DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/8/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1 and 24 is/are amended. Claims 14 and 22-23 was previously canceled. Claims 1-13, 15-21, and 24-53 are now pending examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the new limitation “a fluid fitting coupled to the proximal end of the needle, the fluid fitting comprising an inlet port, the fluid fitting providing fluid communication between the inlet port and the fluid passageway while the stylet is slidably received in the needle bore, the fluid passageway configured to provide fluid communication from the inlet port to the distal end of the needle such that a therapeutic liquid imparted into the inlet port is directed through the fluid passageway and discharged from the distal end of the needle” overcomes the previous rejection over Long. However, a new grounds of rejection is provided as anticipated by Torrie.
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: “locking mechanism” in claim 51.
Claim 51 recites the limitation of a “locking mechanism”. The term “mechanism” is used as a substitute for “means” and is modified by functional language “locking”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “locking mechanism” is “The locking mechanism 22 includes a proximal locking ledge 102, a distal locking ledge 104, and a pull tab 106.” (Paragraph 0103), “a twist type locking mechanism” (Paragraph 0105) or equivalents thereof.
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.
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 6, 27 and 48 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 6 recites the limitation “a fluid fitting”, however, claim 1 as amended includes the recitation of “a fluid fitting”. Thus, it is indefinite as to whether the fluid fitting of claim 6 refers to the same fluid fitting of claim 1 or a second fluid fitting. For examination purposes, the limitation will be seen as “the fluid fitting” of claim 1.
Claim 27 recites the limitation “a fluid passageway”, however claim 24, from which this claim depends recites “a fluid passageway”. Thus, it is indefinite as to whether the fluid passageway of claim 27 is the same as the one recited in claim 24 or is a second fluid passageway/ For examination purposes, the limitation will be seen as the fluid passageway of claim 24.
Claim 48 recites the limitation “a fluid fitting”, however, claim 24, from which this claim depends, as amended includes the recitation of “a fluid fitting”. Thus, it is indefinite as to whether the fluid fitting of claim 6 refers to the same fluid fitting of claim 24 or a second fluid fitting. For examination purposes, the limitation will be seen as “the fluid fitting” of claim 24.
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.
Claim(s) 1-2, 19, 24, 35, and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torrie (US 20160022311 A1).
Regarding claim 1, Torrie discloses a medical instrument for cutting soft tissue (Paragraph 0031) during an interventional radiology procedure ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. The device of Torrie is fully capable of being used during an interventional radiology procedure), the medical instrument comprising:
a hypodermic needle (100) having an inner needle surface (inner surface of 100), an outer needle surface (exterior surface of 100), a proximal needle end (102), a distal needle end (101), and a needle axis, the inner needle surface defining a needle bore (lumen of 105) extending from the proximal needle end to the distal needle end, the distal needle end having a sharpened distal tip (115) configured to puncture soft tissue (Figure 1; Paragraph 0029-31);
a stylet (110) having a stylet body (145), a stylet head (150), an outer stylet surface (175), a proximal stylet end (147) (Figure 6; Paragraph 0034; 0043), a distal stylet end (146), and a stylet axis, the stylet axis being coaxial with the needle axis (Paragraph 0030), the stylet head being located at the distal stylet end (Paragraph 0034), at least a portion of the stylet being located within the needle bore (Paragraph 0030),
the outer stylet surface and the inner needle surface of the hypodermic needle defining at least one fluid passageway (127) therebetween (Paragraph 0030), the stylet being movable relative to the hypodermic needle along the needle axis (Paragraph 0029), the stylet being adjustable between a retracted configuration and a protracted configuration (Paragraph 0029), the stylet head being located within the needle bore when the medical instrument is in the retracted configuration (Figure 7A; Paragraph 0034), the stylet head being located external to the needle bore when the medical instrument is in the protracted configuration (Figure 7B; Paragraph 0034), the fluid passageway enabling fluid to flow from the proximal needle end to the distal needle end when the stylet is in the retracted configuration and in the protracted configuration, the fluid passageway being configured such that fluid in the fluid passageway flows between the outer stylet surface and the inner needle surface,
a fluid fitting (120) coupled to the proximal needle end, the fluid fitting comprising an inlet port (125), the fluid fitting providing fluid communication between the inlet port and the fluid passageway while the at least a portion of the stylet is located within the needle bore (Paragraph 0030; 0043), the fluid passageway configured to provide fluid communication from the inlet port to the distal needle end such that a therapeutic liquid imparted into the inlet port is directed through the fluid passageway and discharged from the distal needle end (Paragraph 0043).
Regarding claim 2, Torrie further discloses wherein the hypodermic needle is configured to conform to a size defined by the Birmingham gauge (the needle is a cylinder is capable of conforming a size defined by the Birmingham gauge).
Regarding claim 19, Torrie further discloses wherein the stylet is a solid monolithic component devoid of any bores (the stylet is shown without any bores or lumens) (Figure 7A; Paragraph 0034).
Regarding claim 24, Torrie discloses a medical instrument for cutting soft tissue (Paragraph 0031) during an interventional radiology procedure ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. The device of Torrie is fully capable of being used during an interventional radiology procedure), the medical instrument comprising:
a hypodermic needle (100) having a needle axis and a proximal (102) and distal (101) end (Paragraph 0029), the needle comprising an inner needle surface (inner surface of 100) defining a needle bore (lumen of 100) extending longitudinally along the needle axis from the proximal end to the distal end (Figure 1; Paragraph 0029);
a stylet (110) slidably received in the needle bore, the stylet having a proximal (147) and distal (146) end (Figure 6; Paragraph 0034),
the stylet being slidable along the needle axis between a retracted position and a protracted position (Paragraph 0029), the distal end of the stylet comprising a stylet head (150) configured to manipulate soft tissue (Figure 6; Paragraph 0034), the stylet head being sheathed by the hypodermic needle in the retracted position and protruding from the distal end of the needle in the protracted position such that the stylet head is exposed (Figure 7A-B; Paragraph 0034), the stylet having an outer stylet surface (175) (Paragraph 0043), wherein the inner needle surface and the outer stylet surface define a fluid passageway (127) therebetween (Paragraph 0029; 0043); and
a fluid fitting (120) coupled to the proximal end of the needle, the fluid fitting comprising an inlet port (125) (Paragraph 0030), the fluid fitting providing fluid communication between the inlet port and the fluid passageway while the stylet is slidably received in the needle bore (Paragraph 0030; 0043), the fluid passageway configured to provide fluid communication from the inlet port to the distal end of the needle such that a therapeutic liquid imparted into the inlet port is directed through the fluid passageway and discharged from the distal end of the needle (the configuration of the needle and stylet allows for liquid to be expelled from the distal ends to the proximal ends, thus is fully capable of being configured to provide fluid communication from the inlet port to the distal end of the needle such that a therapeutic liquid can be discharged from the distal end) (Paragraph 0043).
Regarding claim 35, Torrie further discloses wherein the stylet head comprises an atraumatic region (Paragraph 0034).
Regarding claim 38, Torrie further discloses wherein the distal end portion of the stylet comprises an atraumatic distal tip (Paragraph 0034).
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.
Claim(s) 3-4, 13-15, and 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Hallisey et al. (US 20180333146 A1) (previously of record).
Regarding claim 3-4, Torrie discloses the medical instrument as set forth in claim 2, but fails to explicitly disclose wherein the hypodermic needle is smaller than a 14 gauge needle as defined by the Birmingham gauge and larger than a 28 gauge needle as defined by the Birmingham gauge, wherein the hypodermic needle is smaller than a 17 gauge needle as defined by the Birmingham gauge and larger than a 23 gauge needle as defined by the Birmingham gauge.
Hallisey is directed to a needle device and teaches wherein the hypodermic needle is smaller than a 14 gauge needle as defined by the Birmingham gauge and larger than a 28 gauge needle as defined by the Birmingham gauge and wherein the hypodermic needle is smaller than a 17 gauge needle as defined by the Birmingham gauge and larger than a 23 gauge needle as defined by the Birmingham gauge (Hallisey states “the needle 110 may range in diameter from 9 gauge to 22 gauge”, thus teaches a needle smaller than 14 gauge and larger than 28 gauge, and further between a 17 gauge and 23 gauge) (Paragraph 0029).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie such that wherein the hypodermic needle is smaller than a 17 gauge needle as defined by the Birmingham gauge and larger than a 23 gauge needle as defined by the Birmingham gauge, as taught by Hallisey, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Hallisey by incorporating wherein the hypodermic needle is smaller than a 17 gauge needle as defined by the Birmingham gauge and larger than a 23 gauge needle as defined by the Birmingham gauge in order to accommodate for various sizes of dissection/biopsy areas. Further, has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144.
Regarding claims 13-14, Torrie discloses the medical instrument as set forth in claim 1, but fails to explicitly disclose wherein the medical instrument is adjustable between a locked configuration and an unlocked configuration, the stylet being fixed relative to the hypodermic needle when in the locked configuration and movable relative to the hypodermic needle when in the unlocked configuration.
However, Hallisey teaches wherein the medical instrument is adjustable between a locked configuration and an unlocked configuration, the stylet (130) being fixed relative to the hypodermic needle (110) when in the locked configuration and movable relative to the hypodermic needle when in the unlocked configuration (Paragraph 0046).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Hallisey by incorporating wherein the medical instrument is adjustable between a locked configuration and an unlocked configuration, the stylet being fixed relative to the hypodermic needle when in the locked configuration and movable relative to the hypodermic needle when in the unlocked configuration in order to secure the stylet in place to prevent undesired movement while in the body (Hallisey Paragraph 0046).
Regarding claim 15, the combination of Torrie and Hallisey further teaches wherein the medical instrument is configured such that fluid can flow through the fluid passageway when the medical instrument is in the locked configuration and in the unlocked configuration (the locking mechanism is in the actuator, thus does not impede the ability of fluid to flow between the needle and the stylet. Thus, after being modified, the instrument would be configured such that fluid can flow through the fluid passageway when the medical instrument is in the locked configuration and in the unlocked configuration).
Regarding claim 33-34, Torrie discloses the medical instrument as set forth in claim 24, but fails to explicitly disclose wherein the hypodermic needle has an outer diameter that is less than 2.0 mm, wherein the outer diameter is less than 1.5 mm.
However, Hallisey teaches wherein the hypodermic needle has an outer diameter that is less than 2.0 mm and less than 1.5 mm (Hallisey states “the needle 110 may range in diameter from 9 gauge to 22 gauge”, thus teaches an outer diameter that is less than 2.0 mm and less than 1.5 mm, as any needle smaller than a 17 gauge would have a diameter less than 1.5 mm) (Paragraph 0029).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Hallisey by incorporating the hypodermic needle has an outer diameter that is less than 2.0 mm and less than 1.5 mm in order to accommodate for various size requirements of procedure areas. Further, has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144.
Claim(s) 5-6 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Eckerline et al. (US 20160157839 A1) (previously of record).
Regarding claim 5, Torrie discloses the medical instrument as set forth in claim 1, but fails to explicitly disclose wherein the proximal stylet end extends in a proximal direction from the proximal needle end.
However, Eckerline is directed to a needle device and teaches wherein the proximal stylet end (132) of stylet (124) extends in a proximal direction from the proximal needle end (114) of needle (104) (Figure 3; Paragraph 0025-26).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie such that wherein the proximal stylet end extends in a proximal direction from the proximal needle end, as taught by Eckerline, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Eckerline by incorporating wherein the proximal stylet end extends in a proximal direction from the proximal needle end in order for the stylet to be connected to an actuator and be able to extend distally of the distal end of the needle (Eckerline Paragraph 0026).
As best understood in view of the 112(b) issues above, regarding claim 6, Torrie further discloses wherein the medical instrument further comprises the fluid fitting configured to be removably connected to a syringe (the needle hub 120 comprises opening 125, which is fully capable of removably coupling to a syringe), the fluid fitting being connected to the proximal stylet end of the stylet (Paragraph 0030).
Regarding claim 32, Torrie discloses the medical instrument as set forth in claim 26, and further discloses wherein the hypodermic needle has a length along the needle axis (length of needle) and the longitudinal fluid-passing surface has a length along the needle axis (length of stylet), but fails to explicitly disclose the length of the longitudinal fluid-passing surface being greater than the length of the hypodermic needle.
However, Eckerline is directed to a needle device and teaches wherein the length of the stylet (124) is greater than the length of the hypodermic needle (104) (Figure 3; Paragraph 0025-26). Essentially, the length of the longitudinal fluid-passing surface being greater than the length of the hypodermic needle.
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Eckerline by incorporating the length of the longitudinal fluid-passing surface being greater than the length of the hypodermic needle in order for the stylet to be connected to an actuator and be able to extend distally of the distal end of the needle (Eckerline Paragraph 0026). Further, Torrie is silent to the lengths of the stylet and needle, thus such a modification would be clarifying the device of Torrie.
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Eckerline and further in view of Hopman et al. (US 20130310750 A1) (previously of record).
Regarding claims 7, Torrie as modified by Eckerline teaches the medical instrument as set forth in claim 6, but fail to explicitly disclose wherein the fluid fitting is a Luer lock fitting.
However, Hopman is directed to a needle and teaches the medical instrument further comprises a fluid fitting (20) configured to be removably connected to a syringe (Figure 7-8; Paragraph 0035; 0044), the fluid fitting being connected to the proximal stylet end (80) of the stylet (36) (Figure 7-8; Paragraph 0035; 0045); wherein the fluid fitting is a Luer lock fitting (Paragraph 0035).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie as modified by Eckerline such that the medical instrument further comprises a fluid fitting configured to be removably connected to a syringe, the fluid fitting being connected to the proximal stylet end of the stylet; wherein the fluid fitting is a Luer lock fitting, as taught by Hopman, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie as modified by Eckerline with the teachings of Hopman by incorporating the medical instrument further comprises a fluid fitting configured to be removably connected to a syringe, the fluid fitting being connected to the proximal stylet end of the stylet; wherein the fluid fitting is a Luer lock fitting in order to allow air and other fluids to be expelled from within a patient's body cavity but preventing an open pneumothorax condition from being formed (Hopman Paragraph 0044).
Regarding claims 8-10, Torrie as modified by Eckerline teaches the medical instrument as set forth in claim 6, but fail to explicitly disclose wherein the medical instrument further comprises a collar, the collar being fixedly connected to the proximal needle end; wherein the collar encircles at least a portion of the stylet, the stylet and the fluid fitting being movable relative to the collar; wherein the collar is configured to accommodate at least a portion of the fluid fitting.
However, Hopman further teaches wherein the medical instrument further comprises a collar (12) (Paragraph 0031), the collar being fixedly connected to the proximal needle end (proximal end of 30) (Paragraph 0033; 0037); wherein the collar encircles at least a portion of the stylet (Figure 7-8; Paragraph 0035), the stylet and the fluid fitting being movable relative to the collar (Figure 8; Paragraph 0045); wherein the collar is configured to accommodate at least a portion of the fluid fitting (Figure 1) (the luer fitting screws onto the collar, thus the collar is configured to accommodate at least a portion of the fluid fitting).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie as modified by Eckerline with the teachings of Hopman by incorporating wherein the medical instrument further comprises a collar, the collar being fixedly connected to the proximal needle end; wherein the collar encircles at least a portion of the stylet, the stylet and the fluid fitting being movable relative to the collar; wherein the collar is configured to accommodate at least a portion of the fluid fitting in order to include a handle to be easily held by a user as Torrie is silent to a handle or housing on the proximal end.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Eckerline and Hopman et al. and further in view of Mark (US 20050080355 A1) (previously of record).
Regarding claim 11, Torrie as modified by Eckerline and Hopman teaches the medical instrument as set forth in claim 10, but fails to explicitly disclose wherein the medical instrument further comprises a collar assembly, the collar assembly including the collar and at least one O-ring, the O-ring being positioned within the collar.
However, Mark is directed to a needle device and teaches wherein the medical instrument further comprises a collar assembly, the collar assembly including the collar (75) and at least one O-ring (90), the O-ring being positioned within the collar (Figure 5; Paragraph 0033).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie as modified by Eckerline and Hopman such that the medical instrument further comprises a collar assembly, the collar assembly including the collar and at least one O-ring, the O-ring being positioned within the collar, as taught by Mark, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie as modified by Eckerline and Hopman with the teachings of Mark by incorporating wherein the medical instrument further comprises a collar assembly, the collar assembly including the collar and at least one O-ring, the O-ring being positioned within the collar in order to create a seal, which can assist in creating a vacuum to securely retains tissue samples, resulting in more reliable sampling and larger sample volumes. (Mark Paragraph 0012; 0036).
Regarding claim 12, Hopman further teaches wherein the collar is fluidly connected to the fluid fitting (Figure 3-4; Paragraph 0044).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Hallisey and further in view of Zarins et. al (US 20030050571 A1) (previously of record).
Regarding claim 16, Torrie and Hallisey disclose the medical instrument as set forth in claim 15, but fails to explicitly disclose wherein the medical instrument is configured such that the stylet is in the retracted configuration when the medical instrument is in the locked configuration.
However, Zarins is directed to a biopsy device and teaches wherein the medical instrument is configured such that the stylet (30) is in the retracted configuration when the medical instrument is in the locked configuration (Figure 4A; Paragraph 0059).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie as modified by Hallisey such that the medical instrument is configured such that the stylet is in the retracted configuration when the medical instrument is in the locked configuration, as taught by Zarins, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie as modified by Hallisey with the teachings of Zarins by incorporating the medical instrument is configured such that the stylet is in the retracted configuration when the medical instrument is in the locked configuration in order to prevent premature distal movement of the stylet (Zarins Paragraph 0059).
Regarding claim 17-18, the combination of Torrie and Hallisey further teach wherein the stylet is rotatable about the stylet axis; wherein the medical instrument is configured to adjust from the locked configuration to the unlocked configuration by rotating the stylet about the stylet axis (Hallisey Paragraph 0046).
Claim(s) 20-21, 25-31, and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Long et. al (US 20200187919 A1) (previously of record).
Regarding claim 20, Torrie discloses the medical instrument as set forth in claim 19, but fails to explicitly disclose wherein the outer stylet surface of the stylet body includes at least one flat extending through the needle bore, the flat of the stylet and the inner needle surface of the hypodermic needle collectively forming the fluid passageway.
However, Long is directed to a needle and teaches wherein the outer stylet surface of the stylet body (104) includes at least one flat (122) extending through the needle bore (lumen of 102), the flat of the stylet and the inner needle surface of the hypodermic needle (102) collectively forming the fluid passageway (Figure 1a; Paragraph 0076).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie such that wherein the outer stylet surface of the stylet body includes at least one flat extending through the needle bore, the flat of the stylet and the inner needle surface of the hypodermic needle collectively forming the fluid passageway, as taught by Long, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Long by incorporating wherein the outer stylet surface of the stylet body includes at least one flat extending through the needle bore, the flat of the stylet and the inner needle surface of the hypodermic needle collectively forming the fluid passageway in order to allow the stylet to grasp a portion of tissue or bone to take a sample (Long Paragraph 076).
Regarding claim 21, Torrie discloses the medical instrument as set forth in claim 19, but fails to explicitly disclose wherein the outer stylet surface of the stylet body includes at least one notched region extending through the needle bore, the notched region of the stylet and the inner needle surface of the hypodermic needle collectively forming the fluid passageway.
However, Long teaches wherein the outer stylet surface of the stylet body (104) includes at least one notched region (122) extending through the needle bore (lumen of 102), the notched region of the stylet and the inner needle surface of the hypodermic needle (102) collectively forming the fluid passageway (Figure 1A; Paragraph 0076).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Long by incorporating wherein the outer stylet surface of the stylet body includes at least one notched region extending through the needle bore, the notched region of the stylet and the inner needle surface of the hypodermic needle collectively forming the fluid passageway in order to allow the stylet to grasp a portion of tissue or bone to take a sample (Long Paragraph 076).
Regarding claim 25, Torrie discloses the medical instrument as set forth in claim 24, but fails to explicitly disclose wherein the stylet comprises a bearing surface slidably engaged with the hypodermic needle.
However, Long further teaches wherein the stylet (104) comprises a bearing surface (coupling mechanism-128a, 128b) slidably engaged with the hypodermic needle (Figure 5A-D; Paragraph 0101; 0103; 0114) (Although shown on the cannula, Paragraph 0114 states “the recessed portion and the raised portion forming the mechanical coupling may be reversed such that the recessed portion is provided on the cannula 102 rather than the stylet 104, and the raised portion is provided on the stylet 104 rather than the cannula 102”. As such, the coupling mechanism comprises a raised surface and connects the stylet with needle, thus the stylet comprises a bearing surface slidably engaged with the hypodermic needle).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Long by incorporating wherein the stylet comprises a bearing surface slidably engaged with the hypodermic needle in order to prevent relative rotation or reflexive flexing between the needle and stylet to ensure stability (Long Paragraph 0105).
Regarding claim 26, Torrie as modified by Long teaches the medical instrument as set forth in claim 25, and Torrie further discloses wherein the stylet comprises a longitudinal fluid-passing surface (longitudinal line of the exterior surface of stylet), at least a portion of the longitudinal fluid-passing surface opposing and spaced apart from the inner needle surface (Figure 6; Paragraph 0030; 0034).
As best understood in view of the 112(b) issues above, regarding claim 27, Torrie further discloses wherein the longitudinal fluid- passing surface and the inner needle surface define the fluid passageway (127 including at least some space between needle and stylet within needle bore) (Paragraph 0030), the fluid passageway being configured such that fluid is passable through the needle bore along the stylet (Paragraph 0043).
Regarding claim 28-30, Torrie further discloses wherein the stylet has a perimeter (outer edge of stylet 110), but fails to explicitly disclose the bearing surface comprising at least a first longitudinal bearing surface portion and a second longitudinal bearing surface portion at spaced apart locations around the perimeter; wherein the longitudinal fluid- passing surface comprises at least a first longitudinal fluid-passing surface portion and a second longitudinal fluid-passing surface portion at spaced apart locations around the perimeter; and wherein the first and second longitudinal fluid-passing surface portions are interleaved between the first and second longitudinal bearing surface portions.
However, Long further teaches wherein the stylet has a perimeter (outer edge of stylet 104), the bearing surface comprising at least a first longitudinal bearing surface portion (128a) and a second longitudinal bearing surface portion (128b) at spaced apart locations around the perimeter (Figure 5C-D; Paragraph 0114; 0118); wherein the longitudinal fluid- passing surface comprises at least a first longitudinal fluid-passing surface portion (portion of outer surface of stylet between 128a and 128b) and a second longitudinal fluid-passing surface portion (second portion of outer surface of stylet between 128a and 128b) at spaced apart locations around the perimeter (Figure 5C-D; Paragraph 0114; 0118); and wherein the first and second longitudinal fluid-passing surface portions are interleaved between the first and second longitudinal bearing surface portions (Figure 5C-D; Paragraph 0114; 0118).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Long by incorporating the bearing surface comprising at least a first longitudinal bearing surface portion and a second longitudinal bearing surface portion at spaced apart locations around the perimeter; wherein the longitudinal fluid- passing surface comprises at least a first longitudinal fluid-passing surface portion and a second longitudinal fluid-passing surface portion at spaced apart locations around the perimeter; and wherein the first and second longitudinal fluid-passing surface portions are interleaved between the first and second longitudinal bearing surface portions in order to resist or prevent both relative rotation and relative flexing between the needle and the stylet to ensure stability (Long Paragraph 105).
Regarding claim 31, Torrie as modified by Long teaches the medical instrument as set forth in claim 26, but fails to explicitly disclose wherein the longitudinal fluid-passing surface comprises a flat surface.
However, Long further teaches wherein the longitudinal fluid- passing surface comprises a flat (122) (Figure 1A; Paragraph 0076).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Long by incorporating wherein the longitudinal fluid-passing surface comprises a flat surface in order to collect tissue or a biological sample during the procedure (Long Paragraph 0090).
Regarding claim 36-37, Torrie discloses the medical instrument as set forth in claim 35, but fails to explicitly disclose wherein the stylet has a stylet axis and the stylet head further comprises a cutting edge, the cutting edge and at least a portion of the atraumatic region are angularly spaced apart about the stylet axis; wherein the cutting edge and at least a portion of the atraumatic region are spaced apart along the needle axis.
However, Long further teaches wherein the stylet has a stylet axis and the stylet head further comprises a cutting edge (124), the cutting edge and at least a portion of the atraumatic region are angularly spaced apart about the stylet axis (Figure 1A, 7; Paragraph 0076; 0144); wherein the cutting edge and at least a portion of the atraumatic region are spaced apart along the needle axis (Figure 3A-C; Paragraph 0074; 0144).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Long by incorporating wherein the stylet has a stylet axis and the stylet head further comprises a cutting edge, the cutting edge and at least a portion of the atraumatic region are angularly spaced apart about the stylet axis; wherein the cutting edge and at least a portion of the atraumatic region are spaced apart along the needle axis in order to aid the insertion of the stylet into the tissue (Paragraph 0144).
Claim(s) 41-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Nosler (US 20180116645 A1) (previously of record).
Regarding claims 41-44, Torrie discloses the medical instrument as set forth in claim 24, but fails to explicitly disclose wherein the stylet head comprises a side recess forming a hook region; wherein the stylet head comprises a cutting edge at an interior location of the hook region; wherein the cutting edge faces generally proximally; wherein the hook region comprises a proximally facing tip that is sharpened to a point.
Nosler is directed to a needle and stylet device and teaches wherein the stylet head (1986) comprises a side recess (1990) forming a hook region (1992) (Figure 19; Paragraph 0021; 0137-38); wherein the stylet head comprises a cutting edge (1991) at an interior location of the hook region (Figure 19B; Paragraph 0137); wherein the cutting edge faces generally proximally (Figure 19B); and wherein the hook region comprises a proximally facing tip that is sharpened to a point (Figure 19B).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie such that wherein the stylet head comprises a side recess forming a hook region; wherein the stylet head comprises a cutting edge at an interior location of the hook region; wherein the cutting edge faces generally proximally; wherein the hook region comprises a proximally facing tip that is sharpened to a point, as taught by Nosler, as both references and the claimed invention are directed to a needle and stylet device. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Nosler by incorporating wherein the stylet head comprises a side recess forming a hook region; wherein the stylet head comprises a cutting edge at an interior location of the hook region; wherein the cutting edge faces generally proximally; wherein the hook region comprises a proximally facing tip that is sharpened to a point in order to sever tissue from the target tissue and collect it within the associated void (Nosler Paragraph 0012).
Regarding claim 45, Torrie discloses the medical instrument as set forth in claim 24, but fails to explicitly disclose wherein the stylet head comprises a side recess and the cutting element comprises a proximally facing cutting edge at a distal end portion of the side recess.
However, Nosler teaches wherein the stylet head (1986) comprises a side recess (1990) and a cutting element comprises a proximally facing cutting edge (1991) at a distal end portion of the side recess (Figure 19B; Paragraph 0137-38).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Nosler by incorporating wherein the stylet head comprises a side recess and the cutting element comprises a proximally facing cutting edge at a distal end portion of the side recess in order to sever tissue from the target tissue and collect it within the associated void (Nosler Paragraph 0012).
Claim(s) 46-47 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Peters (US 20080281226 A1) (previously of record).
Regarding claims 46-47, Torrie discloses the medical instrument as set forth in claim 24, but fails to explicitly disclose a handle comprising a housing fixed to the proximal end of the needle and a carriage fixed to the proximal end of the stylet, wherein the housing has an interior extending along the needle axis and at least a portion of the carriage is slidably received in the interior of the housing for movement relative to the housing along the needle axis.
However, Peters is directed to a needle and teaches a housing (1242) fixed to the proximal end of the needle (1270) (Figure 58; Paragraph 0272) and a carriage (1290) fixed to the proximal end of the stylet (20) (Figure 58, 74; Paragraph 0280; 0294), wherein the housing has an interior extending along the needle axis and at least a portion of the carriage is slidably received in the interior of the housing for movement relative to the housing along the needle axis (Paragraph 0280; 0283; 0294).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie to include a handle comprising a housing fixed to the proximal end of the needle and a carriage fixed to the proximal end of the stylet, wherein the housing has an interior extending along the needle axis and at least a portion of the carriage is slidably received in the interior of the housing for movement relative to the housing along the needle axis, as taught by Peters, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie with the teachings of Peters by incorporating a handle comprising a housing fixed to the proximal end of the needle and a carriage fixed to the proximal end of the stylet, wherein the housing has an interior extending along the needle axis and at least a portion of the carriage is slidably received in the interior of the housing for movement relative to the housing along the needle axis in order to control the movement of the stylet (Peters Paragraph 0283).
Regarding claim 50, Peters further teaches wherein the carriage is movable relative to the housing through a range of motion comprising a proximal end position and a distal end position (Figure 82A-C; Paragraph 0280; 0283; 0294).
Claim(s) 48-49 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torrie in view of Peters and further in view of Jenkins et al. (US 20200113597 A1) (previously of record).
As best understood in view of the 112(b) issues above, regarding claim 48, Torrie as modified by Peters teaches the medical instrument as set forth in claim 47, but fails to explicitly disclose wherein one of the housing and the carriage comprises the fluid fitting configured to couple the medical instrument to a fluid source.
However, Jenkins is directed to a needle device and teaches wherein the housing (3141, 3148) comprises a fluid fitting (3191) configured to couple the medical instrument to a fluid source (syringe) (Figure 32A; Paragraph 0186).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Torrie as modified by Peters such that the housing comprises a fluid fitting configured to couple the medical instrument to a fluid source, as taught by Jenkins, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie as modified by Peters with the teachings of Jenkins by incorporating the housing comprises a fluid fitting configured to couple the medical instrument to a fluid source in order to connect the instrument with a medical device such as a stopcock, syringe, IV tubing connector, etc. (Jenkins Paragraph 0186).
Regarding claim 49, Jenkins further teaches wherein the handle comprises passaging (3187) providing sealed fluid communication between the fluid fitting and the needle bore (3193+lumen of needle 3130) (Paragraph 0186).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie as modified by Peters with the teachings of Jenkins by incorporating the handle comprising passaging providing sealed fluid communication between the fluid fitting and the needle bore in order to prevent undesired fluid leakage into the body.
Regarding claim 51, Torrie as modified by Peters discloses the medical instrument as set forth in claim 50, but fails to explicitly disclose wherein the handle comprises a locking mechanism configured to releasably lock the carriage at least at one of the proximal end position and the distal end position.
However, Jenkins is directed to a needle device and teaches wherein the handle (1140) comprises a locking mechanism (1177) configured to releasably lock the carriage (1166) at the proximal end position (Figure 6A-B, 7A-B ; Paragraph 0101; 0108; 0115-116) (As indicated above, the limitation “locking mechanism” invokes 112(f). The corresponding structure in Jenkins is a sliding button including an upward projection 1179 and a downward projection 1184, and cantilever arms 1182 functioning as the present disclosure’s locking ledges and tab, which is equivalent to the structure of “a locking mechanism”, as disclosed in the present disclosure.).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torrie as modified by Peters with the teachings of Jenkins by incorporating the handle comprises a locking mechanism configured to releasably lock the carriage at the proximal end position in order to prevent the carriage from longitudinal movement (Jenkins Paragraph 0015).
Claim(s) 24 and 52-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sampson et al. (WO 2016049676 A1) (previously of record) in view of Torrie.
Regarding claim 24, Sampson discloses a medical instrument for cutting soft tissue during an interventional radiology procedure, the medical instrument comprising:
a hypodermic needle (112) having a needle axis and a proximal (proximal end of 112) and distal end (118), the needle comprising an inner needle surface (inner surface of 112) defining a needle bore (lumen of 112) extending longitudinally along the needle axis from the proximal end to the distal end;
a stylet (114) slidably received in the needle bore, the stylet having a proximal (proximal end of 114) and distal end (136) (Figure 1A-B; Paragraph 00113),
the stylet being slidable along the needle axis between a retracted position (when the stylet is received in the cannula) and a protracted position (a position whereby the angled tip of the stylet is opposed to the angled tip of the cannula) (Paragraph 00104; 00113; 00116), the distal end of the stylet comprising a stylet head (138) configured to manipulate soft tissue (Paragraph 00113) (tip 138 is designed to cut tissue, therefore is fully capable of manipulating tissue), the stylet head being sheathed by the hypodermic needle in the retracted position and protruding from the distal end of the needle in the protracted position such that the stylet head is exposed (Paragraph 00104) (when the stylet reaches a position whereby the angled tip of the stylet is opposed to the angled tip of the cannula, the stylet head would be exposed), the stylet having an outer stylet surface, wherein the inner needle surface and the outer stylet surface define a fluid passageway (fluid may pass in the space between the stylet and interior needle cannula wall) therebetween(Figure 1A-B; Paragraph 00108).
Sampson fails to explicitly disclose a fluid fitting coupled to the proximal end of the needle, the fluid fitting comprising an inlet port, the fluid fitting providing fluid communication between the inlet port and the fluid passageway while the stylet is slidably received in the needle bore, the fluid passageway configured to provide fluid communication from the inlet port to the distal end of the needle such that a therapeutic liquid imparted into the inlet port is directed through the fluid passageway and discharged from the distal end of the needle.
However, Torrie is directed to a needle device and teaches a fluid fitting (120) coupled to the proximal end of the needle, the fluid fitting comprising an inlet port (125) (Paragraph 0030), the fluid fitting providing fluid communication between the inlet port and the fluid passageway while the stylet is slidably received in the needle bore (Paragraph 0030; 0043), the fluid passageway configured to provide fluid communication from the inlet port to the distal end of the needle such that a therapeutic liquid imparted into the inlet port is directed through the fluid passageway and discharged from the distal end of the needle (Paragraph 0043).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sampson such that a fluid fitting coupled to the proximal end of the needle, the fluid fitting comprising an inlet port, the fluid fitting providing fluid communication between the inlet port and the fluid passageway while the stylet is slidably received in the needle bore, the fluid passageway configured to provide fluid communication from the inlet port to the distal end of the needle such that a therapeutic liquid imparted into the inlet port is directed through the fluid passageway and discharged from the distal end of the needle, as taught by Torrie, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sampson with the teachings of Torrie by incorporating a fluid fitting coupled to the proximal end of the needle, the fluid fitting comprising an inlet port, the fluid fitting providing fluid communication between the inlet port and the fluid passageway while the stylet is slidably received in the needle bore, the fluid passageway configured to provide fluid communication from the inlet port to the distal end of the needle such that a therapeutic liquid imparted into the inlet port is directed through the fluid passageway and discharged from the distal end of the needle in order to allow transfer of fluids from the surgical site such as releasing fluid from the site out of the needle (Torrie Paragraph 0043) or providing the ability to administer fluids to the site.
Regarding claim 52, Sampson discloses a method of performing an interventional radiology procedure comprising conducting one of a carpal tunnel release, a trigger finger release, a tarsal tunnel release, a plantar fascia release (Paragraph 0003) using the medical instrument of 24 while imaging target anatomy (Paragraph 0090; 0094).
Regarding claim 53, Sampson further discloses wherein the sole entry point for the interventional radiology procedure is a needle puncture (inserting into a subject a surgical cutting device as described herein to a desired site of cutting of a structure) (Paragraph 0089).
Conclusion
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771