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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/24/2025 and 07/08/2025 are being considered by the examiner.
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 21-39 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.
Claim 21 and its dependents are indefinite because it is not clear whether claim 21 is drawn to the sub-combination of a container for a compressible and expandable heart pump (i.e. catheter, compressible and expandable heart pump), or whether the claim is drawn to the combination of a container and a compressible and expendable heart pump together. This is because while some portion of the claim indicate that what is claimed is the sub-combination (for compressible and expandable heart pump, configured to …etc), other portions of the claim indicate that what is claimed is the combination (note the structural limitations of claim 21, requires the heart pump radially compressed during extraction of the heart pump from the first receiving space through the opening, claim 22 requires “the heart pump in a radially expanded state, wherein in the radially expended state, a diameter of the heart pump is larger than a width of the opening…etc). It is noted further in connection with this limitation that it is by now well settled that features not claimed may not be relied upon in support of patentability. In this office action, the compressible and expandable heart pump and its corresponding features (i.e. the diameter of the heart pump) are presumed not to be claimed in order for the examiner to give the claim its broadest reasonable interpretation. Accordingly, all references in the claim to the compressible and expandable heart pump and its corresponding features are considered to be merely functional. On the other hand, clarification of the scope of claims are required.
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.
Claims 21, 25-27, 36-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaughness (9,167,891).
As to claim 21, Shaughness discloses a container (900) for a compressible and expandable heart pump (compressible and expandable heart pump not claimed, the container structure of Shaughness is capable of holding an medical tool), the container comprising: a receiving space (space for holding item 920) for the compressible and expandable heart pump (compressible and expandable heart pump not claimed), wherein the receiving space is delimited by one or more closure elements (as shown in Figure 24C, the closure member being panel 902 and 904) , wherein the one or more closure elements leave free a first opening (930) and a second opening (934), the first opening sized for passage of a catheter coupled to the compressible and expandable heart pump into the receiving space (the first end is capable of passing articles 914, catheter coupled to the compressible and expandable heart pump are not claimed), wherein the first opening is sized such that the tool through the first opening (heart pump is radially compressed during extraction of the heart pump from the receiving space are not positively claimed), wherein the second opening is larger than the first opening (as shown in Figure 23, the width of the second opening 934 is greater than width of the first opening 930) and is sized such that the compressible and expandable heart pump is introducible into the receiving space through the second opening without radially compressing the heart pump (again, all the structure of the compressible and expandable heart pump are not positively claimed, the second opening is wide enough to let the wider article 920 to pass and the wider article cannot pass through the smaller first opening).
As to claims 25-26, Johansson further discloses wherein the one or more closure elements comprise two half-shell-shaped closure elements that are joined together (Figure 24C, and they are joined via 908), the one or more closure elements comprise first and second closure elements that are undetachably connected to one another (the fastening method comprises stitching , gluing, riveting or ultrasonic welding that are not detachable easily).
As to claim 27, Johansson further discloses the one or more closure elements comprise first and second closure elements and the first opening and the second opening are formed between the first and second closure elements (Figure 23).
As to claim 36, Johansson further discloses the receiving space is delimited by at least two closure elements which are joined along a joining line (along stitching 908), wherein the joining line runs essentially perpendicularly to a passing direction of the article (as shown in Figure 23).
As to claim 37, Johansson further discloses (the receiving space is delimited by at least two closure elements which are joined along a joining line (along stitching 908), wherein the joining line runs in a cross section of the receiving space which is larger than the cross section of the first opening (as shown in Figure 23).
As to claim 38, Johansson in an another embodiment, discloses a container (100) with a receiving space (interior of body 132) a closure element (body 132) with a first opening (130) and a second opening (134), a cover (124, configured to closed the second opening (Figure 10).
As to claim 39, Johansson further discloses the first opening is disposed on a first side of the receiving space and the second opening is disposed on a second side of the receiving space (as shown in Figure 24C).
Claims 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johansson (7,207,437).
As to claim 21, Johansson discloses a container (12) for a compressible and expandable heart pump (compressible and expandable heart pump not claimed, the container structure of Johansson is capable of holding an medical tool), the container comprising: a receiving space (space for holding item 34) for the compressible and expandable heart pump (compressible and expandable heart pump not claimed), wherein the receiving space is delimited by one or more closure elements (as shown in Figure 2, the closure member (sleeve 12), wherein the one or more closure elements leave free a first opening (first opening 19) and a second opening (second opening 20), the first opening sized for passage of a catheter coupled to the compressible and expandable heart pump into the receiving space (the first end 19 is capable of passing articles 28, catheter coupled to the compressible and expandable heart pump are not claimed), wherein the first opening is sized such that the tool through the first opening (heart pump is radially compressed during extraction of the heart pump from the receiving space are not positively claimed), wherein the second opening 20 is larger than the first opening (as shown in Figure 1, the opening of the second opening 20 is greater than the opening of the first opening 19) and is sized such that the compressible and expandable heart pump is introducible into the receiving space through the second opening without radially compressing the heart pump (again, all the structure of the compressible and expandable heart pump are not positively claimed, the second opening 20 is wide enough to let the wider article 34 to pass and the wider article cannot pass through the smaller first opening 19).
As to claim 22, Johansson further discloses the receiving space is sized to contain the heart pump within the receiving space with the heart pump in a radially expanded state, wherein in the radially expanded state, a diameter of the heart pump is larger than a width of the first opening (again, as recited above, all the structure of the compressible and expandable heart pump are not positively claimed, the second opening 20 is wide enough to let the wider article 34 to pass and the wider article cannot pass through the smaller first opening 19).
As to claim 23, Johansson further discloses the one or more closure elements are made of a plastic material (column 2, lines 61-64 which polyurethane is a type of plastic material)
Claims 21, 28-35 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de la Rocha (5,511,654).
As to claim 21, Rocha discloses a container (10) for a compressible and expandable heart pump (compressible and expandable heart pump not claimed, the container structure of Rocha is capable of holding an medical tool 14), the container comprising: a receiving space (space for holding item 14) for the compressible and expandable heart pump (compressible and expandable heart pump not claimed), wherein the receiving space is delimited by one or more closure elements (as shown in Figure 2, the closure member (body 18), wherein the one or more closure elements leave free a first opening (first opening 38) and a second opening (second opening above belly portion 20), the first opening sized for passage of a catheter coupled to the compressible and expandable heart pump into the receiving space (the first end 38 is capable of passing articles body 35, catheter coupled to the compressible and expandable heart pump are not claimed), wherein the first opening is sized such that the tool through the first opening (heart pump is radially compressed during extraction of the heart pump from the receiving space are not positively claimed), wherein the second opening 20 is larger than the first opening (as shown in Figure 1-4, the opening of the second opening 20 is greater than the opening of the first opening 38) and is sized such that the compressible and expandable heart pump is introducible into the receiving space through the second opening without radially compressing the heart pump (again, all the structure of the compressible and expandable heart pump are not positively claimed, the second opening 20 is wide enough to let the wider article 14 to pass and the wider article cannot pass through the smaller first opening 38).
As to claims 28-29, Rocha further discloses the one or more closure elements comprises a first closure element that is configured as part of a blister (the body shield as a blister), the blister comprises a groove (hub passage way 38) formed in the blister exterior to the receiving space, the groove configured to receive at least a portion article 25, the catheter is not being claimed).
As to claim 30, Rocha further discloses the first closure element (18) forms a capture shell (Figure 2).
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As to claims 31-33, Rocha further discloses the first opening at least partly consists of a cylinder-symmetrical channel. (as shown in Figure 4, the passage way channel 38 is a cylindrical channel), the cylinder-symmetrical channel narrows outwardly from inside of the receiving space (as shown in Figure 2 above), the first opening comprises an edge (inner surface of the channel, a hollow-cylindrical sheath element in an axial direction of the cylinder- symmetrical channel, wherein the hollow-cylindrical sheath element is displaceable along the catheter are not positively claimed in combination with the container as applicant use “configured to…”).
As to claims 34-35, Rocha further discloses a groove (passage way forming a groove) formed in a surface of the container and extending from the first opening away from the receiving space (Figure 2), the groove configured to receive at least a portion of the article located in the receiving space and the handle portion projects through the first opening out of the receiving space (catheter and the compressible and expandable heart pump are not positively claimed) and the groove is configured to receive a handle portion of the article (as recited above, the structure of the catheter and a sheath element through which the catheter passes are not positively claim with the combination of the container, the structure of the container of Rocha are full capable to house the items as claimed).
As to claim 38, Rocha further discloses a cover (9) configured to close the second opening (Figure 2).
Claims 21 and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowe et al (5,842,567).
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As to claim 21, Rowe discloses a container (10) for a compressible and expandable heart pump (compressible and expandable heart pump not claimed, the container structure of Rowe is capable of holding an medical tool), the container comprising: a receiving space (as annotated above) for the compressible and expandable heart pump (compressible and expandable heart pump not claimed), wherein the receiving space is delimited by one or more closure elements (as shown in Figure 3 above, the receiving space is delimited by the first half portion 12), wherein the one or more closure elements leave free a first opening (first opening as annotated above) and a second opening (second opening as annotated above), the first opening sized for passage of a catheter coupled to the compressible and expandable heart pump into the receiving space (the first opening forming a channel that is capable for an item to sit in, catheter coupled to the compressible and expandable heart pump are not claimed), wherein the first opening is sized such that the tool through the first opening (the first opening forming a channel that is capable for an item to pass, the heart pump is radially compressed during extraction of the heart pump from the receiving space are not positively claimed), wherein the second opening is larger than the first opening (as shown in Figure 3 above, the opening of the second opening is greater than the opening of the first opening) and is sized such that the compressible and expandable heart pump is introducible into the receiving space through the second opening without radially compressing the heart pump (again, all the structure of the compressible and expandable heart pump are not positively claimed, the second opening is wide enough to let the wider article 20 to pass and the wider article).
As to claims 23 and 24, Rowe further discloses the one or more closure elements are made of a plastic material (column 2, lines 2-4) and the plastic material is a plastic foil.
Conclusion
Examiner has cited particular paragraphs and/or columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the applicant, in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or prior art(s) disclosed by the Examiner (in the attached PTO-892 form).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN HOI CHEUNG whose telephone number is (571)270-5702. The examiner can normally be reached Monday to Friday 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E Aviles can be reached at (571)270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN HOI CHEUNG/Primary Examiner, Art Unit 3736
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