to the American Society for Testing and Materials (ASTM) D6691 under marine conditions at 30 °C is 90% or higher, then the claims would be enabled. However, no determination as to whether such claims would be allowable under 35 U.S.C. 102/103 is made at this time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY G CULBERT whose telephone number is (571)270-0874. The examiner can normally be reached Monday-Friday 9am-4pm.
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/COURTNEY G CULBERT/Examiner, Art Unit 1747
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