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 1 are objected to because of the following informalities:
Regarding claim 1, line 4, the limitation “base member” appears to be amended to recite “the base member” in order to refer to “a base member” recited in claim 1, line 2.
Regarding claim 13, line 4, the limitation “base member” appears to be amended to recite “the base member” in order to refer to “a base member” recited in claim 13, line 2.
Regarding claim 19, line 5, the limitation “base member” appears to be amended to recite “the base member” in order to refer to “a base member” recited in claim 19, line 2.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “the first fastener configured to releasably couple the fabric retaining member with the base member proximate to the distal end of the flap” in claim 1, “the second fastener configured to releasably couple the flap with the base member proximate to the first fastener”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 2, 4, 7-14 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stephens (US 4,193,174).
Regarding claim 1, Stephens teaches a securement device 10 (figure 6 with element 42) for medical tubing 40, 41, comprising:
a base member 11 comprising a proximal end (end of element 11 comprising element 13) and a distal end (end of element 11 comprising element 14), wherein the base member 11 is substantially free of adhesive (no adhesive use is described);
a flap 12 operably connected to the base member 11, wherein the flap 12 and base member 11 together define an opening (opening shown in figure 4 that accommodates element 40) configured to accommodate medical tubing, the flap 12 comprising a proximal end (end of element 12 where element 30 is present and connected to element 11) affixed to the base member 11 and a distal end (end comprising element 36) that is selectively detachable from the base member 11 (column 4, lines 13-20);
a fabric retaining member 42 operably connected to the base member 11, the fabric retaining member 42 comprising a distal end (end of element 42 connecting to element 14) that is affixed to the base member 11 and a proximal end (other end of element 42 extending opposite to an end connected to element 14); and
a first fastener 14 (and corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14) operably connected to the fabric retaining member 42, the first fastener 14 configured to releasably (element 42 could be separated forcibly or by cutting if the element 42 cannot be easily separated from element 11) couple the fabric retaining member 42 with the base member 11 proximate to the distal end of the flap 12.
Regarding claim 2, Stephens teaches wherein the first fastener comprises: a first fastener component 14 disposed at the distal end (end of element 11 comprising element 14) of the base member 11; and another first fastener component (corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14) disposed on the fabric retaining member 42 and configured to engage the first fastener component 14 disposed at the distal end of the base member to mutually, releasably couple the fabric retaining member 42 with the base member 11.
Regarding claim 4, Stephens teaches wherein the first fastener 14 (and corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14) and the flap 42 are outwardly facing (see figure 6).
Regarding claim 7, Stephens teaches further comprising a second fastener 36, 16 operably connected to the flap 12, the second fastener configured to releasably couple the flap with the base member proximate to the first fastener 14 (and corresponding connected located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14).
Regarding claim 8, Stephens teaches wherein the second fastener 36, 16 comprises:
a second fastener component 16 disposed on the base member 11; and
another second fastener component 36 disposed at the distal end of the flap 12 and configured to engage the second fastener component 36 disposed on the base member 11 to mutually, releasably couple the flap 12 with the base member 11.
Regarding claim 9, Stephens teaches wherein the second fastener 36, 16 comprises a snap, a hook-and-loop fastener, a magnet or a combination thereof (column 4, lines 13-20).
Regarding claim 10, Stephens teaches wherein the first fastener and/or the second fastener is non-metallic (column 3, lines 50-53).
Regarding claim 11, Stephens teaches wherein the flap 12 is configured to be selectively detached from the base member 11 and moved to an open position (position shown in figure 3) by moving the distal end of the flap in a direction away from the first fastener (see figure 3).
Regarding claim 12, Stephens teaches wherein the base member 11 further includes a channel (portion of element 11 that receives element 40) that is covered by the flap 12 to define the opening.
Regarding claim 13, Stephens teaches a securement device 10 (figure 6 with element 42) for medical tubing 40, 41, comprising:
a base member 11 comprising a proximal end (end of element 11 comprising element 13) and a distal end (end of element 11 comprising element 14) that includes a first fastener component 14, wherein the base member 11 is substantially free of adhesive (no adhesive use is described);
a flap 12 operably connected to the base member 11, wherein the flap 12 and base member 11 together define an opening (opening shown in figure 4 that accommodates element 40) configured to accommodate medical tubing, the flap 12 comprising a proximal end (end of element 12 where element 30 is present and connected to element 11) affixed to the base member 11 and a distal end (end comprising element 36) that is selectively detachable from the base member 11 (column 4, lines 13-20);
a fabric retaining member 42 operably connected to the base member 11, the fabric retaining member 42 comprising a distal end (end of element 42 connecting to element 13) that is affixed to the base member 11 and a proximal end (end of element 42 connecting to element 14) that includes a first fastener component (corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14),
wherein the first fastener component (corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14) of the fabric retaining member 42 is configured to engage the first fastener component 14 of the base member 11 to form a first fastener 42 (and corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14), and wherein the first fastener is configured to mutually, releasably (element 42 could be separated forcibly or by cutting if the element 42 cannot be easily separated from element 11) couple the fabric retaining member 42 with the base member 11 proximate to the distal end of the flap 12.
Regarding claim 14, Stephens teaches wherein the first fastener 14 (and corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14) and the flap 42 are outwardly facing (see figure 6).
Regarding claim 16, Stephens teaches further comprising a second fastener 36, 16 operably connected to the flap 12, the second fastener configured to releasably couple the flap with the base member proximate to the first fastener 14 (and corresponding connected located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14).
Regarding claim 17, Stephens teaches wherein the second fastener 36, 16 comprises:
a second fastener component 16 disposed on the base member 11; and
another second fastener component 36 disposed at the distal end of the flap 12 and configured to engage the second fastener component 36 disposed on the base member 11 to mutually, releasably couple the flap 12 with the base member 11.
Regarding claim 18, Stephens teaches wherein at least one of the first fastener or the second fastener 36, 16 comprises a snap, a hook-and-loop fastener, a magnet or a combination thereof (column 4, lines 13-20).
Regarding claim 19, Stephens teaches a securement device 10 (figure 6 with element 42) for medical tubing 40, 41, comprising:
a base member 11 comprising a proximal end (end of element 11 comprising element 13) and a distal end (end of element 11 comprising element 14) that includes a first fastener component 14, wherein the base member 11 is substantially free of adhesive (no adhesive use is described) and further includes a second fastener component 16 disposed proximate to the first fastener component 14;
a flap 12 operably connected to the base member 11, wherein the flap 12 and base member 11 together define an opening (opening shown in figure 4 that accommodates element 40) configured to accommodate medical tubing, wherein the flap 12 comprises a proximal end (end of element 12 where element 30 is present and connected to element 11) affixed to the base member 11 and a distal end (end comprising element 36) that is selectively detachable from the base member 11 (column 4, lines 13-20), wherein the flap includes a second fastener component 36 at the distal end of the flap 12;
a fabric retaining member 42 operably connected to the base member 11, the fabric retaining member 42 comprising a distal end (end of element 42 connecting to element 13) that is affixed to the base member 11 and a proximal end (end of element 42 connecting to element 14) that includes a first fastener component (corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14);
wherein the first fastener component (corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14) of the fabric retaining member 42 is configured to engage the first fastener component 14 of the base member 11 to form a first fastener 42 (and corresponding connection located on element 42 engaging with element 14, this could include a loop formed on element 42 to engage with element 14), wherein the first fastener is configured to mutually, releasably (element 42 could be separated forcibly or by cutting if the element 42 cannot be easily separated from element 11) couple the fabric retaining member 42 with the base member 11 proximate to the distal end of the flap 12; and
wherein the second fastener component 36 of the flap 12 is configured to engage the second fastener component 16 of the base member 11 to form a second fastener 16, 36, wherein the second fastener is configured to mutually, releasably couple the flap 12 with the base member 11 proximate to the first fastener.
Regarding claim 20, Stephens teaches wherein the base member 11 includes a platform 15 that extends upward from the base member 11, the platform 15 comprising a top side (side of element 15 facing element 12) that is substantially flat and is configured to support (element 15 provides the support to element 12) the flap 12 when the flap 12 is releasably coupled with the base member 11.
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.
Claims 3, 5, 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Stephens (US 4,193,174) in view of Albany (US 2019/0388652 A1).
Regarding claim 3, Stephens discloses the claimed invention substantially as claimed, as set forth above in claim 1. Stephens further discloses the first fastener but does not disclose the structure therefore, Stephens is silent regarding the first fastener comprises a snap, a hook-and-loop fastener, a magnet, or a combination thereof.
However, Albany teaches a design of a catheter securement device 10 (figure 1A) comprising the first fastener 22 (and corresponding connection/loop structure of element 80 that allows connection of element 80 with element 22) comprises a snap, a hook-and-loop fastener, a magnet, or a combination thereof (paragraph 0125, lines 20-25, paragraph 0126, lines 12-16) for the purpose of using a well-known connection mechanism to securely connect the fabric retaining member with the base member (paragraph 0125, lines 20-25, paragraph 0126, lines 12-16).
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 fastener of Stephens to incorporate wherein the first fastener comprises, a snap, a hook-and-loop fastener, a magnet or a combination thereof as taught by Albany for the purpose of using a well-known connection mechanism to securely connect the fabric retaining member with the base member (paragraph 0125, lines 20-25, paragraph 0126, lines 12-16).
Regarding claims 5 and 6, Stephens discloses the claimed invention substantially as claimed, as set forth above in claim 1. Stephens is silent regarding wherein the fabric retaining member is made of a stretchable material that provides for adjusting a size of the fabric retaining member and wherein the fabric retaining member is an elastic band.
However, Albany teaches wherein the fabric retaining member 80 is made of a stretchable material (paragraph 0125, lines 7-8, “rubber” is stretchable material) that provides for adjusting a size of the fabric retaining member and wherein the fabric retaining member is an elastic band (paragraph 0125, lines 7-8, “rubber” is elastic) for the purpose of using a well-known biocompatible material (paragraph 0125, lines 7-10).
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 fabric retaining member of Stephens to incorporate wherein the fabric retaining member is made of a stretchable material that provides for adjusting a size of the fabric retaining member and wherein the fabric retaining member is an elastic band as taught by Albany for the purpose of using a well-known biocompatible material (paragraph 0125, lines 7-10).
Regarding claim 15, Stephens discloses the claimed invention substantially as claimed, as set forth above in claim 13. Stephens is silent regarding wherein the fabric retaining member is made of a stretchable material such that a size of the band is adjustable.
However, Albany teaches wherein the fabric retaining member 80 is made of a stretchable material (paragraph 0125, lines 7-8, “rubber” is stretchable material) such that a size of the band is adjustable for the purpose of using a well-known biocompatible material (paragraph 0125, lines 7-10).
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 fabric retaining member of Stephens to incorporate wherein the fabric retaining member is made of a stretchable material such that a size of the band is adjustable as taught by Albany for the purpose of using a well-known biocompatible material (paragraph 0125, lines 7-10).
Conclusion
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.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783