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 .
2. Applicant’s response filed on 05/20/2026 is acknowledged.
3. In view of Applicant’s amendment, the Examiner has withdrawn the restriction requirement mailed on 11/20/2025 and will examine all of the pending claims in their current scope.
4. Claims 1-5, 8, 12-13, 15-19, 21-22, 24, 26, 28, 35 and 59 are pending and under consideration.
5. Applicant’s IDS documents filed on 01/11/2023 and 05/20/2026 have been considered.
6. 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.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1-3, 13, 15-16, 21-22, 35 and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2004/074479 (IDS filed on 01/11/2023).
WO 2004/074479 teaches a method for detecting the presence of an antibody against an
allergen in a subject (the method for diagnoses of an allergic response to a Derp1 polypeptide
comprising contacting a biological sample from the subject with a mimotope of Derp1 for an
antibody/peptide complex to form, detection of the complex indicates the presence of an allergic
response to a Derp1 polypeptide; page 27, lines 18-25), the method comprising: a contacting a
reaction sample comprising a display library (constructing an expression library for expressing a
polypeptide for binding to a target protein, expression library is an in vitro display library in
which expressed peptide is linked to the nucleic acid from which it was expressed; page 19, lines
19-25; page 95, lines 29-30; page 96, lines 1-2) with a biological sample comprising antibodies
(contacting a biological sample from the subject with a mimotope of Derp1 polypeptide for an
antibody/peptide complex to form; page 27, lines 18-25), wherein the display library (expression
library is an in vitro display library; page 95, lines 29-30; page 96, lines 1-2) comprises a
plurality of peptides derived from a plurality of allergens (peptides are derived from the libraries
and are selected on abilities to bind target proteins, including c-jun and antibodies raised against
dust mite allergens; abstract); and b detecting at least one antibody bound to at least one peptide
(contacting a sample from the subject with a mimotope of Derp1 for an antibody/peptide
complex to form and detecting the complex; page 27, lines 18-25) expressed by the display
library (expression library is an in vitro display library; page 95, lines 29-30; page 96, lines 1-2),
thereby detecting an antibody against the at least one peptide in the biological sample (detection
of the antibody/peptide complex indicates the presence of an allergic response to a Derp1
polypeptide in the biological sample from the subject; page 27, lines 18-25).
The reference teaches wherein the display library is a phage display library (the expression library is a phage display library; page 99, lines 29-30).
The reference teaches wherein the antibodies are immobilized to a solid support (an arrayed expression library is produced or bound to chip for analysis, in which the peptides are bound or immobilized to a solid support; page 107, lines 13-14) adapted for binding immunoglobulin E IgE subclass (contacting a sample from the subject with a mimotope of Derp1 polypeptide for an antibody/peptide complex to form, subject has IgE that binds to Derp1; page 27, lines 18-25; page 149, lines 5-10).
The reference teaches removing unbound antibody and peptides (by contacting a protein chip with a labeled sample and subsequent washing to remove any unbound proteins, the presence of a bound protein is detected; page 108, lines 10-15) of the display library (the expression library is a phage display library; page 99, lines 29-30).
The reference teaches wherein the plurality of peptides (peptides are derived from the libraries and are selected on abilities to bind target proteins, including c-jun and antibodies raised against dust mite allergens; abstract) are each less than 100 amino acids long (the nucleic acid fragments encode peptides having about 12-15 amino acids in length or at least about 30 amino acids in length; page 16, lines 5-10).
The reference teaches wherein the plurality of peptides (peptides are derived from the libraries and are selected on abilities to bind target proteins, including c-jun and antibodies raised against dust mite allergens; abstract) are each less than 75 amino acids long (the nucleic acid fragments encode peptides having about 12-15 amino acids in length or at least about 30 amino acids in length; page 16, lines 5-10).
The reference teaches wherein deoxyribonucleic acid DNA within a vector (the nucleic acid fragments or amplified DNA are inserted into a suitable vector for expression of each peptide; page 13, lines 5-10) of the display library (the expression library is a phage display library; page 99, lines 29-30) encoding each peptide of the plurality of peptides (the nucleic acid fragments or amplified DNA are inserted into a suitable vector for expression of each peptide; page 13, lines 5-10) comprises common adapter regions flanking the ends of the nucleic acid sequences (DNA from bacterial genomes could be identified in the recombinant phage, adapters were identified; page 184, lines 10-15) encoding the peptides (the nucleic acid fragments or amplified DNA are inserted into a suitable vector for expression of each peptide; page 13, lines 5-10).
The reference teaches wherein the display library (constructing an expression library for expressing a peptide, the amplified sequences are expressed using a bacterial display system; page 8, lines 5-10; page 14, lines 1-5) is a bacterial display library (constructing an expression library for expressing a peptide, the amplified sequences are expressed using a bacterial display system; page 8, lines 5-10; page 14, lines 1-5), a ribosome display library or an mRNA display library (constructing an expression library for expressing a peptide, preferred in vitro display formats include ribosome display or mRNA display; page 13, lines 10-15; page 14, lines 1-5).
The reference teaches wherein the detection step (detection of the antibody/peptide complex indicates the presence of an allergic response to a Derp1 polypeptide in the biological sample from the subject; page 27, lines 18-25) comprises amplifying DNA (the amino acid sequence of the peptide is then be determined by cloning, i.e., amplification, and sequencing; page 126, lines 20-25) within the display library (the expression library is a phage display library; page 99, lines 29-30) vector that encodes the displayed peptide (the vector is suitable for in vitro display of an expressed peptide, preferred in vitro display formats include ribosome display or mRNA display; page 13, lines 10-15).
The reference teaches the step of sequencing the amplified DNA (the amino acid sequence of the peptide is then be determined by cloning and sequencing; page 126, lines 20-25)
The reference teaches wherein the method is used to diagnose (a method for the diagnosing of a disease; page 27, lines 10-15) allergies of an individual from which the biological sample is obtained (detection of the antibody/peptide complex indicates the presence of an allergic response to a Derp1 polypeptide in the biological sample from the subject; page 27, lines 18-25).
The reference teaches wherein the method is used to identify an individual from which the biological sample is obtained as being allergic (the method diagnoses an allergic response to a Derp1 polypeptide in a subject using the biological sample from the subject, wherein detection of the complex indicates the presence of an allergic response to a Derp1 polypeptide, i.e., identifies the subject as being allergic; page 27, lines 18-25).
The reference teaches phage library displaying (the expression library is a phage display library; page 99, lines 29-30) a plurality of allergen peptides (peptides are derived from the libraries and are selected on abilities to bind target proteins, including c-jun and antibodies raised against dust mite allergens; abstract), wherein the plurality of allergen peptides represents a set of peptides from allergens (peptides are derived from the libraries and are selected on abilities to bind target proteins, including c-jun and antibodies raised against dust mite allergens; abstract) known to affect humans (to determine the in vivo modulating activity of the target protein in human; page 124, lines 25-30),
The reference teaches wherein the phage library is constructed (the expression library is a phage display library; page 99, lines 29-30) using a synthetic oligonucleotide DNA library (libraries are produced using short random oligonucleotides produced by synthetic combinatorial chemistry, and the DNA sequences are cloned into an appropriate vehicle for expression; page 7, lines 5-10).
The reference teachings anticipate the claimed invention.
9. 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.
10. Claims 1, 4-5, 8 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004/074479 (IDS filed on 01/11/2023) in view of WO 2013/009210 (IDS filed on 01/11/2023).
WO 2004/074479 has been discussed supra.
The claimed invention differs from the prior art in the recitation of wherein the antibodies are immobilized by contacting with anti-IgE antibodies of claim 4; wherein the anti-IgE antibodies are immobilized to a solid support of claim 5; wherein the antibodies are immobilized by contacting with anti-IgG antibodies of claim 8; wherein at least two antibodies are detected of claim 17; wherein the at least two antibodies are detected simultaneously of claim 18.
WO 2013/009210 teaches wherein the antibodies are immobilized by contacting with anti-IgE antibodies (a biological microchip comprising elements wherein allergens are immobilized and elements wherein anti-human IgE antibodies are immobilized for simultaneous quantitative determination of specific and total IgE; page 23, third paragraph). WO 2013/009210 teaches wherein the anti-IgE antibodies are immobilized to a solid support (biological microchip comprising elements wherein allergens are immobilized and elements wherein anti-human IgE antibodies are immobilized for simultaneous quantitative determination of specific and total IgE; page 23, third paragraph). WO 2013/009210 teaches wherein the antibodies are immobilized by contacting with anti-IgG antibodies (a biological microchip comprising elements wherein allergens are immobilized, elements wherein anti-human lgG antibodies are immobilized for simultaneous quantitative determination of specific and total IgG; page 24, third paragraph). WO 2013/009210 teaches wherein at least two antibodies are detected (the microchip allows simultaneous determination of the levels of total IgE and IgG in one sample, which is of substantial importance for diagnosing allergy; page 10, first paragraph). WO 2013/009210 teaches wherein the at least two antibodies are detected simultaneously (the microchip allows simultaneous determination of the levels of total IgE and IgG in one sample, which is of substantial importance for diagnosing allergy; page 10, first paragraph).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method of WO 2004/074479 wherein the antibodies are immobilized by contacting with anti-IgE antibodies, wherein the anti-IgE antibodies are immobilized to a solid support; wherein the antibodies are immobilized by contacting with anti-IgG antibodies; wherein at least two antibodies are detected and wherein the at least two antibodies are detected simultaneously. All of these modifications would provide additional information on the design of the microarray for peptide or antibody detection and analysis.
From the combined 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 art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
11. Claims 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004/074479 (IDS filed on 01/11/2023) in view of WO 2015/095355 (IDS filed on 01/11/2023).
WO 2004/074479 has been discussed supra.
The claimed invention differs from the prior art in the recitation of lysing the phage of claim 12.
WO 2015/095355 teaches lysing the phage (the detection of a peptide comprises a step of lysing the phage and amplifying the DNA; paragraph [00017]).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method of WO 2004/074479 as taught by WO 2015/095355 to providing additional information on the methodology of detection of the peptide.
From the combined 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 art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. Claims 1 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004/074479 (IDS filed on 01/11/2023) in view of WO 2010/043724 (IDS filed on 01/11/2023).
WO 2004/074479 has been discussed supra.
The claimed invention differs from the prior art in the recitation of “wherein the library comprises at least 10 allergenic peptides” of claim 19.
WO 2010/043724 teaches wherein the library comprises at least 10 allergenic peptides (protein or peptide is encoded by expression library for identifying allergenic proteins and peptides and comprising at least 10 proteins or peptides, as shown in figures 1 and 4a, milk components were incubated with the sera from milk allergic patients to detect bound IgE antibodies; abstract; paragraph [00093]; figures 1, 4a).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method WO 2004/074479 by making the library comprise at least 10 allergenic peptides, as previously disclosed by WO 2010/043724 for providing additional information on the library of allergenic peptides that is useful for diagnoses an allergic response to a polypeptide in a subject
From the combined 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 art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
13. Claims 1, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004/074479 (IDS filed on 01/11/2023) in view of WO 2017/007858 (IDS filed on 01/11/2023).
WO 2004/074479 has been discussed supra.
The claimed invention differs from the prior art in the recitation of “further comprising the step of performing microarray hybridization to detect the amplified sequence” of claim 24.
WO 2017/007858 teaches microarray hybridization (in microarray-based detection, nucleic acids in a sample may be labeled prior to being contacted with a microarray or after hybridization to the microarray and removal of unhybridized nucleic acid; paragraph [00149]).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method, WO 2004/074479, in order to have provided for microarray hybridization, as previously taught by WO 2017/007858 to adjust the methodology of analysis of clones and to improve the effectiveness of detection of the presence of an allergic response to a Derp1 polypeptide
From the combined 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 art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
14. Claims 1, 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004/074479 (IDS filed on 01/11/2023) in view of WO 2016/198609 (IDS filed on 01/11/2023).
WO 2004/074479 has been discussed supra.
The claimed invention differs from the prior art in the recitation of “wherein the detection step comprises amplifying a DNA proxy” of claim 26 and “further comprising the step of sequencing the amplified DNA proxy” of claim 28.
WO 2016/198609 teaches wherein the detection step comprises amplifying a DNA proxy (libraries comprise a DNA tag or barcode linked to a single small molecule or macrocycle, the integrity of DNA-oligonucleotide tags are analyzed by qPCR, i.e., amplification, using tag-specific qPCR probes, where specific barcode sequence is the DNA proxy; page 22, lines 10-15; page 39, lines 15-20). WO 2016/198609 teaches the step of sequencing the amplified DNA proxy (libraries comprise a DNA tag or barcode linked to a single small molecule or macrocycle, the associated oligonucleotide tags can be analyzed by by Next Generation deep sequencing, where specific barcode sequence is the DNA proxy; page 22, lines 10-15; page 62, lines 20-25).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method, as previously taught by WO 2004/074479, in order to have provided for wherein the detection step comprises amplifying a DNA proxy and comprising the step of sequencing the amplified DNA proxy y, as previously taught by WO 2016/198609 to adjust the methodology of analysis of clones (to improve the effectiveness of detection of the presence of an allergic response to a Derp I polypeptide.
From the combined 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 art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
15. No claim is allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
June 26, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights