Et 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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “pillar portions”, “bridging portion”, “first eyelet”, “second eyelet”, “opening”, “lift element”, “cardanic mount”, among others, must be shown or the feature(s) canceled from the claim(s). The Examiner notes the only features shown in Applicant’s drawings are the shield 1, connector 4, cannula tube 2, strap 20, and bridge-like fastening element 11, 11’ – therefore omitting many structural features recited by the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 16, and thus its dependent claims, 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. The Examiner notes the only features shown in Applicant’s drawings are the shield 1, connector 4, cannula tube 2, strap 20, and bridge-like fastening element 11, 11’ (see drawing objection above) – therefore omitting many structural features recited by the claims. As claim 16 recites various limitations relating to the arrangement of the structure of the shield, such as the shield having a first and second eyelet, two pillar portions formed on the proximal surface of the neck plate, and bridging portion connecting the two pillar portions, it is unclear from Applicant’s specification and/or drawings where the pillar portions are disposed in relation to the other structure of the shield. Claims 26 and 29-31 are similarly rejected, as they recite a “lifting element formed on the proximal surface, the lift element forms a ramp with a first end that is substantially flush with the proximal surface and a second end elevated above the proximal surface”, however this feature is not shown in the Figures. Therefore, it is unclear how this lifting element is disposed on the shield.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-17, 19-26, 29, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delaplane et al. (5,975,080).
Regarding claim 16, Delaplane discloses a shield for mounting to a tracheostomy cannula (neck plate 15 for mounting a tracheostomy tube assembly 10, Figure 4 and Col. 2 lines 56-60), the shield comprising: a neck plate having a central region (see neck plate 15 having a central region in which tube 10 is inserted, Figure 4), a first lateral side extending from the central region to a perimeter on a first side of the neck plate (see lateral wings 15a,15b of neck plate 15 extending from central region of plate 15 to outer perimeters, Figure and Col. 2 lines 61-62), and a second lateral side extending from the central region to the perimeter on a second side of the neck plate (see lateral wings 15a,15b of neck plate 15 extending from central region of plate 15 to outer perimeters, Figure and Col. 2 lines 61-62); a proximal surface of the neck plate adapted to face away from a patient's neck during use (see proximal surface of neck plate 15 adapted to face away from patient’s neck 23 during use, Figure 9); a distal surface of the neck plate adapted for placement on the patient's neck during use (see distal surface of neck plate 15 adapted to contact patient’s neck 23 during use, Figure 9); an opening formed through the central region of the neck plate (the tube section 11 is received through an opening in the face of the neck plate 15, Figure 4 and Col. 3 lines 1-3), with the opening sized to receive the tracheostomy cannula (neck plate 15 for mounting a tracheostomy tube assembly 10, Figure 4 and Col. 2 lines 55-60); a first eyelet formed on the first lateral side on the proximal surface of the neck plate between the opening and the perimeter of the neck plate (see eyelet opening 55 formed on a lateral side of the neck plate 15 between the opening for the tube 11 and the perimeter of the neck plate 15, Figures 4-5); and a second eyelet formed on the second lateral side on the proximal surface of the neck plate between the opening and the perimeter of the neck plate (see opposite eyelet opening 55 formed on the other lateral side of the neck plate 15 between the opening for the tube 11 and the perimeter of the neck plate 15, Figures 4-5); wherein each the first eyelet and the second eyelet comprise two pillars formed on and extending away from the proximal surface of the neck plate with a bridging portion connected between the two pillars (see annotated Figure 4 below, showing the eyelet openings 55 having two pillars extending away from proximal surface of neck plate 15 with a bridging portion connecting the two pillar portions).
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Annotated Figure 4
Regarding claim 17, Delaplane further discloses wherein the two pillars formed on and extending away from the proximal surface of the neck plate are spaced apart to form a guide sized to receive a strap insertable into the neck plate (see the two pillars forming eyelet openings 55 spaced apart such that a strap 71 may be inserted, Figure 4) and the bridging portion is rectangular in cross-section (bridging portion is rectangular in cross-section, see annotated Figure 4 above).
Regarding claim 19, Delaplane further discloses wherein the two pillars formed on and extending away from the proximal surface of the neck plate are spaced apart to form a guide sized to receive a strap insertable into the neck plate (see the two pillars forming eyelet openings 55 spaced apart such that a strap 71 may be inserted, Figure 4) and the bridging portion is a curved arch connected between the two pillars (bridging portion is a curved arch connecting the two pillar portions, see annotated Figure 4 above).
Regarding claim 20, Delaplane further discloses wherein each the first eyelet and the second eyelet further comprise a grooved recess formed between the two pillars to provide clearance for a strap attachable to the neck plate (see openings 55 forming a grooved recess between the two pillar portions to provide clearance for a strap 71, annotated Figure 4 above).
Regarding claim 21, Delaplane further discloses wherein the grooved recess formed between the two pillars extends from each respective eyelet to the perimeter of the neck plate (see grooved recess formed in the openings 55 extending to the perimeter of the neck plate 15, Figure 4).
Regarding claim 22, Delaplane further discloses wherein the two pillars are formed on and extend away from the proximal surface at an angle of 90 degrees relative to the neck plate (see the alternative clip arrangement openings 60 comprising two pillar portions extending away from proximal surface of plate 15 at an angle of 90 degrees, Figures 4-5).
Regarding claim 23, Delaplane further discloses wherein the proximal surface of the neck plate is parallel to the distal surface of the neck plate (see proximal/distal surfaces of neck plate 15 parallel to one another, Figure 9).
Regarding claim 24, Delaplane further discloses wherein the distal surface is curved to provide a concave surface in the central region (see distal surface of neck plate 15 being curved, Figure 9).
Regarding claim 25, Delaplane further discloses wherein the distal surface is curved surface from first lateral side of the shield to the second lateral side of the shield (see distal surface of neck plate 15 being curved, Figure 9).
Regarding claim 26, Delaplane further discloses further comprising a lift element formed on the proximal surface between each respective one of the first and second eyelet and the central region, where the lift element forms a ramp with a first end that is substantially flush with the proximal surface and a second end elevated above the proximal surface (the Examiner notes the 112b rejection presented above for this particular limitation – for the purpose of examination, the Examiner will consider the “lift element” of Delaplane’s device as being the supplemental clips 60 as it forms a ramp-like structure with a first end flush to the proximal surface of neck plate 15, and an elevated second end, Figures 4-9).
Regarding clam 29, Delaplane further discloses a lift element formed on the proximal surface between each respective one of the first and second eyelet and the central region, where the lift element forms a ramp with a first end that is substantially flush with the proximal surface and a second end elevated above the proximal surface (the Examiner notes the 112b rejection presented above for this particular limitation – for the purpose of examination, the Examiner will consider the “lift element” of Delaplane’s device as being the supplemental clips 60 as it forms a ramp-like structure with a first end flush to the proximal surface of neck plate 15, and an elevated second end, Figures 4-9); and a grooved recess formed between the two pillars of the first and second eyelet to provide clearance for a strap attachable to the neck plate (see grooved recess formed in the openings 55 extending to the perimeter of the neck plate 15, Figure 4).
Regarding claim 32, Delaplane further teaches further comprising: a strap having a first portion passed through the first eyelet of the neck plate and a second portion passed through the second eyelet of the neck plate (see strap 71 passing through first and second eyelet openings 55, Figure 4), wherein the first portion of the strap and the second portion of the strap contact the proximal surface of the neck plate and are separated away from the distal surface of the neck plate by a thickness of the neck plate (strap 71 contacts proximal surface of neck plate 15 and is separated from the distal surface of neck plate 15 by the thickness of the plate itself 15, Figure 4).
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Delaplane et al. (5,975,080) in view of Waldron (US 8,522,788 B2).
Regarding claim 18, Delaplane teaches the shield of claim 16, further teaching wherein the two pillars formed on and extending away from the proximal surface of the neck plate are spaced apart to form a guide sized to receive a strap insertable into the neck plate (see the two pillars forming eyelet openings 55 spaced apart such that a strap 71 may be inserted, Figure 4), however is silent wherein the bridging portion is circular in cross-section.
However, Waldron teaches an endotracheal tube shield (neck flange 112, Figure 1 and abstract) wherein two pillars extend from the proximal surface of the neck flange such that the cross-section area of the bridging portion between the two pillars is circular (see circular/rounded bridging portion 122, Figures 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Delaplane’s shield device by having the bridging portion have a circular cross-section as opposed to a rectangular cross-section, as taught by Waldron, as providing a circular cross-section of the bridging portion may reduce the number of sharp/blunt edges of the shield device that may make donning the strap on and off more difficult or uncomfortable to the user.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Delaplane et al. (5,975,080) in view of Schwartz et al. (US 5,954,636).
Regarding claim 27, Delaplane teaches the shield of claim 16, however is silent on further comprising a cardanic mount disposed in the central region and attachable to the tracheostomy cannula.
However, Schwartz teaches an endotracheal tube holder (clip 25, Figure 7, Abstract) and further teaches a cardanic mount attachable to the endotracheal tube cannula (a suitable adapter 24 such as the BODAT swivel Y adapter may be used to connect to the endotracheal tube 16, the examiner is interpreting “cardanic mount” as meaning a swivel connection/mount, Figure 7 and Col. 6 lines 13-16).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Delaplane’s shield device by further including a cardanic mount and/or swivel mount attachable to the endotracheal tube, as providing such a swivel connection between the endotracheal tube and the tube holder allows for the physician and/or user to move the endotracheal tube in various directions as needed.
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Delaplane et al. (5,975,080) in view of Russo (US 8,096,300 B2).
Regarding claim 28, Delaplane teaches the shield of claim 16, however is silent on further comprising a separate cushion element adapted to be placed on the distal surface of the neck plate, wherein the separate cushion element is larger than the neck plate and configured to overlap and protrude beyond the perimeter of the neck plate.
However, Russo teaches an endotracheal tube holder (Figure 1, Abstract) comprising a neck plate (plate 52, Figure 7) and further comprising a separate cushion element to be placed on the distal surface of the neck plate (foam core 59, Figure 7 and Col. 6 lines 6-9) wherein the separate cushion element is larger than the neck plate and configured to overlap and protrude beyond the perimeter of the neck pate (see Figure 7 showing the foam core 59 extending beyond the perimeter of the plate 52).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Delaplane’s shield device by including a separate cushion on the distal surface of the neck plate, as taught by Russo, as providing such as cushioning element between the neck plate and the user may provide the user with additional comfort while wearing the device.
Regarding claim 30, Delaplane teaches the shield of claim 16, further teaching a lift element formed on the proximal surface between each respective one of the first and second eyelet and the central region, where the lift element forms a ramp with a first end that is substantially flush with the proximal surface and a second end elevated above the proximal surface (the Examiner notes the 112b rejection presented above for this particular limitation – for the purpose of examination, the Examiner will consider the “lift element” of Delaplane’s device as being the supplemental clips 60 as it forms a ramp-like structure with a first end flush to the proximal surface of neck plate 15, and an elevated second end, Figures 4-9); a grooved recess formed between the two pillars of the first and second eyelet to provide clearance for a strap attachable to the neck plate (see grooved recess formed in the openings 55 extending to the perimeter of the neck plate 15, Figure 4), however is silent on a separate cushion element adapted to be placed on the distal surface of the neck plate.
However, Russo teaches an endotracheal tube holder (Figure 1, Abstract) comprising a neck plate (plate 52, Figure 7) and further comprising a separate cushion element to be placed on the distal surface of the neck plate (foam core 59, Figure 7 and Col. 6 lines 6-9) wherein the separate cushion element is larger than the neck plate and configured to overlap and protrude beyond the perimeter of the neck pate (see Figure 7 showing the foam core 59 extending beyond the perimeter of the plate 52).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Delaplane’s shield device by including a separate cushion on the distal surface of the neck plate, as taught by Russo, as providing such as cushioning element between the neck plate and the user may provide the user with additional comfort while wearing the device.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Delaplane et al. (5,975,080) in view of Schwartz et al. (US 5,954,636) and in further view of Russo (US 8,096,300 B2).
Regarding claim 31, Delaplane teaches the shield of claim 16, further teaching further comprising: a lift element formed on the proximal surface between each respective one of the first and second eyelet and the central region, where the lift element forms a ramp with a first end that is substantially flush with the proximal surface and a second end elevated above the proximal surface (the Examiner notes the 112b rejection presented above for this particular limitation – for the purpose of examination, the Examiner will consider the “lift element” of Delaplane’s device as being the supplemental clips 60 as it forms a ramp-like structure with a first end flush to the proximal surface of neck plate 15, and an elevated second end, Figures 4-9); a grooved recess formed between the two pillars of the first and second eyelet to provide clearance for a strap attachable to the neck plate (see grooved recess formed in the openings 55 extending to the perimeter of the neck plate 15, Figure 4); however is silent on a cardanic mount disposed in the central region and attachable to the tracheostomy cannula; and a separate cushion element adapted to be placed on the distal surface of the neck plate.
In regards to the cardanic mount, Schwartz teaches an endotracheal tube holder (clip 25, Figure 7, Abstract) and further teaches a cardanic mount attachable to the endotracheal tube cannula (a suitable adapter 24 such as the BODAT swivel Y adapter may be used to connect to the endotracheal tube 16, the examiner is interpreting “cardanic mount” as meaning a swivel connection/mount, Figure 7 and Col. 6 lines 13-16).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Delaplane’s shield device by further including a cardanic mount and/or swivel mount attachable to the endotracheal tube, as providing such a swivel connection between the endotracheal tube and the tube holder allows for the physician and/or user to move the endotracheal tube in various directions as needed.
In regards to a separate cushion element, Russo teaches an endotracheal tube holder (Figure 1, Abstract) comprising a neck plate (plate 52, Figure 7) and further comprising a separate cushion element to be placed on the distal surface of the neck plate (foam core 59, Figure 7 and Col. 6 lines 6-9) wherein the separate cushion element is larger than the neck plate and configured to overlap and protrude beyond the perimeter of the neck pate (see Figure 7 showing the foam core 59 extending beyond the perimeter of the plate 52).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Delaplane’s shield device by including a separate cushion on the distal surface of the neck plate, as taught by Russo, as providing such as cushioning element between the neck plate and the user may provide the user with additional comfort while wearing the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Steeves et al. (US 8,704,650 B2) and Freed (5,398,679).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/ Examiner, Art Unit 3785
/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785
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