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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Jun. 30, 2023. Claims 1-19 are pending and currently examined.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. This rejection has the following grounds.
A. The base claim 1 recites the limitations of “(i) the first microparticle reagent that specifically binds to at least one type of SARS-CoV-2 antigen or fragment or variant thereof”, and “(ii) the second microparticle reagent that specifically binds to at least one type of anti-SARS-CoV-2 antibody or fragment or variant thereof”. These limitations are unclear. Neither the claim nor the specification clearly defines the term “variant thereof” for the claimed antigen or antibody. Therefore, it is not clear what structural and/or functional characteristics the “variant thereof” must have.
B. These claims are incomplete for omitting essential steps and/or elements, such omission amounting to a gap between the steps. See MPEP § 2172.01. The claims are directed to a method for detecting presence or determining amount of anti-SAR-CoV-2 antibody or SAR-CoV-2 antigen in a biological sample, comprising: (a) contacting a biological sample with a first microparticle reagent that specifically binds to a SARS-CoV-2 antigen and a second microparticle reagent that specifically binds to an anti-SARS-CoV-2 antibody, and a detection composition comprising a first detection reagent comprising a detectible label that specifically binds to the first microparticle reagent to form a first microparticle reagent-first detection reagent complex and a second detection reagent comprising a detectible label that specifically binds to the second microparticle reagent to form a second microparticle reagent-second detection reagent complex; and (b) assessing the signal from each of the first and second microparticle reagent-detection reagent complexes.
The claims read on a combination of two microparticle-based tests: (i) one for antigen detection (antigen test) using a microparticle comprising a binding agent specific to the antigen to be detected (“the first microparticle reagent”), and (ii) one for antibody detection (antibody test) using a microparticle comprising a binding agent specific to the antibody to be detected (“the second microparticle reagent”). Labeled detection reagents that specifically bind to the microparticle reagents are used to produce signals for detection.
An embodiment (encompassed in claim 3) of the claimed method is shown schematically below:
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It is noted that the claims require that the detection reagent comprises at least one detectable label that specifically binds to the first or second microparticle reagent to form a microparticle-detection reagent complex. Such formation of a “microparticle-detection reagent complex” does not depend on presence of the analyte (e.g., the targeted Ag or Ab). In other words, as indicated in the figure above, the detection reagent binds to the microparticles (MPs) regardless if the MPs are associated to the targeted antigen/antibody or not. I.e., the claimed method, as interpreted above, does not distinguish between positive and negative samples. Therefore, the claims lack an essential step/element for the claimed method to be functional, amounting to a gap between the contacting step (step a)) and the assessing step (step b)).
Claim Rejections - 35 USC § 112 (Enablement)
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 1-19 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wriqht, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:1) the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention, 5) the state of the prior art, 6) the relative skill of those in the art, 7) the predictability of the art, and 8) the breadth of the claims. Id. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
M.P.E.P. §2164.03 [R-2] states: [I]n applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soil, 97 F.2d 623,624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833,839, 166 USPQ 18, 24 (CCPA 1970). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488,496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991 ). A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
The nature of the invention is described in the 112(b) rejection above (see the schematic figure). The steps recited in the claims do not appear to result in a definitive detection of the targeted antibody or antigen since the method as now claimed does not distinguish between positive and negative samples. The specification provides neither a working example nor sufficient guidance on how the omitted gap between the reagent contacting step and the signal assessing step is to be filled. After a considerable amount of search and consideration, no prior art information has been identified that provides teaching or guidance to fill the missing gap between steps a) and b) in the claims to enable the claimed invention. There is no evidence that a skilled artisan at a reasonable level of skills (e.g., PhD, which is considered as a common skill level for researchers in the field) can arrive and/or perform the claimed invention with predictability and without undue experimentation.
In the absence of such guidance and evidence of working examples, the specification fails to provide enablement to the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671