DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Claim 4 objected to because of the following informalities: in the 4th line of the claim, “volxatile” should be corrected to “volatile”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 2-9 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.
Regarding claims 2-8, a broad range or limitation together with a narrow range or limitation that
falls within the broad range or limitation (in the same claim) may be considered indefinite if the
resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See
MPEP § 2173.05(c).
Claim 2 recites the broad recitation “wherein the weight ratio is from 1:0.15 to 1:0.75… wherein said thermal conductivity is from 0.16 W/mK to 0.19 W/mK… wherein preferably said interior space is subject to temperature fluctuations of from 5°C to 50°C”, and the claim also recites “preferably from 1:0.2 to 1:0.75, more preferably from 1:0.25 to 1:0.75… preferably from 0.16 W/mK to 0.18 W/mK… preferably from 8°C to 30°C, more preferably from 10°C to 20°C”, which is the narrower statement(s) of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The broad-to-narrow limitations in claim 2 will be interpreted as if narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required.
Claim 3 recites the broad recitation “wherein said solid article is characterized by a Day 1 Weight Loss Ratio of less than 2”, and the claim also recites “preferably less than 1.9, and more preferably less than 1.8”, which is the narrower statement(s) of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The broad-to-narrow limitations in claim 3 will be interpreted as if narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required.
Furthermore, claim 3 recites the term “Day 1 Weight Loss Ratio”. It is unclear as to what this term specifically embodies, even if the instant Specification teaches a determination of said term/value. There is no recitation within the claim that defines what “Day 1” is, and “Weight Loss Ratio” has a various number of definitions that are potentially different to the method/calculation in the instant Specification. However, off of name value alone, for prosecution purposes, the term will be interpreted as a weight loss ratio from Day 0 to Day 1 at whatever ambient environment the composition is placed in.
Claim 4 recites the broad recitation “wherein preferably said one or more non-aqueous volatile materials are present in an amount ranging from 3% to 85%”, and the claim also recites “more preferably from 15% to 75%, most preferably from 20% to 60% by total weight of the solid article”, which is the narrower statement(s) of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The broad-to-narrow limitations in claim 4 will be interpreted as if narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required.
Claim 5 recites the broad recitation “wherein said one or more polyols or derivatives thereof are selected from the group consisting of polyols, polyester polyols, polyglycerols, and any mixtures thereof”, and the claim also recites “wherein preferably said one or more polyols or derivatives thereof comprises a polyester polyol, more preferably castor oil”, which is the narrower statement(s) of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The broad-to-narrow limitations in claim 5 will be interpreted as if narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required.
Claim 6 recites the broad recitation “wherein said cross-linking agent is selected from the group consisting of isocyanates, isothiocyanates, isocyanurates, oligoioscyanates, polyisocyanates, oligoisothiocyanates, polyisothiocyanates, and any derivatives thereof”, and the claim also recites “wherein preferably said cross-linking agent comprises an oligoisocyanate or polyisocyanate, more preferably a bio-based oligoisocyanate or polyisocyanate”, which is the narrower statement(s) of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The broad-to-narrow limitations in claim 6 will be interpreted as if narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required.
Claim 7 recites the broad recitation “having a form selected from the group consisting of: a tablet, a sheet, a film, and any combinations thereof”, and the claim also recites “wherein preferably the solid article is a tablet having a shape selected from the group consisting of: a circular shape, a polygon shape, and a non-circular and non-polygon shape; wherein more preferably the solid article is a tablet having a non-circular and non-polygon shape with a curved side and/or an open end”, which is the narrower statement(s) of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The broad-to-narrow limitations in claim 7 will be interpreted as if narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required.
Claim 8 recites the broad recitation “wherein each of the first and second central evaporative surfaces is characterized by an evaporative surface area of greater than 2 cm2 and/or less than 200 cm2”, and the claim also recites “preferably from 3 cm2 to 150 cm2, more preferably from 6 cm2 to 60 cm2”, which is the narrower statement(s) of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The broad-to-narrow limitations in claim 8 will be interpreted as if narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required.
Claim 9 is indefinite because the claims merely recite a use without any active, positive steps delimiting how this use is actually practiced (see MPEP 2173.05(q)).
Claim Rejections - 35 USC § 101
5. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
6. Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claims 19-20 recite a use but fails to recite steps, thus does not purport to claim a process, machine, manufacture, or composition of matter (see MPEP 2173.05(q)).
Claim Rejections - 35 USC § 102/103
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
9. Claims 1-7 and 9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kataoka et al. (EP 1142959 A1, provided in Applicant’s IDS filed 04/02/2024).
Kataoka teaches a solid article for sustained delivery of volatile materials in an interior space (molded gel composition, Table 1, 6th composition, see table below, [0006] and [0032]), comprising
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one or more non-aqueous volatile materials (40% wt allyl isothiocyanate) in a chemically cross-linked gel (“gel-like resin molded object”, [0021]); wherein said chemically cross-linked gel is formed by mixing one or more polyols or derivatives thereof (polyol being castor oil, Table 1) with a cross-linking agent (polyisocyanate, Table 1) at a weight ratio of from 1:0.1 to 1:0.8 (60:40 ratio in Table 1 is 1:0.67).
Regarding the limitation of “wherein said solid article is characterized by a thermal conductivity of from 0.16 W/mK to 0.2 W/mK”, the Applicant attributes the thermal conductivity as directly stemming from the polyol-to-crosslinker weight ratio (p.4, line 23 of the instant Specification). Given the non-aqueous volatile material (allyl isothiocyanate) taught by Kataoka is also at a wt % that is between the disclosed range of the instant Specification (p.2, 3rd paragraph), it is apparent that there is no difference in structure to Applicant’s disclosed solid article. Thus, the 6th molded gel composition in Table 1 (highlighted above) inherently should have a thermal conductivity value of the disclosed 0.16 W/mK to 0.2 W/mK range and is thus rejected on anticipatory grounds.
Therefore, the instantly recited limitation of "wherein said solid article is characterized by a thermal conductivity of from 0.16 w/mK to 0.2 W/mK" is necessarily present in the teachings of Kataoka.
When the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). See MPEP §§ 2112 - 2112.02.
Therefore, in the alternative, it would have been obvious to one or ordinary skill in the art before the effective filing date of the invention to modify the solid article of Kataoka have a thermal conductivity of from 0.16 w/mK to 0.2 W/mK since the solid article of Kataoka appears to be substantially similar (the polyol-to-crosslinker ratio is within the disclosed range of from 1:0.1 to 1:0.8, specifically being 1:0.67, Table 1, 6th composition, and the non-aqueous volatile material (allyl isothiocyanate) taught by Kataoka is also at a wt % that is between the disclosed ranges of the instant Specification).
The limitation of “wherein said interior space is subject to temperature fluctuations of at least 5°C” is directed to the manner of operating the apparatus. All the structural limitations of the claim has been disclosed by Kataoka and the gel-like resin composition of Kataoka is capable of being placed in an interior space with temperature fluctuations of at least 5°C. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, [0032] mentions potential interior spaces that the composition can be used in, namely refrigerators or a house/building room. With this variable applicability of the location (each correlating with an ambient temperature), the composition can be used in an ambient temperature fluctuation of 5°C.
Assuming arguendo, comfortable room temperature is conventionally known to have values ranging from 20°C to 25°C, which is a 5°C temperature fluctuation, but rooms can have varying ambient temperatures as long as the occupant sets it to be (e.g., 0°C to 40°C).
Per MPEP 2114,II, claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.
Regarding claim 2, Kataoka teaches wherein the weight ratio is from 1:0.15 to 1:0.75 (60:40 ratio in Table 1, 6th composition is 1:0.67).
Regarding the limitation of “wherein said solid article is characterized by a thermal conductivity of from 0.16 W/mK to 0.19 W/mK”, the Applicant attributes the thermal conductivity as directly stemming from the polyol-to-crosslinker weight ratio (p.4, line 23 of the instant Specification). Given the non-aqueous volatile material (allyl isothiocyanate) taught by Kataoka is also at a wt % that is between the disclosed range of the instant Specification, it is apparent that there is no difference in structure to Applicant’s disclosed solid article. Thus, the 6th molded gel composition in Table 1 (highlighted above) inherently should have a thermal conductivity value of the disclosed 0.16 W/mK to 0.19 W/mK range and is rejected on anticipatory grounds.
Therefore, the instantly recited limitation of "wherein said solid article is characterized by a thermal conductivity of from 0.16 w/mK to 0.19 W/mK" is necessarily present in the teachings of Kataoka.
When the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). See MPEP §§ 2112 - 2112.02.
Therefore, in the alternative, it would have been obvious to one or ordinary skill in the art before the effective filing date of the invention to modify the solid article of Kataoka have a thermal conductivity of from 0.16 w/mK to 0.19 W/mK since the solid article of Kataoka appears to be substantially similar (the polyol-to-crosslinker ratio is within the disclosed range of from 1:0.1 to 1:0.8, specifically being 1:0.67, Table 1, 6th composition, and even the non-aqueous volatile material (allyl isothiocyanate) taught by Kataoka is also at a wt % that is between the disclosed ranges in the instant Specification).
The limitation of “wherein said interior space is subject to temperature fluctuations of from 5°C to 50°C” is directed to the manner of operating the apparatus. All the structural limitations of the claim has been disclosed by Kataoka and the gel-like resin composition of Kataoka is capable of being placed in an interior space with temperature fluctuations of from 5°C to 50°C. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, [0032] mentions potential interior spaces that the composition can be used in, namely refrigerators or a house/building room. With this variable applicability of the location (each correlating with an ambient temperature), the composition can be used in an ambient temperature fluctuation of 5°C.
Assuming arguendo, comfortable room temperature is conventionally known to have values ranging from 20°C to 25°C, which is a 5°C temperature fluctuation, but rooms can have varying ambient temperatures as long as the occupant sets it to be (e.g., 0°C to 40°C).
Regarding claim 3, the limitation “wherein said solid article is characterized by a Day 1 Weight Loss Ratio of less than 2” is directed to the function of the apparatus. All the structural limitations of the claim has been disclosed by Kataoka and the gel-like resin composition of Kataoka is capable of having a Day 1 weight loss ratio of less than 2. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, in the instant Specification the Day 1 weight loss ratio being less than 2 is attributed directly and only to the “improved characteristics” of the solid article (p.5, 2nd paragraph), to which said improved characteristics are from the inherent thermal conductivity range directly affected by the polyol-to-crosslinker weight ratio as described in p.4, 3rd paragraph of the instant Specification.
Per MPEP 2114,II, claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.
Assuming arguendo, because the Day 1 Weight Loss Ratio has no mention of the environmental factors the composition is exposed to (temperature, humidity, pressure, time of exposure, etc.) the disclosed composition is fully capable of reaching this ratio value of less than 2 simply due to adjusted environmental parameters during this testing and subsequent ratio calculation.
Regarding claim 4, Kataoka teaches wherein said one or more non-aqueous volatile materials are sanitizing agents (allyl thioisocyanate is a sanitizing agent, [0001]); and
wherein preferably said one or more non-aqueous volatile materials are present in an amount ranging from 3% to 85% (40% wt allyl isothiocyanate, Table 1).
Regarding claim 5, Kataoka teaches wherein said one or more polyols or derivatives thereof are selected from the group consisting of polyols (polyol, Table 1).
Regarding claim 6, Kataoka teaches wherein said cross-linking agent is a polyisocyanate (polyisocyanate, Table 1).
Regarding claim 7, Kataoka teaches wherein the solid article is a tablet (gel-like resin composition is molded into cylindrical container 1, Fig. 6, meaning the gel-like resin composition is molded to a cylinder, i.e., a circular tablet).
Regarding claim 9, Kataoka teaches the use of a solid article for sustained delivery of volatile materials in an interior space (molded gel composition, Table 1, 6th composition, see table below, [0006] and [0032]), comprising
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one or more non-aqueous volatile materials (40% wt allyl isothiocyanate) in a chemically cross-linked gel (“gel-like resin molded object”, [0021]); wherein said chemically cross-linked gel is formed by mixing one or more polyols or derivatives thereof (polyol being castor oil, Table 1) with a cross-linking agent (polyisocyanate, Table 1) at a weight ratio of from 1:0.1 to 1:0.8 (60:40 ratio in Table 1 is 1:0.67), wherein said interior space is subject to temperature fluctuations of at least 5°C ([0032] mentions potential interior spaces that the composition can be used in, namely refrigerators or a house/building room, to which a conventional refrigerator has a temperature that is greater than 5°C of a difference from conventional room temperature).
Regarding the limitation of “wherein said solid article is characterized by a thermal conductivity of from 0.16 W/mK to 0.18 W/mK”, the Applicant attributes the thermal conductivity as directly stemming from the polyol-to-crosslinker weight ratio (p.4, line 23 of the instant Specification). Given the non-aqueous volatile material (allyl isothiocyanate) taught by Kataoka is also at a wt % that is between the disclosed range of the instant Specification (p.2, 3rd paragraph), it is apparent that there is no difference in structure to Applicant’s disclosed solid article. Thus, the 6th molded gel composition in Table 1 (highlighted above) inherently should have a thermal conductivity value of the disclosed 0.16 W/mK to 0.2 W/mK range and is rejected on anticipatory grounds.
Therefore, the instantly recited limitation of "wherein said solid article is characterized by a thermal conductivity of from 0.16 w/mK to 0.18 W/mK" is necessarily present in the teachings of Kataoka.
When the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). See MPEP §§ 2112 - 2112.02.
Therefore, in the alternative, it would have been obvious to one or ordinary skill in the art before the effective filing date of the invention to modify the solid article of Kataoka have a thermal conductivity of from 0.16 w/mK to 0.18 W/mK since the solid article of Kataoka appears to be substantially similar (the polyol-to-crosslinker ratio is within the disclosed range of from 1:0.1 to 1:0.8, specifically being 1:0.67, Table 1, 6th composition, and the non-aqueous volatile material (allyl isothiocyanate) taught by Kataoka is also at a wt % that is between the disclosed ranges in the instant Specification).
10. Regarding claim 8, Kataoka teaches wherein the solid article has a first central evaporative surface (due to the cylindrical shape of the molded gel-like resin composition in container 1 of Fig. 6, the first central evaporative surface would be the upward facing circular surface of the mold), a second central evaporative surface (opposite, downward facing circular surface of the mold), and a peripheral evaporative surface between the first and second central evaporative surfaces (curved, lateral surface of the mold), but fails to mention wherein each of the first and second central evaporative surfaces is characterized by an evaporative surface area of greater than 2 cm2 and/or less than 200 cm2.
Kataoka repeatedly mentions how the volatilization rate of allyl isothiocyanate can be controlled based on the container the molded gel-like resin composition is contained in (e.g., [0008]), also attributing the vent hole number (i.e., exposure surface area from the container to the environment) to a volatilization rate.
Therefore, it would have been obvious to one of ordinary skill in the art to have arrived at the claimed evaporative surface area of greater than 2 cm2 and/or less than 200 cm2 through routine optimization via manipulation of the container dimensions (i.e., directly correlated to the exposed, upper circular surface area of the molded gel-like resin composition) in order to control the volatilization rate of the drug (i.e., allyl thioisocyanate), because it is known in the art that a greater surface area yields a higher interface/contact area with the environment.
Assuming arguendo, it would have also been obvious to one of ordinary skill in the art to have arrived at the claimed evaporative surface area of greater than 2 cm2 and/or less than 200 cm2 through routine optimization with a reasonable expectation of success via changing the size of the container (which inherently changes the molded gel-like composition), because “mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability” (MPEP 2144.04.IV.A).
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hedi et al. (GB 2531044 A), directed to an aromatic volatile composition having a non-polygonal, non-circular tablet shape.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aham Lee whose telephone number is (703)756-5622. The examiner can normally be reached Monday to Thursday, 10:00 AM - 8:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Aham Lee/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758