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 .
Claims Status
Claims 20-24 is/are cancelled. Claims 1-19 is/are currently pending and under examination.
Claim Interpretation
The claims contain limitations preceded by the term “optional”. All claim limitations recited as “optional” are interpreted as not required. As such, prior art can be applied to teach these limitations, but does not need to be applied.
Claim Objections
Claims 1, 3, 7, 11, 18 are objected to because of the following informalities:
Claim 1 recites that x is at least one of 1-35, 4-29, 4-30, 14-30, 15-30, 11-14, and 30-35. As each value of 1-35 is recited individually in claim 1 lines 9-10, the examiner suggests that the recitations of 4-29, 4-30, 14-30, 15-30, 11-14, and 30-35 in lines 10-11 are not necessary. Examiner suggests the following amendment: “selected from the group consisting of 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35.”
Claim 3 recites “at least four PCC of fatigue symptom” (lines 2-3). This limitation should read “at least four PCC of fatigue symptoms”.
Claim 7 recites that “n is from 40 to 40,000”. For clarity, the examiner suggests the following phrasing: “n is a value selected from 40 to 40,000”.
Claim 11 recites that the subject was infected with SARS-CoV-2 “for a time”. The plain interpretation of this is that the subject had this infection for the entire time period. In order to clearly recite that the subject was infected at a point in time prior to administration, the claim could be modified as follows: The method of claim 1, wherein the subject was infected with SARS-CoV-2 initially 30 days, 50 days, 2 months, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years, or more than 2 years before the administering step, and wherein the infection was resolved before the administering step.
Claim 18 is missing the term “and” between lines 2 and 3 (“for the first two weeks, and two times a week…”).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
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 1-19 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 1 recites that “x” of formula A “is at least one selected from the group consisting of” 4-35. Formula A indicates that x indicates the number of cytosines in formula A. It is unclear how x can be more than one value, and as such, the metes and bounds of claim 1 are unclear and claim 1 is rendered indefinite. Claims 2-7 and 9-19 depend on claim 1 but do not clarify this indefiniteness.
Claim 1 recites that formula A is r(In)·r(CxU)n. However, none of claims 1-6 or 8-19 defines the bounds of variable “n”. The metes and bounds of claim 1 are therefore left undeterminable and unclear, and claim 1 is rendered indefinite. Claims 2-6 and 8-19 depend on claim 1 and do not clarify this indefiniteness, and thus are rendered indefinite. Claim 7 does define the bounds of variable “n”.
Regarding claim 4, the phrases “preferably”, “more preferably”, “most preferably”, and "such as" render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c) and § 2173.05(d).
The term “about” in claims 7 and 15 is a relative term which renders the claims indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. On page 19 of the specification, “about” is defined as a term which “may refer to the statistical uncertainty associated with a measurement or the variability in a numerical quantity that a person skilled in the art would understand does not affect the operation of the disclosure or its patentability.” However, the specification does not disclose the degree of variability or uncertainty encompassed by the term “about”. An artisan would not be able to determine the range of variability or uncertainty encompassed by the term “about”. Thus, claims 7 and 15 are rendered indefinite.
Claim 14 recites the limitation "the…medical device" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 1 and 13, on which claim 14 depends, do not recite a medical device.
112(a):
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 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession 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 the 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. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it”).
According to the MPEP § 2163, "The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutsch land GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")."
Claim 1 recites that formula B is “rugged dsRNA”. However, the claims do not provide a structure of rugged dsRNA or of formula B. The specification provides a description of rugged dsRNA on page 15. While specific formulae are provided (see page 15 lines 19-20), the description does not limit rugged dsRNA to these formulae; the broadest reasonable interpretation of the phrase “in another aspect”, which prefaces the list of rugged dsRNA formulae, is that it indicates optional specifications, similar to the phrase “in an embodiment”. Amendment of claim 1 to additionally recite that the rugged dsRNA is selected from r(In)·r(C-4-29U)n, r(In)·r(C12U)n, r(In)·r(C11-14U)n, r(In)·r(C30U)n, and r(In)·r(C30-35U)n, or that the rugged dsRNA has the structure of r(In)·r(CxU)n, would be remedial.
Claims 2-19 depend on claim 1 and do not rectify the lack of written description of claim 1, and thus claims 2-19 are additionally rejected for lack of sufficient written description.
Subject Matter Not Found in the Prior Art
The following is a statement of reasons for the indication of allowable subject matter: the prior art does not teach a method of treating a subject previously infected with SARS-CoV-2 and exhibiting at least one PCC of fatigue symptom, comprising administering a tdsRNA comprising formulas A and/or B. Methods of treating other post-viral fatigue conditions using a tdsRNA were known in the prior art (see Strayer, 2020). However, at the time of filing, it was not clear that post-COVID-19 conditions of fatigue could be treated with the same methods; while some art suggested that studies should be performed to determine if PCC of fatigue could be treated by administering tdsRNA (Strayer, 2020), no studies had been performed before the effective filing date of the instant application, and no methods of treating post-COVID-19 chronic fatigue with tdsRNA were described in the prior art. As post-COVID-19 chronic fatigue encompasses some of the same symptoms, but not all of the same symptoms, as other post-viral chronic fatigue conditions, and the underlying mechanisms of post-COVID-19 chronic fatigue were not fully understood at the time of filing but were understood to not be identical to the underlying mechanisms of other post-viral fatigue conditions, an artisan would not have been able to assume that a method of treating a different post-viral chronic fatigue condition using a tdsRNA composition such as in Strayer (2020) could be used or modified to be used as a method of treating post-COVID-19 chronic fatigue. As such, claims 1-19 are free of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM EST.
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/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/KIMBERLY CHONG/ Primary Examiner, Art Unit 1636
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