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 . 1
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 27, 2025 has been entered.
Status of Claims
Claims 2,4,14-16,21-24 and 26-28 are pending
Response to Arguments
Applicant’s amendments and canceling of claims, filed June 27, 2025, with respect to the objection of claims 13, 15 and 16 have been fully considered and are persuasive. The objection of claims 13, 15 and 16 has been withdrawn.
Applicant’s arguments filed June 27, 2025, with respect to Claims 13 and 20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/304564 A1 have been fully considered and are persuasive. The rejection of claims 13 and 20 has been withdrawn.
Applicant’s arguments filed June 27, 2025, with respect to Claim 20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/162803 A1 have been fully considered and are persuasive. The rejection of claim 20 has been withdrawn.
Applicant’s arguments filed June 27, 2025, with respect to Claims 13 and 15 rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/304564 A1 in view of U.S. 2018/162803 A1 have been fully considered and are persuasive. The rejection of claims 13 and 15 has been withdrawn.
Note, while claim 16 was previously noted to be allowable, the amendment of claimed subject matter required new searches and consideration of the claims, resulting in the below rejections despite the prior indication of allowable subject matter.
Claim Interpretation
In accordance with MPEP 2111, the broadest reasonable interpretation of Claim 16 is that it is directed to the metal complex or chelate composition that is not required to be prepared by the recited method. See MPEP 2113. Prior art that teaches the claimed composition, without necessarily reciting the claimed process steps will render the claimed metal chelate composition anticipated or obvious.
New Claim Rejections Necessitated by Amendment - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 4, 14-16, 21-24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/304564 A1 (US Pub 564).
Claim 16 is directed to a metal complex or metal chelate composition prepared using a process comprising combining a metal ion and a ligand in a closed system, under an inert gas, in the absence of a desiccant, to produce the metal complex or metal chelate composition, wherein:
the composition has a flowability as determined by a Hausner ratio of less than 1.12 or a Flowdex index of less than 10, and the composition has less than 1 % nanoparticles by total weight of the composition, wherein the nanoparticles have a particle size between 1 and 100 nanometers in at least one dimension.
The balance of claims depend from independent claim 16.
Claim 16 is a product by process claim. Prior art that teaches the claimed composition, without necessarily reciting the claimed process steps will render the claimed metal chelate composition known. Per MPEP 2113, claiming a composition per se, despite the limitations of process claims, prior art teaching the composition will nonetheless teach the composition.
Regarding the metal complex/metal chelate composition limitation US Pub 564 discloses its dry powder/particles contain one or more metal cation salts (see paragraph 64 and Table 2, magnesium, etc.), such as magnesium glycinate, see paragraph 71.
With regard to claim 16 and the limitation of flowability as determined by a Hausner ratio of less than 1.25, US Pub 564 discloses the claimed powder compositions have good flowability where the Hausner ratio of 1.1, 2 see paragraph 223.3
US Pub 564 does not teach the composition comprises less than about 1% nanoparticles by total weight of the composition.
However, US Pub 564 does teach that the volumetric median geometric diameter (VMGD) of the composition is preferably in various ranges of about 10 µM or less (about 0.1 µM (100 nM) to about 10 µM (10000 nM), between 0.1 µM (100 nM) to 1.0 µM (1000 nm)). See paragraph 200. These particle sizes are outside of the claimed nanoparticle size.
While there is a general teaching that the chelates compositions/metal complexes of US Pub 564 particle sizes greater than the 1 to 100 nM claimed size, it does not explicitly recite its composition has less than 1% by weight of composition. However, the teaching of a volumetric median geometric diameter (VMGD) in ranges of about 10 µM, i.e. about 0.1 µM (100 nM) to about 10 µM (10000 nM), is indication evidencing there is minimal presence of nanoparticles in the claimed range.
Further evidencing the near absence of nanoparticles in the composition of US Pub 564 as claimed, is the low Hausner ratio of 1.1, indicative of good flowability as claimed. In contrast to what is evidenced by US Pub 564, if the composition of US Pub 564 had a higher Hausner ratio, indicative of poor flowability, then this would be indicative of the presence of nanoparticles in the claimed range and claimed weight percentage of treat than 1%.
Prior to the filing of the present patent application, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) following the teachings of the US Pub 564 to formulate a metal complex or metal chelate composition such as magnesium glycinate with an overlapping Hausner ratio to modify it with secondary teachings from US Pub 564 in order to achieve the claimed nanoparticle limitation, where the Hausner ratio taught evidences the claimed amount of nanoparticles or lack of nanoparticles thereof. The PHOSITA would have had a reasonable expectation of success because the claimed metal complex/chelate composition with further teachings of the claimed Hausner ratio and particle size as detailed above.
Regarding claims 2 and 26 and the limitation of an amino acid ligand, for example, magnesium bisglycinate, US Pub 564 teaches various ligands with magnesium, in such as glycinate. See paragraph 71.
Regarding claim 4 wherein the composition has less than about 0.5% nanoparticles by total weight of the composition and particle size between 1 and 100 nm, as noted above, these limitations are taught by US Pub 564 as detailed above.
Regarding claim 14 wherein the metal is selected from the group consisting of iron, magnesium, zinc, calcium, and combinations thereof, US Pub 564 discloses various metal salts such as iron, magnesium, calcium see paragraphs 69-71. See also paragraph 77 for the teaching of Zinc.
Regarding claim 15 and the limitation of animal feed, US Pub 564 teaches the preparation of dry particles with its metal cations, including using a feed stock. See paragraph 180. US Pub 564 teaches its dry powders and dry particles include any veterinary product and/or agrochemical substance. See paragraph 91. A PHOSITA would readily envisage using the taught prior art metal chelates and metal complex compositions of US Pub 564 to formulate animal feeds as claimed.
Claims 21-24 and 27-28 recite further limitations of the process such as: a pressurized and jacketed reactor system, further comprising a pressure valve and gases from the process are flushed by inert gas from system; the inert gas comprises nitrogen and argon gas; and further comprises spray drying the metal complex and metal chelate composition; the claimed temperature of 65 Deg F to 23 Deg F; and the process being 30 % faster in the closed system than the process being carried out in an open system.
Regarding claims 21-24 and 27-28 that depend from claim 16, which are product by process limitations for the composition per se or complex per se, because claim 16 is interpreted as a product by process claim, where the limitations of the process of claims 21-25 are incorporated therein. Per MPEP 2113), the process steps of claim 16, are not considered to contribute to the overall patentability of the claimed composition.
Claims 21-24 and 27-28 are considered to be directed to a product-by-process limitations (see MPEP §2113). The manner in which the claimed composition is prepared, namely the process steps of Claims 21-24 and 27-28, that depend from claim 16, are not considered to contribute to the overall patentability of the claimed composition per se.
Conclusion and Correspondence
In summary no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 This application claims earliest priority to Dec 11 2019.
2 Starting at paragraph 221, the Hausner Ratio is a dimensionless number which is calculated by dividing the tap density by the bulk density. It is a number that is correlated to the flowability of a powder or granular material. See USP29<1174> for a further description of this method. There it is noted that dry powders with a Hausner Ratio greater than 1.35 are poor flowing powders. Flow properties and dispersibility are both negatively affected by particle agglomeration or aggregation. It is therefore unexpected that powders with Hausner Ratios that are higher than 1.7 would still be flowable. See paragraphs 221-222.
3 A suitable dry powder comprising the dry particles can have a Hausner Ratio that is at least 1.5, and can be at least 1.6, at least 1.7, at least 1.8, at least 1.9, at least 2.0, at least 2.1, at least 2.2, at least 2.3, at least 2.4, at least 2.5, at least 2.6 or at least 2.7; or, between 1.5 and 2.7, between 1.6 and 2.6, between 1.7 and 2.5, between 1.8 and 2.4, between 1.9 and 2.3. In a further aspect, the Hausner Ratio is about 1.1, about 1.2, about 1.3, about 1.4; or, the dry powder comprising the dry particles can have a Hausner Ratio that is between 1.0 and 1.5, between 1.1 and 1.4, about 1.1, about 1.2, about 1.3, about 1.4.
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