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 .
Priority
This application is a 371 of PCT/US2021/059864 filed 11/18/2021.
PCT/US2021/059864 has PRO of 63116139 filed 11/19/2020.
Accordingly, claims 1-25 are afforded the effective filing date of 11/19/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/28/2024 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
The information disclosure statement (IDS) submitted on 03/04/2024 is not considered by the examiner because the IDS filed on 03/04/2024 is a duplicate of the IDS filed on 02/28/2024. A copy of the strike-through IDS is included with the mailing of this office action.
Election/Restrictions
Applicant’s election of Group I, claims 1-19 and 21-25 in the reply filed on 03/06/2026, is acknowledged. Applicant also elected poly(vinyl alcohol) as the species of water soluble material of Formula I. Applicant asserted that the elected species reads on claims 1-19 and 23-25.
It is noted that the election of “poly(vinyl alcohol)” is not a proper species of water soluble material of Formula I because it is an incomplete election of species. “poly(vinyl alcohol)” as elected by Applicant is only a species of the “P” group of Formula I. Formula I has X, R1, and R2 groups as part of the formula. Nevertheless, the Examiner will move forth with this election of species and restrict the claims as follows.
Claim 21 will also be included in the readable elected species, as the cross-linked polymer of Formula IV in claim 21 contains a poly(vinyl alcohol) backbone. Claim 22 will not be included in the readable elected species, as the crosslinked polymer of Formula V in claim 22 contains a chitosan backbone and thus, does not read on the elected species of poly(vinyl alcohol). Accordingly, the elected species reads on claims 1-19, 21 and 23-25.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 20 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention and species, respectively, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/06/2026.
Status of the Claims
Claims 19 and 23-25 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 19 and 23-25 have not been further treated on the merits
Claim 1-25 are pending in this instant application, of which claims 20 and 22 are withdrawn at this time as being drawn to nonelected group/invention and species, respectively; and claim 19 and 23-25 have not been further treated on the merits due to improper multiple dependency.
Claims 1-18 and 21 are examined herein on the merits for patentability.
Claim Objections
Claims 1 objected to because of the following informalities: please add an “and” after
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of the R1 group. Appropriate correction is required.
Claims 1 objected to because of the following informalities: the recitation of “R2 independently selected from the group consisting of -H and/or -CH3” is an improper Markush language (please refer below for proper Markush languages). Appropriate correction is required.
Claims 1 objected to because of the following informalities: please add an “and” at the end of component “iii.” . Appropriate correction is required.
Claim 21 is objected to because of the following informalities: please add an “and” after
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of the R3 Markush group. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: the recitation of “R4 independently selected from the group consisting of hydrogen and/or methyl” is an improper Markush language (please refer below for proper Markush languages). Appropriate correction is required.
Claim 21 is objected to because of the following informalities: the recitation of “R is an end group independently selected from the group consisting of vinyl, hydrogen and/or methyl” is an improper Markush language (please refer below for proper Markush languages). Appropriate correction is required.
Claim 21 is objected to because of the following informalities: please amend “being a+b+c+d at least 340” to “wherein a+b+c+d being at least 340.” Appropriate correction is required.
Claim 21 is objected to because of the following informalities: please add an “and” after
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of the “P1, P2, P3, P4, P5, and P6” Markush group. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: please add an “and” after
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of the R7 Markush group. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: please add an “and” after
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of the R10 and R11 Markush group. Appropriate correction is required.
When materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.
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 1-18 and 21 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 claim 1, the parenthetical recitation of “(max 95%)” in claim 1 is indefinite because it is unclear if the text within the parenthesis are alternative limitations of the claims or merely descriptors of other elements of the claims. It is noted that [p]arenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
Regarding claim 10, the parenthetical recitation of “(maximum 100%)” in claim 1 is indefinite because it is unclear if the text within the parenthesis are alternative limitations of the claims or merely descriptors of other elements of the claims. It is noted that [p]arenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
Regarding claim 18, the recitation of “the delivery particle according to any preceding claim forming a population” renders claim 18 indefinite because none of the preceding claims is a population of particles and thus, it is not clear how do it form a population. In addition, the recitation of “the delivery particle population” as recited in claim 18 also renders said claim indefinite because there is lack of antecedent basis for a delivery particle population in claim 18, as well as, any of the preceding claims. Thus, it is also not clear what “the delivery particle population” is referring to, as none of the preceding claims are drawn to a delivery particle population. Clarification by amendment in claim 18 is required.
Regarding claims 1-3, 6-8, 10-12, 15, 18 and 21:
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). In the present instance:
claim 1 recites the broad recitation “a polymer heteroatom functionalized with a radical polymerizable group,” and the claim also recites “preferably O or N,” which is the narrower statement of the limitation.
claim 1 recites the broad recitation “m and n are integers independently selected from 1 to 100,” and the claim also recites “preferably from 1 to 50,” “even more preferably from 1 to 10,” which are the narrower statements of the range/limitation.
claim 1 recites the broad recitation “being at least 20%,”, and the claim also recites “preferably 30%,” “even more preferably 40%,” and “(max 95%)” which are the narrower statements of the range/limitation.
claim 2 recites the broad recitation “a fragrance,” and the claim also recites “preferably a fragrance comprising perfume raw materials characterized by a logP of from about 2.5 to about 4.5,” which is the narrower statement of the limitation.
claim 3 recites the broad recitation “the partitioning modifier is selected from the group consisting of isopropyl myristate, vegetable oil, modified vegetable oil, mono-, di-, and tri- esters of C4-C24 fatty acids, dodecanophenone, lauryl laurate, methyl behenate, methyl laurate, methyl palmitate, methyl stearate, and mixtures thereof,” and the claim also recites “preferably isopropyl myristate,” which is the narrower statement of the limitation.
claim 6 recites the broad recitation of R1 being the Markush group recited in claim 1, and the claim also recites “R1 is preferably
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,” which is the narrower statement of the limitation.
Claim 7 recites the broad recitation “at least 50% wt,” and the claim also recites “preferably at least 75% wt,” “more preferably at least 85% wt,” and “even more preferably 95% wt,” which are the narrower statements of the range/limitation.
Claim 8 recites the broad recitation “the water soluble material has a percentage of functionalized heteroatoms from 0.05 to 20%wt,” and the claim also recites “preferably from 0.5 to 10%wt” and “even more preferred from 0.6 to 5%wt,” which are the narrower statements of the range/limitation.
Claim 10 recites the broad recitation “above 30% CO2,” and the claim also recites “preferably above 40%CO2,” “more preferably above 50%CO2,” “even more preferably above 60% CO2,” and “(maximum 100%),” which are the narrower statements of the range/limitation.
Claim 11 recites the broad recitation “from about 30% to about 100% CO2,” and the claim also recites “preferably from about 40% to about 98% CO2,” “more preferably from about 50% to about 95%CO2,” and “even more preferably from about 60% to about 90% CO2,” which are the narrower statements of the range/limitation.
Claim 12 recites the broad recitation “a molecular weight from about 30kDa to about 500kDa,” and the claim also recites “preferably from about 50kDa to about 300kDa” and “even more preferably from about 80kDa to about 200kDa,” which are the narrower statements of the range/limitation.
Claim 15 recites the broad recitation “at least 2 radical polymerizable groups,” and the claim also recites “at least 3,” “preferably at least 4,” “even more preferable at least 5,” “even more preferably 6,” which are the narrower statements of the range/limitation.
Claim 18 recites the broad recitation “a weight ratio of from about 90:10 to about 99:1,” and the claim also recites “more preferably from about 92:8 to about 98:2,” which is the narrower statement of the range/limitation.
Claim 21 encompasses the broad recitation a:b:c:d of any molar ratio, and the claim also recites “preferably, a:b:c:d molar ratio is from about 0.0001:98.9:1:0.1 to about 1:59:30:10,” “preferably from about 0.001:91.8:8:0.2 to about 0.5:70:24.5:5,” and “even more preferably from about 0.001:87:12:1 to about 0.1:79.9:15:5,” which are the narrower statements of the range/limitation.
Claim 21 recites the broad recitation “z and y are integers independently selected from 1 to 10,” and the claim also recites “preferably from 2 to 5,” which is the narrower statement of the range/limitation.
Claim 21 recites the broad recitation “h and i are integers independently selected from 0 to 10,” and the claim also recites “preferably from 1 to 5,” which is the narrower statement of the range/limitation.
The claim(s) 1-3, 6-8, 10-12, 15, 18 and 21 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.
Claims 4-5, 9, 13-14, and 16-17 are also rejected as they depend directly or indirectly from indefinite claim 1.
As a result, claims 1-18 and 21 do not clearly set forth the metes and bounds of patent protection desired.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 18 is not further limiting of any of the preceding claims because all of the preceding claims are drawn delivery particle and thus, the recitation of “The delivery particle according to any preceding claim forming a population, wherein the delivery particle population comprises the core and polymer wall present in a weight ratio of from about 90:10 to about 99:1, more preferably from about 92:8 to about 98:2” as recited in claim 18 has broadened from the scope of the preceding claims, as none of the preceding claims are drawn to population of delivery particles.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-18 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smets et al (US 2020/0002654 A1) in view of Khan et al (J Polym Environ, 2017, 25: 556-568).
The elected species applies here.
Regarding claims 1 and 21, Smets teaches delivery particles comprising a core and a polymer wall encapsulating the core, wherein the core comprises a benefit agent and a partitioning modifier, and the polymer wall is formed from radical polymerization of i) a polyvinyl alcohol having average molecular weight of the polyvinyl alcohol is from about 65,000 Da to about 110,000 Da, ii) tert-butylamino ethyl methacrylate, beta hydroxyethyl acrylate, a hexafunctional aromatic urethane acrylate oligomer (CN975), water soluble initiators (e.g., 4,4′-azobis[4-cyanovaleric acid]) and oil soluble initiators (e.g., 2,2′-azobis(2-methylbutyronitrile)) (Abstract; [0003]-[0122] and [0205]-[0273]; Examples 1-15; claims 1-18). It is noted that the polymer wall that is formed in Smets is crosslinked due to the radical polymerization process.
However, Smets does not teach the polyvinyl alcohol is a modified polyvinyl alcohol according to Formula I or Formula IV of claims 1 and 21, respectively.
Regarding the modified polyvinyl alcohol according to Formula I or Formula IV of claims 1 and 21, Khan teaches a methacrylated polyvinyl alcohol used for controlled release drug delivery system (Abstract; Introduction; pages 557-568). Khan teaches the methacrylated polyvinyl alcohol is biodegradable and can be deployed in pH sensitive controlled release vehicle for drug delivery owing to swelling and prolonged drug release characteristics in alkaline pH (Abstract; Introduction; pages 557 and 568).
It would have been obvious to one of ordinary skill in the art to one of ordinary skill in the art to incorporate the methacrylated polyvinyl alcohol of Khan as the polyvinyl alcohol material in Smets, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Khan suggested that methacrylated polyvinyl alcohol can be used in pH sensitive controlled release vehicle for drug delivery, as they provide prolonged drug release characteristics in alkaline pH, and Smets’ objectives are drawn to provide delivery particles that have improved shell strength and release of benefit agent (i.e., pharmaceuticals, perfumes) when used in pH sensitive environments such as alkaline environments (e.g., detergent compositions) (Smets: Abstract; [0003]-[0122] and [0205]-[0273]; Examples 1-15; claims 1-18). Thus, an ordinary artisan would have looked to incorporate the methacrylated polyvinyl alcohol of Khan as the polyvinyl alcohol material in Smets so as to provide delivery particles that provide prolonged benefit agent release characteristics in alkaline pH environments such as a detergent composition, an objective desired by Smets, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 2, Smets teaches the benefit agent is a fragrance such as perfume raw materials ([0066]).
Regarding claim 3, Smets teaches the partitioning modifier is isopropyl myristate (Examples 1 and 6).
Regarding claim 4, as discussed above, Smets teaches polyvinyl alcohol.
Regarding claim 5, as discussed above, Smets teaches the polymer wall is formed from radical polymerization of i) a polyvinyl alcohol having average molecular weight of the polyvinyl alcohol is from about 65,000 Da to about 110,000 Da, ii) tert-butylamino ethyl methacrylate, beta hydroxyethyl acrylate, a hexafunctional aromatic urethane acrylate oligomer (CN975), water soluble initiators (e.g., 4,4′-azobis[4-cyanovaleric acid]) and oil soluble initiators (e.g., 2,2′-azobis(2-methylbutyronitrile)) (Smets: Abstract; [0003]-[0122] and [0205]-[0273]; Examples 1-15; claims 1-18), thus, the polyvinyl alcohol of Smets in view of Khan would have been covalently bonded into the polymer wall due radical polymerization.
Regarding claim 6, as discussed above, Khan teaches a methacrylated polyvinyl alcohol.
Regarding claim 7, Smets teaches the amount of polyvinyl alcohol used in forming the polymer wall can be optimize to amounts of at least 50 wt% (Examples 1-8). Absent some demonstration of unexpected results from the claimed parameters, the optimization of the weight% amount of the water soluble material in the polymer wall would have been obvious before the effective filing date of applicant's invention. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
Regarding claim 8, the methacrylated polyvinyl alcohol of Khan has multiple functionalized heteroatoms (oxygen atoms) in the methacrylated polyvinyl alcohol (Khan: pages 557-558), and thus, the percentage of functionalized heteroatoms in the methacrylated polyvinyl alcohol of Khan would have reasonably be in the range from 0.05 to 20% wt as claimed. Absent some demonstration of unexpected results from the claimed parameters, the optimization of the percentage of functionalized heteroatoms in the water soluble material would have been obvious before the effective filing date of applicant's invention. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
Regarding claim 9, as discussed above, Khan teaches methacrylated polyvinyl alcohol
Regarding claims 10 and 11, Khan teaches the methacrylated polyvinyl alcohol is biocompatible and biodegradable (Khan: pages 557-558). Since the structure of the polymer wall of claim 1 has been taught and rendered obvious by Smets in view of Khan, it would have been reasonably obvious that the methacrylated polyvinyl alcohol and the resultant polymer wall containing the methacrylated polyvinyl alcohol of Smets in view of Khan would have implicitly exhibited the biodegradability properties as claimed in claim 10 and 11. It is noted that [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "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." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Regarding claim 12, Smets teaches that the suitable polyvinyl alcohol material have a molecular weight of from about 65,000 Da to about 110,000 Da ([0026]; Examples 1-8; claim 1), which overlaps the claimed molecular weight from about 30 kDa to about 500 kDa. Absent some demonstration of unexpected results from the claimed parameters, the optimization of the molecular weight of the water soluble material would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
Regarding claims 13-17, Smets teaches the polymer wall contains radical polymerization of tert-butylamino ethyl methacrylate, beta hydroxyethyl acrylate, and a hexafunctional aromatic urethane acrylate oligomer (CN975) (Examples 1-8).
Regarding claim 18, Smets teaches the contents of the core is high compared to the contents of the polymer wall in the formation of the delivery particles (Examples 1-8). Thus, it would have been reasonable obvious to optimize the weight ratio of core to polymer wall to a high core: polymer ratio as claimed in claim 18. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the in art the before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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