Prosecution Insights
Last updated: April 19, 2026
Application No. 18/266,274

PULSED ELECTRIC FIELD TREATMENT OF BIOLOGICAL CELLS

Non-Final OA §102§103§112§DP
Filed
Jun 09, 2023
Examiner
MCKNIGHT, CIARA A
Art Unit
1656
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Bühler AG
OA Round
1 (Non-Final)
65%
Grant Probability
Favorable
1-2
OA Rounds
3y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allow Rate
41 granted / 63 resolved
+5.1% vs TC avg
Strong +42% interview lift
Without
With
+41.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
23 currently pending
Career history
86
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
35.4%
-4.6% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
35.2%
-4.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 63 resolved cases

Office Action

§102 §103 §112 §DP
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 the Application 1. Claims 1- 9 are pending and subject to examination on the merits. Claims 1-9 are currently under examination. Election/Restrictions 2. Applicant’s species election without traverse of yeast cells in the reply filed on 14 January 2026 is acknowledged. Priority 3. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in EP (EP20212860.9) on 09 December 2020 . Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement 4. The information disclosure statements (IDS) submitted on 0 9 June 2023 ha s been considered by the examiner. See initialed and signed PTO/SB/08’s. Drawings 5. The drawings are objected to because the numbers (010, 012, 016, 018, 019, and 0112) are not defined by the drawing or the “Brief Description of the Figures .” Further, the drawings are objected because it is difficult to discern which sample is which in the drawing, due to the utilization of identical colors and symbols between samples. It is recommended to use more obviously different symbols between samples (i.e. triangles, circles, filled, and unfilled) . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 112(a) 6 . 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. Written Description: 7 . Claims 1- 9 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. The claims are drawn to a method of increasing metabolic activity and/or stimulating cell proliferation of biological cells, yeast ( P. pastoris or S. cerevisiae ), wherein said method comprises: (a) suspending yeast in electrically conductive liquid, (b) position the suspension between two electrodes, and (c) applying 1-100 pulses of electricity, wherein a voltage increase between the two electrodes is from 10-90% of a target, wherein the pulse lasts 0.1-100ns, wherein the pulse duration is 5-5000ns, and wherein the electric field strength is 0.5kV/com-50kV/cm, and wherein step (c) is a batch or recirculation process. MPEP 2163(1): 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) ( en bane); Vas-Gath, Inc. v. Mahurkar , 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim's enablement is not equally conclusive of that claim's satisfactory written description"). The written description requirement has several policy objectives. "[T]he 'essential goal' of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar , 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba , B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Gath, Inc. v. Mahurkar , 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem , Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings. 8 . The claims are drawn to a method of increasing metabolic activity and/or stimulating cell proliferation by (a) suspending yeast in a large and variable genus of electrically conductive liquid (s) , (b) position the suspension between two electrodes, and (c) applying 1-100 pulses of electricity, wherein a voltage increase between the two electrodes is from 10-90% of a target, wherein the pulse lasts 0.1-100ns, wherein the pulse duration is 5-5000ns, and wherein the electric field strength is 0.5kV/cm-50kV/cm . First, the variability in electrically conductive liquids with the large ranges of pulses, voltage increases, pulse duration, pulse time, and electric field strengths is enormous. Sherba et al. teaches that “Cell viability and electro-transfection efficiency ( eTE ) are dependent on various experimental factors, including pulse waveform, vector concentration, cell type/density, and electroporation buffer properties…the rational selection of pulsing conditions and buffer compositions are critical for the design of electroporation protocols to maximize viability” ( Sherba et al., 2020, Nature Scientific Reports —cited herein ; abstract). The specification does not describe a multitude of electrically conductive liquids, varying pulse durations, or electric field strengths. At most the specification describes a single instance of utilizing the yeast, Pichia pastoris , in a very specific defined buffer medium disclosed on pages 12-13 of the Specification , where the potential difference was kept constant at 5kV, pulse length was constant at 100ns, and the pulses of electricity were either 2, 3, 4, or 6. There is no resulting demonstration of an increase in metabolic activity and/or a stimulation of cell proliferation with the utilization of the yeast. The only demonstration of an increase in metabolic activity was in the previous example utilizing E. coli (p. 11-12, Fig. 1). However, how a cell, yeast or otherwise, reacts in certain buffer conditions (i.e. the electrically conductive liquid), especially when treated with pulsed electric fields, says nothing to increasing said cells’ metabolism and/or proliferation , where specifically, Sherba et al. teaches that electroporation (pulsed electric field) outcomes, such as cell viability, are dependent on a variety of experimental parameters, such as electric pulse strength and duration, number of electric pulses, cell types, cell density, buffer conductivity, and buffer composition (p.1, paragraph 3) . Further, Sherba et al. teaches that the large number of experimental variables increase the complexity of protocol optimization and makes it unclear why a buffer is selected for a given cell type, application, or protocol (p.2, paragraph 1). Moreover, metabolism, in and of itself, is a large and variable genus of a many different cellular processes, making it an enormous feat to determine what conditions and specific buffer constituents would enhance any metabolic processes of the cell in question. The metabolic pathways in yeast are complex and controlled by the regulation and crosstalk of multiple pathways and due to the availability of different carbon sources as taught by Ewald (Ewald, 2018, Current Opinion in Microbiology —cited herein; p. 1, last paragraph, p.2 Figure 1). Here the specification is incomplete and it mandates that those skilled in the art must then figure out how to use the aimed invention. Thus, the claims do not find adequate support in any place in the specification to show that possession of methods for increasing metabolism and/or cell proliferation of yeasts in an undefined electric buffer in response to an immense number of pulse electric field type conditions, i.e. the duration, pulses, and target voltages . The courts have established: Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013): A patent, however, "is not a reward for the search, but compensation for its successful conclusion." Ariad, 598 F.3d at 1353 (quoting University of Rochester, 358 F.3d at 930 n.10). For that reason, the written description requirement prohibits a patentee from "leaving it to the ... industry to complete an u finished invention.” Id. Enablement: 9 . Claims 1- 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for the pulse electric field treatment of P. pastoris at the specific conditions, specifically where the reactor cultivations were performed in a modified defined medium (35.29 g/L Glycerol 85%, 2.86 g/L K 2 SO 4 , 0.64 g/L KOH, 2.32 g/L MgSO 4 *7H 2 O, 0.17 g/L CaSO 4 *2H 2 O, 0.6 g/L Na-EDTA*2H 2 O, 0.22 g/L NaCl, 0.1 g/L Antifoam 205, 7.19 g/L H 3 PO 4 85%, 860g/L water, PTM1 stock, and biotin stock), potential difference of 5kV, pulse length of 100ns, and 2, 3, 4, or 6 pulses of electricity per treatment passage, does not reasonably provide enablement for any electrically conductive liquid, any yeast, any increase in metabolism and/or cell proliferation, any positional difference between two electrodes, the application of 1-100 pulses, 10-90% of a target voltage (between 0.5kV/cm to 50kV/cm) of the pulses of electricity, and durations of 0.1-100ns. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims without significant undue experimentation. The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. The claims in their broadest are drawn to a method of increasing metabolic activity and/or stimulating cell proliferation by (a) suspending yeast in a large and variable genus of electrically conductive liquid(s), (b) position the suspension between two electrodes, and (c) applying 1-100 pulses of electricity, wherein a voltage increase between the two electrodes is from 10-90% of a target, wherein the pulse lasts 0.1-100ns, wherein the pulse duration is 5-5000ns, and wherein the electric field strength is 0.5kV/cm-50kV/cm . The direction and guidance coupled with the working examples of the application, however, are drawn only to demonstrating one specific working example of the method , utilizing P. pastoris at the specific conditions, specifically where the reactor cultivations were performed in a modified defined medium (35.29 g/L Glycerol 85%, 2.86 g/L K 2 SO 4 , 0.64 g/L KOH, 2.32 g/L MgSO 4 *7H 2 O, 0.17 g/L CaSO 4 *2H 2 O, 0.6 g/L Na-EDTA*2H 2 O, 0.22 g/L NaCl, 0.1 g/L Antifoam 205, 7.19 g/L H 3 PO 4 85%, 860g/L water, PTM1 stock, and biotin stock), potential difference of 5kV, pulse length of 100ns, and 2, 3, 4, or 6 pulses of electricity per treatment passage. There is no demonstration and/or example of increasing metabolic activity and/or cell proliferation. The quantity experimentation would be considerable because, while the relative skill level in the art is high (PhD or MD), they would be required to ascertain wh at electrically conductive liquid to use, yeast strains, electrode distance, number of pulses required to increase metabolic activity of the cell, voltage increases between the plates, the time periods of the pulses, and the pulse durations. To this end, Sherba et al. teaches that the state of the literature on electroporation techniques and protocols is difficult to draw conclusions from because of the variation in protocols utilized across laboratories and/or commercial offerings , where specifically, i t can often be unclear why a particular buffer is selected for certain cell type, application, or protocol (p. 2, first paragraph). Additionally, there are no working examples in the specification on increasing metabolic activity of the yeast exposed to pulsed electric fields. It would be extremely difficult to be able to discern which claimed combinations would give rise to a yeast with increased metabolic activity and/or proliferation, resulting in an excessive trial and error to devise the claimed method. I t would be almost impossible to reliably predict the combinations of variables and steps to produce the increased metabolically active yeast claimed in the application. Claim Rejections - 35 USC § 112(b) 10 . 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. 1 1 . Claims 1-9 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. 1 2 . Regarding claims 1-2 and 4-6, the phrase "preferably from" (claim 1, part (c): lines 6 , 11 , 12, and 15) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2 and 4-6 are included in the instant rejection, since they do not rectify the deficiency. 12. Regarding claim 3, the phrase "preferably from" (part (c): lines 7, 11, 12, and 15) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). 13. Regarding claims 7-9, the phrase "preferably from" (claim 7, part (c): lines 7, 11, 12, and 15) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 8-9 are included in the instant rejection, since they do not rectify the deficiency. Claim Rejections - 35 USC § 102 14. 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. 15. 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. 16. Claims 1- 3, 5, and 7-8 are rejected under 35 U.S.C. 10 2(a)(1) by Wolfgang et al (Wolfgang et al., 2011, EP2308969A1 —cited herein ) , as evidenced by Zhu and Thompson (Zhu and Thompson, 2019, Nat Rev Mol Cell Biol —cited herein) . Regarding claims 1 - 3, 5, and 7-8 , drawn to an in vitro method of increasing metabolic activity and/or stimulating cell proliferation (claim s 3 and 7 ) of biological cells , wherein said cells are yeast (claim s 2- 3) , comprising (a) suspending the biological cells in an electrically conductive liquid, (b) positioning the suspension between two electrodes, and (c) applying 1-100 pulses of electricity between the electrodes , characterized in that the voltage increase between the electrodes is 10-90% of a target voltage , whe re in the electric field strength is 0.5 kV/cm-50 kV/c m , pulse timing within 0.1-100 ns, and pulse duration of 5-5000 ns , wherein step (c) is carried out in a continuous recirculation process (claims 5 and 7) , Wolfgang et al. teaches accelerating the cell proliferation of biological cell material, comprising (a) providing a cell material and suspending said material in an electrically conductive fluid between two electrodes, and (b) discharging at least one electric field pulse between the electrodes with a rise in voltage between 10-90% of a target voltage within a time period of 0.1-100ns (abstract) . Wolfgang et al. continues to teach that the pulse duration is 5-5000 ns (p. 3, paragraph 8). Further, Wolfgang et al. teaches that the use of cell cultures in cell medium by fermenters, particularly microalgae, bacteria or yeast for the production of active ingredients, foods, or for the production of energy sources, where the suspension may be pumped during rearing, where then the treatment of cells can take place in continuous operation (p. 4, paragraph 4). Zhu and Thompson evidence that cell proliferation is a product of increased metabolic activity, specifically where cell proliferation requires the accumulation of intracellular biomass, such as proteins and lipids to produce daughter cells , where the biosynthesis of these molecules is due through a network of cellular metabolic pathways (p. 436 , Introduction). Claim Rejections - 35 USC § 103 17. 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. 18. Claims 4, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wolfgang et al (Wolfgang et al., 2011, EP2308969A1—cited herein), as evidenced by Zhu and Thompson (Zhu and Thompson, 2019, Nat Rev Mol Cell Biol —cited herein) as applied to claim s 1-3, 5, and 7-8 above, and further in view of Liu et al (Liu et al., 2019, Critical Reviews in Biotechnology —cited herein) . The teachings of Wolfgang et al., as evidenced by Zhu and Thompson, are discussed above and incorporated into the instant rejection. Wolfgang et al., as evidenced by Zhu and Thompson do not teach the batch fermentation (claim 6 ) of the yeast, P. pastoris (claims 4 and 9). Liu et al. teach the fed-batch fermentation of P. pastoris in a high-cell density fermentation reaction ( p. 258; title, abstract), where specifically Liu et al. focus on various stat-induction strategies, co-feeding, and the limited induction strategy. Therefore, it 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 to combine the teachings of Wolfgang et al., as evidenced by Zhu and Thompson, and Liu et al. to devise a method to increase cell proliferation and/or metabolic activity of P. pastoris by (a) suspending the biological cells in an electrically conductive liquid, (b) positioning the suspension between two electrodes, and (c) applying 1-100 pulses of electricity between the electrodes, characterized in that the voltage increase between the electrodes is 10-90% of a target voltage, wherein the electric field strength is 0.5 kV/cm-50 kV/cm, pulse timing within 0.1-100 ns, and pulse duration of 5-5000 ns, wherein step (c) is carried out in a batch process because utilization of pulsed electric field is as versatile as possible as taught by Wolfgang et al. (p. 3, paragraph 3). One would be motivated to combine the teachings to arrive at the instant claims because the method according to Wolfgang et al. is an economically sensible method, since a significantly higher yield of cell material is obtainable with relatively low energy input in the form of electric field strength pulses (p. 6, paragraph 5). Additionally, one would be further motivated to combine the teachings because P. pastoris is utilized extensively to produce various heterologous proteins and industrial enzymes have been successfully produced by fed-batch-high-cell-density fermentation as taught by Liu et al ( p. 258, abstract). There would be reasonable expectation of success, yielding no surprising results when combining the teachings of Wolfgang et al., as evidenced by Zhu and Thompson, with those of Liu et al. since Wolfgang et al. teach the utilization of yeast in a pulse electric field method, and a common yeast utilized in industrial applications is P. pastoris as taught by Liu et al. Double Patenting 19. 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 . 20. Claim s 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 26 , 27 and 31 of copending Application No. 17797853 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ’853 would anticipate the instant claims . The instant claim s in their broadest are drawn to an in vitro method of increasing metabolic activity and/or stimulating cell proliferation (claim 3) of biological cells, comprising (a) suspending the biological cells in an electrically conductive liquid, (b) positioning the suspension between two electrodes, and (c) applying 1-100 pulses of electricity between the electrodes, characterized in that the voltage increase between the electrodes is 10-90% of a target voltage, wherein the electric field strength is 0.5 kV/cm-50 kV/cm, pulse timing within 0.1-100 ns, and pulse duration of 5-5000 ns . The claims in the ‘853 application in their broadest are drawn to a method for treating cells for stimulating cell growth, performed in a device (comprising a unit for generating and emitting electric pulses, and one treatment space that can be penetrated by the emitted electric pulses and an electric field resulting therefrom, wherein the device further comprises a unit which can be moved into and out of said treatment space such that a cell material provided within a compartment of said unit, or provided in a container on or in said unit, can be moved into and out of said treatment space, and wherein said treatment space is provided between only two electrodes or plates of a capacitor parallel to each other, and said unit which can be moved into and out of said treatment space does not exhibit electrodes), wherein the electric field is applied with such electric pulses, so that a voltage increase takes place between the two electrodes or plates of a capacitor of 10% to 90% of a target voltage of the electric pulses within a period of 0.1 to 1000 ns, the electric pulses have a pulse duration of 5 ns to 50000 ns, and the electric pulses, upon reaching the target voltage, have an electric field strength of 0.5 kV/cm to 100 kV/cm. Thus, the difference between the claims are the recitation of the device in the ‘853 patent; however, the ‘853 claims would still anticipate the instant claims, since the method is identical and the device performs the recited methods. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 21. Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26 ,27 and 3 0 of copending Application No. 1779785 7 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ’85 7 would anticipate the instant claims. The instant claims in their broadest are drawn to an in vitro method of increasing metabolic activity and/or stimulating cell proliferation (claim 3) of biological cells, comprising (a) suspending the biological cells in an electrically conductive liquid, (b) positioning the suspension between two electrodes, and (c) applying 1-100 pulses of electricity between the electrodes, characterized in that the voltage increase between the electrodes is 10-90% of a target voltage, wherein the electric field strength is 0.5 kV/cm-50 kV/cm, pulse timing within 0.1-100 ns, and pulse duration of 5-5000 ns. The claims in the ‘85 7 application in their broadest are drawn to a method for treating cells for targeted inactivation, the extraction of bioactive compounds, and the stimulation of cell growth and/or cellular compounds, comprising the steps a) applying an electric field to a treatment space in a treatment unit that has a geometric shape which allows a non-contact passage of cell material, b) introducing cell material through an inlet of the treatment unit into the treatment space, c) passing of the cell material without contact through the treatment space wherein there are no interactions of the cell material with boundary walls of the treatment space during the movement, and the electric field penetrating the treatment space to an outlet of the treatment unit, and supplying the cell material moved through the treatment space to the outlet by means of a receiving device that is provided in the treatment unit, wherein said receiving device is funnel-shaped, and wherein the diameter of the treatment space is wider than the diameter of the inlet, outlet and the receiving device, wherein an electric field is applied with such electric pulses, so that a voltage increase takes place between two electrodes or plates of a capacitor of 10% to 90% of a target voltage of the electric pulses within a period of 0.1 to 1000 ns, the electric pulses have a pulse duration of 5 ns to 50000 ns, and the electric pulses, upon reaching the target voltage, have an electric field strength of 0.5 kV/cm to 100 kV/cm. Thus, the difference between the claims are the recitation of the treatment space in the ‘85 7 patent ; however, the ‘85 7 claims would still anticipate the instant claims, since the method is identical and the treatment space performs the recited methods . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 22. Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 6 and 18 of copending Application No. 17797865 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ’865 would anticipate the instant claims. The instant claims in their broadest are drawn to an in vitro method of increasing metabolic activity and/or stimulating cell proliferation (claim 3) of biological cells, comprising (a) suspending the biological cells in an electrically conductive liquid, (b) positioning the suspension between two electrodes, and (c) applying 1-100 pulses of electricity between the electrodes, characterized in that the voltage increase between the electrodes is 10-90% of a target voltage, wherein the electric field strength is 0.5 kV/cm-50 kV/cm, pulse timing within 0.1-100 ns, and pulse duration of 5-5000 ns. The claims in the ‘865 application in their broadest are drawn to A method for treating isolated cell material of unicellular or multicellular organisms, or unicellular or multicellular organisms of a size of less than 1 cm diameter, for targeted inactivation, the extraction of bioactive compounds, and the stimulation of cell growth and/or cellular compounds, performed in a device, comprising the steps: a) introducing cell material into a treatment space of the device; and b) applying an electric field to said treatment space with the unit for generating and emitting electric pulses and the two or more electrodes or plates of a capacitor that are arranged in one electric circuit with said unit, wherein said treatment space is arranged between said electrodes or plates, wherein the load of said electric field is adjusted to the cell material to be treated by adjusting the at least one adjustable resistor, wherein the step of adjusting said at least one adjustable resistor is carried out before step b) by determining the electric conductivity of the cell material to be treated and automatically adjusting said at least one adjustable resistor depending on said determined electric conductivity. Thus, the difference between the claims are the recitation of the device in the ‘8 65 patent; however, the ‘8 65 claims would still anticipate the instant claims, since the method is identical and the devic e performs the recited methods. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 23. Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27 - 29 of copending Application No. 17797866 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ’865 would anticipate the instant claims. The instant claims in their broadest are drawn to an in vitro method of increasing metabolic activity and/or stimulating cell proliferation (claim 3) of biological cells, comprising (a) suspending the biological cells in an electrically conductive liquid, (b) positioning the suspension between two electrodes, and (c) applying 1-100 pulses of electricity between the electrodes, characterized in that the voltage increase between the electrodes is 10-90% of a target voltage, wherein the electric field strength is 0.5 kV/cm-50 kV/cm, pulse timing within 0.1-100 ns, and pulse duration of 5-5000 ns. The claims in the ‘866 application in their broadest are drawn to a method for treating cells for targeted inactivation, the extraction of bioactive compounds, and/or the stimulation of cell growth and/or cellular compounds, performed in a device, comprising the steps: a) introducing cell material through an inlet of a treatment unit into a treatment space; b) applying electric pulses to the treatment space in the treatment unit; and c) passing the cell material through the treatment space and the electric pulses penetrating the treatment space to an outlet of the treatment unit, wherein an electric field is applied with such electric field strength pulses that a voltage increase takes place between the two electrodes or plates of a capacitor of 10% to 90% of a target voltage of the electric field strength pulses within a period of 0.1 to 1000 ns, the electric field strength pulses have a pulse duration of 5 ns to 50000 ns, and the electric field strength pulses, upon reaching the target voltage, have an electric field strength of 0.5 kV/cm to 100 kV/cm. Thus, the difference between the claims are the recitation of the device in the ‘866 patent; however, the ‘866 claims would still anticipate the instant claims, since the method is identical and the device performs the recited methods. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 24. Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 15 of copending Application No. 18252834 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ’834 would anticipate the instant claims. The instant claims in their broadest are drawn to an in vitro method of increasing metabolic activity and/or stimulating cell proliferation (claim 3) of biological cells, comprising (a) suspending the biological cells in an electrically conductive liquid, (b) positioning the suspension between two electrodes, and (c) applying 1-100 pulses of electricity between the electrodes, characterized in that the voltage increase between the electrodes is 10-90% of a target voltage, wherein the electric field strength is 0.5 kV/cm-50 kV/cm, pulse timing within 0.1-100 ns, and pulse duration of 5-5000 ns. The claims in the ‘834 application in their broadest are drawn to method for treating cells for targeted inactivation, the extraction of bioactive compounds, and the stimulation of cell growth and/or cellular compounds, performed in a device, comprising the steps of:a ) applying electric pulses to a treatment space in a unit for emitting electric pulses, b) introducing cell material, preferably as a suspension in an electrically conductive liquid, from a unit for taking up a fluid into the treatment space, wherein step b) is preferably carried out before step a), c) passing of the cell material through the treatment space and the electric pulses penetrating the treatment space and conveying said cell material back into said or optionally another unit for taking up a fluid , wherein an electric field is applied with such electric field strength pulses, so that a voltage increase takes place between the two electrodes or plates of 10% to 90% of a target voltage of the electric field strength pulses within a period of 0.1 to 1000 ns, the electric field strength pulses have a pulse duration of 5 ns to 50000 ns, and the electric field strength pulses, upon reaching the target voltage, have an electric field strength of 0.5 kV/cm to 100 kV/cm. . Thus, the difference between the claims are the recitation of the treatment space in the ‘8 34 patent; however, the ‘8 34 claims would still anticipate the instant claims, since the method is identical and the treatment space performs the recited methods. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion 25. All claims are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT CIARA A MCKNIGHT whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4791 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:00am-4:30pm . 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, Manjunath Rao can be reached on (571) 272-0939. 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. /CIARA A MCKNIGHT/ Examiner, Art Unit 1656 /SUZANNE M NOAKES/ Primary Examiner, Art Unit 1656
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Prosecution Timeline

Jun 09, 2023
Application Filed
Feb 11, 2026
Non-Final Rejection — §102, §103, §112 (current)

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