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 .
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.
DETAILED ACTION
Claims 1-6, 12-16, and 18 are pending, claims 7-11 and 17 are canceled in this application. This application is a national stage entry of PCT/SG2022/050819, filled on 11/10/202. This application claims foreign priority to SG 10202112736W, filed on 11/16/2021 in Singapore.
Election/Restrictions
Applicants’ election without traverse of Group I, claims 1-6, filed on 06/11/2026 is acknowledged.
Claims 12-16 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 1-6 will presently be examined to the extent they read on the elected subject matter of record.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 112/Second paragraph or (b)
The following is a quotation of the second paragraph 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 3 and 4 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 applicant regards as the invention.
The recitations of di-leucine to tri-leucine ratios in claims 3 and 4 render the claim indefinite. The unit (by weight or base molar) of di-leucine to tri-leucine ratio 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. Hence, one of ordinary skill could not ascertain and interpret the metes and bounds of the di-leucine to tri-leucine ratio claimed in claims 3 and 4 as being based on weight or molar.
To expedite the prosecution di-leucine to tri-leucine ratio is given its broadest reasonable interpretations by the examiner in light of the specification in the 103 rejections as by weight.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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).
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.
Claims 1-6 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kuo et al. (US 2009/0117193 A1).
Kuo et al. teach an inhalation dry powder (the instant claim 1) (claims 1 and 2) with < about 3% moisture (paragraph 24) comprising
an active agent such as α-1-antitrypsin (the instant claim 1) (claim 1 and 22);
about 5-75% by weight of di-leucine or tri-leucine (the instant claim 1) (claims 1, 5, 6, 12-14),
sodium chloride (the instant claim 1) (paragraph 59), and
sucrose (non-reducing sugar in the instant claim 1) (paragraph 56);
wherein the dry powder is prepared by spray-drying (paragraph 12 and 62) → forms crystalline (the instant claim 2) according to the instant specification in the polarograph bridges page 3 and 4.
Kuo et al. do not teach the claimed combination of both di-leucine and tri-leucine in the instant claim 1 (di-leucine or tri-leucine vs the claimed di-leucine and tri-leucine), the same weight percentage in the instant claim 1 (about 5-75% vs the claimed ≥50%), and the claimed increase% of the bioactivity of the dry powder in comparison to pre-formulated α-1-antitrypsin in the instant claim 6; and di-leucine to tri-leucine weight ratio in the instant claims 3 and 4.
This deficiency is cured by the rationales that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art; and that optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to modify the di-leucine or tri-leucine taught by Kuo et al. to combine di-leucine and tri-leucine. It is generally considered to be prima facie obvious to combine compounds each of which is taught by the prior art to be useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from them being recognized in the prior art as useful for the same purpose. See MPEP 2144.06 and MPEP 2141 I:
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
When considering obviousness of a combination of known elements, the operative question is thus “whether the improvement is more than the predictable use of prior art elements according to their established functions.
The claimed range of di-leucine and tri-leucine is ≥50% by weight and the range of di-leucine or tri-leucine (being obvious to be di-leucine and tri-leucine as discussed above) taught in the prior art is about 5-75% by weight and therefor, overlaps with the claimed range. MPEP 2144.05.II.A:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
While it is obvious to be di-leucine and tri-leucine as discussed above, there must be a weight ratio between di-leucine and tri-leucine. Kuo et al. teach dileucine and tripeptides are superior in their ability to increase the dispersibility of powdered compositions (paragraph 45). Thus, the amounts of dileucine and tripeptide, and subsequently the weight ratio between them, in a composition is clearly a result effect parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal weight ratio between dileucine and tripeptide in order to best achieve the desired results. See MPEP 2144.05:
“[W]here 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.”
Kuo et al. are silent about increase% of the bioactivity of the dry powder in comparison to pre-formulated α-1-antitrypsin. Increase% of the bioactivity of the dry powder in comparison to pre-formulated α-1-antitrypsin is the inherent property of the formulation being in spray-dried powder form as compared to suspension form according to the instant specification page 5, line 16-20. The formulation taught by Kuo et al. is the same spray-dried powder, thus the spray-dried powder taught by Huo et al. would necessarily possess the property recited in the instant claims.
Kuo et al. do not teach the same moisture content in the instant claim 5 (< about 3%vs the claimed <1%)
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed range of moisture content is <1% by weight and the range of moisture content taught in the prior art is < about 3% by weight and therefor, includes the claimed range.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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