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 .
Applicant previously cancels claims 1-25. Claims 26-50 are currently pending. Claims 39-50 are withdrawn as being drawn to a nonelected invention. Claims 26-38 are under examination.
Election/Restrictions
Applicant's election of Group I, claims 28-38, drawn to a library of prefabricated precursor microparticles and species election, in the reply filed on February 26, 2026 is acknowledged.
Applicant’s election of the following species: A regent binding molecule attached to said porous matrix (Claim 26), A library of prefabricated microparticles for performing specific detection of one or several analytes of interest in a sample (Claim 30); Hydrogel forming agent being naturally occurring polymers (Claim 30); Reagent binding molecule is streptavidin (Claim 30); Ionizable group are di/tri/oligo/poly amino acids (Claim 30); Binding entity is desthiobiotin (Claim 33); and Reagent binding molecule is streptavidin (claim 33), in the reply filed February 26, 2026 is acknowledged.
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Claims 39-50 are withdrawn from further consideration to 37 CFR 1.142(b) as being
drawn to a nonelected invention, there being no allowable generic or linking claim. Election was
made without traverse in the reply filed on February 26, 2026, and is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements filed November 17, 2022; and July 05, 2023 have been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1),
1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response – Applicant must:
Amend the Sequence Listing Incorporation by Reference paragraph at page 1 of the
specification. It is noted the Sequence Listing Incorporation by Reference paragraph lists the size of the ASCII text file as 3 kilobytes, whereas the ASCII text file itself lists the size as 2,269 bytes.
Specification
The use of the terms “FluoSurf”, “TaqMan” and “PicoSurf”(see Page 75, Lines 22, Page 76, Line 5, Page 81, Line 26, Page 82, Line 20), which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Each claim begins with a capital letter and end with a period. Periods may not be used elsewhere in the claims except for abbreviations. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated be a line indentation (see the requirements of 37 CFR 1.75 (i) for “full, clear, concise, and exact terms”. See MPEP 608.01(m).
Claims 26, 30 and 33-38 are objected to because the claims contain hyphens and/or periods elsewhere in the claim. In particular, hyphens are used in amendments to indicate the addition (double hyphens) and removal (strikethrough) of portions of text. Thus, hyphens inserted into the claims are confusing. Applicant is respectfully requested to remove the hyphens from the claims.
Claims 26-27, 31-32, 34-36 and 38 are objected to because of the following informalities:
In claim 26, lines 2-3, the terms “said prefabricated microparticles being configured for preforming specific detection”, should read “said prefabricated microparticles preform specific detection”.
In claim 26, line 9, the terms “said reagent binding component being one of” should read “said reagent binding component being at least one of:”
In claim 27, line 3, the terms “having its distinct label component attached to” should read “having a respective label component attached to”.
In claim 31, 1-6, the terms “The library of prefabricated precursor-microparticles according to claim 26; or a library of prefabricated microparticles for performing specific detection of one or several analytes of interest in a sample, such specific detection occurring within such microparticles by a suitable chemical or biochemical reaction, each of said prefabricated microparticles comprising a prefabricated precursor-microparticle according to claim 26, and further comprising”, should read “The library of prefabricated precursor-microparticles according to claim 26 further comprising”.
In claim 32, line 3, the terms “non-antibody proteins capable of specifically binding an analyte”, should read “non-antibody proteins that specifically bind to an analyte”
In claim 34, line 6, the terms “having its distinct label component attached to” should read “having a respective label component attached to”.
In claim 35, line 6, the terms “having its distinct label component attached to” should read “having a respective label component attached to”.
In claim 36, line 6, the terms “having its distinct label component attached to” should read “having a respective label component attached to”.
In claim 37, lines 10 and 41, the terms “said reagent binding component being one of” should read “said reagent binding component being at least one of:”
In claim 37, line 20, the terms “a combination of any of (i)—(iv)” should read “a combination of any of (vi)—(ix)”.
In claim 37, line 28, the terms “component by” should read “component by: ”.
In claim 38, lines 5-4 include the limitations “prefabricated precursor-microparticles according to claim 26”, therefore line 8 should be deleted.
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 26-38 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.
Claim 26 is consider vague and indefinite for the following reasons:
In claim 26, the term “suitable” in lines 3-4 is unclear and confusing. It is unclear as to what conditions are considered suitable?
In claim 26, in line 3, the term “several” is unclear and confusing. It is unclear as to how many analytes are considered to be several analytes? For the purposes of examination several is interpreted as being more than one.
Claims 27-29, 31-38 depend from claim 26 and therefore are included in this rejection.
Claim 28 is consider vague and indefinite for the following reasons:
In claim 28, the term “suitable” in line 3 is unclear and confusing. It is unclear as to what conditions are considered suitable?
In claim 28, in line 2, the term “several” is unclear and confusing. It is unclear as to how many analytes are considered to be several analytes? For the purposes of examination several is interpreted as being more than one.
Claims 29 and 32-37 depend from claim 28 and therefore are included in this rejection.
Claim 29 is consider vague and indefinite for the following reasons:
In claim 29, the term “suitable” in lines 9-10 is unclear and confusing. It is unclear as to what net charge is considered suitable and what conditions would make the net charge suitable?
Claim 30 is consider vague and indefinite for the following reasons:
In claim 30, the term “suitable” in line 4 is unclear and confusing. It is unclear as to what conditions are considered suitable?
Claim 30 recites the limitation "said precursor-microparticle" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "said polymer (i)" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "said reagent binding molecule (ii)" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "said at least one ionisable group (iii)" in line 22. There is insufficient antecedent basis for this limitation in the claim.
In claim 30, in line 3, the term “several” is unclear and confusing. It is unclear as to how many analytes are considered to be several analytes? For the purposes of examination several is interpreted as being more than one.
Claim 31 is consider vague and indefinite for the following reasons:
In claim 31, the term “suitable” in line 4 is unclear and confusing. It is unclear as to what conditions are considered suitable?
In claim 31, in line 3, the term “several” is unclear and confusing. It is unclear as to how many analytes are considered to be several analytes? For the purposes of examination several is interpreted as being more than one.
Claim 34 is consider vague and indefinite for the following reasons:
In claim 34, line 8, the terms “all of said at least two, three or more separate subsets” are unclear and confusing. It is unclear if the three or more are included in the at least two or more separate subsets or if all of the at least two subsets comprise three additional separate subsets?
In claim 34, in lines 2-3, the term “several” is unclear and confusing. It is unclear as to how many sample are considered to be several samples? For the purposes of examination several is interpreted as being more than one.
Claim 36 is consider vague and indefinite for the following reasons:
In claim 36, in lines 2-3, 10 and 24, the term “several” is unclear and confusing. It is unclear as to how many samples or subsets are considered to be several? For the purposes of examination several is interpreted as being more than one.
Claim 37 is consider vague and indefinite for the following reasons:
In claim 37, the term “suitable” in line 34 is unclear and confusing. It is unclear as to what net charge is considered suitable and what conditions would make the net charge suitable?
In claim 37, the terms “optionally further containers” in lines 3-4, are unclear and confusing. The claim requires a “further container” in line 26 therefore it is unclear as to how the further container may be optionally included?
Claim 38 is consider vague and indefinite for the following reasons:
In claim 38, the term “suitable” in lines 3-4 is unclear and confusing. It is unclear as to what conditions are considered suitable?
In claim 38, in line 2, the term “several” is unclear and confusing. It is unclear as to how many samples or subsets are considered to be several? For the purposes of examination several is interpreted as being more than one.
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 38 recites the broad recitation “the attachment”, and the claim also recites “preferably the reversible attachment” which is the narrower statement of the range/limitation. The claim is 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.
For the purposes of examination, claim 38 is interpreted as requiring a reversible attachment of said at least one analyte specific reagent to some or all of said prefabricated precursor-microparticles.
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 28 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 28 recites the limitations “A library of prefabricated microparticles for performing specific detection of one or several analytes of interest in a sample, such specific detection occurring within such microparticles by a suitable chemical or biochemical reaction, each of said prefabricated microparticles comprising a prefabricated precursor-microparticle according to claim 26 and further comprising an analyte-specific reagent attached to said precursor- microparticle”. Independent claim 26 requires the identical limitations of “A library of prefabricated precursor-microparticles for making a library of prefabricated microparticles, said prefabricated microparticles being configured for performing specific detection of one or several analytes of interest in a sample, such specific detection occurring within such microparticles by a suitable chemical or biochemical reaction, each of said prefabricated precursor-microparticles in said library comprising… a reagent binding component allowing the attachment of an analyte-specific reagent to the precursor-microparticle”. 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 § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 26-32 and 34-35 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Steinmetzer et al. (European Patent Application EP 3343223 A1, published July 04, 2018), cited on the IDS filed November 17, 2022.
Regarding claim 26, Steinmetzer teaches a library of prefabricated precursor-microparticles for making a library of prefabricated microparticles (Abstract). Steinmetzer teaches said prefabricated microparticles perform specific detection of one or several analytes of interest in a sample (Abstract and Page 2, [0001]). Steinmetzer teaches specific detection occurring within such microparticles by a suitable chemical or biochemical reaction (Page 2, [0003]). Steinmetzer teaches said prefabricated precursor-microparticles comprise a porous matrix having a void volume for receiving an aqueous sample as well as for providing a reaction space for the specific detection of an analyte (Page 2, [0003] and Fig. 1). Steinmetzer teaches a reagent binding component allowing the attachment of an analyte-specific reagent to the precursor-microparticle and said reagent binding component is a reagent binding molecule attached to said porous matrix (Page 2, [0007]-[0009], Page 9, [0037], Page 10, [0043] and Figs. 1-3). Steinmetzer teaches a label component attached to, contained within or otherwise associated with said precursor-microparticle for identifying said analyte-specific reagent, when attached to the precursor-microparticle (Abstract and Page 2, [0001]).
Regarding claim 27, Steinmetzer teaches there are at least two separate subsets of prefabricated precursor-microparticles, with each subset having a respective label component attached to, contained within or otherwise associated with said precursor-microparticles within said subset, such that said at least two or more separate subsets of prefabricated precursor-microparticles differ by the respective label component attached to, contained within or otherwise associated with each subset (Page 3, [0018]).
Regarding claim 28, Steinmetzer teaches a library of prefabricated microparticles for performing specific detection of one or several analytes of interest in a sample (Abstract and Page 2, [0001]). Steinmetzer teaches specific detection occurring within such microparticles by a suitable chemical or biochemical reaction (Page 2, [0003]). Steinmetzer teaches each of said prefabricated microparticles comprising a prefabricated precursor-microparticle according to claim 26 and further comprising an analyte-specific reagent attached to said precursor- microparticle (see instant claim 26 above, Page 2, [0007]-[0009], Page 9, [0037], Page 10, [0043] and Figs. 1-3).
Regarding claim 29, Steinmetzer teaches said analyte-specific reagent that is attached to each of said precursor-microparticles, is attached through said reagent binding component by direct binding of said analyte-specific reagent to said polymer or polymer mixture that forms said porous matrix or is part of said porous matrix (i) (Page 2, [0007]-[0009], Page 3, [0013]-[0014], Page 5, [0029], Page 7, [0035], Page 9, [0037], Page 10, [0043] and Figs. 1-3).
Regarding claim 30 Steinmetzer teaches a library (collection) of prefabricated microparticles for performing specific detection of one or several analytes of interest in a sample (Abstract). Steinmetzer teaches specific detection occurring within such microparticles by a suitable chemical or biochemical reaction and further comprising an analyte-specific reagent attached to said precursor-microparticle (Abstract, Page 2, [0001]-[0003] and [0007]-[0009], Page 3, [0012]-[0014], Page 9, [0037], Page 10, [0043] and Figs. 1-3). Steinmetzer teaches a polymer is a hydrogel-forming agent of naturally occurring polymers (Page 3, [0014]). Steinmetzer teaches a reagent binding molecule is streptavidin (Page 3, [0015], Page 10, [0043] and Figs. 2-3). Steinmetzer teaches at least one ionisable group is a di/tri/oligo/poly amino acid (Page 3, [0012]-[0014]).
Regarding claim 31, Steinmetzer teaches an analyte-specific reagent attached to said precursor- microparticle (Page 2, [0007]-[0009], Page 9, [0037], Page 10, [0043] and Figs. 1-3).; Steinmetzer teaches a porous matrix, or said polymer or polymer mixture that forms or is part of said porous matrix, is composed of a polymer that is not crosslinked (Page 2, [0007]-[0009], Page 3, [0012]-[0014], Page 9, [0037], Page 10, [0043] and Figs. 1-3), Steinmetzer teaches said polymer or polymer mixture that forms or is part of said porous polymeric matrix, is composed of agarose or a combination of agarose and gelatin (Page 3, [0012]-[0014]).
Regarding claim 32, Steinmetzer teaches said analyte-specific reagent is selected from nucleic acids, antibodies or antibody fragments and non-antibody proteins that specifically binds to an analyte or analyte complex (Page 3, [0015]).
Regarding claim 34, Steinmetzer teaches library is for performing a specific detection of a single analyte of interest in several samples (Abstract, Page 4, [0023] and Page 6, [0032]-[0033]). Steinmetzer teaches there are at least two separate subsets of prefabricated microparticles, with each subset having a distinct label component attached to, contained within or otherwise associated with said microparticles of said subset (Pages 6-7, [0030]-[0034] and Fig. 4). Steinmetzer teaches all of said at least two or more separate subsets having the same analyte-specific reagent attached to the porous matrix of said microparticles of said subsets and said analyte-specific reagent being specific for one analyte of interest (Page 4, [0027], Pages 6-7, [0030]-[0034], Page 29, [0029] and Figs. 1-4). Steinmetzer teaches said at least two or more separate subsets of prefabricated microparticles are identical in terms of the analyte-specific reagent attached, but differ by the respective label component attached to, contained within or otherwise associated with said microparticles of each subset and each subset being unambiguously defined and identifiable by said respective label component (Page 4, [0027], Pages 6-7, [0030]-[0034], Page 29, [0029] and Figs. 1-4).
Regarding claim 35, Steinmetzer teaches said library is for performing a specific detection of multiple analytes of interest in a single sample (Abstract and Page 6, [0033]). Steinmetzer teaches at least two separate subsets of prefabricated microparticles, with each subset having a distinct label component attached to, contained within or otherwise associated with said microparticles of said subset (Pages 6-7, [0030]-[0034] and Fig. 4). Steinmetzer teaches having a different analyte-specific reagent attached to the porous matrix of said microparticles of said subset and each analyte-specific reagent being specific for one analyte of interest (Page 4, [0027], Pages 6-7, [0030]-[0034], Page 29, [0029] and Figs. 1-4). Steinmetzer teaches said at least two or more separate subsets of prefabricated microparticles differ by the respective label component attached to, contained within or otherwise associated with said microparticles of each subset and the respective analyte-specific reagent attached to each subset, with each subset being unambiguously defined and identifiable by said respective label component and said respective analyte-specific reagent (Page 4, [0027], Pages 6-7, [0030]-[0034], Page 29, [0029] and Figs. 1-4).
Steinmetzer teaches each and every claim limitation of claims 26-32 and 34-35 and therefore Steinmetzer anticipates claims 26-32 and 34-35.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 33 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Steinmetzer et al. (European Patent Application EP 3343223 A1, published July 04, 2018), cited on the IDS filed November 17, 2022, as applied to claims 26-32 and 34-35 above, in view of Hafeman et al. (U.S. Patent Application Publication US 2006/0211055 A1, published September 21, 2006).
Regarding claim 33, Steinmetzer teaches for each said microparticles, said analyte-specific reagent is attached to said microparticle through said reagent binding component by b) said analyte-specific reagent being conjugated to a binding entity (biotin) which, in turn, binds to said reagent binding molecule (streptavidin) (Page 2, [0007]-[0009], Page 9, [0037], Page 10, [0043] and [0045] and Figs. 1-3). Steinmetzer teaches wherein said reagent binding molecule is streptavidin.
Regarding claim 38, Steinmetzer teaches a method of making a library of prefabricated microparticles for performing specific detection of one or several analytes of interest in a sample (Abstract and Page 2, [0001]). Steinmetzer teaches specific detection occurring within such microparticles by a suitable chemical or biochemical reaction (Page 2, [0003]). Steinmetzer teaches each of said prefabricated microparticles comprising a prefabricated precursor- microparticle according to claim 26 and further comprising an analyte-specific reagent attached to said precursor-microparticle (see claim 26 above). Steinmetzer teaches at least one analyte-specific reagent (Abstract and Page 1, [0001]-[0009]). Steinmetzer teaches mixing said library of prefabricated precursor-microparticles, and the at least one analyte-specific reagent under conditions allowing the attachment, of said at least one analyte-specific reagent to some or all of said prefabricated precursor-microparticles, thus generating a library of prefabricated microparticles (Abstract, Page 1, [0001]-[0009], Page 3, [0015]-[0019] and Figs. 1-4). Steinmetzer teaches washing said prefabricated microparticles to remove any unattached analyte-specific reagent therefrom (Fig. 2).
Steinmetzer does not teach or suggest the reversible attachment of said at least one analyte-specific reagent to some or all of said prefabricated precursor-microparticles or said analyte-specific reagent is reversibly attached to said microparticle through said reagent binding component. Steinmetzer does not teach or suggest the binding entity specifically being desthiobotin.
Hafeman teaches analytic detection of biomolecules (analyte specific reagent) in a chemical library using labeled complexes (Abstract, Page 1, [0002] and Page 2, [0010]). Hafeman teaches using microparticles with a porous matrix (Page 8, [0052]-[0053]). Hafeman teaches ionizable groups capable of changing its charge (Page 4, [0029] and Pages 6, [0040]). Hafeman teaches reversible attachment of said at least one analyte-specific reagent to some or all of said prefabricated precursor-microparticles and said analyte-specific reagent is reversibly attached to said microparticle through said reagent binding component (Pages 6-7, [0040]-[0044]). Hafeman teaches the binding entity specifically being desthiobiotin and the reagent binding molecule is streptavidin (Pages 6-7, [0040]-[0044]). Hafeman teaches using the complex labeling methods allows for improved specificity and sensitivity of detecting the analyte of interest, as well as allows for multiplexing the sample (Page 7, [0043] and Pages 4-5, [0029]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Steinmetzer with the teaching of Hafeman, using analyte-specific reagent that is reversibly attached to a microparticle through said reagent binding component and a binding entity being specifically desthiobiotin bound. Using these labeling methods allows for improved specificity and sensitivity of detecting the analyte of interest, as well as allows for multiplexing the sample (Page 7, [0043] and Page 4-5, [0029]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Steinmetzer et al. (European Patent Application EP 3343223 A1, published July 04, 2018), cited on the IDS filed November 17, 2022, as applied to claims 26-32 and 34-35 above, in view of Griffiths et al. (U.S. Patent Application Publication US 2018/0361346 A1, published December 20, 2018).
Regarding claim 36, Steinmetzer teaches said library (collection) is for performing a specific detection of multiple analytes of interest in several samples (Abstract, Page 4, [0023] and Page 6, [0032]-[0033]). Steinmetzer teaches in said library, there are a plurality of different separate subsets of prefabricated microparticles, with each subset having its distinct label component attached to, contained within or otherwise associated with said microparticles of said subset (Pages 6-7, [0030]-[0034] and Fig. 4). ). Steinmetzer teaches having a different analyte-specific reagent attached to the porous matrix of said microparticles of said subset and each analyte-specific reagent being specific for one analyte of interest (Page 4, [0027], Pages 6-7, [0030]-[0034], Page 29, [0029] and Figs. 1-4). Steinmetzer teaches each analyte-specific reagent being specific for one analyte of interest, such that, in said library, said plurality of different separate subsets of prefabricated microparticles differ by the respective label component attached to, contained within or otherwise associated with said microparticles of each subset (Page 4, [0027], Pages 6-7, [0030]-[0034], Page 29, [0029] and Figs. 1-4). Steinmetzer teaches each subset being unambiguously defined and identifiable by said respective label component and said respective analyte-specific reagent (Page 4, [0027], Pages 6-7, [0030]-[0034], Page 29, [0029] and Figs. 1-4).
Steinmetzer does not teach or suggest there are different classes of separate subsets of prefabricated microparticles, with each of said classes comprising several subsets of microparticles and each class having a different analyte-specific reagent attached to the porous matrix of said microparticles. Steinmetzer does not teach or suggest all subsets of microparticles within one class having the same analyte-specific reagent attached and each separate subset of microparticles forms part of one class of subsets of microparticles as well as said different classes of subsets of microparticles differ by the respective analyte-specific reagent attached, and each of said different classes comprises several subsets of microparticles, all of which subsets within one class having the same analyte-specific reagent attached.
Griffiths teaches methods of synthesizing and identification of molecules in combinatorial libraries using labeled microparticles (Title, Abstract and Figs. 2-4). Griffiths teaches using affinity binding pairs such as biotin and streptavidin (Page , [0117]). Griffiths teaches having a different analyte-specific reagent attached to said microparticles of said subset and each analyte-specific reagent being specific for one analyte of interest (Figs. 2-4). Griffiths teaches there are different classes of separate subsets of prefabricated microparticles, with each of said classes comprising several subsets of microparticles and each class having a different analyte-specific reagent attached to said microparticle (Figs. 2-4). Griffiths teaches all subsets of microparticles within one class having the same analyte-specific reagent attached and each separate subset of microparticles forms part of one class of subsets of microparticles (Figs. 2-4). Griffiths teaches said different classes of subsets of microparticles differ by the respective analyte-specific reagent attached, and each of said different classes comprises several subsets of microparticles, all of which subsets within one class having the same analyte-specific reagent attached (Figs. 2-4). Griffiths teaches using these methods allows for increased sensitivity as well as for the selection of regulation of complicated multi-step chemical transformations and pathways (Page 12, [0152]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Steinmetzer with the teachings of Griffiths using different classes of separate subsets of prefabricated microparticles, with each of said classes comprising several subsets of microparticles and each class having a different analyte-specific reagent attached to said microparticle as well as all subsets of microparticles within one class having the same analyte-specific reagent attached and each separate subset of microparticles forms part of one class of subsets of microparticles. Using these methods allows for increased sensitivity as well as for the selection of regulation of complicated multi-step chemical transformations and pathways as taught by Griffiths (Page 12, [0152]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Steinmetzer et al. (European Patent Application EP 3343223 A1, published July 04, 2018), cited on the IDS filed November 17, 2022, as applied to claims 26-32 and 34-35 above, in view of Ahern (“Biochemical, Reagents Kits Offer Scientists Good Return On Investment” The Scientist, Vol. 9, Issue 15, published July 24, 1995).
Regarding claim 37, Steinmetzer teaches making a library of prefabricated microparticles comprising at least two containers, namely a first and a second container, and, optionally, further containers (Page 10, [0047]-[0048] and Fig. 2). Steinmetzer teaches a subset of prefabricated precursor-microparticles comprising a porous matrix having a void volume for receiving an aqueous sample and for providing a reaction space for the specific detection of an analyte and a reagent binding component allowing the attachment of an analyte-specific reagent to the precursor-microparticle (Abstract, Page 2, [0001]-[0003] and Fig. 1). Steinmetzer teaches a reagent binding component allowing the attachment of an analyte-specific reagent to the precursor-microparticle and said reagent binding component is a reagent binding molecule attached to said porous matrix (Page 2, [0007]-[0009], Page 9, [0037], Page 10, [0043] and Figs. 1-3). Steinmetzer teaches each subset having its distinct label component attached to, contained within or otherwise associated with said precursor-microparticles within said subset, such that said two subsets of prefabricated precursor-microparticles differ by the respective label component attached to, contained within or otherwise associated with each subset (Abstract, Page 2, [0001], Page 4, [0027], Pages 6-7, [0030]-[0034], Page 29, [0029] and Figs. 1-4). Steinmetzer teaches a further container (Fig. 2). Steinmetzer teaches a conditioning solution (Page 9, [0042]-[0045] and Page 12, [0057]-[0058]). Steinmetzer teaches said analyte-specific reagent that is attached to each of said precursor-microparticles, is attached through said reagent binding component by direct binding of said analyte-specific reagent to said polymer or polymer mixture that forms said porous matrix or is part of said porous matrix (i) (Page 2, [0007]-[0009], Page 3, [0013]-[0014], Page 5, [0029], Page 7, [0035], Page 9, [0037], Page 10, [0043] and Figs. 1-3). Steinmetzer teaches said reagent binding component is a reagent binding molecule attached to said porous matrix (Page 2, [0007]-[0009], Page 9, [0037], Page 10, [0043] and Figs. 1-3).
Although Steinmetzer teaches all of the components of a kit, Steinmetzer does not teach or suggest explicitly a kit including the library of prefabricated microparticles.
Ahern teaches investigators can purchase a kit that supplies all of the necessary reagents for a particular research application and even provides them with detailed instructions to follow (Page 5, Paragraph 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the library of microparticles as taught by Steinmetzer, within a kit, as taught by Ahern, because a kit is merely a collection of parts. Ahern teaches Rather than buying individual chemicals, investigators can instead purchase a kit that supplies all of the necessary reagents for a particular research application and even provides them with detailed instructions to follow. Buying premade reagents and kits allows researchers to save time and is an added convenience as taught by Ahern (Page 5, Paragraph 3).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 26-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-25 of copending Application No. 17/786,033 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because while the preambles are different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to perform a method of making a library of prefabricated microparticles that performs specific detection of one or several analytes of interest in sample and perform a method of detecting and/or quantifying an analyte of interest in a plurality of biological liquid samples, using those same steps.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 26-38 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 22, 26, 29-37 and 40, of U.S. Patent No. 11,073,518. Although the claims at issue are not identical, they are not patentably distinct from each other because while the preambles are slightly different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method of making a library of prefabricated microparticles that performs specific detection of one or several analytes of interest in sample and preforming a method of detection of an analyte in a sample, using those same steps. Therefore, the claims are not
deemed to be patentably distinct.
Claims 26-38 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1, 4, 7, 8-14, 16-17 and 20, of U.S. Patent No. 12,007,390. Although the claims at issue are not identical, they are not patentably distinct from each other because while the preambles are slightly different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method of making a library of prefabricated microparticles that performs specific detection of one or several analytes of interest in sample and preforming a method of detection of an analyte in a sample, using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Conclusion
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/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684