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 .
Status of the Claims
Claims 3-4, 6, 8, 12, 14-19, 23-25, 27-28, 30-31, 33, and 39 are cancelled. Claims 1, 2, 5, 7, 9-11, 13, 20-22, 26, 29, 32, 34-38, 40-42 are pending. Claims 3-4, 6, 8, 12, 14-19, 23-25, 27-28, 30-31, 33, and 39 are cancelled. Claims 1, 2, 5, 7, 9-11, 13, 20, 41 and 42 are withdrawn.
Claims 21-22, 26, 29, 32, 34-38, and 40 are under examination.
Priority
This application is a 371 of PCT/EP2022/077586, filed on 10/4/2022. The application is claiming priority to EP21200711.6, filed on 10/4/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/19/2023 and 5/29/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
Applicant's election with traverse of Group II (claims 21-22, 26, 29, 32, 34-38, and 40) in the reply filed on 1/27/2026 is acknowledged. The traversal is on the ground(s) that applicant’s inventive concept isn’t related to dual release products, but is related to the magnesium containing cores which were characterized after a vibration screening and are abrasion resistant. This is not found persuasive because it was noted on page 6 of the election/restriction requirement that groups I and III lack unity of invention with Group II as the inventions of groups I and III necessitated the lipid coating while group II is concerned with characterizing just cores (particles) of magnesium compound, which is not reliant on them being coated (i.e. they are only being characterized for potential coating with lipid). The method of characterizing in group II does not rely on any cores being coated and having a portion be in extended release form. Thus, group II lacks unity for not sharing the same or corresponding technical feature that is shared between groups I and III (the lipid coating for extended release). Group II, claim 21, is also noted as conditional in regards to the characterizing step (use of “if” before reciting fractions of particles that could be characterized). Applicant has elected group II.
The cited prior art that applicant argues was being used to break unity of groups I and III where both of these groups rely on a lipid coated magnesium containing core as an extended release particle along with non-extended release particles of magnesium compound. As the applicant elects group II (the method of characterizing magnesium containing cores/particles), this argument is moot. However, it is noted that the ManufacturingChemist does provide for the type of lipid coating as applicant is claiming with groups I and III and its use on magnesium containing particles where the inventive concept appears to rely on identifying/obtaining magnesium-containing particles suitable for this kind of coating, where ManufacturingChemist teaches that the magnesium containing particle have the coating, and thus, must have been deemed suitable for the coating process. Applicant argues that the reason for the change in methodology was to have cores that are suitable for this kind of coating and Figures 2, 3 and 4 provide for results of the particles with coating compared to uncoated and so the lipid coated particles with magnesium containing cores are the inventive concept in considering groups I and III.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 2, 5, 7, 9-11, 13, 20, 41 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/27/2026.
Claim Objections
Claim 21 item (iii) is objected to for missing the word “after” between “800 µm” and “at least a screening time..”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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 21, 22, 26, 29, 32, 34-38 and 40 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 21 and 40 are indefinite as the final two “-“(dashed) statements in the end of the claim refers to “this screen diameter” where two different fractions of particles with screen diameters are mentioned in part (ii) of the claim. Thus, it is unclear what “screen diameter” is “this screen diameter” that applicant is referring to. The applicant may detail the particles they are referring to rather than using “this”.
Claims 22, 26, 29, 32, and 34-38 are rejected as being dependent on an indefinite claim.
Claim 21 is indefinite for the recitation of “at least a screening time of 5 minutes and a screening time of 60 minutes” as it is unclear if this refers to “at least 5 minutes” for one screening time and “at least 60 minutes” for the other allowing for these ranges or if applicant means to say at least both those screenings have to take place (one at 5 minutes and one at 60 minutes). For the purpose of compact prosecution, the examiner will consider the claim as though one screening is done in a time of 5 minutes and another is done at 60 minutes.
Claims 22, 26, 29, 32, and 34-38 are rejected as being dependent on an indefinite claim.
Claim 21 recites the limitations of "the fine fraction of particles" and “the fraction of particles” in part (ii) of the claim without a previous recitation of “fine fraction of particles” and “fraction of particles” nor a mention of particles. There is insufficient antecedent basis for this limitation in the claim.
Claims 22, 26, 29, 32, and 34-38 are rejected as being dependent on an indefinite claim.
Claim 32 recites the limitation "per screen tray" in the claim without a previous recitation of “a screen tray” or “screen trays” in claim 21, on which claim 32 depends. There is insufficient antecedent basis for this limitation in the claim.
Claim 40 is indefinite for the recitation of “are suitable especially for producing the solid, lipid-coated pharmaceutical or nutraceutical composition” as it is unclear if the item following “especially” is part of the claimed invention or merely a special example. Applicant may delete “especially” from this limitation.
Claim 40 is indefinite for referring to “…which in this test” in line 2 of the claim as it is unclear which test applicant is referring to as “this test” or if applicant is referring to “in the method of characterizing”. As the characterization method can encompass different tests, it would not be certain which test this would be. If applicant means to say that “wherein the method for characterizing results in the magnesium-containing cores that have an abrasion resistance….”, then applicant may consider such wording.
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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 21-22, 34, 38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Colgrove US 20180104719; 911 Metallurgist (Particle size distribution, February 2018, https://www.911metallurgist.com/blog/particle-size-distribution/#:~:text=The%20sieving%20operation%20starts%20by,the%20same%20time%20or%20consecutively.); Liu et al (Powder Technology, 2009, volume 193, pages 208-213), and Sakamoto US 20170042935.
In claim 21, step (i), the step is carrying out a vibration screening, but it is broad as it is not indicated what the vibration screening is carried out on.
In claim 21, step (ii), the step involves determining of screen diameters, but also does not specify the type of particles being determined. Thus, it is construed broadly in regards to particles.
In claim 21, step (iii), this is the first step where magnesium-containing cores are mentioned for a step in the body of the method claim.
In claims 22, 26, 29, 32, and 34-37, applicant uses the word “around” in the same manner as “about” or “approximately” when placed in front of numerical values relating to bulk densities, sizes and masses.
When applicant uses “and optionally” it is considered that the item after it may or may not be used.
Claim 21 and its dependent claims are to characterizing magnesium-containing cores comprising or consisting of a magnesium compound, where the intended use of those cores is “for producing a solid, lipid-coated pharmaceutical or nutraceutical composition in a fluidized bed”. The claim only requires characterizing and does not need the cores to be made into the solid, lipid-coated composition in a fluidized bed. Thus, the claim is examined for the steps (i) and (ii) regarding characterization appearing after “the method comprises the steps of:”. Note the comment on step (iii) using “if” language in claim 21 below.
Additionally, claim 21 notes that “suitable for producing the solid, lipid-coated pharmaceutical or nutraceutical composition in a fluidized bed if they have abrasion resistance such that after carrying out vibration screening….”. The use of “if they” is optional language where what appears after “if” does not have to occur since “if” suggests something that can happen in one scenario. “Characterizing magnesium-containing cores as suitable…” in part (iii) only provides that the cores after undergoing steps (i) and (ii) could be deemed suitable in (iii) “if” they meet the characteristics that appear after “if they” in the limitation.
“Suitable” in claim 40 implies the cores after the characterization are deemed suitable for producing, but the claim does not require steps to actually produce the solid, lipid-coated pharmaceutical or nutraceutical composition”.
For claim 40, in regards to limitation of “screening time of 60 minutes is higher by not more than….relative to the initial fine fraction of this screen diameter after a screening time of 5 minutes”. If the prior art teaches overlapping particle/core size ranges, vibration screening, screen opening/pore sizes, and magnesium containing particles/cores as well as different times for collecting for examining/screening sizes, then it will read on the claim as characterization that can occur after a vibration screening for sizes that are known for particles including those containing magnesium compound(s). This is the same for the limitation of “screening time of 60 minutes is lower by not more than…. relative to the initial fine fraction of this screen diameter after a screening time of 5 minutes”. Essentially, these limitations together imply that after 60 minute screening, one has more/higher number of particles less than 200 microns and somewhat less particles between 200 and 800 microns as compared to what is present with only 5 minutes of screening (in a percentage over zero and up to the percentage listed). “By not more than” means “less than”, so even a very slight increase and very slight decrease, respectively, would qualify.
Colgrove teaches vibration screening machines that include stacked screening deck assemblies with a tower being shown in figure 3 (see abstract and figure 3). Colgrove teaches “The screen assemblies can be secured to respective ones of the plurality of the screen deck assemblies by tensioning the screen assemblies in a direction that a material to be screened flows across the screen assemblies” (abstract). Colgrove also teaches “An undersized material discharge assembly can be configured to receive materials that pass through the screen assemblies, and an oversized material discharge assembly can be configured to receive materials that pass over the screen assemblies” (abstract). Colgrove teaches an embodiment with at least eight screen deck assemblies (paragraph 29). Colgrove teaches openings/pores and magnitudes of 20 microns to 100 microns and additionally 43 microns to 1000 microns (paragraph 68, also paragraph 54 with screen openings). Colgrove provides these sizes for the screen openings/pores, which would overlap with screen diameters for particles. Colgrove teaches particles of material (paragraphs 64 and 69). Importantly, Colgrove notes separating materials of various/varying sizes (paragraphs 23 and 25). Colgrove teaches figure 3 with having collecting pans (paragraph 46) that is in a tower configuration. Colgrove teaches a collection assembly 160 (paragraph 46, figure 3) which appears like a cup to collect materials. Colgrove teaches screen assemblies with a length of 56 cm and width of 30 cm (paragraph 72).
Colgrove allows for various materials/particles to be screened. Colgrove teaches a vibration screening process with tower configuration and multiple screens.
Colgrove does not teach magnesium containing cores as the material particles to be screened. Colgrove does not provide for screening times of 5 and 60 minutes. Colgrove does not teach sample sizes. Colgrove does not teach the sieve trays being round (having a diameter).
911 teaches “Sieving is one of the simplest methods of determining particle size distributions, and is probably used in industrial laboratories more than any other method” (first paragraph). 911 teaches sets of standard screens that are circular/round and in a tower configuration (figure 1). 911 teaches “A method which has been suggested for determining the optimum sample size starts by splitting out, with a sample splitter, samples of varying weights, for instance 25, 50, 100, 150, and 200 g” (Methods of Making Particle Size Determinations). 911 teaches that each sample is sieved for the same length of time with an example of 5 minutes on a nest of sieves (Methods of Making Particle Size Determinations). 911 teaches “The sieving time is somewhat arbitrary. It should be sufficiently long that the changes produced by continued agitation can be considered to be negligible. If accurate comparisons of various materials are to be made, the sieving time, sample size, screens, and method of agitation should all be standardized”. 911 provides for shakers and high frequency vibrators for screens, but also provides in figure 2 a Ro-Tap shaker or a hand operated shake in figure 3 (shaker operates at lower frequency, shaking is still causing vibrations/vibratory). Thus, frequency (indicated as amplitude in applicant claims) is adjustable based on the device used. 911 teaches comparing methods of particle size analysis.
Liu teaches important factors in sieving particles including duration and milling method (impact vs abrasive) (abstract). Liu teaches times for sieving of 60 minutes (section 2.3 and table 1 and section 3.3) and a time distribution for each sieve. Liu provides “The observed difference in sieving efficiency and performance and in sieving loss between the two sieving methods can be attributed to the beneficial effect of oversized particles, since during sieving, the presence of oversized particle can reduce sieve blinding caused by near or sub-sieve sized particles” (Conclusions).
Sakamoto teaches magnesium oxide as a pharmaceutical or food additive (abstract). Sakamoto teaches the percentage of granules having a particle diameter of less than about 150 μm is usually about 10% by weight or less (paragraph 30). Sakamoto teaches “the average particle diameter of the magnesium oxide granules is not particularly limited, and is, for example, usually about 150 to about 425 μm” (paragraph 31). Sakamoto teaches vibration sieving to prepare desired magnesium oxide granules (paragraph 61). Sakamoto teaches the advantage of the magnesium granules is reducing tableting problems and reduced quality defects (paragraph 17).
One of ordinary skill in the art before the time of filing would have used vibration screening taught by Colgrove as an acceptable method of screening particles including magnesium oxide particles of Sakamoto having benefits as pharmaceutical or food additive uses, which also recognizes vibration screening/sieving, as this was seen as a method for size analysis and separation of particulate materials. Each of the references provides for sieving/screening of particles for particulate materials, which would lead one of ordinary skill in the art to combine teachings to produce screening methods for magnesium oxide particles. One of ordinary skill in the art would utilized circular trays (would have a diameter) as vibration screen towers were available in these shapes by teachings of 911 as well as collecting particles at 5 minutes and using sample weights of applicant’s claims in teachings of 911 since these were also taught for screening/sieving methods. One of ordinary skill in the art based on teachings of Liu would have also collected particles at 60 minutes as this time frame was also available for sieving/screening of particle materials. The prior art teaches size ranges of the sieve/screen openings and magnesium oxide containing particles that overlap with applicant’s claimed ranges, and thus, particles less than 200 microns and between 200 to 800 microns after screening were achieved. It is further noted that 911 states “Sieving is one of the simplest methods of determining particle size distributions, and is probably used in industrial laboratories more than any other method”, which means screening was a simple and commonly used method to determine size distributions of various particles. Both 911 and Liu provide for comparisons being made with materials and methods and time being of importance, and thus, one of ordinary skill in the art would look to make comparisons on a material like magnesium oxide at different times after sieving/screening. In regards to the diameter of the screening tray, this would be based on the size of the machine and how much sample was going to be screened. One of ordinary skill in the art would adjust the screen diameter used accordingly. As the prior art provides for a process with vibration screening/sieving of magnesium oxide particles and allows for 60 minutes of screening along with overlapping size ranges of such particles, the teachings allow for preparation of abrasion resistant magnesium oxide.
Claims 26, 29, and 32 in addition to Claims 21-22, 34, 38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Colgrove US 20180104719; 911 Metallurgist (Particle size distribution, February 2018, https://www.911metallurgist.com/blog/particle-size-distribution/#:~:text=The%20sieving%20operation%20starts%20by,the%20same%20time%20or%20consecutively.); Liu et al (Powder Technology, 2009, volume 193, pages 208-213); Sakamoto US 20170042935 and Advantech Mfg (Test Sieving: Principles and Procedures, 2001, pages 1-26).
Colgrove, 911, Liu and Sakamoto teach the claims as discussed above.
Colgrove, 911, Liu and Sakamoto do not teach silica gel additive or the bulk density thereof.
Advantech provides for sieving and test sieving (title and chapter 1). Chapter 2 notes test sieving as being the best test procedure for rapid particle size distribution data (page 5). Advantech teaches flow additives to reduce agglomeration and improve flow characteristics of the sample (chapter 3). Advantech teaches fine silica as a common additive (chapter 3). Advantech teaches silica gel as a pulverized material with a bulk density of 45 lbs/ft3 (720 kg/m3) and 0.72 g/cm3 (table 5). As Advantech teaches silica gel, this is a abrasion resistant silica. Advantech teaches there is a standard test method for magnesium oxide as a magnesium material (table 6). Advantech teaches “Generally, the additive is pre- screened to a known average particle size, blended with the sample (approximately 1% additive by weight) and then screened with the additives value removed from the reported data” (chapter 3). Advantech teaches sieve device as a tower (picture on page 14) and performing sieve analysis of granular/powder materials (pages 11-14). Advantech teaches sample sizes of 50 grams, 100 grams and 200 grams as well as 25 to 100 gram samples (page 13). Advantech teaches various sieves with different designation sizes and size sieve openings (table 1).
One of ordinary skill in the art before the time of filing would have used silica gel particles/material as a common additive to include with the test sample as silicas were known additives for this purpose by teachings of Advantech. Advantech also recognizes a bulk density of the silica gel material that falls within applicant’s claimed ranges. Therefore, there was a reasonable expectation of success in adding silica gel particles as an additive to a sample of magnesium oxide in order to test sieve/test screen the powder or granular material for finding an optimal size distribution for use by the combined teachings of Colgrove, 911, Liu and Sakamoto with Advantech to obtain size distribution data. .
Claims 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Colgrove US 20180104719; 911 Metallurgist (Particle size distribution, February 2018, https://www.911metallurgist.com/blog/particle-size-distribution/#:~:text=The%20sieving%20operation%20starts%20by,the%20same%20time%20or%20consecutively.); Liu et al (Powder Technology, 2009, volume 193, pages 208-213); Sakamoto US 20170042935; Advantech Mfg (Test Sieving: Principles and Procedures, 2001, pages 1-26) and White (Modelling and Simulation in Engineering, 2012, volume 2012, pages 1-12).
Colgrove, 911, Liu, Sakamoto and Advantech teach the claims as discussed above. Advantech teaches silica additives including silica gel materials. The combination of references provides for the other components of the claims.
Colgrove, 911, Liu, Sakamoto and Advantech do not teach the size range of the silica gel/screening aid.
White teaches silica gel granular sizes of 1, 2 and 3 mm in size (section 1.1 Methods and Figure 17). White teaches silica gel has been used in many industries (Introduction).
One of ordinary skill in the prior art before the time of filing would have used silica gel particle sizes of White for the method motivated by Colgrove, 911, Liu, Sakamoto and Advantech as Advantech recognizes the silica gel materials as an additive for sieving/screening and White provides for sizes of silica gel particles. Therefore, as sizes of silica gel particles of 1-3 mm were recognized in the prior art they were available sizes for a variety of industrial applications.
Conclusions
No claim is allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613