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 .
Restriction/Election of Species
In their Response filed on 03 December 2025, Applicant elected Group 1 without traverse.
In their Response filed on 03 December 2025, Applicant elected, without traverse, SEQ ID NO: 248 for Claim 9, SEQ ID NO: 2 for Claim 17, SEQ ID NO: 10 for Claim 18, SEQ ID NO: 4 for Claim 19, and SEQ ID NO: 37 for Claim 25.
Claims 1-7, 9, 11, 13-15, 17-19, 22-23, 25, 27-29, and 65 are currently pending, with Claims 29 and 65 withdrawn from consideration as being drawn to non-elected inventions per Applicant’s Response to the Restriction/Species Election requirement filed on 03 December 2025.
Additionally, Claims 5, 7, and 22-23 are also withdrawn from consideration because, even though they are part of the elected Group, they do not read on the elected species. Claim 5 is being withdrawn because it recites the limitation “The system of claim 3, wherein the viral peptide is a SARS-CoV-2 (COVID-19) peptide, an antigenic fragment thereof, or a combination thereof”. SEQ ID NO: 248, which is the elected Coronavirus peptide sequence , corresponds to the SARS-CoV-1 Spike protein (see Table 2 of the instant Specification). Claim 7 is being withdrawn because it recites the limitation “The system of claim 1, wherein the N protein is NSARS-2,NSARS, NMERS, NOC43, NHKU1, NNL63, N229E, antigenic fragments thereof, or a combination thereof”. Again, SEQ ID NO: 248, which is the elected Coronavirus peptide sequence , corresponds to the SARS-CoV-1 Spike protein (see Table 2 of the instant Specification). Claims 22 and 23 are being withdrawn because they recite the limitations “The system of claim 1, wherein the viral peptide is a structural protein from the Yellow Fever virus, optionally Capsid, pM, E, or a combination thereof” and “The system of claim 1, wherein the viral peptide is a non-structural protein from the Yellow Fever virus, optionally NS1, NS2a, NS2b, NS3, NS4a, NS4b,NS5, or a combination thereof”, respectively. SEQ ID NO: 37, which is the elected Flavivirus peptide sequence, corresponds to a structural protein, namely the E protein, from Zika virus (see Table 2 of the instant Specification).
Accordingly, Claims 1-4, 6, 9, 11, 13-15, 17-19, 25, and 27-28 will be examined on their merits.
Response to Amendment
Applicant’s Amendment filed on 03 December 2025 has been received and entered. Claims 1-7, 9, 11, 13-15, 17-19, 22-23, 25, 27-29, and 65 were pending. No claims have been amended. Claims 8, 10, 12, 16, 20-21, 24, 26, 30-64, and 66-73 have been cancelled. No new claims have been added.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2024/0302369 A1, Published 12 September 2024. Applicant’s amended Specifications as presented on 23 June 2023, 16 June 2023, and 20 January 2023 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statement filed 06 February 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because all of the references cited were previously cited on the IDS filed on 20 January 2023. As such, these references will not be considered again. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statements (IDSes) submitted on 20 January 2023, 06 February 2023, 16 August 2023, and 06 August 2024 have been considered by the examiner. Any individual references with strikethroughs, however, have not 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/PatentLegalFramework), 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 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above. An updated incorporation by reference statement was not included when the most recent Sequence Listing was submitted on 23 June 2023.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The use of the terms Alexa Fluor, Cy, as in Cy3 and Cy5, Oregon Green, Pacific Blue, Pacific Green, Pacific Orange, PE-Cyanine7 (PE-Cy7), PerCP-Cyanine5.5 (PerCP-Cy5.5), Texas Red, eFluor, Super Bright, Qdot, and PALL Vivid, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
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
Claims 1, 3, 6, 9, 11, 13-15, 18, 25, and 28 are objected to because of the following informalities: in Claim 1, it is suggested that it recite “A system for detecting the presence of a virus in a sample comprising: a platform comprising a buffer chamber in fluid communication with a sample receiver, wherein the sample receiver comprises wherein the secondary agent depot comprises wherein the reaction chamber comprises
In Claim 3, “hemagglutinin” is spelled incorrectly. The claim currently recites “hemmaglutinin”.
In Claim 3, it is suggested that it say “wherein the viral peptide is a coronavirus peptide from the hemagglutinin esterase (HEprotein, membrane protein (M), envelope small membrane protein (E), nucleocapsid (N), or spike protein (S), or a combination thereof.
In Claim 6, it is suggested that it say “wherein the S protein is from SSARS-2…”.
In Claim 9, it should say “antigenic fragments thereof” instead of “antigenic fragments”. Also, it is suggested that it say “coronavirus peptide” instead of “coronavirus viral peptide”. The inclusion of the word “viral” in this phrase is redundant.
In Claims 11 and 13, the phrases “or a combination thereof” and “an antigenic fragment thereof” do not need to be italicized.
In Claim 13, it should say “(Marburg virus), an antigenic fragment thereof,…”. There is a comma missing after “virus)”.
In Claims 14-15, it is suggested that they say “wherein the Filoviral peptide is from the…”.
In Claim 14, it is suggested that it say “…matrix protein (VP40)…”.
In Claim 18, it is suggested that it say “an NP sequence” instead of “a NP sequence”.
In Claim 25, “epitopes” is spelled incorrectly. The claim currently recites “eptiopes”.
Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the definitions of the abbreviations SSARS-2, SSARS, SMERS, SOC43, SHKU1, SNL63, and S229E are not provided. For clarity, it is requested that the first recitation of an abbreviation within a claim set be preceded by its full-length name.
Appropriate correction is required.
Claims are only allowed to have one period, as stated in MPEP § 608.01(m). The claim which does not adhere to this rule is Claim 28. Regarding Claim 28, there is a period after “H5N1”. It should be replaced with a comma.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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, 3-4, 6, 9, 13-15, 17-19, 25, and 27-28, and dependent claims 2 and 11 thereof, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, it recites the limitation “A system for detecting the presence of a virus in a sample comprising a platform comprising a buffer chamber in fluid communication with a sample receiver, the sample receiver comprising a sample chamber and a membrane and is in fluid communication with a secondary agent depot, the secondary agent depot comprising a secondary agent and is in fluid communication with a reaction chamber, the reaction chamber comprising an array comprising at least one viral peptide and an optical window and is in fluid communication with a waste chamber”. It is unclear how a “viral peptide” can be used to detect the presence of a virus in a sample, especially if said viral peptide is from the virus in question that is being detected, as the dependent claims 3-4, 6, 9, 13-15, 17-19, 25, and 27-28 recite peptides from specific viruses. Claim 1 does not make sense as it is currently written. It is believed that the claim should recite an “anti-viral peptide” or some other molecule which is capable of binding to a virus, such as an antibody specific for said virus. If a viral peptide is being used to bind to a molecule in the sample being tested, it makes more sense that the molecule being detected would be an antibody that is specific for the viral peptide in question. As such, it is unclear exactly what Applicant is attempting to claim. This lack of clarity renders the claim indefinite. It is suggested that Claim 1 be amended to recite an “anti-viral peptide”, as long as said amendment does not introduce new matter, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 1, 3-4, 6, 9, 13-15, 17-19, 25, and 27-28 are rejected on the grounds of being indefinite. Claims 2 and 11 are also rejected, since they depend upon Claim 1 but do not remedy the deficiencies of Claim 1.
Claims 2-4, 6, 9, 11, 13-15, 17-19, 25, and 27-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 2-4, 6, 9, 11, 13-15, 17-19, 25, and 27-28, they all recite lists of different elements or embodiments, such as types of viruses, peptides, peptide sources, or sequence identifiers. These lists, however, do not contain any connecting words between the penultimate elements and the last elements in each list, making it unclear if these elements are being claimed in the alternative (i.e., “or”), altogether (i.e., “and”), or some combination thereof (i.e., “and/or”). As currently written, it could be interpreted that Applicant is claiming respective embodiments comprising all of the elements recited. For example, in Claim 25, it appears that Applicant is claiming a single peptide which comprises a fusion sequence comprising all of the recited sequences because there is no connecting word between SEQ ID NOs: 241 and 244. Presumably this is not Applicant’s intention, but the lack of clarity renders these claims indefinite. It is suggested that the claims be amended so that connecting words are present which reflect Applicant’s intention, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 2-4, 6, 9, 11, 13-15, 17-19, 25, and 27-28 are rejected on the grounds of being indefinite.
Claims 2 and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 2 and 4, it is unclear if the recited element within parentheses (See e.g. "(COVID-19)") is a required element of the claim. Additionally, the use of “COVID-19” does not make sense as “SARS-CoV-2” is the virus while “COVID-19” is the disease caused by the virus. It is suggested that the Applicant amend the claims to not recite “COVID-19”.
Similarly, Claim 2 recites the limitation “wherein the virus is a coronavirus, preferably SARS- CoV-1, MERS-CoV, SARS-CoV-2 (COVID-19), HCoV-OC43, HCoV-HKU1, HCoV- NL63, HCoV-229E or a combination thereof”. The term “preferably” renders the claim indefinite because it is unclear if the recited elements after “preferably” are required elements of the claim or are merely exemplary. It is suggested that the term be deleted, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 2 and 4 are rejected on the grounds of being indefinite.
Claims 6 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 6 recites the limitation "the S protein" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, upon which Claim 6 depends, does not introduce the limitation of an S protein. As such, it is unclear what S protein Claim 6 is referencing, which renders the claim indefinite. It is suggested that Claim 6 be amended to depend upon Claim 3, which would provide proper antecedence, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 6 is rejected on the grounds of being indefinite.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 9, it recites the limitation “wherein the coronavirus viral peptide comprises a sequence selected from the group consisting of an amino acid sequence with at least about 90% sequence homology to the amino acid sequences of 248, 250, 252, 254,256, 258, 260, 262, 264, 266, 268, 270, 272, 274, antigenic fragments, epitopes contained therein, or combinations thereof”. There is no sequence identifier designation. The claim should recite “SEQ ID NOs: 248, 250, 252, 254,256, 258, 260, 262, 264, 266, 268, 270, 272, 274”. Without this designation, it is unclear what the numbers are referring to. This lack of clarity renders the claim indefinite. It is suggested that “SEQ ID NOs:” be added to the claim prior to the recitation of the numbers, but Applicant is free to amend the claim as they deem necessary.
Claim 9 also recites the limitation "the coronavirus viral peptide" in Line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, upon which Claim 9 depends, does not introduce the limitation of a coronavirus viral peptide, only a generic viral peptide. As such, it is unclear what coronavirus viral peptide Claim 9 is referencing, which renders the claim indefinite. It is suggested that Claim 9 be amended to depend upon Claim 3, which would provide proper antecedence, but Applicant is free to amend the claim as they deem necessary.
Furthermore, Claim 9 recites the viral peptide in the singular, such as “the coronavirus viral peptide”, “a sequence”, and “an amino acid sequence”. The claim also then uses language which implies that multiple peptides are being used, namely “the amino acid sequences” and “antigenic fragments thereof”. These latter limitations refer to multiple peptides being present and thus conflicts with the apparent recitation of a single peptide earlier in the claim. As such, it is unclear if Applicant is claiming a single peptide or multiple. This lack of clarity renders the claim indefinite. It is suggested that the claim be amended
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 9 is rejected on the grounds of being indefinite.
Claims 13-15 and 17-19 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 13 recites the limitation “the Ebola virus peptide” in Line 1. Claims 14-15 recite the limitation “the Filoviral peptide” in Line 1 of each respective claim. There is insufficient antecedent basis for these limitations in these claims. Claim 11, upon which Claims 13-15 depend, does not introduce the limitation of an Ebola virus peptide or a Filoviral peptide. Claim 11 introduces that the virus can be a filovirus. Claim 1 also does not introduce limitation of an Ebola virus peptide or a Filoviral peptide. As such, it is unclear what Ebola virus peptide or Filoviral peptide is being referenced by Claims 13 and 14-15, respectively, which renders the claims indefinite. It is suggested that the claims be amended to properly introduce the respective limitations, but Applicant is free to amend the claims as they deem necessary.
Claims 17-19 recite the limitation “the Filoviral peptide” in Line 1 of each respective claim. There is insufficient antecedent basis for these limitations in these claims. Claim 11, upon which Claims 17-19 depend, does not introduce the limitation of a Filoviral peptide. Claim 1 also does not introduce limitation of a Filoviral peptide. As such, it is unclear what Filoviral peptide is being reference by Claims 17-19, which renders the claims indefinite. It is suggested that the claims be amended to properly introduce these limitations, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 13-15 and 17-19 are rejected on the grounds of being indefinite.
Claims 18-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 18-19, they recite the limitations “The system of claim 11, wherein the Filoviral peptide comprises a NP sequence selected from the group consisting of an amino acid sequence with at least about 90% sequence homology to the amino acid sequences of SEQ ID NOs: 4, 10, 16, 22,28, 34, an antigenic fragment thereof, an epitope therein, or a combination thereof” and “The system of claim 11, wherein the Filoviral peptide comprises a VP sequence selected from the group consisting of the amino acid sequences of SEQ ID NOs: 4, 10, 16, 22, 28, 34, an antigenic fragment thereof, an epitope therein, or a combination thereof”, respectively. The sequences recited all correspond to the NP of a Filovirus, not the VP, as recited in Claim 19. As such, it appears that part of Claim 18 was inadvertently duplicated in Claim 19. It would make more sense for Claim 19 to recite “NP” based on the sequences listed, but this would essentially make it the same as Claim 18. Thus, it is unclear which claim is supposed to be drawn to which viral protein. This lack of clarity renders the claims indefinite. It is suggested that the claims be amended by making sure they correspond to the desired viral protein and recite the appropriate viral peptide sequences or to delete Claim 19 which appears to be a partial duplicate of Claim 18, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 18-19 are rejected on the grounds of being indefinite.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 19, it recites the limitation “The system of claim 11, wherein the Filoviral peptide comprises a VP sequence selected from the group consisting of the amino acid sequences of SEQ ID NOs: 4, 10, 16, 22, 28, 34, an antigenic fragment thereof, an epitope therein, or a combination thereof”. The use of the term “VP” renders the claim indefinite, as it is unclear which VP is being referenced. As noted in Claim 14, there are multiple options, namely VP30, VP35, VP40, and VP24. The lack of a number makes it unclear which specific “VP” is being recited. It is also unclear if “VP” is being used generically to encompass all possible VPs. Additionally, as noted in the indefiniteness rejection above, none of the sequences recited actually correspond to a VP and instead correspond to NPs. As such, it is unclear how these sequences can refer back to a specific VP as recited in the claim. It is suggested that the claim be amended to specify the correct sequences and to identify the specific VP being referenced, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 19 is rejected on the grounds of being indefinite.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 25, it recites the limitation “The system of claim 1, wherein the viral peptide is a flaviviral peptide and comprises an amino acid sequence with at least 90% sequence homology to the amino acid sequence of SEQ ID NO: 37, 40, 43, 46, 49, 52, 55, 58, 61, 64, 67, 70, 73, 76,79, 82, 88, 91, 94, 97, 100, 103, 106, 109, 112, 115, 118, 121, 124, 127, 130, 133, 136, 139,142, 145, 148, 151, 154, 157, 160, 163, 166, 169, 172, 175, 178, 181, 184, 187, 190, 193,196, 199, 202, 205, 208, 211, 214, 217, 220, 223, 226, 229, 232, 235, 238, 241, 244, antigenic fragments thereof, epitopes contained therein, or a combination thereof”. The claim recites the viral peptide in the singular, such as “the viral peptide”, “a flaviviral peptide”, “an amino acid sequence”, and “the amino acid sequence”. The claim also then uses language which implies that multiple peptides are being used, namely “antigenic fragments thereof”. This latter limitation refers to multiple peptides being present and thus conflicts with the apparent recitation of a single peptide earlier in the claim. As such, it is unclear if Applicant is claiming a single peptide or multiple. This lack of clarity renders the claim indefinite.
It is suggested that the claim be amended to recite “The system of claim 1, wherein the viral peptide is a flaviviral peptide and comprises an amino acid sequence with at least 90% sequence homology to the amino acid sequence of SEQ ID NOs: 37, 40, 43, 46, 49, 52, 55, 58, 61, 64, 67, 70, 73, 76,79, 82, 88, 91, 94, 97, 100, 103, 106, 109, 112, 115, 118, 121, 124, 127, 130, 133, 136, 139,142, 145, 148, 151, 154, 157, 160, 163, 166, 169, 172, 175, 178, 181, 184, 187, 190, 193,196, 199, 202, 205, 208, 211, 214, 217, 220, 223, 226, 229, 232, 235, 238, 241, or 244, an antigenic fragment
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 25 is rejected on the grounds of being indefinite.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
For the purposes of examining the claims on their merits, the term “about” in Claims 9 and 18 will be interpreted as defined by Applicant in the Paragraph 0054 of the instant Specification. This paragraph states “‘About’, as used herein, refers broadly to up to a 5% variance in a given numeric value”.
Claim Rejections - 35 USC § 112(a); First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9, 18, and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for viral peptide sequences which are 100% identical to instant SEQ ID NOs: 2, 4, 10, 37, and 248, does not reasonably provide enablement for variants of the claimed sequences with less than 100% sequence identity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. The claims are drawn to a system for detecting the presence of a virus in a sample comprising a platform comprising a buffer chamber in fluid communication with a sample receiver, the sample receiver comprising a sample chamber and a membrane and is in fluid communication with a secondary agent depot, the secondary agent depot comprising a secondary agent and is in fluid communication with a reaction chamber, the reaction chamber comprising an array comprising at least one viral peptide and an optical window and is in fluid communication with a waste chamber, wherein the coronavirus viral peptide comprises a sequence selected from the group consisting of an amino acid sequence with at least about 90% sequence homology to the amino acid sequences of SEQ ID NOs: 248, 250, 252, 254,256, 258, 260, 262, 264, 266, 268, 270, 272, or 274, antigenic fragments thereof, epitopes contained therein, or combinations thereof, wherein the Filoviral peptide comprises a NP sequence selected from the group consisting of an amino acid sequence with at least about 90% sequence homology to the amino acid sequences of SEQ ID NOs: 4, 10, 16, 22,28, 34, an antigenic fragment thereof, an epitope therein, or a combination thereof, and wherein the viral peptide is a flaviviral peptide and comprises an amino acid sequence with at least 90% sequence homology to the amino acid sequence of SEQ ID NO: 37, 40, 43, 46, 49, 52, 55, 58, 61, 64, 67, 70, 73, 76,79, 82, 88, 91, 94, 97, 100, 103, 106, 109, 112, 115, 118, 121, 124, 127, 130, 133, 136, 139,142, 145, 148, 151, 154, 157, 160, 163, 166, 169, 172, 175, 178, 181, 184, 187, 190, 193,196, 199, 202, 205, 208, 211, 214, 217, 220, 223, 226, 229, 232, 235, 238, 241, or 244, an antigenic fragment thereof, epitopes contained therein, or a combination thereof.
State of the prior art/Predictability of the art. The art teaches that protein chemistry is probably one of the most unpredictable areas of biotechnology. For example, replacement of a single “lysine” residue at position 118 of acidic fibroblast growth factor by “glutamic acid” led to the substantial loss of heparin binding, receptor binding and biological activity of the protein (Burgess et al., J of Cell Bio. 111:2129-2138, 1990). In transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen (Lazar et al. Molecular and Cellular Biology 8:1247-1252, 1988). As these references illustrate, it is unpredictable that a polypeptide variant of a known target protein binder will also bind said target. It is also unpredictable that they would bind said target in the same way, having the same effect on the target (i.e. inhibit or activate). Ju (Proceedings of the National Academy of Sciences, U.S.A., Vol. 88, Pg. 2658-2662, 1991) teaches that the interleukin 1 receptor (IL-1R) antagonist IL-1ra is a naturally occurring protein with no agonist activity in vitro or in vivo (Abstract). However, substitution of a single amino acid lysine145 to aspartic acid changes the property of this peptide to a partial agonist of IL-1R (Abstract). Thus, even a single substitution can change the biological property of a peptide.
This substitution need not be at a position where said residue would contact the target protein. Baker (Immunity, Vol. 13, Pg. 475-484, 2000) teaches that Tax-peptide is an agonist of the of T cell activity (Abstract). However, mutation of proline at position 6 of this peptide to alanine creates a T cell antagonist (Abstract). Importantly, this residue does not contact the T cell receptor (Abstract).
In another case, Huang (The Journal of Biological Chemistry, Vol. 272, No. 43, Pg. 27155-27159, 1997) teaches that conjugation of peptides to other proteins can change their biological properties. They teach that multiple conjugation of the peptide TGFβ1 (residues 41-65) to carrier proteins enhances its antagonist activity but also confers partial agonist activity as well (Abstract). Thus, the chemical context of a biologically active peptide is also important.
Truncation of proteins can also lead to adverse effects on protein structure and thus protein function. Martindale (Nature Genetics, Vol. 18, Pg. 150-154, 1998) teaches that truncation of huntingtin leads to aggregate development which compromises cell viability (Abstract). Nonaka (Human Molecular Genetics, Vol. 18, No. 18, Pg. 3353-3364, 2009) teaches that truncation of TDP-43 to its C-terminal fragments causes abnormally phosphorylated and ubiquitinated inclusions of the protein (Abstract). Taken together, not just any truncation of a protein will yield a soluble, functional, protein fragment.
In summary, these examples teach that the biological function of peptide variants is unpredictable because even a single mutation can abolish activity or give a different function. For example, agonist and antagonist peptides can be interconverted through conjugation or mutagenesis. Importantly, binding can still occur after mutation or conjugation in the literature examples provided above, illustrating that a simple show of binding is not predictive of the nature of a peptide’s biological activity. This point is underlined by Montrose-Rafizadeh (The Journal of Biological Chemistry, Vol. 272, Pg. 21201-21206, 1997) who teaches that receptor binding does not predict agonist or antagonist activity (Pg. 21205, Column 2, Paragraph, first full, Sentence, first).
Working examples. No working examples of the claimed sequence variants are disclosed in the specification.
Guidance in the specification. The specification provides guidance towards assays shown using constructs which are presumably 100% identical to the claimed sequences (see Examples 4-6). The instant Specification fails to disclose the critical or essential amino acids which must be present and any variants of the claimed sequences. The instant Specification does not even provide insight into what kinds of changes can be tolerated. All the instant Specification states with regard to substitutions is that “the inclusion of sequences within the peptide that are more common to other coronavirus species will lower the specific assay signal for each coronavirus, while amino acid substitutions within these conserved sequences can be used to reduce the amount of non-specific antibody binding” (see Paragraph 0144). Similar statements are made regarding the filovirus and flavivirus sequences (see Paragraphs 0155 and 0170).
Amount of experimentation necessary. Since the art teaches that it is unpredictable whether or not peptide variants of known sequences will function as expected, and the specification does nothing to ameliorate these concerns, one would be burdened with undue experimentation to use the products of the instant claims as broadly as they are currently claimed.
Claims 9, 18, and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant application attempts to tie sequence identity to function in the context of a system for detecting the presence of a virus in a sample comprising a platform comprising a buffer chamber in fluid communication with a sample receiver, the sample receiver comprising a sample chamber and a membrane and is in fluid communication with a secondary agent depot, the secondary agent depot comprising a secondary agent and is in fluid communication with a reaction chamber, the reaction chamber comprising an array comprising at least one viral peptide and an optical window and is in fluid communication with a waste chamber, wherein the coronavirus viral peptide comprises a sequence selected from the group consisting of an amino acid sequence with at least about 90% sequence homology to the amino acid sequences of SEQ ID NOs: 248, 250, 252, 254,256, 258, 260, 262, 264, 266, 268, 270, 272, or 274, antigenic fragments thereof, epitopes contained therein, or combinations thereof, wherein the Filoviral peptide comprises a NP sequence selected from the group consisting of an amino acid sequence with at least about 90% sequence homology to the amino acid sequences of SEQ ID NOs: 4, 10, 16, 22,28, 34, an antigenic fragment thereof, an epitope therein, or a combination thereof, and wherein the viral peptide is a flaviviral peptide and comprises an amino acid sequence with at least 90% sequence homology to the amino acid sequence of SEQ ID NO: 37, 40, 43, 46, 49, 52, 55, 58, 61, 64, 67, 70, 73, 76,79, 82, 88, 91, 94, 97, 100, 103, 106, 109, 112, 115, 118, 121, 124, 127, 130, 133, 136, 139,142, 145, 148, 151, 154, 157, 160, 163, 166, 169, 172, 175, 178, 181, 184, 187, 190, 193,196, 199, 202, 205, 208, 211, 214, 217, 220, 223, 226, 229, 232, 235, 238, 241, or 244, an antigenic fragment thereof, epitopes contained therein, or a combination thereof.
While a percent identity cutoff is provided in the claims, the instant Specification fails to disclose the critical or essential amino acids which must be present and any variants of the claimed sequences. The specification only provides guidance towards assays shown using constructs which are presumably 100% identical to the claimed sequences (see Examples 4-6). The instant Specification does not even provide insight into what kinds of changes can be tolerated. All the instant Specification states with regard to substitutions is that “the inclusion of sequences within the peptide that are more common to other coronavirus species will lower the specific assay signal for each coronavirus, while amino acid substitutions within these conserved sequences can be used to reduce the amount of non-specific antibody binding” (see Paragraph 0144). Similar statements are made regarding the filovirus and flavivirus sequences (see Paragraphs 0155 and 0170). The claims, as currently written, read on variants of the claimed sequences with insertions, deletions, and even non-conservative substitutions present. As such, it would be unclear to a person having ordinary skill in the art to know what to change and what not to change.
Furthermore, while it is not explicitly stated, it is assumed that the constructs shown in the data provided have sequences which are 100% identical to the claimed sequences. Even if that is not the case, the data shown do not explicitly include any claimed variants having as little as 90% sequence identity, or even 91-99% sequence identity, relative to the instant sequences, raising questions about how effective these claimed variants would be in the experiments performed. Thus, it was not clear what was tested, it does not appear that any claimed variants were tested, and the essential characteristics of the genera being claimed by Applicant have not been identified or disclosed.
One way to overcome the instant Written Description rejection is for Applicant to show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
As such, it does not appear Applicant was possession of the full scope of the claimed invention at the time of filing and thus Claims 9, 18, and 25 do not meet the written description requirement.
Claim Rejections – Improper Markush Grouping
Claims 17-19, 22-23, and 25 are rejected on the judicially-created basis that they contain an improper Markush grouping of alternatives.
See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
MPEP 803.02 provides guidance on the analysis of a proper Markush group. Members of a proper Markush group are disclosed in the specification to possess at least one property in common which is mainly responsible for their function in the claimed relationship, and it is clear from their very nature or from the prior art that all of them possess this property. The MPEP further provides that in the members of a proper Markush group there should be (1) a common utility, and (2) a substantial structural feature essential to that utility.
The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. In the instant case, the Markush groupings of the recited viral peptides in the claimed limitations are improper because the alternatives defined by each respective Markush grouping do not share both a structural similarity and a common use because the alternatives are not all members of the same recognized physical or chemical class or the same art-recognized class as the viral peptides recited all have different sequences and structures.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
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.
Claims 1-4, 6, 9, 11, 13-15, 17-19, 25, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Huff et al. (US 2018/0275088 A1, Published 27 September 2018), Cady (US 2022/0034896 A1, earliest Priority Date 03 July 2020), Pronyk and Erichsen (US 2021/0228717 A1, earliest Priority Date 27 April 2018), Khurana (US 2021/0208160 A1, earliest Priority Date 08 January 2020), Manuguerra et al. (US 2014/0274762 A1, Published 18 September 2014), Blaney et al. (US 2014/0212434 A1, Published 31 July 2014), Holmes and Gibbons (US 2018/0209976 A1, Published 26 July 2018) (cited on IDS filed on 06 August 2024), and Meegan et al. (US 2009/0305899 A1, Published 10 December 2009).
Huff et al. teach methods, devices, and systems for analyte analysis using a nanopore using a first and second binding member that each specifically bind to an analyte in a biological sample (see Abstract), wherein the analyte can be a virus, including Filoviruses such as Ebola virus (see Paragraphs 0216, 0249, 0419, 0527), or wherein the analyte can be antibodies specific for a certain antigen or vice versa, such as a viral antigen (see Paragraphs 0217, 0232). Huff et al. also teach a system comprising a microfluidics module and a nanopore module comprising a first chamber for the droplet containing the biological sample and a second chamber comprising a buffer, wherein the droplet can be moved using a liquid transfer system (see Paragraphs 0205-0208, 0310; Figures 1A and 1B). Additionally, Huff et al. teach a system comprising a membrane that allows passage or analysis of a single molecule at one time and wherein the system comprises a membrane containing the nanopore held between two reservoirs or chambers (see Paragraphs 0160, 0164, 0243, 0270, 0272, 0289). Furthermore, Huff et al. teach a system comprising a conduit for electron migration between the two chambers which allows for electrical contact of the two chambers as well as a system comprising an a first substrate and a second substrate arranged in a spaced apart manner wherein the first substrate is separated from the second substrate by a gap/space and where the steps are of contacting the sample with a first binding member, contacting the analyte with a second binding member, removing second binding member not bound to the analyte bound to the first binding member, and cleaving the tag attached to the second binding member is carried out in the space/gape between the first and second substrates (see Paragraph 0204). Finally, Huff et al. teach a system comprising an optical detection chamber for optical detection and quantification of the analyte (see Paragraphs 0025, 0131, 0438-0443, 0446, 0471-0478; Figures 52A-52E) and wherein said system can include means for supplying reagent and collecting waste materials, such as chambers and reservoirs (see Paragraphs 0356-0357) as well as a DMF chamber operably connected to the imaging chamber and reversibly coupled to the analyte detection region (see Paragraphs 0490-0491; Figure 52) and a chip for optical detection of a signal in which an analyte is transported from the reaction zone to the detection zone, which is a separate part of the chip, and positioned adjacent to an optical fiber, which is then used to measure the optical signal generated by the analyte (see Paragraphs 0471-0473, 0478; Figure 50), which reads on the instant limitation of a system comprising a sample receiver comprising a sample chamber and a membrane, wherein said sample receiver is in fluid communication with a secondary agent depot and wherein said secondary agent depot comprises a secondary agent and is in fluid communication with a reaction chamber.
Huff et al. does not teach a system comprising a reaction chamber comprising an array comprising at least one viral peptide or the use of their system for detecting coronaviruses or flaviviruses or antibodies against these viruses, but does teach the use of their system for detecting influenza virus HA antigen (see Paragraph 0217).
Cady teaches the detection of antibodies against coronavirus as well as SEQ ID NO: 1, which comprises a sequence that is 100% identical to instant SEQ ID NO: 248 (see Paragraph 0003; Sequence Listing), which corresponds to the SARS-CoV-1 spike protein. Cady teaches wherein said antibodies being detected are specific for a Coronavirus spike protein corresponding to prior art SEQ ID NO: 1 (see Claim 12).
Pronyk and Erichsen teach a multianalyte immunoassay for detecting antibodies against Zika virus as well as SEQ ID NO: 3, which is 99.9% identical to instant SEQ ID NO: 37 (see Sequence Listing). Pronyk and Erichsen teach wherein said antibodies being detected are specific for a Zika Envelope protein corresponding to prior art SEQ ID NO: 3 (see Paragraphs 0008, 0010-0014, 0019, 0108; Figure 1).
Khurana teaches a method of identifying a biological sample containing Filovirus-specific antibodies using peptides and full-length VP35, VP40 and/or NP (see Paragraphs 0005, 0010) as well as SEQ ID NO: 17, which is 99.9% identical to instant SEQ ID NO: 2 (see Sequence Listing), which corresponds to the VP40 from Zaire Ebola virus. Khurana teaches wherein said antibodies being detected are specific for Filovirus epitopes (see Abstract) such as those present on the VP40 from Zaire Ebola virus corresponding to prior art SEQ ID NO: 17 (see Paragraph 0054).
Manuguerra et al. teach a method and a multiplex screening immunoassay for detecting target antibodies in a biological sample against viruses such as Flaviviruses and Ebolaviruses (see Page 1, Lines 5-29) as well as SEQ ID NO: 111, which is 99.9% identical to instant SEQ ID NO: 4 (see Sequence Listing), which corresponds to the NP of Zaire Ebola virus. Manuguerra et al. teach wherein said antibodies being detected are specific for fusion proteins comprising a viral antigen, such as the NP of Zaire Ebola virus corresponding to prior art SEQ ID NO: 111.
Blaney et al. teach multivalent vaccines against rabies and filoviruses as well as methods for evaluating a sample for the presence of antibodies raised against rabies and/or a filovirus, such as Ebola virus, using Ebola virus proteins (see Paragraphs 0120-0121). Blaney et al. also teach SEQ ID NO: 13, which is 99.9% identical to instant SEQ ID NO: 10 (see Sequence Listing), which corresponds to the NP of Sudan Ebola virus. Additionally, Blaney et al. teach wherein said antibodies being detected are specific for Ebola virus proteins such as prior art SEQ ID NO: 13 (see Table 2).
Holmes and Gibbons teach a system and methods for detecting an analyte or analytes indicative of an influenza viral infection (see Abstract), wherein the analyte or analytes are the H5 and N1 proteins from Influenza A, as well as a system for detecting antibodies against Influenza A H5N1 (see Paragraphs 0028-0030).
Meegan et al. teach compositions and methods for identifying molecules, such as antibodies, in samples that bind to molecules associated with pathogenic or infectious agents and for identifying individuals exposed to one or more pathogenic agents or who have generated antibodies in response to one or more pathogenic agents (see Abstract). Meegan et al. also teach protein or immunogen microarrays comprising proteins or peptides from viruses, such as Rubella virus, HIV, HPV, and hemorrhagic fever viruses, as well as compositions containing molecules, like said proteins or peptides, linked to solid supports via covalent or non-covalent bonds in such a way as to form an array (see Paragraphs 0012, 0014-0015, 0018-0019, 0022, 0087, 0214; Figures 1A and 1B).
Huff et al. also teach a system comprising a microfluidics module and a nanopore module comprising a first chamber for the droplet containing the biological sample and a second chamber comprising a buffer, wherein the droplet can be moved using a liquid transfer system, which constitutes the platform comprising a buffer chamber in fluid communication with a sample receiver of instant Claim 1. Huff et al. teach a system comprising a membrane that allows passage or analysis of a single molecule at one time and wherein the system comprises a membrane containing the nanopore held between two reservoirs or chambers. Furthermore, Huff et al. teach a system comprising a conduit for electron migration between the two chambers which allows for electrical contact of the two chambers as well as a system comprising a first substrate and a second substrate arranged in a spaced apart manner wherein the first substrate is separated from the second substrate by a gap/space, which constitutes the sample receiver comprising a sample chamber and a membrane which is in fluid communication with a secondary agent depot of instant Claim 1. Huff et al. teach a system comprising an optical detection chamber for optical detection and quantification of the analyte (see Paragraphs 0025, 0131, 0438-0443, 0446, 0471-0478; Figures 52A-52E) and wherein said system can include means for supplying reagent and collecting waste materials, such as chambers and reservoirs (see Paragraphs 0356-0357) as well as a DMF chamber operably connected to the imaging chamber and reversibly coupled to the analyte detection region (see Paragraphs 0490-0491; Figure 52) and a chip for optical detection of a signal in which an analyte is transported from the reaction zone to the detection zone, which is a separate part of the chip, and positioned adjacent to an optical fiber, which was then used to measure the optical signal generated by the analyte (see Paragraphs 0471-0473, 0478; Figure 50), which reads on the instant limitation of a system comprising a sample receiver comprising a sample chamber and a membrane, wherein said sample receiver is in fluid communication with a secondary agent depot and wherein said secondary agent depot comprises a secondary agent and is in fluid communication with a reaction chamber of Claim 1. The teachings of Cady, Pronyk and Erichsen, Khurana, Manuguerra et al., Blaney et al., and Holmes and Gibbons all teach detection of specific viruses and/or antibodies against those viruses, all of which could be readily adapted to the system of Huff et al. and the array or microarray of Meegan et al. using samples obtained from a subject. The proteins or peptides of Cady, Pronyk and Erichsen, Khurana, Manuguerra et al., Blaney et al., and Holmes and Gibbons, linked to solid supports via covalent or non-covalent bonds in such a way as to form the array or microarray of Meegan et al., which could then be adapted to be the first binding member(s) immobilized on a solid support of Huff et al., wherein the first binding member(s) specifically bind(s) to the target analyte(s) (see Paragraph 0021 of Huff et al.) and wherein the solid support is in or is the DMF chamber of Huff et al., which is operably connected to the imaging chamber and reversibly coupled to the analyte detection region of the optical chip of Huff et al.
It would have been obvious to a skilled artisan to modify the teachings of Huff et al. with those of Cady, Pronyk and Erichsen, Khurana, Manuguerra et al., Blaney et al., Holmes and Gibbons, and Meegan et al. in order to develop an assay to detect multiple viruses and/or antibodies against those viruses. Huff et al. and Meegan et al. provide basic systems or devices and an array or microarray which could be modified by a skilled artisan depending on the virus needing to be detected and/or the symptoms being shown by a subject. The teachings of Cady, Pronyk and Erichsen, Khurana, Manuguerra et al., Blaney et al., and Holmes and Gibbons all teach detection of specific viruses and/or antibodies against those viruses, all of which could be readily adapted to the system of Huff et al. and the array or microarray of Meegan et al. using samples obtained from a subject. The combination of the system of Huff et al. and the array or microarray of Meegan et al. would provide a rapid, multiplex point-of-care assay for multiple viruses or the evidence of infection by multiple viruses at the same time and using minimal sample volume. This would reduce the time necessary to diagnose, or at least rule out, certain viral infections and provide insight as to the necessary medical procedures to follow. As such, the combined teachings of these references render the instant claims obvious.
For at least these reasons, instant Claims 1-4, 6, 9, 11, 13-15, 17-19, 25, and 27-28 are rejected under 35 U.S.C. 103 as being obvious over the prior art.
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 1, 11, 13-15, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 11-12, 14, 24, 56-58 of U.S. Patent No. 11,414,461 in view of Huff et al. (US 2018/0275088 A1, Published 27 September 2018) and Meegan et al. (US 2009/0305899 A1, Published 10 December 2009).
Both claim sets are drawn to detecting filovirus-specific antibodies in a sample. Also, patented SEQ ID NOs: 2, 4, and 10 are 100% identical to instant SEQ ID NOs: 2, 4, and 10, respectively.
The main difference between the claim sets is that the instant claims are drawn to a system for the detection of virus or antibodies against a virus, while the patented claims are drawn to a method for specifically detecting filovirus-specific antibodies.
The teachings of Huff et al. and Meegan et al. have been summarized above.
It would have been obvious to a skilled artisan to combine the teachings of the patented claims with those of Huff et al. and Meegan et al. in order to develop a system for detecting filovirus-specific antibodies. The combination of the system of Huff et al. and array or microarray of Meegan et al. could be modified for detecting any virus and/or antibodies against said virus, such as the method of the patented claims, especially since Huff et al. specifically contemplates detection of antibodies in a sample as well as the detection of Filoviruses, such as Ebola virus, in a sample and Meegan et al. teach protein or immunogen microarrays comprising proteins or peptides from viruses, such as hemorrhagic fever viruses, as well as compositions containing molecules, like said proteins or peptides, linked to solid supports via covalent or non-covalent bonds in such a way as to form an array. As such, the combination of these teachings renders the instant claims obvious.
For at least these reasons, instant Claims 1, 11, 13-15, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the patented claims in view of Huff et al. and Meegan et al.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Gilboa-Geffen et al. (WO 2020/072843 A1, Published 09 April 2020),
Gilboa-Geffen et al. teach systems and methods for target detection in samples. This reference has not been utilized, as rejection would have been redundant to those set forth above.
Ulrich and Kamata (US 2023/0050394 A1, earliest Priority Date 03 January 2014)
Ulrich and Kamata teach compositions, assays, methods, and kits comprising one or more amino acid sequences of a filovirus protein or a fragment thereof for detecting a filovirus infection and/or the presence of antibodies specific for a filovirus in a biological sample. This reference has not been utilized, as rejection would have been redundant to those set forth above.
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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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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