DETAILED ACTION
This Office Action is in response to the filing of a preliminary amendment on 6/22/2023. As per the preliminary amendment, claims 13-14 have been amended, claims 1-10 and 15-30 have been cancelled, and claims 31-45 have been added. Thus, claims 11-14 and 31-45 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 11-14 and 31-32, and 34-45 are objected to because of the following informalities:
Claim 11 recites the language “so as to cause” in lines 2-4. Examiner suggests changing to read --configured to cause-- in order to clarify that the claim is not claiming a patient’s trachea (line 4), which is not patent-eligible subject matter.
Claim 11 recites the term “the tube” in lines 2 and 3. Examiner suggests changing to read --the tracheostomy tube-- in order to maintain consistent terminology.
Claims 12-14, 31-32 recite the language “A tracheostomy tube as claimed in” in line 1, respectively. Examiner suggests changing to read --The tracheostomy tube as claimed in-- in order to properly refer back to the same tracheostomy tube of claim 11.
Claim 12 recites the term “the tube” in lines 2 and 3. Examiner suggests changing to read --the tracheostomy tube-- in order to maintain consistent terminology.
Claim 31 recites the term “the tube” in lines 2, 4, and 5. Examiner suggests changing to read --the tracheostomy tube-- in order to maintain consistent terminology.
Claim 34 recites the language “securable around a patient’s neck” in lines 1-2. Examiner suggests changing to read --configured to be secured around a patient’s neck-- in order to clarify that the claim is not claiming a patient’s neck, which is not patent-eligible subject matter.
Claims 35-45 recite the language “A tracheostomy kit according to claim” in line 1, respectively. Examiner suggests changing to read --The tracheostomy kit according to claim-- in order to properly refer back to the same tracheostomy kit of claim 34.
Appropriate correction is required.
Claim Interpretation
It is noted that independent claim 33 is directed to an incision guide and incision sleeve for performing a tracheotomy, and does not positively claim a tracheostomy tube, retention elements, or the respiration of the patient. However, claim 33 by itself is close enough to other claims (e.g. claims 36-38) such that there is presently no significant burden to examine claim 33 alongside the rest of the claims. However, the Examiner reserves the right to restrict claim 33 and any dependents that may depend upon claim 33 during future prosecution, should the claim(s) include further limitations which are directed to performing an incision for a tracheotomy and surgical steps thereof, as opposed to structural components of a tracheostomy tube device.
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: “retention element” in claim 11.
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 11-14, 31-33 and 36-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the language “A tracheostomy tube having a distal end thereof a resilient retention element, the retention element being radially outwardly biased with respect to the tube” in lines 1-2. However, the claim is directed to a tracheostomy tube, and the retention element is biased with respect to the tracheostomy tube. It is unclear how the retention element can be part of the tracheostomy tube, while also being biased with respect to the tracheostomy tube (that it is a part of). Thus, it is unclear whether or not the applicant is attempting to claim the combination of a tracheostomy tube and a retention element, or just the tracheostomy tube.
Claim 13 recites the limitation "the wall" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the term “may breathe when the tube is inserted” in lines 2-3. It is unclear whether or not the ability for a patient to breathe through the tube is positively claimed, or merely an optional function of the tube.
Claim 13 recites the limitation "the other" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to read --the other end of the tube-- in order to clearly identify what “other” element is being referred to.
Claim 32 recites the term “multiple such subsidiary lumens” in lines 2-3 and “each subsidiary lumen” in line 2. It is unclear if these are the same or different from the “subsidiary interior lumens” of claim 31, as there is no antecedent basis connecting the lumens of claim 32 to the lumens of claim 31.
Claim 33 recites the limitation "the body" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 36 recites the term “can be guided” in line 2. It is unclear whether or not the limitations which follow are being positively claimed.
Any remaining claims are rejected for being dependent on a rejected claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 12-14 are each directly solely to limitations that further limit the “retention element.” However, as seen in the above 35 U.S.C. 112(b) rejection of claim 11, the “retention element” has not been previously positively claimed. Thus, further limiting the retention element does not further limit the claimed invention, as the claimed invention does not have the retention element in combination with the tracheostomy tube.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 11 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guerra et al. (US Pub. 2014/0128902).
Regarding claim 11, Guerra discloses a tracheostomy tube (tracheostomy tube system 2 as seen in Fig. 1) having at a distal end thereof a resilient retention element (see Figs. 1 and 12A-12F where a balloon 7 is at a distal end of the tracheostomy tube 2, and acts as a retention element), the retention element being radially outwardly biased with respect to the tube (see Figs. 1 and 12A-12F where the balloon 7 extends radially outward from tube 2) so as to cause an outer part thereof to expand radially away from the tube when the distal end of the tube extends into a patient's trachea (see Figs. 1 and 12A-12F where the balloon 7 has an outer surface that expands radially away from tube 2, which occurs when the distal end of the tube 2 extends into the patient’s trachea).
Regarding claim 33, Guerra discloses an incision guide for a tracheostomy tube (see Fig. 1 and Figs. 12A-12F including guide wire tube 23 and peelable insertion element 25 to guide the tube 2), the guide comprising an incision sleeve and two or more wings extending from one end of the body in opposing directions (see Figs. 11A-12F and [0071] where peelable insertion element 25 has two arms 25A and 25B which are half-tube members forming an incision sleeve, each arm having an extension on the proximal end that protrude in opposite directions from one another), the incision sleeve having two or more zones of weakness along its length whereby it can be drawn apart to detach it from a tracheostomy tube passing through the sleeve (see [0071] and Figs. 11B-11D where the two arms 25A and 25B are detachable from one another, having two zones of weakness that allow the two arms to peel apart from one another).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Guerra as applied to claim 11 above, and further in view of Curley et al. (US Pub. 2012/0304984).
Regarding claim 12, Guerra discloses wherein the retention element, when expanded, has the form of a conical wall extending about the tube (see Figs. 1 and 12A-12F; see also [0061] where balloon 7 is understood to have a conical shape).
Guerra lacks a detailed description of the radially larger end of the conical wall being more proximal relative to the tube than the radially smaller end of the conical wall.
However, Curley teaches a tracheal stoma dilation device, where a tracheal cuff member on a tracheostomy tube is shaped such that the radially larger end of a conical wall is more proximal relative to the tube than the radially smaller end of the conical wall (see Fig. 11, where a reverse tapered cuff 76 can be shaped such that the radially larger end is proximal and the radially smaller end is distal).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuff of Guerra to be a reverse tapered cuff as taught by Curley, as it would be a simple substitution of one cuff member for another, to yield the predictable result of providing a cuff to help hold the tube in place, with the added benefit of applying more pressure near the proximal end of the tracheal passageway to re-open the stoma (Curley; see [0039]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Guerra as applied to claim 11 above, and further in view of Wondka et al. (US Pat. 10,058,668).
Regarding claim 13, Guerra discloses a wall of the retention element.
Guerra lacks a detailed description of wherein the wall of the retention element is perforate.
However, Wondka teaches a tracheostomy tube device, where a retention element can be perforate (see Figs. 24-26 and see Col. 18 line 66 to Col. 19 line 8 and see also the description of Figs. 24-26 on Col. 19 line 9 to Col. 20 line 22, where a shield member can be a cuff and is fenestrated and airflow permeable).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuff of Guerra to be fenestrated and airflow permeable as taught by Wondka, as it would allow for sensor to be included and able to receive information through the cuff, while the cuff is still able to retain the tube in place.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Guerra as applied to claim 11 above, and further in view of Guo et al. (CN 110548204; see attached translated copy).
Regarding claim 14, Guerra discloses the retention element interacts with the interior of the patient's trachea (cuff presses against tracheal tissues).
Guerra lacks a detailed description of wherein the retention element is provided with suckers on its proximal face for attachment to the interior of the patient's trachea.
However, Guo teaches a tracheal tube device, where a cuff member of the tube is provided with a plurality of suction cups are arranged on the exterior of the cuff to face and interact with the tracheal tissues to form a tight and comfortable seal (see Figs. 1 and 5-8 where suction cups 33 are arranged on a surface of a cuff 30; see also page 4 paragraphs 3-5).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuff of Guerra to include a plurality of outwardly arranged exterior suction cups as taught by Guo, as it would be a simple substitution of one means for holding the cuff in place for another, with the benefit of providing a good and comfortable seal (Guo; see page 4 paragraphs 3-5).
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Guerra as applied to claim 11 above, and further in view of Wood et al. (US Pub. 2011/0315147).
Regarding claim 31, Guerra discloses wherein the tracheostomy tube has a wall defining a principal interior lumen through which a patient may breathe when the tube is inserted into the patient's trachea (the lumen of tracheostomy tube 2 in Fig. 1).
Guerra lacks a detailed description of one or more subsidiary interior lumens extending through the wall from one end of the tube to the other whereby fluid communication can be made to the interior of the patient's trachea when the tube is inserted therein.
However, Wood teaches a tracheal tube device, where a tracheal tube (which can be a tracheostomy tube as seen in [0023]) has one or more subsidiary interior lumens extending through the wall from one end of the tube to the other (see Fig. 1 where tube 10 has multifunctional lumen 34 extending through the length of the tube; and see Fig. 9 where an embodiment of a multifunctional lumen has three lumens 34/ 34’/ 34’’; see [0044]-[0046]) whereby fluid communication can be made to the interior of the patient's trachea when the tube is inserted therein (see Figs. 1 and 9 and [0044]-[0046] where the lumens 34/ 34’/ 34’’ reach and are in fluid communication with the trachea).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lumen of Guerra to have additional subsidiary lumens as taught by Wood, as it would allow for additional devices and/or sensors to be used while the tracheostomy tube is in place.
Regarding claim 32, the modified Guerra device has multiple such subsidiary lumens, each subsidiary lumen being separated from the others by material of the wall (Wood; see Fig. 9 where each of lumens 34/ 34’/ 34’’ are separate from one another by the wall of the tube 10).
Claims 34, 36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Roberson, Jr. et al. (US Pat. 7,267,124; hereinafter “Roberson”) in view of Guerra.
Regarding claim 34, Roberson discloses a tracheostomy kit (see abstract) comprising a neck brace securable around a patient's neck (see Fig. 1 guide 10, and Col. 2 lines 1-9 where the substrate 16 holds the guide around at least a portion of the neck area), the neck brace defining an aperture arranged to be located at a tracheostomy incision site when the neck brace is secured around the patient's neck (see aperture 20 in Fig. 1), a tracheostomy tube slidably guidable through the aperture (breathing tube 14 in Fig. 3), and an introducer to make an incision at the tracheostomy incision site (see cutting instrument 12 in Fig. 2).
Roberson lacks a detailed description of an introducer guidable through the tracheostomy tube to make an incision at the tracheostomy incision site.
However, Guerra teaches a tracheostomy device, where an introducer is guidable through the tracheostomy tube to make an incision at the tracheostomy incision site (see Figs. 2-4 and [0072]-[0073] where a dilator 19 is passed through the tracheostomy tube 2 in order to produce the incision).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cutting instrument of Roberson to be designed to be a guided dilator through the tracheostomy tube as taught by Guerra, as it would be a simple substitution of one type of tracheotomy incision device for another, to yield the predictable result of providing an incision for a tracheostomy.
Regarding claim 36, the modified Roberson device has an introducer.
The modified Roberson device lacks a detailed description of an incision sleeve through which the tracheostomy tube can be guided into the incision.
However, Guerra further teaches an incision sleeve through which the tracheostomy tube can be guided into the incision (Guerra; see Figs. 11A-12F and [0071] where insertion element 25 is an incision sleeve about the tube 2).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer of the modified Roberson device to include an incision sleeve as taught by Guerra, as it would be a simple substitution of one type of dilation system for another, to yield the predictable result of dilating the incision.
Regarding claim 38, the modified Roberson device has wherein the incision sleeve comprises two half-sleeves, each forming half of a circumference of the sleeve (Guerra; see Figs. 11A-12F where the insertion elements 25 has arms 25A/25B which are half sleeves around a half-circumference of the tube).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra as applied to claim 34 above, and further in view of Christopher (US Pub. 2001/0035185).
Regarding claim 35, the modified Roberson device has wherein the neck brace comprises a plate locatable at the front of the patient's neck (Roberson; see Fig. 1 guide 10 being a plate located on the front of a patient’s neck).
The modified Roberson device lacks a detailed description of two flexible elements attached laterally to the plate, the flexible elements being attachable to each other at the back of the neck.
However, Christopher teaches a head-mounted respiratory device, where each end of the device has a flexible element that extends around to the back of the head to connect with the other flexible element (see Figs. 3-5 where each end of delivery tube 20 has a strap 25 which extends out from the head and connects at the back of the patient’s head; see also [0030]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive of the modified Roberson device to be a pair of straps that extend around the head as taught by Christopher, as it would be a simple substitution of one mechanism for holding the guide against the patient’s neck for another, to yield the predictable result of holding the guide steady and in position.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra as applied to claim 36 above, and further in view of Schnell (US Pat. 8,251,068).
Regarding claim 37, the modified Roberson device has the incision sleeve.
The modified Roberson device lacks a detailed description of wherein the incision sleeve has a sharp distal end for widening the incision.
However, Schnell teaches a tracheotomy device, where a dilation member is conically shaped and has a sharp distal end (see Figs. 2-3 and Col. 6 lines 15-22 where the tip of insertion aid 2 is conical and sharp).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the incision sleeve of the modified Roberson device to be conical and sharp at a distal end as taught by Schell, as it would allow for the distal end of the incision sleeve to fit into smaller incisions before dilating them.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra as applied to claim 34 above, and further in view of Wood et al. (US Pub. 2011/0073115).
Regarding claim 39, the modified Roberson device has a flexible retaining element, for retaining the tracheostomy tube in the trachea (Guerra; cuff 7 in Fig. 1).
The modified Roberson device lacks a detailed description of a flexible, funnelshaped drogue, arranged around the tracheostomy tube, for retaining the tracheostomy tube in the trachea.
However, Wood teaches a tracheal tube device, where a flexible, funnelshaped drogue, arranged around the tracheal tube, for retaining the tracheal tube in the trachea (see Figs. 2 and 5 cuff assembly 14 which is a funnelshaped cuff (drogue) that holds against the tracheal walls (see [0019])).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the cuff of the modified Roberson device to be a funnelshaped drogue as taught by Wood, as it would be a simple substitution of one shape of cuff for another, to yield the predictable result of holding the cuff and tube against the tracheal walls.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra in view of Wood as applied to claim 39 above, and further in view of Guo.
Regarding claim 40, the modified Roberson device has the drogue.
The modified Roberson device lacks a detailed description of wherein the drogue includes suckers for securing the drogue to the inside of the trachea.
However, Guo teaches a tracheal tube device, where a cuff member of the tube is provided with a plurality of suction cups are arranged on the exterior of the cuff to face and interact with the tracheal tissues to form a tight and comfortable seal (see Figs. 1 and 5-8 where suction cups 33 are arranged on a surface of a cuff 30; see also page 4 paragraphs 3-5).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drogue of the modified Roberson device to include a plurality of outwardly arranged exterior suction cups as taught by Guo, as it would be a simple substitution of one means for holding the cuff in place for another, with the benefit of providing a good and comfortable seal (Guo; see page 4 paragraphs 3-5).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra as applied to claim 34 above, and further in view of Idemoto et al. (US Pat. 4,832,683).
Regarding claim 41, the modified Roberson device has the introducer includes a cutting tip.
The modified Roberson device lacks a detailed description of wherein the introducer includes a ceramic cutting tip.
However, Idemoto teaches a cutting device for surgical use, where the cutting tip can be ceramic (see Col. 2 lines 49-52 where a blade for cutting tissue is ceramic).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cutting tip of the modified Roberson device to be a ceramic cutting tip as taught by Idemoto, as it would be a simple matter of design choice for a person of ordinary skill in the art to choose a well-known and biocompatible cutting tip material, such as ceramic.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra as applied to claim 34 above, and further in view of Smith et al. (US Pat. 5,139,019).
Regarding claim 42, the modified Roberson device has the introducer makes the incision.
The modified Roberson device lacks a detailed description of wherein the introducer comprises a laser for making the incision.
However, Smith teaches a tracheal device, where an incision can be done by laser (see Col. 1 lines 15-23 and Col. 5 lines 8-12).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer that performs the incision of the modified Roberson device to be a laser that performs the incision as taught by Smith, as it would be a simple substitution of one cutting mechanism for another, to yield the predictable result of being able to cut an incision into the tissue of the patient.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra as applied to claim 34 above, and further in view of Masury et al. (US Pub. 2007/0088374).
Regarding claim 43, the modified Roberson device has wherein the introducer includes a proximal end, for advancing the introducer with respect to the tracheostomy tube (Guerra; see Fig. 1 where a proximal end of guide wire 6 is manually advanced within the tracheostomy tube 2).
The modified Roberson device lacks a detailed description of wherein the introducer includes a manually actuatable part at a proximal end.
However, Masury teaches a medical device for performing incisions, where a proximal end of an introducer system is manually actuatable (see Figs. 5-6 where actuator 16 is proximal the central portion 72, and includes a spring 66 for blade retraction; see [0025]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer of the modified Roberson device to have an actuator and retraction spring as taught by Masury, as it would allow for the practitioner to manually choose when to make the incision by using an actuator, to better ensure that the patient is prepped and ready.
Regarding claim 44, the modified Roberson device has a spring for returning the introducer to a retracted state (Masury; see spring 66 in Fig. 5 and [0025]).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra as applied to claim 34 above, and further in view of Wondka.
Regarding claim 45, the modified Roberson device has the tracheostomy tube and kit.
The modified Roberson device lacks a detailed description of an ultrasonic attachment for scanning the trachea.
However, Wondka teaches a tracheostomy tube device, which can include ultrasonic sensors for intra-airway sensing (see Col. 3 lines 35-40).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tracheostomy tube of the modified Roberson device to include ultrasonic sensors attached to it as taught by Wondka, as it would provide sensing of the airway and breathing characteristics to better monitor patient condition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Rasor et al. (US Pat. 9,913,956) and Schell (US Pat. 8,474,459) are cited to show tracheostomy devices with dilation systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Thurs 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached at (571)272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785