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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-14, drawn to a surgical method, classified in USPC 128/898000.
II. Claims 15-21, drawn to an artificial intestinal device, classified in USPC 604/343000.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the device may be used with a laparoscopic procedure.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different classification;--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Tingting Liu on 26AUG2026 a provisional election was made without traverse to prosecute the invention of Group II, claims 15-21. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-14 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 therefore, 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 15-21 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).
Claims 15 and 21 recite “a first incision of the ileum” and “a second incision of the ileum” which is considered to read on a human organism by positively claiming a portion of the ileum.
Claims 16-20 are rejected based on their dependency.
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 15-21 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.
The term “a little bit” in claim 15 is a relative term which renders the claim indefinite. The term “a little bit” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what extent “a little bit” covers in the claim or how much smaller the second incision must be when compared to the diameter of the middle portion.
Claims 16-21 are rejected based on their dependency.
REASONS FOR ALLOWANCE
Claims 16-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
US 7033373 B2 (de la Torre et al.), US 20170165458 A1 (Yu), US 20110015475 A1 (Hanuka et al.), US 20260207372 A1 (Mariani), and US 20160038379 A1 (Delegge et al.) are the closest prior art of record.
De la Torre teaches a fixing member including a first portion, a second portion, and a cushion portion between the first and second portions, wherein the fixing member is flexible and the first and second portions have a long stripe shape.
De la Torre fails to teach the cushion portion is used for being suspended beneath a near terminal ileum portion of an ileum after one of the first portion and the second portion is passed through a mesentery behind the near terminal ileum portion of the ileum or an artificial ileal tube as claimed. While the intragastric system taught by de la Torre similarly restrains an internal organ against the abdominal wall, there is little motivation to combine the device with an artificial ileal tube as claimed, as this would require significant rework to the device for use in the retaining the ileum.
Yu teaches an artificial ileal tube including a middle tube portion, an inflated collector portion and a guiding member having a tip portion at one end and a connection portion at the other end.
Yu fails to teach the claimed fixing member, instead relying on sutures to attach the ileum to the muscle of the abdominal wall. Additionally, due to the design of Yu, alteration to be capable of the claimed insertion through two incisions of the ileum would require a redesign in both form and function of said device.
Hanuka teaches a fixing member including a first portion, second portion, and cushion portion as claimed.
While Hanuka teaches a fixing member which is similar in structure to the claimed device, the device as taught is not capable of being suspended beneath a near terminal ileum portion after one of the first portion and second portion is passed through a mesentery. Passing either the first or second portions through the mesentery would prevent the device from operating as intended and Hanuka therefore fails to teach the claimed device, alone or in combination.
Mariani teaches an artificial ileal tube including a middle tube portion, an inflated collector portion and a guiding member having a tip portion at one end and a connection portion at the other end.
Mariani fails to teach the claimed fixing member, or insertion of the artificial ileal tube through first and second incisions in the ileum. As the device of Mariani is designed to be held against the abdominal wall between the inflated collector portion and retaining means (corresponding to the fixing flange detailed in dependent claims of the instant application), there is no obvious reason to incorporate the fixing member as claimed. Mariani therefore fails to teach the claimed device, alone or in combination.
Delegge teaches an artificial ileal tube including a middle tube portion, an inflated collector portion and a guiding member having a tip portion at one end and a connection portion at the other end.
Delegge fails to teach the claimed fixing member, or insertion of the artificial ileal tube through first and second incisions in the ileum. Delegge relies on a spring clip to cause frictional engagement which retains the system in place and would not readily be modified to incorporate the fixing member as claimed.
While artificial ileal tubes having a middle tube portion, an inflated collector portion and a guiding member having a tip portion at one end and a connection portion at the other end are well known in the art, the devices are not taught to be capable of passing through incisions in the ileum to be positioned as claimed. Additionally, while a variety of fixing elements are known which operate similarly to the claimed fixing member (e.g. twist-ties), these generally lack a cushion portion. Fixing members may usually be substituted where capable of performing the required task, but these members were generally intended for retaining the ileal tube (or similar fluid passing element), and not for use in positioning the ileum against the abdominal wall as detailed in the claims. When considering the simple substitution of one fixation element for another, the inclusion of a cushion portion as claimed serves a function which is not generally required, or considered, in the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
