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 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 1-20 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.
Claims 1 and 18 recite the phrases “extending between a jejunal proximal end and a jejunal distal end” and “extending between a gastric proximal and a gastric distal end” and claim 13 recites “a jejunal proximal end,” “a jejunal distal end,” “a gastric proximal end,” and “a gastric distal end.” This phrasing makes it unclear if the distal and proximal ends are the ends of the stomach and jejunum themselves, or the ends of the jejunal tubular member and gastric tubular member. These jejunal and gastric proximal and distal ends are interpreted to be the distal and proximal ends of the jejunal tubular member and gastric tubular member, for examination. Claims 2-12, 14-17 and 19 and 20 are included because claims that depend on a rejected claim inherit the problems of their parent claims.
Claims 11, 12 and 19 recite the limitation "the jejunal gastric member". There is insufficient antecedent basis for this limitation in the claim. It is also unclear what structure "the jejunal gastric member" refers to. For the purposes of examination, the jejunal gastric member is interpreted to refer to the jejunal tubular member and/or the gastric tubular member.
Claim 10 recited the phrase “comprises a subitizable material.” It is unclear what “subitizable” is meant to define, and it is also not supported by the specification. Based on the specification, for purposes of examination, this limitation is interpreted as “comprises a sanitizable 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Soloman (US 20040220516) in view of Vazquez (US 4356824).
Regarding claim 1, Soloman discloses a gastric secretion reinfusion (GSR) system (Fig. 11: para. [0061]), comprising: a jejunal tubular member extending between a jejunal proximal end and a jejunal distal end (Fig. 11: 19; para. [0061], sentence 4, inserted into the jejunum; proximal end at 23, distal end at 22), wherein the jejunal tubular member is dimensioned and configured such that, responsive to the GSR system being inserted into a body, the jejunal proximal end is couplable to a jejunal port (Fig. 11: port where 19 connects to 23), and the jejunal distal end is located in a jejunum of the body (Fig. 11: 22 of 19 located within jejunum per para. [0061]); a gastric tubular member centrally coupled to the jejunal tubular member extending between a gastric proximal and a gastric distal end (Fig. 11: 18, proximal end at 23, distal end at 21), wherein the gastric tubular member is dimensioned and configured such that, responsive to the GSR system being inserted into the body, the gastric proximal end is couplable to a gastric port (Fig. 11: port where 23 connects to 18), and the gastric distal end is located in a stomach of the body (Fig. 11: 21 located in stomach 3); and a gastric secretion reinfusion conduit for coupling the gastric drainage port to the jejunal feeding port and providing a fluid connection between the gastric tubular member and the jejunal tubular member (Fig. 11: 23; para. [0061], last two sentences). However, although Soloman discloses that 23 may be operated via a tube that extends outside the patient’s body, Soloman does not explicitly disclose that the proximal ends of 18 and 19 as well as 23 are located outside of the body.
Vazquez teaches an analogous gastric and jejunal system, wherein the proximal end of the jejunal tubular member (Fig. 1: 45) is located outside of the body (Fig. 1 and claim 1) and comprises a jejunal feeding port (Fig. 1: port where 45 connects to feeding bag), and the proximal end of the gastric tubular member (Fig. 1: 24) is located outside of the body (Fig. 1 and claim 1) and comprises a gastric drainage port (Fig. 1: port where 24 connects to gastric aspirator). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gastric reinfusion system of Soloman by incorporating the teachings of Vazquez that the proximal ends of tubes 18 and 19 as well as 23 be located outside of the body of the patient, in order to allow for easy access to the part for cleaning and adjusting, and to avoid medical complications of implanting the systems.
Regarding claim 2, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, wherein the gastric reinfusion conduit creates fluid communication between the gastric drainage port and the jejunal feeding port (Soloman: Fig. 11: 23 connects 18 to 19).
Regarding claim 3, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, wherein the gastric secretion reinfusion conduit defines a gastric flow path for gastric fluids from the gastric distal end of the gastric tubular member to travel to the jejunal distal end of the jejunal tubular member (Soloman: para. [0061], last three sentences).
Regarding claim 4, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, wherein the jejunal tubular member and the gastric tubular member are coupled to a position assist when in use (Soloman: Fig. 11: position assist balloon anchors 2 and 20).
Regarding claim 5, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, wherein a first end of the gastric reinfusion conduit is connectable the jejunal feeding port (Soloman: Fig. 11: 23 coupled to 19; para. [0061], last three sentences).
Regarding claim 6, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, wherein a second end of the gastric reinfusion conduit is connectable the gastric feeding port (Soloman: Fig. 11: 23 coupled to 18; para. [0061], last three sentences).
Regarding claim 7, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, wherein the jejunal tubular member defines a first flow path of fluid, the first flow path extending both internally and externally to the body, when the gastric secretion reinfusion system is in use (Soloman: Fig. 11: the first flow path being the flow from 23 to 22 through 19; extending also externally to the body according to combination with Vazquez).
Regarding claim 8, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 7, as described above, wherein the gastric member defines a second flow path of fluid, the second flow path extending both internally and externally to the body, when the gastric secretion reinfusion system is in use (Soloman: Fig. 11: the second flow path being the flow from 21 to 23 through 18; extending also externally to the body according to combination with Vazquez).
Regarding claim 9, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 8, as described above, wherein the gastric reinfusion conduit defines a gastric flow path of fluid, the gastric flow path extending externally to the body, when the gastric secretion reinfusion system is in use (Soloman: para. [0061], last three sentences; located outside of the body according to combination with Vazquez).
Regarding claim 13, Soloman discloses a method of providing a gastric secretion reinfusion system, the method comprising the steps of: providing a jejunal tubular member (Fig. 11: 19) having a jejunal proximal end configured to be coupled to a jejunal port (Fig. 11: 19, proximal end at 23) and a jejunal distal end configured to be inserted into a jejunum of a body (Fig. 11: 19, distal end at 22, located within jejunum per para. [0061]); providing a gastric tubular member (Fig. 11: 18) having a gastric proximal end configured to be coupled to a gastric port (Fig. 11: 18, proximal end at 23) and a gastric distal end configured to be inserted into a stomach of the body (Fig. 11: 18, distal end at 21); and providing a gastric secretion reinfusing conduit that is couplable the jejunal feeding port and the gastric drainage port (Fig. 11: 23), the gastric secretion reinfusion conduit for providing a flow path, between the stomach and the jejunum (para. [0061], last three sentences). However, although Soloman discloses that 23 may be operated via a tube that extends outside the patient’s body, Soloman does not explicitly disclose that the proximal ends of 18 and 19 as well as 23 are located outside of the body.
Vazquez teaches an analogous gastric and jejunal system, wherein the proximal end of the jejunal tubular member (Fig. 1: 45) is located outside of the body (Fig. 1 and claim 1) and comprises a jejunal feeding port (Fig. 1: port where 45 connects to feeding bag), and the proximal end of the gastric tubular member (Fig. 1: 24) is located outside of the body (Fig. 1 and claim 1) and comprises a gastric drainage port (Fig. 1: port where 24 connects to gastric aspirator), as well as the analogous gastric secretion port being the aspirator system, being located outside of the body. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gastric reinfusion system of Soloman by incorporating the teachings of Vazquez that the proximal ends of tubes 18 and 19 as well as 23 be located outside of the body of the patient, in order to allow for easy access to the part for cleaning and adjusting, and to avoid medical complications of implanting the systems.
Regarding claim 14, Soloman in view of Vazquez teaches the method of claim 13, as described above, wherein the gastric secretion reinfusion conduit defines a gastric flow path for gastric fluids from the gastric distal end of the gastric tubular member to travel to the jejunal distal end of the jejunal tubular member (Soloman: Fig. 11 and para. [0061], last three sentences).
Regarding claim 15, Soloman in view of Vazquez teaches the method of claim 13, as described above, comprising providing a position assist to secure the jejunal tubular member and the gastric tubular member when in use (Soloman: Fig. 11: 2 and 20, para. [0061], sentences 2 and 4).
Regarding claim 16, Soloman in view of Vazquez teaches the method of claim 13, as described above, comprising providing a first end of the gastric reinfusion conduit, wherein the first end is connectable the jejunal feeding port (Soloman: Fig. 11: 23 coupled to 19; para. [0061], last three sentences).
Regarding claim 17, Soloman in view of Vazquez teaches the method of claim 13, as described above, comprising providing a second end of the gastric reinfusion conduit, wherein the second end is connectable the gastric feeding port (Soloman: Fig. 11: 23 coupled to 18; para. [0061], last three sentences).
Claims 10, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Soloman (US 20040220516) in view of Vazquez (US 4356824) in further view of Blatter (US 7131959).
Regarding claim 10, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, but fails to explicitly teach the material of the gastric reinfusion conduit being sanitizable.
Blatter teaches an analogous implantable tubular system with external ports, wherein the outside portion comprises a sanitizable material (Fig. 2A: external portions of 70a and 70b; col. 7, lines 40-43 and col. 14, lines 30-39). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the external gastric reinfusion conduit portion of the Soloman-Vazquez system by incorporating the Blatter teaching of a sanitizable material in order to allow for the components to be easily and effectively sanitized to avoid infection
Regarding claim 18, Soloman discloses a gastric secretion reinfusion (GSR) system (Fig. 11: para. [0061]), comprising: a jejunal tubular member extending between a jejunal proximal end and a jejunal distal end (Fig. 11: 19; para. [0061], sentence 4, inserted into the jejunum; proximal end at 23, distal end at 22), wherein the jejunal tubular member is dimensioned and configured such that, responsive to the GSR system being inserted into a body, the jejunal proximal end is couplable to a jejunal port (Fig. 11: port where 19 connects to 23), and the jejunal distal end is located in a jejunum of the body (Fig. 11: 22 of 19 located within jejunum per para. [0061]), wherein the jejunal tubular member defines a first flow path of fluid (Fig. 11: the first flow path being the flow from 23 to 22 through 19), when the gastric secretion reinfusion system is in use; a gastric tubular member centrally coupled to the jejunal tubular member extending between a gastric proximal and a gastric distal end (Fig. 11: 18, proximal end at 23, distal end at 21), wherein the gastric tubular member is dimensioned and configured such that, responsive to the GSR system being inserted into the body, the gastric proximal end is couplable to a gastric port (Fig. 11: port where 23 connects to 18), and the gastric distal end is located in a stomach of the body (Fig. 11: 21 located in stomach 3), wherein the gastric member defines a second flow path of fluid (the second flow path being the flow from 21 to 23 through 18), when the gastric secretion reinfusion system is in use; and a gastric secretion reinfusion conduit coupled to the gastric port and to the jejunal port (Fig. 11: 23) and providing a fluid connection between the gastric tubular member and the jejunal tubular member (Fig. 11: 23; para. [0061], last two sentences), wherein the gastric reinfusion conduit defines a gastric flow path of fluid (para. [0061], last three sentences), when the gastric secretion reinfusion system is in use. However, although Soloman discloses that 23 may be operated via a tube that extends outside the patient’s body, Soloman does not explicitly disclose that the proximal ends of 18 and 19 as well as 23 are located outside of the body.
Vazquez teaches an analogous gastric and jejunal system, wherein the proximal end of the jejunal tubular member (Fig. 1: 45) is located outside of the body (Fig. 1 and claim 1) and comprises a jejunal feeding port (Fig. 1: port where 45 connects to feeding bag), and the proximal end of the gastric tubular member (Fig. 1: 24) is located outside of the body (Fig. 1 and claim 1) and comprises a gastric drainage port (Fig. 1: port where 24 connects to gastric aspirator). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gastric reinfusion system of Soloman by incorporating the teachings of Vazquez that the proximal ends of tubes 18 and 19 as well as 23 be located outside of the body of the patient, in order to allow for easy access to the part for cleaning and adjusting, and to avoid medical complications of implanting the systems. It directly follows that this combination for adjusting the location of 23 and the proximal ends of 18 and 19, would result in the first flow path extending both internally and externally to the body, the second flow path extending both internally and externally to the body, and the gastric flow path extending externally to the body. However, Soloman in view of Vazquez fails to explicitly teach that the gastric secretion reinfusion conduit is removable from the ports it is coupled to.
Blatter teaches an analogous implantable tubular system with external ports, wherein the external conduit (Fig. 2C: the blood dialysis pump) is removably coupled to the ports (Fig. 2C: two ports 60; Figs. 2A and 2C; col. 9, lines 7-8). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Soloman-Vazquez device by incorporating the connectable/removable friction-fit coupling of the tubular ports, as taught by Blatter, in order to easily attach the conduit device and remove it for flushing and cleaning of the ports (col. 14, lines 30-44), such that the gastric secretion reinfusion conduit removably couple to the gastric port and to the jejunal port.
Regarding claim 20, Soloman in view of Vazquez in further view of Blatter teaches the gastric secretion reinfusion system of claim 18, as described above, wherein a first end of the gastric reinfusion conduit is connectable the jejunal feeding port and a second end of the gastric reinfusion conduit is connectable the gastric feeding port (Soloman: Fig. 11: 23 coupled to 19 and 18; para. [0061], last three sentences).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Soloman (US 20040220516) in view of Vazquez (US 4356824) in further view of Cragg (US 6315789).
Regarding claim 11, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, but fails to explicitly disclose the connection mechanism of the gastric reinfusion conduit and the jejunal gastric member.
Cragg teaches an analogous fluid-tight, implantable tube system, wherein the conduit is coupled to the member by one of a Luer lock connection mechanism or an interference fit (col. 10, lines 8-12). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular connection between 18/19 and 23, with the luer lock fitting taught by Cragg, in order to form a simple, affordable, fluid tight connection between the structures.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Soloman (US 20040220516) in view of Vazquez (US 4356824) in further view of Swisher (US 8777930).
Regarding claim 12, Soloman in view of Vazquez teaches the gastric secretion reinfusion system of claim 1, as described above, but fails to teach a y connector being coupled to the gastric reinfusion system.
Swisher teaches an analogous implantable tubular system for feeding, with a y connection (Fig. 11: y connector 12), wherein the y connection is concurrently coupled to the jejunal gastric member (Fig. 11: feeding tube 14) and has an open connection for nutritional infusion (Fig. 11: open port 24 for feeding). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection of 19 and 23 in the Soloman-Vazquez device, by incorporating the y connector taught by Swisher, in order to allow for feeding fluid or even medicinal fluid to be selectively added to the fluid flow to the jejunum.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Soloman (US 20040220516) in view of Vazquez (US 4356824) in further view of Blatter (US 7131959) in further view of Gulati (US 20180098917).
Regarding claim 19, Soloman in view of Vazquez in further view of Blatter teaches the gastric secretion reinfusion system of claim 18, as described above, but fails to explicitly teach a y connection with luer lock or interference fit connections.
Gulati teaches an analogous jejunal feeding system, wherein a y connection is concurrently coupled to the jejunal gastric member (Fig. 5: y connector 54 connected to feeding tube to jejunum) by one of a Luer lock connection mechanism or an interference fit (para. [0024], first two sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection of 19 to 23 in the Soloman-Vazquez system, by incorporating the y connector, taught by Gulati, which connects to outer connections/devices via luer lock or interference fit. This incorporation would have been obvious in order to allow for feeding fluid or even medicinal fluid to be selectively added to the fluid flow to the jejunum, and to form a simple, affordable, fluid tight connection between them.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
