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 filed on 1/28/2026 has been considered. See the attached PTO 1449 form.
Status of Action/Claims
Receipt of Remarks/Amendments filed on 1/28/2026 is acknowledged. Claims 1-8 and 10-16 are currently pending and presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Maintained Claim(s) Objection(s)/Rejection(s)
Claim Rejections - 35 USC § 103
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 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 1-3, 6, 8, and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Patenaude et al. (US 2017/0014130A1; Jan. 19, 2017) in view of Tegaderm (3M Tegaderm IV advanced securement dressing, 3/2014), 3M (3M Science Applied to Life, Proper medical tape application and removal, 2017) and Inzirillo et al. (General Thoracic and Cardiovascular Surgery; November 2012).
Patenaude throughout the reference teaches article useful for atraumatic closure of a wound and/or securement of medical devices (Abstract). Patenaude teaches the article comprises a substrate having opposing first and second major surfaces and an adhesive adjacent the second major surface (claim 1). Patenaude discloses the term “adjacent” means adjoining, abutting (touching) so as to have a common interface/surface or border. This reads on the adhesive integrated with the scaffolding. Patenaude teaches the substrate comprises woven or nonwoven web of cotton, silk (animal derived, i.e., silkworm), or hemp (claim 4). Thus, Patenaude teaches animal-derived bioprotein (i.e., silk) scaffolding formed of bioprotein fibers woven together. Further, the reference teaches only 2 choices, woven or non-woven animal derived bioprotein and thus one of ordinary skill in the art would have immediately envisioned utilizing either. Patenaude teaches a method for atraumatic securement of a medical device to a patient’s tissue using the article, wherein, a medical device is inserted into the patient and the article substrate is adhered to the patient’s tissue next to where the device has been inserted into the patient (para 0011; figure 7a and 7b). Figure 7a of Patenaude discloses an IV tube inserted in a subject’s arm that is secured to the patient using the article system and figure 7b discloses a patient that has been intubated, wherein the tube is secured to the patient using the system. Patenaude discloses the term “atraumatic” is used to denote wound care system involves no penetration or piercing of the subject’s tissue, for example with a needle, staple or other conventional suturing or wound closure technique (para 0029), which reads on claim 8.
The teachings of Patenaude have been set forth above.
Patenaude does not expressly exemplify an article for securement of medical devices comprises a pressure sensitive adhesive and wherein the adhesive is waterproof pressure sensitive adhesive. However, Patenaude teaches suitable adhesives include pressure sensitive adhesives and exemplary adhesives for use in the invention include acrylics (para 0034). As disclosed in paragraph 0032 of instant specification, acrylic based adhesive have waterproof feature, and therefore, acrylic adhesive taught in Patenaude read on waterproof pressure sensitive adhesive recited in claim 3.
While Patenaude teaches the inventive article/substrate can be cross-sectionally torn or cut into one or more pieces that conform to the shape of the wound opening to be closed (para 0029), Patenaude does not expressly teach the limitations recited in claims 10-13 and 16 of the instant application. However, Tegaderm helps cure these deficiencies.
Tegaderm teaches application and removal techniques for dressing which are used to secure medical devices (e.g., IV catheters). Tegaderm discloses dressings with slit forming a split region comprising two tails and the dressing comprising a non-split region. In the application technique, Tegaderm discloses the non-split region adhered onto the patient on one side of the IV catheter and the tail region on the opposite side of the catheter. The application and removal technique with the dressing also provide a barrier to external contaminants. (see: Page 2; Page 3, 1683 Application Technique).
Patenaude also does not expressly teach utilizing the adhesive integrated with the scaffold to secure the medical apparatus to the patient, wrapping a portion and specifically the tails of the dressing/scaffold around the medical apparatus and wherein the wrapping is in a roman sandal manner. However, 3M and Inzirillo help cure this deficiency.
3M discloses techniques for applying and removing medical tape/adhesive products to help reduce the risk of medical adhesive related skin injury and increase consistency of care. 3M discloses a method of securing medical tube wherein a portion of the medical adhesive is attached to the skin and another portion of the medical adhesive is wrapped around the medical tube in roman sandal method. (see: Securing Tubing: Chevron Technique; Entire Document).
Inzirillo teaches roman sandal method for securing chest drains to the skin. Inzirillo teaches the roman sandal method for securing chest drain to the skin is elegant, effective, quick application and removal of the drainage and excellent cosmetic results (Abstract; Introduction).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to include a pressure sensitive adhesive and particularly acrylic adhesive (waterproof adhesive) as the adhesive in the wound dressing article taught by Patenaude. As discussed supra, Patenaude already teaches including an adhesive in the article and it would have been obvious to one of ordinary skill in the art to substitute the adhesives disclosed in the Patenaude reference as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Patenaude to incorporate the teachings of Tegaderm and have the wound dressing article of Patenaude form slit and apply to the wound site per the teachings of Tegaderm. As discussed supra, Patenaude teaches the inventive article/substrate can be cross-sectionally torn or cut into one or more pieces that conform to the shape of the wound opening to be closed. Tegaderm provides particular techniques for securing a medical apparatus device which provide a barrier to external contaminants and it would have been obvious to one skilled in the art to look towards the teachings of Tegaderm when using the article of Patenaude for application on to a patient for securement of a medical device such as a catheter. Particularly, Tegaderm discloses the method of claims 10-13 and 16 for medical apparatus securement was known in the art and one skilled in the art would have been motivated to look towards the teachings of Tegaderm when using the article of Patenaude for securing medical device on a patient.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified Patenaude to incorporate the teachings of 3M and Inzirillo and wrap the tails of the wound dressing article around the medical apparatus in a roman sandal manner as suggested by 3M and Inzirillo. One would have been motivated to do so because, as discussed supra, 3M discloses techniques for applying and removing medical adhesive products to help reduce the risk of medical adhesive related skin injury and increase consistency of care. 3M discloses a method of securing medical tube wherein a portion of the medical adhesive is attached to the skin and another portion of the medical adhesive is wrapped around the medical tube in roman sandal method. Further, as discussed supra, Inzirillo teaches the roman sandal method for securing chest drain to the skin is elegant, effective, provides quick application and removal of the drainage and has excellent cosmetic results. Inzirillo teaches that the claimed roman sandal manner was known in the art and further provides motivation to use this method to secure medical apparatus. In addition, as discussed supra, Patenaude teaches an adhesive integrated to the surface of the scaffold wound dressing and it would have been obvious to one skilled in the art to affix the wound dressing to the medical apparatus utilizing the adhesive when wrapping the wound dressing around the medical apparatus in a roman sandal manner because the adhesive would be able to stick to the medical apparatus and secure the medical apparatus in place.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Patenaude et al. (US 2017/0014130A1; Jan. 19, 2017) in view of Tegaderm (3M Tegaderm IV advanced securement dressing, 1/25/2021), 3M (3M Science Applied to Life, Proper medical tape application and removal, 2017) and Inzirillo et al. (General Thoracic and Cardiovascular Surgery; November 2012) as applied to claims 1-3, 6, 8, 10-13, and 14-16 above, and further in view of Barkam (WO 2019/040850A1; Feb. 28, 2019) and Lowenhielm (US 2013/0101633 A1; Apr. 25, 2013).
The teachings of Patenaude, Tegaderm, 3M and Inzirillo have been set forth above.
Patenaude teaches additional components such as antibiotic ointment can be included in the kit comprising the wound dressing article (para 0043). However, Patenaude, Tegaderm, 3M and Inzirillo do not teach wherein an antimicrobial agent is integrated with the scaffolding and wherein the antimicrobial agent comprises ammonium or silver. Barkam and Lowenhielm help cure this deficiency.
Barkam also teaches silk derived wound dressings. Barkam teaches the silk fibroin article comprise at least one active agent such as antibiotic or antimicrobial compound and wherein the active agent is dispersed within silk fibroin (Abstract; Page 17, 2nd paragraph).
Lowenhielm also teaches wound dressings and the reference teaches silver incorporated in wound dressings provides antimicrobial activity for wounds (abstract; summary of invention; para 0005-0006).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified the combined teachings of Patenaude, Tegaderm, 3M and Inzirillo, to incorporate the teachings of Barkam and Lowenhielm and include antimicrobial agent such as silver into the wound dressing article of Patenaude. As discussed supra, Patenaude already teaches additional components such as antibiotic ointment can included in the kit comprising the wound dressing article. Barkam teaches similar wound dressing articles and such articles having antibiotics integrated within the article. One would have been motivated to incorporate the teachings of Barkam into Patenaude’s wound article and incorporate the antibiotics into the article because such method would remove an extra step of separately applying antibiotic ointment and would quicken the process of application of the wound dressing article onto the patient. Further, one would have been motivated to use silver as the antimicrobial because, as discussed supra, Lowenhielm teaches silver providing antimicrobial effect when used in wound dressings.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Patenaude et al. (US 2017/0014130A1; Jan. 19, 2017) in view of Tegaderm (3M Tegaderm IV advanced securement dressing, 1/25/2021), 3M (3M Science Applied to Life, Proper medical tape application and removal, 2017) and Inzirillo et al. (General Thoracic and Cardiovascular Surgery; November 2012) as applied to claims 1-3, 6, 8, 10-13, and 14-16 above, and further in view of Ovington (US 2012/0059300 A1; Mar. 8, 2012).
The teachings of Patenaude, Tegaderm, 3M and Inzirillo have been set forth above.
While Patenaude teaches the method suitable for securing various devices to a patient include tracheal tubes, nasogastric tubes, ventilators, drains, catheters, IVs, central lines, arterial lines, and the like, the combination of references cited above do not teach the medical apparatus comprises a lead for an electrical device. However, this deficiency is cured by Ovington.
Ovington throughout the reference teaches antimicrobial dressings and percutaneous device securement. Ovington teaches percutaneous medical devices for which the dressings can used include catheters and pacemaker leads (para 0024).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified the combined teachings of Patenaude, Tegaderm, 3M and Inzirillo, to incorporate the teachings of Ovington and use the wound dressing article of Patenaude to secure pacemaker leads. As discussed supra, Patenaude teaches the method is suitable for securing various devices including catheters and Ovington teaches using dressings for securing catheters and pacemaker leads. Therefore, it would have been obvious to one skilled in the art to use the dressing article of Patenaude to secure pacemaker leads in place of catheters because the combination of Patenaude and Ovington suggest the two medical apparatus’s can be substituted with each other.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant argued Patenaude teaches away from the method disclosed in 3M and one would not modify Patenaude’s method to incorporate teachings of 3M. Applicant argued Patenaude teaches the adhesive substrate is affixed to the patient while the medical apparatus is secured by a thread or string. It’s argued that Patenaude teaches advantage of the invention is that there is little localized trauma to the patient to secure the device which can be easily removed be cutting or removing the thread. Patenaude teaches away from any modification that would require the removal of adhesive substrate.
In response, firstly the examiner argues that while Patenaude discloses an advantage of the dressing is that there is little localized trauma to the patient to secure the device which can be easily removed be cutting or removing the thread, this does not suggest that Patenaude teaches away from other methods of securing a device, which are not taught by Patenaude. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123. 3M recognizes that applying and removing medical adhesive products can cause trauma to skin (Medical Adhesive-Related Skin Injury) and 3M teaches the techniques for applying and removing medical adhesive products can help reduce the risk of Medical Adhesive-Related Skin Injury (MARSI) and increase consistency of care. Patenaude teaches the dressing should cause little trauma to the patient to secure and remove the device and adhesive and 3M teaches a technique which reduces trauma to the skin. Thus, the method of 3M does not appear to go against the teachings of Patenaude.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALI SAEED whose telephone number is (571)272-2371. The examiner can normally be reached M-F 8-5 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, SUE X LIU can be reached at 5712725539. 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.
/A.S/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616