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 .
Examiner’s Note
It is noted that a Sequence Listing in accordance with 37 CFR 1.823 is missing in instant Application. See MPEP 2424.
Election Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 5, 10, 20-23, 25 and 27 drawn to an assay, in the reply filed on 11/04/2025 is acknowledged.
Claims 29, 58-62, 69-72, 74, 75, 77, 78, 82, 83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1, 2, 5, 10, 20-23, 25 and 27 are under examination on the merits.
Priority
Applicant’s claim for domestic benefit of prior-filed provisional application No. 63/142,035 filed on 01/27/2021, 63/051,144 filed on 07/13/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/051,144 filed on 07/13/2020, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1, 2, 5, 10, 20-23, 25 and 27. Therefore, claims 2, 5, 10, do not receive domestic benefit to the provisional application No. 63/051,144 filed on 07/13/2020 because it does not disclose a unit score comprising a U-IBBR value. For purposes of applying prior art, the filing date for claims 2, 5, 10 is 01/27/2021.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 09/25/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 01/13/2023. The drawings are objected to because the labels should read “FIG.” instead of “FIGURE”. Further, the graphs and/or graphics in Figures 2, 3, 10, 13, 16, 18, 20 are difficult to read because the resolution is too low. B, 2D, and 2E fail to show colored sections as described in the specification. Further, the Specification (page 8) refers to Figure 5 as showing cutoff values using S and S1 total. However, no data is visible in these graphs.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, for example in page 1. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
It is noted that the Specification is missing a paragraph indicating cross-references to related applications.
Claim Objections
Claim 2 is objected to because of the following informalities:
On claims 2, the recitation of “U-IBBR” should be defined at first mention. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 5, 10, 20-23, 25 and 27 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 1 recites “An assay for determining immune status in a subject”. It is not clear if the claimed assay refers to a method/process or to a product, which are different statutory categories of invention. Withdrawn claim 29 recites a “method for determining the immune status in a subject” indicating that claim 1 and its dependents refer to a product. Further, it is noted that claim 1 does not recite any steps which provides further indication that claim 1 and its dependents refer to a product. However, it remains unclear whether the claimed assay of claim 1 refers to a method/process or to a product because the limitations of claim 1 and its dependent claims seems to refer to a method of determining the immune status in a subject. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, claim 1 is indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, based on the reasons presented above claim 1 was herein interpreted as referring to an assay, wherein the assay is a product.
On claim 22 the recitation of “the antigen comprises or consists of” is not clear because it does not define the scope of the claim in relation to the polypeptide sequence of SEQ ID NO:1. Specifically, it is not clear if the claim is to be interpreted in an open-ended manner as indicated by the term “comprises”, or a closed manner as indicated by the term “consists of” to define the scope of a claim in relation SEQ ID NO:1. See MPEP 2111.03. Therefore, the claim is indefinite. For purposes of compact prosecution and applying prior art, claim 22 was interpreted herein as reciting the open-ended language of comprising SEQ ID NO: 1.
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 5, 10, 20-23, 25 and 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
See claims 1, 2, 5, 10, 20-23, 25 and 27 as submitted on 09/25/2023.
The instant claims are drawn to a assay for determining immune status in a subject, the assay comprising a probe, wherein the probe comprises an antigen, wherein the antigen comprises a SARS-CoV-2 Si or S2 protein or a variant or combination thereof, wherein the antigen comprises the polypeptide sequence of SEQ ID NO: 1. As such, the instant claims are drawn to a composition of matter, which is a statutory category of matter (Step 1: YES).
The instant claims require “a probe, wherein the probe comprises an antigen, wherein the antigen comprises a SARS-CoV-2 Si or S2 protein or a variant or combination thereof, wherein the antigen comprises the polypeptide sequence of SEQ ID NO: 1.” The Specification evidences that the “the polypeptide sequence of SEQ ID NO: 1” is derived from comprises a spike protein of SARS-CoV-2 and as such it has the potential to bind to anti-SARS-CoV-2 antibodies in a sample from a subject (pages 6-7). Further, Wu et al. “A new coronavirus associated with human respiratory disease in China” (Nature. 2020;579(7798):265-269) published 02/03/2020 and Wu et al. GenBank: MN908947. (See PTO-892: Notice of References Cited.)
further teach a sequence of the SARS-CoV-2 surface glycoprotein (GenBank: MN908947) which shares 100% identity with instant SEQ ID NO: 1. See alignment below (Qy is instant SEQ ID NO: 1; Db is Wu et al.’s sequence). It is noted that only the first ~200 residues are shown in the alignment, however the sequences are identical throughout all 1208 residues. As such, absent evidence to the contrary, SEQ ID NO: 1 corresponds to naturally occurring viral protein produced by the SARS-CoV-2 virus.
The instant claims alternatively require “antigen comprises a SARS-CoV-2 Si or S2 protein or a variant or combination thereof, wherein the antigen comprises the polypeptide sequence of SEQ ID NO: 1.” The Specification indicates that a “variant” comprises at least about 50%, 60%, 70%, 80%, 90%, 95%, or 99% sequence identity to the native S1 and S2 proteins, the native conformational epitope, or SEQ ID NO:1 (page 7) provided the antigen variant retains the ability to detect and/or generate SARS-CoV-2 antibodies (page 6). The broadest reasonable interpretation encompasses a polypeptide having anywhere from one amino acid substitution relative to SEQ ID NO: 1 to having 50% of the amino acid residues present in SEQ ID NO: 1 substituted, added, inserted, and/or deleted relative to wild-type SEQ ID NO: 1, so long as the polypeptide has the ability to detect and/or generate SARS-CoV-2 antibodies. The instant claims encompass altering up to 50% of the residues in SEQ ID NO: 1 into any spike protein with the ability to detect and/or generate SARS-CoV-2 antibodies. Accordingly, the instant claims encompass all naturally occurring spike proteins with the ability to detect and/or generate SARS-CoV-2 antibodies, and DNA encoding the same; including all natural variants within the same coronavirus genera or across genera, which would encompass naturally occurring spike proteins from known SARS-CoV-2 variants such as the Alpha, Beta, Gamma, Delta, or Omicron variants.
As such, the instant claims encompass spike proteins and DNA encoding the same, which would not possess any markedly different characteristics with respect to structure, function, or any other property to distinguish the spike proteins and DNA encoding the same from their naturally occurring counterparts. Accordingly, the instant claims recite a judicial exception (JE) in the form of a natural phenomenon (Step 2A, Prone One: YES).
It is noted that the claims further recite “for measuring disease-specific antibodies in a sample from the subject to determine a unit score.” This not a particular field of use, but, rather, a generic way to obtain a read out. Hence, the instant claims do not recite additional elements that integrate the judicial exception (natural phenomenon) into a practical application. Integration into a practical application requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html). Further, there is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a). Further, generally linking of the use of the judicial exception to a particular technological environment or field of use is not indicative of integration into a practical application – see MPEP 2106.05(h)”.
The instant claims are drawn solely to JE, and not a method of using the JE. As such, the instant claims do not recite any additional elements that integrate the exception into a practical application (Step 2A, Prone Two: NO).
Since the instant claims are drawn solely to JE, the instant claims do not recite any additional elements the amount to significantly more that the judicial exception (Step 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
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 1, 2, 5, 10, 20, 21, 23, 25 and 27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US PGPub 2021/0389308 A1 to Lapointe et al. effectively filed on 04/03/2020. See PTO-892: Notice of References Cited.
See claims 1, 2, 5, 10, 20, 21, 23, 25 and 27 as submitted on 09/25/2023.
Regarding claims 1, Lapointe et al. teach an assay for determining the immune status of a subject comprising an antigen probe for measuring the binding of the probe to neutralizing antibodies against the disease-causing pathogen in a biological sample from the subject, wherein the pathogen is SARS-CoV-2 (Abstract ¶¶ [0014]-[0015]). It is noted that the recitation on claim 1 of “for measuring” and “to determine”, refer to intended use of the claimed assay which, while full considered, does not carry patentable weight.
Regarding claim 2, the assay of Lapointe et al. is employed to generate a measurement output (unit score) which is associated (predictive, as recited in claim 2) with of the immune status of the subject (¶¶ [0013]-[0024], [0027]). It is noted that the recitations on claim 2 of “wherein the unit score comprises an U-IBBR value, wherein the U-IBBR value is predictive of the immune status of the subject and/or wherein the U-IBBR value stratifies the subject into an immune status group” do not impart any additional structural features to the assay as recited in claim 1, therefore this recitation is considered to flow from the features already present in the assay as recited in claim 1. Further, given that instant claims are directed to an assay and not to a method of using the assay, the recitations with respect to the manner in which the claimed assay is indented to be employed do not differentiate the claimed assay from any prior art assay that meet the structural limitations as recited in claim 1. See also MPEP 2111.04 (II). Therefore, any assay in the prior art having the all of the structural limitations recited in claim 1 would be capable of generating a measurement output (unit score) which is associated with of the immune status of a subject.
Regarding claim 5, Lapointe et al. further teach the assay of claim 2 wherein the assay is further employed to confirm the presence of neutralizing antibodies against a coronavirus in the subject, wherein the absence or a low quantity of the antibody-antigen complex in the sample is associated with lower immunity and high quantity of antigen complex in the sample is associated with higher immunity, and wherein the quantities are relative to an index or a control (¶¶ [0013]-[0024], [0027]). It should be noted here that similarly to claim 2 above, the recitations on claim 5 of “wherein the immune status group comprises a low immunity group and a high immunity group…” do not impart any additional structural features to the assay as recited in claim 2, therefore this recitation is considered to flow from the features already present in the assay as recited in claim 2. Further, given that instant claims are directed to an assay and not to a method of using the assay, the recitations with respect to the manner in which the claimed assay is indented to be employed do not differentiate the claimed assay from any prior art assay that meet the structural limitations as recited in claim 2. See also MPEP 2111.04 (II). Therefore, any assay in the prior art having the all of the structural limitations recited in claim 2 would be capable of generating a measurement output (unit score) which is associated with of the immune status of a subject.
Regarding claim 10, Lapointe et al. further teach the assay of claim 5 wherein the assay is further employed to confirm the presence of neutralizing antibodies against a coronavirus in the subject, wherein the absence or a low quantity of the antibody-antigen complex in the sample is associated with lower immunity and high quantity of antigen complex in the sample is associated with higher immunity, and wherein the quantities are relative to an index or a control (¶¶ [0013]-[0024], [0027]). It should be noted here that similarly to claims 2 and 5 above, the recitations on claim 10 of “wherein the U-IBBR value ranges from 0 to about 90 in the low immunity group and the U-IBBR value ranges from about 110 to about 300 in the high immunity group…” do not impart any additional structural features to the assay as recited in claim 4, therefore this recitation is considered to flow from the features already present in the assay as recited in claim 5. Further, given that instant claims are directed to an assay and not to a method of using the assay, the recitations with respect to the manner in which the claimed assay is indented to be employed do not differentiate the claimed assay from any prior art assay that meet the structural limitations as recited in claim 5. See also MPEP 2111.04 (II). Therefore, any assay in the prior art having the all of the structural limitations recited in claim 5 would be capable of generating a measurement output (unit score) which is associated with of the immune status of a subject, wherein the unit score ranges from an arbitrary set of values in the low immunity group and the unit score ranges from an second arbitrary set of values in the high immunity group.
Regarding claims 20, 21, 23, 25 and 27, Lapointe et al. further teach the assay of claim 1 wherein the sample comprises a blood or serum or saliva sample ((¶ [0238]) and wherein the samples are tested with a probe comprising an antigen from SARS-CoV-2 and the analyte is an anti-SARS-CoV-2 S1 or S2 antibody (¶¶ [0119], [0166]), and wherein the presence of the target analyte is associated to SARS-CoV-2 infection or disease (¶ [0063]).
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over 2 Lapointe et al. (previously cited), as applied to claims 1, 2, 5, 20, 21, 23, 25 and 27 above, in view of Wu F, et al. “A new coronavirus associated with human respiratory disease in China” (Nature. 2020;579(7798):265-269) published 02/03/2020 and Wu et al. GenBank: MN908947. See PTO-892: Notice of References Cited.
See claim 22 as submitted on 09/25/2023.
Regarding claim 22, Lapointe et al. teach the assay of claim 21. Lapointe et al. do not explicitly teach a sequence comprising instant SEQ ID NO: 1.
However, Wu et al. teach the entire genomic sequences of SARS-CoV-2, including sequences encoding the S1 and S2 domains which contain the receptor binding domain (RBD), HR1 and HR2 domains which are mainly responsible for binding of the virus to the receptor (Abstract, pages 265-267). Wu et al. further teach a sequence of the SARS-CoV-2 surface glycoprotein (GenBank: MN908947) which shares 100% identity with instant SEQ ID NO: 1. See alignment below (Qy is instant SEQ ID NO: 1; Db is Wu et al.’s sequence). It is noted that only the first ~200 residues are shown in the alignment, however the sequences are identical throughout all 1208 residues.
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the amino acid sequence of Wu et al. into the assay as taught by Lapointe et al. for the benefit of including an antigen comprising regions of a SARS-CoV-2 responsible for binding of the virus to the receptor. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating the amino acid sequence of Wu et al. into the assay as taught by Lapointe et al. given that the methods of formulating binding assays with known antigens are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, claim 22 was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672