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 claims 8-20 in the reply filed on Aug. 7, 2026 is acknowledged.
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 8, 11, 13, 15, 16, and 20 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.
Claim 8 recites “comprising a and cut-out region” in lines 13-14. The recitation is not clear.
Claim 8 recites the limitation “the base” in line 14. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes the claim was considered for examination purposes as reciting “the base region.”
Claim 11 recites “the base region further comprises one or more projections configured to engage with the cut-out region.” The phrase “further” implies an additional element, however the limitation is present in claim 8 from which claim 11 depends.
Claim 13 recites “one or more ribs or ridges in the configured…” The claim is unclear grammatically.
Claim 15 recites “hub” in line 9. The claim is not clear. The Examiner notes the claim was considered for examination purposes as reciting “the hub.”
Claim 15 recites “by folding along the living hinge region up to 180 degrees or more” in lines 16-17. The recitation “up to 180 degrees or more” is not clear.
Claim 15 recites “to secure the medical tubing with the channel” is not clear. The Examiner notes the claim was considered for examination purposes as reciting “to secure the medical tubing within the channel.”
Claim 16 recites “the base region further comprises one or more projections configured to engage with the cut-out region.” The phrase “further” implies an additional element, however the limitation is present in claim 15 from which claim 16 depends.
Claim 20 recites “the hub comprise a Luer lock.” The claim is not clear. The Examiner notes the claim was considered for examination purposes as reciting “the hub comprises a Luer lock.”
Claim Rejections - 35 USC § 102
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) 8, 9, 11, 12, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ciccone et al. (US 2012/0136314 A1) (“Ciccone”).
With respect to claim 8, Ciccone discloses a medical tubing support device having a three-dimensional shape (abstr.), comprising a body portion comprising a sheet of material comprising a base region – element 22 (0055-0057, 0065), a channel region projecting from the base region, the channel region configured to hold a bifurcated medical tubing, wherein the channel region comprises a first branch region forming a first channel and a second branch region forming a second channel (0064, 0084-0087, Figs. 4, 14, 15), wherein the first channel and the second channel are joined adjacent to a branch securement region – the channels are joined by a ridge at the end of the base region shown in e.g. Fig. 14, also see Fig. 15, wherein the channel region extends from the base region and has one or more walls extending from the base region in a first angle that is greater than 90˚ relative to an adjacent base region – the curved walls of the channels extend from the base region at an angle greater than 90˚ (Fig. 14); a securement door formed of the material – element 24, the securement door comprising openings – elements 79 – configured to engage with a projection on the base region – elements 81 (0100, Figs. 4, 6); and a living hinge region in the material between the channel region and the securement door, wherein the securement door is configured to close over the first and second channels by folding along the living hinge region to secure the medical tubing therebetween (0073-0077).
The recitation “wherein the sheet has been deformed from a flat plane to form…” defines the product by how the product is made, thus, claim 8 is a product by process claim. For purposes of examination product-by-process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (MPEP 2113). In the instant case the recited steps imply the structure of claim 8. The reference teaches the structure.
Regarding claim 9, Ciccone teaches the device of claim 8, comprising an adhesive substrate portion coupled to at least a portion of the base region, wherein the adhesive substrate portion comprises a liner – element 18 - on a face opposite the base region (0055, 0061, Figs. 1-3).
As to claim 11, Ciccone teaches the device of claim 8. Ciccone discloses the base region comprises more than one projection configured to engage with the cut-out region - the securement door comprising openings – elements 79 – configured to engage with a projection on the base region – elements 81 (0100, Figs. 4, 6).
Applicant is advised that should claim 8 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
With respect to claim 12, Ciccone teaches the device of claim 11. Ciccone discloses the one or more projections comprises a snap configured to releasably lock onto the cut-out region – implied in par. [0100].
Regarding claim 14, Ciccone teaches the device of claim 8, wherein the material comprises a polycarbonate or a polyethylene (0065).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ciccone, in view of Hopman et al. (US 2012/0046582 A1) (“Hopman”).
With respect to claim 10, Ciccone teaches the device of claim 8, but is silent with respect to an elastic modulus of the material being greater than 0.4 GPa. Hopman discloses a medical support device (abstr., 0057, 0058, 0064), wherein the material used is a thermoplastic having a modulus of elasticity in the range of 965-1448 MPa (0068). The range of modulus of elasticity overlaps the range recited in claim 10; overlapping ranges have been held to establish prima facie obviousness (MPEP 2144.05). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to form the device of Ciccone from a material having a modulus of elasticity as disclosed in Hopman, as it is known in the art to use materials having such modulus of elasticity in medical support devices.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ciccone et al. (US 2012/0136314 A1) (“Ciccone”).
Regarding claim 13, Ciccone teaches the device of claim 8. Ciccone discloses the walls form ridges (0089). Ciccone does not specify the ridges are configured to increase rigidity of the channel region, however, it would be obvious to one of ordinary skill in the art that since Ciccone discloses all the elements of the device as recited in claim 13, the device according to Ciccone is capable to perform as intended.
Claim Rejections - 35 USC § 102
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) 15-18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ciccone et al. (US 2012/0136314 A1) (“Ciccone”).
With respect to claim 15, Ciccone discloses a medical tubing support device having a three-dimensional shape (abstr.), comprising a body portion comprising a sheet of material comprising a base region – element 22 (0055-0057, 0065), a channel region projecting from the base region, the channel region comprising a channel configured to hold a medical tubing having a hub – catheter branching site 112 has been interpreted as corresponding to a hub recited in the claim (0084, 0085), the channel region comprising an abutment region at a proximal end that is configured to prevent the medical tubing and the hub from moving in a proximal direction within the channel (0085, 0086), wherein the channel region comprises external walls extending from the base region in a first angle that is greater than 90˚ relative to an adjacent base region – the curved walls of the channels extend from the base region at an angle greater than 90˚ (Fig. 14); a securement door formed of the material – element 24, the securement door comprising openings – elements 79 interpreted as corresponding to a cut-out region, configured to engage a projection on the base region – elements 81 (0100, Figs. 4, 6); and a living hinge region in the material between the channel region and the securement door, wherein the securement door is configured to close over the channel by folding along the living hinge region up to 180˚ to secure the medical tubing within the channel, and between the channel region and the securement door (0073-0077).
The recitation “wherein the sheet has been deformed from a flat plane to form…” defines the product by how the product is made, thus, claim 15 is a product by process claim. For purposes of examination product-by-process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (MPEP 2113). In the instant case the recited steps imply the structure of claim 15. The reference teaches the structure.
As to claim 16, Ciccone teaches the device of claim 15. Ciccone discloses the base region comprises more than one projection configured to engage with the cut-out region - the securement door comprising openings – elements 79 – configured to engage with a projection on the base region – elements 81 (0100, Figs. 4, 6).
Applicant is advised that should claim 15 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
With respect to claim 17, Ciccone teaches the device of claim 16. Ciccone discloses the one or more projections comprises a snap configured to releasably lock onto the cut-out region – implied in (0100).
Regarding claim 18, Ciccone teaches the device of claim 15, comprising an adhesive substrate portion coupled to at least a portion of the base region, wherein the adhesive substrate portion comprises a liner – element 18 - on a face opposite the base region (0055, 0061, Figs. 1-3).
As to claim 20, Ciccone teaches the device of claim 15. The Examiner notes “the hub” is not an element of the device.
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.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ciccone, in view of Hopman et al. (US 2012/0046582 A1) (“Hopman”).
With respect to claim 19, Ciccone teaches the device of claim 15, but is silent with respect to an elastic modulus of the material being greater than 0.4 GPa. Hopman discloses a medical support device (abstr., 0057, 0058, 0064), wherein the material used is a thermoplastic having a modulus of elasticity in the range of 965-1448 MPa (0068). The range of modulus of elasticity overlaps the range recited in claim 19; overlapping ranges have been held to establish prima facie obviousness (MPEP 2144.05). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to form the device of Ciccone from a material having a modulus of elasticity as disclosed in Hopman, as it is known in the art to use materials having such modulus of elasticity in medical support devices.
Information Disclosure Statement
The prior art of made of record not relied upon is considered pertinent to Applicant’s disclosure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNA PLESZCZYNSKA whose telephone number is (571)270-1617. The examiner can normally be reached M-F ~ 11:30-8.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Veronica Ewald can be reached at 571-272-8519. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Joanna Pleszczynska/
Primary Examiner, Art Unit 1783
