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 .
CONTINUING DATA
This application is a 371 of PCT/JP2022/034943 09/20/2022
FOREIGN APPLICATIONS
JAPAN 2021-156321 09/27/2021
Claims 10-17 are pending.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP-2004531539-A, machine translation.
JP-2004531539-A teaches the use of azithromycin (which has a 15-membered ring) for treating rheumatoid arthritis. See claims 1 and 7. The dose is 30-1500 mg. See claim 23. Treatment of emphysema is also taught in claim 2 of the reference. The composition can be administered locally [0047]. An exemplified dose is 500 mg [0070].
Diseases accompanied with destruction of bone tissue or lung tissue include rheumatoid arthritis and emphysema as recited on page 14 of the current specification, so subjects suffering from these disorders are in need of treatment for regenerating bone or lung tissue. The current specification page 11 states that an effective dose is generally about 100 µg to 1200 mg. Thus, JP-2004531539-A teaches administration of an effective amount of azithromycin for treating subjects in need of regenerating bone or lung tissue and subjects suffering from a disease accompanied with destruction of bone tissue or lung tissue.
Claim(s) 10-13 and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sotgia (CN 201980079188 A, machine translation).
Sotgia teaches a method of delaying the onset of an age-related disease by administering azithromycin, roxithromycin, telithromycin, or their analogs (claim 29). The age-related disease is osteoporosis (claim 30).
Diseases accompanied with destruction of bone tissue or lung tissue include osteoporosis as recited on page 14 of the current specification, so subjects suffering from osteoporosis are in need of treatment for regenerating bone or lung tissue, or treating a disease accompanied with destruction of bone tissue, or preventing deterioration of bone regenerative capacity, or for activating bone regenerative capacity.
Claim(s) 10-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaur (DJAS 4(11), 94-103, 2016) as evidenced by Thronton-Evans.
Kaur teaches that local delivery of azithromycin (a 15-membered macrolide antimicrobial drug) encourages bone formation in the treatment of periodontitis. See abstract. Subjects were in the age group of 25-60 years, so subjects are reasonably interpreted to be aging. See page 96, Patient Population.
Thornton-Evans (CDC Supplements, November 22, 2013, 62(03); 129-135) teaches that Periodontitis increases with age. See Introduction. Thus, periodontitis is associated with aging. The current specification paragraph [0002] recognizes that bone destruction is associated with periodontitis.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693
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