DETAILED ACTION
Application Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is in response to Applicant’s submission dated 09/28/2026. Claim(s) 1–4 & 25-40 are pending.
Election/Restrictions
Applicant’s election of Group I, claims 1–4 (now claims 1–4 & 25–40) without traverse in the reply filed on 09/28/2026 is acknowledged.
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.
Claim 38 is 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. Specifically, the phrase “network interface device” is subject to a means-plus-function interpretation, but there is insufficient support in the Specification to determine what constitutes a “network interface device” or how it couples the processing device to the one or more load sensors. As such, examination under §§ 102 & 103 in not possible at this time. Appropriate action is necessary.
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(s) is/are:
“a processing device … configured to measure mass change of components of the freeze-drying system during a freeze-drying process” in claim 1, which has been interpreted to mean “a programmable flow controller preprogramed with code to measure the mass change of components in the freeze-drying system during a freeze-drying process”;
“a stoppering mechanism configured to apply pressure to a shelf rack disposed within the freeze-drying chamber” in claim 4, which has been interpreted to mean “a hydraulic ram;”
“a heating element for temperature control” in claim 33, which has been interpreted to mean “an electric heating device or a fluid line”; and
“a network interface device” in claim 38, which cannot be interpreted due to lack of clarity in the Specification (see § 112 rejection above).
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.
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 § 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) 1–2 & 34–37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/094523 to Steele.
With regard to claim 1, Steele discloses a freeze-drying system (¶ 0002) comprising: a freeze-drying chamber (119, 219) (Fig. 1; ¶ 0058); a condenser (116, 216) coupled to the freeze-drying chamber (119, 219) (Fig. 1; ¶¶ 0069–0070); one or more load sensors (114, 214) (Fig. 1; ¶ 0060); and a processing device (125, 225, 803) operatively coupled to the one or more load sensors (114, 214) and configured to measure mass change of components of the freeze-drying system during a freeze-drying process (¶¶ 0080, 0086).
With regard to claim 2, Steele further discloses the one or more load sensors (114, 214) are disposed on support structures (110, 210) of the freeze-drying chamber (119, 219) (Fig. 1; ¶¶ 0060, 0065).
With regard to claim 34, Steele further discloses a housing (137) that encloses or supports the freeze-drying chamber (119, 219) and the condenser (116, 216) (Fig. 1; ¶ 0076).
With regard to claim 35, Steele further discloses the freeze-drying chamber (119, 219) further comprises a door (106, 2016) configured to seal the freeze-drying chamber (119, 219) and sustain vacuum conditions within the freeze-drying chamber (119, 219) (Fig. 1; ¶ 0058).
With regard to claim 36, Steele further discloses the processing device is configured to execute a freeze-drying recipe (¶¶ 0080–0082).
With regard to claim 37, Steele further discloses the processing device is further configured to periodically adjust a process recipe to cause a computed drying parameter to reach and stabilize at or near a target drying parameter (¶¶ 0080–0082).
Claims 1, 3, 25–26, 29–34, & 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/189655 to Marco et al.
With regard to claim 1, Marco discloses a freeze-drying system (¶ 0002) comprising: a freeze-drying chamber (2) (Fig. 1; ¶ 0024); a condenser (4) coupled to the freeze-drying chamber (2) (Fig. 1; ¶ 0024); one or more load sensors (6a) (Fig. 3; ¶ 0031); and a processing device (16) operatively coupled to the one or more load sensors (6a) and configured to measure mass change of components of the freeze-drying system during a freeze-drying process (¶ 0035).
With regard to claim 3, Marco further discloses the one or more load sensors (6a) are disposed on support structures of the condenser (4) (Fig. 3; ¶ 0031).
With regard to claim 25, Marco further discloses the mass change measured by the processing device corresponds to ice accumulation on the condenser during the freeze-drying process (¶¶ 0031, 0039).
With regard to claim 26, Marco further discloses the processing device is further configured to compute a drying parameter of a product in the freeze-drying chamber corresponding to a given point or period in time based on mass transfer from the product to the condenser as accumulated ice during the freeze-drying process (¶ 0030).
With regard to claim 29, Marco further discloses the one or more load sensors (6a) include load cells (¶ 0031).
With regard to claim 30, Marco further discloses the condenser (4) is an external condenser (Fig. 1).
With regard to claim 31, Marco further discloses the condense (4) is coupled to the freeze-drying chamber (2) via one or more conduits (Fig. 1).
With regard to claim 32, Marco further discloses the freeze-drying chamber (2) further comprises a shelf stack (3) disposed therein for holding samples during the freeze-drying process (Fig. 1; ¶¶ 0024, 0048).
With regard to claim 33, Marco further discloses the freeze-drying chamber further comprises a shelf stack (3) disposed therein (Fig. 1; ¶¶ 0024, 0048), wherein shelves of the shelf stack are thermally coupled to a heating element for temperature control (Fig. 1; ¶¶ 0024, 0048).
With regard to claim 34, Marco further discloses a housing that encloses or supports the freeze-drying chamber (2) and the condenser (4) (Fig. 2).
With regard to claim 36, Marco further discloses the processing device is configured to execute a freeze-drying recipe (¶¶ 0010, 0030).
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 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.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Marco in view of US 2008/0098614 to Tchessalov et al.
Marco fails to disclose the drying parameter is selected from a batch average temperature, cake resistance, and heat transfer coefficient. Tchessalov teaches the drying parameter is a heat transfer coefficient (¶ 0066). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the freeze drier of Marco with the heat transfer coefficient calculation of Tchessalov because such a combination would have had the added benefit of providing the heat transfer coefficient to the user or automated system to more closely control the freeze drying process.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Marco in view of US 11,744,257 to Haddock et al.
Marco fails to disclose a display device operatively coupled to the processing device, wherein the processing device is configured to cause the display device to display a drying parameter during the freeze-drying process. Haddock teaches a display device (24) operatively coupled to the processing device (Col. 5, lines 41–42, 56–64), wherein the processing device is configured to cause the display device to display a drying parameter during the freeze-drying process (Col. 5, lines 41–42, 56–64). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the freeze-dryer of Marco with the display of Haddock because such a combination would have had the added benefit of informing a user about the status of the freeze-drying process.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Marco in view of US 6,122,836 to Tenedini et al.
Marco fails to explicitly disclose the processing device is configured to monitor a mass transfer rate from a product in the freeze-drying chamber to the condenser during the freeze-drying process. Tenedini teaches the processing device is configured to monitor a mass transfer rate from a product in the freeze-drying chamber to the condenser during the freeze-drying process (Col. 5, lines 40–49, 50–53). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the freeze dryer of Marco with the mass transfer rate of Tenedini because such a combination would have had the added benefit of
Allowable Subject Matter
Claims 4 & 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see attached PTO-892. Applicant is encouraged to review the cited references prior to submitting a response to this office action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J LAUX whose telephone number is (571) 270-7619. The examiner can normally be reached 8:30-5:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Helena Kosanovic can be reached at (571) 272-9059. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID J LAUX/Primary Examiner, Art Unit 3762
October 13, 2026
