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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. See Pg. 1, Ln. 20-28 of the specification. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it exceeds 150 words in length and refers to purported merits of the invention (“The connection method can be carried out in a reliable, reproducible and automated manner with reasonable effort.”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
On line 35 of page 1, the reference to “claim 1” should be replaced. Claim 1 is canceled, and, even though the claims are renumbered upon allowance, further claim amendments during prosecution may make this reference inaccurate.
This same issue also applies to the references to each of claims 2-9. See Pg. 2, Ln. 32; Pg. 3, Ln. 13, 19, and 24; and Pg. 4, Ln. 5, 10, 16, and 21.
Appropriate correction is required.
Claim Objections
Claims 10 and 13-16 are objected to because of the following informalities:
In line 5 of claim 10, “that face each other” should be replaced with “to face each other”.
In claim 10, “by UV light irradiation by means of a UV light irradiation” should be replaced with “by means of UV light irradiation” for consistency with line 3.
In line 3 of claim 13, “the end face portions” should be replaced with “end face portions”.
In claim 13, “a feeding device for the flowable silicone” should be replaced with “a feeding device for flowable silicone”.
In claim 13, “by UV light irradiation by means of a UV light irradiation” should be replaced with “by means of a UV light irradiation” for consistency with line 4.
Claim 14 should be rewritten to more directly state its limitation that the UV sources of claim 13 are separate UV sources. Additionally, in the last line, “wave-length” should be replaced with “wavelength”.
Claim 15 should be rewritten to more directly state its limitation that the UV sources of claim 13 are a single UV source.
In claim 16, “for the laboratory use, the clinical use, the use in a clean room environment or for the use in a pre-series environment” should be replaced with “for laboratory use, clinical use, use in a clean room environment or use in a pre-series environment”.
Appropriate correction is required.
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: “positioning device” in claim 13.
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. As discussed below, the applicant’s disclosure does not describe any corresponding structure for the claimed positioning device.
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 § 112
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 11-20 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 11 refers to “a method according to claim 1”. Claim 1 is canceled, which makes the scope of claim 11 unclear. For purposes of examination, claim 11 is being interpreted as referring to “claim 10” instead. Claim 12 is rejected based on its dependency from claim 11.
Claim 16 recites the language “several castors”. It is unclear which numeric values are encompassed by “several”. For purposes of examination, claim 16 is being interpreted as reciting “a plurality of castors” instead.
Regarding claims 16 and 18, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination, the limitations following “in particular” are being treated as not being part of the claimed invention.
Regarding claim 17, the phrase "namely" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination, the limitations following “namely” are being treated as not being part of the claimed invention.
Claim 17 recites the limitations “the tubes” in line 4, “the silicone supply tube” in line 5, and “the silicone discharge tube” in line 5. There is insufficient antecedent basis for these limitations in the claim. While claim 17 depends from claim 13, which references claim 10, claim 13 is not drafted to be consistent with claim 10. Note at least “a UV light irradiation with a UV sterilization wavelength”, “an overmolding mold”, and “a UV light irradiation with a UV curing wavelength” in claim 13.
Regarding claim 19, as discussed in MPEP 2173.05(q), attempts to claim a process without setting forth any steps involved in the process raises an issue of indefiniteness. Claim 20 is rejected based on its dependency from claim 19.
Claim limitation “positioning device” in claim 13 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. See above. 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. The relevant portions of the specification state that such positioning devices are known in the art but do not describe any corresponding structure. See Pg. 3, Ln. 20-22 and Pg. 6, Ln. 23-26. 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. Claims 14-18 are rejected based on their dependency from claim 13.
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 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.
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.
Claims 10-14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0200038 (“Gagne”) (cited in an IDS) in view of US 2021/0199226 (“Zhang”) (cited in an IDS), US 2017/0252550 (“Wegener”), and US 2013/0093124 (“Andersson”).
Regarding claim 10, Gagne discloses a method for connecting two silicone tube sections ([0013]), comprising:
positioning the end face portions of the silicone tube sections to be connected that face each other in an overmolding mold (Fig. 3; [0031]-[0032]);
overmolding the end face portions in the overmolding mold by filling an overmolding cavity of the overmolding mold with flowable silicone ([0032]); and
curing the flowable silicone by UV light irradiation by means of a UV light irradiation with a UV curing wavelength ([0032]).
Gagne does not disclose that the end face portions of the silicone tube sections abut one another. However, the end face portions nearly abut one another in the embodiment of Fig. 2B. Additionally, Zhang discloses abutting tube ends (Figs. 1A-B, [0047]) and overmolding at the seam ([0053]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have abutted the end face portions of Gagne if desired since Zhang discloses that such an arrangement is suitable in an overmolded tube connection.
Gagne does not disclose sterilizing end face portions of the silicone tube sections to be connected by means of UV light irradiation with a UV sterilization wavelength or that the UV curing wavelength differs from the UV sterilization wavelength.
Wegener discloses a device and method for connecting two medical fluid flow systems, each having a respective connector, by using an ultraviolet (UV) light source to irradiate the connectors ([0009]-[0010], Figs. 5A-D), thereby providing a sterile connection ([0036]). The UV light source preferably provides UV-C light (e.g., in the range of 250-280 nm), which is known to kill or inactive microorganisms ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sterilized the end face portions of Gagne, as taught by Wegener, to ensure a sterile connection. Note that Gagne relates to connectors “used by pharmaceutical and biological applications or other hygienic process industries” ([0002]).
With respect to the UV sterilization wavelength being different from the UV curing wavelength, Gagne using liquid silicone rubber for the overmolding ([0032]), and liquid silicone rubber is cured using a different wavelength range than the range disclosed by Wegener for sterilization. Specifically, while Gagne does not disclose any particular wavelength for the UV curing, Andersson teaches that 365 and 395 nm are preferred wavelengths for curing liquid silicone rubber ([0075]). As noted above, Wegener teaches that it is preferred to use UV-C light (e.g., in the range of 250-280 nm) to kill or inactive microorganisms ([0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the preferred wavelengths identified by Wegener and Andersson for the sterilization of the tube ends and the curing of the liquid silicone rubber, respectively.
Regarding claim 11, see the rejection of claim 10. Modified Gagne discloses a pharmaceutical media transfer method for supplying a pharmaceutical medium from a source reservoir to a target reservoir ([0002]-[0004] of Gagne), comprising:
providing the pharmaceutical medium in the source reservoir ([0002]-[0004] of Gagne) including a silicone supply tube being in media communication with the source reservoir (the tubing segment 12 of Gagne can serve as an inlet; [0024]-[0025]);
providing the target reservoir ([0002]-[0004] of Gagne) including a silicone discharge tube being in media communication with the target reservoir (the tubing segment 14 or 16 of Gagne can serve as an outlet; [0024]-[0025]);
displacing the pharmaceutical medium in a silicone supply tube section of the silicone supply tube ([0002]-[0004] of Gagne);
cutting the silicone supply tube section of the silicone supply tube for creating a sterile end face portion of the silicone supply tube section; cutting a silicone discharge tube section of the silicone discharge tube for creating a sterile end face portion of the silicone discharge tube section ([0042] of Zhang discloses that the tubes being joined can be cut. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have cut the tubing segments of Gagne as needed to achieve the desired length. This would represent a combination of prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).);
connecting the silicone supply tube section with the silicone discharge tube section with a method according to claim 1, wherein the silicone supply tube section on the one hand and the silicone discharge tube section on the other hand represent the two silicone tube sections to be connected by the method (see the rejection of claim 10 as well as the corresponding § 112(b) rejection); and
transferring the pharmaceutical medium from the source reservoir to the target reservoir via the connected tube sections ([0002]-[0004] of Gagne).
Regarding claim 12, modified Gagne does not explicitly disclose that the cutting of the silicone supply tube section and/or the silicone discharge tube section is performed at a cutting temperature that is less than 80° C. However, Zhang discloses that “Any method of cutting is envisioned” ([0042]). In addition, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, see the rejections of claims 10 and 11. With respect to the claimed positioning device for positioning the silicone tube sections to be connected, see [0045] and Figs. 5A-B of Wegener. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a positioning device like that of Wegener at least during the sterilization process to eliminate the need for a human and help maintain the desired sterility. See MPEP 2144.04(III) and 2143(I)(A).
Regarding claim 14, modified Gagne discloses that the apparatus has a first UV source for sterilizing the end face portions of the silicone tube sections to be connected by means of a UV light irradiation with a UV sterilization wavelength (the UV light bulb 62 of Wegener; [0035]; Fig. 1) and a second UV source for curing the flowable silicone by means of a UV light irradiation with a UV curing wave-length (the UV light source 48 of Gagne; [0031]-[0032]; Fig. 3).
Regarding claim 19, see the rejection of claim 10.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gagne in view of Zhang, Wegener, and Andersson, as applied to claim 13 above, and further in view of US 2013/0026682 (“Rist”).
Regarding claim 15, modified Gagne does not disclose that the apparatus has a collective UV source configured such that the respective irradiation wavelengths for sterilizing the end face portions of the silicone tube sections to be connected and for curing the flowable silicone are settable by corresponding filters.
Rist discloses an irradiation unit for curing polymers with a selectable UV light source that enables the ideal wavelength to be chosen for the polymer being cured ([0144]-[0147]). The UV light source can be a UV lamp with wavelength-selective filters ([0136]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the irradiation unit of Rist in place of the separate UV light sources of Wegener and Gagne since Rist teaches that a single UV light source can still enable the use of different wavelengths, as desired for sterilization and curing. This would represent a simple substitution of one known element for another (one UV source configuration for another) to obtain predictable results. See MPEP 2143(I)(B).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gagne in view of Zhang, Wegener, and Andersson, as applied to claim 13 above, and further in view of US 2023/0203419 (“Strange”).
Regarding claim 16, modified Gagne does not explicitly disclose a mobile configuration for the laboratory use, the clinical use, the use in a clean room environment or for the use in a pre-series environment, wherein the apparatus is designed to be mobile and has several castors, which are mounted on a frame of the apparatus, and wherein the apparatus in particular has a traction drive, in particular an electric motor.
Strange discloses a robotic device 2 to manipulate a fluid connection between a first consumable 13 and a second consumable 13 to create an aseptic connection that enables a controlled transfer of fluid or cell material between the first consumable 13 and the second consumable 13 ([0129]). The robotic device 2 can comprise a wheel-mounted base unit 2a, which can house a motor and other control and communication componentry that are together configured to enable the robotic device 2 to move within or around a floor 17 of a bioprocessing system 1 ([0123]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the apparatus of modified Gagne with wheels and a motor to enable the apparatus to connect different components of a system as needed. Note [0002]-[0004] of Gagne, which disclose that various reactants, solutions, and washes are often pumped or otherwise transported to various subsystems using conduits and associated valves and that there may be a large numbers of conduits.
Regarding claims 17 and 18, modified Gagne does not disclose the features of these claims.
Strange discloses a robotic device 2 to manipulate a fluid connection between a first consumable 13 and a second consumable 13 to create an aseptic connection that enables a controlled transfer of fluid or cell material between the first consumable 13 and the second consumable 13 ([0129]). Tubes 150 can have identification marks 150-1, such as QR codes, to provide data about the tubes 150, such as their location, orientation, materials, size, and/or other properties ([0142]). For example, the identification mark 150-1 can indicate: a unique reagent ID, a tube size and material (which can affect welding and pumping parameters), a distance between the identification mark 150-1 and the corresponding container 13, and/or the orientation of the tube (such as to indicate which direction leads towards the container 13) ([0142]). One advantage of providing the identification marks 150-1 is that the identification marks 150-1 can be used to indicate to a processing and control unit 38 what settings should be used for welding and pumping ([0142]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have placed QR codes on the tubes of modified Gagne so that connection of the tubes could proceed based on factors such as tube size and material, as taught by Strange. This would drive selection of the cutting blade and overmolding mold. Specifically, the overmolding mold would need to be sized appropriately for the tube size, and the cutting blade would depend on the tube size and/or material.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gagne in view of Zhang, Wegener, and Andersson, as applied to claim 19 above, as evidenced by US 5,952,397 (“Fujiki”).
Regarding claim 20, modified Gagne does not explicitly disclose that the UV curing of the silicone material in cured state has a hardness in the range of Shore A40 to Shore A60. However, this property is expected to be present. See MPEP 2112. Additionally, Fujiki discloses that, when a photocurable liquid silicone rubber composition is exposed to UV light, it forms a product having a Shore A hardness of 20-60 (Col. 1, Ln. 66 to Col. 2, Ln. 5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Specifically, see the abstract of DE 10 2013 102 236.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John DeRusso whose telephone number is (571)270-1287. The examiner can normally be reached Monday-Friday, 10:00 AM-6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sam Zhao, can be reached at (571) 270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/John J DeRusso/Primary Examiner, Art Unit 1744