DETAILED ACTION
Claims 1-20 are pending in this application.
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 with traverse of Group I (claims 1-15) in the reply filed on 12/22/2025 is acknowledged. The traversal is on the ground(s) that the examination would not be an undue burden for the examiner since Group I and II have similar elements of a first portion, as second portion, and a retrieval mechanism. This is not found persuasive because the restriction is proper due to the inventions of Group I and II having a separate status in the art in view of their different classifications, recognized divergent subject matter, different fields of search required, different applicable prior art, and different non-prior art issues, as indicated in the office action filed 11/07/25.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/22/2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “retrieval mechanism” in claims 1, 7, 8, 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3-6 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.
Claim 3 recites “the recess attaches to the needle when the needle is inserted into the recess”. It is unclear whether or not Claim 3 is positively reciting “the needle”, since independent Claim 1 (upon which Claim 3 depends) only functionally recites the needle (in line 4 of Claim 1 it reads “a second portion with a recess to receive a needle from an instrument”). For examination purposes, the limitation in Claim 3 will be read as –the recess is configured to attach to the needle when the needle is inserted into the recess-.
Claim 4 recites “a cavity inside of the device receives the needle when the needles is inserted into the recess”. It is unclear whether or not Claim 4 is positively reciting “the needle”, since independent Claim 1 (upon which Claim 4 depends) only functionally recites the needle (in line 4 of Claim 1 it reads “a second portion with a recess to receive a needle from an instrument”). For examination purposes, the limitation in Claim 4 will be interpreted as only functionally reciting the needle and read as --a cavity inside of the device is configured to receive the needle when the needle is inserted into the recess--.
Claim 5 recites “the second portion of the device is coupled to the instrument upon receiving the needle”. It is unclear whether or not Claim 5 is positively reciting “the instrument”, since independent Claim 1 (upon which Claim 5 depends) only functionally recites the instrument (in line 4 of Claim 1 it reads “a second portion with a recess to receive a needle from an instrument” and further “a retrieval mechanism to retrieve the device after removal of the device from the instrument, wherein the device is collapsible in the structure when removed from the instrument after insertion of the instrument and the device into the structure”). For examination purposes, the limitation in Claim 5 will be interpreted as only functionally reciting the instrument and read as --the second portion of the device is configured to couple to the instrument upon receiving the needle--.
Similar to Claim 5 above, it is unclear whether or not Claim 6 is positively reciting “the instrument”. For examination purposes, the limitation in Claim 6 will be interpreted as only functionally reciting the instrument and read as --the device is configured to couple to the instrument by retracting the needle into the instrument--.
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 1-10 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al., hereinafter “Chen” (U.S. Pub. No. 2014/0191012).
Regarding claim 1, Chen discloses a device (Figures 1-3) comprising:
a first portion (rounded distal end 15; Figure 2) with a rounded shape for introduction into an opening of a structure ([0082]; the rounded shape is introduced into a body of a patient);
a second portion (including central tube 21; Id.) with a recess (within 21) to receive a needle from an instrument (Figure 3, [0079]; central tube 21 receives a needle, or tip of trocar 9 of a stapler); and
a retrieval mechanism (“traction string” connected to traction hole 23; [0080], [0082]) to retrieve the device after removal of the device from the instrument (Id.; the traction string is pulled to remove the device from the stapler), wherein the device is collapsible in the structure when removed from the instrument after insertion of the instrument and the device into the structure (when the traction string is pulled, the device goes from a wound configuration [as in Figures 2-3] to a collapsed, unwound configuration; Id.).
Regarding claim 2, Chen discloses the device introduces the instrument into the structure (the device is configured to introduce the stapler into the patient’s body, such as tubular tissue; [0006], [0007], [0082]), and dilates the structure as the instrument is guided through the structure by the device (depending on the diameter of the tubular tissue portion, the device is capable of expanding the structure as it is introduced with the stapler and advanced through the patient’s body).
Regarding claim 3, Chen discloses the recess (within central tube 21) is configured to attach to the needle 9 when the needle is inserted into the recess ([0079]).
Regarding claim 4, Chen discloses a cavity (within cylinder 27 and/or middle section 31; Figure 2) inside of the device is configured to receive the needle when the needle is inserted into the recess (Figure 3).
Regarding claim 5, Chen discloses the second portion (including central tube 21) of the device is configured to couple to the instrument upon receiving the needle 9 ([0079]).
Regarding claim 6, Chen discloses the device is configured to couple to the instrument by retracting the needle into the instrument (Figures 2-3, [0075], [0081]; trocar 9 is movably disposed in the stapler, and when retracted, may be capable of coupling the device to the stapler via outer peripheral surface 29 of cylinder 27 attaching to an inner side face 13 of the stapler).
Regarding claim 13, Chen discloses the device is removable from the instrument by retracting the needle into the instrument (Figure 3; if the trocar 9 and stapler are withdrawn relative to the device, the device is capable of being removed from the stapler).
Regarding claim 14, Chen discloses the instrument performs a stapling procedure while the device is collapsed on a side of the instrument (when device is unwound from the stapler, a stapling procedure may be performed; [0075]).
Regarding claim 15, Chen discloses the retrieval mechanism is configured to retrieve the device from the structure (“traction string” is capable of being pulled to retrieve the device from the body; [0082]).
Regarding claim 1 (and claims 7-10 below), another embodiment of Chen (Figures 19-20) discloses a device comprising:
a first portion (rounded distal end 15; Figure 19) with a rounded shape for introduction into an opening of a structure ([0109]; the rounded shape is introduced into a body of a patient);
a second portion 57 (Id.) with a recess (within 57) to receive a needle from an instrument (Id.; 57 is capable of receiving a needle, or tip of trocar 9 of a stapler as in Figure 3); and
a retrieval mechanism (“traction member 33”; [0108]-[0109]) to retrieve the device after removal of the device from the instrument (Id.; the traction member is pulled to remove the device from the stapler), wherein the device is collapsible in the structure when removed from the instrument after insertion of the instrument and the device into the structure (when the traction member is pulled, the device goes from a wound configuration [as in Figures 19-20] to a collapsed, unwound configuration; Id.).
Regarding claim 7, Chen discloses the retrieval mechanism 33 is placed through the recess (within 57) to the first portion 15 (Figure 19).
Regarding claim 8, Chen discloses the device includes a channel (middle portion of device within conical wall 51; Id.) from the recess (within 57) to the first portion 15, and the retrieval mechanism is placed through the channel (Id.).
Regarding claims 9-10, Chen discloses the first portion 15 comprises a first material (first flexible strip 53; [0105]) at a tip of the device (tip of device can include both strips 53, 55), and the first portion comprises a second material (second flexible strip 55; Id.) on a side of the device, wherein the first material is harder than the second material (Id.; the first flexible strip 53 is made of relatively rigid material and the second flexible strip 55 is made of relatively soft material).
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Myers (U.S. Patent No. 7,182,239).
Regarding claim 1, Myers discloses a device (Figures 4-9) comprising:
a first portion 14a with a rounded shape (col. 1, lines 58-60; smooth, rounded exterior surface) for introduction into an opening of a structure (Figure 7);
a second portion 14b with a recess (within 14b) to receive a needle from an instrument (Figures 4-5; a needle, or center post C of a stapler is received within 14b); and
a retrieval mechanism (“retraction wire 34” and “grip 36”; col. 4, lines 50-55) to retrieve the device after removal of the device from the instrument (Id.), wherein the device is collapsible in the structure when removed from the instrument after insertion of the instrument and the device into the structure (col. 3, lines 52-58; Myers teaches that the device is formed of a resilient material that gives as a result of pressure, and therefore after removal of the device from the stapler within a body lumen structure, the device is capable of being collapsed with a certain degree of outside pressure applied to the resilient material).
Regarding claim 2, Myers discloses the device introduces the instrument into the structure (the device is configured to introduce the stapler into the patient’s body, such as in hole 38 of abdominal wall 40 in Figure 7) and dilates the structure as the instrument is guided through the structure by the device (depending on the diameter of a patient’s abdominal wall hole, the device is capable of expanding the wall hole as it is introduced with the stapler and advanced through the abdominal wall).
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.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Myers (U.S. Patent No. 7,182,239) in view of Kleinhaus (U.S. Pub. No. 2020/0086095).
Regarding claims 11-12, Myers discloses the claimed invention, as discussed above, except for a set of leaflets, wherein the leaflets are collapsible, and wherein: a leaflet in the set of leaflets is coupled from a center stud to a side of the device, or a leaflet in the set of leaflets is coupled from the first portion to the second portion.
Kleinhaus teaches a device (Figures 1-7) including a first portion 104 with a rounded shape (rounded, conical exterior) for introduction into an opening of a structure ([0047]), a second portion with a recess (including lumen 105; Figure 2) capable of receiving a needle from an instrument, and the device further comprising a set of leaflets (ribs 112), and a leaflet in the set of leaflets is coupled from a center stud 118 to a side of the device, or a leaflet in the set of leaflets is coupled from the first portion to the second portion.
It would have been obvious to one of ordinary skill before the effective filing date to modify the device of Myers with leaflets as claimed, as taught by Kleinhaus, since the leaflets reduce the friction force of the device as it is moved through tissue in the body (Kleinhaus; [0047], [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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, Darwin Erezo can be reached at 571-272-4695. 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.
/DIANE D YABUT/Primary Examiner, Art Unit 3771