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 .
Information Disclosure Statement
The IDS form(s) submitted on 11/24/2025 is/are in compliance with the requirements of the provisions of 37 CFR 1.97. Accordingly, the information disclosure(s) are being considered by the examiner.
Response to Amendment
This office action is responsive to the claim amendments filed on 11/24/2025. As directed by the amendment: claims 1, 4, 6, 9-12, and 14-15 have been amended; and claim 17 has been added. Thus, claims 1-17 are presently pending in this application.
Applicant’s amendments to the claims 1, 4, 6, and 12 have overcome Examiner’s rejections under 35 USC § 112(b) and are therefore withdrawn.
Response to Arguments
Applicant's arguments filed 11/24/2025 with regards to Examiner’s rejection of claim 14 under 35 USC § 112(a) is found persuasive and is therefore withdrawn.
Applicant’s argument, filed 11/24/2025, “Farr does not disclose at least the following features - F1: … …F2: … …F3: … …For at least these reasons, claim 1 is neither disclosed nor anticipated by Farr.” on beginning pg. 7 line 23 is not found persuasive. Regarding F1 argument “Farr is primarily an access and visualization tool, not a dedicated “catheter” (1) specifically designed for delivery of medicinal liquid or powder in spray form”. US 2014/0343359 A1 to Farr et al. is considered to teach a catheter as claimed as citing in previous rejection to elements 406a and 406b of Fig. 4d. Merriam-webster definition of catheter relied upon in this determination “a tubular medical device for insertion into canals, vessels, passageways, or body cavities usually to permit injection or withdrawal of fluids or to keep a passage open”. See also Farr para. 38 for description of elements 406a-b “means for suction and delivery of liquid agents and medications”. Applicant is reminded although claims are read in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1 further recites “comprising” language. Therefore, the recited catheter is considered to read upon the limitations of the claim as written. Regarding F2 argument “said catheter comprising a deformable catheter body designed to be inserted into the trachea through vocal cords of the subject”. Farr teaches para. 4 specifically “laryngoscope (larynx+the [sic] voice box)”. As the larynx contains the vocal cords Farr is considered fully capable of performing the intended use limitation. Regarding F3 argument “a drive member for folding of the deformable catheter body along a predetermined orientation”. Farr teaches para. 59 “shape retaining wires” these are considered to be the drive member as they drive the deformable catheter body into the predetermined orientation. The orientation is considered predetermined as the wires are shape memory, and the final shape has to be set prior to use.
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: Claim 1 line 9 recites “drive member for folding”. As understood from the specification the drive member can be a rigid rod, preformed tube, or activating wire. Claim 12 line 6 recites “device for commanding the administration”. As understood from the specification the command unit is a user interface. See Specification pg. 10 lines 24-30 “command center 100 may comprise a user interface”. Claim 14 lines 2-3 recite “means for controlling a temperature of the medicinal liquid or powder in the reservoir”. As understood from the specification the temperature control means is a heating band or temperature regulating means. See Specification pg. 18 lines 14-24.
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 § 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.
(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) 1-3, 7, 9-13, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0343359 A1 to Farr et al.
In regard to claim 1:
A catheter (Fig. 4d element 406a-b) for delivering a medicinal liquid or a powder in spray form (Fig. 4d elements 408a-b, para. 59 “where spray nozzles 408a-b at the end of the delivery tubes 406a-b, are also manipulated and pointed towards the same object of interest 490”, para. 63 “spectral imaging can be performed concurrently or at various time windows, and with spraying of the site with specific diagnostic agents using spray nozzles 408a-b”) into a trachea of a subject (considered intended use limitation. Device of Farr is considered fully capable of spraying in the trachea due to para. 3 “present invention relates generally to an apparatus for visualization of endoscopic and borescopic [sic] fields, in minimally invasive surgical (MIS) procedures, general or diagnostic medical or industrial procedures using endoscopes or borescopes, respectively”, and para. 4 “Specialized endoscopes are named depending on where they are intended to look. Examples include: cystoscope (bladder), nephroscope (kidney), bronchoscope (bronchi), laryngoscope (larynx+the [sic] voice box), otoscope (ear), arthroscope (joint), laparoscope (abdomen), gastrointestinal endoscopes, and specialized stereo endoscopes used as laparoscopes or for endoscopic cardiac surgery”), said catheter comprising a deformable catheter body (Figs. 4a-4d demonstrate the deformation of element 406a-b) designed to be inserted into the trachea through vocal chords of the subject (considered functional limitation. The device taught by Farr is considered fully capable of performing the claimed function due to Para. 59 “Where upon deployment, the body 402 and all the inside electrical and tubular connections are elongated (FIG. 4b), and articulated into position (FIG. 4b-c), where spray nozzles 408a-b at the end of the delivery tubes 406a-b, are also manipulated and pointed towards the same object of interest 490 (along the line of site or distal tip axis 460 in FIG. 4d). In operational position of distal tip axis along 460, the illumination light (from illuminator 202), as well as the imaging FOV (of the vision module 201), can be directed to the surgical site 490, from beyond the endoscope body 402 in FIG. 4a, where articulation of an OE module holding structure 405 at the distal end 402a, positions the vision module, and the distal tip of the access channel 401 off axis (along 460) from the axis of the insertion body (depicted by the dashed line 450 in FIG. 4a-d), increasing the functionality of the surgical device” as well as sections of paras. 3 and 4 recited above) and comprising a spray device for expelling the medicinal liquid or powder introduced into the catheter in the spray form (Para. 59 “where spray nozzles 408a-b at the end of the delivery tubes 406a-b”, para. 63 “As in device 300, the surgical area 490 under observation of device 400, can further be locally anesthetized or numbed with medication sprayed onto the site 490, from nozzles 408a-b”), said deformable catheter body comprising, further, a first lumen (Figs. 4a-4d element 204 exterior lumen) for the passage of an optic for generating an image of a zone situated in an extension of a distal end of said catheter element (para. 60 “The portable control and display unit 210 in FIGS. 4a-c is connected to the pluggable module 200, using USB electrical cable 205b, which extends as electrical cable 205a to the electrical connection 209 of the electronic circuit board 207 of the OE vision (201) and illumination (202) module near distal end 402a of device 400 (through vision port opening 410a, and illumination port opening 410b). The vision module 201 and illuminator 202 in FIGS. 4a-c sit on a rigid component block 405 and connected to flexible section of electrical board 207, where they receive power from the electrical connection 209 (as depicted in FIGS. 4a-c), which could be made to run as a USB device. LED illuminator 202 is mounted on or near or behind optical window 403 (in front of the vision module 201), for efficient heat transfer from the LED to the window as anti-fogging means. Alternatively, a passive resistor could be mounted on the window 403 to act as de-fogging unit, when the device is used inside the body with higher temperature than outside.”) and comprising a drive member for folding the deformable catheter body along a predetermined orientation (Fig. 4a-d element 402 (deformable catheter body). Para. 59 “Alternatively certain parts that are normally inside the device 400 during use, such as cable 205a (extension of USB cable 205b), or shape retaining wires inside the collapsing body 402, can be pushed outside the device from the handle 409, in the collapsed configuration of device 400 depicted in FIG. 4a” (emphasis added), shape retaining wires considered to be the drive member).
In regard to claim 2:
The catheter according to claim 1, wherein the deformable catheter body () comprises a second lumen defining a passage channel (Fig. 4d element 406b) for supplying the spray device (Fig. 4d element 408b) and a third lumen comprising the drive member (Figs. 4a-4d element 402)
In regard to claim 3:
The catheter according to claim 1, wherein said drive member makes it possible to drive an orientation of a distal part of the deformable catheter body with a proximal part of said deformable catheter body so as to control said orientation of the distal part in a predetermined direction (Fig. 4d element 402, see annotated Fig. 4d below).
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In regard to claim 7:
The catheter according to claim 1, wherein the spray device comprises aerosolization means for expelling the medicinal liquid in aerosol form (Figs. 4c-4d elements 408a and 408b, para. 59 “spray nozzles 408a-b”).
In regard to claim 9:
The catheter according to claim 1, wherein said first lumen for the passage of an optic is designed to receive the optic fiber extending along said first lumen up to the distal end of the deformable catheter body (considered functional limitation to which element 204 is considered fully capable of receiving an optic fiber extending along said lumen as there is sufficient space around element 204 as shown in Figures 4a-4d inside of element 402. Examiner notes the limitation does not require the optic fiber to be within said lumen, merely the lumen allows passage of optic and the capability to receive an optic fiber extending along it).
In regard to claim 10:
The catheter according to claim 9, wherein said first lumen for passage of the optic comprises, at the distal end of the deformable catheter body a transparent and leak tight wall for protecting the first lumen from contaminations of an external environment (Fig. 4a-4d elements 403, 410a and 410b, Para. 60 “The portable control and display unit 210 in FIGS. 4a-c is connected to the pluggable module 200, using USB electrical cable 205b, which extends as electrical cable 205a to the electrical connection 209 of the electronic circuit board 207 of the OE vision (201) and illumination (202) module near distal end 402a of device 400 (through vision port opening 410a, and illumination port opening 410b). The vision module 201 and illuminator 202 in FIGS. 4a-c sit on a rigid component block 405 and connected to flexible section of electrical board 207, where they receive power from the electrical connection 209 (as depicted in FIGS. 4a-c), which could be made to run as a USB device. LED illuminator 202 is mounted on or near or behind optical window 403 (in front of the vision module 201), for efficient heat transfer from the LED to the window as anti-fogging means. Alternatively, a passive resistor could be mounted on the window 403 to act as de-fogging unit, when the device is used inside the body with higher temperature than outside.” Considered leak tight as the window would not need anti-fogging on the interior side if it was exposed to the exterior environment.
In regard to claim 11:
The catheter according to claim 9, wherein said optic fiber is also designed to light a zone situated in a distal extension of the catheter (Examiner notes the optic fiber is not a positively recited structure. However, elements 201 and 202 demonstrate the claimed capability. See paragraphs 62-64).
In regard to claim 12:
A medical system comprising the catheter according to claim 1, and comprising a command unit (para. 14 “Embodiments of the invention also relate to the layouts and functionality of such removable and pluggable vision systems within the body of a disposable endoscope or other disposable medical devices, or within a disposable container (access device) in which the removable and pluggable OE illumination and vision modules are housed, and plugged onto a separate non-disposable control unit.”), said command unit comprising: a reservoir for receiving a volume of the medicinal liquid or powder (Para. 46 “By delivery and spraying of diagnostic chemical agent (using spray nozzles 308a-b, and 408a-b at the distal tip 304a and 402a of disposable medical access device 300, 300a, and 400, through tubing 306a-c and 406a-b from external source 321, or internal reservoirs 327, 427a-b)” Fig. 4c element 427a and 427b), a device for commanding the administration respectively of the medicinal liquid (Fig. 4c element 210 portable control and display unit considered a user interface , para. 64 “Alternately or additionally, the portable control and display unit 210 can include image processing electronics that provide image processing of image data received from multiple OE vision modules 201a,b, perform autofocus, or initiate drug and chemical agent delivery to the site from spray nozzles 308a-b” although referenced with respect to alternative elements 308a-b (spray nozzles) element 210 is universal to both embodiments as indicated by Fig. 4c element 210) or powder for driving a high pressure pump (considered optional limitation due to the use of “or”)
In regard to claim 13:
The medical system according to claim 12, further comprising a display screen for displaying images of the optic (Para. 33 “The portable control and display unit 210 generally includes a display screen, housing, illumination and imaging control electronics, image processing electronics, and/or a power supply, such as a battery”).
In regard to claim 16:
The catheter according to claim 1, wherein the subject is a premature newborn baby (considered intended use limitation. Device of Farr is considered fully capable of spraying in the trachea due to para. 3 “present invention relates generally to an apparatus for visualization of endoscopic and borescopic [sic] fields, in minimally invasive surgical (MIS) procedures, general or diagnostic medical or industrial procedures using endoscopes or borescopes, respectively”, and para. 4 “Specialized endoscopes are named depending on where they are intended to look. Examples include: cystoscope (bladder), nephroscope (kidney), bronchoscope (bronchi), laryngoscope (larynx+the [sic] voice box), otoscope (ear), arthroscope (joint), laparoscope (abdomen), gastrointestinal endoscopes, and specialized stereo endoscopes used as laparoscopes or for endoscopic cardiac surgery”)
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 4-6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0343359 A1 to Farr et al. in view of US 2018/0333553 A1 to Brown et al.
In regard to claim 4:
The catheter according to claim 1, taught by Farr as described in parent claim rejection above.
Farr does not appear to disclose the positioning piece and its intended cooperation with the mouth as claimed. Brown teaches, comprising a positioning piece intended to cooperate with a mouth of the subject (Fig. 3 element 108), said positioning piece extending radially at least partially around the deformable catheter body of the catheter to form a buccal support (Fig. 6d instrument inserted through element 123 and 108. Para. 36 “As shown in FIG. 3, the valved end of the housing 112 can define a port 123 through which instruments may be inserted.”) designed to limit a volume of air transiting outside the catheter between an inside and an outside of the mouth (considered fully capable of limiting the volume of air transiting outside of the catheter as claimed due to para. 66 “The connector 116 can be secured to any suitable interface of an assisted respiration source 205. In the illustrated embodiment, a corrugated tube 204 couples the assisted respiration source 205 to the connector 116. The assisted respiration source 205 can be configured to deliver oxygen, and optionally other gases (e.g., air) to the patient P. The gases can be unpressurized or pressurized, depending on the application. In some instances, the assisted respiration source 205 comprises any suitable ventilation machine, such as, for example, ventilation machines that are commonly used in NIPPV applications. Such NIPPV applications can include continuous positive airway pressure (CPAP) and/or variable or bilevel positive airway pressure (VPAP or BiPAP). In other or further instances, the assisted respiration source 205 may comprise a bag, which can be configured for use in bag valve mask ventilation procedures.” As element 116 is controlling the flow of air it is therefore limiting the flow of air around the catheter to the flow of air through element 116).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the catheter taught by Farr to include the intubation system with positioning piece as taught by Brown. This would have been motivated by Brown para. 63 “The bite block 108 can be configured to withstand biting by a patient so as to maintain the passageway 173 open.”
In regard to claim 5:
The catheter according to claim 4, taught by Farr as described in parent claim rejection above.
Farr does not appear to disclose the positioning piece and its ability to be translated on the catheter body as claimed. Brown teaches, wherein the positioning piece is translationally moveable on the deformable catheter body of the catheter (Figs. 6a-6e the various positions of elements 220’s and 108’s relative positions demonstrate the capability to be moved on the deformable catheter body).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the catheter taught by Farr to include the intubation system with positioning piece it’s translational motion as taught by Brown. This would have been motivated by Brown para. 71 “The bite block 108 can be removed from the mouth of the patient P and the adapter 110, the mask 102, the conduit 132, and the bite block 108 can be withdrawn over a proximal end of the endotracheal tube 220. The proximal end of the endotracheal tube 220 can then be coupled with an assisted respiration source 205” (emphasis added). Allowing the mouthpiece to be translate on the catheter body facilitates entry of the catheter into the throat of the patient as well as the option to leave an endotracheal tube for assisted respiration should the treatment require.
In regard to claim 6:
The catheter according to claim 4, taught by Farr as described in parent claim rejection above.
Farr does not appear to disclose the positioning piece and guide as claimed. Brown teaches, wherein the positioning piece comprises a guide to orientate an introduction of the catheter into respiratory tracts of said subject (para. 53 “The bite block 108 can include a guide plate 174 that extends rearwardly from the upper bite plate 170. An upper surface of the guide plate 174 can be contoured so as to be able to fit against or near a roof of a mouth of a patient. For example, the upper surface can be convexly rounded (see FIG. 5D), although other configurations are also possible. A lower surface of the guide plate 174 can be concavely rounded. In the illustrated embodiment, the guide plate 174 angles upwardly from the upper bite plate 170” (emphasis added)).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the catheter taught by Farr to include the intubation system with positioning piece and guide as taught by Brown. This would have been motivated by Brown para. 54 “the guide plate 174 may be restricted to the hard palette region of the roof of the mouth, and may be configured so as not to trigger a pharyngeal or gag reflex in the patient.”
In regard to claim 15:
comprising a catheter according to claim 1, taught by Farr as described in claim 1 rejection above.
Farr does not appear to explicitly teach the intubation system and probe as claimed. Brown teaches, an intubation system (Fig. 1 element 100), and an intubation probe (Fig. 3 elements 130, 108,132, 140, and 162), said probe being designed to receive said catheter being capable of moving within said probe (Fig. 6d element 220 (endotracheal tube, catheter) demonstrates the capability of said catheter to move within said probe).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the catheter taught by Farr to include the intubation system with probe and catheter motion as taught by Brown. This would have been motivated by Brown para. 71 “The bite block 108 can be removed from the mouth of the patient P and the adapter 110, the mask 102, the conduit 132, and the bite block 108 can be withdrawn over a proximal end of the endotracheal tube 220. The proximal end of the endotracheal tube 220 can then be coupled with an assisted respiration source 205” (emphasis added). Allowing the mouthpiece to be translate on the catheter body facilitates entry of the catheter into the throat of the patient as well as the option to leave an endotracheal tube for assisted respiration should the treatment require.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0343359 A1 to Farr et al. in view of US 3,503,385 to Stevens.
In regard to claim 8:
The catheter according to claim 1, taught by Farr as described in parent claim rejection above.
Farr does not appear to explicitly teach the drive member with preformed tube and removable rigid rod as claimed. Stevens teaches, wherein the drive member comprises: a preformed tube extending into an orientation lumen of the deformable catheter body (col 4:20-32 “I prefer a tip formed of smooth soft thermoplastic material, e.g., elastomeric polyurethane such as Estane which is described in Modern Plastics Encyclopedia for 1965, at page 170. The preferred tip is about three inches long, and heat set to give a distal curve through 120° of arc over 1 / inches length at the distal end and a proximal curve at the proximal end through 650° of arc over about one inch length.”); a removable rigid rod extending into a cavity of the preformed tube (Fig 1 element 20 “control wire” col 3:1-5 “control wire 20 within the catheter is arranged for reciprocal motion within the distal curved portion, which, when advanced, will cause the distal curve to straighten substantially.”); the preformed tube being designed in such a way that it comprises a preformed portion which, when the removable rigid rod is removed, takes a curved shape, inducing an angle between the parts of the tube on either side of said preformed portion in a predetermined plane (Col 2:5-20 “When the control wire is in its forward most position, extending past the curve, it causes the curve to substantially straighten so that the catheter may be directed forwardly during insertion. When the wire is withdrawn from the tip, its curved shape is resumed and the catheter may be caused to enter a branching vessel, Preferably, the tip of the catheter is formed with a double curvature, a distal curve which functions as described above, and a few inches proximally thereof a secondary curve, which facilitates the leading of the catheter by riding against the wall opposite the cannulated orifice”.
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the drive member taught by Farr to include the preformed tube with curve and removable rigid rod. This would have been motivated by Stevens’s col 130- “In certain diagnostic techniques it is necessary to insert a catheter through the blood vessels to a particular destination, and this frequently makes it necessary to guide the catheter into one of several alternate channels, as into a branching vessel. Vascular catheters are commonly formed with a curved but flexible distal tip portion which may be used to guide the cannula by twisting it from side to side during insertion to select the desired one of several vessels. In addition, attempts have been made to control the curvature of the distal tip so that it may be directed forward or to the side as desired during its insertion. None of these has until now however been satisfactory.”, col 1:45-60 “With my new construction, the catheter is more precisely controlled and more easily inserted than has heretofore been the case. In particular, the catheter may be simply directed past a branching vessel by causing the tip to straighten, whereas in the past it would have been necessary to rotate the catheter so that the tip is not aligned to enter the branching vessel”. Examiner notes this is directed towards branching blood vessels but to one of ordinary skill in the art this would be motivation around the trachea due to the bifurcation between the trachea and esophagus, as well as the vocal cords.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0343359 A1 to Farr et al. in view of US 3,730,183 to Goldsmith et al.
In regard to claim 14:
The medical system according to claim 12, taught by Farr as described in parent claim rejection.
Farr does not appear to teach the means for controlling temperature in accordance with 112f as claimed. Goldsmith teaches, wherein the reservoir (Fig. 1 element C) comprises means for controlling a temperature of the medicinal liquid or powder in the reservoir (Fig. 1 element 30).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the reservoir taught by Farr to include the temperature control means as taught by Goldsmith. This would have been motivated by keeping deliverable fluids near human body temperature to reduce and/or prevent thermal shock induced cellular stress to the body tissues.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0343359 A1 to Farr et al. in view of US 2013/0110055 A1 to McKinnon et al.
In regard to claim 17:
The catheter according to claim 1, taught by Farr as described in parent claim rejection.
Farr does not appear to teach the insert as claimed. McKinnon teaches, wherein the spray device (Fig. 8 considered analogous to the spray device of Farr) comprises - an insert (Fig. 8 element 74) arranged inside a passage channel (See annotated Fig. 8 below) and comprising an outer surface comprising at least one furrow (Fig. 8 elements 80), suited for passage of the medicinal liquid or powder, winding around the outer surface of the insert (Fig. 8 elements 80); - a receiving chamber (See annotated Fig.8 below), arranged between an outlet of a furrow of the insert and the distal orifice (See annotated Fig.8 below); - an outlet channel comprising a first portion (See annotated Fig.8 below), connected to the receiving chamber, a section of which decreases in a distal direction (See annotated Fig.8 below), and a second portion connected to the distal orifice, a section of which is substantially constant (See annotated Fig.8 below).
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Annotated Fig. 8
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the spray device taught by Farr to include the insert and receiving chamber taught by McKinnon. This would have been motivated by McKinnon Para. 48 “The use of helical flow channels causes a faster flow rate and a more turbulent flow when compared to a pusher of the same design with straight longitudinal flow channels”. The increased turbulence helps ensure the medicament is properly mixed and right before delivery.
Farr does not expressly disclose the distal orifice diameter between 20 pm and 100pm.
It would have been obvious to one of ordinary skill in the art prior to the effective date of filing to cause the device of Farr to have the spray device comprises a distal orifice having a diameter between 20 pm and 100pm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Farr would not operate differently with the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “preferentially comprised” within the claimed ranges (specification pg. 17 lines 6-10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm EST.
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, Bhisma Mehta can be reached at (571) 272-3383. 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.
/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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