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 .
Claim Objections
Claims 2 and 5-8 are objected to because of the following informalities:
In claims 2 and 5-8, remove “wherein when.”
Appropriate correction is required.
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.
Claims 1, 9, 10, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Scherich et al. (US 20220218955 A1) in view of Furukawa (US 20050038358 A1) [Prior art references found within the IDS filed on 2/5/2024].
Regarding Claim 1, Scherich discloses an instrument delivery device for advancement of an instrument into an intravenous catheter assembly (Paragraph 0037, a vascular access instrument configured to advance distally through the catheter assembly and into the vasculature of the patient),
the instrument delivery device (instrument advancement device – element 10) comprising: a housing (extension tube – element 14) comprising a proximal end, a distal end, and a sidewall therebetween defining an interior (Figures 1, 3-4), the housing comprising a connecter (distal adaptor – element 18) at the distal end thereof for reversibly connecting the instrument delivery device to the intravenous catheter assembly (Paragraph 0038; Figure 6A);
a displaceable instrument (instrument – element 16) is received within the housing interior and includes a proximal end and a distal end (paragraphs 0035-0038), the instrument comprising one of a guidewire and a probe (Paragraphs 0035-0038; [Examiner’s note, the claim limitation discloses the instrument comprises one of the two elements that are listed; Scherick teaches the instrument to include a guidewire.]), wherein the instrument is advanceable from a first, proximal position in which the distal end does not extend beyond a distal end of a catheter of the intravenous catheter assembly to a second, distal position in which the distal end extends beyond the distal end of the catheter of the intravenous catheter assembly (Paragraph 0066; Figure 8D).
Scherich is silent in disclosing the distal end of the instrument includes an antithrombogenic material, the antithrombogenic material comprising an antithrombogenic coating applied to at least part of the instrument or an antithrombogenic composition from which at least part of the instrument is formed.
Furukawa teaches the distal end of the instrument includes an antithrombogenic material, the antithrombogenic material comprising an antithrombogenic coating applied to at least part of the instrument or an antithrombogenic composition from which at least part of the instrument is formed (Furukawa | Paragraphs 0134-0135; [Examiner’s note, anti-thrombus coating material and antithrombogenic material are synonymous to one another.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich to incorporate the teachings of the antithrombogenic material from Furukawa because the antithrombogenic material on the instrument allows smooth insertion into tissue or blood vessels without getting stuck (Furukawa | Paragraph 0134).
Regarding Claim 9, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Scherick teaches the instrument comprises a guidewire including: a core wire; and a coil member wrapped around the core wire, at a distal end of the core wire (Scherich | Paragraph 0036).
Scherick is silent in teaching the antithrombogenic material is provided in or on the distal end of the core wire and the coil member.
Furukawa teaches the antithrombogenic material (Furukawa | lubricating coating – element 12) is provided in or on the distal end (Furukawa | tip end portion – element 9) of the core wire and the coil member (Furukawa | coil and resin - element 11; Paragraph 0134). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich to incorporate the teachings of the antithrombogenic material from Furukawa because the antithrombogenic material on the instrument allows smooth insertion into tissue or blood vessels without getting stuck (Furukawa | Paragraph 0134).
Regarding Claim 10, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Scherich teaches the instrument comprises a coreless coiled guidewire (Scherich | Paragraph 0036; [Examiner’s note, a spring is a coreless coiled guidewire.]). Scherich is silent in teaching the antithrombogenic material is provided in or on a distal end of the coil.
Furukawa teaches the antithrombogenic material (Furukawa | lubricating coating – element 12) is provided in or on the distal end (Furukawa | tip end portion – element 9) of the coil (Furukawa | coil and resin - element 11; Paragraph 0134). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich to incorporate the teachings of the antithrombogenic material from Furukawa because the antithrombogenic material on the instrument allows smooth insertion into tissue or blood vessels without getting stuck (Furukawa | Paragraph 0134).
Regarding Claim 15, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Scherich is silent in teaching the antithrombogenic material is provided in or on an entire length of the instrument. Furukawa teaches the antithrombogenic material is provided in or on an entire length of the instrument (Furukawa | Paragraph 0134). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich to incorporate the teachings of the antithrombogenic material from Furukawa because the antithrombogenic material on the instrument allows smooth insertion into tissue or blood vessels without getting stuck (Furukawa | Paragraph 0134).
Regarding Claim 16, Scherich in view of Furukawa teaches the instrument delivery device of claim 1, further comprising an advancement member (Scherich | housing – element 12) positioned on the housing (extension tubing – element 14) and moveable relative thereto Scherich | Paragraph 0043), the advancement member (Scherich | housing – element 12) coupled to the instrument (Scherich | instrument – element 16) such that movement of the advancement member causes a corresponding movement of the instrument (Scherich | Paragraph 0043).
Regarding Claim 17, Scherich in view of Furukawa teaches the instrument delivery device of claim 1, wherein the connector (Scherich | distal adaptor – element 18) comprises a plurality of arms configured to engage a needleless connector (Scherich | Paragraph 0047).
Regarding Claim 18, Scherich in view of Furukawa teaches the instrument delivery device of claim 1, wherein the connector (Scherich | distal adaptor – element 18) comprises a blunted cannula (Scherich | cannula – element 30) configured to pierce a septum of the needleless connector (Scherich | Paragraphs 0046-0047, 0058).
Regarding Claim 19, Scherich discloses a catheter system (Paragraph 0006), comprising:
a catheter assembly (Paragraph 0008) comprising: a catheter adapter, comprising a distal end, a proximal end, a lumen extending between the distal end and the proximal end (Paragraph 0038); and a catheter secured to the catheter adapter and extending distally from the catheter adapter (Paragraph 0038), wherein the catheter comprises a distal end and a proximal end (Paragraph 0038); and
the instrument delivery device (instrument advancement device – element 10) comprising: a housing (extension tube – element 14) comprising a proximal end, a distal end, and a sidewall therebetween defining an interior (Figures 1, 3-4), the housing comprising a connecter (distal adaptor – element 18) at the distal end thereof for reversibly connecting the instrument delivery device to the intravenous catheter assembly (Paragraph 0038; Figure 6A);
a displaceable instrument (instrument – element 16) is received within the housing interior and includes a proximal end and a distal end (paragraphs 0035-0038), the instrument comprising one of a guidewire and a probe (Paragraphs 0035-0038; [Examiner’s note, the claim limitation discloses the instrument comprises one of the two elements that are listed; Scherick teaches the instrument to include a guidewire.]), wherein the instrument is advanceable from a first, proximal position in which the distal end does not extend beyond a distal end of a catheter of the intravenous catheter assembly to a second, distal position in which the distal end extends beyond the distal end of the catheter of the intravenous catheter assembly (Paragraph 0066; Figure 8D).
Scherich is silent in disclosing the distal end of the instrument includes an antithrombogenic material, the antithrombogenic material comprising an antithrombogenic coating applied to at least part of the instrument or an antithrombogenic composition from which at least part of the instrument is formed.
Furukawa teaches the distal end of the instrument includes an antithrombogenic material, the antithrombogenic material comprising an antithrombogenic coating applied to at least part of the instrument or an antithrombogenic composition from which at least part of the instrument is formed (Furukawa | Paragraphs 0134-0135; [Examiner’s note, anti-thrombus coating material and antithrombogenic material are synonymous to one another.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich to incorporate the teachings of the antithrombogenic material from Furukawa because the antithrombogenic material on the instrument allows smooth insertion into tissue or blood vessels without getting stuck (Furukawa | Paragraph 0134).
Regarding Claim 20, Scherich in view of Furukawa teaches the system of claim 19, wherein the catheter assembly comprises a needleless access connector (Scherich | Paragraph 0039), and wherein the distal end of the instrument delivery device housing is reversibly coupleable to the needleless access connector (Scherich | Paragraph 0039; [Examiner’s note, the distal adaptor (18) is capable of being reversibly coupled to the needleless access connector.]).
Claims 2-5 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Scherich in view of Furukawa and McGowan et al. (US 20170182295 A1) [Prior art references found within the IDS filed on 2/5/2024].
Regarding Claim 2, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Though Scherich in view of Furukawa teaches of the antithrombogenic material (Furukawa | Paragraph 0134), it is silent in teaching the antithrombogenic material comprises the antithrombogenic coating, the antithrombogenic coating includes one or more of a hydrophilic material, heparin, a heparin mimetic, albumin, a hydrophilic lubricant, a fluorinated lubricant, and a triblock polymer.
McGowan teaches the antithrombogenic material comprises the antithrombogenic coating (McGowan | Paragraph 0064), the antithrombogenic coating includes one or more of a hydrophilic material, heparin (McGown | Paragraph 0066; [Examiner’s note, heparin is a hydrophilic material.]), a heparin mimetic, albumin, a hydrophilic lubricant, a fluorinated lubricant, and a triblock polymer [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of antithrombogenic coating from McGowan because the antithrombogenic coating allows for the reduction of blood coagulation or thrombus formation (McGowan | Paragraph 0063).
Regarding Claim 3, Scherich in view of Furukawa and McGowan teaches the instrument delivery device of claim 2, wherein the triblock polymer comprises poly(ethylene oxide) (PEO) and poly(propylene oxide) (PPO) [Examiner’s note, claim 2 recites a list of antithrombogenic coatings. McGowan teaches of the hydrophilic material and heparin being the antithrombogenic coating. Therefore, the triblock polymer is optional language in claim 2].
-- Regarding Claim 4, Scherich in view of Furukawa and McGowan teaches the instrument delivery device of claim 3, wherein the triblock polymer is a PEO-PPO-PEO polymer [Examiner’s note, claim 2 recites a list of antithrombogenic coatings. McGowan teaches of the hydrophilic material and heparin being the antithrombogenic coating. Therefore, the triblock polymer is optional language in claim 2].
Regarding Claim 5, Scherich in view of Furukawa and McGowan teaches the instrument delivery device of claim 2. Scherich in view of Furukawa are silent in teaching the antithrombogenic material comprises the antithrombogenic coating, the antithrombogenic coating includes poly(ethylene glycol) or poly(ethylene oxide), one or more sulfate and/or sulfonate groups, and heparin.
McGowan teaches the antithrombogenic material comprises the antithrombogenic coating (McGowan | Paragraph 0064), the antithrombogenic coating includes poly(ethylene glycol) or poly(ethylene oxide), one or more sulfate and/or sulfonate groups (McGowan | Paragraph 0065), and heparin (McGowan | Paragraph 0066). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of antithrombogenic coating from McGowan because the antithrombogenic coating allows for the reduction of blood coagulation or thrombus formation (McGowan | Paragraph 0063).
Regarding Claim 11, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Scherich in view of Furukawa is silent in teaching the instrument comprises a probe including: a support wire; and a sensor positioned at a distal end of the support wire configured to measure one or more physiological parameters; wherein the antithrombogenic material is provided in or on the distal end of the support wire and applied to the sensor as an antithrombogenic coating.
McGowan teaches the instrument comprises a probe (McGowan | blood pressure sensing guidewire – element 10) including: a support wire (McGowan | tubular member/shaft – element 12); and a sensor (McGowan | blood pressure sensor – element 20) positioned at a distal end of the support wire configured to measure one or more physiological parameters (McGowan | Figure 1; Paragraph 0058); wherein the antithrombogenic material is provided in or on the distal end of the support wire (McGowan | Figure 1; Paragraph 0064) and applied to the sensor as an antithrombogenic coating (McGowan | Paragraphs 0079-0080). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of the probe from McGowan because the probe allows for continuous monitoring of the user (McGown | Paragraph 0054) and the antithrombogenic coating within the probe allows for the reduction of blood coagulation or thrombus formation (McGowan | Paragraph 0063).
Regarding Claim 12, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Scherich in view of Furukawa is silent in teaching the instrument comprises a probe including: an outer tubing; an optical fiber contained within the outer tubing; and a sensor coupled to a distal end of the optical fiber, at a distal tip of the outer tubing, the sensor configured to measure one or more physiological parameters; wherein the antithrombogenic material is provided in or on the distal tip of the outer tubing and applied to the sensor as an antithrombogenic coating.
McGowan teaches the instrument comprises a probe (McGowan | blood pressure sensing guidewire – element 10) including: an outer tubing (McGowan | tubular member/shaft – element 12); an optical fiber (McGowan | optical fiber cable – element 24) contained within the outer tubing (McGowan | Paragraph 0059); and a sensor (McGowan | pressure sensor – element 20) coupled to a distal end of the optical fiber (McGowan | Paragraph 0059), at a distal tip of the outer tubing (McGowan | Figure 1), the sensor configured to measure one or more physiological parameters (McGowan | Figure 1; Paragraph 0058); wherein the antithrombogenic material is provided in or on the distal tip of the outer tubing (McGowan | Figure 1; Paragraph 0064) and applied to the sensor as an antithrombogenic coating (McGowan | Paragraphs 0079-0080). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of the probe from McGowan because the probe allows for continuous monitoring of the user (McGown | Paragraph 0054) and the antithrombogenic coating within the probe allows for the reduction of blood coagulation or thrombus formation (McGowan | Paragraph 0063).
Regarding Claim 13, Scherich in view of Furukawa and McGowan teaches the instrument delivery device claim 11. Scherich in view of Furukawa is silent in teaching the sensor is configured to acquire measurements of the one or more physiological parameters over a continuous period of time.
McGowan teaches the sensor (McGowan | pressure sensor – element 20) is configured to acquire measurements of the one or more physiological parameters over a continuous period of time (McGowan | Paragraphs 0054, 0061, 0062). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of the probe from McGowan because the sensor, within the probe, allows for continuous monitoring of the user like blood pressure (McGown | Paragraph 0054).
Regarding Claim 14, Scherich in view of Furukawa and McGowan teaches the instrument delivery device of claim 13. Scherich in view of Furukawa is silent in teaching application of the antithrombogenic coating to the sensor prevents fouling of the sensor.
McGowan teaches application of the antithrombogenic coating to the sensor prevents fouling of the sensor (McGowan | Paragraphs 0080-0081; [Examiner’s note, the anti-thrombogenic coating, hydrophilic silicon coating, around the sensor prevents fouling of the sensor.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of the application of the antithrombogenic coating to the sensor prevents fouling of the sensor from McGowan because the antithrombogenic coating prevents interference with the sensing capability of pressure sensor (McGown | Paragraph 0063).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Scherich in view of Furukawa and Harnek et al. (US 20030004565 A1) [Prior art reference found within the IDS filed on 2/5/2024].
Regarding Claim 6, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Scherich in view of Furukawa is silent in teaching the antithrombogenic material comprises the antithrombogenic coating, the antithrombogenic coating includes any of phosphorylcholine and poly(2-methoxyethyl acrylate).
Harnek teaches the antithrombogenic material comprises the antithrombogenic coating, the antithrombogenic coating includes any of phosphorylcholine (Harnek | Paragraph 0041) and poly(2-methoxyethyl acrylate) [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of the antithrombogenic coating from Harnek because the antithrombogenic coating dissolves any biological agents when the device is inserted into the user (Harnek | Paragraph 0041).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Scherich in view of Furukawa and Takaoka et al. (JP 2004216130 A) [Prior art reference found within the IDS filed on 2/5/2024].
Regarding Claim 7, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Scherich in view of Furukawa is silent in teaching the antithrombogenic material comprises the antithrombogenic composition, the antithrombogenic composition includes fluoro or fluorine-containing functional moieties.
Takaoka teaches the antithrombogenic material comprises the antithrombogenic composition, the antithrombogenic composition includes fluoro (Takaoka | Pages 9-10 on paragraphs (9) and (10)) or fluorine-containing functional moieties [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of the antithrombogenic coating from Takaoka because the antithrombogenic coating reduces frictional resistance and improving the ease of insertion into the user (Takaoka | Pages 18-19 on Paragraph 0024).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Scherich in view of Furukawa and Modak et al. (US 20050192547 A1) [Prior art reference found within the IDS filed on 2/5/2024].
Regarding Claim 8, Scherich in view of Furukawa teaches the instrument delivery device of claim 1. Scherich in view of Furukawa is silent in teaching the antithrombogenic material comprises the antithrombogenic composition, the antithrombogenic composition includes an antibiotic or antiseptic comprising minocycline-rifampicin or chlorhexidine-silver sulphadiazine.
Modak teaches the antithrombogenic material comprises the antithrombogenic composition, the antithrombogenic composition includes an antibiotic or antiseptic comprising minocycline-rifampicin or chlorhexidine-silver sulphadiazine (Modak | Paragraph 0045). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the instrument delivery device of Scherich in view of Furukawa to incorporate the teachings of the antithrombogenic coating from Modak because the antiseptic compounds decrease the likelihood of an infection (Modak | Paragraph 0002).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Friday: 9AM to 5PM 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, Robert Chen can be reached at 571-272-3672. 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.
/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
Prosecution Insights