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 .
Election/Restrictions
Claims 20-24 and 25 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/29/2025.
Response to Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but is not persuasive. The Declaration submitted under 37 C.F.R. § 1.132 has been fully considered. However, the Declaration is not persuasive because the alleged advantages and experimental results are not commensurate in scope with the claims, do not establish criticality of the claimed ranges, and do not overcome the prima facie case of obviousness established by the cited prior art.
First, the Declaration relies on Examples 2 and 3, which are limited to specific compositions employing carboxymethylcellulose (CMC) as the gelling agent and wood pulp as the fibrous organic filler, at particular compositions identified as “ASS5–ASS8.” However, claim 1 is not limited to CMC, is not limited to wood pulp, and broadly recites cellulosic gelling agents and fibrous organic fillers across wide compositional ranges. The Declaration provides no data for compositions using other claimed cellulosic gelling agents, other fibrous organic fillers, or other combinations encompassed by the claims. Accordingly, the alleged improvements are not shown to occur across the full scope of the claims.
Second, the Declaration does not establish criticality of the claimed filler range of about 15–35 wt% or the combined gelling agent and filler range of about 20–75 wt%. The Declaration does not include comparative data showing that compositions outside the claimed ranges fail to achieve similar aerosol performance, nor does it identify a sharp change in properties at the claimed boundaries. Instead, the data merely show performance differences between selected example formulations, which is insufficient to demonstrate that the claimed ranges are critical rather than result-effective variables.
Third, the Declaration attributes the observed improvements to the thermal properties of CMC and its interaction with fibrous filler (e.g., higher gelatinization and melting temperature relative to pectin), rather than to the claimed compositional ranges themselves. Thus, the Declaration does not demonstrate that the claimed ranges — as opposed to the specific material selection used in the examples — are responsible for the alleged advantages.
Accordingly, the Declaration does not rebut the prima facie case of obviousness because it fails to demonstrate unexpected results that are commensurate in scope with the claims and fails to establish criticality of the claimed ranges.
Applicant argues that amended claim 1 is not obvious over Ghanouni, Aoun, alone or in combination with Watanabe, asserting that the cited references do not teach (i) the claimed filler amount of about 15–35 wt%, (ii) a fibrous organic filler in combination with cellulosic gelling agents, or (iii) a combined gelling agent and filler amount of about 20–75 wt%. Applicant further argues that the cited references focus on alginate and pectin gelling agents and rely on calcium crosslinking, allegedly teaching away from the presently claimed invention. These arguments are not persuasive for at least the following reasons.
Ghanouni and Aoun each disclose aerosol-generating compositions comprising an amorphous solid that includes an aerosol-generating agent, a gelling agent/binder, and a filler, with broad, overlapping compositional ranges that encompass the amounts now recited in amended claim 1.
As previously set forth in the Office Action, both references disclose gelling agents (including cellulosic gelling agents) and fillers across ranges that overlap the claimed 15–35 wt% filler and 20–75 wt% combined gelling agent and filler. Selecting a value or sub-range that falls within or overlaps a disclosed range constitutes routine optimization of a result-effective variable, absent a showing of criticality. Applicant has not provided persuasive evidence that the claimed sub-ranges are critical relative to the broader ranges taught by the prior art.
Applicant asserts that Ghanouni and Aoun merely list cellulosic gelling agents among longer lists and do not emphasize them. However, a reference need not describe a feature as “preferred” to constitute a teaching. Both Ghanouni and Aoun expressly disclose cellulosic gelling agents as suitable binders/gelling agents for aerosol-generating compositions. The claims do not require that the cellulosic gelling agent be preferred, exemplified, or exclusively used.
Accordingly, the presence of other disclosed gelling agents (e.g., alginate or pectin) does not negate or teach away from the use of cellulosic gelling agents.
Applicant’s arguments rely heavily on calcium crosslinking and alleged teaching away due to premature crosslinking concerns. However, neither amended claim 1 nor dependent claims 28 or 29 require the presence of calcium, calcium ions, or crosslinking.
Both Ghanouni and Aoun disclose that crosslinking and calcium-based setting agents are optional embodiments, not mandatory features of the aerosol-generating compositions. A reference does not teach away simply because it discloses an optional feature that the claims exclude. The claims are directed to compositions without requiring crosslinking, which remains fully consistent with the disclosures of Ghanouni and Aoun.
Aoun discloses the use of organic fillers, including cellulose-based materials, as fillers in aerosol-generating compositions. To the extent Aoun does not expressly quantify the filler amount, Watanabe teaches the use of cellulose-based fibrous fillers (including plant-derived fibers) in aerosol-forming compositions for structural and processing benefits.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a fibrous organic filler as taught by Watanabe for use in the aerosol-generating compositions of Aoun or Ghanouni, motivated by predictable improvements in mechanical integrity, handling, and aerosol performance.
Applicant relies on a Declaration alleging unexpected results. However, the asserted advantages are tied to specific experimental conditions and combinations that are not commensurate in scope with amended claim 1, which broadly encompasses a wide range of gelling agents, fillers, and compositional ratios. Moreover, the Declaration does not demonstrate that the alleged results are attributable to the claimed numerical ranges, as opposed to other variables disclosed in the specification.
Accordingly, the Declaration is insufficient to overcome the prima facie case of obviousness.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4, 6, 8-12, 14-15 18 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Ghanouni et al. (WO2020028468) using (US 2021/0315266) as a citing reference.
Regarding claim 1 and 8, Ghanouni teaches an aerosol-generating composition comprising an amorphous solid (¶[0025], [0058]). The amorphous solid comprises:
an aerosol generating agent in an amount of from about 1 to 80 wt% of the amorphous solid (¶[0027], [0062]: glycerol, propylene glycol, sorbitol, 5–80 wt%);
one or more gelling agents selected from cellulosic gelling agents (¶[0059]–[0060]: 1–60 wt% gelling agents, including carboxymethylcellulose, hydroxypropyl cellulose, microcrystalline cellulose);
a filler wherein the fille comprises a fibrous organic filler, including wood pulp, cellulose, and cellulose derivatives (¶[0076]);
a flavorant (¶[0064]: 0.1–60 wt%, including menthol); and
Ghanouni teaches filler amounts of 1-60 wt% including narrower discloses ranges of 5-50 wt%, 5-30wt%, and 10-20wt% (¶[0073]) which overlap the claimed filler amount of about 15-35 wt% (claim 1) and filler amount of about 20-25 wt (claim 8).
Claim 1 further requires that the amount of gelling agent and filler taken together is from about 20 to 75 wt% of the amorphous solid.
Ghanouni teaches gelling agents present in amounts of 1-60wt% (¶[0059]) and fillers present in amounts of 1-60 wt% (¶[0073]). In embodiments where, for example, the gelling agent is present in amounts of 20-40 wt% (¶[0059]) and the organic fibrous filler is present in amounts of 15-35 wt% (¶[0073]), the combined amount of gelling agent and filler necessarily falls within the claimed range of about 10-75 wt%.
It has been held that the discovery of an optimum value of a result-effective variable within a disclosed range is ordinarily considered obvious, and that overlapping ranges establish a prima facie case of obviousness (see MPEP 2144.05(II)).
Here, Ghanouni expressly teaches that both the amount of gelling agent and the amount of organic fibrous filler. Ghanouni teaches that the fibrous organic fillers improve the mechanical strength of the amorphous solid, including tensile strength (¶[0076]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to have been motivated to select and adjust the amount of fibrous organic filler within the ranges taught by Ghanouni as a matter of routine optimization to achieve the reinforced amorphous solid disclosed therein.
Regarding claim 4, Ghanouni teaches filler present in amounts of ≥10 wt% within the disclosed 10–20 wt% (¶[0073]).
Regarding claim 6, Ghanouni teaches flavorants including menthol (¶[0064]).
Regarding claim 9, Ghanouni teaches aerosol generating agents in the range of 30–35 wt% (¶[0063]).
Regarding claim 10, Ghanouni teaches gelling agents in the range of 20–40 wt% (¶[0059]).
Regarding claim 11, Ghanouni discloses flavorants present in 20–50 wt%, within the disclosed 0.1–60 wt% (¶[0064]).
Regarding claim 14, Ghanouni teaches gelling agents including carboxymethylcellulose (¶[0060]).
Regarding claim 15, Ghanouni teaches fillers including wood pulp (¶[0075]).
Regarding claim 18, Ghanouni teaches aerosol generating agents including glycerol and propylene glycol (¶[0063]).
Regarding claim 28, As set forth above, claim 1 is rendered obvious by Ghanouni. Ghanouni discloses aerosol-generating compositions comprising an amorphous solid including one or more gelling agents such as hydrocolloids and cellulosic materials (¶¶ [0058]—[0060])).
Ghanouni further teaches that crosslinking is optional, explaining that the gelling agent may be combined with a setting agent, such as calcium source during formation of the amorphous solid but is not required (¶ [0060]).
Because Ghanouni expressly teaches embodiments both with and without crosslinking, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to select a non-crosslinked gelling agent as recited in claim 28.
Regarding claim 29, As discussed above, Ghanouni teaches that calcium crosslinking is optional, stating that the gelling agent may be combined with a calcium source to form a calcium-crosslinking alginate or pectin, but does not require such crosslinking in all embodiments (¶ [0060]). Ghanouni therefore discloses compositions in with no calcium source is used, and the gelling agent remains not calcium-crosslinked.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to select a gelling agent that is not calcium-crosslinked as recited in claim 29.
Claim(s) 1, 4, 6, 8-11, 14-15, 18 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Aoun (US 2018/0279666 A1), and further in view of Watanabe (US 2021/0092992 A1).
Regarding claim 1 and 8, Aoun discloses an aerosol-generating material comprising a solid formed from a slurry and dried into a non-fibrous sheet (¶[0026], [0042], [0051]). Applicant’s as-filed specification defines an “amorphous solid” broadly to include a dried gel, a monolithic non-fibrous solid, or a solid material that may retain fluid. Under this construction, Aoun’s dried sheet corresponds to an amorphous solid.
Specifically, Aoun teaches:
an aerosol-generating agent in an amount of 10–35 wt% (propylene glycol, glycerol, glycols; ¶[0012], [0026], [0043]);
one or more gelling agents (binders such as carboxymethylcellulose, alginates, starches, etc.; ¶[0049]–[0051]);
a fibrous organic filler such as wood pulp (¶ [0011]) in an amount of 50–80 wt%, including specific embodiments of 67 wt% filler (¶ [0042]); and
a flavorant (¶[0059]).
Accordingly, Aoun teaches an aerosol-generating composition comprising an amorphous solid including an aerosol-generating agent, a cellulosic gelling agent, a fibrous organic filler and a flavorant.
Aoun does not expressly teach that the filler present in an amount of about 15-35 wt% (claim 1) or 20-35 wt% (claim 8) of the amorphous solid and the claimed limitation that the amount of gelling agent and filler taken together is from about 20 to 75 wt% of the amorphous solid.
However, Watanabe discloses aerosol-generating compositions for non-combustible aerosol provision systems that include plant-derived filler materials, including cellulose-based and plant fiber materials, as structural components of the aerosol-generating composition (¶¶ [0007], [0015]–[0018]). Watanabe further teaches that the amount of filler is selected and adjusted in view of the desired properties of the aerosol-generating composition (¶¶ [0055]–[0057]). In particular, Watanabe discloses filler contents of about 1–15 wt%, preferably 3–12 wt%, and more preferably 5–10 wt% (¶¶ [0055]–[0057]).
These teachings demonstrate that filler amount is treated as a result-effective variable in aerosol-generating compositions and that plant-derived fibrous fillers are suitable for use across a range of filler contents.
Aoun and Watanabe are in the same field of endeavor, namely aerosol-generating compositions for non-combustible aerosol provision systems, and address the same general problem of formulating solid aerosol-generating materials suitable for aerosol generation.
In view of Watanabe’s teaching that plant-derived fibrous filler content is selected and adjusted within defined ranges, one of ordinary skill in the art would have been motivated to optimize the amount of the fibrous organic filler in Aoun’s composition. Selection of a filler amount within the claimed range of about 15–35 wt% represents a matter of routine optimization in view of the neighboring and overlapping filler ranges disclosed by Watanabe.
It has been held that the discovery of an optimum value of a result-effective variable within a disclosed range is ordinarily considered obvious, and that overlapping or neighboring ranges establish a prima facie case of obviousness. See MPEP § 2144.05(II).
Aoun discloses embodiments in which the filler is present at about 67 wt% and the gelling agent is present at about 6–7 wt% (¶¶ [0042], [0051]), such that the combined amount of filler and gelling agent is approximately 73–74 wt%, which falls within the claimed range of about 20–75 wt%. Upon adjustment of the filler amount as taught by Watanabe, the combined amount of gelling agent and filler would remain within the claimed range.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Aoun’s aerosol-generating composition in view of Watanabe by adjusting the amount of the fibrous organic filler, thereby arriving at a composition meeting all limitations of amended claim 1.
Regarding claim 4, Aoun discloses a filler in an amount of 50–80 wt% (¶[0042]), which meets the requirement of at least 10 wt% filler.
Regarding claim 6, Aoun discloses flavorants including menthol (¶[0061]), which meets the requirement of claim 6.
Regarding claim 9, claim 9 requires the aerosol-generating agent to be present in an amount of 30–60 wt%. Aoun discloses aerosol-generating agents such as propylene glycol and glycerol in an amount of 10–35 wt% (¶[0026], [0043]). The range disclosed by Aoun overlaps with the claimed 30–60 wt% range at 30–35 wt%.
It has been held that the discovery of an optimum value of a result-effective variable within a known range is ordinarily considered obvious, and that overlapping ranges establish a prima facie case of obviousness. See MPEP § 2144.05(II).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to adjust the aerosol-generating agent content as taught by Aoun, arriving at the claimed range of 30–60 wt%.
One would have been motivated to adjust the aerosol-generating agent content within Aoun’s disclosed range, including values of 30–35 wt%, to control aerosol output and optimize performance of the composition.
Regarding claim 10, claim 10 requires the gelling agent to be comprised in the amorphous solid in an amount of from about 20 to about 40 wt%. Aoun discloses a binder comprising alginate or cellulose materials that functions as a gelling agent (¶¶ [0049]–[0053]). Aoun further teaches that the binder may be present in an amount of 5–10 wt%, such as 6.2–6.8 wt% (¶ [0051]).
Although Aoun’s disclosed range is numerically below the claimed range of 20–40 wt%, the claim language is broad and leaves room for interpretation under the broadest reasonable interpretation (BRI) standard. In particular, the claim does not limit the type of gelling agent, the precise method of incorporation, or exclude values slightly outside the stated range. As such, Aoun’s disclosure of a binder (a type of gelling agent) at 5–10 wt% falls close to the claimed range.
It has been held that where the claimed ranges and the prior art ranges are close or touch, a prima facie case of obviousness exists. See MPEP § 2144.05; In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to adjust the amount of gelling agent taught by Aoun to arrive at the claimed 20–40 wt% range.
One would have recognized that optimizing binder content to achieve desired mechanical strength, viscosity, or gelation properties of the amorphous solid would have been a matter of routine experimentation.
Regarding claim 11, claim 11 requires the composition to comprise from about 1 to about 50 wt% flavorant. Aoun discloses an aerosol-generating material comprising tobacco extract (¶[0031]–[0037]), which functions as a flavorant by imparting taste and aroma to the aerosol. Aoun further teaches that the tobacco extract may be present in amounts such as 5–35 wt% (¶[0031]) and in other embodiments at least 2%, 5%, 10%, 15%, 20%, 25%, or 30% up to 70% (¶[0039]). These explicitly disclosed ranges fall within the claimed 1–50 wt% range. Thus, claim 11 is anticipated by Aoun.
Regarding claim 14, Aoun discloses binders (gelling agents) including carboxymethylcellulose (¶[0050]), which meets the requirement of claim 14.
Regarding claim 15, Aoun discloses fillers including wood pulp (¶[0011]), which meets the requirement of claim 15.
Regarding claim 18, Aoun discloses aerosol-generating agents including glycerol, optionally in combination with propylene glycol (¶[0012]), which meets the requirement of claim 18.
Regarding claim 28, Aoun discloses aerosol-generating compositions comprising a gelling agent (binder) selected from alginates, celluloses, modified celluloses, starches, and natural gums (¶¶[0013], [0049]–[0050]). Aoun does not require crosslinking of the gelling agent; rather, crosslinking is discussed only in connection with certain alginate embodiments and processing conditions and is therefore optional.
Accordingly, the use of a non-crosslinked gelling agent represents the selection of an embodiment already encompassed by Aoun’s disclosure. Excluding an optional feature disclosed in the prior art does not confer patentable distinction.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to employ a gelling agent that is not crosslinked, as recited in claim 28.
Regarding Claim 29, Aoun discloses that the gelling agent may comprise alginate binders, including sodium alginate, calcium alginate, potassium alginate, or ammonium alginate (¶[0013]). Calcium-crosslinked alginate is thus disclosed as one optional embodiment, and Aoun expressly contemplates the use of non-calcium alginate binders and non-alginate gelling agents.
Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a gelling agent that is not calcium-crosslinked, as recited in claim 29.
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 1-2, 4, 8-10 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5, 10 of copending Application No. 18042861 in view of Aoun et al. (US 2018/0279666). Claim 1 of U.S. Application No. 18/042,861 recites: “An aerosol-generating composition comprising an amorphous solid, the amorphous solid comprising: (a) an aerosol generating agent in an amount of from about 25 to 80 wt% of the amorphous solid; (b) one or more gelling agents selected from methyl cellulose, guar gum and mixtures thereof; and (c) filler in an amount of at least about 15 wt% of the amorphous solid, wherein the amount of gelling agent and filler taken together is from about 20 to 75 wt% of the amorphous solid.”
The instant claim 1 differs in that it further requires the composition to include a flavorant.
Aoun discloses aerosol-generating materials comprising flavorants such as tobacco extracts, menthol, and other additives that impart flavor (¶¶ [0033], [0058], [0060]). Thus, Aoun teaches the addition of flavorants to aerosol-generating compositions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of claim 1 of U.S. Application No. 18/042,861 to further include a flavorant as taught by Aoun, since flavorants are routinely incorporated into aerosol-generating compositions to provide desired sensory characteristics, see MPEP § 2144.
Regarding claim 2 of the instant application, claim 10 of the ’861 application recites the presence of a filler in the amorphous solid in overlapping ranges, rendering the subject matter not patentably distinct.
Similarly, claims 4, 8, and 15 of the instant application recite filler limitations that are fully encompassed by claim 10 of the ’861 application.
Regarding claim 9 of the instant application, claims 2 and 3 of the ’861 application recite overlapping ranges of aerosol generating agent in the amorphous solid, rendering the subject matter not patentably distinct.
Regarding claim 10 of the instant application, claims 5 of the ’861 application recite overlapping ranges, rendering the subject matter not patentably distinct.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER KESSIE whose telephone number is (571)272-7739. The examiner can normally be reached Monday - Thursday 7:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at (571) 270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747