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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/19/2025 is acknowledged.
Claim Objections
Claim 16 is objected to because of the following informalities: The word
“osmolite” is misspelled. It should be “osmolyte”. Appropriate correction is required.
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, 2, 4-6, 8, 10-12, 14, 16 and 17 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 is vague and indefinite because the phrase "under conditions effective to encapsulate the one or more lyophilised microspheres with a coating formulation" is unclear. It is unclear of what are exactly the metes and bounds for conditions that will effectively encapsulate the one or more lyophilised microspheres with a coating formulation, the claim is not providing the technical features necessary for achieving this result.
Claims 16 is vague and indefinite because it is unclear what are the metes and bounds for the term “small molecule” and what type of molecules are considered small.
Additionally, the term "small" in claim 16 is a relative term which renders the claim indefinite. The term "small" is not defined by the claim, 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. The specification does not define “small” and provides no examples. The skilled artisan would not know which groups meet the limitation “small”.
Note that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Also see In re Van Geuns, 988 F.2d 1181,26 USPQ2d 1057 (Fed. Cir. 1993). Also see, In reZletz, 13 USPQ2d 1320,1322. “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.”
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 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.
Claim(s) 1, 2, 4-6, 8, 10-12, 14, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kosak et al. US 5550044A in view of Lang et al. US 5200236A and further in view of Becker et al. WO 2022/072193 A1.
Kosak et al. discloses droplets of molten wax or waxy polymer containing a reagent are dropped onto the surface of liquid nitrogen, the droplets remain on the surface until solidified and the droplets are removed from the surface before they sink into the liquid nitrogen to provide beads containing the reagent. The reagent can be any material that can be entrapped in the beads and does not undergo excessive inactivation when the beads are melted by heating to release the reagent. Examples of reagents are heat resistant enzymes, enzyme substrates, metal salts, oligonucleotides, inclusion compounds, surfactants, emulsifiers, antioxidants, stabilizers, drugs, antibiotics, antibodies and antigens… The beads can be used in various in vitro chemical, biochemical and immunological reactions including the PCR, where the reagent is released by heating and melting the beads. Kosak et al. discloses the encapsulation of nucleic acid amplification agents, which are considered to fall under the unclear term "nucleic acid sequence reagents" (Abstract, figure 2). A broad range of reagents, such as enzyme for entrapping are disclosed by Kosak et al. (col 5, lines 44 to 52) (this is viewed to be inclusive of claims 14, 16 and 17).
Kosak et al. discloses in col. 20, lines 12 to 26, under the sub-heading Wax Coated Freeze-Dried Beads: a method including the following steps: - providing a freeze-dried beads (viewed as the instant microspheres); spraying them in a fluidized bed with a molten wax. The conditions of the fluidization process are disclosed in Lang et al. (US 5200236 A) (col. 20, lines 12 to 26).
With regards to claims 4-5, Lang et al. teaches in example 1), the diameter of the nozzle and the atomizing rate.
With regards to claim 6, Lang et al. teaches “The process steps of encapsulating the solid core particles comprise:
a) selecting a core material to be encapsulated,
b) optionally agglomerating the selected core material to form a particle having a diameter of 100 to 2,500 microns,
c) suspending the particles in a fluid bed,
d) selecting one or more paraffin waxes to provide the coating, the waxes having a melting point between about 40°C and about 50°C, and a solids content of from 100% to about 35% at 40°C and a solids content of from 0 to about 15% at 50°C.
e) heating the one or more paraffin waxes to a temperature sufficiently above the melting temperature to melt all the wax,
f) fluidizing the bed by passing warm air through the core particles, so as to maintain a bed temperature no higher than the wax melting point, and
g) spraying the melted paraffin wax onto the fluidized bed at an atomization temperature which is preferably at least 5°C above the melting temperature of the wax for a time sufficient to form a continuous, coherent paraffin wax coating of a thickness of from 100 to 1,500 microns on the particles preferably from 200 to 750 microns.
The amount of coating applied to the core particles is typically from about 20 to 90%, preferably about 40 to 60% and most preferably 40-50% by weight of the total particle (i.e., core plus coating).(col.9 -10).
With regards to claims 10-12, it is considered that in Lang et al., the particles are delivered to the fluidizer bed reactor at a temperature below 30 °C, while heating to a second temperature above 40°C is also disclosed (col. 9, line 61 to col 10, line 19; col. 11 lines 37-col.12 line 69).
Kosak et al. does not specifically disclose the fluidization rate of claim 1 and the humidity level of claim 2. However, said embodiments in claims 1-2 are merely some of the several straightforward possibilities which the skilled person would select, in accordance with circumstances, without requiring any inventive skill in order to solve the problem posed because said features appears to be an arbitrary choice in the rate of fluidization (see Kosak example 1; Lang et al. col.11-14). One of ordinary skill in the art would have been motivated to modify the primary references in the manner of the claims to achieve the expected benefits, optimizations and/or expanded applications as this is well known practice in the art. MPEP states wherein the “[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 Alter, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Routine optimization is not considered inventive and no evidence has been presented that fluidization rate was other than routine, that the products resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Hence, the skilled person would, during routine optimization and depending on the desired result, modify the humidity level inside the fluidized bed environment. With regards to claim 8, Lang et al. teaches particles have been directly sprayed with coating material in fluidized bed apparatuses, operated in a "Wurster" mode (col 13-14). Said Wurster mode is well known in the art and one skilled person would design different configuration, during routine experimentation (see Becker et al. WO 2022/072193 A1, figure 1, [0080]-[0082], [0085]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEZIA RILEY whose telephone number is (571)272-0786. The examiner can normally be reached 7:30-6:00pm.
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/JEZIA RILEY/Primary Examiner, Art Unit 1681 13 December 2025