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 .
Claim Objections
Claim(s) 32-51 is/are objected to because of the following informalities:
Claim 32, Ln. 5 recites “the second” which should read “the second connector”
Claim 40 twice recites “comprises one or more of” which should each be followed by a colon
Claim 42, Ln. 1 recites “the blocking member” which should read “the at least one blocking member” for consistency with claim 41, unless only a single blocking member is intended
Appropriate correction is required.
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(s) 40 is/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. Claim 40 recites “the first part of the flow modifying arrangement comprises one or more of: a constriction or an obstruction, an orifice, a venturi, or a blocking member; and the second part of the flow modifying arrangement comprises one or more of: a constriction or an obstruction, an orifice, a venturi, or a blocking member”. The “one or more of” language for both the first part and the second part covers many embodiments which fall outside of the scope of the disclosed invention. For example, one of ordinary skill in the art would not expect applicant to have been reasonably in possession of a flow modifying arrangement which simultaneously uses all of the disclosed first part options together with all of the disclosed second part options. The claim thus lacks sufficient written description support in the application as originally filed for the breadth of possibilities recited by the instant claim. Applicant should amend the claim to only pair options for the first part and the second part clearly disclosed in combination together in the originally filed specification.
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.
Claim(s) 35 and 48-49 is/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 pre-AIA the applicant regards as the invention.
Claim 35 recites the limitation “the first and second parts form a dominant flow restriction in a respiratory system” which deems the claim indefinite. The claim cannot be properly interpreted without requiring the respiratory system to be read as part of the connector assembly (i.e. “form a dominant flow restriction”). However, the connector assembly is only understood to be a subcombination of the overall combination of the respiratory system. The claim needs to be consistent as either a subcombination claim (e.g. only claiming features of the connector assembly) or to positively set forth the combination of the connector assembly in a respiratory system. For the purposes of examination the claim will not be read as positively reciting the respiratory system, leaving the limitation as only suggestive (and running the risk of failing to meet the requirements of 35 U.S.C. 112(d)).
Claim 48 recites the limitation “the first connector is coupled to an inspiratory conduit or filter” which deems the claim indefinite. The disclosure of the instant application clearly distinguishes between the connector assembly and any structures to which the connector assembly is coupled, such as an inspiratory conduit or filter (e.g. ¶0199 of the PGPub copy of the instant application). The disclosed connector assembly is only understood to be a subcombination of an overall combination which would include an inspiratory conduit or filter. The claim needs to be consistent as either a subcombination claim (e.g. only claiming features of the connector assembly) or to positively set forth the combination of the connector assembly in a system with other components. For the purposes of examination the claim will not be read as positively reciting the inspiratory conduit or filter. In order to be consistent with the preamble as a connector assembly the limitation will be interpreted as reading “the first connector is configured to be coupled to an inspiratory conduit or filter”.
Claim 49 recites the limitation “the second connector is coupled to a patient interface conduit or filter” which deems the claim indefinite. The disclosure of the instant application clearly distinguishes between the connector assembly and any structures to which the connector assembly is coupled, such as a patient interface conduit or filter (e.g. ¶0199 of the PGPub copy of the instant application). The disclosed connector assembly is only understood to be a subcombination of an overall combination which would include a patient interface conduit or filter. The claim needs to be consistent as either a subcombination claim (e.g. only claiming features of the connector assembly) or to positively set forth the combination of the connector assembly in a system with other components. For the purposes of examination the claim will not be read as positively reciting the patient interface conduit or filter. In order to be consistent with the preamble as a connector assembly the limitation will be interpreted as reading “the second connector is configured to be coupled to a patient interface conduit or filter”.
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: “flow modifying arrangement first part” and “flow modifying arrangement second part” both in claim 32 (“flow modifying” as function and “arrangement” and “part” both as nonce terms).
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.
The “flow modifying arrangement first part” is best understood from the specification as at least: first part 104 (Figs. 3-4), first part 204 (Figs. 5-8), blocking member 304 (Figs. 13-16), bar 404 (Figs. 17-27), cross bar 504 (Figs. 28a-29c), cross bars 604a,b (Figs. 30a-30b) or cross bars 704 (Figs. 31a-31b).
The “flow modifying arrangement second part” is best understood from the specification as at least: second part 114 (Figs. 3-4), second part 214 (Figs. 5-8), orifice plate 314 (Figs. 13-16), venturi 414 (Figs. 17-27), protrusions 514b (Figs. 28a-28b), orifice plate 514d (Figs. 29a-29c), protrusions 614b (Figs. 30a-30b) or cross bars 714 (Figs. 31a-31b).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 32-36, 38-47 and 50-51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeVries (U.S. Patent 5014694).
Regarding claim 32, DeVries discloses a connector assembly (Fig. 1 #10; Col. 5-6) for use in a respiratory support system (Fig. 2), the connector assembly comprising: a first connector (Fig. 1 #44; Col. 6, Ln. 36-65); a second connector (Fig. 1 #12; Col. 5-6) that engages the first connector to thereby define a gas flow path through the first connector and the second connector; and a flow modifying arrangement (Fig. 1 #66; Col. 7, Ln. 62 – Col. 8, Ln. 6 and Fig. 1 #30; Col. 8, Ln. 23-41) having a first part (Fig. 1 #66) and a second part (Fig. 1 #30), wherein the first connector comprises the first part of the flow modifying arrangement (Fig. 1) and the second connector comprises the second part of the flow modifying arrangement (Fig. 1), wherein the flow modifying arrangement is configured to change a property of a gas flow along the gas flow path (e.g. pressure, concentration, etc.). It is noted that the reading of the first and second connectors from DeVries can be reversed. The structures cited for the first part and second part correspond to structural options of the disclosed flow modifying arrangement in the instant application’s disclosure.
Regarding claim 33, DeVries discloses the property of a gas flow along the gas flow path is one or more of: a pressure of the gas flow, a turbulence of the gas flow, or a velocity of the gas flow (Fig. 1; Col. 7, Ln. 51 – Col. 8, Ln. 53).
Regarding claim 34, DeVries discloses the first and second parts of the flow modifying arrangement together define a high resistance portion of the flow path having a higher resistance to flow than portions of the flow path immediately upstream and downstream of the flow modifying arrangement (Fig. 1 holes 66 restrict flow which causes increased resistance, Fig. 1 interaction between valve seat 30 and poppet 82 causes increased resistance). Note also the situation when poppet 82 will engage against valve seat 30.
Regarding claim 35, DeVries discloses the first and second parts are capable of forming a dominant flow restriction in a respiratory system. It is noted that no portion of the respiratory system other than the first and second connectors have been positively recited. The resistance to flow caused by holes 66, valve seat 30 and poppet 82 create a dominant resistance within blender 10, particularly when poppet 82 is engaged against valve seat 30.
Regarding claim 36, DeVries discloses the first and second parts of the flow modifying arrangement together define a tortuous flow path through the flow modifying arrangement (Fig. 1 flow path through #66 and #30 is winding and non-linear).
Regarding claim 38, DeVries discloses the first part of the flow modifying arrangement is proximate to the second part (Fig. 1).
Regarding claim 39, DeVries discloses the first and second parts of the flow modifying arrangement define a high resistance flow path through the flow modifying arrangement (Fig. 1 holes 66 restrict flow which causes increased resistance, Fig. 1 interaction between valve seat 30 and poppet 82 causes increased resistance), the flow path having a cross sectional area that is selected to provide a pre-determined change to the property of gas flow across the flow modifying arrangement (e.g. sizing of valve seat 30 is determined to correspond to size of poppet 82 for particular gas flow changes).
Regarding claim 40, DeVries discloses the first part of the flow modifying arrangement comprises one or more of: a constriction or an obstruction, an orifice (Fig. 1 #66), a venturi, or a blocking member (Fig. 1 #44); and the second part of the flow modifying arrangement comprises one or more of: a constriction (Fig. 1 #30) or an obstruction, an orifice, a venturi (Fig. 1 #30), or a blocking member. The instant claim does not invoke 35 U.S.C. 112(f).
Regarding claim 41, DeVries discloses the first part of the flow modifying arrangement comprises at least one blocking member (Fig. 1 #44) that is substantially cylindrical (Fig. 1), The instant claim does not invoke 35 U.S.C. 112(f) in relation to the “first part of the flow modifying arrangement”.
Regarding claim 42, DeVries discloses the blocking member comprises a longitudinal axis that is substantially parallel to a longitudinal axis of the first connector (Fig. 1 central axis of #11).
Regarding claim 43, DeVries discloses the second part of the flow modifying arrangement comprises an annular venturi (Fig. 1 #30). The instant claim does not invoke 35 U.S.C. 112(f) in relation to the “second part of the flow modifying arrangement”.
Regarding claim 44, DeVries discloses the first part of the flow modifying arrangement is capable of causing a smaller change to the property of the gas flow across the first connector when the first connector is not engaged with the second connector. When either proportioning device 12 or tubular segment 44 is not engaged in cavity 11 the device will not be suitable for use and thus no meaningful change in flow would be caused.
Regarding claim 45, DeVries discloses the second part of the flow modifying arrangement is capable of causing a smaller change to the property of the gas flow across the second connector when the second connector is not engaged with the first connector. When either proportioning device 12 or tubular segment 44 is not engaged in cavity 11 the device will not be suitable for use and thus no meaningful change in flow would be caused.
Regarding claim 46, DeVries discloses the first connector is releasably engageable with the second connector (Fig. 1 by threaded connections to #11; Col. 5, Ln. 63-68 & Col. 6, Ln. 44-49).
Regarding claim 47, DeVries discloses the first and second connectors comprise alignment features that orientate the first part of the flow modifying arrangement relative to the second part of the flow modifying arrangement (Fig. 1 abutting at flange 29; Col. 6, Ln. 40-44).
Regarding claim 50, DeVries discloses the flow modifying arrangement is capable of use in a high flow type respiratory support system. There is no reason to expect the oxygen delivery of DeVries could not be provided at a “high” rate of flow. The language “high flow” is particularly discussed in ¶0174 of the PGPub copy of the instant application. It is noted that the high flow type respiratory support system is not positively recited.
Regarding claim 51, DeVries discloses the flow modifying arrangement is capable of use at flow rates of more than 20 L/min. There is no reason to expect the oxygen delivery of DeVries could not be provided at a suitably high rate of flow. It is noted that the no structure is positively recited which would provide the claimed flow rate.
Claim(s) 32-51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allum et al. (U.S. Pub. 2018/0200475).
Regarding claim 32, Allum discloses a connector assembly (Figs. 1 & 3 #130; ¶0020) for use in a respiratory support system (Fig. 1), the connector assembly comprising: a first connector (Fig. 3 #310; ¶0027); a second connector (Fig. 3 #320; ¶0027) that engages the first connector to thereby define a gas flow path through the first connector and the second connector; and a flow modifying arrangement (e.g. Fig. 3 upward hole in #303, #326, #203, #321; see also Fig. 4) having a first part (Fig. 3 upward hole in #30 and/or #326 and/or #203) and a second part (Fig. 3 #321), wherein the first connector comprises the first part of the flow modifying arrangement (Fig. 3) and the second connector comprises the second part of the flow modifying arrangement (Fig. 3), wherein the flow modifying arrangement is configured to change a property of a gas flow along the gas flow path (e.g. ¶¶0028, 0030, 0032-0033; see also Fig. 4). It is noted that the reading of the first and second connectors from Allum can be reversed. The structures cited for the first part and second part correspond to structural options of the disclosed flow modifying arrangement in the instant application’s disclosure.
Regarding claim 33, Allum discloses the property of a gas flow along the gas flow path is one or more of: a pressure of the gas flow, a turbulence of the gas flow, or a velocity of the gas flow (Figs. 3-4; ¶¶0028, 0030, 0032-0033).
Regarding claim 34, Allum discloses the first and second parts of the flow modifying arrangement together define a high resistance portion of the flow path having a higher resistance to flow than portions of the flow path immediately upstream and downstream of the flow modifying arrangement (e.g. Fig. 4 vs. remainder of Fig. 3).
Regarding claim 35, Allum discloses the first and second parts are capable of forming a dominant flow restriction in a respiratory system (e.g. Fig. 4 vs. remainder of Fig. 3). It is noted that no portion of the respiratory system other than the first and second connectors have been positively recited.
Regarding claim 36, Allum discloses the first and second parts of the flow modifying arrangement together define a tortuous flow path through the flow modifying arrangement (Figs. 3-4 flow path is winding and non-linear).
Regarding claim 37, Allum discloses the first and second parts of the flow modifying arrangement are arranged co-axially (Figs. 3-4).
Regarding claim 38, Allum discloses the first part of the flow modifying arrangement is proximate to the second part (e.g. Fig. 4).
Regarding claim 39, Allum discloses the first and second parts of the flow modifying arrangement define a high resistance flow path through the flow modifying arrangement (e.g. Fig. 4), the flow path having a cross sectional area that is selected to provide a pre-determined change to the property of gas flow across the flow modifying arrangement (e.g. Fig. 4; ¶0033).
Regarding claim 40, Allum discloses the first part of the flow modifying arrangement comprises one or more of: a constriction (Fig. 4 narrowing of #311) or an obstruction, an orifice (Fig. 3 upward hole in #303 or passage through #326), a venturi, or a blocking member (Fig. 3 #327); and the second part of the flow modifying arrangement comprises one or more of: a constriction or an obstruction (Figs. 3-4 #321), an orifice, a venturi, or a blocking member (Figs. 3-4 #321). The instant claim does not invoke 35 U.S.C. 112(f).
Regarding claim 41, Allum discloses the first part of the flow modifying arrangement comprises at least one blocking member (Figs. 3-4 #321) that is substantially cylindrical, frustoconical, cuboidal, pyramidal, prismatic, conical, or spherical (e.g. Figs. 3-4; ¶0036). The instant claim does not invoke 35 U.S.C. 112(f) in relation to the “first part of the flow modifying arrangement”. It is noted that the instant claim uses the alternate reading from claim 32 which reverses the reading of the first part and the second part as there is no language in the claims to require them to only be read in a single orientation.
Regarding claim 42, Allum discloses the blocking member comprises a longitudinal axis that is substantially parallel to a longitudinal axis of the first connector (Figs. 3-4).
Regarding claim 43, Allum discloses the second part of the flow modifying arrangement comprises an annular venturi (Fig. 4 #311). The instant claim does not invoke 35 U.S.C. 112(f) in relation to the “second part of the flow modifying arrangement”. It is noted that the instant claim uses the alternate reading from claim 32 which reverses the reading of the first part and the second part as there is no language in the claims to require them to only be read in a single orientation.
Regarding claim 44, Allum discloses the first part of the flow modifying arrangement is capable of causing a smaller change to the property of the gas flow across the first connector when the first connector is not engaged with the second connector. When upstream body half 310 is detached from downstream body half 320, by way of their threaded interface (e.g. ¶¶0028, 0033), neither will be suitable for use and thus no meaningful change in flow would be caused.
Regarding claim 45, Allum discloses the second part of the flow modifying arrangement is capable of causing a smaller change to the property of the gas flow across the second connector when the second connector is not engaged with the first connector. When upstream body half 310 is detached from downstream body half 320, by way of their threaded interface (e.g. ¶¶0028, 0033), neither will be suitable for use and thus no meaningful change in flow would be caused.
Regarding claim 46, Allum discloses the first connector is releasably engageable with the second connector (¶¶0028, 0033 – threaded connection).
Regarding claim 47, Allum discloses the first and second connectors comprise alignment features that orientate the first part of the flow modifying arrangement relative to the second part of the flow modifying arrangement (¶¶0028, 0033 – threaded connection).
Regarding claim 48, Allum discloses the first connector is configured to be coupled to an inspiratory conduit (Fig. 1 #105 or #106; ¶0020) or filter.
Regarding claim 49, Allum discloses the second connector is configured to be coupled to a patient interface conduit (Fig. 1 #106; ¶0020) or filter.
Regarding claim 50, Allum discloses the flow modifying arrangement is capable of use in a high flow type respiratory support system. There is no reason to expect the oxygen delivery of Allum could not be provided at a “high” rate of flow as it is user selectable to provide different flow rates (e.g. ¶¶0020-0021, 0023). The language “high flow” is particularly discussed in ¶0174 of the PGPub copy of the instant application. It is noted that the high flow type respiratory support system is not positively recited.
Regarding claim 51, Allum discloses the flow modifying arrangement is capable of use at flow rates of more than 20 L/min. There is no reason to expect the oxygen delivery of Allum could not be provided at a suitably high rate of flow as it is user selectable to provide different flow rates (e.g. ¶¶0020-0021, 0023). It is noted that the no structure is positively recited which would provide the claimed flow rate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. It is noted that because of the breadth of the present claims two different references have been applied against the claims. Beyond the above cited references further attention is drawn to following prior art which may additionally be read on claim 32: Burke et al. (U.S. Pub. 2018/0333555; Figs. 3A-3F), Johnson et al. (U.S. Pub. 2022/0280819; Fig. 3), and Johnson et al. (U.S. Pub. 2023/0121027; Fig. 1A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785