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
Applicant’s election of Species c figures 19-28, claims 1-3, 6-21 in the reply filed on 12/10/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
On pages 32 and 56 of the specification WO 2021/209983 is listed., but not provided in an IDS.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it contains two paragraphs. Line 17 should be deleted. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 2, 3, 6-7, 10-15, and 17-20 are objected to because of the following informalities: The preamble of these claims line 1 must be corrected with “The”. Appropriate correction is required.
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 8, 15, and 19-20 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 8, 15, and 19 in line 1, and claim 20: there is no antecedent basis for “the partitioning elements”.
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.
Claim 21 is 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).
Claim 21 set forth “a lumen… sealably isolated …by a partitioning element as claimed in claim 1”. The lumen is part of an elongated body within the human body in light of the specification. Therefore, it is positively claiming part of the human body.
Claim Rejections - 35 USC § 102
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.
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 9, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinnreich (US 4,198,981 A).
Regarding claim 9, Sinnreich discloses (figs 1-3) a method for isolating a first portion of an elongated lumen 26 from a second portion thereof, the method comprising:
providing a partitioning element 10 comprising:
an expandable carrier element 16 extending from a proximal end to a distal end and having a bore 14 extending longitudinally therethrough and being radially expandable from a first state defining a first transverse cross-sectional area to a second state defining a second transverse cross-sectional area greater than the first transverse cross-sectional area,
an isolating element 23 carried on and secured to the carrier element and being urgeable from a non-isolating state to an isolating state as the carrier element expands from the first state thereof to the second state thereof, and
a connector at 15 formed by a part of the carrier element,
the method further comprising:
placing the partitioning element in the lumen at a location between the first and second portions thereof with the carrier element 16 in the first state thereof and the proximal end of the carrier element located adjacent the second portion of the lumen (figs 2-3), and
radially expanding the carrier element 16 from the first state thereof until the one of the isolating element and the carrier element 16 engages an inner surface of the lumen with the isolating element extending transversely across the lumen substantially sealably isolating the first portion thereof from the second portion thereof. Sinnreich discloses (in col. 2 lines 10-16) that both balloons are separately controllable. Therefore, due to the size of inner lumen and balloons one of the balloons (16,23) will engage the inner lumen separating it into first and second portions.
Regarding claim 16, Sinnreich discloses a method for insufflating a first portion of a lumen in which a minimally invasive procedure is to be carried out without insufflating an adjacent second portion of the lumen, the method comprising:
providing a partitioning element 10 expandable radially from a first state defining a first transverse cross-sectional area to a second state defining a second transverse cross-sectional area greater than the first transverse cross-sectional area,
placing the partitioning element 10 in the first state (fig 2) thereof in the lumen 26 between the first portion thereof and the second portion thereof,
radially expanding the partitioning element 10 from the first state (fig 2) thereof until the partitioning element 10 engages an inner surface of the lumen 26 with the partitioning element 10 extending transversely across the lumen substantially sealably isolating the first portion thereof from the second portion thereof, and
insufflating the first portion of the lumen by an insufflating gas (col. 2 lines 10-16).
Regarding claim 17, Sinnreich discloses the partitioning element 10 comprises:
an expandable carrier element 16 extending from a proximal end to a distal end, and having a bore 14 extending longitudinally therethrough and being radially expandable from a first state defining the first transverse cross-sectional area to the second state defining the second transverse cross-sectional area,
an isolating element 23 carried on and secured to the carrier element and being urgeable from a non-isolating state to an isolating state for substantially sealably isolating the first portion of the lumen from the second portion thereof, the isolating element being urgeable from the non-isolating state to the isolating state as the carrier element expands from the first state to the second state, and
a connector at 15 formed by a part of the carrier element.
Claim Rejections - 35 USC § 103
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.
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.
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sinnreich in view of Sachdeva et al (US 5885258 A).
Regarding claims 10 and 12, Sinnreich discloses the invention substantially as claimed. However, it fails to disclose the method further comprising delivering the partitioning element 10 by a delivery element to the location in the lumen between the first and second portions thereof with the partitioning element located in the delivery element, and discharging the partitioning element from the delivery element; and the partitioning element is discharged from the delivery element by urging the delivery element proximally in the lumen relative to the partitioning element.
Sachdeva teaches a delivery element 13 (fig 1a) for delivering a device 11 to a site and where the delivery tube can be moved (Col 3 lines 39-42) axially relative to each other, and therefore proximally to device 11. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Sinnreich’s partitioning element by including a delivery element as taught by Sachdeva since such modification would have enhanced the controlled delivery of the partitioning element Sinnreich within the lumen.
Allowable Subject Matter
Claims 1-3, 6-7 allowed.
The following is an examiner’s statement of reasons for allowance: regarding claim 1, the art of record does not teach or render obvious a partitioning element including a connector adapted to be releasably or non-releasably connectable with an operating element for withdrawing the partitioning element from the lumen, the connector being formed by a part of the carrier element or by a part of the isolating element or being connected either to the isolating element or to at least two lanyards secured to the periphery of the carrier element at circumferentially spaced apart intervals adjacent the proximal end thereof, in combination with the elements set forth in the claim.
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.”
Claim 8, 15, 19-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 11, 13-14, 18 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783