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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/01/2026 has been entered.
Claim Status
Claims 1-5 and 7-20 are pending. Claims 1 and 15 have been amended. Claim 6 has been canceled. The claim set of 12/03/2025 is being examined as the last claim set submitted and by virtue of the RCE filed 07/01/2026.
Response to Arguments
Applicant’s arguments with respect to claims 1-5 and 7-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-5 and 7-20 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 and 15 recite the limitation "on the surface of a freeze cylinder assembly" in line 2. There is insufficient antecedent basis for this limitation in the claims (the surface should be “a surface”).
Claims 1 and 15 both recite “a freeze cylinder assembly” twice within each claim, respectively. The preambles of claims 1 and 15 therefore do not appear to positively recite the freeze cylinder. The recitation of “a freeze cylinder assembly” twice in claims 1 and 15, render the claims indefinite and unclear. It is indefinite and unclear if it is one freeze cylinder assembly or more than one freeze cylinder assembly in the respective systems.
By virtue of dependency, claims 2-5, 7-14, and 16-20 are also rejected.
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 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 1-5 and 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weyermanns et al. (5,186,019), hereafter referred to as “Weyermanns,” in view of Schreiner (3,172,546), Germain (5,442,927), Kennedy (US 2008/0075777 A1), Scherzer et al. (US 2004/0137070 A1), hereafter referred to as “Scherzer,” and Colton (2,751,762).
Regarding Claim 1: Weyermanns teaches a system for freezing of item (title) comprising: (i) a freezing roller drum assembly (3, 4, and 6 in Figure 1; or 20 and rotating shaft and motor not shown in Figure 2), comprising: (1) a freeze cylinder assembly (6 or 20); (2) a scraper assembly (5); (3) a frame assembly (supports not shown in Figure 1 and 18 in Figure 2); (4) a motor assembly (4); and (5) a manifold assembly (wall of 1 for piping 8 and 10 in Figure 1 and wall of 1 with 15 and 16 in Figure 2); and wherein the freezing roller drum assembly (6 or 20) includes a product inlet (pipe 8 or pipe 15 to feed products via another pipe not shown, Column 2, lines 49-53) and product exit (opening of 6 or 20).
Weyermanns fails to teach that the system is a system for thin film freezing of an active pharmaceutical agent or a pharmaceutical composition on the surface of a freeze cylinder assembly and wherein the freeze cylinder assembly is maintained at a temperature of below -50°C.
Schreiner teaches a system (title) for freezing of an active agent or a composition (Column 1, lines 62-72) and wherein a cryogen cooled system (Column 1, lines 62-72) is a freeze cylinder assembly (10/12 in 11) that is maintained at a temperature of below -50°C (Column 1, lines 62-72).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided wherein the freeze cylinder assembly is maintained at a temperature of below -50°C to the structure of Weyermanns as taught by Schreiner in order to advantageously provide freezing the agents to low enough temperature to provide indefinite storage at the low temperature (see Schreiner, Column 1, lines 62-72).
Germain teaches a system (title) for thin film freezing of an active agent or a composition (Column 2, lines 1-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the system for thin film freezing of an active agent or a composition to the structure of Weyermanns modified supra as taught by Germain in order to advantageously provide layering of the cryogen onto the items for freezing (see Germain, Column 1, lines 29-32).
Weyermanns modified supra fails to teach a pharmaceutical agent or pharmaceutical composition; and droplets of the active pharmaceutical agent or pharmaceutical composition to impact the surface of the freeze cylinder assembly resulting in freezing of the droplets; and a filter or filtration system to reduce or remove particulates from entering the system.
Scherzer teaches a system for thin film freezing of an active pharmaceutical agent or a pharmaceutical composition (paragraph [0008]) on the surface of a freeze cylinder assembly (12, paragraph [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided that the system is a system for thin film freezing of an active pharmaceutical agent or a pharmaceutical composition on the surface of a freeze cylinder assembly to the structure of Weyermanns modified supra as taught by Scherzer in order to advantageously provide a cold surface to enable good heat transfer (see Scherzer, paragraph [0026]).
Colton teaches a pharmaceutical agent or pharmaceutical composition (Column 1, lines 58-62); and wherein a freezing roller drum assembly (54, 63) includes a product inlet (32) and product exit (ends of sieve 54 or through mesh of 54) that allows droplets (Column 1, lines 20-23, and 45-54) of the active pharmaceutical agent or pharmaceutical composition (Column 1, lines 58-62) to impact the surface of the freeze cylinder assembly (54 from 32) resulting in freezing of the droplets (Column 1, lines 58-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a pharmaceutical agent or pharmaceutical composition; wherein the freezing roller drum assembly includes a product inlet and product exit that allows droplets of the active pharmaceutical agent or pharmaceutical composition to impact the surface of the freeze cylinder assembly resulting in freezing of the droplets to the structure of Weyermanns modified supra as taught by Colton in order to advantageously rapidly freeze pharmaceuticals in the assembly (see Colton, Column 1, lines 55-62).
Kennedy teaches a filter (paragraph [0062]) or filtration system to reduce or remove particulates from entering a system (functional limitation of the filter, paragraph [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a filter or filtration system to reduce or remove particulates from entering the system to the structure of Weyermanns modified supra as taught by Kennedy in order to advantageously prevent containments from entering the system (see Kennedy, paragraph [0062]).
Regarding Claim 2: Weyermanns teaches further comprising a shroud (1, housing) covering at least a portion of each of assemblies (1)-(5) (see Figures 1-2).
Regarding Claim 3: Weyermanns further teaches wherein at least a portion of the shroud (1) is a double-paned shroud (1 is an insulated cabinet, Column 2, lines 45-46).
Regarding Claim 4: Weyermanns teaches further comprising at least one gas plenum (10 or 16) to allow a cryogenic liquid (Column 2, lines 18-22), a cryogenic gas, or a heat transfer fluid to circulate within the system (see Figures 1-2).
Regarding Claim 5: Weyermanns teaches wherein the cryogenic source is a cryogenic solid, a cryogenic gas, a cryogenic liquid (Column 2, lines 18-22), or a heat transfer fluid capable of maintaining temperatures below -50°C (functional limitation of the liquid cryogen).
Regarding Claim 7: Weyermanns teaches wherein the cryogenic solid, cryogenic gas, cryogenic liquid (Column 2, lines 18-22), or heat transfer fluid is capable of maintaining temperatures below -50°C (functional limitation of the liquid cryogen).
Regarding Claim 8: Weyermanns further teaches wherein a cryogenic gas (7, Column 2, lines 18-22) contacts the freezing cylinder (6 or 20, see Figures 1 or 2) assembly to maintain a temperature below -50°C (functional limitation of the liquid cryogen).
Regarding Claim 9: Weyermanns teaches wherein a cryogenic liquid (7, Column 2, lines 18-22) contacts the freezing cylinder (6 or 20, see Figures 1 or 2) assembly to maintain a temperature below -50°C (functional limitation of the liquid cryogen).
Regarding Claim 10: Weyermanns teaches further comprising a heat exchanger (7, Column 2, lines 18-22) to maintain a temperature below -50°C (functional limitation of the liquid cryogen).
Regarding Claim 11: Weyermanns further teaches wherein the cryogenic liquid is an inert liquified gas (Column 2, lines 13-16).
Regarding Claim 12: Weyermanns further teaches wherein the inert liquid gas is liquified helium, liquified nitrogen (Column 2, lines 13-16), or liquified argon, or combinations thereof.
Regarding Claim 13: Weyermanns fails to teach wherein the cryogenic source is dry ice.
Schreiner teaches a cryogenic source is dry ice (Column 2, lines 34-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided wherein the cryogenic source is dry ice to the structure of Weyermanns as taught by Schreiner in order to advantageously provide different known cryogen to freeze biological specimens (see Schreiner, Column 3, lines 1-14).
Regarding Claim 14: Weyermanns fails to teach wherein the active agent or composition comprises a small molecule active agent or biologic active agent.
Schreiner teaches wherein an active agent or composition comprises a small molecule active agent or biologic active agent (Column 1, lines 29-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided wherein the active agent or composition comprises a small molecule active agent or biologic active agent to the structure of Weyermanns as taught by Schreiner in order to advantageously provide the cryogenic system to freeze biological specimens (see Schreiner, Column 1, lines 63-71).
Regarding Claim 15: Weyermanns teaches a system (title) for freezing of an item (title) comprising: (i) a freezing roller drum assembly (3, 4, and 6 in Figure 1; or 20 and rotating shaft and motor not shown in Figure 2) comprising: (1) a freeze cylinder assembly (6 or 20); (2) a scraper assembly (5); (3) a frame assembly; (4) a motor assembly (motor 4); (5) a manifold assembly (wall of 1 for piping 8 and 10 in Figure 1 and wall of 1 with 15 and 16 in Figure 2); and (6) a shroud covering at least a portion of each of assemblies (1)-(5) (housing 1); and wherein the freezing roller drum assembly (6 or 20) includes a product inlet (pipe 8 or pipe 15 to feed products via another pipe not shown, Column 2, lines 49-53) and product exit (opening of 6 or 20).
Weyermanns fails to teach that the system is a system for thin film freezing of an active pharmaceutical agent or a pharmaceutical composition on the surface of a freeze cylinder assembly and wherein the freeze cylinder assembly is maintained at a temperature of below -50°C.
Schreiner teaches a system (title) for freezing of an active agent or a composition (Column 1, lines 62-72) and wherein a cryogen cooled system (Column 1, lines 62-72) is a freeze cylinder assembly (10/12 in 11) that is maintained at a temperature of below -50°C (Column 1, lines 62-72).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided wherein the freeze cylinder assembly is maintained at a temperature of below -50°C to the structure of Weyermanns as taught by Schreiner in order to advantageously provide freezing the agents to low enough temperature to provide indefinite storage at the low temperature (see Schreiner, Column 1, lines 62-72).
Germain teaches a system (title) for thin film freezing of an active agent or a composition (Column 2, lines 1-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the system for thin film freezing of an active agent or a composition to the structure of Weyermanns modified supra as taught by Germain in order to advantageously provide layering of the cryogen onto the items for freezing (see Germain, Column 1, lines 29-32).
Weyermanns modified supra fails to teach a pharmaceutical agent or pharmaceutical composition; and droplets of the active pharmaceutical agent or pharmaceutical composition to impact the surface of the freeze cylinder assembly resulting in freezing of the droplets; and a filter or filtration system to reduce or remove particulates from entering the system.
Scherzer teaches a system for thin film freezing of an active pharmaceutical agent or a pharmaceutical composition (paragraph [0008]) on the surface of a freeze cylinder assembly (12, paragraph [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided that the system is a system for thin film freezing of an active pharmaceutical agent or a pharmaceutical composition on the surface of a freeze cylinder assembly to the structure of Weyermanns modified supra as taught by Scherzer in order to advantageously provide a cold surface to enable good heat transfer (see Scherzer, paragraph [0026]).
Colton teaches a pharmaceutical agent or pharmaceutical composition (Column 1, lines 58-62); and wherein a freezing roller drum assembly (54, 63) includes a product inlet (32) and product exit (ends of sieve 54 or through mesh of 54) that allows droplets (Column 1, lines 20-23, and 45-54) of the active pharmaceutical agent or pharmaceutical composition (Column 1, lines 58-62) to impact the surface of the freeze cylinder assembly (54 from 32) resulting in freezing of the droplets (Column 1, lines 58-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a pharmaceutical agent or pharmaceutical composition; wherein the freezing roller drum assembly includes a product inlet and product exit that allows droplets of the active pharmaceutical agent or pharmaceutical composition to impact the surface of the freeze cylinder assembly resulting in freezing of the droplets to the structure of Weyermanns modified supra as taught by Colton in order to advantageously rapidly freeze pharmaceuticals in the assembly (see Colton, Column 1, lines 55-62).
Kennedy teaches a filter (paragraph [0062]) or filtration system to reduce or remove particulates from entering a system (functional limitation of the filter, paragraph [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a filter or filtration system to reduce or remove particulates from entering the system to the structure of Weyermanns modified supra as taught by Kennedy in order to advantageously prevent containments from entering the system (see Kennedy, paragraph [0062]).
Regarding Claim 16: Weyermanns further teaches wherein at least a portion of the shroud (1) is a double-paned shroud (1 is an insulated cabinet, Column 2, lines 45-46).
Regarding Claim 17: Weyermanns teaches wherein the freezing cylinder assembly (6 or 20, see Figures 1-2) is maintained at a temperature of below -50°C using a cryogenic source (liquid nitrogen, Column 2, lines 13-16).
Regarding Claim 18: Weyermanns further teaches further comprising at least one gas plenum (10 or 16) to allow a cryogenic source (7, Column 1, lines 13-16) to circulate in the system (see Figures 1-2).
Regarding Claim 19: Weyermanns further teaches wherein the cryogenic source is a cryogenic solid, a cryogenic gas, a cryogenic liquid (7, Column 1, lines 13-16), or a heat transfer fluid capable of maintaining cryogenic temperatures.
Regarding Claim 20: Weyermanns teaches a method for freezing of an item (title) comprising: (a) utilizing the system of claim 1 (see claim 1 above), the method comprising: (i) cooling a surface of a freeze cylinder assembly (3, 4, and 6 in Figure 1; or 20 and rotating shaft and motor not shown in Figure 2) to a temperature below -50°C (via the liquid cryogen, 7); (ii) dissolving or dispersing an active agent or composition (12) into a liquid carrier to form an intermediate liquid mixture (12 in 7); (iii) contacting the intermediate liquid mixture (12 into 7) comprising the item (12) with the freeze cylinder assembly (3, 4, and 6 in Figure 1; or 20 and rotating shaft and motor not shown in Figure 2) to freeze the intermediate mixture (in bath 7).
Weyermanns fails to teach the method is for thin film freezing of an active agent or a composition and dissolving or dispersing an active agent or composition into the liquid carrier to form an intermediate liquid mixture.
Schreiner teaches a system (title) for freezing of an active agent or a composition (Column 1, lines 62-72) and wherein a cryogen cooled system (Column 1, lines 62-72) is a freeze cylinder assembly (10/12 in 11) that is maintained at a temperature of below -50°C (Column 1, lines 62-72) and dissolving or dispersing an active agent or composition (24) into a liquid carrier (11) to form an intermediate liquid mixture (see Figure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided wherein the freeze cylinder assembly is maintained at a temperature of below -50°C dissolving or dispersing an active agent or composition into a liquid carrier to form an intermediate liquid mixture to the structure of Weyermanns as taught by Schreiner in order to advantageously provide freezing the agents to low enough temperature to provide indefinite storage at the low temperature (see Schreiner, Column 1, lines 62-72).
Germain teaches a system (title) for thin film freezing of an active agent or a composition (Column 2, lines 1-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the system for thin film freezing of an active agent or a composition to the structure of Weyermanns modified supra as taught by Germain in order to advantageously provide layering of the cryogen onto the items for freezing (see Germain, Column 1, lines 29-32).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brahmbhatt (US 2006/0277927 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRSTIN U OSWALD whose telephone number is (571)270-3557. The examiner can normally be reached 10 a.m. - 6 p.m. M-F.
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/KIRSTIN U OSWALD/Examiner, Art Unit 3763
/ERIC S RUPPERT/Primary Examiner, Art Unit 3763
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