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 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 15 is objected to because of the following informalities:
Regarding claim 15, the claim should be amended to recite “the fluid reservoir chamber” in line 2 to keep terminology consistent.
Appropriate correction is required.
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 1-15 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 1, the claim recites “a molded shape” in line 6. “Molded” denotes a specific type of fabrication method and does not impart any specific shape. An item can be molded into any shape depending on the specific mold used. Therefore, the type of shape which would be covered by the claim is not understood. For examination purposes, the limitation is interpreted to define the process by which the shape of the membrane is made.
Claim 9 recites the limitation "the finger plates" in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the claim was examined as if depending on claim 7.
Claim 13 contains the trademark/trade name Elastollan. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a thermoplastic polyurethane and, accordingly, the identification/description is indefinite.
Regarding claim 14, the claim recites “the cassette being secured to the pump with the cassette base region within the receiving region” in the last line of the claim. It is unclear how this limitation relates to the rest of the claim or when this condition needs to occur. The claim is directed towards a lock and recites that the cassette is insertable/removable from the pump when the lock is open. Therefore, it is unclear if the cassette is secured to the pump when the lock is open or if the claim intends to mean that the cassette is secured when the lock is in the closed position. For examination purposes, the second is interpretation is used. The examiner notes that this interpretation appears consistent with Applicant’s specification on pg. 10, lines 19-21.
Claims 2-8, 10-12, and 15 are also rejected by virtue of being dependent on claim 1.
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) 1-4, 6, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clement (EP 1393762).
Regarding claim 1, Clement discloses a device for delivering a beneficial agent (fig. 1), comprising:
a pump (10 in fig. 2a) including a pump housing (16 in fig. 1a) containing a pump assembly (20 and 22 in fig. 2a) having a fluid drive component (22 in fig. 2a), the pump housing having a receiving region disposed proximate the fluid drive component (see below), the pump housing comprising a rear closure portion (frame 40 in fig. 2a) including a membrane (38 in fig. 2a) disposed between the receiving region and the fluid drive component (fig. 2b shows the frame/membrane between a portion of the receiving region designated below and rollers 22), the membrane having a shape configured to conform to at least one feature of the pump housing (the membrane has a curved shape configured to conform to several features of the pump housing, like the drive assembly and the male part 26, as seen in fig. 2b); and
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a cassette (12 in fig. 1) including a cassette housing (30 in fig. 1) comprising a cassette body region (see below) defining a fluid reservoir chamber therein (paragraph 16, lines 137-139), and a cassette base region having a boundary configured to be received by the receiving region (see below, counterpiece 34 is inserted into the receiving region).
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Regarding the shape of the membrane being molded (see 112b rejection/interpretation above), it is noted by the examiner that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself and does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 227 USPQ 964. Therefore, as the step of molding the membrane into its shape does not impart a physical limitation which differentiates over the prior art, Clement is considered as reading on the limitation "the membrane having a molded shape".
Regarding claim 2, Clement discloses the rear closure portion includes a slot proximate a lateral edge of the receiving region (see below), the membrane being molded over the slot (fig. 2b shows the membrane fitted over the slot and paragraph 9 discloses that the membrane is stretched over the frame so that the membrane is molded over the slot) and defining a protrusion extending to said lateral edge of the receiving region (see below and fig. 2b).
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Regarding claim 3, Clement discloses the slot comprises a plurality of edges to support the membrane (see below), the membrane being molded over the edges (fig. 2b shows the membrane stretched over the edges).
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Regarding claim 4, Clement discloses the receiving region includes a support rib proximate to the rear closure portion (see below), the membrane being molded over the support rib (fig. 2b shows the membrane molded so it is shaped to fit the curvature of the rib).
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Regarding claim 6, Clement discloses the cassette comprises a delivery tube assembly extending from the fluid reservoir chamber (paragraph 16, lines 137-139 describes a delivery tube assembly comprising a flexible tube, a connector, and a tubing terminating in an injection needle), the delivery tube assembly comprising a peristaltic tube in functional relationship to the fluid drive component with the membrane disposed therebetween when the cassette base region boundary is received by the receiving region (“flexible tube” in paragraph 16, lines 137-139; paragraph 17, lines 151-153).
Regarding claim 8, Clement discloses the membrane has a curvature corresponding to a curvature of the peristaltic tube (paragraph 16, lines 140-144 and paragraph 17, lines 151-153 disclose that when the tube is mounted on the concave part, the curvature matches the curvature of the tube).
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 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clement, as applied to claim 1 above, and further in view of Lindsey (US 5807322).
Regarding claim 10, Clement discloses all of the claimed limitation set forth in claims 1 and 6, as discussed above, but does not teach or disclose the peristaltic tube engages an occlusion sensor proximate the rear closure portion when the cassette base region boundary is received by the receiving region.
Lindsay is directed towards an infusion pump having a tube (tube 28 in fig. 4) which engages an occlusion sensor (sensor 50 in fig. 4) proximate the fluid drive component when the tube is received adjacent the fluid drive component (fig. 4; 3:46-57). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Clement to have an occlusion sensor proximate the rear closure portion, which is proximate the fluid drive component, when the cassette base region boundary is received by the receiving region when the peristaltic tube is operationally engaged with the fluid drive component, as taught by Lindsay. Lindsay teaches that this sensor is very small and inexpensive to implement (3:46-57) and can monitor for occlusions to improve patient safety.
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clement, as applied to claim 1 above, and further in view of Borsanyi (US 4493706) and in further view of Rakowicz (20130154252).
Regarding claim 13, Clement discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose regarding the membrane comprises Elastollan S95A55N material.
Borsanyi teaches a similar device (fig. 1) having a pump housing (18 in fig. 11) comprising a fluid drive component (28 in fig. 3) and a membrane (40 in fig. 3) separating the fluid drive component from a peristaltic tube (12 in fig. 10). Borsanyi teaches that the membrane is made from an elastomeric material (4:31-36). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the membrane of Clement to be made from an elastomeric material since this modification would allow for easy fitting and stretching of the membrane over the rigid frame of Clement.
Rakowicz teaches an elastomeric tether (paragraph 17) and further teaches the tether comprises Elastollan S95A55N material (paragraph 19). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the membrane disclosed by modified Clement to be comprised of Elastollan S95A55N material for the purpose of providing an art recognized and commercially available elastomeric material.
Claims 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clement, as applied to claim 1 above, and further in view of Moeri (EP 1384490).
Regarding claim 14, Clement discloses all of the claimed limitations set forth in claim 1, as discussed above but does not explicitly teach or disclose a lock member coupled to the pump housing and movable between an open position and a closed position, the cassette capable of being inserted into and removed from the receiving region when the lock member is in the open position, and the cassette being secured to the pump with the cassette base region within the receiving region.
Moeri teaches a substantially similar pump (fig. 1a) having a lock member (24 in fig. 1a) coupled to the pump housing (14 in fig. 1b) and movable between an open position and a closed position (paragraph 25), the cassette capable of being inserted into and removed from the receiving region when the lock member is in the open position (paragraph 25 discloses that when the pull tab is actuated the button 22 can be depressed which enables the two modules to be separated), and the cassette being secured to the pump with the cassette base region within the receiving region (paragraph 25 discloses in the rest position the translation of button 22 is blocked so that the pump and cassette cannot be separated).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified device of Clement to have a lock member coupled to the pump housing and movable between an open position and a closed position, the cassette capable of being inserted into and removed from the receiving region when the lock member is in the open position, and the cassette being secured to the pump with the cassette base region within the receiving region, as taught by Moeri. This modification would ensure the pump and cassette are securely fastened to each other and cannot be inadvertently separated.
Regarding claim 15, in the modified device of Clement, Clement discloses the delivery tube fluidly coupled with the fluid reservoir (paragraph 16, lines 137-139), wherein a length of the delivery tube is operatively engaged with the fluid drive component when the lock member is in the closed position (paragraph 17, lines 151-153).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10213546 in view of Borsanyi and in further view of Minami (US 5568912).
Regarding instant claim 1, issued claim 1 claims all of the claimed limitations set forth in instant claim 1 except in that issued claim 1 does not claim the membrane having a molded shape configured to conform to at least one feature of the pump housing.
Borsanyi teaches a device for delivering a beneficial agent (fig. 11) comprising a membrane (40 in fig. 1) having a shape configured to conform to at least one feature of the pump housing (fig. 3 shows the membrane has a shape which conforms to the pump mechanism 28, which is a part of the pump housing). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of issued claim 1 to include the membrane having a shape configured to conform to at least one feature of the pump housing, as taught by Borsanyi. This modification would enable the membrane to conform to the pump mechanism to protect both the tube against damage or wear and the pump mechanism against fluid contact (1:60-67).
Minami teaches an elastomeric membrane (12 in fig. 1) which can be made using a molding technique (7:12-19). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the membrane of issued claim 1 to be molded since Minami teaches that molding is a common fabrication technique used to produce membranes.
App Claims
Patent Claims
Teaching
1
1
see discussion above
2
2
3
3
4
4
5
5
6
1 and 6
7
7
8
8
9
9
10
1
11
1
12
9
13
10
14
11
15
12
Allowable Subject Matter
Claims 5, 7, 9, 11, and 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and the double patenting rejections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 5 and 7, the closest piece of art is Clement which fails to teach or disclose the fluid drive component comprises a plurality of finger plates. Instead, Clement discloses that the fluid drive component comprises “three pressure rollers” (paragraph 22, lines 200-201). It is the examiner’s opinion that these rollers cannot reasonably be considered to be “finger plates”.
Regarding claim 11, the closest piece of art is Clement which fails to teach the membrane includes an occlusion sensor protrusion configured to surround a portion of the occlusion sensor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following prior art are directed towards infusions pumps which comprise fluid drive components in the form of finger plates:
Kaplan (US 4909710) -- see fig. 2
Meijer (US 5165873) – see fig. 2
Miyazaki (US 20100143168) – see fig. 5, abstract
Moubayed (US 6164921) – see fig. 7
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NATHAN PRICE can be reached on 571-270-5421. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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