I. ACKNOWLEDGEMENT
This Office Action addresses U.S. Application No. 18/887428 (“’428 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is September 17, 2024.
This action is being issued following Applicant’s response of 8/03/2026, which included a claims listing and a response to the restriction requirement.
II. STATUS OF CLAIMS
Claims 1-20 were filed with the application. The response of 8/3/2026 withdrew claims 16-20 without traverse, and added claims 28-30. Therefore, as of the date of this Office Action, the status of the claims is:
a. Claim 1-15 (“Pending Claims”).
b. Claim 16-20 are withdrawn (“Withdrawn Claims”).
c. Claims 1-15 are examined (“Examined Claims”).
III. PRIORITY AND CONTINUING DATA
The ‘428 application claims the benefit of provisional application 63/583641, filed 9/19/2023. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. RESPONSE TO RESTRICTION
Applicant’s election of Group I in the reply filed on 8/3/2026 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)).
V. REJECTIONS UNDER 35 USC 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 says that the distal row of teeth forms a planar surface. However, the teeth do not form any surface. They are just discrete points. Hence, the limitation lacks an adequate written description. It appears that Applicant means that the teeth all line in a plane. Clarification is required.
VI. ART REJECTION
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.
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 1, 2 and 4-6 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Walak et al US PG PUB 2016/0015372 in view of Rowe et al US PG PUB 2022/0257221.
As to claim 1, Walak shows in figure 10 a medical device that includes a sheath 604 and an expandable tissue collecting member 602 having a plurality of teeth 626 thereon. As noted in paragraph [0034], the sheath and tissue collecting member are moveable relative to each other. Such that when the sheath moves proximally relative to the tissue collecting member, the tissue collecting member transitions from a collapsed state to an expanded state. The tissue collecting member does not have a liner and a support structure. However, Rowe shows in figure 6 a similar tissue collecting member formed of a film 98 formed on a wire form 96. As such, it would have been obvious to modify Walak to use the structure of Rowe, as it is merely the use of a known structure for a similar device in the art.
As to claim 2, the wire form is a lattice.
As to claim 4, there are multiple rows of teeth.
As to claim 5, the distal row of teeth are formed in a plane.
As to claim 6, as the tissue collecting member 602 is retracted into the sheath, the proximal row of teeth close before the distal row.
As to claim 8, the sheath proximal end is connected to a handle, i.e. a grip, to move the sheath proximally or distally.
As to claims 9 and 10, Rowe does not show a device with a larger distal width than a proximal width or with a curved cone or cylindrical shape. However, figures 4A and $b of Rowe show a similar device having a conical shape with a larger distal diameter than proximal diameter. As such, it would have been obvious to modify Walak to use the shape of Rowe figures 4a and 4B, as it is merely the substitution of one known equivalent shape for another.
As to claim 11, Rowe teaches in figures 30-34 using a guidewire with a corkscrew 453 as an anchoring device during biopsy procedures. As such, it would have been obvious to modify Walak to use such an anchoring mechanism, to improve the biopsy procedure.
As to claim 12, the anchor is corkscrew shaped.
As to claims 13, the anchor in Rowe is separately maneuverable, i.e. there is a handle to manipulate it.
As to claim 14, the Examiner notes that a corkscrew works by rotation. Hence, there is inherently a separate mechanism to rotate the corkscrew for advancement.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Walak in view of Rowe, as applied to claims 1, 2, 4-6, and 8-10 above, further in view of Bonneau et al US Patent 9,743,944.
The teeth of Walak do not face proximally. However, Bonneau shows in figure 8A a similar tissue collection device that has proximally facing teeth, to pull tissue into the collecting device. As such, it would have been obvious to modify the combination to orient the teeth to face proximally, so as to assist in pulling the tissue sample into the tissue collecting device.
Claims 1, 3, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkins et al US PG PUB 2018/0193050.
As to claim 1, Hawkins shows in figure 6 a medical device having a sheath, i.e. colonoscope 10 (figure 2) and an expandable member 28 having a support structure 24 and a liner 30, where there are teeth 26 and the end of the liner.
As to claim 3, the support member comprises struts 24,
As to claim 15, there is a snare loop 42 coupled to the distal end of the expandable member.
VII. PRIOR ART
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee et al US PG PUB 2015/0272556 shows a biopsy device with rotatable anchors 1160 and 1260.
Miyamoto et al 2008/0033467 shows a device having a conical expandable member with teeth in figure 37.
VIII. CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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, Alexander Kosowski can be reached at (571) 272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT L NASSER/
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