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 .
Receipt is acknowledged of Amendments and Remarks filed on 08/06/25 and 10/14/25. Claims 1, 3, 6-13, 16-17, 19, 30-31 and 33 have been amended, claims 14-15, 18, 20-27, 29 and 32 have been cancelled and no new claims have been added. Accordingly, claims 1-13, 16-17, 19, 28, 30-31 and 33 remain pending.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 08/06/25 is acknowledged. The traversal is on the ground(s) that the claims do not meet the requirement for Unity of Invention. Applicant argues that “The Examiner indeed has acknowledged the composition of claim 1 is a common technical feature of all of the claims….. conclusion that the composition of claim 1 cannot be an innovative technical feature is improper”.
The argument is not found persuasive. This is not found persuasive because the special technical feature linking all inventions I-VIII is the composition which is known and has been employed in the relevant art previously. Since the technical feature linking each instant invention is known, it does not constitute a special technical feature as defined by PCT Rule 13.2. The claims of inventions I-VIII lack unity of invention, a posteriori. That is this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kuo et al. (US 20110171312, cited in the International Search Report) or Kuo et al (US 20090117193).
Whether a particular technical feature makes a “contribution” over the prior art, and therefore constitutes a “special technical feature,” is considered with respect to novelty and inventive step. The shared technical feature lacks novelty or inventive step because Kuo et al teach the composition as claimed. As such Kuo et al read on the technical feature of the instant claims. Thus, the claim elements are expressly taught or are rendered obvious by Kuo et al and is not above the prior arts, and therefore is not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
NOTE: With the amendments of 10/14/25, claim 16 depend on claim 2. This place claim 16 in Group I. As such claim 16 is rejoined and herein examined.
Accordingly, claims 1-12, 16 and 33 are under examination on the merits. Claims 13, 17, 19, 28 and 30-31 are withdrawn.
Claim Rejections - 35 USC § 112
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 1-12, 16 and 33 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.
Claims 1-12, 16 and 33 are indefinite because claims 1 and 11-12 recite components with their concentration in percentages. This is indefinite because the claims do not clearly specify the reference point used in calculating the recited percentage. It is unclear whether the wt% of the said components is expressed relative to i) the total weight of the formulation, ii) the weight of excipients, or another basis.
Remaining claims are also rejected for depending on claim 1 and including the same rejection.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation a ratio of about 1:1 to about 12:1, and the claim also recites optionally from about 1:1 to about 7:1 by weight; and optionally about 5.25:1 which are the narrower statements of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 33 is indefinite because it recites “the formulation of claim 1, for use in a method of treatment, wherein the formulation is to be administered by inhalation”. Because “the formulation” is a product and “administered by inhalation” is an active step of using the product, the claim is directed to more than one statutory class of invention. Note: MPEP 2173.05(p)(II). A single claim which claims both an apparatus (or product) and the method steps of using the apparatus (or product) is indefinite because it creates confusion as to when direct infringement occurs. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).
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.
and
(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.
Claims 1-10, 16 and 33 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gong et al (US 20050186146).
Applicant’s claims
Claim 1 is directed to a dry powder formulation including a plurality of microparticles, the microparticles comprising: a. about 2% to about 20% leucine by weight; b. about 0.5% to about 10% trileucine by weight; and c. an active agent,
wherein the leucine and the trileucine are present at a ratio of leucine:trileucine of about 0.1:1 to about 30:1 by weight.
Gong et al teach Interleukin-13 (IL-13) antagonist powders, spray-dried particles and a method of administering them to the lung (See Title and abstract).
Regarding claims 1, 3-7 and 9-10, Gong et al teach a dry powder formulation comprising particles with MMD of from about 0.5 micron to about 10 microns, (reading on microparticles), comprising: leucine; trileucine; an active agent (IL-13, an antibody), a sugar and a buffer. Gong et al disclose that the excipients including amino acids such as leucine and trileucine may be present from about 1% to about 60 wt% (See [0010], [0048], [0062], [0085], [0090], claim 37 and Table 16).
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The exemplified composition in Table 16 anticipates the claimed formulation as the formulation comprises an antibody, a glass stabilization agent, sucrose, a citrate buffer, leucine and trileucine. Leucine at 64% of the vehicle (assuming at 45% of the composition, 55% being the antibody) and trileucine at 20% of the vehicle amount to 28.8% and 9% respectively and wherein the ratio of leucine to trileucine is 3.2:1, meeting ratio limitation of both claims 1 and 10.
It is noted that 1- claim 1 is not clear on the basis of the said percentages and 2- the Specification defines “about” as variance of 10%. Thus, 28.8% is variance of 10% and meets the claimed about 20% of leucine.
The Specification states “When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%” (See [0036} of published Spec).
Regarding claims 2 and 16, Gong et al teach that the said dry powders preferably have a bulk density ranging from about 0.1-10 g/cc, such as about 0.25-4 g/cc, about 0.5-2 g/cc, or about 0.7-1.4 g/cc (See [0109]).
Regarding claims 6 and 18 Gong et al teach that the composition comprises at least one member selected from dextran, mannitol, raffinose, sorbitol, sucrose, trehalose, etc, (See [0092] and claim 35).
Regarding claim 7, Gong et al teach that the IL-13 antagonist compositions may also include a buffer such as salts of citric acid (to provide the corresponding citrate), ascorbic acid, phosphate buffer (See [0093]).
Regarding claim 33, Gong et al teach that the IL-13 antagonist compositions are delivered to the subject’s lung by inhalation (See [0013], [0044], [0058] and claim 47).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 1-12, 16 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al (US 20050186146).
Gong et al’s teachings are delineated above and incorporated herein.
Gong et al do not expressly disclose a composition comprising about 8% to about 11% leucine by weight and about 2% to about 4% trileucine by weight (Claim 11) or about 10.5% leucine and about 2% trileucine by weight (Claim 12).
However, Gong et al disclose that the excipients including amino acids such as leucine and trileucine may be present from about 1 to about 60 wt% (See [0085], [0090], claims 17 and 40).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have followed the teachings of Gong et al to arrive at the instant invention. It would have been obvious to do so because Gong et al teach the claimed compositions comprising dry (micro)particles comprising an active agent and excipients including leucine and trileucine, a buffer and a carbohydrate for administration to a subject’s lung by inhalation and provide guidance on the amount of such excipients. The teachings of Gong et al differ from the examined claims in that Gong et al do not expressly disclose a composition comprising the claimed ranges of leucine and trileucine. However, the broader disclosure clearly points one of ordinary skill in the art to the claimed ranges. That is, while Gong et al’s examples may contain higher amounts of leucine and/or trileucine or not expressly disclose the specific amounts in claims 11-12, one of ordinary skill in the art would have been motivated to have selected lower amounts to determine if the lower amounts would provide the same benefits in a dry powder formulation.
Regarding the modifications in concentration ranges, MPEP 2144.05 states “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed.Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Thus, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 1-12, 16 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Kuo et al (US 20090117193).
Kuo et al teach a highly dispersible formulation comprising an active agent and a dipeptide or tripeptide comprising at least two leucines, which possesses superior aerosol properties and is thus preferred for aerosolized administration to the lung (See abstract, [0006], [0019] and claim 25).
Regarding claims 1 and 10-12, Kuo et al teach that the said compositions comprise dry powder particles with a mass median diameter of less than about 10 microns (reading on microparticles) and contain from about 1% to about 99% by weight di- or tripeptide, preferably from about 2% to about 75% by weight di- or tripeptide, and even more preferably from about 5% to about 50% by weight di- or tripeptide. A preferred tripeptide is trileucine (See [0009], [0050]-[0051]). The said compositions also comprise an excipient including amino acids such as leucine (See [0019], [0046] and [0055]).
Kuo et al disclose test formulations comprising 5% or 20% leucine or 5% and 20% trileucine and state that tri-leucine is much more effective than leucine in improving the aerosol performance of dry powders. Moreover, a maximum in aerosol performance is typically achieved by the addition of only from about 5%-25% (wt) trileucine (See [0128] and [0133]).
Regarding claims 2 and 16, Kuo et al teach that the dry powder comprises particles having a bulk density from 0.1 to 10 g/cm3 and more preferably from about 0.15-1.5 g/cm3 (see [0009], [0075] and claims 23-24).
Regarding claims 3-8, Kuo et al teach that the said compositions comprise carbohydrate excipients such as fructose, glucose, lactose, sucrose, trehalose, raffinose, dextrans, mannitol, and the like. The compositions may also include a buffer include organic acid salts of citric acid (e.g. sodium citrate), ascorbic acid, acetic acid, phosphate buffers, etc, (See [0057]-[0058] and Table 15).
Regarding claim 9, Kuo et al teach that the active agent may be an antibody (See [0040] and claim 34).
Regarding claim 33, Kuo et al teach that said composition is suitable for delivery to the lung or deep lung by inhalation (See [0014], [0025]-[0026] and claims 2 and 39-40).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have followed the teachings of Kuo et al to arrive at the instant invention. It would have been obvious to do so because Kuo et al teach the claimed compositions comprising dry (micro)particles comprising an active agent and excipients including leucine and trileucine, a buffer and a carbohydrate for administration to a subject’s lung by inhalation and provide guidance on the amount of such excipients. The teachings of Kuo et al differ from the examined claims in that Kuo et al do not expressly disclose a composition comprising the claimed ranges of leucine and trileucine. However, the broader disclosure clearly points one of ordinary skill in the art to the claimed ranges. That is, while Kuo et al’s examples may contain higher amounts of leucine and/or trileucine or not expressly disclose the specific amounts in claims 11-12, one of ordinary skill in the art would have been motivated to have selected lower amounts to determine if the lower amounts would provide the same benefits in a dry powder formulation.
Regarding the modifications in concentration ranges, MPEP 2144.05 states “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed.Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Thus, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 1-12, 16 and 33 are rejected. Claims 13, 17, 19, 28 and 30-31 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616