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 .
Election/Restrictions
Applicant’s election of Invention I and Species V in the reply filed on 07/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Note, Applicant did not meet requirement (ii) on Page 6 of the 05/21/2026 Requirement for Restriction to identify the claims encompassing the elected species. As such, Examiner has determined which claims read on elected Species V, withdrawing claims which read on unelected species, as described below.
Claims 3 & 8-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 0721/2026.
Claim 3 is withdrawn since elected Species V, shown in instant application Figure 7, does not contain a second luer taper adapter. A second luer taper adapter is shown in at least Figure 8, Species VI, covering the proximal end of the elastomeric seal 120. Figure 7 shows the proximal end of the elastomeric seal 120 is a free end of the claimed lamprey lock device. As such, the second luer taper adapter is a distinct feature of unelected species.
Claim 8 is withdrawn since elected Species V, shown in instant application Figure 7, does not contain a three-way stopcock. A stopcock is shown in at least Figure 20, Species XI, attached to the distal end of first luer taper adapter 102a. Figure 7 shows the distal end of the first luer taper adapter 102 is a free end of the claimed lamprey lock device. As such, the stopcock is a distinct feature of unelected species. Claim 9 depends on Claim 8, so is also withdrawn.
Claim 10 is withdrawn since elected Species V, shown in instant application Figure 7, does not contain a tubing. A tubing is shown in at least Figure 9, Species VI, attached to the distal end of housing 118. Figure 7 shows the distal end of housing 118 is a free end of the claimed lamprey lock device. As such, the tubing is a distinct feature of unelected species. Claims 11-20 depend on Claim 10, so are also withdrawn.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2 & 4-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2 & 4-7 of U.S. Patent No. 11,596,781 (Cusumano). Although the claims at issue are not identical, they are not patentably distinct from each other as described below.
As to Claim 1, Cusumano teaches a lamprey lock device comprising:
a tubular shaped housing having a proximal end, a distal end and length therebetween, the housing further having an external surface and an internal surface, such that a lumen is formed within the internal surface along its length (Claim 1, Lines 6-11);
an O-ring positioned within the lumen at the distal end (Claim 1, Line 12);
a first luer taper adapter positioned within the lumen and proximal to the O-ring, wherein the first luer taper adapter has a threaded internal surface (Claim 1, Lines 14-17); and
an elastomeric ring positioned within the lumen and proximal to the first luer taper adapter (Claim 1, Lines 18-20).
As to Claim 2, Cusumano teaches all the limitations of Claim 1, and continues to teach the O-ring, the first luer taper adapter and the elastomeric ring each has an internal diameter equal to or greater than 4 mm (Claim 2).
As to Claim 4, Cusumano teaches all the limitations of Claim 1, and continues to teach the elastomeric ring has a width of greater than 1 mm (Claim 4).
As to Claim 5, Cusumano teaches all the limitations of Claim 1, and continues to teach an elastomeric coating on the internal surface of the first luer taper adapter (Claim 5).
As to Claim 6, Cusumano teaches all the limitations of Claim 1, and continues to teach the threaded internal surface of the first luer taper adapter has a spiral rotation of at least 0.5 (Claim 6).
As to Claim 7, Cusumano teaches all the limitations of Claim 1, and continues to teach the elastomeric ring has an interior diameter ranging between 5 - 8 mm (Claim 7).
Claim Objections
Claims 1-2 & 4-7 are objected to because of the following informalities.
Claim 1 should read --A lamprey lock device comprising:
a tubular shaped housing having a proximal end, a distal end and a length therebetween, the housing further having an external surface and an internal surface, such that a lumen is formed within the internal surface along the length;
an O-ring positioned within the lumen at the distal end of the housing;
a first luer taper adapter positioned within the lumen and proximal to the O-ring, wherein the first luer taper adapter has a threaded internal surface; and
an elastomeric ring positioned within the lumen and proximal to the first luer taper adapter.—
Claim 5 should read --The lamprey lock device of claim 1, further comprising an elastomeric coating on the threaded internal surface of the first luer taper adapter.--
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 2, 4 & 6 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.
As to Claim 2, the limitation “the O-ring, the first luer taper adapter and the elastomeric ring each has an internal diameter equal to or greater than 4 mm” is indefinite. The limitation claims an unbounded range. As such, the range is considered indefinite. Additionally, one of ordinary skill in the art would not be able to reasonably conclude a natural upper boundary of any of the internal diameters.
As to Claim 4, the limitation “the elastomeric ring has a width of greater than 1 mm” is indefinite. The limitation claims an unbounded range. As such, the range is considered indefinite. Additionally, one of ordinary skill in the art would not be able to reasonably conclude a natural upper boundary of the elastomeric ring width.
As to Claim 6, the limitation “the threaded internal surface of the first luer taper adapter has a spiral rotation of at least 0.5” is indefinite. The limitation claims an unbounded range. As such, the range is considered indefinite. Additionally, one of ordinary skill in the art would not be able to reasonably conclude a natural upper boundary of the spiral rotation.
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.
Claims 1-2, 4 & 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Stroup (WO2015065958A1), in view of Dadson (WO2008086631A1), further in view of Connell (U.S. PGPub 2005/0197646).
As to Claim 1, Stroup teaches a lamprey lock device (10) comprising:
a tubular shaped (as shown in Figure 8) housing (12) having a proximal end (11), a distal end (13) and length therebetween (the length between 11 and 13, as viewed in Figure 8), the housing (12) further having an external surface (the outer radial surface of 12, as viewed in Figure 8) and an internal surface (the inner radial surface of 12 with threads 32, as viewed in Figure 7), such that a lumen (the lumen of housing 12 within which first luer taper adapter 14 sits within, as viewed in Figure 8) is formed within (as shown in Figure 8) the internal surface (the inner radial surface of 12 with threads 32, as viewed in Figure 7) along (as shown in Figure 8) its length (the length between 11 and 13, as viewed in Figure 8)…
a first luer taper adapter (14) positioned within (as shown in Figure 8) the lumen (the lumen of housing 12 within which first luer taper adapter 14 sits within, as viewed in Figure 8), wherein the first luer taper adapter (the lumen of housing 12 within which first luer taper adapter 14 sits within) has a threaded internal surface (the inner radial surface of 14 with threads 34, as viewed in Figure 8); and
a ring (15) positioned within (as shown in Figure 8) the lumen (the lumen of housing 12 within which first luer taper adapter 14 sits within, as viewed in Figure 8) and proximal to (as shown in Figure 8) the first luer taper adapter (14).
Stroup does not teach an O-ring positioned within the lumen at the distal end, so does not teach the first luer taper adapter proximal to the O-ring. Additionally, Stroup is silent on the material makeup of the ring.
Dadson describes a similar device, and teaches an O-ring (34) positioned within (as shown in Figure 10) the first luer taper adapter (62) at the distal end (the left side of 62, as viewed in Figure 10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the O-ring, as taught by Dadson, in the first luer adapter, as taught by Stroup, to tightly seal respective connectors (Paragraph 0050).
Modifying Dadson into Stroup results in an O-ring (Dadson 34) positioned within (as shown in Dadson Figure 10, where one of ordinary skill in the art would conclude placing Dadson O-ring 34 at the Stroup distal end 13 of Stroup first luer taper adapter 14 would result in Dadson O-ring 34 being within the Stroup housing 12 lumen at the Stroup distal end 13) the lumen (the Stroup lumen of Stroup housing 12 within which Stroup first luer taper adapter 14 sits within, as viewed in Stroup Figure 8) at the distal end (Stroup 13), and the first luer taper adapter (Stroup 14) proximal to (down, as viewed in Stroup Figure 8) the O-ring (Dadson 34).
Connell describes a similar device, and teaches an elastomeric (Paragraph 0085) ring (18).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to make the ring, as taught by Stroup, as modified, of an elastomeric material, as taught by Connell, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. (1960)
As to Claim 2, Stroup, as modified, teaches all the limitations of Claim 1, but is silent on any dimensions within for any of the described structures. As such Stroup, as modified, does not explicitly teach the O-ring, the first luer taper adapter and the elastomeric ring each has an internal diameter equal to or greater than 4 mm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the internal diameters of each of the O-ring, the first luer taper adapter and the elastomeric ring equal to or greater than 4 mm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Stroup, as modified, would not operate differently with the claimed internal diameter values, since the rest of the pertinent structures may also be adjusted for size. Further, Applicant has not placed any criticality on the claimed range, only indicating the diameters are within the claimed range throughout the specification.
As to Claim 4, Stroup, as modified, teaches all the limitations of Claim 1, but is silent on any dimensions for any of the described structures. As such Stroup, as modified, does not explicitly teach the elastomeric ring has a width of greater than 1 mm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the width of the elastomeric ring greater than 1mm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Stroup, as modified, would not operate differently with the claimed width, since the rest of the pertinent structures may also be adjusted for size. Further, Applicant has not placed any criticality on the claimed range, only indicating the width within the claimed range throughout the specification.
As to Claim 6, Stroup, as modified, teaches all the limitations of Claim 1, but is silent on any dimensions for any of the described structures. As such Stroup, as modified, does not explicitly teach the threaded internal surface of the first luer taper adapter has a spiral rotation of at least 0.5.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the spiral rotation of the threaded internal surface at least 0.5, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Stroup, as modified, would not operate differently with the claimed spiral rotation, since the companion thread would need to match the threaded internal surface thread. Further, Applicant has not placed any criticality on the claimed spiral rotation, only indicating the spiral rotation be within the claimed range throughout the specification.
As to Claim 7, Stroup, as modified, teaches all the limitations of Claim 1, but is silent on any dimensions for any of the described structures. As such Stroup, as modified, does not explicitly teach the elastomeric ring has an interior diameter ranging between 5 - 8 mm.
It would have been obvious before the invention was effectively filed, to a person having ordinary skill in the art, to make the interior diameter of the elastomeric ring between 5-8 mm, since it has been held “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). In the instant case, the device of Stroup, as modified, would not operate differently with the claimed interior diameter, since the rest of the pertinent structures may also be adjusted for size. Further, Applicant has not placed any criticality on the claimed interior diameter, only indicating the interior diameter be within the claimed range throughout the specification.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stroup, in view of Dadson, further in view of Connell, further in view of Miraki (U.S. Patent 6,248,092).
As to Claim 5, Stroup, as modified, teaches all the limitations of Claim 1, but does not teach an elastomeric coating on the internal surface of the first luer taper adapter.
Miraki describes a similar device with threading and used with catheters, and teaches an elastomeric coating (Column 17, Lines 19-21) on the internal surface (the radially inner surface of 182 with threads 228, as viewed in Figure 7) of the first luer taper adapter (182).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the elastomeric coating, as taught by Miraki, on the threaded internal surface of the first luer taper adapter, as taught by Stroup, as modified, “to improve the seal (Column 17, Lines 19-21).”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Uber (2015/0034194 – see Figure 20) teaches a similar device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
