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 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.
Us9e 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.
In claim 2, means for procuring a biopsy from a desired location. Which are disclosed and actuatable pincers on the end of a catheter
In claim 2, means for administering medicine to the desired location. Which is disclosed as a catheter.
In claim 2, means to tamponade the targeted location. Which is disclosed as a catheter with an inflatable balloon.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: harvesting means in claim 3.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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, 3-5 and 7 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 1, it is unclear how “a fluid” on line 15 is related to that on line 13. They are treated as the same.
In claims 1 and 7, it is unclear how “bidirectional egress” of fluid may occur. Egress suggests only one direction, while bidirectional suggests two. It is treated as an opening allowing flow in both directions.
In claim 3, it is unclear how a harvesting means for grasping samples can consist of the group of a set of pincers, cryobiopsy and a needle. Specifically, how either cryobiopsy or a needle are capable of grasping anything. While they are certainly capable of acquiring samples, it is unclear how they are capable of grasping samples.
In claim 7, it is unclear how “a fluid” is related to that in claim 6.
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) 2, 6-8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grabek et al (US 6,231,518).
Regarding claim 2, Grabek discloses a catheter comprising: a plurality of systems, a first system providing means for procuring a biopsy from a desired location (pincers 200), a second system providing means for administering medicine to the desired location (catheter 106 with fluid port 122)
While Grabek substantially discloses the invention as claimed, it does not disclose a third system providing means to tamponade the targeted location.
Grabek discloses other embodiments where a balloon is used to prevent the device from becoming inadvertently dislodged (figs 20 and 21, balloon 553 for example, Col.15 ll 18-20). This balloon is a material that is flexible.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the embodiment of fig 11 with means to tamponade the targeted location (in the form of a balloon at the end of the catheter), to prevent the device from becoming inadvertently dislodged.
Regarding claim 3, wherein said first system comprises a first tube having a proximal and distal end, wherein a handle is cooperatively connected to the proximal end of said first tube, said distal end having a harvesting means for grasping samples selected from the group consisting of a) a set of pincers; b) cryobiopsy; and c) a needle (pincers 200).
Regarding claim 6, wherein said second system comprises a second tube having a proximal and distal end, wherein said proximal end includes a port for injecting a fluid that promotes coagulation (capable of such via Luer).
Regarding claim 7, wherein said distal end of said second tube includes an opening permitting a bidirectional egress of a fluid (proximal end has a Luer and distal end is capable of accommodating a guidewire through it, Col.9 ll 55-57, thus permitting bidirectional egress of a fluid).
Regarding claim 8, wherein said third system comprises a third tube 103 having a proximal and distal end wherein said third tube is wrapped about said first and said second tube (fig 12).
Regarding claim 10, wherein said distal end of said third tube being made from a material that is flexible (see combination in claim 2, an inflatable balloon is made from flexible material).
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) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grabek et al (US 6,231,518) in view of Faith (US 2017/0157369) and Griego et al (US 2005/0124912).
Regarding claim 1, Grabek discloses a catheter comprising: a plurality of systems, wherein a first system includes a first tube 104 having a proximal and distal end, wherein a handle 110 is cooperatively connected to the proximal end of said first tube, said distal end having a set of pincers 200 for grasping samples, wherein said pincers being cooperatively connected to said handle (fig 11), wherein said handle has several positions, including a first position wherein the pincers are closed (fig 11), a second position wherein the pincers are open (fig 13), and a third position wherein the pincers are partially open (fig 14); a second system includes a second tube 106 having a proximal and distal end, wherein said proximal end includes a port 122 for injecting a fluid that promotes coagulation (via Luer, capable of such), wherein said distal end of said second tube includes an opening permitting a bidirectional egress of a fluid (proximal end has Luer connector for fluid – distal end is capable of accommodating a guidewire, Col.9 ll 55-57, out of it and is thus capable of bidirectional egress of fluid); a third system includes a third tube 103 having a proximal and distal end wherein said third tube is wrapped about said first and said second tube (fig 12).
While Grabel substantially discloses the invention as claimed, it does not disclose the pincers being cooperatively connected to said handle via wires inside said first tube, said proximal end of said third tube having a port to receive a gas supply and gas control valve, nor said distal end of said third tube being made from a material that is flexible where said third tube provides bidirectional passage of a gas enabling inflation and deflation of said distal end of said third tube.
Griego discloses a catheter which uses wires inside a tube to actuate pincers (¶61).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Grabek such that the are pincers cooperatively connected to said handle via wires inside said first tube as taught by Griego as they are known, alternative means by which to actuate pincers in a catheter.
Grabek discloses other embodiments where a balloon is used to prevent the device from becoming inadvertently dislodged (figs 20 and 21, balloon 553 for example, Col.15 ll 18-20). This balloon is a material that is flexible.
Faith discloses a device which has a balloon at the distal end, uses gas, and which has a valve to allow control of gas flow (both toward and away from the balloon, aka bidirectional - ¶58).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Grabek such that said proximal end of said third tube has a port to receive a gas supply and gas control valve, and said distal end of said third tube being made from a material that is flexible where said third tube provides bidirectional passage of a gas enabling inflation and deflation of said distal end of said third tube as taught by both Grabek and Faith in order to prevent the device to be inadvertently dislodged while being used.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grabek et al (US 6,231,518) in view of Griego et al (US 2005/0124912).
Regarding claim 4, wherein said pincers being cooperatively connected to said handle via wires inside said first tube.
Griego discloses a catheter which uses wires inside a tube to actuate pincers (¶61).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Grabek such that the are pincers cooperatively connected to said handle via wires inside said first tube as taught by Griego as they are known, alternative means by which to actuate pincers in a catheter.
Regarding claim 5, wherein said handle has several positions, including a first position wherein the pincers are closed (fig 11), a second position wherein the pincers are open (fig 13), and a third position wherein the pincers are partially open (fig 14).
Claim(s) 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grabek et al (US 6,231,518) in view of Faith (US 2017/0157369).
Regarding claims 9 and 11, while Grabek substantially discloses the invention as claimed, it does not disclose said proximal end of said third tube having a port to receive a gas control valve and a gas supply, nor said third tube provides bidirectional passage of a gas enabling inflation and deflation of said distal end of said third tube.
Grabek discloses other embodiments where a balloon is used to prevent the device from becoming inadvertently dislodged (figs 20 and 21, balloon 553 for example, Col.15 ll 18-20). This balloon is a material that is flexible.
Faith discloses a device which has a balloon at the distal end, uses gas, and which has a valve to allow control of gas flow (both toward and away from the balloon, aka bidirectional - ¶58).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Grabek such that said proximal end of said third tube has a port to receive a gas supply and gas control valve, and said distal end of said third tube being made from a material that is flexible where said third tube provides bidirectional passage of a gas enabling inflation and deflation of said distal end of said third tube as taught by both Grabek and Faith in order to prevent the device to be inadvertently dislodged while being used.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783