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 .
DETAIL ACTION
This office action is a response to a 371 application filed 2/16/2024, which is a national stage application of PCT/US2022/075485 filed 8/24/2022, which claims domestic priority to 63/239,038 filed 8/31/2021.
As filed, claims 1-7, 13, 14, 16-21, 24-26, 30, and 31 are pending; and claims 8-12, 15, 22, 23, and 27-29 are cancelled.
Election/Restrictions
Regarding the election of species requirement, Applicant elected the species of dexamethasone for the instantly claimed alternative treatment; and the species of SARS (SARS-CoV) for the instantly claimed lower respiratory tract infection, which can be found in pg. 6 and 2 of the instant specification, respectively. The Examiner finds that the claims, which read on both elected species, are instant claims 1-7, 14, 16-21, 24-26, 30, and 31.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, appear to make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Because the Markush-type claims (i.e. claims 1 and 2) appeared to be free of prior art, claim 13 is rejoined and examined herein. Accordingly, the election of species requirement is hereby withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/4/2024 and 4/23/2025 has been considered by the Examiner.
The information disclosure statement (IDS) submitted on 10/17/2024 has been considered by the Examiner except Cite No. 1 under the section of “NON-PATENT LITERATURE DOCUMENTS”, where it was lined through.
In order to consider the non-patent literature, an English translation of the cited reference is needed.
Claim Rejections - 35 USC § 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, 3, 5-7, 13, 14, 16, 17, 21, 24-26, and 30 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.
Claim 1 recites the limitation, “alternative treatment”, in reference to the instantly claimed process. Applicant has not described the claimed genus of “alternative treatment” in a manner that would indicate they were in possession of the full scope of the genus, or even to describe what the genus is comprised of.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
In the instant case, the claimed ““alternative treatment” encompasses any known and unknown molecule (e.g. compound, siRNA, antibody, etc.) that has therapeutic activity toward lower respiratory tract infection. Applicants described antiviral medication (e.g. remdesivir); steroid (e.g. prednisone or dexamethasone) or monoclonal antibody as examples of “alternative treatment”, which are not described adequately enough to allow one skilled in the art to ascertain that Applicant is in possession of the entire scope of the genus. Applicants have not described this genus in a manner that would allow one skilled in the art to immediately envisage the therapy contemplated for use.
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(pg. 9, lines 3-10 of the instant specification)
The law recognizes the pharmaceutical art as an unpredictable art and requires each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970). Accordingly, the more unpredictable an area is the more specific disclosure is necessary in order to satisfy the statute. Section 2164.02 of the MPEP provides:
"[C]orrelation” as used herein refers to the relationship between in vitro and in
vivo animal model assays and a disclosed or a claimed method of use . . . if the
art is such that a particular model is recognized as correlating to a specific
condition, then it should be accepted as correlating unless the examiner has
evidence that the model does not correlate.
In light of these remarks, the Examiner finds that one of ordinary skill in the art would agree with the court; that is, the pharmaceutical art is unpredictable. Thus, a substantial correlation is necessary for the claimed “alternative treatment”. As such, the claims lack adequate written description for the claimed “alternative treatment”.
Regarding claims 3, 5-7, 13, 14, 16, 17, 21, 24-26, and 30, these claims are dependent of claim 1, and they failed to correct the defective issue of claim 1, which rendered these claims defective.
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.
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, 5-7, 13, 14, 16, 17, 21, 24-26, and 30 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, the claim recites the phrase, “the probability”, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” probability. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 1, the claim recites the phrase, “the treatment”, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” treatment. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 1, the claim recites the phrases, “the level of SP present in the plasma sample is elevated” and “the level of SP present in the plasma sample is not elevated”. It is unclear to the Examiner how a person of ordinary skill in art can determine what level of SP present is considered elevated or not elevated. With such ambiguity, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
Regarding claim 17, the claim recites the phrase, “the tradipitant dose”, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” tradipitant dose. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 30, the claim recites the names of the following crystalline forms of tradipitant, such as crystalline form IV or crystalline form V, without providing any PXRD pattern. Accordingly, it is unclear to the Examiner what are the metes and bounds of these crystalline forms, based on only the abovementioned names. As a result, the claim does not stand alone and one must refer back to the specification to define the claimed invention to determine the metes and bounds of the claim and thus, the claim is rendered indefinite.
Regarding claims 3, 5-7, 13, 14, 16, 17, 21, 24-26, and 30, these claims are dependent of claim 1, and they failed to correct the indefinite issue of claim 1, which rendered these claims indefinite.
Claim Objections
Claims 1, 2, 21, and 31 are objected to because of the following informalities:
Regarding claims 1 and 2, the claims recite the phrase, “SP present in the plasma sample”.
Such expression can be clarified by reciting -- SP present in
Regarding claims 21 and 31, the claims recite the phrase, “wherein administering the tradipitant to the patient tradipitant further comprises”, which contains typographical error.
Such expression can be corrected by reciting -- wherein administering the tradipitant to the patient --.
Appropriate correction is required.
Claims 4 and 18-20 are objected to as being dependent upon an objected base claim, but would be allowable if the objection of the base claim is corrected.
Conclusion
Claims 1, 3, 5-7, 13, 14, 16, 17, 21, 24-26, and 30 are rejected.
Claims 1, 2, 4, 18-21, and 31 are objected.
Claim 13 is withdrawn.
Claims 8-12, 15, 22, 23, and 27-29 are cancelled.
The particular patient population having an elevated level of substance P present in a plasma sample do not appear to have been disclosed previously in the prior arts. For at least this reason, the instant claims are substantially differentiated from any prior art reference, such as non-patent literature titled “Odyssey: A Study to investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 infection”, hereinafter NCT04326426 (see IDS filed 10/4/2024). Furthermore, the prior art provide insufficient guidance or motivation that would have led a person having ordinary skill in the art to arrive at the instantly claimed process.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
