Prosecution Insights
Last updated: July 17, 2026
Application No. 17/968,217

DISPOSABLE BIOPROCESS SYSTEM SUPPORTING BIOLOGICAL ACTIVITY

Final Rejection §103§112§DOUBLEPATENT
Filed
Oct 18, 2022
Priority
Aug 08, 2015 — DK PA201500453 +3 more
Examiner
HENKEL, DANIELLE B
Art Unit
1799
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Stobbe GmbH
OA Round
2 (Final)
56%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
80%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
362 granted / 643 resolved
-8.7% vs TC avg
Strong +24% interview lift
Without
With
+23.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
18 currently pending
Career history
668
Total Applications
across all art units

Statute-Specific Performance

§103
80.9%
+40.9% vs TC avg
§102
3.6%
-36.4% vs TC avg
§112
2.3%
-37.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 643 resolved cases

Office Action

§103 §112 §DOUBLEPATENT
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 . DETAILED ACTION Summary This is the initial Office action on the 17/968217 application filed on 10/18/22. Claims 1-16 are pending and have been fully considered. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/18/22 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claim 14 is objected to because of the following informalities: The claim ends in a comma (,) which appear to be a typographical error as every claim should end in a period (.) . Appropriate correction is required. Claim 16 is objected to because of the following informalities: The claim contains an apostrophe in the last instance of System, which appears to be a typographical error. 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: liquid pumping device, permeable membrane filter device and fluid flow control device in claim 1, second liquid flow control device in claim 2, inlet fluid flow control device, outlet fluid flow control device, and electronic controller device in claim 10. 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 § 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 1-16 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. Regarding claim 1, limitation c) recites: at least one fluid flow control device, however limitation a) also recites: to at least one permeable membrane filter device. It is unclear from the claim if there are two separate permeable membrane filter devices provided or if the two limitations are referring to the same one. If they are the same it is recommended to correct the second instance to the or said at least one permeable membrane filter device. Regarding claim 11, lines 2-3 recite “at least one fluid flow control device”. As at least one fluid flow control device is the same language already used in claim 1, it is unclear if this is a second/additional fluid flow control device or is intending to refer back to the one recited in claim 1. Regarding claim 14, line 7, 9 recite “at least one membrane filter device” and “said membrane filter”, respectively. It is unclear if these limitations are meant to refer back to the at least one membrane filter device of claim 1, or if they are introducing a second/additional membrane filter device. It is also noted that naming of structures should be consistent throughout the claims to make clear the antecedent basis, therefore “said membrane filter” and “said filter device” should be replaced with – said membrane filter device. Claim 14 recites the limitation "said at least one electronically controlled liquid pumping device" in lines 3-4, 5-6 and “said second retentate outlet port” in line 8. There is insufficient antecedent basis for these limitations in the claim. Claim 14 recites the limitation "said third permeate outlet port" in bullet 5. There is insufficient antecedent basis for this limitation in the claim. Claim 15 recites the limitation "said first retentate port" in bullet 4. There is insufficient antecedent basis for this limitation in the claim. Claim 15 recites the limitation "said third permeate outlet port" in bullet 5. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 15, line 3-4, 16-18 recite “at least one membrane filter device” and “said membrane filter”, respectively. It is unclear if these limitations are meant to refer back to the at least one membrane filter device of claim 1, or if they are introducing a second/additional membrane filter device. It is also noted that naming of structures should be consistent throughout the claims to make clear the antecedent basis, therefore “said membrane filter” and “said filter device” should be replaced with – said membrane filter device. Claims 2-16 depend from claim 1 and therefore contain the same deficiency noted above. 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. Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over SHEVITZ (US 6544424) as applied above, and further in view of STOBBE (US 2011/0223581). With respect to claim 1, SHEVITZ discloses a fluid filtration system adapted to be connected to a fluid storage vessel (fluid tight container), the system comprising: A diaphragm pump 24 (liquid pumping device) configured to convey process liquid from the container to at least one membrane filter (Col 7, line 32-Col 8, line 42, Fig 1); A first fluid control valve 12 (fluid flow control device) configured to control fluid communication between the interior of the container and the filter, A filter containing compartment 4 (filter device) that is configured to communicate with process liquid and separates the process liquid from the exterior, the filter element can be a hollow fiber filtration membrane (membrane filter device, permeable membrane), the filter configured to receive and separate the process liquid into retentate and permeate, (Claims 28-31, Col 9, line 5-29, Fig 1); It is noted the fluid tight container is not a positively recited structure of the claimed invention and therefore structural limitations thereof do not further limit the claim and do not carry patentable weight. SHEVITZ discloses a controller for controlling the movement of the diaphragm pump (operation is controlled) (Col. 8, lines 25-57) and microprocessor control of suitable valves (Col. 8, lines 17-18) and automated mass flow regulators (Col. 13, lines 5-6) but does not explicitly disclose the details of the controller/microprocessor including being a PLC system. However, STOBBE discloses an electronically controlled diaphragm pump that receives action signals from a PLC which also receives information about pumped volume from a membrane displacement sensor and provides very accurate control of the pump and powers valves (0130, 0151) and this digital control allows fluid line valves to be controlled (0149). It would have been obvious to one of ordinary skill in the art to modify the controller of SHEVITZ to include a PLC controlling operation of the pump and valves as taught by STOBBE because the pump and its control prevent a known phenomenon that causes internal damage to diaphragm pumps, and the control device can hold a program for regulating channels, valves and power to control multiple processes in the system in addition to the pump, and the valves may easily be controlled (0143-151). With respect to claim 2, STOBBE discloses the valve (fluid control device) is adapted to regulate the opening and closing and duration of the valve flow (conveyance of process liquid volume in) by electrical means (0149). With respect to claim 3, SHEVITZ discloses the filter containing compartment 4 (filter device) that is configured to communicate with process liquid and separates the process liquid from the exterior, the filter element can be a hollow fiber filtration membrane (membrane filter device, permeable membrane barrier), the filter configured to receive and separate the process liquid into retentate and permeate, comprising a retentate side inlet 13 (process liquid inlet port) and retentate side outlet (retentate outlet port) communicating with the container and a filtered permeate that can be withdrawn (communicating with exterior) through a fluid harvest port (permeate outlet port) (Claims 28-31, Col 9, line 5-29, Fig 1); and a second valve 10 (second liquid flow control device) configured to control fluid communication between the filter device (retentate outlet port) and the container (Fig 1, Col.6, lines 24-Col. 7, line 31). With respect to claim 4, STOBBE discloses the valve (fluid control device) is adapted to regulate the opening and closing and duration of the valve flow (conveyance of process liquid volume in) by electrical means (0149). With respect to claim 5, SHEVITZ discloses the filter system is combined with a process vessel (fluid tight container) suitable for a fluid, including bioreactors (for cultivation) (Col 6, lines 24-35) which is used in semi-continuous flow with fluid containing cells (Col 13, lines 7-22) in high cell concentrations (Col. 14, lines 44-46) and is therefore capable of being used with more than 20 million cells per mL in the container. With respect to claim 6, SHEVITZ discloses the pump is configured to be externally arranged with respect to the process vessel to pump liquid from the vessel via ports extending through the wall of the container (Fig 1). With respect to claim 7, SHEVITZ does not explicitly disclose either ethe pump or filter is adapted to be arranged inside the interior of the fluid tight container. However, STOBBE discloses the pump and filters can be integrated within the housing of a bioreactor (fluid tight container) (0116, 0192, Fig. 5). It would have been obvious to one of ordinary skill in the art at the time of the inventio to modify the device of SHEVITZ to include the components all adapted to be arranged inside the same housing as taught by STOBBE because it results in a stand-alone unit (0035, 0192) which has a smaller footprint and therefore requires less space to operate. With respect to claim 8, SHEVITZ discloses the cells in the system need nutrients, especially oxygen (Col 3, lines 10-19) but does not explicitly disclose the sensors as claimed. However, STOBBE discloses the bioreactor can provide measurements to the control device from integrated disposable sensors for pH and oxygen (0119-0128). It would have been obvious to one of ordinary skill in the art at the time of the inventio to modify the process vessel of SHEVITZ to include the sensors as taught by STOBBE because the sensor provides input measurement signals which allow the control device to be used for easy digital control over the performance of the system (0135). With respect to claims 9, “first means of liquid communication” has been interpreted under 35 USC 112f as stated above, to be the tubes, hoses or ports as recited in the specification (see published application paragraph 0115) and their functional equivalents. SHEVITZ discloses the fluid connectors between the vessel and either the pump or filter include pipes, tubes, hoses and the like, which have the above recited valves to control flow (Fig 1, Col 6, lines 36-60). With respect to claim 10, SHEVITZ discloses the pump has an entrance end (inlet valve) and a sampler valve (outlet valve), as well as air inlet port (controlled action process fluid inlet valve) and vacuum line (outlet valve), the pump and valves configured to be connected to an electronic controller for control of the pumped volume (Fig 1, Col 7, lines 32-Col 8, line 64) but does not explicitly disclose the details of the controller incorporating a PLC system. However, STOBBE discloses an electronically controlled diaphragm pump that receives action signals from a PLC which also receives information about pumped volume from a membrane displacement sensor and provides very accurate control of the pump and powers valves (0130, 0151) and this digital control allows fluid line valves to be controlled (0149). It would have been obvious to one of ordinary skill in the art to modify the controller of SHEVITZ to include a PLC controlling operation of the pump as taught by STOBBE because the pump and its control prevent a known phenomenon that causes internal damage to diaphragm pumps, and the control device can hold a program for regulating channels, valves and power to control multiple processes in the system in addition to the pump, and the valves may easily be controlled (0143-151). With respect to claim 11, SHEVITZ discloses the filter system is combined with a process vessel (fluid tight container) having at least one port on top connected to valve 12 (fluid flow control device) (Col 6, lines 24-35, Col 13, lines 7-22). the pump and valves configured to be connected to an electronic controller for control of the pumped volume (Fig 1, Col 7, lines 32-Col 8, line 64) but does not explicitly disclose the details of the controller incorporating a PLC system. However, STOBBE discloses an electronically controlled diaphragm pump that receives action signals from a PLC which also receives information about pumped volume from a membrane displacement sensor and provides very accurate control of the pump and powers valves (0130, 0151) and this digital control allows fluid line valves to be controlled (0149). It would have been obvious to one of ordinary skill in the art to modify the controller of SHEVITZ to include a PLC controlling operation of the pump as taught by STOBBE because the pump and its control prevent a known phenomenon that causes internal damage to diaphragm pumps, and the control device can hold a program for regulating channels, valves and power to control multiple processes in the system in addition to the pump, and the valves may easily be controlled (0143-151). With respect to claim 12, SHEVITZ discloses the pump is a diaphragm pump with two housing ports and a fluid entrance end (liquid port) in one chamber (first housing part) and the opposite a dome shaped chamber with another port (second housing part) with a flexible (elastic) diaphragm membrane between the two chambers separating them into a liquid contacting chamber and a controlling drive fluid pressure chamber, the pump is configured to create an alternating motion of the diaphragm and the liquid volume within the pump housing (Fig 1, Col 7, lines 32-Col 8, line 64). With respect to claim 13, SHEVITZ discloses the pump and a controller for controlling the movement of the diaphragm pump using sensors to accurately control the position of the diaphragm in the pump (Col. 8, lines 25-57) but does not explicitly disclose the details of the sensor control. However, STOBBE discloses an electronically controlled pump system comprising a pump housing (element for conveying liquid) (0039) with an upper housing part (first housing chamber) and a lower housing part (second housing chamber) separated by an elastic, flexible diaphragm with a gas and liquid tight circumference (0085) which is non—porous (0018), the upper housing part having fluid connections (first housing chamber is adapted for conveying liquid media through a port) and lower housing part having a an external tube connection for pressurized drive gas (second housing chamber is adapted for drive fluid connection through a port for position of said diaphragm) (0175, Fig. 4), the diaphragm pump has a displacement sensor for detecting displacement or position of the diaphragm (membrane has a position sensor) in real time (dynamic position) (0172) which can be a laser type displacement sensor (0042-43, 0049, 0217) that accurately informs the controller about the actual distance of the membrane (of better than 2 mm) (0099), and is able to measure the distance to and the position of the membrane with a flexible transparent window on the wall (second housing has window) in order to separate the pressure sensors from the fluid (0217) and control circuitry including microprocessor (PLC), connected to the displacement sensor for determining the displacement or position of the diaphragm and adapted for supplying the control signals to the gas pressure means (0042-45) to adjust the actual membrane position (0163, 0168). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the fluid delivery pump of SHEVITZ to include the diaphragm pump with membrane position sensor configured to forward data to the PLC as taught by STOBBE because the disposable diaphragm pump provides a system with benefits of the move to disposable devices providing reduction in sterilization and cleaning requirements, improved plant flexibility, reduced costs and faster time to market (0002), overcomes the issue of very expensive peristaltic pumps (0004), and offers gentle conveyance of liquids and is ideal for a sensitive media (0006), and the position sensor allows for built in measures to track the actual volume being pumped which overcomes the disadvantages of previously available diaphragm pumps (0006). With respect to claim 14, “means of liquid communication” has been interpreted under 35 USC 112f as stated above, to be the tubes, hoses or ports as recited in the specification (see published application paragraph 0115) and their functional equivalents. SHEVITZ discloses a fluid filtration system of claim 1 as stated above, and further discloses the fluid connectors between the vessel and either the pump or filter include pipes, tubes, hoses and the like, which have the above recited valves to control flow (Fig 1, Col 6, lines 36-60), in which one port extends from the top of the vessel, the valve 12 (fluid flow control device) positioned in the liquid path between the membrane and vessel, and the permeate port 50 communicates between the filter and exterior facility for conveying filtered liquid for harvesting (Fig 1), but does not explicitly disclose the arrangement of valves in the liquid communication lines and recirculation of retentate from the filter back to the container as claimed. However, STROBBE discloses a biopharmaceutical process apparatus in which valves are placed in the lines (liquid communication means) between a pump and a fluid reservoir as well as between the pump and the inlet/outlet of the filter device, and wherein fluid is returned (recirculated) back through the system before being delivered to a product collection container (0171-174, 0305, 0314, 0318). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of SHEVITZ to include the valve and lines arrangement including the fluid return as taught by STROBBE because the system provides a high degree of flexibility for process design and the biopharmaceutical process plant can be modified more easily to fit with new requirements as to its modularity (0014). Any additional limitations regarding the location of lines and valves would have been obvious to one of ordinary skill in the art since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04. With respect to claim 15, “means of liquid communication” has been interpreted under 35 USC 112f as stated above, to be the tubes, hoses or ports as recited in the specification (see published application paragraph 0115) and their functional equivalents. SHEVITZ discloses a fluid filtration system of claim 1 as stated above, and further discloses the fluid connectors between the vessel and either the pump or filter include pipes, tubes, hoses and the like, which have the above recited valves to control flow (Fig 1, Col 6, lines 36-60), in which one port extends from the top of the vessel, the valve 12 (fluid flow control device) positioned in the liquid path between the membrane and vessel, and the permeate port 50 communicates between the filter and exterior facility for conveying filtered liquid for harvesting (Fig 1), but does not explicitly disclose the arrangement of valves in the liquid communication lines and recirculation of retentate from the filter back to the container as claimed. However, STROBBE discloses a biopharmaceutical process apparatus in which valves are placed in the lines (liquid communication means) between a pump and a fluid reservoir as well as between the pump and the inlet/outlet of the filter device, and wherein fluid is returned (recirculated) back through the system before being delivered to a product collection container (0171-174, 0305, 0314, 0318). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of SHEVITZ to include the valve and lines arrangement including the fluid return as taught by STROBBE because the system provides a high degree of flexibility for process design and the biopharmaceutical process plant can be modified more easily to fit with new requirements as to its modularity (0014). Any additional limitations regarding the location of lines and valves would have been obvious to one of ordinary skill in the art since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04. With respect to claim 16, SHEVITZ discloses multiple systems (two or more) can be operated in parallel (Col. 11, lines 40-53) and STOBBE discloses it is possible to have multiple pump systems working in parallel (0092) and the PLC controller operating both using stored memory (0130-150). 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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11414642. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over the reference claims. The difference lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus, the invention of the patent is in effect a "species" of the "generic" invention of pending claims of the present application. See In re Goodman, 11F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Omum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12110484. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over the reference claims. The difference lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus, the invention of the patent is in effect a "species" of the "generic" invention of pending claims of the present application. See In re Goodman, 11F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Omum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO 892 for references related to the invention. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays. 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, Michael Marcheschi can be reached at 571-272-1374. 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. /DANIELLE B HENKEL/Examiner, Art Unit 1799 /William H. Beisner/Primary Examiner, Art Unit 1799
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Prosecution Timeline

Oct 18, 2022
Application Filed
Oct 02, 2025
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT
Mar 26, 2026
Response Filed
Jul 14, 2026
Final Rejection mailed — §103, §112, §DOUBLEPATENT (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12680066
CASSETTE ASSEMBLY
4y 9m to grant Granted Jul 14, 2026
Patent 12674129
MINIATURIZED CENTRIFUGAL BIOREACTOR AND ROTOR SYSTEM
4y 7m to grant Granted Jul 07, 2026
Patent 12662655
Device for Distributing a Flow
5y 1m to grant Granted Jun 23, 2026
Patent 12644093
Pyrotechnic Cell Disruption Apparatus and Pyrotechnic Cell Disruption Method
4y 1m to grant Granted Jun 02, 2026
Patent 12637639
RESIDUE EMPTYING
4y 8m to grant Granted May 26, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

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Prosecution Projections

3-4
Expected OA Rounds
56%
Grant Probability
80%
With Interview (+23.7%)
3y 8m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 643 resolved cases by this examiner. Grant probability derived from career allowance rate.

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