DETAILED ACTION
Notice of 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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 4 is 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.
Claim 4 recites the limitation "the anchor member of the occlusion device” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2 and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gupta et al. (US Patent Publication 2019/0298559).
Claim 1: Gupta’559 discloses a method of bypassing a duodenum portion of a small intestine (Figure 2f), the method comprising:
creating an anastomosis between a stomach and a jejunum portion of the small intestine (Figure 2f; paragraph [0029]).
positioning an occlusion device (265) within the duodenum portion (Figure 2f; paragraph [0030]); and
positioning a bypass device (260) at the anastomosis and extending along the jejunum portion (Figure 2f; the widened, anchoring portion of element 260 is positioned along the jejunum).
Claim 2: Gupta’559 discloses the occlusion device is positioned adjacent a pyloric sphincter (Figure 2f; paragraph [0037]).
Claim 9: Gupta’559 discloses a method of bypassing a proximal portion of a small intestine (Figure 2f), the method comprising:
positioning an occlusion device (265) in the small intestine at a location between a stomach and the proximal portion of the small intestine (Figure 2f);
forming an anastomosis between the stomach and a location of the small intestine that is distal of the proximal portion of the small intestine (Figure 2f; paragraph [0030]); and
positioning a bypass device (260) through the anastomosis and into the small intestine that is distal of the anastomosis (Figure 2f; the widened, anchoring portion of element 260 is positioned distal of the anastomosis).
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 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 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.
Claims 5 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta’559, as applied to claims 1 and 9, further in view of Levy et al. (US Patent 7,803,195).
Claim 5, 13: Gupta’559 does not teach the occlusion device is an inflatable balloon.
Like Gupta’559, Levy’195 teaches an occlusion device (10 comprising 20, 30, 40; column 10, lines 50-62; column 11, lines 14-49) located in the pylorus (Figure 2). Levy’195 teaches an occlusion device (10, Fig. 14) includes an occlusion member in the form of an inflatable balloon 23’’, 23’’) (column 11, lines 15-50) in order to control the occlusion level depending on if the practitioner is seeking rapid weight loss or maintain a particular weight (column 11, lines 30-35).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify Gupta’559’s occlusion member 265 with the inflatable occlusion member taught by Levy’195 to control the occlusion level depending on if the practitioner is seeking rapid weight loss or to maintain a particular weight (column 11, lines 30-35).
Claim 14: Levy’195 further teaches the inflatable occlusion member (23’’) includes an inflation port (12’’). Levy’195 does not explicitly show an inflation line in Figure 14, but in an alternate embodiment, Levy’195 teaches an inflation line 16 connects with a port 12 (column 8, lines 51-55 and Figure 8). It would be obvious to provide Levy’195’s occlusion member 23’’ with an inflation line since it is needed to inflate the balloon via the port 12’’, as described at column 11, lines 35-40.
Claim 15: Levy’195 teaches an inflation line (16) is removably coupled to an inflation port at column 8, lines 51-55 and Figure 8-9). It would be obvious the inflation line (discussed in claim 4 above) needed to connect with port 12’’ would also be removably coupled with the occlusion since Levy’195 teaches a removable inflation line connecting with an inflation port in a different embodiment.
Claim 16: Gupta’559 does not teach the occlusion member is a bumper made of a soft, pliable material.
Like Gupta’559, Levy’195 teaches an occlusion device (10 comprising 20, 30, 40; column 10, lines 50-62; column 11, lines 14-49) located in the pylorus (Figure 2). Levy’195 teaches an occlusion device (10, Fig. 14) includes an occlusion member in the form of an inflatable balloon 23’’, 23’’) (column 11, lines 15-50) in order to control the occlusion level depending on if the practitioner is seeking rapid weight loss or maintain a particular weight (column 11, lines 30-35). The inflatable occlusion member (23’’) taught by Levy’195 (see the rejection to claim 3 above) is considered a bumper formed of a soft pliable material because the balloon moves from an unexpanded delivery configuration towards an expanded configuration. The balloon will be soft in at least the unexpanded configuration because it is flexible.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify Gupta’559’s occlusion member 265 with the inflatable occlusion member taught by Levy’195 to control the occlusion level depending on if the practitioner is seeking rapid weight loss or to maintain a particular weight (column 11, lines 30-35).
Claim 17: Gupta’559 does not teach the occlusion device comprises a tubular body that extends along the proximal portion of the small intestines.
Like Gupta’559, Levy’195 teaches an occlusion device (10 comprising 20, 30, 40; column 10, lines 50-62; column 11, lines 14-49) located in the pylorus (Figure 2). Levy’195 teaches providing the occlusion device (10) with a tubular body (50) that extends through the jejunum (column 7, lines 48-50) in order to provide a bypass of a length of absorptive tissue in order to reduce absorption of nutrients (column 7, lines 50-53).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Gupta’559 with the tubular body taught by Levy’195 such that the occlusion device of Gupta’559 would extend from an anastomosis between the stomach and the small intestine (i.e. the jejunum), in order to provide a bypass of a length of absorptive tissue and enhance the obesity treatment device.
Claim 18: The tubular body (50) of Levy’195 is tapered and flexible (Figure 2 shows tapered; it is flexible because it follows the shape of the small intestines in Figure 2).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gupta’559, as applied to claims 1 and 9, further in view of in view of Zhang et al. (WO 2019/009918).
For ease, the Office notes WO 2019/009918 is available as US Patent Publication 2020/0170641; however, the rejection relies solely on the WIPO document.
Claim 19: Gupta’559 fails to disclose the bypass device includes a liner configured to extend from the anastomosis through a portion of a jejunum; and an anchor member at a proximal end portion of the liner.
Like Gupta’559’s element 260, Zhang’918 teaches an anastomosis device (10) for maintaining a passageway between the stomach and jejunum (Figure 3). Zhang’918 additionally teaches providing the device with an anchor (20) and a liner (250; Figure 3) in order to limit nutrient contact to provide additional efficacy for obesity treatment compared to the anastomosis alone (paragraph [0048]). The term “anchor member” is interpreted under 112f to have a conical shape or equivalents thereof – see paragraph [0011] of the instant specification. Zhang’918’s anchor (20) aids in directing food through the anastomosis to exclude the lined portions of the stomach and accelerate food delivery to the jejunum to mimic roux-en-y gastric bypass surgery (paragraph [0046]). It is considered equivalent to the claimed “anchor member” because it is disclosed as an anchor.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Gupta’559, as modified, with the anchor and liner, as taught by Zhang’918, in order to provide the stated advantages.
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 § 2146 et seq. 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.
The claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1-7, 9-19 are is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,161,574. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘574 patent, as outlined in the chart below:
Claims of present application 18/937,754
Anticipated by claims of 12,161,574
1
1
2
1
3
1
4
1
5
2
6
1
7
1
9
1
10
1
11
1
12
7
13
2
14
3
15
4
16
5, 6
17
9
18
8
19
1
Claims 1-4, 7, 9, 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/354,155. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘155 application, as outlined in the chart below:
Claims of present application 18/937,754
Anticipated by claims of 18/354,155
1
1
2
1
3
4
4
7
4
9
1
10
1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/354,286. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘286 application, as outlined in the chart below:
Claims of present application 18/937,754
Anticipated by claims of 18/354,286
1
1
2
1
7
1
8
2
9
1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/354,304. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘304 application, as outlined in the chart below:
Claims of present application 18/937,754
Anticipated by claims of 18/354,304
1
1
2
1
7
1
8
1
9
1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 7, 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/223,269. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘269 application, as outlined in the chart below:
Claims of present application 18/937,754
Anticipated by claims of 18/223,269
1
1
2
2
7
1
9
1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 16 of copending Application No. 18/240,112. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘112 application, as outlined in the chart below:
Claims of present application 18/937,754
Anticipated by claims of 18/240,112
1
1, 16
2
1, 16
7
1, 16
8
3
9
1, 16
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 3-4, 6-8, 10-12 and 20 are only rejected under double patenting and/or 35 USC 112. These claims would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and/or to overcome 35 USC 112a rejections and/or a terminal disclaimer is filed to overcome any double patenting rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Wednesday 9:30 am-5 pm and alternating Thursdays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Lindsey Bachman
/L.B./Examiner, Art Unit 3771 20 April 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights