DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 2 is objected to because of the following consistency informalities:
Claim 2, line 9, “subcutaneous layer”, should read, “subcutaneous region”.
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 2-16 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 2, it recites the limitation “the skin penetration point” in lines 2-3.
There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets “the skin penetration point” as “a skin penetration point”.
Claims 3-16 are rejected due to being dependent on claim 2, rendering them indefinite.
Regarding claim 12, recites the limitation "the adhesive strip fold axis" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets “the adhesive strip fold axis” as “an adhesive strip fold axis”.
Regarding claim 13, recites the limitation "the adhesive strip fold axis" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets “the adhesive strip fold axis” as “an adhesive strip fold axis”.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 2-4 and 10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rosenberg et al. (US Pub No. 20090326473 A1, herein, Rosenberg) in view of Nordstrom (US Pub No. 3906946 A).
Regarding claim 2, Rosenberg discloses a method of using a medical anchor system (Para [0006]), the method comprising:
simultaneously inserting subcutaneous tines (130a/130b – Fig.1) of an anchor device (100 – Fig.1) through a skin penetration point (32 – Fig.1) and into a subcutaneous region (34 – Fig.1) adjacent to an underside of a skin layer (36 – Fig.1) while a retainer body (110 – Fig.1) of the anchor device is in a non-folded condition (Fig.6B) and external to the skin penetration point, wherein the retainer body comprising a first body portion (150 – Fig.2A) movable relative to a second body portion (160 – Fig.2A) about a longitudinal fold axis (154 – Fig.2A) so that the subcutaneous tines of the anchor device are generally adjacent to each other and oriented to extend in substantially the same direction (Para [0031]);
adjusting the anchor device to a folded condition (Fig.1) after the subcutaneous tines are inserted into the subcutaneous layer so that the subcutaneous tines are in an anchored position while the retainer body of the anchor device remains external to the skin penetration point (Fig.6B, “The retainer members can then be transitioned to the closed configuration to thus retain the catheter in a desired position relative to the penetration point” – Para [0039]) and
adhesively securing an exterior surface of a medical instrument (20 – Fig.1) to a flexible adhesive strip (145, shown at 150, shown at 160 – Fig.2A, “the retention members and can include an adhesive coating” – Para [0028]) coupled to the retainer body of the anchor device (Para [0026]) after the subcutaneous tines are adjusted to the anchored position in the subcutaneous region (“To retain the catheter in an operative position, the catheter can be positioned along the channel of the retainer body and the adhesive pad” – Para [0039])
however, Rosenberg does not expressly disclose simultaneously inserting subcutaneous tines of an anchor device through the skin penetration point and into a subcutaneous region adjacent to an underside of a skin layer while a retainer body of the anchor device is in a folded condition
Nordstrom teaches inserting an anchor device (Fig.1) through the skin while a retainer body (4 – Fig.4) of the anchor device is in a folded condition (Fig.3, Fig.5)(“form gripping and guide means which can be held between the thumb and forefinger of the manipulator during the insertion procedure. – Col. 5, lines 18-21).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the anchor device of Rosenberg to have the retainer body in a folded condition when inserting the anchor device through the skin as taught by Nordstrom since Nordstrom teaches that folding the retainer body allows a user to grip and guide the anchor device during insertion, allowing enhanced user manipulation and precision (Nordstrom, Col. 5, lines 18-21).
Additionally, Rosenberg does not expressly disclose adjusting the anchor device to a non-folded condition after the subcutaneous tines are inserted into the subcutaneous layer.
Nordstrom teaches adjusting the anchor device to a non-folded condition after the device is inserted into the skin (“Once the catheter has been inserted into the vein and the flexible wings have been unfolded” – Col.5, lines 21-22).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the anchor device of Rosenberg to be to adjusted to a non-folded condition after being inserted into the skin as taught by Nordstrom since Nordstrom teaches that it is to form the supporting and securing means of the device (Nordstrom, Col.5, lines 23-24).
Regarding claim 3, Rosenberg discloses the method as recited above, wherein the anchor device comprises first (124a – Fig.2A) and second (124b – Fig.2A) anchor shafts that extend distally from a distal end of the retainer body on opposite sides of the longitudinal fold axis (Fig.2A), the first anchor shaft extending distally toward a first subcutaneous tine (130a – 2A) of the subcutaneous tines, and the second anchor shaft extending distally toward a second subcutaneous tine (130b – 2A) of the subcutaneous tines (Fig.2A).
Regarding claim 4, Rosenberg discloses the method as recited above, wherein said adhesively securing comprises folding the flexible adhesive strip (145, shown at 150, shown at 160 – Fig.2A) upon itself about an adhesive strip fold axis (164 – Fig.2A) and around the exterior surface of the medical instrument (Fig. 2B, “a holding force to the catheter” – Para [0027]), the adhesive strip fold axis being substantially parallel to and offset from the longitudinal fold axis (154 – Fig.2A) of the retainer body (Fig.2A).
Regarding claim 10, Rosenberg discloses the method as recited above, wherein the flexible adhesive strip (145, shown at 150, shown at 160 – Fig.2A) extends proximally from a proximal end of the retainer body (See annotated Fig.2A below).
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Claims 5-9 and 11-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rosenberg in view of Nordstrom as applied to claim 2 above, and further in view of Bracken et al. (US Pub No. 20100298778 A1, herein, Bracken).
Regarding claim 5, Rosenberg discloses the method, as modified as set forth above, further comprising the flexible adhesive strip (145, shown at 150, shown at 160 – Fig.2A) that exposes an adhesive layer (“the retention members and can include an adhesive coating” – Para [0028]) before said adhesively securing the exterior surface of the medical instrument (20 – Fig.1) (Fig.1, Fig. 2B, Para [0026]-[0028], “a holding force to the catheter” – Para [0027]).
However, Rosenberg does not expressly disclose wherein the method further comprises removing a releasable liner of the flexible adhesive strip.
Bracken teaches a method comprising removing a releasable liner (40a – Fig.1B) of the flexible adhesive strip (10 – Fig.1A).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the method of Rosenberg to further comprise a releasable liner as taught by Bracken as Bracken teaches that the release liner covers the adhesive strip to protect the adhesive surface and removing the liner is necessary to expose the adhesion to the medical instrument for ease of attachment (Bracken, Para [0069]).
Regarding claim 6, Rosenberg discloses the method, as modified as set forth above, wherein the flexible adhesive strip (145 – Fig.2A) includes a flexible substrate (“foam” – Para [0024]) carrying the adhesive layer (“adhesive pad” – Para [0024]) along a major surface thereof (Fig.2A).
However, Rosenberg does not expressly disclose wherein there is a releasable liner over the adhesive layer.
Bracken teaches a method comprising a releasable liner (40a – Fig.1B) over the adhesive layer (30 – Fig.1A, Fig.1B).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the method of Rosenberg to further comprise a releasable liner over the adhesive layer as Bracken teaches that the release liner covers the adhesive strip to protect the adhesive surface (Bracken, Para [0069]).
Regarding claim 7, Rosenberg discloses the method as recited above, wherein the flexible substrate comprises at least one of a polymer sheet material (“foam” – Para [0024]).
Regarding claim 8, Rosenberg discloses the method, as modified as set forth above, but Rosenberg does not expressly disclose wherein a releasable liner comprises at least one of a polymer sheet material and wax paper material.
Bracken teaches a releasable liner (40a – Fig.1B) comprising at least one of a polymer sheet material and wax paper material (“polycoated, siliconized paper” – Para [0069]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the method of Rosenberg to comprise a releasable liner comprises at least one of a polymer sheet material since Bracken teaches that a polymer material is a well-known material that a release liner may comprise (Bracken, Para [0069]).
Regarding claim 9, Rosenberg discloses the method, as modified as set forth above, but Rosenberg does not expressly disclose wherein the flexible adhesive strip has a lateral width extending generally perpendicular to the longitudinal fold axis and a longitudinal length extending generally parallel to the longitudinal fold axis, wherein the lateral width of the flexible adhesive strip is greater than the longitudinal length of the respective flexible adhesive strip.
However, Bracken teaches a flexible adhesive strip (10 – Fig.2) has a lateral width and a longitudinal length, wherein the lateral width of the flexible adhesive strip is greater than the longitudinal length of the respective flexible adhesive strip (See annotated Fig.3 below).
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It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the flexible adhesive strip of Rosenberg to have the same dimensions as the flexible adhesive strip taught by Bracken since Bracken teaches that the strip is used to secure a medical instrument (Bracken, Para [0069]) and since medical instruments vary in size and configuration, the dimensions of the strip would be selected or adjusted as needed to accommodate the particular instrument being secured.
Regarding claim 11, Rosenberg discloses the method, as modified as set forth above, but Rosenberg does not expressly disclose the method further comprising tearing a tear strip of the flexible adhesive strip, the tear strip extending substantially parallel to and offset from the longitudinal fold axis of the retainer body.
Bracken teaches a method further comprising tearing a tear strip (40a – Fig.1B, “edges are exposed beyond the securement device” – Para [0069]) of the flexible adhesive strip (10 – Fig.1A) that extends generally parallel to a longitudinal axis of a retainer (30 – Fig.1A).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the flexible adhesive strip of Rosenberg to comprise a tear strip that extends generally parallel to a longitudinal axis of a retainer to tear off the flexible adhesive strip as taught by Bracken since Bracken teaches that it provides a grasping edge for easy removal of the release liner (Bracken, Para [0069]).
Regarding claim 12, Rosenberg discloses the method, as modified as set forth above, but Rosenberg does not expressly disclose the method wherein a tear strip is substantially parallel to and offset from an adhesive strip fold axis.
Bracken teaches a tear a tear strip (40a – Fig.1B).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the method of Rosenberg to comprise the tear strip taught by Bracken, where the tear strip would be substantially parallel to and offset from the adhesive strip fold axis of Rosenberg since Bracken teaches that a tear strip provides a grasping edge for easy removal of the release liner (Bracken, Para [0069]).
Regarding claim 13, Rosenberg discloses the method, as modified as set forth above, but Rosenberg does not expressly disclose the method wherein the tear strip is configured to be aligned with the longitudinal fold axis of the retainer body when folded upon itself about an adhesive strip fold axis around an exterior surface of the medical instrument.
Bracken teaches a tear a tear strip (40a – Fig.1B).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the method of Rosenberg to comprise the tear strip taught by Bracken, where the tear strip is configured to be aligned with the longitudinal fold axis of the retainer body when folded upon itself about an adhesive strip fold axis around an exterior surface of the medical instrument of Rosenberg since Bracken teaches a tear strip provides a grasping edge for easy removal of the release liner (Bracken, Para [0069]).
Claims 14-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rosenberg (herein, Rosenberg 473’) in view of Nordstrom as applied to the claims above, and further in view of Rosenberg et al. (US 20100204656 A1, herein, Rosenberg 656’).
Regarding claim 14, Rosenberg 473’ discloses the method as recited above, wherein the first (150 – Fig.2A) and second (160 – Fig.2A) body portions of the retainer body (110 – Fig.2B) are movably coupled about the longitudinal fold axis (Fig.2B).
However, Rosenberg does not expressly disclose wherein in response to said adjusting the anchor device to the non-folded condition, the subcutaneous tines extend outwardly away from one another.
Rosenberg 656’ teaches a method wherein in response to said adjusting an anchor device (110 – Fig.5) to the non-folded condition (Fig.5), subcutaneous tines (145a,145b – Fig.5) extend outwardly away from one another (Fig.5).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the anchor device of Rosenberg 473’ wherein said adjusting the anchor device to the non-folded condition, the subcutaneous tines extend outwardly away from one another as taught by Rosenberg 656’ since Rosenberg 656’ teaches that extending the subcutaneous tines outwardly allows the anchor device to be secured to the patient without the retainer body penetrating though the skin of the patient and without necessarily requiring sutures or adhesive tapes bonded to the skin (Rosenberg 656’, Para [0021]).
Regarding claim 15, Rosenberg discloses the method as recited above, wherein the longitudinal fold axis (154 – Fig.2A) is defined by a flexible web portion (See annotated Fig.3A) positioned generally centrally between the first (150 – Fig.2A) and second (160 – Fig.2A) body portions and extending longitudinally from the distal end of the retainer body to a proximal face of the retainer body (Fig.3A).
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Regarding claim 16, Rosenberg 473’ discloses the method as recited above, wherein said adhesively securing the exterior surface of the medical instrument (20 – Fig.1) to the flexible adhesive strip (“To retain the catheter in an operative position, the catheter can be positioned along the channel of the retainer body and the adhesive pad” – Para [0039]) comprises engaging the medical instrument with a region of the retainer body (110 – Fig.1).
However, Rosenberg 473’ does not expressly disclose a retainer body with a sloped nose region of the retainer body that has a generally planar upper surface oriented at a decline angle extending distally from the first and second body portions.
Rosenberg 656’ teaches a retainer body (111 – Fig.1) with a sloped nose region (See Fig.1 below) of the retainer body that has a generally planar upper surface (See Fig.1 below) oriented at a decline angle extending distally from the first (114a – Fig.7) and second (114b – Fig.7) body portions.
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the retainer body of Rosenberg 473’ to comprise a sloped nose region that has a generally planar upper surface oriented at a decline angle extending distally from the first and second body portions as taught by Rosenberg 656’ since a sloped nose region would assist in guiding the medical instrument in position and reducing bending of the medical instrument.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783