DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of 1-11 in the reply filed on 1/15/2026 is acknowledged.
Furthermore, claim 1 contains two embodiments: 1) wherein changing the phase of the composition comprises freezing the composition, and 2) wherein changing the phase of the composition comprises thawing the composition. Claims 2-8 are directed at the freezing embodiment and claims 9-11 are directed at the thawing embodiment. Since both groups share the technical feature of claim 1, and claim 1 is anticipated by Thompson, the two groups lack unity of invention because claim 1 is not a special technical feature. Note: The Examiner has constructively elected claims 1-8 for examination.
Therefore, claims 9-13, 17-21, and 24 have been withdrawn from consideration.
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.
Claim(s) 1, 3-6, 8 are rejected under 35 U.S.C. 102a1 as being anticipated by Thompson (US 20190285342 A1).
Regarding claim 1, Thompson discloses a method for changing the phase of a composition, in particular a pharmaceutical composition, comprising:
storing a quantity of the composition in a vial (claim 1);
changing the phase of the composition in the vial by applying thermal gas to the vial (paras. 45-53); and
wherein changing the phase of the composition comprises freezing or thawing the composition (para. 39), and wherein the thermal gas is respectively a cooling gas or a heating gas (paras. 45-53);
wherein changing the phase of the composition is characterized by performing at least one of (A), (B): (C), wherein (A) is an initial temperature change control scheme performed before entering a phase wherein the crystallization amount of the composition changes; (B) is a crystallization change control scheme during a phase wherein the crystallization amount of the composition changes; (C) is a final temperature change control scheme performed until the composition reaches its final temperature;
obtaining the composition after the change in phase is complete (para.82);
wherein the initial temperature change control scheme (A) comprises:
(I) performing an initial measurement (using heat flux sensor) on the vial and/or the composition to determine whether the phase wherein the crystallization amount of the composition changes has started (i.e., nucleation) (paras. 77-82);
(II) controlling the temperature and/or flow rate of the thermal gas such that the temperature of the vial and/or the composition is in accordance with a pre-determined initial temperature evolution over time (paras. 77, 170); and
repeating steps (I) and (II) until the initial measurement determines that the phase wherein the crystallization amount of the composition changes has started (the heat flow is constantly monitored and controlled throughout the whole process, including during a nucleation step; see paras. 77-82, 84);
wherein the crystallization change control scheme (B) comprises:
(I) performing a crystallization-change measurement on the vial and/or the composition to determine whether there is no longer a change in the crystallization amount in the composition (paras. 92, 169);
(II) controlling the temperature and/or flowrate of the thermal gas such that the temperature of the vial and/or the composition is in accordance with a pre-determined crystallization-change temperature evolution over time (paras. 169-170);
repeating steps (I) and (II) until there is no longer a change in the crystallization amount in the composition (the heat flow is constantly monitored and controlled throughout the whole process, including during a crystallization step); and
wherein the final temperature change control scheme (C) comprises:
(I) controlling the temperature and/or flow rate of the thermal gas such that the temperature of the vial and/or the composition is in accordance with a pre-determined final temperature evolution over time (para. 77-82, 85);
(II) performing a final temperature measurement on the vial and/or the composition to determine whether the vial and/or the composition has reached its pre-determined final temperature (para. 92); and
repeating steps (I) and (II) until the final temperature measurement determines that the vial and/or the composition has reached its pre-determined final temperature (the heat flow and temperature is constantly monitored and controlled throughout the whole process, including at the end of the crystallization step).
Regarding claim 3, Thompson discloses the method for freezing injectable compositions according to claim 1, wherein the initial measurement, the crystallization-change measurement, and/or the final temperature measurement are performed using a thermal sensor for capturing thermal information and/or a sensor for capturing spectroscopy information (para. 164).
Regarding claim 4, Thompson discloses the method according to claim 1, wherein changing the phase of the composition is freezing the composition (para. 92);
wherein the composition is injectable (it’s a liquid; therefore, it is injectable) and stored in the vial as a quantity of a dispersion of the injectable composition in an aqueous dispersion medium (paras. 5, 20);
wherein the initial temperature change control scheme is an initial cooling control scheme (X) before nucleation has occurred in the dispersion layer (para. 21), wherein the crystallization change control scheme is a crystallization control scheme (Y) during crystallization of the dispersion layer (para. 5), and wherein the final temperature change control scheme is a final cooling control scheme (Z) after the dispersion layer has crystallized (para. 92);
wherein in the initial cooling control scheme (X) the initial measurement is a nucleation measurement to determine whether nucleation has occurred in the dispersion, wherein the initial temperature evolution over time is an initial cooling temperature evolution over time (the heat flux/temperature, nucleation, and crystal growth are measured throughout the whole process, as explained in the rejection of claim 1), and wherein steps (I) and (II) are repeated until the nucleation measurement determines that nucleation has occurred in the dispersion (paras. 84, 142);
wherein in the crystallization control scheme (Y) the crystallization-change measurement determines whether crystallization has finished in the dispersion (para. 169), wherein the crystallization-change temperature evolution over time is a crystallization temperature evolution over time (para. 169), and wherein steps (I) and (II) are repeated until the crystallization measurement determines that crystallization has finished in the dispersion (para. 169); and
wherein in the final cooling control scheme (Z) the final temperature evolution over time is a final cooling temperature evolution over time (para. 170).
Regarding claim 5, Thompson discloses the method for freezing injectable compositions according to claim 4, wherein (X) and (Y), (Y) and (Z), (X) and (Z), or (X), (Y) and (Z) are performed.
Regarding claim 6, Thompson discloses the method for freezing an injectable composition according to claim 4, wherein the initial cooling control scheme (X) further comprises inducing condensation nuclei in the distribution (para. 84), and/or inducing artificial density gradients in the composition by acoustic waves or pressure waves, and/or inducing thermal shocks in the distribution.
Regarding claim 8, Thompson discloses the method for freezing an injectable composition according to claim 4, wherein the method is a method for freeze-drying injectable compositions, by additionally performing a drying step while applying a vacuum and supplying heat (para. 33).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 20190285342 A1).
Regarding claim 2, Thompson discloses the method for changing the phase of a compositions according to claim 1, except wherein in at least one of (A), (B) and (C) before repeating steps (I) and (II), the control scheme can wait a pre-determined amount of time.
However, this limitation is a matter of optimization. First, it is inherent that some time must pass before repeating the steps since nothing is instantaneous. Second, a pre-determined time delay is a type of hysteresis control used in devices such as thermostats. It is used to reduce stress on the control system and in Thompson, it would prevent unnecessary over-corrections, especially if there are temperature/heat flux fluctuations. However, if the delay is too long then it would prolong the process or possibly reduce the quality of the final product.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 20190285342 A1) in view of Nordin (WO 2012087232 A1).
Regarding claim 7, Thompson discloses the method for freezing an injectable composition according to claim 4, except wherein the method further comprises: rotating the vial at least for a period of time to form a dispersion layer at an inner surface of a circumferential wall of the vial; cooling the vial by applying cooling gas to the rotating vial.
However, Nordin teaches a freeze-drying method comprising: rotating the vial at least for a period of time to form a dispersion layer at an inner surface of a circumferential wall of the vial (pg. 11, last paragraph); cooling the vial by applying cooling gas to the rotating vial (pg. 8, last paragraph and pg. 11, second paragraph).
It would have been obvious to a person skilled in the art at the time of effective filing of the application to modify Thompson to include the optional steps of rotating the vial at least for a period of time to form a dispersion layer at an inner surface of a circumferential wall of the vial; cooling the vial by applying cooling gas to the rotating vial. The motivation to combine is to give the system of Thompson the ability to produce thin-film freeze dried compounds, as taught by Nordin.
Conclusion
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/JASON LAU/Primary Examiner, Art Unit 3762
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