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 .
DETAILED ACTION
Applicant’s response filed on 02/18/2026 is duly acknowledged.
Claims 1-15 (original) were previously canceled by applicants.
Claims 16-37 (newly presented on 08/23/2023) are pending in this application.
Priority
This application is a 371 of PCT/EP2022/055000 (filed on 02/28/2022), which claims foreign priority from an European application EP 21159635.8 (filed on 02/26/2021).
Election/Restrictions
Applicant’s election without traverse of Group I (claims 16-35; directed to “An enzyme particle…”) in the reply filed on 02/18/2026 (see REM, p. 2) is acknowledged.
Claims 36 and 37 (drawn to non-elected inventions of Groups II-III) are withdrawn from further considerations.
Claims 16-35 (elected invention of Group I, without traverse; directed to “An enzyme particle…”) are examined on their merits.
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 25 and 26 (as presented) 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.
Claims 25 and 26 are as follows:
“Claim 25 (New): The enzyme particle of claim 16, wherein the particle has a pore volume corresponding to an oil uptake of at least 0.5 gram of oil per gram of particles.”
“Claim 26 (New): The enzyme particle of claim 16, wherein the particle has a pore volume corresponding to an oil uptake of at least 1 gram of oil per gram of particles.”
It is noted that the instant disclosure of record does not specifically define the term “pore volume” as to what exactly it encompasses in terms of volume required in order to meet the aforementioned limitations in instant claims 25 and 26 per se. The specification of record (on page 3, lines 13-16) states the following:
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It is noted that the “oil uptake” into the pores of the support particles may depend variously depending on the type, mass ratio of components, extent of porosity, and other excipients, or relevant conditions of the particles, and therefore the term requiring the amount of “oil uptake” as a measure of “pore volume” per se is deemed ambiguous and indefinite, especially as the disclosure does not provide guidance for the detail conditions and/or explanation for such a measure. Appropriate correction and/or explanation is required.
For the prior art purposes herein, instant claims 25 and 26 have been interpreted for having the porosity of the particles (as recited in instant claims 23-24 for instance), as meeting the limitations required by the claims.
NOTICE: 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.
Claim Rejections - 35 USC § 102
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.
Claims 16, 17, 20 and 29-33 (as presented) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia-Galan et al (2014; NPL previously made of record by examiner) as evidenced by [Souter et al (US 2009/0217464 A1; USPGPUB cited in applicant’s IDS dated 08/23/2023) and Technical Data Sheet (2026; NPL cited as ref. [U] on PTO 892 form)].
Claim 16 is directed to “An enzyme particle, comprising:
(a) 50-99% w/w of a copolymer of styrene and divinylbenzene; and
(b) 1-20% w/w active enzyme protein of a 1,3 specific lipase from enzyme class EC 3.1.1.3;
wherein the 1,3 specific lipase has at least 80% amino acid sequence identity to SEQ ID NO: 1.”
Instant claims have been interpreted as a composition comprising a copolymer particle carrier having an immobilized lipase enzyme as recited in claim 16.
See also limitations of dependent claims 17, 20 and 29-33 as currently presented.
Garcia-Galan et al (2014) disclose the immobilized active enzyme composition on beads comprising styrene-divinylbenzene (regarding instant claim 16; taken herein as an "enzyme particle" composition), wherein the enzyme is a lipase preparation from Rhizomucor miehei (RML), which has the same amino acid sequence (i.e. 100% identical to SEQ ID NO: 1; as evidenced by the disclosure from Souter et al designated as SEQ ID NO: 5; see pages 24-25; and also the sequence homology reproduced below):
SEQUENCE ALIGNMENT: (SEQ ID NO: 1; Instant claim 16)
AXQ88300
ID AXQ88300 standard; protein; 269 AA.
XX
AC AXQ88300;
XX
DT 12-NOV-2009 (first entry)
XX
DE Rhizomucor miehei lipase SEQ:5.
XX
KW Lipase; surfactant; textile.
XX
OS Rhizomucor miehei.
XX
CC PN US2009217464-A1.
XX
CC PD 03-SEP-2009.
XX
CC PF 26-FEB-2009; 2009US-00393136.
XX
PR 29-FEB-2008; 2008US-0067720P.
XX
CC PA (SOUT/) SOUTER P F.
CC PA (LANT/) LANT N J.
XX
CC PI Borch K, Haynes TC, Jorgensen CI, Lant NJ, Mikkelsen LM;
CC PI Patkar SA, Souter PF, Svendsen A, Van Der Lans R, Vind J;
XX
DR WPI; 2009-N33485/61.
XX
CC PT Detergent composition, useful for e.g. treating and/or cleaning surface
CC PT or fabric and manufacturing in-detergent stable formulation, comprises
CC PT variant of parent lipolytic enzyme, where the variant has amino acid
CC PT sequence.
XX
CC PS Disclosure; SEQ ID NO 5; 39pp; English.
XX
CC The present invention relates to a detergent composition comprising a
CC variant of the parent lipolytic enzyme. An independent claim is included
CC for a method of treating and/or cleaning a surface or fabric. The
CC composition is useful: in the hydrolysis of a carboxylic acid ester; in
CC the hydrolysis, synthesis or interesterification of an ester; and for the
CC manufacture of an in-detergent stable formulation. The composition has
CC has improved in-detergent stability. The present sequence represents a
CC Rhizomucor miehei lipase used in a detergent composition as described in
CC the invention.
XX
SQ Sequence 269 AA;
Query Match 100.0%; Score 1424; Length 269;
Best Local Similarity 100.0%;
Matches 269; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SIDGGIRAATSQEINELTYYTTLSANSYCRTVIPGATWDCIHCDATEDLKIIKTWSTLIY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 SIDGGIRAATSQEINELTYYTTLSANSYCRTVIPGATWDCIHCDATEDLKIIKTWSTLIY 60
Qy 61 DTNAMVARGDSEKTIYIVFRGSSSIRNWIADLTFVPVSYPPVSGTKVHKGFLDSYGEVQN 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DTNAMVARGDSEKTIYIVFRGSSSIRNWIADLTFVPVSYPPVSGTKVHKGFLDSYGEVQN 120
Qy 121 ELVATVLDQFKQYPSYKVAVTGHSLGGATALLCALDLYQREEGLSSSNLFLYTQGQPRVG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ELVATVLDQFKQYPSYKVAVTGHSLGGATALLCALDLYQREEGLSSSNLFLYTQGQPRVG 180
Qy 181 DPAFANYVVSTGIPYRRTVNERDIVPHLPPAAFGFLHAGEEYWITDNSPETVQVCTSDLE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 DPAFANYVVSTGIPYRRTVNERDIVPHLPPAAFGFLHAGEEYWITDNSPETVQVCTSDLE 240
Qy 241 TSDCSNSIVPFTSVLDHLSYFGINTGLCT 269
|||||||||||||||||||||||||||||
Db 241 TSDCSNSIVPFTSVLDHLSYFGINTGLCT 269
In addition, as evidenced by the disclosure in Technical Data Sheet (evidentiary NPL cited as ref. [U]) for commercially available MCIGEL® CHP20P comprises rigid, porous, polystyrene-divinylbenzene (PS-DVB) matrix/support having a controlled pore size distribution and large surface area (see Technical Data Sheet, page 1, 1st paragraph). It is noted that Garcia-Galan et al disclose the loading capacity of MCI GEL® CHP20P beads (see Garcia-Galan et al, page 7632, Table 1, for instance) for RML enzyme that is up to 310 mg/g of the wet support (see also "Experimental" starting on page 7638, sections 3.3 and 3.4, in particular); wherein the enzyme immobilization was performed using 3 or 50 mg of protein per g of wet support (see page 7639, section 3.3. “Immobilization of Lipases”), which translates into a corresponding enzyme particle preparation having 5% w/w active lipase enzyme protein (taking 50 mg RML protein/g of MCIGEL® CHP20P beads = 5 g/100 g beads = 5%w/w; i.e. within the range of “1-20% w/w active enzyme protein” in the enzyme particle composition), as currently required by instant claim 16.
Regarding instant claim 17, Garcia-Galan et al disclose the immobilized enzyme particle composition, wherein the copolymer of styrene and divinylbenzene is in an amount of 80-99% w/w (enzyme particle preparation having 5% w/w active lipase enzyme protein, i.e. rest 95% comprising the polystyrene-divinylbenzene support matrix in the form of MCI GEL® CHP20P beads).
Regarding instant claim 20, Garcia-Galan et al disclose the immobilized enzyme particles, wherein the 1,3 specific lipase RML is in an amount of 1-15% w/w active enzyme protein (i.e. disclose 5% w/w active RML lipase enzyme protein; see teachings above).
Regarding instant claims 29-33, Garcia-Galan et al disclose the immobilized enzyme particles, wherein the 1,3 specific lipase RML is a Rhizomucor miehei lipase that has 100% identical amino acid sequence of SEQ ID NO: 1 (see evidentiary disclosure from Souter et al, as discussed above).
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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.
Claims 18, 19, 21-28, 34 and 35 (as newly presented) are rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Galan et al (2014; NPL previously made of record by examiner) as evidenced by [Souter et al (US 2009/0217464 A1; USPGPUB cited in applicant’s IDS dated 08/23/2023) and Technical Data Sheet (2026; NPL cited as ref. [U] on PTO 892 form)] in view of Wilmar-Shanghai (WO 2015/081879 A1; WIPO document cited in applicant’s IDS dated 08/23/2023; Google machine translation attached herewith as ref. [V] on PTO 892 form).
The detailed teachings and/or suggestions from the cited prior art reference of Garcia-Galan et al as evidenced by [Souter et al and Technical Data Sheet] have been discussed above as pertaining to instant claims 16, 17, 20 and 29-33, and are further relied upon in the same manner, hereinafter.
However, the specific limitations of instant claims 18, 19, 21-28, 34 and 35 (see detailed recitations reproduced below) have not been explicitly taught by the cited prior art reference of Garcia-Galan et al, as discussed above.
Claims 18, 19, 21-28, 34 and 35 recite the following:
“Claim 18 (New): The enzyme particle of claim 16, wherein the copolymer of styrene and divinylbenzene comprises styrene and divinylbenzene units in a ratio of from 100:1 to 2:1.”
“Claim 19 (New): The enzyme particle of claim 16, wherein the copolymer of styrene and divinylbenzene comprises styrene and divinylbenzene units in a ratio of from 50:1 to 3:1.”
“Claim 21 (New): The enzyme particle of claim 16, wherein the particle has a surface area of 5-1000 m2/g.”
“Claim 22 (New): The enzyme particle of claim 16, wherein the particle has a surface area of 10-750 m2/g.”
“Claim 23 (New): The enzyme particle of claim 16, wherein the particle has an average pore size of 0.05-0.1 μm.”
“Claim 24 (New): The enzyme particle of claim 16, wherein the particle has an average pore size of 0.1-0.5 μm.”
“Claim 25 (New): The enzyme particle of claim 16, wherein the particle has a pore volume corresponding to an oil uptake of at least 0.5 gram of oil per gram of particles.”
“Claim 26 (New): The enzyme particle of claim 16, wherein the particle has a pore volume corresponding to an oil uptake of at least 1 gram of oil per gram of particles.”
“Claim 27 (New): The enzyme particle of claim 16, wherein the particle has an average diameter of 200-1200 μm.”
“Claim 28 (New): The enzyme particle of claim 16, wherein the particle has an average diameter of 300-900 μm.”
“Claim 34 (New): The enzyme particle of claim 16, wherein the copolymer of styrene and divinylbenzene comprises more than 90% of styrene and divinylbenzene units.”
“Claim 35 (New): The enzyme particle of claim 16, wherein the copolymer of styrene and divinylbenzene consists of styrene and divinylbenzene units.”
(See also 112b rejection of instant claims 25-26, as discussed above)
Wilmar-Shanghai (WIPO 2015; all citations per English machine translation attached) discloses a method for immobilizing Sn-1 ,3 selective lipase, which has both esterification and transesterification catalytic functions (see Abstract, Claims, and “Summary of the Invention” on pages 2-3), on a carrier comprising a copolymer of styrene and divinylbenzene (DVB) in a ratio of 5:1, a particle size distribution of 0.1 to ~0.4 mm (average diameter being 0.22 mm), a pore size distribution of 15 to 60 nm and a surface area of 100 to 600 m2/g; wherein the 1,3-specific lipase is selected from the group consisting of Thermomyces lanuginose, Rhizomucor miehei, Mucor miehei, Pseudomonas sp., Rhizopus sp., Aspergillus niger and Burkholderia sp. (see page 3); wherein Wilmar-Shanghai discloses the methods for preparation of such polymeric resin carriers in the form of microspheres having suitable mass ratio of components (i.e. styrene and divinylbenzene), pore size distribution, particle size range, and/or desired particle surface area (see page 4, for instance); wherein the desired lipase (such as lipase from Rhizomucor miehei, RM enzyme) can be immobilized using adsorption method (see Examples 20-22 on page 10), for instance, in order to obtain active lipase immobilized on such carrier(s) that can provide desired enzymatic esterification and/or ester exchange characteristic of the lipase.
Thus, to a person of ordinary skill in the art, given the detailed disclosure for the preparation of suitable polystyrene skeleton resin microspheres specifically for use in immobilization of the same type of lipase enzymes (including lipase from Rhizomucor miehei; see discussion above) that can be made with desired mass ratio of components (i.e. a styrene-divinylbenzene copolymer) that result in suitable particle size range, pore size distribution, as well as desired surface area of the particles (see teachings from Wilmar-Shanghai, as discussed above), it would have been obvious to an artisan of ordinary skill in the art to modify the carrier (i.e. the immobilization matrix/support) disclosed by Garcia-Galan et al (see detailed teachings of the same polystyrene-divinylbenzene based MCI GEL® CHP20P matrix disclosed by Garcia-Galan et al, as discussed above) in order to achieve desired resin particle or microsphere characteristics as currently recited in instant claims 18, 19, 21-24, 27, 28, 34 and 35, unless evidence and/or data provided on record to the contrary (which is currently lacking on record; see instant disclosure, Example 1 on page 10, for instance). In addition, the specific limitations of “pore volume” in the context of “oil uptake” (see instant claims 25-26) would also be deemed obvious and/or fully contemplated by an artisan of ordinary skill in the art because the disclosure from Wilmar-Shanghai provides the same particle size range, pore size distribution, and surface area of the polystyrene-DVB (PS-DVB) based carrier microspheres/particles that are found suitable for the same purposes of immobilizing Sn-1, 3-specific lipases (such as from Rhizomucor miehei, having amino acid sequence of SEQ ID NO: 1, as disclosed by both Garcia-Galan et al and Wilmar-Shanghai) in order to obtain enzymatically active preparations of immobilized enzyme particles as currently claimed (see instant claims 16, 29-33, for instance). Since, the method of making such resin microspheres having polystyrene-DVB resin has already been fully disclosed by Wilmar-Shanghai (see teachings above), the limitations of the amounts, mass ratio, and/or extent of components (i.e. polystyrene and DVB) present in the particle matrix used for making such carrier matrix (see instant claims 34-35) would have been obvious (as one of the result-effective variables) and/or fully contemplated by an artisan in the art of immobilization of lipase enzymes, as disclosed by the cited prior art references discussed above. Therefore, the invention as currently presented fails to distinguish itself over the combined teachings and/or suggestions from the cited prior art references of , as specifically discussed above.
It is to be noted that no unexpected result(s) and/or superior comparative data commensurate with the claimed scope has been presented on record by the applicants in order to assess the novelty and/or any criticality of the invention as generically claimed.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
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