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
Applicant’s election without traverse of claims 1-9 in the reply filed on 11/05/2025 is acknowledged.
Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/05/2025.
Priority
The Applicant’s claims the benefit of a prior-filed application PCT/US2020/054957, which is now US Patent 12,377,416.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551,32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, PCT/US2020/054957, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application.
Since claims 1-9 contain language that does not appear to be supported by App. PCT/US2020/054957 these claims do not receive the earlier filing date and will be examined based on the filing date of the present application.
Claim 1 recites “A fluid analysis system comprising … a sealing fluid delivery system to fill the fluid branch with a sealing fluid”
Claims 2-9 are dependent claims are claim 1 and thus also comprises “a sealing fluid delivery system to fill the fluid branch with a sealing fluid.”
Prior filed App. PCT/US2020/054957 does not provide support the system comprising a sealing fluid delivery system. Because the parent document preceding this application does not disclose the features recited supra as set forth in the claims of the instant invention, applicant only has priority for claims 1-9 back to the filing date the instant application (PCT/US2021/050189) filed on September 14, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/21/2023 and 9/9/2024 are being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a sealing fluid delivery system to fill the fluid branch” in claim 1.
“a number of actuators to transport the sealing fluid and the fluid sample” in claim 9
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In the instant case, the corresponding structure for:
“a sealing fluid delivery system” is a reservoir with an inlet to the fluid analysis system (para. 0034) and equivalents thereof.
“a number of actuators” do not have a corresponding structure. See 35 U.S.C. 112a and 35 U.S.C. 112b rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is 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.
Claim 9 recites "a number of actuators to transport the sealing fluid and the fluid sample" in claim 9, wherein the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While paragraphs 0018 and 0062 in the Specification and Fig. 5 in the Drawings disclose sealing fluid actuators (524-2) and sample actuators (524-1) for transporting the sealing fluid and the fluid sample, respectively, the disclosure is silent on what structure actuators 524-1 and 524-2 comprises that contribute to transport the sealing fluid and the fluid sample. Thus, the disclosure is devoid of any structure of “actuators" that performs the function in the claim. Therefore, the specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary sill in the art can reasonably conclude that the invention had possession of the claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6 and 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.
Regarding claim 9, claim limitation “actuators to transport the sealing fluid and the fluid sample” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While paragraphs 0018 and 0062 in the Specification and Fig. 5 in the Drawings disclose sealing fluid actuators (524-2) and sample actuators (524-1) for transporting the sealing fluid and the fluid sample, respectively, the disclosure is silent on what structure actuators 524-1 and 524-2 comprises that contribute to transport the sealing fluid and the fluid sample. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 3 recites the limitation "upstream of the gas chamber" in line 2. It is unclear what direction the term “upstream” is indicating because it is unclear which fluid (gas or sealing fluid) flow, “upstream” is referring to. For example, Fig. 3A shows that 212-2 is upstream of the gas chamber if it is referring the direction of the sealing fluid flow, but 212-2 is downstream of the gas chamber if it is referring to the direction of gas flow. Clarification is requested. For the purpose of examination, it is being interpreted as referring to the direction of the sealing fluid flow.
Claims 4-6 are indefinite because of their dependency on claim 3.
Claim Rejections - 35 USC § 102
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.
Claims 1, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (CN 108855260 A).
Regarding claim 1, Wang et al. teaches a fluid analysis system (Example 5 and Fig. 8, see annotated Fig. A below), comprising:
an inlet channel (the channel between the entrance of inlet 9 to the sample storage cavity 14)(interprets inlet 9 has a height/thickness that is the distance between the entrance of 9 to the exit of 9) to an analysis chamber (14), wherein the analysis chamber (14) is to receive a fluid sample to be analyzed (interpreted intended use. A fluid sample is not positively recited. cavity 14 meets the structural limitation of the intended use. Moreover, para. 0046, cavity 14 receives reagent A, and cavity is structurally capable of supporting an analysis to performed on reagent A);
a fluid branch (between 8 to the exit 9) having a fluidic junction (exit of 9) along the inlet channel;
a gas chamber (gas cavity 7) to house a volume of trapped gas (air), the gas chamber being in fluid communication with the fluid branch (Fig. 8 and para. 0046, air in gas chamber push molten paraffin into the fluid branch);
a sealing fluid delivery system (solid paraffin storage cavity 8) to fill the fluid branch with a sealing fluid (interpreted as an intended use. A sealing fluid is not positively recited. Moreover, para. 0046, third step, paraffin melted and pushed into fluid branch by expanded gas); and
a heater (one of the heating resistors) adjacent the gas chamber (7)(a heating resistor is adjacent to the gas chamber as evidenced by the heating of the gas chamber, para. 0046) to heat the gas chamber (para. 0046, third step) such that the trapped gas expands to push the sealing fluid into the inlet channel to seal the analysis chamber (para. 0046, third step).
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Figure A. Annotate Fig. 8 of Wang et al.
Regarding claim 7, Wang teaches all of the elements of the current invention as stated above with respect to claim 1. Wang further teach the fluid analysis system comprising a gas chamber capillary break (the narrow channel connecting between 7 and 8) to prevent the sealing fluid from entering the gas chamber (interpreted as a intended use. the sealing fluid is not positively recited. the abrupt increase in space from the narrow channel to the opening of 7 is a typically capillary break structure).
Regarding claim 8, Wang teaches all of the elements of the current invention as stated above with respect to claim 1. Regarding the limitation “the sealing fluid has a lower vapor pressure than the fluid sample and is immiscible with the fluid sample,” the sealing fluid is not positively recited and thus not part of the invention. Since the limitation is directed to the sealing fluid, the limitation does not further limit the structure of the instant invention. For compact prosecution, Wang does teach the sealing fluid (paraffin) has a lower vapor pressure than the fluid sample and is immiscible with the fluid sample (reagent A)(para. 0046).
Claims 1-2 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Handique et al. (US 20150142186 A1)(provided by the Applicant’s IDS of 04/21/2023).
Regarding claim 1, Handique teaches a fluid analysis system (see annotated Fig. B below), comprising:
an inlet channel (1 and 4) to an analysis chamber (reaction/detection subassembly built from a chamber, para. 0064), wherein the analysis chamber is to receive a fluid sample to be analyzed (para. 0064);
a fluid branch (1) having a fluidic junction (the area adjacent to h3; see annotated figure B below)(junction is being interpreted as something that joins) along the inlet channel;
a gas chamber (heat 1 has a gas reservoir, para. 0112 ) to house a volume of trapped gas, the gas chamber being in fluid communication with the fluid branch (Fig. 1);
a sealing fluid delivery system (the “external manual or robotic device” and inlet 1)(the structural equivalent for the “sealing fluid delivery system” is a reservoir with an inlet to the analysis system and equivalent thereof. Para. 0113, fluid introduced into inlet1, for example, by an external manual or robotic device”) to fill the fluid branch with a sealing fluid (interpreted as an intended use. A sealing fluid is not positively recited. The external manual or robotic device connect to inlet 1 meets the structurally limitation of the intended use and is capable of introducing fluid into the system, para. 0113);
a heater (heater 1) adjacent the gas chamber (gas reservoir)(para. 0112) to heat the gas chamber such that the trapped gas expands to push the sealing fluid into the inlet channel (controlled gas pressure generated by heater 1 propels fluid beyond h3 to channel 4) to seal the analysis chamber (interpreted as an intended use. The sealing fluid is not positively recited. The heater, gas chamber and inlet channel meets the structural limitation of the intended use).
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Figure B. Annotated Fig. 1 of Handique et al.
Regarding claim 2, Handique teaches all of the elements of the current invention as stated above with respect to claim 1. Handique further teaches the fluid analysis system further comprising a first capillary break (h3)(para. 0107, a hydrophobic region) at the fluidic junction to prevent the sealing fluid from entering the inlet channel prior to heating the gas chamber (para. 0113).
Regarding claim 7, Handique teaches all of the elements of the current invention as stated above with respect to claim 1. Handique further teaches the fluid analysis system comprising a gas chamber capillary break (h1)(para. 0107, a hydrophobic region) to prevent the sealing fluid from entering the gas chamber (interpreted as an intended use. The sealing fluid is not positively recited. h1 meets the structural limitation of the intended use. Moreover, para. 0113).
Regarding claim 8, Handique teaches all of the elements of the current invention as stated above with respect to claim 1. Regarding the limitation “the sealing fluid has a lower vapor pressure than the fluid sample and is immiscible with the fluid sample,” the sealing fluid is not positively recited and thus not part of the invention. Since the limitation is directed to the sealing fluid, the limitation does not further limit the structure of the instant invention.
Regarding claim 9, Handique teaches all of the elements of the current invention as stated above with respect to claim 1. Handique further teaches the fluid analysis system comprising a number of actuators (m5, m6) to transport the sealing fluid and the fluid sample throughout the fluid analysis system (paras. 0063, 0064 and 0112).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
103 rejection using Wang et al. (CN 108855260 A) as the primary reference
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 108855260 A) in view of Mcbride (US 6444106 B).
Regarding claim 2, Wang teaches all of the elements of the current invention as stated above with respect to claim 1.
Wang teaches that upon heating, the gas in the gas chamber expands and consequently pushes the molten paraffin to flow in to the fluidic junction and then the inlet channel (para. 0046), but Wang does not explicitly teach a capillary break is the reason expansion of gas is needed to push or thrush the molten paraffin to flow into the fluid junction; therefore, Wang fails to teach the fluid analysis system further comprising a first capillary break at the fluidic junction to prevent the sealing fluid from entering the inlet channel prior to heating the gas chamber.
However, Mcbride teaches a moving fluid in a microfluidic device. Mcbride further teaches controlling flow using a capillary break, where a narrow channel ends abruptly as the entrance to a larger space. Capillary forces pull the fluid up to the end of the small cross-section channel but not beyond and thus stops the fluid flow until additional pressure is provided (col. 1, lines 35-41.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluidic junction taught by Wang to include a capillary break, a structure comprising a narrow channel that ends abruptly into a larger space as taught by Mcbride in order to control the flow of paraffin and thus prevent the paraffin flowing into the inlet channel prior to heating the gas chamber with a reasonable expectation of success (Mcbride, col. 1, lines 35-41)(MPEP 2143)(I)(G).
103 rejections using Handique et al. (US 20150142186 A1) as the primary reference
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Handique et al. (US 20150142186 A1)(provided by Applicant’s IDS of 04/21/2023) in view of Gravesen et al. (US 20180177941 A), and further in view of Biswas et al. (Switchable Hydrophobic Valve for Controlled Microfluidic Processing, ChemPhysChem 2016, 17, 817 – 821).
Regarding claim 3, Handique teaches all of the elements of the current invention as stated above with respect to claim 2.
Handique teaches Overflow 1 port connected to a channel in the fluid branch upstream of the gas chamber (see annotated Fig. A above) to allow excess fluid to flow out (para. 0113) which can alleviate backflow of the sealing fluid through the fluid branch, but Handique fails to teach a second capillary break in the fluid branch upstream of the gas chamber to prevent backflow of the sealing fluid through the fluid branch.
However, Gravesen teaches a microfluidic device (abstract). Gravesen further teaches the use of inlet check valve to prevent backflow (para. 0090).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the channel immediately adjacent to inlet 1 of Handique to comprise a inlet check valve taught by Gravesen in order to help prevent backflow to the inlet with a reasonable expectation of success. (Biswas, p. 817, right col.) (MPEP 2143)(I)(G).
In addition, Biswas teaches the use of hydrophobic patch valve, which is a hydrophobic area formed on the surface of a microchannel (Biswas, p. 817, right col., 2nd para.), instead of a check valve because of hydrophobic valve are simpler to fabricate and integrate (Biswas, p. 817, right col., 1st para.).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the check valve at passage 1 near the inlet taught by modified Handique to be a hydrophobic patch valve, hydrophobic valve comprising a hydrophobic area formed on the surface of a microchannel, taught by Biwas in order to have for simple fabrication and integration with a reasonable expectation of success (Biswas, para. 0107) (MPEP 2143)(I)(G).
Regarding claim 4, Modified Handique teaches all of the elements of the current invention as stated above with respect to claim 3. Modified Handique further teaches wherein the second capillary break (modified Handique has a hydrophobic patch valve at the portion of passage 1 by inlet 1) has a smaller opening than the first capillary break (Fig. 1 and para. 0113, h3 is located in the widened part of the channel and the hydrophobic patch valve in modified Handique is at portion of passage 1 by inlet 1 which is narrower, Fig. 1).
Regarding claim 5, modified Handique teaches all of the elements of the current invention as stated above with respect to claim 3. Modified Handique further teaches wherein the second capillary break has different characteristics as compared to the first capillary break (first capillary breaks has a wider opening since the hydrophobic patch in modified Handique is at the portion of passage 1 by inlet 1 which is narrower, Fig. 1).
Regarding claim 6, modified Handique teaches The fluid analysis system of claim 5, wherein a characteristic that is different between the second capillary break and the first capillary break is selected from the group consisting of:
a width (h3 is at a widen part of the channel, the hydrophobic patch in modified Handique is at the portion of passage 1 by inlet 1 which is narrower)
(The strike-out parts are not required).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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/M.L.C./ Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/ Primary Examiner, Art Unit 1758