DETAILED ACTION
This detailed action is in response to the amendments and arguments filed on 01/02/2025, and any subsequent filings.
Notations “C_”, “L_” and “Pr_” are used to mean “column_”, “line_” and “paragraph_”.
Claims 1-15 are canceled. Claims 16-35 are pending.
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 Interpretation
Claims 17-20, 22-23, 25, and 27 are interpreted as product-by-process claims (see MPEP 2113).
Claims depending on the aforementioned claim(s) are also affected by this interpretation.
Claim 35 reads “the system is configured to perform hemodialysis, hemofiltration, hemodiafiltration and any combination thereof”. This is being interpreted to mean that the system is configured to perform hemodialysis, hemofiltration, hemodiafiltration or any combination thereof.
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 16-35 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 16, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Dependent claims not recited above require all of the limitations of independent Claim 16, and therefore are rejected for the same reasons set forth above.
Regarding claim 18, the phrase "particularly" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 29, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-18, 21-32 and 34-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Japanese Publication JP2005118506A (‘Shoichi’). Machine translations accompany this detailed action and the claims are mapped to those translations and the drawings in the original documents.
The Applicant’s claims are directed towards an apparatus.
Regarding Claims 16-18, 21-32 and 34-35, Shoichi discloses a dialyzer for blood treatment ([0001]), comprising:
a housing (Fig. 1, [0025], structure comprising first cylindrical container and second cylindrical container) defining a cavity comprising a first cavity region (Fig. 1, [0059], first cylindrical container 11a) and a second cavity region (Fig. 1, [0059], second cylindrical container 21a) which are communicated with each other by a pass-through passage (Fig. 1, [0059], blood communication channel 35a);
a plurality of hollow fiber membranes (Fig. 1, [0059] and [0063], hollow fiber bundles 12a, 22a) extending from the first cavity region to the second cavity region across the passage;
a flow restricting structure (Fig. 1, [0068], connecting portion 31a) located in an area of the passage so as to restrict flow of medical fluid ([0068]), for example dialysate, between the first cavity region and the second cavity region;
a first port and a second port (Fig. 1, [0061-0062], dialysate outlet 14a and first cavity connecting port 16a) each fluidly communicated with the first cavity region (Fig. 1, [0061-0062]); and
a third port and a fourth port (Fig. 1, [0065-0066], dialysate inlet 24a and second cavity connecting port 26a) each fluidly communicated with the second cavity region (Fig. 1, [0061-0062]).
Additional Disclosures Included:
Claims 17, 23, and 27: the flow restricting structure (Fig. 1, [0084]) is configured to be formed during or after injection molding of the housing.
Claim 18: the flow restricting structure comprises a protrusion (Fig. 1, [0068]) formed during injection molding of the housing; or
the flow restricting structure is formed at least partially by a shrinkable structure which can be shrunk after injection molding of the housing, particularly after loading of the hollow fiber membranes.
Claim 21: the passage is configured as a narrowed region defined at least partially by the flow restricting structure (Fig. 1); and/or
the dialyzer is configured without any potting in the area of the passage.
Claims 22 and 25: the flow restricting structure is configured to be disposed within the housing (Fig. 1) or to be integrally formed on the housing ([0059]); and/or
the flow restricting structure is designed while considering expansion property of the hollow fiber membranes in use; and/or
the flow restricting structure is configured to relatively tightly hold the hollow fiber membranes.
Claim 23: the flow restricting structure (Fig. 1, [0084]) is configured to be formed during or after injection molding of the housing.
Claims 24, 26 and 28: the first port or the second port is fluidly connected with the third port or the fourth port (Fig. 1, [0067], first connecting port 16a and second connecting port 26a) through a fluid flow control device (Fig. 1, [0067], connecting passage 46a) to control flow of the medical fluid therebetween ([0074]).
Claim 29: the housing has a substantially cylindrical configuration ([0021]) and the first port, the second port, the third port and the fourth port are disposed on the housing sequentially in an axially spaced manner from each other in an axial direction (Fig. 1), preferably in a row.
Claim 30: the second port and the third port are fluidly connected (Fig. 1, [0067], first connecting port 16a and second connecting port 26a) by the fluid flow control device (Fig. 1, [0067], connecting passage 46a).
Claim 31: the fluid flow control device comprises an on-off valve and/or a flow restriction (Fig. 1, [0074], connecting tube 41a).
Claim 32: the on-off valve and the flow restriction are connected in parallel between the second port and the third port; and/or
the on-off valve is a solenoid valve; and/or
the flow restriction is a variable flow restriction ([0074] and [0081]); and/or
the fluid flow control device further comprises a flow sensor for detecting a flowrate of the medical fluid between the second port and the third port.
Regarding Claims 34-35: a system for blood treatment (Fig. 6, [0078]), comprising:
the dialyzer according to claim 16 (see analysis of Claim 16);
a blood line (Fig. 6, [0071], blood supply line connects to blood inlet 13a then the blood returns to the patient via blood outlet 23a through the blood return line); and
a medical fluid line (Fig. 6, [0078-0079], dialysate supply line leads to dialysate inlet 24a then the dialysate exits through outlet 44a to the dialysate discharge channel);
wherein the blood line and medical fluid line are fluidly connected with the dialyzer (Fig. 6, [0071] and [0078-0079]).
Additional Disclosures Included:
Claim 35: the system is configured to perform hemodialysis ([0001]), hemofiltration ([0004]), hemodiafiltration and any combination thereof ([0004] and [0031]).
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 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Japanese Publication JP2005118506A (‘Shoichi’) in view of Japanese Publication JP2003334244A (‘Takashi’). Machine translations accompany this detailed action and the claims are mapped to those translations and the drawings in the original documents.
The Applicant’s claims are directed towards an apparatus.
Regarding Claims 19-20, Shoichi discloses the dialyzer of Claim 18, except that the protrusion is formed by a curved wall portion of the housing; or the shrinkable structure comprises a heat-shrinkable tube.
Takashi also relates to a dialyzer for blood treatment ([0001]), including that the protrusion is formed by a curved wall portion of the housing (Fig. 1, [0017] and [0019], see curved portion of housing 11); or the shrinkable structure comprises a heat-shrinkable tube (Fig. 1, [0018], heat-shrinkable tube 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the protrusion of Shoichi to be formed by a curved wall portion of the housing, as demonstrated by Takashi, to have a reduced diameter portion, so that the cross-sectional area of the dialysate flow path decreases, in turn promoting internal filtration and internal back filtration (Takashi, [0017]). It would have been obvious for the flow restricting structure of Shoichi to be formed at least partially by a shrinkable structure, such as the heat-shrinkable tube of Takashi, to increase internal filtration and internal back filtration, allowing for larger volumes of filtration and fluid replacement, thus providing a dialyzer with high dialysis efficiency (Takashi, [0012]).
Additional Disclosures Included:
Claim 20: the heat-shrinkable tube forms at least a portion of the housing (Takashi, Fig. 1, [0019]) or disposed within the housing (Takashi, Fig. 1, [0019]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Japanese Publication JP2005118506A (‘Shoichi’) in view of U.S. Publication US20040195157A1 (‘Mullins’).
The Applicant’s claims are directed towards an apparatus.
Regarding Claim 33, Shoichi discloses the dialyzer of Claim 28, except that the fluid flow control device is integrated as a shunt interlock assembly.
Mullins also relates to a dialyzer for blood treatment ([0022]), including that the fluid flow control device is integrated as a shunt interlock assembly ([0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the fluid flow control device of Shoichi to be a shunt interlock assembly to provide the user the ability to set the pressure supplied (Mullins, [0034] and [0012]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BOI-LIEN THI NGUYEN whose telephone number is (703)756-4613. The examiner can normally be reached Monday to Friday, 8 am to 6 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, Bobby Ramdhanie can be reached at (571) 270-3240. 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.
/BOI-LIEN THI NGUYEN/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779
Prosecution Insights