DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-6 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the limitation “is implanted in a patient and bypasses a section of the intestine” encompasses the human body.
Claims 2-6 are rejected as dependents of claim 1.
Regarding claim 2, the limitation "wherein the sleeve is anchored at a pyloric junction of a patient joining the stomach and the intestine" claims the human body.
Claims 3-5 are rejected as dependents of claim 2.
Regarding claim 3, the limitation "one flange on an intestinal side and one flange on a stomach side” claims the human body.
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 1-6 and 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). See MPEP 2173.05(p). In this case, the limitation “is implanted” and “used in combination” suggests a method claim while the device is a product (system) claim, making the claim both claim an apparatus and method steps of using the apparatus. Consequently, claim 1 is indefinite.
Claims 2-6 are rejected as dependents of claim 6.
Regarding claim 2, the limitation “the sleeve is anchored at a pyloric junction” renders the claim indefinite, as this suggests a method claim while the device is a product claim, making the claim both claim an apparatus and method steps of using the apparatus.
Claims 3-5 are rejected as dependents of claim 2.
Regarding claims 6 and 20, the limitation “otherwise modified” renders the claim indefinite as it is unclear what the scope of this term is and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-11, 13, 14, and 17-20 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Thompson et al. (WO 2012/103531), disclosed by applicant in an IDS.
Regarding claim 1, Thompson discloses a system capable of affecting intestinal microbial flora (see para. 207, materials disclosed can affect intestinal microbial flora when released) comprising: an intestinal sleeve that is implanted in a patient and bypasses a section of the intestine (see Figs. 11-20, para. 7) and probiotics, prebiotics or pharmacologic therapy used in combination with the intestinal sleeve (para. 205).
Regarding claim 2, Thompson discloses the system further comprising an anchoring element 110, 224, 229, wherein the sleeve is anchored at a pyloric junction of a patient joining the stomach and the intestine by the anchoring element (see Figs. 11-20).
Regarding claim 3, Thompson discloses wherein the anchoring element comprises two flanges 141, 142 or alternatively 225, 226, with one flange on an intestinal side and one flange on a stomach side (see Figs. 5, 6, 18, and 19).
Regarding claim 4, Thompson discloses wherein the anchoring element is made from Nitinol (see para. 146).
Regarding claim 5, Thompson discloses wherein the anchoring element further comprises a covering comprising a biocompatible polymer of fabric (see para. 143).
Regarding claim 6, Thompson discloses wherein the sleeve is impregnated, coated or otherwise modified to include the probiotics, prebiotics or pharmacologic therapy (see para. 205).
Regarding claim 7, Thompson discloses a method comprising the steps of: implanting an intestinal sleeve in a patient that bypasses a section of the intestine (see Figs. 5 and 6) and administering probiotics, prebiotics or pharmacologic therapy to patient (see para. 207).
The language “of affecting intestinal microbial flora” is directed to the results of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency [Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993)]. As Thompson is capable of affecting intestinal microbial flora with the insulin, penicillin, amoxicillin and various other materials disclosed as released by the sleeve (see para. 207), Thompson fulfills this limitation.
Regarding claim 8, Thompson discloses wherein the sleeve is attached to an anchoring element that anchors the intestinal sleeve at a pyloric junction of the patient (see Figs. 5-6).
Regarding claim 9, Thompson discloses wherein the anchoring element comprises two flanges 141, 142, or alternatively 225, 226, with one flange on an intestinal side and one flange on a stomach side (see Figs. 5-6, 18-19).
Regarding claim 10, Thompson discloses wherein the anchoring element further comprises a covering comprising a biocompatible polymer or fabric (see para. 143).
Regarding claim 11, Thompson discloses wherein the sleeve is implanted in the patient for a finite period of time (see para. 162).
Regarding claim 13, Thompson discloses wherein the probiotics, prebiotics or pharmacologic therapy is administered to the patient when the sleeve is implanted (see para. 205, 207).
Regarding claim 14, Thompson discloses wherein the method further comprises the step of removing the sleeve from the patient (see para. 162).
Regarding claim 17, Thompson discloses wherein the sleeve is implanted endoscopically (see para. 2).
Regarding claim 18, Thompson discloses wherein the sleeve is removed endoscopically (see para. 2).
Regarding claim 19, Thompson discloses a method comprising the steps of: implanting a sleeve in the patient's intestine that bypasses a section of the intestine (see Figs. 1, 5, and 6); and removing the sleeve after a period of time (see paragraph 162) and after intestinal microbial flora has been affected (see paragraph 207).
The language “of affecting intestinal microbial flora” is directed to the results of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency [Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993)]. As Thompson is capable of affecting intestinal microbial flora (see para. 207, release of various materials that can affect intestinal microbial flora), Thompson fulfills this limitation.
Regarding claim 20, Thompson discloses wherein the sleeve is impregnated, coated or otherwise modified to include probiotics, prebiotics or pharmacologic therapy (see para. 205, 207).
Claims 1, 2, 6, 7, and 13 are rejected under pre-AIA 35 U.S.C. 102(a) or, alternatively 102(e), as being anticipated by Raven et al. (Pub. No. US 2012/0232460), disclosed by Applicant in an IDS.
Regarding claim 1, Raven discloses a system capable of affecting intestinal microbial flora (see paragraphs 62-64) comprising: an intestinal sleeve 12 that is implanted in a patient and bypasses a section of the intestine (see Fig. 1); and probiotics, prebiotics or pharmacologic therapy used in combination with the intestinal sleeve (see para. 62-64).
Regarding claim 2, Raven discloses the system further comprising an anchoring element 32, wherein the sleeve is capable of being anchored at a pyloric junction of a patient joining the stomach and the intestine by the anchoring element (see Fig. 2).
Regarding claim 6, Raven discloses wherein the sleeve is impregnated, coated or otherwise modified to include the probiotics, prebiotics or pharmacologic therapy (see para. 62-64).
Regarding claim 7, Raven discloses a method comprising the steps of: implanting an intestinal sleeve in a patient that bypasses a section of the intestine (see Fig. 1); and administering probiotics, prebiotics, or pharmacologic therapy to a patient (see para. 62-64).
The language “of affecting intestinal microbial flora” is directed to the results of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency [Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993)]. As Raven discloses a device capable of affecting intestinal microbial flora (see para. 62-64), Thompson fulfills this limitation.
Regarding claim 13, Raven discloses wherein the probiotics, prebiotics or pharmacologic therapy is administered to the patient when the sleeve is implanted (see para. 62-64).
Claim Rejections - 35 USC § 103
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 of this title, 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-11, 13, 14, and 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Belhe et al. (Pub. No. US 2010/0256775), disclosed by Applicant in an IDS, in view of Raven.
Regarding claim 1, Belhe discloses a system comprising: an intestinal sleeve (see para. 6, 11, 15, 37) that is implanted in a patient and bypasses a section of the intestine (see Fig. 1); and probiotics, prebiotics or pharmacologic therapy used in combination with the intestinal sleeve (see para. 96, use of drugs).
Belhe does not disclose the system for affecting intestinal microbial flora.
Raven discloses the use of drugs within the intestine that would affect intestinal microbial flora in the form of an active agent used to treat the patient (see para. 62-64). It would have been obvious to a person having ordinary skill in the art at the time of invention to use drugs such as those disclosed by Raven in the system of Belhe in order to treat the patient, the drugs affecting intestinal microbial flora.
Regarding claim 2, the system of Belhe and Raven is disclosed above, and Belhe further discloses the system comprising an anchoring element, wherein the sleeve is anchored at a pyloric junction of a patient joining the stomach and the intestine by the anchoring element (see Fig. 77).
Regarding claim 3, the system of Belhe and Raven is disclosed above, and Belhe further discloses wherein the anchoring element comprises two flanges, with one flange on an intestinal side and one flange on a stomach side (see Fig. 77).
Regarding claim 4, the system of Belhe and Raven is disclosed above, and Belhe further discloses wherein the anchoring element is made from Nitinol (see para. 6, 95, 101).
Regarding claim 5, the system of Belhe and Raven is disclosed above, and Belhe further discloses wherein the anchoring element further comprising a covering comprising a biocompatible polymer or fabric (see para. 96).
Regarding claim 6, the system of Belhe and Raven is disclosed above, but these references as described above do not specifically disclose wherein the sleeve is impregnated, coated or otherwise modified to include the probiotics, prebiotics or pharmacologic therapy.
However, Raven discloses wherein a sleeve is impregnated, coated or otherwise modified to include probiotics, prebiotics, or pharmacologic therapy in order to treat a patient and control the treatment of active agents to a patient (see paragraphs 62-64). It would have been obvious to a person having ordinary skill in the art at the time of invention to have the combination of Belhe and Raven further include wherein the sleeve is impregnated, coated or otherwise modified to include probiotics, prebiotics, or pharmacologic therapy in order to treat a patient and control the treatment of active agents to a patient, as disclosed by Raven.
Regarding claim 7, Belhe discloses a method comprising the steps of: implanting an intestinal sleeve in a patient that bypasses a section of the intestine (see Figs. 1 and 77); and administering probiotics, prebiotics or pharmacologic therapy to a patient (see paragraph 96).
Belhe does not disclose the method for affecting intestinal microbial flora.
Raven discloses the use of drugs within the intestine that would affect intestinal microbial flora in the form of an active agent used to treat the patient (see para. 62-64). It would have been obvious to a person having ordinary skill in the art at the time of invention to use drugs such as those disclosed by Raven in the method of Belhe in order to treat the patient, the drugs affecting intestinal microbial flora.
Regarding claim 8, the method of Belhe and Raven is disclosed above, and Belhe further discloses wherein the sleeve is attached to an anchoring element that anchors the intestinal sleeve at a pyloric junction of the patient (see Fig. 77).
Regarding claim 9, the method of Belhe and Raven is disclosed above, and Belhe further discloses wherein the anchoring element comprises two flanges, with one flange on an intestinal side and one flange on a stomach side (see Fig. 77).
Regarding claim 10, the method of Belhe and Raven is disclosed above, and Belhe further discloses wherein the anchoring element further comprises a covering comprising a biocompatible polymer of fabric (see para. 96).
Regarding claim 11, the method of Belhe and Raven is disclosed above, and Belhe further discloses wherein the sleeve is implanted in the patient for a finite period of time (see para. 2, 5, 6, 10).
Regarding claim 13, the method of Belhe and Raven is disclosed above, and Belhe further discloses wherein the probiotics, prebiotics or pharamacologic therapy is administered to the patient when the sleeve is implanted (see rejection of claim 7, with the coating, once implanted the therapy would be administered).
Regarding claim 14, the method of Belhe and Raven is disclosed above, and Belhe further discloses the step of removing the sleeve from the patient (see para. 107).
Regarding claims 17 and 18, the method of Belhe and Raven is disclosed above, and Belhe further discloses wherein the sleeve is implanted and removed endoscopically (see para. 2, 6, 10, 11, 16, 17, 20, 26, 107).
Regarding claim 19, Belhe discloses a method comprising the steps of: implanting a sleeve in the patient’s intestine that bypasses a section of the intestine (see Fig. 1 and 77); and removing the sleeve after a period of time (see para. 2, 5, 6, 10, 107).
Belhe does not disclose the method for affecting intestinal microbial flora in a patient.
Raven discloses the use of drugs within the intestine that would affect intestinal microbial flora in the form of an active agent used to treat the patient (see paragraphs 62-64). It would have been obvious to a person having ordinary skill in the art at the time of invention to use drugs such as those disclosed by Raven in the method of Belhe in order to treat the patient, the drugs affecting intestinal microbial flora. Additionally, the removal would be done after the intestinal microbial flora has been affected, as the drugs would interact with the body once the device has been placed in the body.
Regarding claim 20, the method of Belhe and Raven is disclosed above, but the combination described above does not specifically disclose wherein the sleeve is impregnated, coated or otherwise modified to include the probiotics, prebiotics or pharmacologic therapy.
However, Raven discloses wherein a sleeve is impregnated, coated or otherwise modified to include probiotics, prebiotics, or pharmacologic therapy in order to treat a patient and control the treatment of active agents to a patient (see paragraphs 62-64). It would have been obvious to a person having ordinary skill in the art at the time of invention to have the combination of Belhe and Raven further include wherein the sleeve is impregnated, coated or otherwise modified to include probiotics, prebiotics, or pharmacologic therapy in order to treat a patient and control the treatment of active agents to a patient, as disclosed by Raven.
Claims 7, 12, and 14-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Belhe in view of Schiffrin (Pub. No. US 2010/0135971), as disclosed in an IDS.
Regarding claim 7, Belhe discloses a method comprising the steps of : implanting an intestinal sleeve in a patient that bypasses a section of the intestine (see Figs. 1 and 77) as well as administering pharmacologic therapy to a patient (see paragraph 96). However, Belhe does not disclose the method for affecting intestinal microbial flora.
Schiffrin discloses administering probiotics, prebiotics or pharmacologic therapy to a patient for affecting intestinal microbial flora in order to treat the patient before and/or after surgery (see para. 96, 99, three days before surgery) as well as to reduce complications of post-operative sepsis (see para. 25). It would have been obvious to a person having ordinary skill in the art at the time of invention to administer probiotics, prebiotics or pharmacologic therapy to a patient for affecting intestinal microbial flora within the method of Belhe in order to treat the patient three days before and/or after surgery as well as to reduce complications of post-operative sepsis, as disclosed by Schiffrin.
Regarding claim 12, the teachings of Belhe and Schiffrin are disclosed above, and further disclose wherein the probiotics, prebiotics or pharmacologic therapy is administered to the patient starting a few days before the sleeve is implanted (see rejection of claim 1 above).
Regarding claim 14, the teachings of Belhe and Schiffrin are disclosed above, and Belhe further discloses removing the sleeve from the patient (see para. 107).
Regarding claim 15, the teachings of Belhe and Schiffrin are disclosed above, and further disclose wherein the probiotics, prebiotics or pharmacologic therapy is administered to the patient starting a few days prior to removing the sleeve (see rejection of claim 7, a few days before surgery would include a few days before the removal surgery).
Regarding claim 16, the teachings of Belhe and Schiffrin are disclosed above, and further disclose wherein the probiotics, prebiotics or pharmacologic therapy is administered to the patient after the sleeve is removed (see rejection of claims 7 and 14, administration of therapy after surgery and surgery would occur after sleeve is removed). As this combination discloses starting therapy after surgery, then after surgery would include the day of removal surgery.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-11, 13, 14, 16, 19, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,159,699, hereinafter ‘699.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘699 includes all the limitations required by claims 1 and 6 of the current application; claim 2 of ‘699 includes those limitations required by claim 2 of the current application; claim 3 of ‘699 includes those limitations required by claim 3 of the current application; claim 4 of ‘699 includes those limitations required by claim 4 of the current application; claim 5 of ‘699 includes those limitations required by claim 5 of the current application; claim 1 of ‘699 discloses those limitations required by claim 7 of the current application as use of the device of claim 1 would lead to the method of claim 7 of the current application; claim 2 of ‘699 discloses those limitations required by claim 8 of the current application; claim 3 of ‘699 discloses those limitations required by claim 9 of the current application; claim 5 of ‘699 discloses those limitations required by claim 10 of the current application; claim 1 of ‘699 would lead to those limitations required by claim 11 of the current application in use of the device of claim 1 and the period of placement of that device would be finite due to claim 1 including implantation and removal of device; claim 1 of ‘699 discloses those limitations required by claim 13 of the current application due to configuration of treatment while the intestinal sleeve is implanted; claim 1 of ‘699 includes those limitations required by claim 14 of the current application due to claim 1 having the sleeve being removable; claim 1 of ‘699 includes those limitations required by claim 16 of the current application as the treatment of claim 1 promotes beneficial microbial flora along the treatment length after the sleeve is removed; claim 1 of ‘699 includes those limitations required by claim 19 of the current application as the use of the device of claim 1 in being configured to be removed suggests removal of the sleeve and having microbial flora affected while the sleeve is implanted suggests removal after microbial flora has been affected; and claim 1 of ‘699 discloses those limitations required by claim 20 of the current application as those limitations would be required in the use of the device of claim 1.
Claims 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,159,699, hereinafter ‘699, in view of Schriffin.
Regarding claims 12 and 15, claim 1 of ‘699 discloses substantially all limitations required by claims 12 and 15 in use of the device of claim 1 except for the probiotics administered to the patient starting a few days before the sleeve is implanted or the probiotics being administered to the patient starting a few days prior to removing the sleeve.
Schiffrin discloses administering probiotics, prebiotics or pharmacologic therapy to a patient for affecting intestinal microbial flora in order to treat the patient before and/or after surgery (see para. 96, 99, three days before surgery) as well as to reduce complications of post-operative sepsis (see para. 25). It would have been obvious to a person having ordinary skill in the art at the time of invention to administer probiotics, prebiotics or pharmacologic therapy to a patient for affecting intestinal microbial flora within the method of using device of claim 1 of ‘699 in order to treat the patient three days before and/or after surgery as well as to reduce complications of post-operative sepsis, as disclosed by Schiffrin, which would lead to a few days before the surgery of implantation of the sleeve and a few days before the surgery of the removal of the sleeve.
Claims 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,159,699, hereinafter ‘699, in view of Belhe.
Regarding claims 17 and 18, claim 1 of ‘699 discloses substantially all limitations required by claims 12 and 15 in use of the device of claim 1 except for the sleeve implanted endoscopically or removed endoscopically.
Belhe discloses wherein an intestinal sleeve is implanted and removed endoscopically (see para. 2, 6, 10, 11, 16, 17, 20, 26, 107). It would have been obvious to a person having ordinary skill in the art at the time of invention to have the method of use of the device of claim 1 of ‘699 include implantation and removal endoscopically, disclosed by Belhe, in order to implant and remove the device, as claim 1 of ‘699 discloses the device configured for implantation and removal.
Claims 1-3, 5, 7-11, 13-14, and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 9, or 10 of U.S. Patent No. 11,793,839, hereinafter ‘839. Although the claims at issue are not identical, they are not patentably distinct from each other because the following claims of the current application are disclosed by the following claims of ‘839:
Application claims
1
2
3
5
7
8
‘839 claims
1
4
5
6
1
4
Application claims
9
10
11
13
14
16
‘839 claims
5
6
1
9
1
9
Application claims
17
18
19
‘839 claims
10
10
1
Claims 4, 6, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 or 1 of ‘839 in view of Thompson.
Regarding claim 4, claim 4 of ‘839 discloses substantially all limitaitons required by claim 4 except the anchoring element made from Nitinol.
Thompson discloses the system further comprising an anchoring element 110, 224, 229, wherein the sleeve is anchored at a pyloric junction of a patient joining the stomach and the intestine by the anchoring element (see Figs. 11-20), the anchoring element made from Nitinol (see par. 146). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Consequently, It would have been obvious to a person having ordinary skill in the art at the time of invention to have the anchor made of Nitinol as Thompson discloses such a material acting an anchor at a pyloric junction, and therefore Thomson shows that such a material is suitable for its intended use, similar to as in Sinclair.
Regarding claims 6 and 20, claim 1 of ‘839 discloses substantially all limitations required by claims 1 and 19 except that the sleeve is impregnated, coated or otherwise modified to include the probiotics, prebiotics or pharmacologic therapy.
Thompson discloses wherein the sleeve is impregnated, coated or otherwise modified to include the probiotics, prebiotics or pharmacologic therapy (see para. 205). It would have been obvious to a person having ordinary skill in the art at the time of invention to have the sleeve impregnated, coated or otherwise modified to include pharmacologic therapy, as disclosed by Thompson, to therapeutically treat the patient with additional drugs, peptides, or other therapeutics.
Claims 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘839 in view of Schriffin.
Regarding claims 12 and 15, claim 1 of ‘839 discloses substantially all limitations required by claims 12 and 15 in use of the device of claim 1 except for the probiotics administered to the patient starting a few days before the sleeve is implanted or the probiotics being administered to the patient starting a few days prior to removing the sleeve.
Schiffrin discloses administering probiotics, prebiotics or pharmacologic therapy to a patient for affecting intestinal microbial flora in order to treat the patient before and/or after surgery (see para. 96, 99, three days before surgery) as well as to reduce complications of post-operative sepsis (see para. 25). It would have been obvious to a person having ordinary skill in the art at the time of invention to administer probiotics, prebiotics or pharmacologic therapy to a patient for affecting intestinal microbial flora within the method of using device of claim 1 of ‘839 in order to treat the patient three days before and/or after surgery as well as to reduce complications of post-operative sepsis, as disclosed by Schiffrin, which would lead to a few days before the surgery of implantation of the sleeve and a few days before the surgery of the removal of the sleeve.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781