DETAILED ACTION
Response to Arguments
Applicant’s arguments filed 11/21/2025 have been fully considered but they are not persuasive.
In response to applicant’s arguments, the examiner appreciates applicant’s explanation regarding the digital controller. It is to be noted that the “digital controller” claim limitation was not a direct subject of the 35 U.S.C. 112 (a) and (b) rejection. It is the position of the Office that one of ordinary skill in the art would understand that digital controllers are comprised of a variety of structural elements e.g., but not limited to a sensor, an actuator, a communication network, a power supply, a digital signal processor or a microcontroller, all of which have differing functions. Further, a digital controller may comprise varying components based on its intended use. Applicant states that the specification links the digital controllers to the DNP managers, recipe managers, reporting managers, differed generators, and GUI managers however, applicant has failed to point out any corresponding structure that specifically define the DNP managers, recipe managers, reporting managers, differed generators, and GUI managers. Furthermore, it is the structure of the DNP managers, the recipe managers, the reporting managers, the differed generators, and the GUI managers that is required to provide a link to the respective claimed function and not the digital controller as applicant has suggested. Since the specification as filed remains void of any corresponding structure that clearly define a DNP manager, a recipe manager, a reporting manager, a differed generator, and a GUI manager, the rejection is maintained.
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: bioprocess machine in claims 1-3, 5-7, 9-11, 14-16 and 19-20; a biotechnological fluid treater in claim 1; a digital controller in claims 1, 5, 14-15 and 19-20; a bioprocess machine helper in claims 1-3, 5-12, 14-17 and 19-20; a biotechnological fluid treater helper in claims 1, 3-4, 8, 12, 14-15,17 and 19-20; a reporting manager in claims 1-3 and 8-10; a machine to machine communication tool (MtoM communication tool) in claims 1, 13 and 18; a discovery negotiation pairing manager (DNP manager) in claims 1, 6-8, 11 and 16; a differed generator in claim 2; a recipe manager in claims 15 and 20; and a graphical user interface manager (GUI manager) in claims 14 and 19.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: the “bioprocess machine” according to the applicant’s specification comprises a mixer (see applicant’s specification page 13, line 1); the “biotechnological fluid treater” according to the applicant’s specification comprises a tank and agitator if the bioprocess machine is a mixer (see applicant’s specification page 13, lines 1-2); the “bioprocess machine helper” according to the applicant’s specification comprises a pump if the biotechnological fluid treater helper is a driving member such as the rollers of a peristaltic pump and a pH probe and flow probe if the biotechnological fluid treater helper is a pH or flow sensor (see applicant’s specification page 13, lines 2-6); the “digital controller” according to the applicant’s specification comprises a recipe manager, GUI manager, MtoM communication tool, a DNP manager and a file (see applicant’s specification pages 7 and 12); the “reporting manager” according to the applicant’s specification comprises a data logger and a differed generator (see applicant’s specification page 4, lines 12-14); and the “MtoM communication tool” according to the applicant’s specification comprises a OPC UA server and a OPC UA client (see applicant’s specification page 25, lines 13-14).
Additionally, if the “bioprocess machine” is different from a mixer according to the applicant’s specification the “bioprocess machine” may comprises, for instance a bioreactor, a chromatograph, a virus inactivation or a tangential flow filtration (see applicant’s specification page 86, lines 19-20).
If “the bioprocess machine helper” are different from a pump, a flow sensor and a pH sensor, for example other active components such as valves or mass flow controllers; other sensors whether mechanical, electronic, opto-electronic, infrared, ultra-violet, etc. like pressure sensors, temperature sensors, OD (Optical Density) sensors, DO (Dissolved Oxygen) sensors, gas (CO2, ...) sensors, weight sensors, speed (RPM...) sensors, flow (gas/air) rate sensors, humidity sensors, hygrometry sensors, light/lux sensors, position (valve, actuator, switch...) sensors, power (watt..) sensors, galvanometers, motion sensors, vacuum sensors, title sensors, viability sensors, resistivity sensors, proximity/distance sensors, volume sensors, UV sensors, IR sensors, frequency sensors, molar concentration sensors, duration/time sensors, radiation sensors, colorimeters, glucometers, opacimeters, osmometers, photometers, spectroscopes, acoustic pressure sensors, sonometers, video sensors, photosensors, electrical charge sensors, particle counters, viscosity sensors or lactate sensors; other types of instrumentation; and/or ancillary devices such as a cell retention device or a mixer which are capability providers (unlike the mixer in the above example) (see applicant’s specification page 86, line 21-page 87, line 5).
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-8, 10, 12-14 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, 10 and 12-15 of copending Application No. 18/022,347 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claim recitations anticipated the presently recited subject matter.
Claims 2-3, 9, 11, 15 and 17-20 depend on independent claim 1 and are therefore, rejected for the same reason.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
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.
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.
As explained above, claim limitations “DNP manager”, “recipe manager”, “reporting manager”, “differed generator” and “GUI manager” invoke 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 for performing the entire claimed function and to clearly link the structure to the function. Therefore, claims 1, 2, 6-8, 11, 14-16 and 19-20 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement, and under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 3-5, 9-10, 12-13 and 17-18 depend on independent claim 1 and are therefore, rejected for the same reason.
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.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796