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 .
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 1-13 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.
Regarding claim 1, claim 1 recites “the chamber” in line 4. It is unclear if “the chamber” is the same or different from “plurality of chambers” established in line 3. Is “the chamber” one of the “plurality of chambers”? It is suggested to recite “the chamber” as “a respective chamber of the plurality of chambers”. Claims 2-13 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites “the opening” in line 5. It is unclear if “the opening” is the same or different from “plurality of openings” established in line 2. Is “the opening” one of the “plurality of openings”? It is suggested to recite “the opening” as “a respective opening of the plurality of openings”. Claims 2-13 are rejected by virtue of their dependency on claim 1.
Regarding claim 2, claim 2 recites “the chamber in which the transport part is accommodated” in lines 7-8. It is unclear if “the chamber” and “the transport part” is the same or different from the “plurality of chambers” and “plurality of transport parts” established in claim 1. Is “the chamber” and “the transport part” one of the “plurality of chambers” and “plurality of transport parts”? It is suggested to recite, for example, “the chamber in which the transport part is accommodated” as “one of the plurality of chambers in which one transport part of the plurality of transport parts is accommodated”. Claims 3-6 are rejected by virtue of their dependency on claim 2.
Regarding claim 7, claim 7 recites “the opening” in line 3. It is unclear if “the opening” is the same or different from “plurality of openings” established in claim 1. Is “the opening” one of the “plurality of openings”? It is suggested to recite “the opening” as “one opening of the plurality of openings”. Claims 8-10 are rejected by virtue of their dependency on claim 7.
Regarding claim 9, claim 9 recites the limitation "the subject" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is suggested to recite “the subject” as “a subject”.
Regarding claim 11, claim 11 recites the limitation "the lumen of the subject" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is suggested to recite “the lumen of the subject” as “a lumen of a subject”.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US 20200297925 A1) in view of Bohr et al. (US 20230338719 A1; effectively filed 11/02/2020) and Kim et al. (KR 20190135333 A; cited in the IDS filed 06/11/2024; see machine translation).
Regarding claim 1, Park teaches a device (abstract; Figs. 1-14, device 1) for conveying biological material (abstract; [0057]) comprising:
a body part (Fig. 1, body 11) comprising an opening formed through a rear surface thereof (Fig. 2, aperture 1141 formed through plate 114 at a rear surface of body 11), and a plurality of chambers formed therein to correspond to the opening (Figs. 1-4 teach a plurality of channels P, i.e. chambers, formed in the body 11 to correspond to aperture 1141; Figs. 5 and 9-10 [0103],[0106] teaches the capsules of the channels may be aligned with the aperture to transfer each capsule);
a plurality of transport parts (Figs. 1-4, conveying element 122 and rod 121) each accommodated in the chamber (Fig. 4 shows conveying element 122 and rod 121 accommodated in the channel P) to store a biological material (Figs. 1-4 shows the channel P storing capsules C; [0064] teaches the capsule contains biological material) and capable of protruding out of the body part through the opening (Fig. 5 shows conveying at least element 122 protruding out of the body 11 through the aperture); and
a magnetic driving part (Figs. 1-4, linear driving element 133, linear guide 134, and second magnetic element 135) configured to be moved within the body part (Figs. 4-6 and [0090] teaches in operation, the linear driving element 133, linear guide 134, and second magnetic element 135 moves within body 11) by a driving element ([0088]-[0090] teaches linear driving element 133 includes a motor to move the linear guide 134 and second magnetic element 135) and to selectively apply pressure to one of the plurality of transport parts ([0088]-[0090] and Figs. 4-6 teach the linear guide 134 and second magnetic element operating to push, i.e. applying pressure, to one of the first magnetic elements 125 and therefore to one of the conveying elements 122 and rods 121).
Park fails to teach: the body part comprising a plurality of openings formed through a rear surface thereof; the plurality of chambers formed therein to correspond to the openings; the magnetic driving part configured to be moved within the body part by an external magnetic field.
Bohr teaches a capsule device for swallowing into a lumen of a gastrointestinal tract of a patient for intestinal delivery of a therapeutic substance (abstract). Bohr teaches the device includes an outlet for a single injection needle configured to be inserted into mucosal tissue at a target location; and the outlet may be provided in alternative forms, such as comprising a plurality of injection needles, or as one or more outlet nozzle openings for expelling a substance directly through the outlet ([0074]).
Since Bohr teaches known alternatives of a single opening for a single injection needle and multiple openings for multiple injection needles ([0074]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body part of Park to incorporate Bohr’s teachings of a capsule device for intestinal delivery of a therapeutic substance that includes a plurality of openings corresponding to a plurality of injection needles for expelling substances ([0074]) to provide: the body part comprising a plurality of openings formed through a rear surface thereof; the plurality of chambers formed therein to correspond to the openings. Doing so would have a reasonable expectation of successfully improving expelling or conveying of biological material of each chamber out of the body part as taught by Bohr.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the body part comprising a plurality of openings formed through a rear surface thereof; the plurality of chambers formed therein to correspond to the openings) by known methods with no change in their respective functions (i.e. allowing for conveying of desired materials out of the device via respective openings), and the combinations yielded nothing more than predictable results (i.e. providing the body part comprising a plurality of openings formed through a rear surface thereof and the plurality of chambers formed therein to correspond to the openings would yield nothing more than the obvious and predictable result of enabling expelling or conveying of biological material of each chamber out of the body part). See MPEP 2143(A).
Modified Park fails to teach: the magnetic driving part configured to be moved within the body part by an external magnetic field.
Kim teaches a capsule endoscope having a biopsy member including a punch-shaped tissue collection tool and an operating system thereof ([0001]). Kim teaches an urgent need to develop technology for a wireless capsule endoscope equipped with a biopsy component capable of collecting and storing biological tissue within the digestive tract ([0005]). Kim teaches the capsule endoscope (Figs. 1-3) including a body (10) and biopsy member located within the body (110) and independently controlled by a magnetic field applied from the outside ([0009],[0026]). Kim teaches the biopsy member (110) includes a second magnetic body (112) (Figs. 1-3; [0011]). Kim teaches a magnetic field is applied to the second magnetic body to allow for movement of a biopsy punch and the biopsy punch can be controlled independently without movement of the body ([0037]; Fig. 2); wherein the movement of the biopsy punch from inside to outside or outside to inside of the punch tube can be performed without an additional power source other than the external magnetic field ([0038]). Kim teaches three dimensional electromagnetic drive devices can be used for propulsion drive or steering drive of capsule devices ([0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic driving part of modified Park to incorporate Kim’s teachings of external magnetic fields to independently control movement of a parts of a capsule within a patient ([0009],[0026],[0037],[0038],[0047]) to provide: the magnetic driving part configured to be moved within the body part by an external magnetic field. Doing so would have a reasonable expectation of successfully allowing for external and independent control of each of the transport parts without an additional power source in the device as taught by Kim.
Additionally, simple substitution of one known equivalent elements (Park’s magnetic driving part) for another (Kim’s magnetic body and external magnetic field) would achieve the predicable result of allowing for external and independent control of each of the transport parts without an additional power source in the device (see MPEP 2144.05 (II), In re Williams, 36 F.2d 436, 438 (CCPA 1929), “…the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent”).
Regarding claim 7, Park further teaches the device for conveying biological material of claim 1, wherein the transport part comprises a sealing member formed at a rear end thereof in a shape corresponding to the opening ([0071] teaches an opening and closing element provided in aperture 1141).
Regarding claim 8, Park further teaches the device for conveying biological material of claim 7, wherein the transport part (Figs. 1-4, conveying element 122 and rod 121) further comprises a collection member (Figs. 1-4 and [0080] teach the conveying element 122 includes a sorbent configured to sorb and collect biological material) disposed on a front side of the sealing member ([0071] teaches an opening and closing element provided in aperture 1141; Figs. 1-4 and [0080] teach the conveying element 122 includes a sorbent; therefore, the conveying element 122 with the sorbent is interpreted as on a front side of the opening and closing element in the aperture 1141) and capable of collecting a biological material from a subject when the transport part protrudes out of the body part (Figs. 5-7 and [0080],[0098],[0100] teach the conveying element 122 includes a sorbent configured to sorb and collect biological material when the conveying element is outside of the second chamber 112).
Regarding claim 9, Park further teaches the device for conveying biological material of claim 7, wherein the transport part (Figs. 1-4, conveying element 122 and rod 121) further comprises a delivery member (Figs. 1-6, capsule C) disposed on the front side of the sealing member ([0071] teaches an opening and closing element provided in aperture 1141; Figs. 1-4 teaches the capsule C on one side of the aperture 1141; therefore, the capsule C is disposed on a front side of the opening and closing element in aperture 1141) while storing a biological material ([0064] teach capsule C contains biological material), the delivery member being capable of delivering the biological material to the subject when the transport part protrudes out of the body part (Figs. 4-6; [0070],[0079]).
Regarding claim 10, Park further teaches the device for conveying biological material of claim 7, wherein the transport part (Figs. 1-4, conveying element 122 and rod 121) further comprises a second magnetic body (first magnetic element 125) disposed at a front end thereof (Fig. 4 shows first magnetic element 125 at a front end of rod 121) to generate attractive force by magnetic force with the magnetic driving part (interpreted as an intended use, see MPEP 2114; Fig. 4 and [0082] teaches first magnetic element 125 is magnetically coupled to second magnetic element 135, i.e. magnetic driving part; therefore, the first magnetic element 125 is capable of generating a magnetic force with second magnetic element 135 to magnetically couple together).
Regarding claim 11, modified Park fails to teach the device for conveying biological material of claim 1, wherein the magnetic driving part is pressurized by an external magnetic field to move the body part along the lumen of the subject.
Kim teaches a capsule endoscope having a biopsy member including a punch-shaped tissue collection tool and an operating system thereof ([0001]). Kim teaches an urgent need to develop technology for a wireless capsule endoscope equipped with a biopsy component capable of collecting and storing biological tissue within the digestive tract ([0005]).Kim teaches the capsule endoscope is moved to the location of the target lesion for tissue collection by controlling an external magnetic field to propel or steer the capsule endoscope ([0041]). Kim teaches driving force or steering force provided for driving control of the capsule endoscope is provided by a magnetic field generating unit outside the human body which functions to generate magnetic field in any direction in three dimensions ([0044]). Kim teaches three dimensional electromagnetic drive devices can be used for propulsion drive or steering drive of capsule devices ([0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the magnetic driving part of modified Park to incorporate Kim’s teachings of external magnetic fields to propel or steer the capsule endoscope to a location ([0041],[0044],[0047]) to provide: the device for conveying biological material of claim 1, wherein the magnetic driving part is pressurized by an external magnetic field to move the body part along the lumen of the subject. Doing so would have a reasonable expectation of successfully improving external control to propel or steer the device to a target location as taught by Kim.
Regarding claim 12, Park further teaches the device for conveying biological material of claim 11, further comprising a receiving part (Figs. 1-2, communication element 142) configured to receive a signal generated from the outside of the subject by the magnetic driving part ([0092] teaches the communication element communicates with a computer outside of the device and can be implemented by a magnet or electromagnet; therefore, the communication element is capable of receiving a signal by the magnetic driving part).
Regarding claim 13, Park further teaches the device for conveying biological material of claim 11, wherein the front surface of the body part partially comprises a dome shape (Figs. 1-2, tip portion 113 is shown as a dome shape).
Allowable Subject Matter
Claims 2-6 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the closest prior art of Park et al. (US 20200297925 A1) in view of Bohr et al. (US 20230338719 A1; effectively filed 11/02/2020) and Kim et al. (KR 20190135333 A; cited in the IDS filed 06/11/2024; see machine translation) further teaches the device for conveying biological material of claim 1 (see above rejection of claim 1 under 35 U.S.C. 103), wherein the magnetic driving part (Park, Figs. 1-4, linear driving element 133, linear guide 134, and second magnetic element 135) comprises a rod (linear guide 134) configured to protrude from a body (133) toward the chamber in which the transport part is accommodated (Figs. 4-6).
Modified Park fails to teach: wherein the body part comprises a shaft disposed therein in the anteroposterior direction thereof, and wherein the magnetic driving part comprises: a ring-shaped first magnetic body through which the shaft extends, so as to be movable according to the anteroposterior direction of the shaft; and the rod configured to protrude from the first magnetic body toward the chamber in which the transport part is accommodated.
A reference Chinnock et al. (US 5056902 A) teaches a magnetically coupled lens actuator (abstract) including a ring shaped permanent magnet 36 that surrounds tube 16, where the magnet 36 slides freely along tube 16 (column 2, lines 20-26). However, Chinnock fails to teach or suggest all of the limitations of claim 2 and fails to teach or suggest motivation to have modified the device of modified Park to arrive at the claimed invention.
None of the prior art fairly teaches or suggests, alone or in combination, all of the limitations of claim 2, specifically the structures of the claimed shaft, ring-shaped first magnetic body, and rod. Therefore, claim 2 is deemed allowable. Claims 3-6 are deemed allowed based on their dependency on claim 2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wrigglesworth et al. (US 20160038086 A1) teaches a device for sampling internal substances in the gastrointestinal tract of an animal (abstract; Figs. 2A-2B), wherein the device is capable of elongating from the closed compressed state to the open expanded state (Figs. 2A-2B; [0097]).
Jones (US 20210228157 A1) teaches a non-invasive system for sampling gastrointestinal microbiota (abstract; Figs. 1-4) including multiple channels (20).
Kam et al. (US 11660436 B1) teaches a device includes a capsule sized to pass through a lumen of a gastrointestinal tract (abstract; Figs. 9B-9C) comprising multiple openings (32) for deploying tissue penetrating members (40) out of the openings (32) to deliver functionalized particles (100) to an intestinal wall (IW). Kam teaches the user may externally send a signal to a release 58 or directly to actuator 50 to activate the actuator 50 to deliver functionalized particles 100; this may be achieved by means of RF, magnetic or other wireless signaling means known in the art; and release may include magnetically controlled valves (column 23, lines 29-47).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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