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 .
Claim Rejections - 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
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 1-3, 5, 6, 8-16, and 20 are 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. Claims 1 and 12 recite “a passage to the outlet orifice is maintained in each of closed, partially closed, and fully opened.” The term “maintained” is not found in the specification. In the remarks Applicant indicates the term maintain means “to sustain or preserve.” It is not immediately clear what structure in the specification is “maintaining” the passage as recited.
Claims 1-3, 5, 6, 8-16, and 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 1 and 12 recite “a passage to the outlet orifice is maintained in each of closed, partially closed, and fully opened.” This phrase is incomplete. It is considered as “a passage to the outlet orifice is maintained in each of a closed, a partially closed, and a fully opened position.” Further, the term “maintain” appears to be a relative term which renders the claim indefinite. The term “maintain” 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. In the remarks Applicant indicates the term maintain means “to sustain or preserve.” However, it is not clear how long a position must be sustained or preserved to be “maintained.” For purposes of examination, as long as the position is able to be achieved for any period of time if it able to be “maintained.”
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 5, 6, and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fields (US 3,311,268).
With regard to claims 1, 5, and 11, Fields teaches a drip chamber for a fluid administration system, comprising: a reservoir (Fig. 3 member 20) comprising an inlet orifice at a top end region for inserting a fluid (Fig. 3 member 19), and an outlet orifice at a bottom end region (Fig. 3 member 23a in a bottom sidewall of the reservoir), wherein the bottom end region is located in gravitational direction opposite and below the top end region, and a plunger element moveably arranged (Fig. 3 members 29 and 24 move vertically) within the reservoir between a first position in the top end region and a second position in the bottom end region, wherein the plunger element comprises a fluid conducting channel for regulating the flow of fluid from the inside of the reservoir to the outlet orifice when the plunger element is located in the second position (Fig. 3 channel through 24 connected to 27), wherein depending on a position of the plunger element within the reservoir an a controlled spatial arrangement between the fluid conducting channel and the outlet orifice, a passage to the outlet orifice is maintained in each of closed, partially closed, or fully opened (Fig. 3 due to the tapered/rounded tip at 29 the orifice may be partially closed during insertion of 29 into portion 18, further a user may grasp 24 to move or hold the plunger in a particular position).
With regard to claim 2, alternatively the reservoir is considered to include both portions 20 and 30, the outlet orifice is considered as 30a, the channel in 24 extends from 27 to a port opening to 30a (Fig. 3).
With regard to claim 6, alternatively the reservoir is considered to include both portions 20 and 30, the outlet orifice is considered as 30a which forms a nozzle connecting the remainder of tube 30 (Fig. 3).
With regard to claims 12, 13, and 15, Fields teaches a method to operate a drip chamber for a fluid administration system, the method comprising: connecting a fluid container (Fig. 1 member 9) comprising a fluid to an inlet orifice (Fig. 3 member 19) at a top end region of a reservoir (Fig. 3 member 20) to allow a fluid stream inside the reservoir, wherein the reservoir further comprises an outlet orifice at a bottom end region (Fig. 3 member 23a), wherein the bottom end region is located in gravitational direction opposite and below the top end region, moving a plunger element within the reservoir from a first position in the top end region to a second position in the bottom end region of the reservoir (see Figs. 2 and 3, vertical movement), wherein the plunger element comprises a fluid conducting channel for regulating the flow of fluid from the inside of the reservoir to the outlet orifice when the plunger element is located in the second position (Fig. 3 channel through 24 connected to 27), wherein depending on a position of the plunger element within the reservoir an a controlled spatial arrangement between the fluid conducting channel and the outlet orifice, a passage to the outlet orifice is maintained in each of closed, partially closed, or fully opened (Fig. 3 due to the tapered/rounded tip at 29 the orifice may be partially closed during insertion of 29 into portion 18, further a user may grasp 24 to move or hold the plunger in a particular position).
With regard to claim 14, see Fig. 13, inlet port at 27 outlet port in 30a. 24 extends through the material of the plunger to open the passage.
Claim(s) 1, 2, 5, 6, 8, 9, 11, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (US 2006/0249541 A1).
With regard to claims 1, 2, 5, and 11, Wang teaches a drip chamber for a fluid administration system, comprising: a reservoir (Fig. 1 member 31) comprising an inlet orifice at a top end region for inserting a fluid (Fig. 1 member 34), and an outlet orifice at a bottom end region (Fig. 1 within 35 which is a bottom sidewall), wherein the bottom end region is located in gravitational direction opposite and below the top end region, and a plunger element moveably arranged (Fig. 31 37 moves vertically) within the reservoir between a first position in the top end region and a second position in the bottom end region, wherein the plunger element comprises a fluid conducting channel for regulating the flow of fluid from the inside of the reservoir to the outlet orifice when the plunger element is located in the second position (see transition Figs. 1 to Fig. 2, channels 38, inlet end outlet ports at either end which open to the outlet orifice), wherein depending on a position of the plunger element within the reservoir an a controlled spatial arrangement between the fluid conducting channel and the outlet orifice, a passage to the outlet orifice is maintained in each of closed, partially closed, or fully opened (Fig. 2 as 39 moves away from 37 there would be a positions where the passage is partially closed, the piston is moved by a motor which is capable of holding it in various positions as it controls the rate, abstract, [0028]).
With regard to claim 6, nozzle 21 connects to tubing 20 (Fig. 2).
With regard to claim 8, it is not numbered but the plunger is shown to have ribs on the side, as evident by the notch in the side, which comprises a sealing member (Fig. 2).
With regard to claims 9 and 20, the driving member includes 35 and 43 which form a handle, 35 extends into the bottom half of the reservoir which extends it into the bottom end region (Fig. 2).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fields (US 3,311,268) as applied to claim 1 above, and further in view of Rondeau (US 2011/0125103 A1).
With regard to claim 10, Fields does not disclose a filter. However, Rondeau teaches placing a filter within a plunger element in a drip chamber for controlling flow ([0053]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a filter in Fields as Rondeau teaches it is beneficial to provide filtering.
Claim(s) 3, 10, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2006/0249541 A1) as applied to claim 1 above, and further in view of Rondeau (US 2011/0125103 A1).
With regard to claim 10, Wang does not disclose a filter. However, Rondeau teaches placing a filter within a plunger element in a drip chamber for controlling flow ([0053]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a filter in Wang as Rondeau teaches it is beneficial to provide filtering.
With regard to claims 3 and 16, the outlet port of 38 extends at least partly around a circumferential surface of 38 as it is adjacent the circumference. The outlet orifice is circular, regarding claim 16 the increasing width is optionally recited. Wang does not disclose the outlet port to have an increasing width, the full cross-section of the opening is not shown. However, Rondeau teaches passages for flow through a plunger element which have an increasing width in a radially outward direction (Fig. 4 passages 45). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use passages in Wang as shaped in Rondeau as this would yield the same result of passing fluid. Further, Rondeau teaches varying shapes and dimensions to control flow ([0045]). As such one of ordinary skill would be able to determine the shape needed for desired flow it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new limitations are rejected with the references as above. The Examiner would suggest further clarifying the structure involved in positioning the plunger such that it is maintained in each position listed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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