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
Status of Claims
Claims 2,4,14-16,21-24 and 26-31 are pending
Response to Arguments
Applicant’s arguments and claim amendments, filed Feb 18 2026, with respect to Claims 2, 4, 14-16, 21-24 and 26-28 rejected under 35 U.S.C. 103 as being unpatentable U.S. 2017/304564 A1 (US Pub 564) have been fully considered. The amendment of claim 16 have necessitated the modified rejection below over the same prior art. The rejection of claims 2, 4, 14-16, 21-24 and 26-28 is modified and maintained as detailed below.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 31, that depends from independent claim 16, is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 has been amended to be limited to these specific ligands: “a ligand that is an amino acid, organic acid, monosaccharide, or protein. . . .”
Dependent claim 31 recites the ligand is ethylene diamine, which is not an amino acid, organic acid, monosaccharide or protein. Further, the specification, when defining ligands such as an amino acid, organic acid, monosaccharide, or protein, specifically defines ethylene diamine, outside the scope of those ligands listed in claim 16. See paragraph 11 reproduced below.
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Applicant may cancel the claim 31 amend the claim to place it in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 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 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/304564 A1 (US Pub 564). US Pub 564 (also referred to by Applicant as DeHaan) has been previously cited by the Examiner.
As reproduced below with amendments underlined, amended Claim 16 is a metal complex or metal chelate composition prepared using a process comprising combining a metal ion that is zinc, copper, magnesium, iron, chromium, selenium, calcium, or a combination thereof; and a ligand that is an amino acid, organic acid, monosaccharide, or protein 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,
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; and
the composition has a % water content of less than 7% and a% water activity of less than 0.5%.
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 (zinc metal and amino acid chelate, glycinate) 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. 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.
With regard to claim 16, US Pub 564 discloses the claimed powder compositions have good flowability (less than 1.25) where the Hausner ratio of 1.1, 2 see paragraph 223.3
With regard to claim 16 and moisture limitations (% water content less than 7%, water activity of less than 0.5 %), it is noted that US Pub 564 teaches its water content of compositions (dry particles/powders) of various amounts but typically in amounts of water content less than about 7% by weight, down to less than about 1% by weight. See paragraph 263.
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 low water content and water activity taught, 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, for example, magnesium bisglycinate, US Pub 564 teaches various amino acid ligands with magnesium, 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, 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, US Pub 564 teaches the preparation of dry particles with its metal cations, including using a feed stock, aka animal feed. 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.
Regarding claims 29-30, US Pub 564 teaches monodentate and multidentate ligands such as magnesium phosphate that bonds to metal through a single election pair, monodentate (paragraph 71); further, US Pub 564 teaches magnesium glycinate, where glycinate is a known multidentate (bidentate) ligand, see paragraph 71.
Claims 2, 4, 14-16, 21-24, and 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/304564 A1 (US Pub 564) in view of US 2004/0228950 (US Pub 950). US Pub 950 is cited on the PTO-892 form.
As detailed above, independent claim 16 and claims dependent 2, 4, 14, 21-24, and 26-30, stand rejected as being obvious over US Pub 564, teaching the claimed metal complex/chelate, inclusive of a ferric/iron metal chelate/complex with a ligand such as an amino acid, as detailed above, but they do not explicitly teach the amine ligand, ethylene diamine ligand of claim 31.
Regarding claim 31, US Pub 950 teaches use of compositions, comprising iron (ferric/ferrous forms) as a metal chelated and/or complexed with amino acid chelates/ligands and/or sugar-carboxylate complexes. See claim 2. US Pub 950 teaches such iron/ferrous forms include, among other complexing agents, ethylene diamine tetra acetate (EDTA). See claim 3. This is similar to US Pub 564 disclosing 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
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 in view of US Pub 950 of claim 31, where both references are directed to metal complexed/chelated with known ligands such as those taught in US Pub 564 and specifically, the known ligand, ethylene diamine, also known as EDTA. The PHOSITA would have had a reasonable expectation of success because the claimed metal complex/chelate composition and choice of metal ligands such as EDTA are known in the art.
RESPONSE TO ATTORNEY ARGUMENTS:
The Attorney response argues any modifications, manipulations of particle sizes/physical properties of DeHaan (aka US Pub 564) would have been solely to produce an alternative asthma inhaler of dry powders with particular inhalable medicament parameters.
In response to applicant's argument that US Pub 564 is nonanalogous art (producing an asthma inhaler with particular medicament parameters, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, despite the attorney arguments noting differences from the cited art (art of asthma inhalers) and the implication it differs from the claimed invention, the claimed invention is nonetheless broadly claimed to be a metal complex/chelate as recited therein taught by the cited prior art US Pub 564 as detailed above.
In response to applicant's argument that there is no evidence that any of the claimed parameters, including flowability, nanoparticle percentage, water content/activity are desirable or suitable for any inhaled medications, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
While the Attorney response that there is no evidence the claimed parameters are suitable for the disclosure of the cited prior art, (i.e., an express suggestion in any or all of the references) the claimed invention is nonetheless broadly claimed to be a metal complex/chelate as recited therein taught by the cited prior art US Pub 564 as detailed above.
The Attorney response states DeHaan notes the production of powders having higher Hausner ratios that are still flowable, see paragraph 0222 of US Pub 564. See also paragraph 223.
In response, while US Pub 564 discloses the flowability of powders at levels greater than claimed (Hausner ratio 1.1), there is no teaching away by US Pub 564 that the Hausner ratios of less than 1.1 are NOT flowable.
Conclusion
In summary no claims are allowed. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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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