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 .
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 Claims
Claims 1-15 are pending and under examination.
Claim Objections
Claim 14 is objected to because of the following informalities: Claim 14 recites “sulhydryl” is typographical error and must be corrected. Appropriate correction is required.
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 1-15 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.
In claim 1, the phrases “protein-type compound” and “enzyme-type compound” are unclear to the metes and bounds of the claimed invention. The claim is written to establish structural differences to a protein and enzyme. However, (1) the specification does not provide a specific definition for these phrases and (2) there is no example provided for these phrases. Meanwhile, claim 11 does recite that these phrases are selected from oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases which are only directed to enzymes. Therefore, it is unclear to what are the structures associated to these phrases and the structural differences between a protein vs. protein-type compound and enzyme vs. enzyme-type compound. Claims 2-15 are rejected as being dependent from claim 1.
Claim 9 recites that different building blocks interact with different functional constituents is unclear because claim 1 only recites a particular functional constituent. Therefore, are these different functional constituents from different proteins or enzymes or they are part of a different structure like the protective layer?
Claim 14 recites a crosslinker for crosslinking amine to thiol functions or crosslinker for crosslinking thiol to thiol functions do not provide structural limitation to the phrase crosslinker. Therefore, what are the structures associated to these crosslinkers for crosslinking amine to thiol functions or thiol to thiol functions? Does it contain amine or thiol?
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 7 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.
In dependent claim 7, the limitations of at least one functional constituent is selected from a protein and a protein-type compound fail to further limit claim 1 because the limitation has broaden the scope of the functional constituent being an enzyme or enzyme-type compound.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez-Lafuente et al. (“ Facile synthesis of artificial enzyme nano-environments via solid-phase chemistry of immobilized derivatives: Dramatic stabilization of penicillin acylase versus organic solvents,” Enzyme and Microbial Technology 24:96 –103, 1999, IDS submitted 07/12/2023 cite no. 3) in view of Naik et al. (US2005/0095690, published 05/05/2005, IDS submitted 07/12/2023 cite no. 1) and Shahgaldian et al. (WO2012/034946A1, published 03/22/2012, IDS submitted 07/12/2023 cite no. 4).
Fernandez-Lafuente discloses (page 97, scheme 1) a penicillin acylase (PGA) enzyme fully embedded in a protective layer and further shows the interaction of the enzyme with aldehyde-dextran, the claimed protective layer (the claimed “a protective layer for protecting the at least one functional constituent by completely embedding the at least one functional constituent in the protective layer, wherein the protective layer is built on the surface of the solid carrier and the at least one functional constituent immobilized on the surface of the solid carrier and completely embedded in the protective layer so as to provide a first interaction of a weak force with the at least one functional constituent and a second interaction of form-locking the at least one functional constituent in the protective layer, wherein the first interaction and the second interaction are capable of retaining the at least one functional constituent in a form-locked manner that prevents release from the solid carrier”). Fernandez-Lafuente discloses in Scheme 1 the functional constituent (enzyme) interacting with protective layer by an amine (the claimed “wherein the at least one functional constituent of the protective layer interacting with the protein or protein-type compound is an alcohol or an amine; see claim 10). Fernandez-Lafuente discloses the enzyme is tethered (the claimed “wherein the at least one functional constituent selected from the protein or the protein-type compound is an enzyme or enzyme-type compound and wherein the enzyme or enzyme-type compound is covalently bound to the surface of the solid carrier”).
Fernandez-Lafuente discloses the enzyme is attached to an aldehyde-dextran support (Scheme, caption). Fernandez-Lafuente discloses the enzyme can be covalently immobilized on solid supports (page 2, left column, top paragraph). See, Scheme 2 showing immobilization of the enzyme on a solid support. Fernandez-Lafuente discloses the protective layer (scheme 1) which fully embeds the enzyme (the claimed “functional constituent a protective layer for protecting the at least one functional constituent by completely embedding the at least one functional constituent in the protective layer, wherein the protective layer is built on the surface of the solid carrier”).
Fernandez-Lafuente discloses (abstract) the enzyme was firstly multipoint immobilized on a highly activated support (the claimed “solid support”) having an internal morphology composed by large hydrophilic surfaces. Fernandez-Lafuente discloses (abstract) after irreversible enzyme immobilization, a high molecular weight polyamine molecule was further immobilized on the same support surface. Fernandez-Lafuente discloses (abstract) in this way, all areas of the enzyme next to the support surface may become embedded in a hydrophilic environment (b); or the immobilized enzyme was modified with a high molecular weight poly-aldehydic polymer which also becomes a hydrophilic poly-hydroxyl macromolecule after borohydride reduction. Fernandez-Lafuente scheme 1 discloses the enzyme is tethered (the claimed “first and second interactions are capable of retaining the at least one functional constituent in a form-locked manner that prevents release). Because the enzyme retained catalytic activity (see pg. 98, right col., last para.), the enzyme was retained in the claimed “form-locked manner”. In scheme 1, Fernandez-Lafuente shows the enzymes is completely embedded in the aldehyde dextran protective layer (the claimed “wherein the protective layer completely embeds a catalytically active site of the enzyme such that the enzyme as immobilized and completely embedded in the protective layer retains is activity of its catalytically active site and its structural integrity”).
Fernandez-Lafuente differs from the claims in that the reference fails to disclose the organo silane monomers are building blocks wherein the organo silane monomers comprise trivalent silane monomers and tetravalent silane monomers.
Naik discloses entrapment of biomolecules and inorganic nanoparticles by biosilicification (title). Naik discloses [0009] the immobilized biomolecule can be an enzyme in a silica matrix [0020]. Naik discloses [0025] the silica matrix is formed from tetramethylorthosilicate ("TMOS"), tetraethyl-orthosilicate ("TEOS"). Naik discloses [0020] the silica matrix can include particles or nanosphere that have a diameter of ranging from approximately 400 to 600 nm. Naik discloses [0030] the biosilicification product produced by the immobilization reaction may have an increased stability compared to the stability of an immobilization molecule encapsulated by a conventional sol-gel process and the stability is improved because the biosilicification product is formed from a solid material. As such, the pores are stable and do not collapse when the biosilicification product is dried and the porous nature of the silica matrix maintains the activity of the molecule by allowing access and diffusion into the biosilicification product.
Shahgaldian discloses (see abstract) a method for preparation of a molecular recognition element and the method readily applicable for preparation of a molecular recognition element useful as diagnostic agent or catalyst. Shahgaldian discloses (see pg. 9, bottom of para. 2 and pg. 4, para. 2) the composition of the recognition material depends on the reaction mixtures such as structural building blocks TEOS and APTES. Shahgaldian discloses (see pg. 4, last para.) controlling the thickness of the growth of the polymerized recognition material.
It would have been obvious to a person of ordinary skill before the effective filing date of the claimed invention to have modified the Fernandez-Lafuente matrix with a silane matrix to form a layer as taught by Naik and Shahgaldian because Naik discloses that the biosilicification product is formed from a solid material and the pores are stable and do not collapse when the biosilicification product is dried and that the porous nature of the silica matrix maintains the activity of the molecule by allowing access and diffusion into the biosilicification product and Shahgaldian discloses that the silane matrix is controllable in thickness during polymerization.
The person would have been motivated to have formed a composition comprising an enzyme with a silica matrix as disclosed by Naik because Naik discloses a silica matrix preserves the activity of the immobilized molecule even when the product is exposed to room temperature for extended periods of time.
One of ordinary skill would have had a reasonable expectation of success in forming a composition comprising an enzyme in a silica matrix because it has been well understood by Naik that [0028] a silica matrix preserves the activity of the immobilized molecule even when the product is exposed to room temperature for extended periods of time.
With respect to claim 2, Fernandez-Lafuente does not disclose the solid carrier is a nanoparticle. Shahgaldian discloses (see pg. 10, para. 4) the template is nanoparticles. It would have been obvious to have used nanoparticles as a solid carrier because Shahgaldian discloses the invention can be used for different applications such diagnostic agent.
With respect to claim 3, Fernandez-Lafuente does not disclose the carrier is a particulate carrier with a particle size up to 100 µm. Naik discloses (see para. [0038]) the silica particles have an average diameter of 500 nm. Shahgaldian discloses (see pg. 16, para. 1) the silica nanoparticle is about 400 nm. It would have been obvious to have used nanoparticles as a solid carrier because Naik recognizes that silica particles are produced into nanoparticle sizes and Shahgaldian discloses the invention can be used for different applications such diagnostic agent.
With respect to claim 4, Fernandez-Lafuente does not disclose the thickness of the protective layer is in a range of 1-100 nm. Shahgaldian discloses (see pg. 4, last para.) the thickness is 1-200 nm. Although the references do not teach the claimed range, it would be prima facie obvious for the person to produce the claimed thickness as Shahgaldian’s thickness overlaps with the claimed invention.
With respect to claims 5-6, Fernandez-Lafuente does not disclose the claimed pore sizes or dimensions. Naik discloses (see para. [0038]) butyrylcholinesterase was immobilized in the pores of the silica matrix. Although these references do not disclose the claimed pore sizes, it has been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum ratio for a result-effective variable in incorporating an enzyme. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation" Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In particular, Naik discloses (see para. [0038]) butyrylcholinesterase was immobilized in the pores of the silica matrix. Thus, it would have been obvious to the person of ordinary skill to discover the optimum pore size to fit the enzyme.
With respect to claim 7, Fernandez-Lafuente does not disclose a bifunctional cross-linker. Shahgaldian discloses (see pg. 21, para. 2) the crosslinker is APTE, glutaraldehyde. Shahgaldian discloses (see pg. 7, para. 3) that cross-linkers containing reactive ends to specific functional groups such as amines or sulfhydryls which bind on one side to the surface of the carrier material. Therefore, it would have been obvious to have incorporated functional groups for covalent interactions.
With respect to claim 8, Fernandez-Lafuente discloses (Scheme 1) the first interaction between the monomer building blocks of the protective layer and the at least one functional constituent is affected between amino acid side chains of the protein or protein compound based on weak force interaction.
With respect to claim 9, Fernandez-Lafuente discloses (Scheme 1) wherein a plurality of different building blocks are provided so that different building blocks interact with different functional constituents or different amino acid side chains.
With respect to claim 10, Fernandez-Lafuente discloses (Scheme 1) the functional constituent of the protective layer interacting with the protein or protein compound is amine or alcohol.
With respect to claim 11, Fernandez-Lafuente discloses (Scheme 1) penicillin acylase (PGA) is a hydrolase.
With respect to claims 12-13, Fernandez-Lafuente does not disclose the solid carrier is, for example, an inorganic nanoparticle. Naik discloses (see para. [0038]) the silica particles have an average diameter of 500 nm. Shahgaldian discloses (see pg. 16, para. 1) the silica nanoparticle is about 400 nm. It would have been obvious to have used nanoparticles as a solid carrier because Naik recognizes that silica particles are produced into nanoparticle sizes and Shahgaldian discloses the invention can be used for different applications such diagnostic agent.
With respect to claims 14-15, Fernandez-Lafuente does not disclose the crosslinkers. Shahgaldian discloses (see pg. 8, lines 10-20) crosslinkers are available for cross-linking amine to sulfhydryl thiol is SPDP. Shahgaldian discloses (see pg. 7 bottom of last para.) crosslinkers are versatile and can be applied to any kind of carrier material, as long as it possesses the appropriate chemical functions. It would have been obvious to have used the crosslinkers of Shahgaldian because Shahgaldian discloses that crosslinkers are versatile and immobilize the enzyme.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678