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
Claim 3 is objected to because of the following informalities:
In claim 3, the phrase "an pocket" contains a grammatical error (should be "a pocket"). 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 1 and 4 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.
In claim 1, the term "subcutaneous cannulation chamber" lacks proper antecedent basis. The claim previously recites "a cannulation chamber defining a cannulation port", but later introduces "the subcutaneous cannulation chamber" without having established that the chamber itself is subcutaneous.
In claim 4, the phrase "the legs operatively engage" lacks proper antecedent basis. The claim previously describes "a base portion terminating in longitudinal edges", but never introduces "legs" extending from those edges before referring to "the legs".
In claim 4, the phrase "the needle passage of the body member" lacks proper antecedent basis. The claim previously recites "at least one passage opening into the inner surface", but then refers to "the needle passage".
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 1, 2, 5, 6, 7, 8, 9, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gage et al. (US 2014001872A1; hereinafter “Gage”) in view of Gardiner (US 4,228,796A).
In relation to independent claim 1, this claim recites an apparatus for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in a body of a subject, the arteriovenous dialysis graft including a flexible conduit defining a longitudinal flow passageway and having a first end portion configured to connect to an artery of the subject and a second end portion configured to connect to a vein of the subject such that blood flows through the longitudinal flow passageway of the conduit from the first end portion to the second end portion, and a cannulation chamber defining a cannulation port between the first end portion and the second end portion, the conduit extending through the cannulation chamber for receiving the needle inserted through the cannulation port, the guiding apparatus comprising: an elongated tubular sleeve having a longitudinal axis, the sleeve defining an opening having a longitudinal dimension and a lateral dimension adapted to be substantially equal to a longitudinal dimension and a lateral dimension of the cannulation chamber, wherein the sleeve is configured to accommodate the body of the subject adjacent the subcutaneous cannulation chamber of the access graft such that the opening surrounds the cannulation chamber for guiding location of a needle insertion into the cannulation port.
An apparatus for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in a body of a subject, the arteriovenous dialysis graft including a flexible conduit defining a longitudinal flow passageway and having a first end portion configured to connect to an artery of the subject and a second end portion configured to connect to a vein of the subject such that blood flows through the longitudinal flow passageway of the conduit from the first end portion to the second end portion, and a cannulation chamber defining a cannulation port between the first end portion and the second end portion, the conduit extending through the cannulation chamber for receiving the needle inserted through the cannulation port.
Gage discloses “[a]n arteriovenous dialysis access graft configured to be implanted in a subject.” The graft “includes at least one flexible conduit having first and second end portions, wherein the first end portion is configured to connect to an artery of the subject and the second end portion is configured to connect to a vein of the subject such that blood flows through the at least one conduit”… and “at least one cannulation chamber positioned between the first end portion and the second end portion of the at least one conduit.” The chamber includes: an elongated housing having an inlet and an outlet, a posterior wall, a pair of sidewalls, and an open anterior portion defining a cannulation port. (Gage ¶ [0010].)
the guiding apparatus comprising: an elongated tubular sleeve having a longitudinal axis, the sleeve defining an opening having a longitudinal dimension and a lateral dimension adapted to be substantially equal to a longitudinal dimension and a lateral dimension of the cannulation chamber, wherein the sleeve is configured to accommodate the body of the subject adjacent the subcutaneous cannulation chamber of the access graft such that the opening surrounds the cannulation chamber for guiding location of a needle insertion into the cannulation port.
Gage discloses the arteriovenous dialysis access graft, but does not expressly disclose the guiding apparatus comprising an elongated tubular sleeve with an opening configured to accommodate the body of the subject and guide location of a needle insertion. Gardiner fills this gap by disclosing “a guide for informing an insulin user as to where to administer an injection. The guide is comprised of a flexible sheet-like material which has fifteen holes passing therethrough... A pair of straps including Velcro attachments are adapted to support the guide on the right thigh... The user can then inject himself through the hole”. (Gardiner, col. 1, ll. 42-52.) Gardiner further discloses that “the straps 20 and 22 are wrapped around the person's leg and are secured... After the guide 10 is placed on the leg, the proper hole is selected and the user administers an injection to his thigh through the selected hole.” (Gardiner, col. 2, starting in line 63.) The straps wrapped around the leg form a tubular sleeve structure that accommodates the body of the subject.
Claim 2: The guiding apparatus as recited in claim 1 wherein the material of the sleeve is selected from a film, paper, a woven fabric, or a non-woven fabric.
To the extent the primary reference does not expressly disclose the material of the sleeve, Gardiner fills this gap by disclosing “[g]uide 10 is comprised of a body portion 12 which is made from a substantially flexible and flat sheet-like material”. (Gardiner, col. 2, ll. 20-23.) Furthermore, Gardiner discloses “These straps 20 and 22 are covered on both sides thereof with a felt-like material”. (Gardiner, col. 2, ll. 29-31.)
Claim 5: The guiding apparatus of claim 1, wherein the material of the sleeve includes a flexible, resilient fabric.
To the extent the primary reference does not expressly disclose the material of the sleeve, Gardiner fills this gap by disclosing “[g]uide 10 is comprised of a body portion 12 which is made from a substantially flexible and flat sheet-like material”. (Gardiner, col. 2, ll. 20-23.)
Claim 6: The guiding apparatus of claim 1, wherein the opening of the sleeve has a generally elongated ovular shape.
To the extent the primary reference does not expressly disclose the shape of the opening, Gardiner discloses “a plurality of holes 32 passing therethrough”. (Gardiner, col. 2, ll. 47-48.) Modifying the shape of the hole to be elongated or ovular to match the underlying cannulation chamber would have been an ordinary application of Gardiner's disclosed model to ensure the needle properly accesses the port.
Moreover, in relation to changes in shape, the court in In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) held that the configuration of a disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In the case at hand, the shape in question is not considered to be significant, and therefore, the shape modification is considered an obvious alternative in the design of the apparatus. (see MPEP 2144.04, IV, (B) Changes in Shape.)
Claim 7: The guiding apparatus of claim 1, wherein the opening is a first opening and the sleeve defines a second opening that is circumferentially spaced from the first opening.
To the extent the primary reference does not expressly disclose multiple openings, Gardiner fills this gap by disclosing “a plurality of holes 32 passing therethrough”. (Gardiner, col. 2, ll. 47-48.) Gardiner also discloses “if there are fifteen holes, these may be consecutively numbered one to fifteen on the right side of the body portion 12 and may be numbered sixteen to thirty on the left side thereof.” (Gardiner, col. 3, ll. 15-20.)
Claim 8: The guiding apparatus of claim 1, wherein the sleeve defines a pocket.
To the extent the primary reference does not expressly disclose a pocket, Gardiner fills this gap by disclosing “[a] plurality of pockets 14, 16 and 18 are formed in the body portion 12 adjacent one edge thereof.” (Gardiner, col. 2, ll. 22-24.)
Claim 9: The guiding apparatus of claim 8, wherein the pocket is defined in part by a layer of material configured to be placed adjacent to skin of the subject.
To the extent the primary reference does not expressly disclose the pocket configuration, Gardiner fills this gap by disclosing “the device can be mounted about a person's thigh with either the front surface of the body portion 12 exposed and the rear surface against the person's leg”. (Gardiner, col. 2, ll. 42-45.)
Claim 10: The guiding apparatus of claim 9, further comprising an applicator, the pocket configured to receive and retain the applicator.
To the extent the primary reference does not expressly disclose an applicator in the pocket, Gardiner fills this gap by disclosing “[p]ocket 14 is constructed so as to be sufficiently large to store one or more syringes therein. Vials of insulin may be stored in pockets 16 and 18.” (Gardiner, col. 2, ll. 24-27.) A syringe functions as an applicator for the injection.
Claim 11: The guiding apparatus of claim 10, wherein the applicator device defines a needle passage.
To the extent the primary reference does not expressly disclose a needle passage in the applicator, Gardiner fills this gap by disclosing “[p]ocket 14 is constructed so as to be sufficiently large to store one or more syringes therein.” (Gardiner, col. 2, ll. 24-27.) A syringe inherently includes a needle passage.
Motivation to combine [applicable to claims 1, 2, and 5-11].
Based on the above teachings, it would have been obvious to a person of ordinary skill in the art to combine the arteriovenous graft of Gage with the injection guide of Gardiner. The rationale for this combination is to provide a reliable and consistent means for a patient or medical technician to locate the optimal cannulation site on the subcutaneously implanted graft without relying solely on palpation, thereby reducing the risk of missing the target, causing trauma to the graft, or creating hematomas, as addressed by the use of an external guide with designated needle openings secured around the limb.
Claims 3, 12, 13, 14, 15, 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gage et al. (US 2014/001872A1; hereinafter “Gage”) in view of Bangera et al. (US 9,199,044B2; hereinafter “Bangera”) and Gardiner (US 4,228,796A).
In relation to independent claim 3, this claim recites an apparatus for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in a body of a subject, the arteriovenous dialysis graft including a flexible conduit defining a longitudinal flow passageway and having a first end portion configured to connect to an artery of the subject and a second end portion configured to connect to a vein of the subject such that blood flows through the longitudinal flow passageway of the conduit from the first end portion to the second end portion, and a cannulation chamber defining a cannulation port between the first end portion and the second end portion, the conduit extending through the cannulation chamber for receiving the needle inserted through the cannulation port, the guiding apparatus comprising: an elongated body member having a longitudinal axis and an inner surface, the body member comprising a base portion terminating in longitudinal edges, a distance between the longitudinal edges of the base portion being substantially equal to a lateral dimension of the cannulation chamber; and an elongated tubular sleeve having a longitudinal axis, the sleeve defining an pocket having a longitudinal dimension and a lateral dimension configured to receive the body member, wherein the body member is adapted to be received in the pocket of the sleeve for securing adjacent the subcutaneous cannulation chamber such that the inner surface of the base portion is aligned with the cannulation port for guiding location of a needle insertion.
An apparatus for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in a body of a subject ....
Gage discloses the arteriovenous dialysis access graft with a flexible conduit and a cannulation chamber defining a cannulation port. (Gage ¶ [0010].)
the guiding apparatus comprising: an elongated body member having a longitudinal axis and an inner surface, the body member comprising a base portion terminating in longitudinal edges, a distance between the longitudinal edges of the base portion being substantially equal to a lateral dimension of the cannulation chamber.
Gage does not expressly disclose the external guiding apparatus body member. Bangera fills this gap by disclosing “[a] wearable injection guide includes, but is not limited to: a rigid material formed to substantially conform in shape to a topography of a body region of an individual, the rigid material substantially impenetrable to an injection needle, and the rigid material including one or more injection needle access regions arranged in a treatment pattern.” (Bangera, col. 2, ll. 8-14.) The rigid material conforming to the body region topography constitutes a body member with an inner surface and a base portion.
and an elongated tubular sleeve having a longitudinal axis, the sleeve defining an pocket having a longitudinal dimension and a lateral dimension configured to receive the body member, wherein the body member is adapted to be received in the pocket of the sleeve for securing adjacent the subcutaneous cannulation chamber such that the inner surface of the base portion is aligned with the cannulation port for guiding location of a needle insertion.
Bangera does not expressly disclose a tubular sleeve with a pocket for receiving the body member. Gardiner fills this gap by disclosing “a guide for informing an insulin user as to where to administer an injection. The guide is comprised of a flexible sheet-like material... A pair of straps including Velcro attachments are adapted to support the guide”. (Gardiner, col. 1, ll. 42-49.) Gardiner further discloses “[a] plurality of pockets 14, 16 and 18 are formed in the body portion 12”. (Gardiner, col. 2, ll. 22-24.) Using the sleeve and pocket structure of Gardiner to hold the rigid guide body member of Bangera would be an obvious alternative in the design of the apparatus.
Claim 12: The apparatus of claim 3, wherein the material of the elongated tubular sleeve includes a flexible, resilient fabric.
To the extent the primary reference does not expressly disclose the material, Gardiner fills this gap by disclosing “[g]uide 10 is comprised of a body portion 12 which is made from a substantially flexible and flat sheet-like material”. (Gardiner, col. 2, ll. 20-22.)
Claim 13: The apparatus of claim 3, wherein the elongated tubular sleeve defines an opening having a generally elongated ovular shape.
To the extent the primary reference does not expressly disclose the shape of the opening, Gardiner discloses “a plurality of holes 32 passing therethrough”. (Gardiner, col. 2, ll. 47-48.)
Modifying the shape of the hole to be elongated or ovular to match the underlying cannulation chamber would have been an ordinary application of Gardiner's disclosed model to ensure the needle properly accesses the port.
Moreover, in relation to changes in shape, the court in In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) held that the configuration of a disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In the case at hand, the shape in question is not considered to be significant, and therefore, the shape modification is considered an obvious alternative in the design of the apparatus. (see MPEP 2144.04, IV, (B) Changes in Shape.)
Claim 14: The guiding apparatus of claim 13, wherein the opening is a first opening and the elongated tubular sleeve defines a second opening that is circumferentially spaced from the first opening.
To the extent the primary reference does not expressly disclose multiple openings, Gardiner fills this gap by disclosing “a plurality of holes 32 passing therethrough”. (Gardiner, col. 2, ll. 47-48.)
Claim 15: The apparatus of claim 3, wherein the elongated tubular sleeve defines a pocket.
Gardiner discloses “[a] plurality of pockets 14, 16 and 18 are formed in the body portion 12 adjacent one edge thereof.” (Gardiner, col. 2, ll. 22-24.)
Claim 16: The apparatus of claim 15, wherein the pocket is defined in part by a layer of material configured to be placed adjacent to skin of the subject.
Gardiner discloses “the device can be mounted about a person's thigh with either the front surface of the body portion 12 exposed and the rear surface against the person's leg”. (Gardiner, col. 2, ll. 42-46.)
Claim 17: The apparatus of claim 16, further comprising an applicator, the pocket configured to receive and retain the applicator.
Gardiner discloses “Pocket 14 is constructed so as to be sufficiently large to store one or more syringes therein.” (Gardiner, col. 2, ll. 26-28.)
Claim 18: The apparatus of claim 17, wherein the applicator device defines a needle passage.
Gardiner discloses storing syringes in the pocket. (Gardiner, col. 2, ll. 24-27.) A syringe inherently includes a needle passage.
Motivation to combine [applicable to claims 3 and 12-18].
Based on the above teachings, it would have been obvious to a person of ordinary skill in the art to combine the graft of Gage with the rigid body member of Bangera and the sleeve/pocket securing mechanism of Gardiner. The rationale is to provide a rigid, conforming guide that accurately targets the cannulation port of the underlying graft (Bangera) while utilizing a convenient, wearable strap and pocket system (Gardiner) to securely hold the guide in place on the patient's limb during the hemodialysis procedure.
Claims 4, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gage et al. (US 2014/001872A1; hereinafter “Gage”) in view of Bangera et al. (US 9,199,044B2; hereinafter “Bangera”) and Yang (US 2010/0198153A1).
In relation to independent claim 4, this claim recites a kit comprising: at least one dialysis needle for accessing an arteriovenous dialysis access graft subcutaneously implanted in a body of a subject, the arteriovenous dialysis graft including a flexible conduit defining a longitudinal flow passageway and having a first end portion configured to connect to an artery of the subject and a second end portion configured to connect to a vein of the subject such that blood flows through the longitudinal flow passageway of the conduit from the first end portion to the second end portion, and a cannulation chamber defining a cannulation port, the conduit extending through the cannulation chamber for receiving the needle inserted through the cannulation port; a dispenser; and a plurality of elongated body members, each body member having a longitudinal axis and an inner surface, the body member comprising a base portion terminating in longitudinal edges, a distance between the longitudinal edges of the base portion being substantially equal to a lateral dimension of the cannulation chamber, wherein the body member is adapted to be secured adjacent the subcutaneous cannulation chamber such that the legs operatively engage the cannulation chamber for aligning the inner surface of the base portion with the cannulation port for guiding location of a needle insertion, and wherein each body member has at least one passage opening into the inner surface of the body member for passing a needle, the needle passage of the body member being in a different position than the needle passage of any other body member.
A kit comprising: at least one dialysis needle for accessing an arteriovenous dialysis access graft subcutaneously implanted in a body of a subject....
Gage discloses the arteriovenous dialysis access graft with a flexible conduit and a cannulation chamber defining a cannulation port. (Gage ¶ [0010].)
a dispenser; and a plurality of elongated body members, each body member having a longitudinal axis and an inner surface, the body member comprising a base portion terminating in longitudinal edges, a distance between the longitudinal edges of the base portion being substantially equal to a lateral dimension of the cannulation chamber, wherein the body member is adapted to be secured adjacent the subcutaneous cannulation chamber such that the legs operatively engage the cannulation chamber for aligning the inner surface of the base portion with the cannulation port for guiding location of a needle insertion.
Gage does not expressly disclose the plurality of body members. Bangera fills this gap by disclosing “[a] wearable injection guide includes, but is not limited to: a rigid material formed to substantially conform in shape to a topography of a body region of an individual, the rigid material substantially impenetrable to an injection needle, and the rigid material including one or more injection needle access regions arranged in a treatment pattern.” (Bangera, col. 2, ll. 8-14.)
and wherein each body member has at least one passage opening into the inner surface of the body member for passing a needle, the needle passage of the body member being in a different position than the needle passage of any other body member.
Bangera discloses injection needle access regions. To the extent Bangera does not expressly disclose providing a plurality of guides with needle passages in different positions to vary the injection site, Yang fills this gap by disclosing “[w]hen insulin is repetitively injected at the same spot of a patient, lipohyperplasia may occur to the patient. Thus, the patient is required to continuously move an injection spot.” (Yang ¶ [0007].) Yang further discloses a sheet where “A plurality of injection holes is formed... A day of a week is indicated corresponding to and adjacent to each of the injection holes.” (Yang ¶ [0012].) Providing a kit with multiple guides, each having a hole in a different position, achieves the same goal of rotating injection sites to prevent tissue damage.
Claim 19: The kit of claim 4, further comprising an elongated tubular sleeve having a longitudinal axis, the sleeve defining an pocket having a longitudinal dimension and a lateral dimension configured to receive the body member.
To the extent the primary references do not expressly disclose a sleeve with a pocket, Gardiner fills this gap by disclosing “a guide for informing an insulin user as to where to administer an injection. The guide is comprised of a flexible sheet-like material... A pair of straps including Velcro attachments are adapted to support the guide”. (Gardiner, col. 1, ll. 42-48.) Gardiner further discloses “[a] plurality of pockets 14, 16 and 18 are formed in the body portion 12”. (Gardiner, col. 2, ll. 22-24.)
Claim 20: The kit of claim 19, wherein the sleeve defines an opening having a generally elongated ovular shape.
To the extent the primary references do not expressly disclose the shape of the opening, Gardiner discloses “a plurality of holes 32 passing therethrough”. (Gardiner, col. 2, ll. 47-48.) Modifying the shape of the hole to be elongated or ovular would be an obvious design choice.
Motivation to combine [applicable to claims 4, 19, and 20].
Based on the above teachings, it would have been obvious to a person of ordinary skill in the art to combine the graft of Gage with the rigid body member of Bangera and the varied-position concept of Yang. The rationale is to provide a comprehensive kit that allows a patient to accurately target the cannulation port of the graft (Bangera) while systematically rotating the exact needle insertion site across multiple dialysis sessions to prevent tissue damage and graft degradation, as taught by Yang. Adding the sleeve and pocket of Gardiner provides a convenient way to secure these interchangeable body members to the patient.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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