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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/28/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: a control valve 101. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 2, 8, 10, 12, 13, 14, 15, and 19 are objected to because of the following informalities: Per 37 CFR 1.75(i), “Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation.”. Each of these claims sets forth a plurality of elements and limitations which are difficult to understand when present in the long paragraph style. The examiner suggests indenting lines of the claim to better separate limitations and more clearly represent what the applicant intends to claim. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: In line 1 of the claim, “An implantable liquid transfer device” is missing its appropriate reference number “(10)”. The examiner suggests adding the reference number after reciting the element for continuity with the other elements within the claims. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 sets forth “a control valve (101)” which is later defined as “a first control valve (13), a second control valve (14) and a one-way valve (163)” in claim 1. It is confusing to the examiner how a single control valve, as represented by the article “a”, can become three different valves. Further, as the reference number 101 was not used in the drawings, the examiner is further confused how the single control valve is incorporated into the implantable liquid transfer system as a whole. The examiner suggests either modifying “a control valve” to be “a control valve system” to better represent the plurality of valves used, or completely removing “a control valve (101)” from the claims, as “a first control valve (13), a second control valve (14) and a one-way valve (163)” are clear. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: In the twelfth and thirteenth lines of claim 1, the claim states “the branch pipes and the plurality of the branch pipes”. The examiner suggests modifying the part of the claim to state “the first branch pipe and second branch pipe, and the first branch pipe and the second branch pipe” to stay consistent with the terms previously presented in the claim.
Claim 10 objected to because of the following informalities: Claim 10 utilizes commas and the conjunction “and” to separate elements and limitations, whereas the examiner suggests semi-colons and the occasional “wherein” to provide better clarify how each of the limitations are represented in the claim as a whole. The end of the claim gets repetitive when discussing the parts and functions of “the second magnetic rotation member (142)”. The examiner suggests rewriting, utilizing the above claim rejection regarding indentations, to more clearly communicate “the second magnetic rotation member (142)”. The examiner’s suggested corrections for punctuation are as follows: “the second control valve (14) is a magnetic control valve, and the second control valve (14) comprises a second valve housing (141) and a second magnetic rotation member (142); wherein the second valve housing (141) has a second accommodating cavity (141a) and three third ports (141b) communicating with the second accommodating cavity (141a), and the three third ports (141b) are respectively connected with the liquid outlet pipe (16), the first branch pipe (161), and the second branch pipe (162); wherein the second magnetic rotation member (142)…”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The claim utilizes commas and the conjunction “and” to separate limitations, but the examiner suggests the use of a semi-colon and “wherein” to better clarify the separation of limitations. Also, in the claim, “a plurality of microbubble structures” should be “the plurality of microbubble structures”, as the feature was already mentioned in previous line 23. The examiner’s suggested corrections for punctuation are as follows: “the fixing device (164) comprises an injection port (164a), a control pipe (164b) and a plurality of microbubble structures (164c); wherein the injection port (164a) is communicated with the plurality of microbubble structures (164c) through the control pipe (164b), and the microbubble structures (164c) are made of elastic materials.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1, 5, 9, 11, 12, 13, 15 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 1 recites the limitation "the other end of the pump body" in line 5 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the other end of the liquid outlet pipe" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the pump housing " in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The term “far away from” in claim 5 is a relative term which renders the claim indefinite. The term “far away from” 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. Utilizing the term “far away from” does not give a clear distance of the location of “one end of the liquid inlet pipe” from “the pump body”. There is no associated unit to define “far”, which leads to indefiniteness of the entire claim.
Regarding claims 1 and 14, the claim interchangeably uses “a plurality of magnetic membrane flaps” (lines 18), “the magnetic membrane flaps” (lines 19), and “the magnetic membrane flap” (lines 20-22). The inconsistency in the amount of magnetic membrane flap or flaps being referenced leads to a lack of clarity for the examiner. It is not clear if all the of magnetic membrane flaps are capable of the limitations claims from an initial state to an infusion state, or just a single magnetic membrane flap. This confusion renders the claim indefinite. The examiner suggests modifying each of the references to the magnetic membrane flaps to all be of the singular or plural tense in order to remain consistent throughout the entire claim.
Regarding claim 12, the claim interchangeably uses “a plurality of microbubble structures” (lines 2-4) and “the microbubble structures” (line 4). The inconsistency in the amount of microbubble structures being referenced leads to a lack of clarity for the examiner. It is not clear if all the of microbubble structures are meant to be a plurality, as well as how many of the microbubble structures are made of elastic materials. This confusion renders the claim indefinite. The examiner suggests modifying each of the references to the microbubble structures to all be either “a plurality of microbubble structures” or “microbubble structures” in order to remain consistent throughout the entire claim.
Claim 13 recites the limitation "the edema area" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the liquid" in line 6 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the inflammatory condition" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the other end of the pump body" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the other end of the liquid outlet pipe" in line 9 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the pump housing " in line 16 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the operation state of the driving module" in line 9 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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 1, 7, and 14 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).
Claim 1, in line 13, positively recites “the plurality of the branch pipes (160) are respectively provided at different tissues”.
Claim 7, in lines 2-3, positively recites “every branch structure (122) is respectively provided in a different edema area”.
Claim 14, in lines 14-15, positively recites “the plurality of the branch pipes (160) are respectively provided at different tissues”.
Therefore, the claims appear to positively recite “tissues” and “edema area” which are directed to a human organism and thus rejected under 35 U.S.C. 101. To overcome the rejection, the applicant could adopt the following language:
For claim 1, “the plurality of the branch pipes (160) are configured to be respectively provided at different tissues”.
For claim 7, “every branch structure (122) is configured to be respectively provided in a different edema area”.
For claim 14, “the plurality of the branch pipes (160) are configured to be respectively provided at different tissues”.
Due to claim dependency from claims 1, 7, and 14, claims 2-3, 5-6, 8-10, 12-13, and 15-20 are subsequently rejected.
Allowable Subject Matter
Claims 1-3, 5-10, 12-20 would be allowable if rewritten to overcome the rejections 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.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
Regarding independent claims 1 and 14, the prior art of record, either alone or in combination, fails to disclose or render obvious “a plurality of magnetic membrane flaps provided in the valve pipe, and the magnetic membrane flaps can be unfolded or rolled up in a magnetic field; wherein in an initial state, the magnetic membrane flap curls in the valve pipe and blocks the conduction of the valve pipe; and in an infusion state, the magnetic membrane flap unfolds and curls at intervals in an infusion direction” in addition to the other claimed structural features. The closest prior art of record is as follows:
Burke et al. (United States Patent Application Publication No. US 2009/0093797 A1) teaches an implantable liquid transfer device (FIG. 1, entire figure is an infusion apparatus; [0004], “the infusion apparatus being implantable into a living body”), comprising a pump body (accumulator pump 30), a control valve (inlet valve 26 or outlet valve 28), a liquid inlet pipe (Annotated on FIG. 2 below) and a liquid outlet pipe (Annotated on FIG. 2 below); ]); and the first control valve is provided on the liquid inlet pipe (See annotated FIG. 2 below, inlet valve 26 located on inlet pipe); and the second control valve is provided on the liquid outlet pipe (See annotated FIG. 2 below, outlet valve 28 located on outlet pipe).
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Memtsoudis (United States Patent Application Publication No. US 2017/0361063 A1) teaches the liquid outlet pipe is provided with two branch pipes (FIG. 6, plurality of catheters 12), namely a first branch pipe and a second branch pipe respectively (Annotated on FIG. 2 below).
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Sik (KR 20010082434 A) teaches a multi-way valve (three-way valve 100).
However, the prior art of record fails to teach or render obvious “a plurality of magnetic membrane flaps provided in the valve pipe, and the magnetic membrane flaps can be unfolded or rolled up in a magnetic field”. Therefore, the independent claims and all depending claims thereof have been found allowable over the prior art.
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Harper (United States Patent No. US 8,360,106 B2) is considered relevant prior art with regards to a one-way valve compressible spring for stopping flow in any direction.
Nelson et al. (United States Patent Application Publication No. US 2004/0247445 A1) is considered relevant prior art with regards to a pump with inlet and outlet valves and pipes.
Burke et al. (United States Patent Application Publication No. US 2020/0030528 A1) is considered relevant prior art with regards to an external device having a processor that may also be configured to notify medical personnel who may be located remotely.
Hanson et al. (United States Patent No. US 5,985,307 A) is considered relevant prior art with regards to a device having therapeutic agent delivery means comprising a plurality of micropores.
Schautzgy et al. (WO 2019/238768 A1) is considered relevant prior art with regards to a magnetic shape memory element that controls the passage of fluid.
Hakim et al. (United States Patent Application Publication No. US 2020/0282200 A1) is considered relevant prior art with regards to a valve with a magnetic motor which includes a stator and rotor that rotates relative to the stator 528 responsive to an external magnetic control field.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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