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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12 in the reply filed on 8/3/2026 is acknowledged.
Claim Objections
Claims 5 and 11 are objected to because of the following informalities:
Regarding claim 5, line 2, the recitation “second plastic skin layer” appears to be amended to recite “the second plastic skin layer” in order to refer to “second plastic skin layer” recited in claim 3.
Regarding claim 11, line 2, the recitation “the second adhesive” appears to be amended to recite “the second adhesive layer” in order to refer to the same limitation consistently in the entire claim.
Appropriate correction is required.
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 3-6 and 11 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.
Regarding claim 3, line 14, the recitation “a first adhesive layer” renders the claim indefinite because the claim is unclear if “a first adhesive layer” comprises “an adhesive surface” recited in claim 1 or additional. For examination purposes, examiner construes that “a first adhesive layer” comprises “an adhesive surface” recited in claim 1.
Claims 4-6 and 11 being dependent on claim 3 are also rejected.
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.
Claim 12 is 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. Claim 12 further limits the scope of “the vascular device” which is not positively claimed as a part of the claimed invention in claim 1. Therefore, claim 12 fails to further limit the scope of the claimed invention. 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
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.
Claims 1, 7, 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel (US 4,419,094).
Regarding claim 1, Patel teaches an attachment system 84 (figure 3) comprising:
a base adhesive attachment layer (entire element 86 without element 88) comprising an adhesive surface 100 suitable for attachment to mammalian skin; and
a polymeric hardgood article 88 (column 5, line 67-column 6, line 4, column 3, line 45 “plastic” refers to article being a polymeric hardgood, see “P” in figure 3 below for examiner’s interpretation when referring to element 88) for holding a vascular device 24, the polymeric hardgood article being attached to the base adhesive attachment layer, and the polymeric hardgood article defining a hole 96 (examiner is referring to a hole in element 84 that allows element 24 to pass through) that passes therethrough and a pathway 104 adjacent to the hole 96, the pathway 104 comprising:
a channel 104 extending to an edge surface (element 104 is located at an edge of element 88) of the polymeric hardgood article or
a series of posts (see “SP” in figure 8 below), wherein the series of posts define the pathway 104.
PNG
media_image1.png
242
788
media_image1.png
Greyscale
PNG
media_image2.png
330
242
media_image2.png
Greyscale
Regarding claim 7, Patel teaches wherein the pathway 104 comprises the channel 104, and wherein the channel 104 comprises a linear channel (element 104 is linear) or a curved channel.
Regarding claim 10, Patel teaches wherein the pathway 104 comprises the series of posts (see “SP” in figure 8 above) and wherein the series of posts comprises 2 or more posts (see figure 8).
Regarding claim 12, Patel teaches wherein the vascular device 24 comprises a PICC (peripherally Inserted Central venous Catheter), a CVC (Central Venous Catheter) or other catheter 24.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edward et al. (EP 1698368 A1).
Regarding claim 1, Edward teaches an attachment system (figure 1) comprising:
a base adhesive attachment layer 12 (figure 1) comprising an adhesive surface (paragraph 0038, lines 2-7) suitable for attachment to mammalian skin; and
a polymeric hardgood article 30 (paragraph 0045) for holding a vascular device 26, the polymeric hardgood article being attached to the base adhesive attachment layer 12, and the polymeric hardgood article defining hole 20 the passes therethrough and a pathway 32 adjacent to the hole 20, the pathway comprising:
a channel 32 extending to an edge surface (edge of element 20) of the polymeric hardgood article or
a series of posts (see “P” in figure 4 below), wherein the series of posts define the pathway.
PNG
media_image3.png
418
434
media_image3.png
Greyscale
Regarding claim 2, Edward teaches further comprising a cover film article (integrated structure formed by elements 22 and 24) comprising a cover film 22 and an adhesive layer (paragraph 0036, lines 9-11) in contact with the cover film 22 and the polymeric hardgood article 30 (paragraph 0039, lines 4-6).
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 4,419,094) in view of Ludwig (WO 2021064696 A1).
Regarding claim 3, Patel discloses the claimed invention substantially as claimed. Patel further discloses wherein the base adhesive attachment layer comprises a multi-layer removable article (see figure 3 where element 86 comprises at least 2 layers excluding element 88. Patel is silent regarding a multi-layer removable article being a multi-layer stretch removable article comprising: a multi-layer extensible backing substrate, wherein the multi-layer extensible backing substrate comprises at least three layers comprising: a first plastic skin layer; a core elastomeric layer; and a second plastic skin layer, wherein the core elastomeric layer is in contact with the first plastic skin layer and the second plastic skin layer; and a first adhesive layer in contact with the first plastic skin layer, wherein the first adhesive layer is suitable for attachment to mammalian skin; and a second adhesive layer in contact with the second plastic skin layer, wherein the second adhesive layer attaches the multi-layer stretch removable article to the polymeric hardgood article.
However, Ludwig teaches a design of a film backing for releasable securement comprising a multi-layer stretch removable article (figure 3) comprising: a multi-layer extensible backing substrate 100, wherein the multi-layer extensible backing substrate comprises at least three layers (see layers shown in figure 3, paragraph 0006, lines 3-5) comprising: a first plastic skin layer (paragraph 0006, lines 3-5, second of the two plastic layers opposite to element 114); a core elastomeric layer 112; and a second plastic skin layer 114, wherein the core elastomeric layer 112 is in contact with the first plastic skin layer (paragraph 0006, lines 3-5) and the second plastic skin layer 114; and a first adhesive layer 120 in contact with the first plastic skin layer, wherein the first adhesive layer 120 is suitable for attachment to mammalian skin; and a second adhesive layer 130 in contact with the second plastic skin layer 114, wherein the second adhesive layer attaches the multi-layer stretch removable article to the polymeric hardgood article (device shown in figure 4 attached to element 130) for the purpose of having an attachment layer that attaches securely to the patient’s skin and easily removes from the skin without trauma (paragraph 0003).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the base adhesive attachment layer of Patel to incorporate a multi-layer stretch removable article comprising: a multi-layer extensible backing substrate, wherein the multi-layer extensible backing substrate comprises at least three layers comprising: a first plastic skin layer; a core elastomeric layer; and a second plastic skin layer, wherein the core elastomeric layer is in contact with the first plastic skin layer and the second plastic skin layer; and a first adhesive layer in contact with the first plastic skin layer, wherein the first adhesive layer is suitable for attachment to mammalian skin; and a second adhesive layer in contact with the second plastic skin layer, wherein the second adhesive layer attaches the multi-layer stretch removable article to the polymeric hardgood article as taught by Ludwig for the purpose of having an attachment layer that attaches securely to the patient’s skin and easily removes from the skin without trauma (paragraph 0003).
Regarding claim 4, Patel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Patel is silent regarding wherein the core elastomeric layer comprises at least one of SEBS, SEPS, SIS, SBS, polyurethane, ethyl vinylacetate (EVA), ethyl methyl acrylate (EMA), ultra low linear density polyethylene (ULLDPE), or hydrogenated polypropylene, or combinations or blends thereof.
However, Ludwig teaches wherein the core elastomeric layer (paragraph 0032) comprises at least one of SEBS, SEPS, SIS, SBS, polyurethane, ethyl vinylacetate (EVA), ethyl methyl acrylate (EMA), ultra low linear density polyethylene (ULLDPE), or hydrogenated polypropylene, or combinations or blends thereof for the purpose of having an attachment layer that attaches securely to the patient’s skin and easily removes from the skin without trauma (paragraph 0003).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the base adhesive attachment layer of Patel to incorporate wherein the core elastomeric layer comprises at least one of SEBS, SEPS, SIS, SBS, polyurethane, ethyl vinylacetate (EVA), ethyl methyl acrylate (EMA), ultra low linear density polyethylene (ULLDPE), or hydrogenated polypropylene, or combinations or blends thereof as taught by Ludwig for the purpose of having an attachment layer that attaches securely to the patient’s skin and easily removes from the skin without trauma (paragraph 0003).
Regarding claim 5, Patel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Patel is silent regarding wherein the first plastic skin layer or second plastic skin layer comprises polypropylene, polyethylene, high density polyethylene (HDPE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), a polyurethane, EVA, or EMA, or combinations or blends thereof.
However, Ludwig teaches wherein the first plastic skin layer or second plastic skin layer comprises polypropylene, polyethylene, high density polyethylene (HDPE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), a polyurethane, EVA, or EMA, or combinations or blends thereof (paragraph 0033) for the purpose of having an attachment layer that attaches securely to the patient’s skin and easily removes from the skin without trauma (paragraph 0003).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the base adhesive attachment layer of Patel to incorporate wherein the first plastic skin layer or second plastic skin layer comprises polypropylene, polyethylene, high density polyethylene (HDPE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), a polyurethane, EVA, or EMA, or combinations or blends thereof for the purpose of having an attachment layer that attaches securely to the patient’s skin and easily removes from the skin without trauma (paragraph 0003).
Regarding claim 6, Patel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Patel is silent regarding further comprising one or more tabs at a perimeter portion of the multi-layer extensible backing substrate.
However, Ludwig teaches further comprising one or more tabs 140 at a perimeter portion of the multi-layer extensible backing substrate 100 for the purpose of providing means to stretch the backing substrate in a lateral length (paragraph 0030, lines 5-7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the base adhesive attachment layer of Patel to incorporate further comprising one or more tabs at a perimeter portion of the multi-layer extensible backing substrate as taught by Ludwig for the purpose of providing means to stretch the backing substrate in a lateral length (paragraph 0030, lines 5-7).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 4,419,094) in view of Choi (KR 101822793 B1, English translation is being used to refer to the specification).
Regarding claim 8, Patel discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Patel is silent regarding wherein the channel comprises the curved channel, and wherein the curved channel comprises an S-shaped curved channel.
However, Choi teaches a design of a medical tube fixing assembly (figure 3) wherein the channel 210 comprises the curved channel 210, and wherein the curved channel comprises an S-shaped curved channel 210 for the purpose of using an alternative shape for securely holding the tube in a stable manner (page 7, lines 13-15).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the shape of the channel of Patel to incorporate wherein the channel comprises the curved channel, and wherein the curved channel comprises an S-shaped curved channel as taught by Choi for the purpose of using an alternative shape for securely holding the tube in a stable manner (page 7, lines 13-15).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 4,419,094) in view of Mulrooney (US 2018/0214672 A1).
Regarding claim 9, Patel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Patel further discloses wherein the pathway 104 comprises the series of posts (see “SP” in figure 8 above), and wherein the series of posts form a tortuous pathway 104 but is silent regarding comprise a material with a coefficient of friction of greater than 0.5.
However, Mulrooney teaches a design of a catheter fixing clip (figure 1) comprising a material with a coefficient of friction of greater than 0.5 (paragraph 0026, polypropylene and Santoprene would have coefficient of friction of greater than 0.5 depending on the chosen counter surface) for the purpose of preventing movement of the tube with respect to the device (paragraph 0026).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of the series of posts of Patel to incorporate a material with a coefficient of friction of greater than 0.5 as taught by Mulrooney for the purpose of preventing movement of the tube with respect to the device (paragraph 0026).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 4,419,094) in view of Ludwig (WO 2021064696 A1) and further in view of Khan et al. (US 5,686,096).
Regarding claim 11, Patel/Ludwig (hereinafter referred as “modified Patel”) discloses the claimed invention substantially as claimed, as set forth above in claim 3. Modified Patel is silent regarding wherein at least one of the first adhesive layer or the second adhesive comprises an anti-microbial adhesive layer.
However, Khan teaches a design of a medical device for protecting a catheter penetration site comprising an anti-microbial adhesive layer (column 3, lines 15-18) for the purpose of creating a zone of microbial inhibition around the catheter penetration site (see abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first or second adhesive layer of modified Patel to incorporate an anti-microbial adhesive layer as taught by Khan for the purpose of creating a zone of microbial inhibition around the catheter penetration site (see abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Patenaude (US 2019/0380879 A1): discloses a design of a multi-layered adhesive substrate comprising plurality of layers to secure medical dressing and devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. 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.
/NILAY J SHAH/Primary Examiner, Art Unit 3783
Prosecution Insights