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 .
This is the first action on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: the term “subject” should be replaced with a “subject in need thereof” in claim 1. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: the terms “cream, emulsion, gel, liposome, nanoparticle, or ointment” are not carriers. A “carrier” is a substance that “carries” the active ingredient. Said terms are “forms” of the composition that may be “formed” as a result of the carrier or other substances in the composition. Appropriate correction is required.
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 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.
Claim Rejections - 35 USC § 102
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.
Claim(s) 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (BioRxiv, 2021, 1-23).
The reference teaches “Avoralstat inhibited several proteins that were structurally similar to TMPRSS2, including Factor VIla and Tryptase b2, despite being distant in primary sequence (Fig. 2f),” see page 5.
Thus, claim 18 is anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 7-18 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Sun et al. (BioRxiv, 2021, 1-23, cited on IDS) in view of Kato et al. (US 20050043304, cited on IDS), Gilmore et al. (US 6878706), Holgate et al. (Nature, 2008, 8, 218-230) and Burks (J Clin Invest., 2003, 111(7), 950-952).
The present claims are drawn to a method of treating allergy, asthma or mast cell activation syndrome comprising administering a tryptase inhibitor, e.g. avoralstat.
The Sun reference teaches “Avoralstat inhibited several proteins that were structurally similar to TMPRSS2, including Factor VIla and Tryptase b2, despite being distant in primary sequence (Fig. 2f),” see page 5. Therefore, Sun teaches avoralstat as a tryptase b2 inhibitor. Sun does not teach avoralstat as a treatment for allergy, asthma or mast cell activation syndrome.
Kato et al. teach “β-tryptase specifically induces airway contraction and airway inflammation owing to the degranulation of mast cells, and does not act on a living body unless the mast cells are degranulated. From the above, it is conjectured that a substance inhibiting human β-tryptase is useful in a treatment for the disease due to the mast cell activation, in particular, an allergic disease such as bronchial asthma,” paragraph [0004].
Burks teaches ingestion of peanuts, in a peanut-allergic individual, causes a cascade of events, which leads to activation of the mast cell, see page 951, Figure 1.
Thus, it would be obvious to one skilled in the art of medicinal chemistry to use avoralstat to treat an allergic disease, asthma or mast cell activation syndrome since Sun teaches avoralstat is a tryptase inhibitor, Kato teaches tryptase inhibitors as treatments for an allergic disease, asthma or mast cell activation syndrome and Burk teaches mast cell activation in peanut-allergic individuals.
The Kato reference further teaches regarding dosing, “Such an amount of the compound is administered at once or is divided into several portions to be administered. A dosage varies depending on various conditions, so that an amount less than any of the above dosage ranges may suffice,” see page 16, paragraph [0167]. Determining dosing, modes of administration, excipients and carriers is routine and conventional, unless such variables are critical. "Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). The adjustment of result-effective amounts taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results, unless there is evidence to the contrary. See also US 6878706 that notes this is routine optimization, columns 97-98, and more specifically at column 98, lines 12-14.
Holgate teaches corticosteroids, beta-2-adrenoceptor agonists and antihistamines as treatments for allergies and asthmas, see pages 221-222. It has been held that combinations of two or more compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). Thus, combining them flows logically from having been individually taught in the prior art.
Therefore, said claims are rendered obvious over
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSANNA MOORE/Primary Examiner, Art Unit 1624