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 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 18 is 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 18 recites “a reinforced slit”. It is unclear whether “a reinforced slit” in lines 1-2 of claim 18 refers to “a slit” in line 3 of claim 11 or an additional slit which is reinforced. For purpose of examination, the recitation of “a reinforced slit” in lines 1-2 of claim 11 will be interpreted as the slit of claim 11 being a reinforced slit.
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, 6, 11, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ariely et al (US 20230035969 A1).
Regarding claim 1, Ariely et al disclose a patch (300, fig 6) for providing access to medical tubes and lines (500) through clothing (100), comprising: a panel (320) made of a fabric material (para 0061); a slit (370) formed in the panel (fig 6), through which a medical tube or line (500, fig 14) can pass (para 0064); and an adhesive backing (330) for attaching the patch to clothing (para 0061, examiner notes: adhesive layer may be adhered to the interior or exterior of the medical garment and see claim 12).
Regarding claim 6, Ariely et al disclose a method (300) for providing access to medical tubes and lines (500) through clothing (100), comprising: providing a patch (300) comprising a panel (320) made of a fabric material (para 0061), a slit (370) formed in the panel (fig 6), and an adhesive backing (330); and applying the patch to a clothing item such that the slit formed in the panel made of the fabric material (fig 14, para 0061), wherein the fabric material aligns with a desired access point for a medical tube or line (fig 14, para 0064 and claim 12).
Regarding claim 11, Ariely et al disclose a garment (100) with an integrated access patch (300), comprising: a fabric panel (para 0037) configured to be worn by a user (0040); an access patch (300) affixed to the fabric panel (claim 12, fig 14), the access patch comprising a fabric material (para 0061), a slit (370) formed in the fabric material (fig 6), and an adhesive backing (330) for attaching the access patch to the fabric panel (para 0064 and claim 12); and wherein the slit is configured to allow passage of a medical tube or line through the fabric panel (para 0064, fig 14).
Regarding claim 17, Ariely et al disclose the garment of claim 11, wherein the access patch further comprises a moisture-resistant or antimicrobial coating to prevent bacterial buildup and enhance hygiene (para 0059 and 0061, lines 17-21).
Regarding claim 19, Ariely et al disclose the garment of claim 11, wherein the access patch is attached using a removable fastening mechanism, selected from the group consisting of hook-and-loop fasteners, magnetic strips, snap buttons, or adhesive strips, allowing for repositioning or reuse across multiple garments (adhesive strip/adhesive backing 330, para 0061-63, examiner notes: 330 provides a detachable connection with the medical garment 100, thus it can be used across multiple garment).
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.
Claims 2, 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ariely et al (US 20230035969 A1) and further in view of Rock (US 20130183495 A1).
Regarding claim 2, Ariely et al disclose the limitations of claim 1 but fail to teach said patch, wherein the fabric material is a woven polyester rayon blend twill.
However, Rock discloses antibacterial fabrics for use in environments such as healthcare environments in which articles with antimicrobial properties are desirable (para 0002) wherein the fabric material is a woven polyester rayon blend twill (para 0042 and 0048).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fabric material of Ariely et al and incorporate the teachings of Rock to have said fabric material be a woven polyester rayon blend twill. This would provide the benefit of having antimicrobial fabrics which have antimicrobial properties that are desirable in healthcare settings (para 0002 and 0027).
Regarding claim 7, Ariely et al disclose the limitations of claim 6 but fail to teach wherein the fabric material is a woven polyester rayon blend twill.
However, Rock discloses antibacterial fabrics for use in environments such as healthcare environments in which articles with antimicrobial properties are desirable (para 0002) wherein the fabric material is a woven polyester rayon blend twill (para 0042 and 0048).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fabric material of Ariely et al and incorporate the teachings of Rock to have said fabric material be a woven polyester rayon blend twill. This would provide the benefit of having antimicrobial fabrics which have antimicrobial properties that are desirable in healthcare settings (para 0002 and 0027).
Regarding claim 12, Ariely et al disclose the limitations of claim 11 but fail to teach wherein the fabric material is a woven polyester rayon blend twill.
However, Rock discloses antibacterial fabrics for use in environments such as healthcare environments in which articles with antimicrobial properties are desirable (para 0002) wherein the fabric material is a woven polyester rayon blend twill (para 0042 and 0048).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fabric material of Ariely et al and incorporate the teachings of Rock to have said fabric material be a woven polyester rayon blend twill. This would provide the benefit of having antimicrobial fabrics which have antimicrobial properties that are desirable in healthcare settings (para 0002 and 0027).
Claims 3, 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ariely et al (US 20230035969 A1) and further in view of Griswold et al (US 20080114098 A1).
Regarding claim 3, Ariely et al disclose the limitations of claim 1 but fail to teach said patch, wherein the adhesive backing comprises a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate.
However, Griswold et al disclose a backing material comprising a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate (see para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the adhesive backing of Ariely et al and incorporate the teachings of Griswold et al to have the adhesive backing comprises a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate. This would provide the benefit of having pressure-sensitive adhesives for easy repositioning and resistant to the migration of liquid or drug flowing through the tubes (para 0015 and 0056).
Regarding claim 8, Ariely et al disclose the limitations of claim 6 but fail to teach wherein the adhesive backing comprises a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate.
However, Griswold et al disclose a backing material comprising a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate (see para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the adhesive backing of Ariely et al and incorporate the teachings of Griswold et al to have the adhesive backing comprises a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate. This would provide the benefit of having pressure-sensitive adhesives for easy repositioning and resistant to the migration of liquid or drug flowing through the tubes (para 0015 and 0056).
Regarding claim 13, Ariely et al disclose the limitations of claim 11 but fail to teach wherein the adhesive backing comprises a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate.
However, Griswold et al disclose a backing material comprising a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate (see para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the adhesive backing of Ariely et al and incorporate the teachings of Griswold et al to have the adhesive backing comprises a blend of polyurethane, polyamide, polyethylene, and ethylene/vinyl acetate. This would provide the benefit of having pressure-sensitive adhesives for easy repositioning and resistant to the migration of liquid or drug flowing through the tubes (para 0015 and 0056).
Claims 4, 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ariely et al (US 20230035969 A1) and further in view of Ip (US 20040117057 A1).
Regarding claim 4, Ariely et al disclose the limitations of claim 1 but fail to teach said patch, wherein the panel is laser-cut to specific dimensions.
However, Ip discloses a method of generating pattern via laser cutting process wherein the fabric is laser-cut to specific dimensions (see fig 3, para 0001, 0003 and 0004).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the panel of Ariely et al and incorporate the teachings of Ip to have the panel to be laser-cut to specific dimensions. This would provide the benefit of preventing material from shedding due to irregularity when having a slit formed in the panel (see para 0003-4).
Regarding claim 9, Ariely et al disclose the limitations of claim 6 but fail to teach wherein the panel is laser-cut to specific dimensions.
However, Ip discloses a method of generating pattern via laser cutting process wherein the panel is laser-cut to specific dimensions (see fig 3, para 0001, 0003 and 0004).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Ariely et al and incorporate the teachings of Ip to have the panel to be laser-cut to specific dimensions. This would provide the benefit of preventing material from shedding due to irregularity when having a slit formed in the panel (see para 0003-4).
Regarding claim 14, Ariely et al disclose the limitations of claim 11 but fail to teach wherein the panel is laser-cut to specific dimensions.
However, Ip discloses a method of generating pattern via laser cutting process wherein the panel is laser-cut to specific dimensions (see fig 3, para 0001, 0003 and 0004).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the access patch of Ariely et al and incorporate the teachings of Ip to have the panel to be laser-cut to specific dimensions. This would provide the benefit of preventing material from shedding due to irregularity when having a slit formed in the panel (see para 0003-4).
Claims 5, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ariely et al (US 20230035969 A1).
Regarding claim 5, Ariely et al disclose the limitations of claim 1 but fail to teach said patch, wherein the slit is 1 mm in length.
However, Ariely et al disclose a slit (370) where medical tube can pass (see fig 14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the slit of Ariely et al to have the slit is 1 mm in length since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the slit of Ariely et al would not operate differently with the claimed length and since a slit is long enough to allow medical tube to pass, the device would function appropriately having the claimed length. Further, applicant places no criticality on the range length, indicating simply that the slit formed in the patch, although described as being 1 mm (specification pp. [0042]).
Regarding claim 10, Ariely et al disclose the limitations of claim 6 but fail to teach wherein the slit is 1 mm in length.
However, Ariely et al disclose a slit (370) where medical tube can pass (see fig 14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the slit of Ariely et al to have the slit is 1 mm in length since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ariely et al would not operate differently with the claimed length and since a slit is long enough to allow medical tube to pass, the device would function appropriately having the claimed length. Further, applicant places no criticality on the range length, indicating simply that the slit formed in the patch, although described as being 1 mm (specification pp. [0042]).
Regarding claim 15, Ariely et al disclose the limitations of claim 1 but fail to teach said patch, wherein the slit in the access patch is 1 mm in length.
However, Ariely et al disclose a slit (370) where medical tube can pass (see fig 14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the slit of Ariely et al to have the slit is 1 mm in length since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the slit of Ariely et al would not operate differently with the claimed length and since a slit is long enough to allow medical tube to pass, the device would function appropriately having the claimed length. Further, applicant places no criticality on the range length, indicating simply that the slit formed in the patch, although described as being 1 mm (specification pp. [0042]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ariely et al (US 20230035969 A1) and further in view of Bentley (US 11382371 B2).
Regarding claim 16, Ariely et al disclose the limitations of claim 11 but fail to teach said garment, wherein the fabric panel is configured as a onesie, shirt, pant, or blanket.
However, Bentley discloses a garment (100, see fig 1) comprises a patch with a fabric panel (118) wherein the fabric panel is configured as a shirt or an onesie (see figs 1 and 7, col 5, lines 19-27).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the garment of Ariely et al and incorporate the teachings of Bentley to have the fabric panel configured as a shirt or an onesie. This would provide the benefit of having said garment designed to be worn used by patients, including infants, children, adolescents, adults and geriatric patients (col 5, lines 4-18).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ariely et al (US 20230035969 A1) and further in view of Geraghty (US 11191307 B2).
Regarding claim 18, Ariely et al disclose the garment of claim 11, wherein the access patch includes a slit (slit 370, see fig 6) with a flexible membrane or elasticized material, allowing for a secure yet adaptable opening that accommodates various tube diameters while minimizing exposure (para 0064 and 0066) but fails to expressly teach said slit is a reinforced.
However, Geraghty discloses a garment (100) comprising a fabric panel (146) having a slit (166) wherein the slit is a reinforced slit (168/170, see fig 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the access patch of Ariely et al and incorporate the teachings of Geraghty to have said slit to be a reinforced slit. This would provide additional flexibility and durability while accommodating various tubing diameters (see col 6, lines 1-10)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ariely et al (US 20230035969 A1) and further in view of Hess et al (US 20010004481).
Regarding claim 20, Ariely et al disclose the limitations of claim 11 but fail to teach wherein the access patch comprises a heat-sealed or thermally resistant layer to enhance durability and prevent fraying of the fabric surrounding the slit.
Hess et al disclose woven fabric (abstract and para 0013) comprises a heat-sealed or thermally resistant layer to enhance durability and prevent fraying of the fabric (para 0023).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the access patch of Ariely et al and incorporate the teachings of Hess et al to have the access patch comprises a heat-sealed or thermally resistant layer. This would provide the benefit of increasing the durability of the access patch by having polymeric coatings layer that provide thermal protection of the polymeric and reduced fabric end fray (see para 0023).
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered.
In regard to the arguments that the Ariely does not teach “A patch for providing access to medical tubes and lines through clothing”, examiner respectfully disagrees. Ariely teach a patch that can be adhered to the interior or exterior of the medical garment or directly adhered to the patient (para 0061 and claims 11, 12). Thus, Ariely teach a patch (300) for providing access to medical tubing 300 through clothing 100 (see fig 14).
In regards to the arguments that “Ariely Does Not Disclose a Slit in a Fabric Panel of the Claimed Type and Ariely's "exit port 210" is part of a flap system integrated into a medical garment assembly ”, examiner acknowledges that slit 210 is not a slit in the fabric but rather teach a slit of the medical garment. However, upon further consideration, Ariely et al disclose in figure 6 and para 0064, a slit (370) formed in the panel (fig 6), through which a medical tube or line (500, fig 14) can pass (para 0064).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783