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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2025 has been entered.
Claim Status
As of the Final Office Action mailed 3/11/2025, claims 1, 3-4, 6, 9, 11, 14-17, 20, 22, and 27 were pending.
In Applicant's Response filed on 8/11/2025, claims 1, 20, and 22 were amended.
As such, claims 1, 3-4, 6, 9, 11, 14-17, 20, 22, and 27 are pending and have been examined herein.
Withdrawn Rejections
The rejection of record of claim 1, 3-4, 6, 9, 11, 14-17, 20, 22, and 27 under 35 USC § 112(b) have been withdrawn in view of Applicant’s amendment to claim 1, 20, and 22.
Maintained Rejections
Applicant's arguments regarding the rejection of record of claims 1, 3-4, 6, 9, 11, 14-16, and 27 under 35 USC § 103 as being unpatentable over Nowakowska (18 Nov 2016; p.1-112; Ref. 3 of Non-Patent Literature in IDS filed 15 Feb 2021; previously cited) as evidenced by Pike et al (ThermoFisher Scientific, 8 Oct 2020; accessed 18 Jan 2024; previously cited), in view of Cao et al (CN106665560A, 16 Jan 2017; Published 17 May 2017) and Liu et al (Biotechnol Prog. 22 June 2010;26(6):1635-1643; previously cited) have been fully considered but they are not persuasive. Thus, the rejection has been maintained. The rejection has been recast below and response to argument will follow the rejection.
Applicant's arguments regarding the rejection of record of claims 17, 20, and 22 under 35 USC § 103 as being unpatentable over Nowakowska (18 Nov 2016; p.1-112; Ref. 3 of Non-Patent Literature in IDS filed 15 Feb 2021; previously cited) in view of Cao et al (CN106665560A, 16 Jan 2017; Published 17 May 2017) and Liu et al (Biotechnol Prog. 22 June 2010;26(6):1635-1643; previously cited) as applied to claims 1, 3-4, 6, 9, 11, 14-16, and 27 above, and further in view of Zhang et al (US 20180273903 A1; 28 Dec 2017; previously cited) have been fully considered but they are not persuasive. Thus, the rejection has been maintained. The rejection has been recast below and response to argument will follow the rejection.
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.
Claims 1, 3-4, 6, 9, 11, 14-16, and 27 remain rejected under 35 U.S.C. 103 as being unpatentable over Nowakowska (18 Nov 2016; p.1-112; Ref. 3 of Non-Patent Literature in IDS filed 15 Feb 2021; previously cited), as evidenced by Pike et al (ThermoFisher Scientific, 8 Oct 2020; accessed 18 Jan 2024; previously cited), in view of Cao et al (CN106665560A, 16 Jan 2017; Published 17 May 2017; previously cited) and Liu et al (Biotechnol Prog. 22 June 2010;26(6):1635-1643; previously cited).
Nowakowska teaches a cryopreservation solution in which human serum albumin (HSA) is combined with CryoStor CS10 medium in a 1:1 ratio as a base cryopreservation solution to freeze parental NK-92 and NK-92/5.28.z cells that have been modified to express a CAR (see p. 28, “2.5.3 Cryopreservation solutions”, para 1) (“population of immortalized, modified NK cells” and “freezing the mixture” as in instant claim 1 in-part; (“wherein the population of immortalized, modified NK cells express a . . . chimeric antigen receptor” as in instant claim 27)). The combination of human albumin (i.e., second composition) and CS10 (i.e., first composition) in a 1:1 ratio also renders prima facie obvious “contacting the population of immortalized, modified NK cells with a second composition before contacting a first composition” as in instant claim 1 in-part as the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (see MPEP § 2144.04.IV.C). This reads on “wherein the albumin in the second composition is human albumin” as in instant claim 6. This overlaps with the instantly claimed volume ratio of “between 1:5 and 5:1” as in instant claim 14. MPEP 2144.05.I states that “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Thus, a 1:1 ratio of CryoStor CS10 and HSA reads on instant claim 14. The reference also teaches that HAS combined with CS10 containing 5% DMSO had at least 60% recovery directly post-thaw of genetically modified NK cells (see p. 48, “3.1.5 Establishment of cryopreservation protocols, para 1 and Fig. 3.5A).
Evidentiary reference Pike describes robust formulation and cryopreservation strategy for cell therapy manufacturing (title). Specifically, it lists the components of CryoStor CS10, which is a proprietary formula containing 1) 10% DMSO (“DMSO” as in instant claims 1(g) and “10% DMSO” as in instant claim 9), 2) dextran-40, sucrose, and glucose ( “at least one sugar” as in instant claim 1(d) and “a simple sugar” as in instant claim 4), 3) sodium, potassium, calcium, and magnesium (“one or more electrolytes consisting of potassium ions, sodium ions, magnesium ions, and calcium ions” as in instant claims 1(a)), 4) phosphate (H2PO4-) and HEPES (“a pH buffer” as in instant claims 1(c); also see Table 1 of instant specification), 5) lactobionate (“an impermeant agent . . . consisting of lactobionate” as in instant claim 1(f)), 6) mannitol (“at least one sugar alcohol” as in instant claims 1(e) and “6-carbon sugar alcohol” as in instant claim 3; also see Table 1 of instant specification), 7) adenosine (“one or more substrate . . . selected from . . . adenosine” as in instant claim 11) and glutathione (“glutathione” as in instant claim 9), 8) HSA (“one or more macromolecular agents selected from . . . human albumin” as in instant claims 1(b)). This shows that CryoStor CS10 as in Nowakowska also reads on instant claim 1 in-part, as well as instant claims 9, and 11.
The difference between Nowakowska and the instantly claimed invention is that it does not teach thawing the frozen cells in a mixture comprising the first and second composition and the population of NK cells and administering the thawed cells in the mixture directly to a patient in need.
Cao teaches an immune cell cryopreservation liquid for direct intravenous infusion composed of a liquid A and liquid B, wherein liquid A contains 4-16% DMSO, 0.3-5.5% hydroxyethyl starch (i.e., “starch” as in instant claim 1(b)), 0.3-5.5% dextran (i.e., “at least one sugar” as in instant claim 1(d)), 0.5-5.5% glucose, 1-1000 U//mL heparin sodium (i.e, “polysaccharide” as in instant claim 1(b)) and liquid B is 2-25% human serum albumin (i.e., “second composition comprises albumin” as in instant claim 1 in-part) (see claim 1 of Cao translation) (overlaps with “wherein the mixture contains less than 10% DMSO” as in instant claim 15). The reference teaches that immune cells are Nk cells, and that the cells are frozen to -80C then transferred to a liquid nitrogen storage tank for long term storage (see claims 5 and 6 of Cao) (“wherein the method further comprises freezing the cells using a controlled rate freezer to reach a final temperature of -80C or lower, thereby producing preserved cells” as in instant claim 16). When the frozen cells are to be used, the cells are taken out of the liquid nitrogen tank, placed in a water bath at 37C until completely melted and within 1 hour after thawing are used for intravenous infusion (see claim 8 of Cao) (“the method further comprising thawing the frozen cells in the mixture comprising the first and second compositions and the population of immortalized, modified NK cells, and administering the thawed cells in the mixture directly to a patient in need” as in instant claim 1 in-part).
Liu discusses the cryopreservation of bone marrow-derived MSCs with reduced DMSO and well-defined freezing solutions (title and abstract). The reference teaches measuring post-thaw cell viability, early apoptotic behaviors, metabolic activities, and growth dynamics of cells with or without the presence of albumin (abstract). It teaches that albumin contributes to prevention of viability loss during freezing and thawing (p. 1641, col 1, first para). It also teaches that bovine serum albumin may play a significant role in membrane structure stabilization and reduced damage caused by cold shock or osmotic stress as a lipid peroxidation inhibitor or an emulsifying substance to protect lipids against oxidation (p. 1641 col 2, top para). Finally, it teaches that the same results can be expected when using human serum albumin (same para) (i.e., both are useful for the same purpose).
Nowakowska, Cao, and Liu are silent on contacting the cells with albumin prior to the addition of the cryopreservation medium, however, MPEP 2144.04.IV.C states that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Since Nowakowska shows that albumin and CryoStor10 can be combined to freeze NK cells and Liu teaches that serum albumin contributes to the prevention of viability loss and stabilizes cell membrane structure and reduces damage caused by cold shock, it would have been well within the purview of one of ordinary skill, prior to the effective filing date of the instantly claimed invention, to add the second albumin composition to the NK cells prior to the addition of CryoStor10 with the reasonable expectation that the subsequent cold shock produced by the freezing medium would advantageously not damage the cells and the NK cells would remain viable post-thaw.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to freeze NK cells in albumin and CryoStor10 as taught by Nowakowska, where the cells are thawed in a water bath and directly infused into a patient as taught by Cao, to arrive at the instantly claimed invention. As Cao shows that a first composition containing at least some of the components of CryoStor 10 and a second composition of albumin can be thawed and directly infused into a patient after thawing, one of ordinary skill would expect the frozen cells of Nowakowska to be able to be advantageously infused directly post thaw with a reasonable expectation of success as taught by the prior art.
It would have been prima facie obvious to try, from a finite number of identifiable, predictable solutions, prior to the effective filing date of the instantly claimed invention, to freeze NK cells with CryoStor 10 and human serum albumin, where additional albumin is added to the cells first, with a reasonable expectation of success as taught by Liu.
It also would have been prima facie obvious to try, from a finite number of identifiable, predictable solutions, to mix CryoStor CS10 and human serum albumin in any ratio, including between 1:5 and 5:1 with a reasonable expectation of success as taught by the prior art.
Response to Arguments
Applicant’s arguments and the Declaration filed by Dr. Ali (referred herein as the “Ali Declaration”) have been fully considered but are not persuasive.
First, Applicant argues (see p. 7-11 of Remarks) that Nowakowska, Cao, and Liu are all silent on a freezing method where the cells are contacted with albumin prior to the addition of a cryopreservation medium. Applicant also argues that Nowakowska, Cao, and Liu do not disclose that their cells were directly administered to human patients such that no combination of these references teach or suggests all the method features recited in claim 1. Second, Applicant argues that, based on the information provided in the Ali Declaration, the cells of the claimed method were used in clinical trials (NCT03586869 and NCT04390399) fulfilled the strict guidelines imposed by the FDA and, as a result, constitutes strong evidence that the cell can be safely administered to patients directly. Applicant also argues that the cells resulting from the instantly claimed method were able to be directly administered into patients and that an additional advantage of the cells was that they could alternatively be frozen for long-term storage and, thus, increasing shelf-life. Applicant argues that no combination of the previously cited references could provide one of ordinary skill in the art to arrive at such cells for direct infusion into humans. Applicant argues that the lack of evidence in the references of any clinical trial data or human safety, coupled with purported unpredictability of translation of in vitro and animal model data into human clinical research, shows that the claimed method and the cells produced therefrom satisfy a long-felt need where others have failed.
In response, the examiner respectfully disagrees. First, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (see MPEP § 2144.04.IV.C). While Nowakowski does not teach the order in which the cells are contacted with the albumin and CryoStor10, the Liu reference provides sufficient motivation as to why one of ordinary skill would contact the cells with albumin before the cryopreservation medium. Liu specifically teaches that albumin contributes to prevention of viability loss during freezing and thawing (p. 1641, col 1, first para). It also teaches that serum albumin plays a significant role in membrane structure stabilization, improved viability post-thaw, and reduced damage caused by cold shock. Thus, one of ordinary skill in the art would have recognized the protective qualities of albumin on cells prior to the effective filing date of the instantly claimed invention. One of ordinary skill would have reasonably expected, regardless of the order in which the albumin is added (including before the addition of cryopreservation medium), that the cells would receive these protective qualities inherent to the albumin itself.
Second, as iterated in the previous non-final Office action, previously cited reference Cao specifically teaches that “when the frozen immune cells are used, the freezing bag is quickly taken out from the liquid nitrogen tank, placed in a 37°C water bath until completely thawed, and within 1 hour after thawing completing intravenous infusion” (see claim 8 of Cao). This teaching runs contrary to Applicant’s assertion.
Third, submissions to the FDA may be material to ongoing patent proceedings, however, considerations made by the FDA for approving clinical trials are different from those made by the USPTO in determining whether a claim is patentable. Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F.4th 1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021) (MPEP § 2001.06(e)). Applicant’s arguments and Declaration regarding the technical solution the instant claims purportedly improve upon are appreciated, however, it is not persuasive in light of the fact that the applied Cao reference explicitly describes the same improvements as instantly argued. The examiner directs Applicant’s attention to, for example, paras 4, 6, and 8 of the “Background” section of the Cao reference. Paragraph 4 states “the technical problem is that the frozen stock solution contains animal-derived serum, has potential risk of introducing animal-derived antigen substances, and cannot be directly returned to a human body.” Paragraph 6 states “the main component of the frozen stock solution [of the prior art] is a cell culture medium, does not have the effect of a stabilizer and cannot be directly used for clinical reinfusion.” Paragraph 8 states “the effective components of the existing freezing medium [of the prior art] mostly contain scientific research-grade cell culture medium, fetal bovine serum and other components, cannot be directly applied to human infusion, and is expensive. Therefore, there is a need to research a frozen immune cell stock solution with better frozen effect, lower price, more convenient use, and safer application.” Notably, the last paragraph of the “Disclosure of Invention” section states that “Compared with the prior art, the invention has high safety, does not contain animal-derived serum with potential pathogenic risk, and can be stably stored for a long time by the two components. The cryopreservation method is simple and easy to implement, can meet the requirements of clinical large-scale operation, is superior to the conventional cryopreservation method in cryopreservation effect, can be directly infused after cells are recovered, and reduces the damage to the cells caused by intermediate complicated treatment links and washing.”
"A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue." In re Corkill, 771 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (see MPEP § 716.02(a)). The examiner also notes that the claims read on any immortalized NK cells (not just the NK-92 cells of the instant specification working examples/those utilized in the clinical trials). The Ali declaration is vague in its reference to the NK cells and the clinical trials. Furthermore, the clinical trial data provided in the Ali Declaration (administering immortalized NK cells modified to express high affinity CD16 receptors and/or IL-2 as a pancreatic cancer vaccine) is not commensurate in scope to the NK cells embraced by instantly claimed method of freezing. Thus, neither the arguments posited nor the Ali Declaration provide any evidence that the instantly claimed method of freezing any benefits/unintended results not previously contemplated by the prior art. The combination of the applied references render the claims prima facie obvious in light of their disclosures and the rejection is proper.
Claim(s) 17, 20, and 22 remain rejected under 35 U.S.C. 103 as being unpatentable over Nowakowska (18 Nov 2016; p.1-112; Ref. 3 of Non-Patent Literature in IDS filed 15 Feb 2021; previously cited) in view of Cao et al (CN106665560A, 16 Jan 2017; Published 17 May 2017; previously cited) and Liu et al (Biotechnol Prog. 22 June 2010;26(6):1635-1643; previously cited) as applied to claims 1, 3-4, 6, 9, 11, 14-16, and 27 above, and further in view of Zhang et al (US 20180273903 A1; 28 Dec 2017; previously cited).
The teachings of Nowakowska, Cao, and Liu in combination were recited in the above 35 U.S.C. 103 rejection as applied to claim 1 of which claims 17, 20, and 22 depend. The teachings will not be repeated here.
The difference between the combined teachings and the invention as instantly claimed is that they do not teach storing the cells at -80°C to -196°C (related to claim 17), that more than 70% of the cells are viable at thawing (claim 20), or that the thawed cells either i) have a direct cytoxicity of at least 80% against K562 cells at an effector to target ratio of 10:1;ii) have a direct cytotoxicity that is 70-100% of that of the population of immortalized, modified NK cells before the cells are frozen; iii) have an ADCC activity of at least 80-120% against Ramos cells at an effector to target ratio of 10:1 in the presence of an antibody targeting the Ramos cells; or iv) have a ADCC activity that is 80-100% of that of the cells before the cells are frozen (claim 22).
Zhang teaches genetically modified NK cells (abstract), such as TGF-beta knockout NK-92 cells (p. 38, para 0260) that can be preserved, placed under conditions that allow for long-term storage or under conditions that inhibit cell death (p. 16, para 0136). Suitable cryopreservation medium includes CryoStor CS10 and additional agents such as human serum albumin (p. 16, para 0137). It also discloses that the cells can be cooled in a controlled-rate freezer at 0.1 to 2° C./min to -80 to -180° C (p. 18, para 0144) and storing the cryopreserved sample below -80° C. (p. 17, para 0139) (“storing the cells at -80 to -196° C” as in instant claim 17). The NK cells can be thawed in a thawing medium such that 60% to 98% of the cells are still viable as determined by automatic cell counter or trypan blue method (p. 19, para 0146) and can be used in a pharmaceutical composition suitable for infusion (p. 19, para 0155) to a human in need of cancer therapy (p.2, para 0012) (“wherein more than 70% of the cells are viable at the time of thaw” as in instant claim 20). Finally, the reference teaches that the NK cells can have at least 75% cytotoxicity against K562 cells when the NK cells and K562 cells are co-cultured in vitro at a ratio of 10:1 (p.14, para 0120, also see Fig. 18A) (“have a direct cytotoxicity of at least 80% against K592 cells at an effector to target ratio of 10:1” as in instant claim 22). This cytotoxicity percentage overlaps with the instantly claimed range of at least 80% direct cytotoxicity. MPEP 2144.05.I states that “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Thus, the “at least 75% cytotoxicity” of Zhang reads on instant claim 22.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to contact cells with CryoStor CS10 and human serum albumin as taught by Nowakowska, Cao, and Liu in combination, where the cells are stored at as taught by Zhang, to arrive at the instantly claimed invention. As Zhang shows that cryopreserved NK cells can be stored at -80°C to -196°C after freezing and exhibits at least 75% cytotoxicity against K562 cells, one of ordinary skill would reasonably expect the cryopreserved cells of Nowakowska, Cao, and Liu in combination to exhibit a similar cytotoxicity when frozen and thawed in a similar medium composition.
Response to Arguments
On, p. 8 of Remarks, Applicant argues that cited reference Zhang does not disclose successful administration of cells directly into human patients and, thus, does not remedy the deficiencies of cited references Nowakowska, Cao, and Liu. As discussed above, previously cited reference Cao explicitly discloses the administration of immune cells, such as NK cells, immediately post-thaw after freezing in the presence of albumin and a cryopreservation medium. The Zhang reference was cited to render prima facie obvious (1) that genetically modified NK cells frozen in a cryopreservation medium containing CryoStor10 and additional human serum albumin can be done at -80 to 196 degrees Celsius, (2) more than 70% of the cells are viable post-thaw, and (3) that the NK cells have at least 75% cytotoxicity against K592 cells when co-cultured at a ratio of 10:1 as instantly claimed. Applicant has not provided any arguments that challenge these specific teachings provided by the Zhang reference. Absent evidence to the contrary, the combined teachings of Nowakowska, Cao, Liu, and Zhang render instant claims 17, 20, and 22 prima facie obvious. Thus, the rejection is proper.
New Grounds of Objections/Rejections
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “ . . . the method comprising: contacting the population of immortalized, modified NK cells with a second composition before contacting a first composition thereby forming a mixture comprising the first and second compositions and the population of immortalized, modified NK cells.” The way that the compositions of the instant method are identified is confusing. The examiner suggests (1) renumbering the compositions such that the first composition is albumin and the second composition is the freezing medium, and (2) amending the claim language to recite that the population of NK cells is contacted with the first composition (albumin) followed by the second composition (freezing medium components).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, 6, 9, 11, 14-17, 20, 22, and 27 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.
Claim 1 recites, inter alia, “A method of freezing a population of immortalized, modified NK cells for direct infusion, the method comprising: . . .; and freezing the mixture; and the method further comprises: thawing the frozen cells in the mixture comprising the first and second compositions and the population of immortalized, modified NK cells, and administering the thawed cells in the mixture directly to a patient in need.” While the method contains the language “further comprises”, the administration step goes beyond the objective stated in the preamble. There is no nexus between the freezing steps and the administration. Thus, the claim is indefinite. Claims 3-4, 6, 9, 11, 14-17, 20, 22, and 27 are included in this rejection for being dependent on indefinite claim 1. The examiner suggests amending the claim to recite, for example, “A method of administering a population of immortalized, modified NK cells comprising . . .” to make the claim language clearer.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached T-F 7-3.
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/G.R./Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632