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.
Claim 10-12 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 10-12 recite “preferably”. This renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-8, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burrell (US 2314767 – cited by Applicant).
Regarding Claim 1, Burrell teaches: A valve assembly (title) for controlling fluid flow in a channel (column 1), which extends along a longitudinal proximodistal central axis (CA) (figures 1, 2, 4), said valve assembly comprising:
a switch (elements 14, 15);
a deformable tube enclosing the channel (element 3); and
a sphere (element 9) arranged within the tube between a distal channel portion (upper part of figure 1 above element 9) and a proximal channel portion of the channel (lower part of figure 1 below element 9);
wherein when the tube is in a non-deformed resting state (figure 1), the valve assembly is in a closed state, and the sphere is in direct contact with said tube, forming a fluid seal with the tube; and
wherein when a force is applied to the switch, the tube is in a deformed non-resting state, and the valve assembly is in an open state, whereby fluids are allowed pass the sphere (column 1 line 43 – column 2 line 3).
Regarding Claim 2, Burrell teaches: The valve assembly according to claim 1, wherein when the valve assembly is in its open state, the tube is stretched transversally, perpendicularly to an extension of the channel (135) (column 1 line 43 – column 2 line 3).
Regarding Claim 3, Burrell teaches: The valve assembly according to claim 1, wherein when the valve assembly is in its open state, an opening is arranged between at least a part of the sphere and the tube (column 1 line 43 – column 2 line 3).
Regarding Claim 4, Burrell teaches: The valve assembly according to claim 1, wherein the tube has a platform extending laterally from the tube, wherein the platform is in communication with the switch and is configured to receive force applied to the tube by the switch (elements 11, 13).
Regarding Claim 5, Burrell teaches: The valve assembly according to claim 4, wherein the switch comprises at least one leg in contact with said platform, which transfers a force applied to the switch to the platform (element 14).
Regarding Claim 6, Burrell teaches: The valve assembly according to claim 1, wherein the channel is made of a material which is more rigid than the material forming the tube (column 1 lines 25-36).
Regarding Claim 7, Burrell teaches: The valve assembly according to claim 1, wherein the distal channel portion has a distal channel slit at its proximal end, and the proximal channel portion has a proximal channel slit at its distal end, wherein the distal and proximal slits face the sphere (upper and lower portions of slot 8 and clearance 10).
Regarding Claim 8, Burrell teaches: The valve assembly according to claim 7, wherein the distal and proximal slits extend transversally to the channel portions (figures 3 and 5).
Regarding Claim 12, Burrell teaches: The valve assembly according to claim 1, wherein the tube is made of an elastomer, preferably being a rubber or a silicone (column 1 lines 25-36).
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burrell.
Regarding Claim 9, Burrell teaches: The valve assembly according to claim 7, but does not mention wherein the distal and proximal slits have a U-formed shape in a direction transversal to the distal and proximal channel portions. However, Examiner notes that it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention to include wherein the distal and proximal slits have a U-formed shape in a direction transversal to the distal and proximal channel portions as this is merely a design choice. Applicant does not provide details of criticality, advantages or unexpected results with respect to the shape of the slits. One of ordinary skill would have expected any shape of slits to perform equally well as they perform the same function – allowing adequate fluid flow.
Claim(s) 10, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burrell in view of Gulev et al. (WO 2017/129735 A1 – cited by Applicant), hereinafter Gulev.
Regarding Claim 10, Burrell teaches: The valve assembly according to claim 1, but does not mention wherein the valve assembly is arranged in a syringe, preferably the valve assembly being arranged in a distal end portion, between a distal tip and a barrel, of the syringe.
Gulev teaches that valve assembly can be arranged in a syringe, preferably the valve assembly being arranged in a distal end portion, between a distal tip and a barrel, of the syringe (figure 1A and 1B). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention wherein the valve assembly is arranged in a syringe, preferably the valve assembly being arranged in a distal end portion, between a distal tip and a barrel, of the syringe in order to control the flow of fluid out of a syringe.
Regarding Claim 11, Burrell in view of Gulev teach: The valve assembly according to claim 10, wherein the syringe comprises a platform receiving recess, configured to receive the platform when force is applied to the switch, preferably said platform receiving recess being arranged in the distal end portion of the syringe (Gulev - claim 10; see also Burrell - column 1 lines 45-55 and column 2 lines 17-24).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gulev in view of Burrell.
Regarding Claim 13, Gulev teaches: A biopsy syringe (title) extending along a longitudinal proximodistal central axis (CA), wherein the biopsy syringe comprises a valve assembly (figure 1A and 1B). Gulev does not mention that the valve is according to claim 1.
Burrell teaches a valve according to claim 1 (column 1-2; figures 1-4). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention to include that the valve is according to claim 1 as the substitution of one valve assembly for another would have yielded predictable results to one of ordinary skill.
Regarding Claim 14, Gulev in view of Burrell teach: The biopsy syringe according to claim 13, wherein the biopsy syringe is a fine-needle aspiration syringe or a core-needle biopsy syringe (Gulev – page 5 lines 20-22).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ra; US 20180133404 A1 – syringe with sphere comprising check valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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