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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 November 2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
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) 1-7, 9-11, 13-16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lauryssen et al. US 2003/0183545 and Rippstein Jr. US 6,193,695.
Regarding claim 1, Lauryssen teaches as seen in fig. 3:
an adapter assembly 10, comprising: a housing 12 including:
a channel (interior portion) formed within the housing, and configured to receive a medical device (syringe 50);
a first groove (top portion), and configured to at least partially receive a first retaining element (upper O-ring 34) which is fixed relative to the interior wall; and
a second groove (bottom portion), and configured to at least partially receive a retaining element (lower O-ring 34) which is fixed relative to the interior wall;
wherein each of the first groove and the second groove extends circumferentially about the interior wall of the channel (fig. 3 shows the groove extending around the interior wall of the channel which would be required to house the O-ring which is circular by definition);
wherein the first retaining element (top) is configured to extend outward from the first groove, such that each of the first retaining element abuts against a body of the medical device that is received through the channel (fig. 3 illustrates the retaining element 34 as extending outward from the first groove and abutting against a body of the medical device as described in paragraph 040); and
wherein the first retaining element is configured to compress radially-outward from a central longitudinal axis of the channel while remaining longitudinally fixed relative to the interior wall, when the body of the medical device is received through the channel (paragraph 0040).
Lauryssen does not explicitly disclose the grooves as being “formed along the interior wall of the channel” as claimed, but rather that they are formed between elements 20 and 24b. Lauryssen does not explicitly teach the first and second grooves as being “formed along the interior wall of the channel, but rather are formed between the connection to the two surrounding elements as seen in fig. 3.
Rippstein teaches a syringe device as seen in fig. 2 which includes an O-ring 49 placed within a groove 48 which is formed in the housing. It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Rippstein with those of Lauryssen in order to provide the O-ring in a dedicated channel as taught by Rippstein to ensure it stays in place and to help prevent it from falling out when in use.
Regarding claim 2, Lauryssen teaches the first and second retaining elements as configured to align the body of the medical device relative to a central longitudinal axis (vertical axis following needle 54 of the channel).
Regarding claim 3, as seen in fig. 3 of Lauryssen, when the medical device 50 is placed in the housing 12, the retaining elements 34 maintain it in a suspended position relative to the housing and permit movement of the medical device relative to the first and second retaining elements as the medical device is received through the channel.
Regarding claim 4, as seen in fig. 3 of Lauryssen, when the medical device 50 is placed in the housing 12, the retaining element 34 offsets a proximal end (bottom end) of the body from a proximal surface of the housing when the medical device is in the suspended position (a gap exists at both the top and bottom of the housing where the device is suspended).
Regarding claim 5, in combination, the first and second retaining elements of Lauryssen are arranged in the claimed manner and would therefore be configured to minimize a load applied to the medical device by the housing when separating the proximal end of the body from the proximal surface of the housing since they meet the structural limitations of the claim.
Regarding claim 9, Lauryssen discloses a configuration seen in fig. 5 or fig. 6 comprising a handle (grasping member 106a or 112a) which would allow for the housing to be removably coupled to a testing instrument and the medical device including a syringe when assembled wherein the medical device comprise a syringe.
Regarding claim 10, when used in combination with a testing instrument, the adapter assembly of Lauryssen would be configured to align the needle relative to the testing instrument when the adapter assembly is coupled to a testing instrument since the needle would need to be placed in the correct location for sample handling. Additionally, the limitation of the alignment of the needle within the testing device is directed towards the needle being guided into the instrument. Fig. 5 for example, of Lauryssen teach an external device in the form of members 102a and 102b into which the needle is aligned in when the medical device is connected thereto.
Regarding claim 11, the adapter of Lauryssen teaches the claimed invention but does not explicitly disclose the syringe as suspended within the testing instrument in the claimed manner. Fig. 5 of Lauryssen illustrates an embodiment in which the body of the syringe is separated from any connecting device. Since the testing instrument is not part of the adapter assembly claimed, it would have been obvious to one of ordinary skill in the art at the time of filing to have applied the same teachings seen in fig. 5to the attachment of any external object such as a testing instrument to ensure the syringe needle is inserted cleanly without damaging it.
Regarding claim 13, the adapter assembly of Lauryssen, has a first cross-sectional dimension of the channel, the first retaining element and the second retaining element which define a grip diameter of the adapter assembly which varies along a longitudinal length of the housing as claimed (fig. 3 illustrates the channel as varying in diameter at different points between the bottom and the top due to the addition of the retaining elements for example).
Regarding claim 14, the first and second retaining elements of Lauryssen are elastomeric elements as claimed (0040).
Regarding claim 15, Lauryssen teaches as seen in fig. 3,
an adapter assembly 10, comprising: a housing 12 including:
a channel (interior portion) formed within the housing, and configured to receive a medical device (syringe 50);
a pair of grooves ( located at the top and bottom portions) longitudinally offset from one another along the interior wall,
a pair of retaining elements (upper and lower O-rings 34) which are partially within the grooves and fixed relative to the interior wall,
wherein each of the first groove and the second groove extends circumferentially about the interior wall of the channel (fig. 3 shows the groove extending around the interior wall of the channel which would be required to house the O-ring which is circular by definition);
wherein each of the pair of retaining elements is configured to extend outward from the pair of grooves into the channel, thereby interfacing with a portion of the medical device that is received through the channel (fig. 3 illustrates the retaining element 34 as extending outward from the first groove and abutting against a body of the medical device as described in paragraph 040); and
wherein pair of retaining elements is configured to compress into the grooves and out of the channel while remaining longitudinally fixed relative to the interior wall when the portion of the medical device is received through the channel (fig. 3).
Lauryssen does not explicitly teach the first and second grooves as being “formed along the interior wall of the channel, but rather are formed between the connection to the two surrounding elements as seen in fig. 3.
Rippstein teaches a syringe device as seen in fig. 2 which includes an O-ring 49 placed within a groove 48 which is formed in the housing. It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Rippstein with those of Lauryssen in order to provide the O-ring in a dedicated channel as taught by Rippstein to ensure it stays in place and to help prevent it from falling out when in use. Regarding claim 2, Lauryssen teaches the first and second retaining elements as configured to align the body of the medical device relative to a central longitudinal axis (vertical axis following needle 54 of the channel).
Claim(s) 6, 7, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lauryssen and Rippstein, and further in view of Tibbs US 3,702,608.
Regarding claims 6 and 7, and claims 16 and 17, Lauryssen and Rippstein disclose the claimed invention but do not explicitly teach the alignment mechanism as claimed. Tibbs teaches a housing for a medical device (syringe) in which an alignment mechanism 104 is positioned on a proximal (top) surface of a housing 62 for a syringe 50 and configured to position the proximal end of the device 50 relative to the housing (mechanism 104 can move the plunger vertically within the housing as seen in fig. 3). The housing further includes a slot 32 to slidably receive the alignment mechanism between a plurality of positions within the slot (fig. 3). It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Tibbs with those of Lauryssen and Rippstein in order to allow for an automated plunging device such as that of Tibbs to be used to more accurately control the plunger during use.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lauryssen and Tibbs.
Regarding claim 20, Lauryssen teaches a method for holding a medical device in an adapter assembly comprising:
inserting the medical device (syringe 50) through a channel of the adapter assembly 12 the channel including a pair of grooves (housing element 345 in fig. 3) separated from one another along a longitudinal length of the channel (top and bottom) and at least one retaining element 34 received in one of the pair of grooves (top or bottom) for suspending the medical device inside the channel (as seen in fig. 3), wherein each of the pair of grooves extends circumferentially about an interior wall of the channel and the at least one retaining element is configured to compress radially outward away from the channel when the medical device is received through the channel (paragraph 0040). Lauryssen does not explicitly teach positioning an alignment mechanism of the adapter assembly in a first position to impede movement of the medical device relative to the channel by engaging a portion of the medical device, and positioning the alignment mechanism of the adapter assembly in a second position to allow movement of the medical device relative to the channel by disengaging the portion of the medical device as claimed.
Tibbs teaches a housing for a medical device (syringe) in which an alignment mechanism 104 is positioned on a proximal (top) surface of a housing 62 for a syringe 50 and configured to position the proximal end of the device 50 relative to the housing (mechanism 104 can move the plunger vertically within the housing as seen in fig. 3). The housing further includes a slot 32 to slidably receive the alignment mechanism between a plurality of positions within the slot (fig. 3). It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Tibbs with those of Lauryssen in order to allow for an automated plunging device such as that of Tibbs to be used to more accurately control the plunger during use.
Allowable Subject Matter
Claims 8, 12, 18 and 19 are objected to as being dependent upon a rejected base claim, but may be allowable if rewritten in independent form including 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: the prior art of record fails to teach the specifics of the alignment mechanism is movable between a first position and a second position relative to the slot; wherein in the first position, the alignment mechanism is configured to limit movement of the proximal end of the medical device relative to the housing, and in the second position, the alignment mechanism is configured to allow movement of the proximal end of the medical device relative to the housing (claim 8), the first retaining element and the second retaining element are configured to minimize a load applied to the syringe by the testing instrument by separating a proximal flange of the syringe from the housing and the one or more surfaces of the testing instrument (claim 12), the alignment mechanism configured to engage a portion of the medical device, thereby obstructing movement of the medical device relative to the adapter assembly in a first position, and, in a second position of the alignment mechanism relative to the slot, the alignment mechanism is configured to disengage the portion of the medical device, thereby permitting movement of the medical device relative to the adapter assembly (claim 17), and the alignment mechanism includes a movable body and a connector coupled to the movable body, the movable body has a pair of apertures that are each configured to receive a securing mechanism for coupling the movable body to the connector (claim 18). Claim 19 which depends from claim 18 is indicated as allowable for the same reasons as claim 18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A. Shabman whose telephone number is (571)272-8589. The examiner can normally be reached M-F 8:00-4:30 EST.
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/MARK A SHABMAN/Primary Examiner, Art Unit 2855