DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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.
The following claim limitations
Retention mechanism (claim 2)
Locking mechanism (claim 7)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Mechanism (Retention mechanism - claim 2)
Mechanism (Locking mechanism - claim 7)
coupled with functional language
to hold the GJ tube device in place (Retention mechanism - claim 2)
to releasably couple the inner cannula to the outer sheath (Locking mechanism - claim 7)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 2 and 7 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
a balloon (¶0006) (Retention mechanism - claim 2)
threaded tube lock or any suitable locking mechanism
known to or conceivable to one of skill in the art could also be used, including a tab and groove lock or a pressure fitting (¶0037)(Locking mechanism - claim 7)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 1-22 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:
The claim recites the limitation "the gastric and jejunal spaces" in the final line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 1-22 are rejected due to their dependence on claim 1.
Regarding claim 8:
The claim recites the limitation "the locking mechanism" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9:
The claim recites the limitation "the patient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 19:
The claim is unclear because of the limitation “The kit of claim 19” in line 1. The claim depends on itself which is unclear. For the sake of examination, the office has assumed this claim depends on claim 18 however the applicant should amend the claim to clarify.
Regarding claim 21:
The claim limitation “A method of using the device of claim 1 wherein…” in line 1. The claim is unclear for several reasons. First, its unclear where the preamble of the claim ends and the body begins which raises a question of what step is required by the claim. Second, the limitation is unclear since it is a method claim but the claim does not recite a method step to be performed only a wherein statement. For the sake of examination, the office has assumed that the function after the wherein statement is actually a step to be performed. The applicant should amend the claim to address the clarity issues.
Regarding claim 22:
The claim limitation “A method of using the device of claim 1 comprising removing the inner cannula.…” in line 1. It’s unclear where the preamble of the claim ends and the body begins which raises a question of what step is required by the claim. The office has assumed that the preamble ends with comprising however the applicant should amend the claim to clarify (insert a colon after comprising).
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.
Claims 1-3, 7, 9, 11, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5527280 to Goelz.
Goelz discloses:
Regarding claim 1:
A sleeved gastrojejunostomy (GJ) tube device (figure 1) comprising:
an outer sheath (11) having a proximal end (see end B in figure 1 below) and a distal end (see end A in figure 1 below), wherein an outer wall (11) of the outer sheath (11) defines an inner lumen (12) that extends from the proximal end (B in figure 1 below) of the outer sheath (11) to the distal end (A in figure 1 below) of the outer sheath (11);
an inner cannula (32) having a proximal end (see end D in figure 1 below) and a distal end (see end C in figure 1 below), wherein an outer wall (32) of the inner cannula (32) defines an inner lumen (35) that extends from the proximal end (D in figure 1 below) of the inner cannula (32) to the distal end (C in figure 1 below) of the inner cannula (32), wherein the inner cannula (32) is removably disposed within the inner lumen (12) of the outer sheath (11) (32 can be installed through 11 as indicated in column 4, lines 1-13);
a hub (25) disposed at a proximal end of the device (see the proximal end B in figure 1 below), wherein the hub (25) comprises ports (24, 26 and 27) to provide access to the gastric and jejunal spaces (tubes 11 and 32 are gastric tubes and jejunal tubes as indicated in column 4, lines 28-40).
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Figure 1 - figure 1 in Lampropoulos, annotated by the examiner
Regarding claim 2:
The device of claim 1 further comprising a retention mechanism (see the balloon 13 consistent with the 35 USC 112(f) interpretation above) to hold the GJ tube device in place.
Regarding claim 3:
The device of claim 2 wherein the retention mechanism comprises a balloon (13).
Regarding claim 4:
The device of claim 1 wherein the outer sheath (11) and the inner cannula (32) define fenestrations (see the plurality of ports 33 and 36 on the outer sheath and the inner cannula respectively) for delivering medication or other substances to a patient.
Regarding claim 7:
The device of claim 1 further comprising a locking mechanism (see 38 which is consistent with the 35 USC 112(f) interpretation above) to releasably couple the inner cannula to the outer sheath.
Regarding claim 9:
The device of claim 1 further comprising a grommet (14) to cover a stoma (16) of the patient.
Regarding claim 11:
The device of claim 3 wherein the hub (25) is further configured with a balloon port (24) to allow for insufflation of the balloon (column 5, lines 30-45).
Regarding claim 18:
A kit comprising the device of claim 1 (see the kit as shown in figure 1 above).
Regarding claim 19:
The kit of claim 19 further comprising a lubricant (see lubricant mentioned in column 5, lines 30-40).
Note: claims 21 are hybrid method claims that depend on claim 1 however they only recite the structure of the device in claim 21 in the preamble and do not require the complete structure of the claim (only an inner cannula). For this reason, they have been rejected with another reference that teaches the method step and includes the structure required by the body of the claim.
Claims 21 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5772639 A to Lampropoulos et al. (Lampropoulos).
Lampropoulos discloses:
Regarding claim 21:
A method of using the device (figures 22 and 23) of claim 1 wherein the inner cannula (300) can be exchanged outside of a procedure site (column 21, line 62- column 22, line 7 indicate the catheter/cannula 300 can be replaced while keeping the outer sheath 307 in place and exchanging it after the previous catheter/cannula has been inserted (under the broadest reasonable interpretation the previous insertion was the previous procedure site)).
Regarding claim 22:
A method of using the device (figures 22 and 23) of claim 1 comprising removing the inner cannula and delivering nutrition through the outer sheath, as an emergency backup (column 21, line 62- column 22, line 7 indicates the delivery means within the stoma can be maintained while the catheter/cannula is replaced).
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) 5, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5527280 to Goelz as applied to claim 1 above, and further in view of US 20200030575 A1 to Bogusky et al. (Bogusky).
Regarding claim 5:
Goelz fails to disclose:
The device of claim 1 further comprising a stiffener.
Bogusky teaches:
A device (figure 2c) that includes a catheter/cannula (216) that can further include a stiffening mechanism (stiffener) that may include a plurality of NiTiNol wires (¶0067). The addition of the wires allows the catheter/cannula to hold is position or location (¶0067).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goelz to further include a stiffener made of NiTiNol as taught by Bogusky in order for the catheter to hold its location or position when implanted (Bogusky, ¶0067).
Regarding claim 15:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 5 by Goelz and Bogusky:
The device of claim 5 wherein the stiffener is formed from one selected from a group consisting of a shape memory metal (see the NiTiNol wires/stiffener of Bogusky incorporated into Goelz), a hardened strip of plastic, a hardened strip of rubber, and a hardened integral portion of the outer sheath.
Regarding claim 16:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 5 by Goelz and Bogusky:
The device of claim 15 wherein the stiffener is formed from NiTiNol (see the NiTiNol wires/stiffener of Bogusky incorporated into Goelz).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5527280 to Goelz as applied to claim 1 above, and further in view of US 20140323966 A1 to Dziak et al. (Dziak).
Regarding claim 6:
Goelz fails to disclose:
The device of claim 1 further comprising distal weights positioned on a distal end of the outer sheath.
Dziak teaches:
A device that includes GJ tube (26) and further teaches that a weight can be added to the tube to keep the tube in its extended position (¶0011).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goelz to further include weights at the distal end of the outer sheath as taught by Dziak to hold it in position when it has been inserted (Dziak, ¶0011).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5527280 to Goelz as applied to claim 1 above, and further in view of US 20050277900 A1 to Klein et al. (Klein).
Regarding claim 8:
Goelz fails to disclose:
The device of claim 1 wherein the locking mechanism comprises a threaded tube lock.
Klein teaches:
A device including a gastrostomy tube (1) that includes a threaded cap (13)(¶0051) that seals the end of the gastrostomy tube.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goelz to further include replacing frictional fit between the locking mechanism and the hub with a thread as taught by Klein. This is a simple substitution of one known element (friction fit between the locking mechanism and the hub as disclosed by Goelz) for another (threaded connection between the locking mechanism and the hub as taught by Klein) to obtain predictable results (to hold the locking mechanism and the inner cannula in place).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5527280 to Goelz as applied to claim 1 above, and further in view of US 20110098660 A1 to Porreca.
Regarding claim 10:
Goelz fails to disclose:
The device of claim 1 wherein at least a portion of the inner cannula defines a first lumen and a second lumen.
Porreca teaches:
An feeding lumen (figure 5) that includes an outer sheath (340) and an inner cannula (312). The inner cannula defines a first and a second lumen (366 and 326).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goelz to further include two lumens within the inner cannula as taught by Porreca in order to have redundancy in the case that one lumen clogs (Porreca, ¶0067).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5527280 to Goelz as applied to claim 1 above, and further in view of EP 1537891 A2 to Fujikura et al. (Fujikura).
Regarding claim 12:
Goelz fails to disclose:
The device of claim 1 wherein the hub is further configured with a lubrication port to provide lubrication between the outer sheath and the inner cannula.
Fujikura teaches:
An insertion device that includes an outer sheath (52/58) and inner insertion section (12). Further, the system includes a lubricant port (66) that supplies lubricant between the outer sheath and insertion section (¶0040).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goelz to further include a lubricant port on the hub as taught by Fujikura in order to supply lubricant between the outer sheath and the inner cannula (Fujikura, ¶0040).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5527280 to Goelz and EP 1537891 A2 to Fujikura et al. (Fujikura) as applied to claim 12 above, and further in view of US 6656153 B1 to Sakai et al. (Sakai).
Regarding claim 13:
Goelz and Fujikura fail to disclose:
The device of claim 12 further comprising at least one selected from a group consisting of cured silicone coating, oil-based lubricants, MED6670, and MS3130 lubricants.
Sakai teaches:
A device or balloon catheter (figure 8b) that uses a silicone oil for lubricant (column 12, lines 18-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goelz and Fujikura to replace the lubricant used in Goelz with the silicone oil as taught by Sakai. This is a simple substitution of one known element (lubricant of Goelz) for another (silicone oil as taught by Sakai) to obtain predictable results (to lubricate between the outer sheath and the inner cannula).
Claim(s) 14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5527280 to Goelz as applied to claim 1 above, and further in view of US 5092850 A to Buma.
Regarding claim 14:
Goelz fails to disclose:
The device of claim 1 wherein the outer sheath and the inner cannula are formed from silicone.
Buma teaches:
A device that includes a catheter (43) that is made from silicone and the can be made from an injections molding process (column 3, lines 10-15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goelz to replace the material of the outer sheath and the inner sheath with silicone that can be injection molded as taught by Buma. This is a simple substitution of one known element (material of the outer sheath and inner cannula as disclosed by Goelz) for another (silicone as taught by Buma) to obtain predictable results (to form the structure of the outer sheath and inner cannula to supply feeding material to the patient).
Regarding claim 17:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 14 by Goelz and Buma:
The device of claim 14 wherein the device is formed with one selected from a group consisting of a silicone extruder, injection molding (see the silicone made from the injection molding process as taught by Buma and incorporated into Goelz), and casting.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5527280 to Goelz as applied to claim 18 above, and further in view of US 5772639 A to Lampropoulos et al. (Lampropoulos).
Regarding claim 20:
Goelz fails to disclose:
A second kit comprising at least one replacement inner cannula wherein the replacement inner cannula is configured to replace the inner cannula provided in the kit of claim 18.
Lampropoulos teaches:
An assembly including an outer sheath (307) and inner cannular (300). Further, column 21, line 62- column 22, line 7 indicates the catheter/cannula (300) can be replaced while keeping the outer sheath (307) in place and exchanging it after the previous catheter/cannula has been inserted.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goelz to further include secondary or replacement inner cannulas when the previously inserted cannula needs to be replaced as taught by Lampropoulos in order to effectively retract the catheter without causing discomfort to the patient (Lampropoulos, column 1, lines 54-63).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20030225393-A1
McMichael
See the balloon 42, sheath 51 and inner cannula 22
US-20080097348-A1
Itrich
See the cannula 21 with fenestrations 26
US-20150352014-A1
Lamport
See the sheath 102 and inner cannula 116
US-20030225392-A1
McMichael
See the balloon 42, sheath 51 and inner cannula 22
US-5405334-A
Roth
See outer sheath 48 and inner cannula 22
WO-2016183320-A1
GULATI
See the cannula 22
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783