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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-10, 12 and 14 and the species patient or individual positive for or at risk for SAR-CoV2 infection or having COVID-19 and the species of treatment for a patient or individual having auto-Abs against one or more type I IFN and not having auto-Abs against IFN-a2 in the reply filed on 06/01/26 is acknowledged. The traversal is on the ground(s) that the alternative species can be examined without burden and with related searches by the Examiner (NOTE: It is noted that the Applicant did not traverse the Groupings but only traversed the species). This is not found persuasive because the different patients and the different treatments based on the presence/absence of the autoantibodies causes different search strategies and different search terms which place an undue burden on the Examiner. Further, while searches would be expected to overlap, there is no reason to expect the searches to be coextensive.
The requirement is still deemed proper and is therefore maintained.
Currently, claims 1-10, 12, 14, 16-17, 20-21, 24-25, 28-29, 31, 33-34, 36, 38, 41, 43-44 and 46 are pending. Claims 3, 6-7, 12, 14, 16-17, 20-21, 24-25, 28-29, 31, 33-34, 36, 38, 41, 43-44 and 46 are withdrawn as being directed toward non-elected inventions. Accordingly, claims 1-2, 4-5, and 8-10 are under examination.
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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g. page 45, paragraph 00161). 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.
The use of the terms Tween and Tween 20 (e.g. para’s 00182, 00192, 00214, 00276), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
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.
Written Description
Claims 1-2, 4-5 and 8-10 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a method for evaluating the presence of anti-type I IFN specific auto-antibodies (auto- Abs) in a patient or individual positive for or at risk for SARS-CoV-2 infection, having COVID-19 discase, prior to vaccination with live attenuated vaccine (LAV), or having vaccine-associated discase and thereby determining treatment and treating the patient or individual by evaluating a serum or plasma sample from any and all patients or individuals for autoantibodies specific for one or more type I IFN. The limitations 'patient’ and ‘individual represents a genus and encompasses human and non-human including mouse, monkey, dog, rat, pig, insects, kangaroo, horse, canine and snake to name a few. However, there is inadequate written description in the instant specification for a method of such broad scope as claimed currently.
In order to fulfill the written description requirements set forth under 35 U.S.C § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, each member correlated with the requisite function, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicants have possession the claimed invention. Applicants have not described and established structure-function correlation for a representative number of species within the broad genus of at least the recited ‘patient’, and ‘individual’ the the presence of the auto-antibodies such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the full scope of the claimed invention at the time the application was filed.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. When there is substantial structural variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
A review of the instant specification indicates the following. The specification in paragraphs 00032-00034, 00192, 00319, 00324 discloses the use of labeled anti-human immunoglobulin to detect the human auto-antibodies in the sample. The specification in paragraph 00076 discloses there are 17 human type I IFN. The specification in paragraph 000207 discloses the detection of auto-Abs in humans of different ages and ancestries. Paragraph 000244 discloses human type I IFN. The examples in the specification are limited to the detection of auto-antibodies in serum or blood in humans and the correlation with SARS-CoV2 and COVID-19
The specification does not provide data, testing or examples with a showing that any all and all patients or individuals provide the recited auto-antibodies which can be specifically correlated with SARS-CoV-2 infection and COVID-19. Also, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract).
The only examples utilized in the specification appears to be limited to patients or individuals that are human and the of the recited auto-antibodies in either serum or blood samples from the patients/individuals for evaluating SARS-CoV-2 or COVID-19. The specification does not disclose that the recited auto-antibodies which appear in serum or plasma of humans also appear in mice, monkey, dog, rat, pig, insects, kangaroo, horse, canine or snakes and are specifically correlated with SARS-CoV-2 or COVID-19. As stated supra the specification appears to be limited to patients or individuals that are human and the detection of the recited auto-antibodies in either serum or blood samples from the patients for evaluating SARS-CoV-2 or COVID-19.
The specification also fails to provide for a correlation of the recited auto-antibodies in all patients such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease). The examples in the specification appear to be limited to patients or individuals that are human and the detection of the recited auto-antibodies in either serum or blood samples from the patients for evaluating SARS-CoV-2 or COVID-19 . The purpose of the ‘written description; requirement is broader than to merely explain how to ‘make and use’, Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
It must be noted that "[t]he applicant must . . . convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir.1991). The invention, is for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the claimed invention at the time of filing. The Written Description Guidelines state: There is an inverse correlation between the level of predictability in the art and the amount of disclosure necessary to satisfy the written description requirement. For example, if there is a well-established correlation between the structure and function in the art, one skilled in the art will be able to reasonably predict the complete structure of the claimed invention from its function. Furthermore, the written description provision of 35 U.S.C § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ‘Written Description’ Requirement (66 FIR 1099-1111, January 5,2001) state, ‘[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention’ (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. Factual evidence of an actual reduction to practice has not been disclosed in the instant specification, nor has Applicant shown the invention was ‘ready for patenting’. The Guidelines further state, ‘[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus' (Id. at 1106). For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Instant claims are viewed as not meeting the written description provision of 35 U.S.C § 112, first paragraph. The specification fails to disclose the detection of the recited auto-antibodies in any and all individuals wherein the presence of the auto-antibodies is specifically correlated with evaluating SARS-CoV-2 or COVID-19.
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, 4-5 and 8-10 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 is indefinite in reciting “evaluating the blood or serum sample for autoantibodies” because the term “evaluating” appears to intend a mental step of deciding; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “evaluating” and replace it with --testing--. See also the deficiency found in claim 2.
Claim 1, lines 6-17 is indefinite in reciting improper Markush language in reciting “for one or more type I IFN selected from” because it appears to intend to limit the scope of the type I IFN and antibodies thereto recited in the claims but improperly defines it as such. Perhaps, Applicant intends “for one or more type I IFN selected from the group consisting of”.
Claim 1, step (c) the recitation “a patient or individual” is vague and indefinite because it is unclear if the applicant is referring to the patient or individual recited in the preamble of the claim or not. See deficiencies throughout the remainer of the claim(s).
Claim 5 the phrase “such as” renders the claim indefinite because it us unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d).
Claim 9 is indefinite in reciting improper Markush language in reciting “for one or more type I IFN selected from” because it appears to intend to limit the scope of the type I IFN and antibodies thereto recited in the claims but improperly defines it as such. Perhaps, Applicant intends “for one or more type I IFN selected from the group consisting of”.
Claim 10 is indefinite in reciting improper Markush language in reciting “for one or more type I IFN selected from” because it appears to intend to limit the scope of the type I IFN and antibodies thereto recited in the claims but improperly defines it as such. Perhaps, Applicant intends “for one or more type I IFN selected from the group consisting of”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9 and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 9 and 10 recite an alternative scenario which appears to try and replace the type I IFN of claim 1 with the type I IFN of claims 9 or 10 and thus is changing the type I IFN of claim 1 and not further limiting the type I IFN of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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, 4-5 and 8-10 rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims are directed to a naturally occurring correlation between the presence of auto-antibodies specific for type I IFN in blood or serum samples from a patient or individual positive for or at risk for SARS-CoV2 infection, having COVID-19 disease.
Step 2A, Prong 2
The additional elements of isolating a blood or serum sample from the patient or individual and evaluating the blood or serum sample does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “evaluating the blood or serum sample for auto-antibodies specific for one or more type I IFN …..”. The “evaluating” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the biomarkers being correlated with SARS-CoV2 infection, COVID-19, or vaccine-associated disease. No active method steps are invoked or clearly required; the “evaluating” statement does not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by Meager (PLos Med, June 13, 2006, Vol. 3, No. 7, pgs 1152-1164) (submitted in the IDS filed 04/19/23) it is well known, routine and conventional in the art for evaluating the presence of anti-type IFN specific auto-antibodies (auto-Abs) in a patient using an assay comprising: isolating a blood or serum sample from said patient or individual: Evaluating the blood or serum sample for auto-antibodies specific for one or more type IFN selected from: IFN-a2 and IFN-omega (e.g. pgs 1152, 1154).
With respect to the “is treated to remove or deplete the auto-abs and/or is administered a type I IFN…” as recited in claim 1. Although the claim invokes administering a treatment to the subject the claim currently also recites a scenario “wherein a patient or individual having one or more auto-antibody is not administered the vaccine” and with the or situations this embodiment allows for a scenario wherein not treatment is administered at all. Therefore, the claims as currently recited do not recite something significantly more than the judicial exception.
Also, claim 2 as recited allows for a scenario wherein the patient or individual does not have the antibodies and therefore no treatment step would be performed.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al (US 2023/0357754) in view of of Kypros et al (US 2012/0135427).
Rosen et al discloses a method for detecting autoantibodies in COVID-19 patients (cohort) and discloses that the autoantibodies in these patients target type I interferons (IFN) such as IFNa14, IFNa13, IFNw1, IFNa2 and IFNa6 (e.g. para 0413, Fig. 14, Table 3 pgs 67-68). Rosen et al discloses obtaining a sample such as blood or serum from the patients and evaluating the sample for the antibodies (e.g. para’s 0029-0030, 0192-0195, 0240, 0450). Rosen et al discloses treating the COVID-19 patients by administering a treatment to decrease the activity of the autoantibodies or administering a composition such as IfNa2 (e.g. para 0296) or by means of removing the autoantibodies from the circulation of the patients by administering IFna autoantigens (e.g. para 0420).
Rosen et al differs from the instant invention in failing to explicitly teach performing the method on a subject (individual).
Kypros et al teaches that it is known and conventional in the art to apply methods toward an individual (subject) wherein the markers have been established in a cohort (e.g. para’s (e.g. para’s 0011-0017. 0021 and 0066-0070, 0086, Figures 1-2 and example 1).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate the detection of the autoantibodies in an individual subject such as taught by Kypros et al into the method of Rosen et al because Kypros et al shows that it is known and conventional in the art to apply the teachings of a cohort to that of an individual subjects. Thus, absent evidence to the contrary one of ordinary skill in the art would have a reasonable expectation of success incorporating the detection of the autoantibodies in an individual subject such as taught by Kypros et al into the method of Rosen et al.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al in view of Kypros et al as applied to claims1-2 and 8-9 above, and further in view of Wu et al (medRxiv, April, 20, 2020, pages 1-20).
See above for the teachings of Rosen et al and Kypros et al.
Rosen et al and Kypros et al differs from the instant invention in failing to teach evaluating the sample for neutralizing antibodies.
Wu et al teaches the detection of neutralizing antibodies in COVID-19 patients and teaches that the detection of these neutralizing antibodies is helpful prior to use of convalescent plasma from prevention or treatment (e.g. pages 2, 4-6)
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate the detection of neutralizing antibodies such as taught by Wu et al into the modified method of Rosen et al because Wu et al shows that it is known and conventional and further teaches that the detection of these neutralizing antibodies is helpful prior to use of convalescent plasma from prevention or treatment. Thus, one of ordinary skill would have a reasonable expectation of success incorporating the detection of neutralizing antibodies such as taught by Wu et al into the modified method of Rosen et al.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al in view of Kypros et al as applied to claims1-2 and 8-9 above, and further in view of Bjh correspondence (British Journal of Haematoglogy 2020, 190, e181-e183, epub 2020 June 12).
See above for the teachings of Rosen et al and Kypros et al.
Rosen et al and Kypros et al differs from the instant invention in failing to teach conducting plasmapheresis on the patient.
Bjh Correspondence (Bjh) teaches that it is known in the art that patients having COVID-19 can be treated by performing therapeutic plasma exchange (plasmapheresis) on the patients (e.g. e181). Bjh teaches that therapeutic plasma exchange is effective for cytokine storm and is widely used in the treatment of a variety of severe and critical patients (e.g. e181).
Allard et al teaches
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate therapeutic plasma exchange with the patients of Rosen et al because Bjh shows that it is known in the art and that therapeutic plasma exchange is effective for cytokine storm and is widely used in the treatment of a variety of severe and critical patients. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating therapeutic plasma exchange with the patients of Rosen et.
Allowable Subject Matter
Claim 10 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a), and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, 112 (d) and 101 rejections set forth in this Office action. The prior art of record does not teach nor fairly suggest detecting autoantibodies specific IFN-k or IFN-e and correlating the detection with SAR-CoV-2 infection, having COVID-19 disease as currently recited.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Allard et al (US 2022/0257841) discloses that plasmapheresis may be used in COVID-19 patients (e.g. para 0146).
Meager (PLos Med, June 13, 2006, Vol. 3, No. 7, pgs 1152-1164) (submitted in the IDS filed 04/19/23) teaches a method for evaluating the presence of anti-type IFN specific auto-antibodies (auto-Abs) in a patient using an assay comprising: isolating a blood or serum sample from said patient or individual: Evaluating the blood or serum sample for auto-antibodies specific for one or more type IFN selected from: IFN-a2 and IFN-omega.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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