Prosecution Insights
Last updated: August 15, 2026
Application No. 18/472,466

METHODS OF IN SITU OPTICAL ANALYSIS OF SYRINGES AND SYSTEMS

Non-Final OA §102§103§112
Filed
Sep 22, 2023
Priority
Sep 23, 2022 — provisional 63/376,809
Examiner
BANKS, KEONA LAUREN
Art Unit
3763
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Florida State University Research Foundation Inc.
OA Round
2 (Non-Final)
56%
Grant Probability
Moderate
2-3
OA Rounds
0m
Est. Remaining
58%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
19 granted / 34 resolved
-14.1% vs TC avg
Minimal +2% lift
Without
With
+1.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
39 currently pending
Career history
77
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
50.2%
+10.2% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
30.8%
-9.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 34 resolved cases

Office Action

§102 §103 §112
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 . Status of Claims The Office Action is in response to the remarks and amendments filed on 12/15/2025. Claims 2 and 4 are cancelled. Claims 21 and 22 are new. Accordingly, claims 1,3, and 5-22 are pending for consideration in this Office Action. Claim Objections Claim 6 is objected to because of the following informalities: Please amend the recitation “The method according to claim 1” to - - “The system according to claim 1” for clarity. Appropriate correction is required. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: an apparatus configured to move the lens relative to the reservoir in at least Claim 1; Peripheral devices configured to measure leakage and stopper friction; and monitor and control pressure within a reservoir in claim 21 and claim 22. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The apparatus can comprise, for example, a linear stage. See Applicant specification at least page 5, lines 11-12. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 § 112(a) The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 21 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding Claims 21 and 22, claim 21 recites “measuring using one or more peripheral devices of the system, at least one of leakage and stopper friction”. Similarly claim 22 recites the limitations “peripheral devices configured to: (i) measures leakage and stopper friction; and (ii) monitor and control internal pressure within a reservoir”. The term “peripheral devices” invokes a claim interpretation governed under 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph), which requires a review of the specification to determine the appropriate structure, material or act to carry out the claimed limitation. However, the specification as originally filed, fails to describe a corresponding structure or technique by which the system measures leakage and stopper friction and monitors and controls pressure within a reservoir. A mere restatement of the functions does not suffice as a statement of structure. Thus, it does not appear that applicant had possession of the claimed invention because the specification does not disclose structure which is capable of measuring leakage and stopper friction and monitoring and controlling pressure within a reservoir. When a description of the structure, material or act is not provided or is not sufficient to perform the entire claimed function, or no association between the structure and the claimed function can be found in the specification, the written description fails to clearly define the boundaries of the claim. § 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. Regarding Claims 21 and 22, Claim limitation “peripheral devices” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure of structure that measures leakage and stopper friction and monitors and control internal pressure within a reservoir. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Claim Rejections - 35 USC § 102 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 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1,3,5,7, 9-15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mujat et al. (US20120294328A1). Regarding Claim 1, Mujat teaches a system [where a freeze dryer and an OCT system form a microscopy system; 0023], comprising: a reservoir [vial 260, Figure 2] configured to retain a fluid [product 205, Figure 2; where freeze drying is defined by drying the liquid of the product formulation; 0024]; a lens [the OCT system included scanning optics 200, Figure 2; 0034; where in a time domain implementation of the OCT setup the microscopic objective 490 is seen in Figure 3] disposed adjacent the reservoir [where the OCT beam passes to product via window 220, Figure 2; 0034]; a temperature controller [where the temperature control block is controlled using a computer; 0036] configured to modify a temperature of the reservoir and the fluid [where the computer controls the temperature of the temperature block; 0036; where the temperature control block freeze dries the product 205 while it is contained in the vial 260;0034]; and a heat exchanger [freeze dryer including the drying chamber; 0035, visible in Figure 2 housing vial 260] configured to house the reservoir [vial 260, Figure 2]; and an apparatus configured to move the lens relative to the reservoir [where a motorized translation stage that can translate along the z-axis along the incident beam (en-face image); 0045], wherein the apparatus is configured to facilitate observation at different focal distances from the reservoir [where dynamic focusing includes moving the microscope objective 490 on the translation stage; 0054] and at different focal planes with the reservoir [where the system can achieve 3D scanning including depth scanning such that the focal plane of the objective always overlaps with the coherence gate that produces the OCT image of a 3D volume;0053; 0054]. Regarding Claim 3, Mujat teaches the invention of claim 1, and further teaches where the apparatus comprises a linear stage [a translation stage; 0054]. Regarding Claim 5, Mujat teaches the invention of claim 1, and further teaches where the system comprises at least one additional reservoir housed by the heat exchanger [where the holder can be configured to hold one or more vials; 0013] Regarding Claim 7, Mujat teaches the invention of claim 1 and further teaches a thermocouple [temperature sensor 240, Figure 2] configured to measure a temperature of the fluid [where the temperature sensor can be a thermocouple placed within the product at the bottom center location for the determination of the product temperature; 0037]. Regarding Claim 9, Mujat teaches the invention of claim 1 and further teaches wherein the heat exchanger [a freeze dryer; 0039] is configured to achieve or maintain a temperature of the reservoir [where the freeze dryer includes temperature control block 230 that can control the amount for cooling agent 235 that flows through; 0034; from below -40 ° C to over 20 ° C; 0036] that is suitable for storage of the reservoir's contents [where freeze dried products would be shelf-stable; 0003]. Regarding Claim 10, Mujat teaches the invention of claim 1 and further teaches where the heat exchanger is configured to cool the reservoir [vial 260, Figure 2] using a coolant [where the freeze dryer includes temperature control block 230 that can control the amount for cooling agent 235 that flows through; 0034]. Regarding Claim 11, Mujat, as modified, teaches the invention of claim 1 and further teaches where the reservoir contains a biologic, a vaccine, or a combination thereof [where vial 260 contains product 205, Figure 2; where products can include drug products, such as vaccines and anti-cancer therapies; 0007] Regarding Claim 12, Mujat teaches the invention of claim 1 and further teaches memory having computer-executable instructions stored thereon [where the essential elements of the computer are a processor for executing instructions and one or more memory devices for storing instructions; 0062]; and a processor in operable communication with the memory [a processor suitable for execution of instructions from a memory device; 0062] and configured to access the memory and execute the computer-executable instructions [0062]. Regarding Claim 13, Mujat teaches the invention of claim 1 and further teaches where the lens [microscope objective 490, Figure 3] is a component of a camera [the imager, where the system produces two-dimensional and three-dimensional images of samples; 0023; 0053] configured to observe the reservoir [vile 260, Figure 1] through a cryostat [where the cooling agent of the freeze dryer can be liquid nitrogen or liquid cryogens; 0034] viewing port [window 220, Figure 2]. Regarding Claim 14, Mujat teaches the invention of claim 13 and further teaches where the camera [the imager, where the system produces two-dimensional and three-dimensional images of samples; 0023] has an adjustable focal distance [where the A TDOCT instrument, as shown in Figure 3, can have dynamic focusing; 0047]. Regarding Claim 15, Mujat teaches the invention of claim 1 and further teaches a method of monitoring a reservoir, the method comprising: A) providing the system according to claim 1 [refer to the rejection of claim 1 above]; and B) at least one of the following steps: 1) collecting two or more images of the reservoir with the lens [where the processor is configured to receive images; 0051], comparing the two or more images to determine a change of (i) a position or a movement of one or more components of the reservoir, the fluid in the reservoir, or both [where the system can measure 3D product structures allowing tracking of the continuously moving dry interface zone of the product, Figure 1A; 0048], (ii) a phase transformation of the fluid [where the system determines the product critical temperature by determining a temperature at which a product structure event during freeze drying; 0050], (iii) a reduction or a loss of contact among a reservoir and the one or more components of the reservoir [where the system determines collapse where collapse 120 occurred behind the detachment portion 107, Figure 1A, 1B, 1C; 0030;0031], or (iv) a combination thereof [refer to (i), (ii) and (iii) above]; and 2) collecting a temperature of the fluid in the reservoir [via temperature sensor 240, Figure 2; where the temperature sensor can be a thermocouple placed within the product at the bottom center location for the determination of the product temperature; 0037 ], at two or more times, and comparing the temperatures [where relative rates of drying at different temperature can be determined with the system;0033]. Claim 15 recites functional limitations drawn toward the intended use or manner of operating the claimed apparatus. The functional limitations are the method steps. When the cited prior art teaches all of the positively recited structure of the claimed apparatus, it will be held that the prior art apparatus is capable of performing all of the claimed functional limitations of the claimed apparatus. Regarding Claim 18, Mujat teaches the invention of claim 15 and further teaches where the system [where product 205, Figure 2; where freeze drying is defined by drying the liquid of the product formulation; 0024, Figure 1] is subjected to changes in external pressure [where the ice sublimation process is initiated by lowering the pressure in the product chamber; 0025;] before the performance of step (B) [before the sublimation process; 0024; and where the vacuum pump 270 is configured be used to control the pressure within the freeze drying microscopy system during ; 0036; where images are taken through the sublimation process; refer to the rejection of claim 15 above]. Regarding Claim 19, Mujat teaches the invention of claim 15, and further teaches wherein the two or more images are collected at multiple focal planes [where the Figure 1B is a three-dimensional image of a freeze-dried product structure near the surface of the vial and Figure 1C is a three-dimensional image of a freeze-dried product structure away from the surface of the vial following viscous flow and structural collapse; 0019;0020, showing how depth of the product is scanned and compared over time]. Claim 19 recites functional limitations drawn toward the intended use or manner of operating the claimed apparatus. The functional limitations are “wherein the two or more images are collected at multiple focal planes”. When the cited prior art teaches all of the positively recited structure of the claimed apparatus, it will be held that the prior art apparatus is capable of performing all of the claimed functional limitations of the claimed apparatus. Regarding Claim 20, Mujat teaches the invention of claim 15 and further teaches where the collecting of the two or more images [where the processor is configured to receive images; 0051] or the temperature generates data [where the temperature control block is controlled using a computer; 0036] stored in at least one computer memory configured to store computer-executable instructions [; where a processor is suitable for execution of instructions from a memory device; 0062], wherein the method further comprises accessing the at least one computer memory and, via at least one computer processor, executing instructions to operate one or more components of the system [where the essential elements of the computer are a processor for executing instructions and one or more memory devices for storing instructions; 0062], and wherein the instructions operate the temperature controller [0036]. 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. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mujat et al. (US20120294328A1) as applied to claim 1 above and in further view of Eckhoff (US20130306656A1) and Cheng (US20110283717A1), hereinafter Cheng ‘717. Regarding Claim 6, Mujat teaches the invention of claim 1 and does not teach where the temperature controller [where the temperature control block 230 is controlled by a computer; 0036] comprises inline heaters configured to: control cooling and heating rates of the system; maintain a temperature of the system; or both. However, Cheng ‘717 teaches a method of lyophilization using cryogenic refrigeration [0002] where the temperature controller [control hardware to coordinate the freeze-dryer equipment; 0019] comprises an inline heater [heater 226 along heat transfer fluid circuit upstream of chamber 202, Figure 1] configured to: maintain a temperature of the system [where heater provides supplemental heat; 0017]; where one of ordinary skill in the art could have combined the elements as claimed by known methods and that in combination, each element would perform the same function as it did separately and one of ordinary skills would have recognized that the results of the combination were predictable i.e., providing supplemental heat to the heat transfer fluid and the lyophilization chamber as may be required during the drying processes [Cheng ‘717, 0017] Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Mujat to have in line heaters in view of the teachings of Cheng ‘717 where the elements could have been combined by known methods with no change in their respective functions, and the combination would have yielded predictable results i.e., providing supplemental heat to the heat transfer fluid and the lyophilization chamber as may be required during the drying processes [Cheng ‘717, 0017] Mujat does not teach where the temperature controller is a proportional, integral, derivative (PID) temperature controller. However, Eckhoff teaches a temperature controlled container [10, Figure 1] where the temperature controller [where controller 360 controls the rate of evaporation of evaporative liquid 400, Figure 3] is a proportional, integral, derivative (PID) temperature controller [where the controller is a PID controller; 0127] where one of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art, i.e., providing more accurate temperature regulation through feedback control. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Mujat to have where the temperature controller is a proportional, integral, derivative (PID) temperature controller in view of the teachings of Eckhoff where this known technique could have been applied to a known device that was ready for improvement and the results would have been predictable, i.e., providing more accurate temperature regulation through feedback control. Claim 8 and 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mujat et al. (US20120294328A1) as applied to claim 1 above and in further view of Hsu et al. (US20140194827A1) Regarding Claim 8, Mujat teaches the invention of claim 1 and does not teach wherein the reservoir comprises a syringe. However, Hsu teaches where a reservoir comprises a syringe [a disposable pre-filled syringe; 0032, Figure 1] where one of ordinary skill in the art would have been capable of applying the substitution of known elements, vaccine vials, for another, pre-filled syringes, and yield predictable results, i.e., simplifying the handling process and reducing medical waste when administering medication [Hsu, 0005]. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Mujat to where the reservoir comprises a syringe in view of the teachings of Hsu where the substitution of an element for another would have yielded predictable results i.e., simplifying the handling process and reducing medical waste when administering medication [Hsu, 0005]. Regarding Claim 16, Mujat teaches the invention of claim 15 and does not teach where the reservoir comprises a syringe, and the one or more components of the reservoir comprises a stopper. However, Hsu teaches where a reservoir comprises a syringe [a disposable pre-filled syringe; 0032, Figure 1] and the one or more components of the reservoir comprises a stopper [plug 42, Figure 1], where one of ordinary skill in the art would have been capable of applying the substitution of known elements, vials for another, pre-filled syringes, and yield predictable results, i.e., simplifying the handling process and reducing medical waste when administering medication [Hsu, 0005]. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Mujat to have the reservoir comprise of a syringe, and where the one or more components of the reservoir comprises a stopper in view of the teachings of Hsu where the substitution of two elements for another would have yielded predictable results i.e., simplifying the handling process and reducing medical waste when administering medication [Hsu, 0005]. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mujat et al. (US20120294328A1) as applied to claim 1 above and in further view of Cheng (US20120318017A1), hereinafter Cheng ‘017. Regarding Claim 17, Mujat teaches the invention of claim 15 and teaches at least one of the reservoir [vial 260, Figure 2] and the fluid [product 240, Figure 2] is at, or cooled to a temperature, before and during the performance of step (B) [where the system uses a cryogenic condenser typically at -70 ° C; 0025] but does not teach the temperature is -100 °C or less. However, Cheng ‘017 teaches freeze drying with a cryogenic condensing system [0005] where applications that use alcohol-based formulations require very low condensation temperatures colder than -100 C [0003] where one of ordinary skill in the art would have been capable of applying routine optimization of a known result effective variable, temperature, to achieve a recognized result, i.e., effectively freezing biological products [Cheng ‘017;0004] Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Mujat to have where temperature is -100 °C or less in view of the teachings of Cheng ‘017 where the modification constitutes routine optimization of a known result-effective variable to achieve a recognized result, i.e., effectively freezing biological products [Cheng ‘017;0004] Claim 17 recites functional limitations drawn toward the intended use or manner of operating the claimed apparatus. When the cited prior art teaches all of the positively recited structure of the claimed apparatus, it will be held that the prior art apparatus is capable of performing all of the claimed functional limitations of the claimed apparatus. Response to Arguments Applicant’s arguments on pages 7-9 filed 12/15/2025 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. Applicant does not separately argue the rejection of claims 3 and 5-20 except for their dependence upon claim 1. Accordingly, the rejections of record are considered proper and remain. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEONA LAUREN BANKS whose telephone number is (571)270-0426. The examiner can normally be reached Mon-Fri 8:30- 6:00 EST. 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, Jerry-Daryl Fletcher can be reached at 5712705054. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KEONA LAUREN BANKS/Examiner, Art Unit 3763 /ELIZABETH J MARTIN/Primary Examiner, Art Unit 3763
Read full office action

Prosecution Timeline

Sep 22, 2023
Application Filed
Jun 16, 2025
Non-Final Rejection mailed — §102, §103, §112
Dec 15, 2025
Response Filed
Apr 06, 2026
Final Rejection mailed — §102, §103, §112
Aug 05, 2026
Response after Non-Final Action

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Prosecution Projections

2-3
Expected OA Rounds
56%
Grant Probability
58%
With Interview (+1.6%)
2y 5m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 34 resolved cases by this examiner. Grant probability derived from career allowance rate.

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