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 .
Claim Objections
Claim 9 is objected to because of the following informalities: The term “and” should be inserted before the phrase “a sealing portion lumen” on line 11 in order to be grammatically correct.. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The term “and” should be inserted before the term “entirely” on line 10 in order to be grammatically correct. 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 1-5, 9-11, 13, 15-20 and 22 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.
Each of independent claims 1, 9 and 15 have been amended to recite “the sealing portion comprising a distal end at the end of the coupling portion, a proximal end, a sealing portion lumen extending therebetween and configured to engage with the tubing”. The recitation of the term “therebetween” renders it unclear which elements the “sealing portion lumen” is located between. Specifically, the elements in question are “a distal end”, “the end of the coupling portion”, and “a proximal end”. For the sake of examination, the term “therebetween” is interpreted as referring to the “distal end” and the “proximal end”. Accordingly, it is suggested to replace the term “therebetween” with the phrase “between the distal end and the proximal end”. Claims 4-5, 10, 11, 13, 16-20 and 22 are rejected due to their dependence on claims 1, 9 and 15.
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 1-4, 22, 25 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu et al. (US Pat 5,489,274).
Re claim 1, Chu discloses a connector (as seen in Fig 4B; it is noted that, since Fig 4B does not include most of the reference characters, all reference characters cited below refer to Fig 2,2B unless otherwise noted) comprising: a coupling portion (the distal portion of body 4 labeled in annotated Fig B below) comprising an internal threaded luer connection (the threads seen but not labeled in Fig 4B; Col 6, Lines 57-59) configured to engage with a mating connector (the italicized text constitutes functional language and, therefore, “a mating connector” is not a part of the claimed invention; this limitation is met in view of Fig 2); a tubing portion (body 12 + the proximal portion of body 4 labeled in annotated Fig B below) extending from an end (the right end in Fig B below) of the coupling portion and configured to extend away from the mating connector (as seen in Fig 4B), the tubing portion comprising a tubing portion elastic modulus (inherent as all materials have an elastic modulus) and the tubing portion defining a lumen (within which sealing member 22 resides in Fig 4B) in fluid communication with the coupling portion (as seen in Fig 4B), wherein the tubing portion is configured to engage with a tubing (the italicized text constitutes functional language and, therefore, “a tubing” is not a part of the claimed invention; this limitation is met in view of Col 6, Lines 62-65); and a cylindrical sealing portion 22 extending from the end of the coupling portion and at least partially into the tubing portion (as seen in Fig 4B) to sealingly engage with the lumen of the tubing portion (as seen in Fig 4B), the sealing portion comprising a distal end (to the left in Fig 4B) at the end of the coupling portion (as seen in Fig B below), a proximal end (to the right in Fig 4B), a sealing portion lumen (as seen in Fig 4; Col 7, Lines 9-12) extending therebetween and configured to engage with the tubing (as set forth above, “the tubing” is not a part of the claimed invention; since the sealing portion is structurally capable of receiving tubing having a smaller outer diameter than the sealing portion’s inner diameter, this limitation is met), and a sealing portion elastic modulus (inherent as all material comprises an elastic modulus), wherein the sealing portion elastic modulus is lower than the tubing portion elastic modulus (since the sealing portion is deformed by the tubing portion as described in Col 7, Lines 12-16).
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Re claim 2, Chu discloses that the sealing portion comprises a same material as the tubing (this limitation is met since “the tubing” is not a part of the claimed invention – as set forth in the rejection of claim 1 above – and a user could choose a tubing of the same material as the sealing portion).
Re claim 3, Chu discloses that tubing portion is configured to receive the tubing within the lumen (as set forth in the rejection of claim 1 above, “the tubing” is not a part of the claimed invention; this limitation is met in view of Fig 4B that shows that the tubing portion has an open lumen (surrounding the sealing portion) through which tubing could be received).
Re claim 4, Chu discloses that the sealing portion is coupled to an inner surface of the lumen (as seen in Fig 4B).
Re claim 22, Chu discloses that the proximal end of the cylindrical sealing portion is distally spaced apart from a proximal end of the tubing portion (as seen in Fig 4B).
Re claim 25, Chu discloses a connector (as seen in Fig 4B; it is noted that, since Fig 4B does not include most of the reference characters, all reference characters cited below refer to Fig 2,2B unless otherwise noted) comprising: a coupling portion (the distal portion of body 4 labeled in annotated Fig B above) comprising an internal threaded luer connection (the threads seen but not labeled in Fig 4B; Col 6, Lines 57-59) configured to engage with a mating connector (the italicized text constitutes functional language and, therefore, “a mating connector” is not a part of the claimed invention; this limitation is met in view of Fig 2); a tubing portion (body 12 + the proximal portion of body 4 labeled in annotated Fig B above) extending from an end (the right end in Fig B above) of the coupling portion and configured to extend away from the mating connector (as seen in Fig 4B), the tubing portion comprising a tubing portion elastic modulus (inherent as every material has an elastic modulus) and the tubing portion defining a lumen (within which sealing member 22 resides in Fig 4B) in fluid communication with the coupling portion (as seen in Fig 4B), wherein the tubing portion is configured to engage with a tubing (the italicized text constitutes functional language and, therefore, “a tubing” is not a part of the claimed invention; this limitation is met in view of Col 6, Lines 62-65); and a cylindrical sealing portion 22 disposed within the tubing portion (as seen in Fig B above) to sealingly engage the lumen of the tubing portion (as seen in Fig 4B), the sealing portion comprising a distal end (to the left in Fig 4) at the end of the coupling portion (as seen in Fig B above), and a sealing portion elastic modulus (inherent as all materials have an elastic modulus), wherein the sealing portion elastic modulus is lower than the tubing portion elastic modulus (since the sealing portion is deformed by the tubing portion as described in Col 7, Lines 12-16) and the sealing portion is configured to sealingly engage against the tubing (as set forth above, “the tubing” is not a part of the claimed invention; since the sealing portion is structurally capable of receiving tubing having a smaller outer diameter than the sealing portion’s inner diameter, this limitation is met).
Re claim 26, Chu discloses that the proximal end of the cylindrical sealing portion is distally spaced apart from a proximal end (to the right in Fig 4B) of the tubing portion (as seen in Fig 4B and Fig B above).
Claims 1, 3, 4, 9-11, 15-18, 20, 22, 25 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanford et al. (US Pat 5,549,583).
Re claim 1, Sanford discloses a connector 2+3 (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) comprising: a coupling portion (the portion of body 2 extending distal to boss 30, as labeled in annotated Fig A below) comprising an internal threaded luer connection 32 (Col 3, Line 6) configured to engage with a mating connector (the italicized text constitutes functional language and, therefore, “a mating connector” is not a part of the claimed invention; this limitation is met in view of Col 3, Lines 4-8); a tubing portion (the portion of body 2 extending along and proximal to boss 30, as labeled in annotated Fig A below) extending from an end (to the left in Fig A below) of the coupling portion and configured to extend away from the mating connector (as seen in Fig 2), the tubing portion comprising a tubing portion elastic modulus (inherent as every material has an elastic modulus) and the tubing portion defining a lumen 22 in fluid communication with the coupling portion (as seen in Fig 1C), wherein the tubing portion is configured to engage with a tubing (the italicized text constitutes functional language and, therefore “a tubing” is not a part of the claimed invention; this limitation is met in view of Fig 2 that shows tubing 1); and a cylindrical sealing portion 3 extending from the end of the coupling portion (as seen in Fig A below) and at least partially into the tubing portion (as seen in Fig A below) to sealingly engage the lumen of the tubing portion (Col 3, Lines 34-37), the sealing portion comprising a distal end (to the right in Fig A below) at the end of the coupling portion (as seen in Fig A below), a proximal end (to the left in Fig A below), a sealing portion lumen (within which stem 10 resides in Fig 2) extending therebetween and configured to engage with the tubing (as seen in Fig 2), and a sealing portion elastic modulus (inherent as every material has an elastic modulus), wherein the sealing portion elastic modulus is lower than the tubing portion elastic modulus, and the sealing portion is configured to sealingly engage against the tubing (Col 3, Lines 34-37) since the sealing portion 3 axially compresses and the tubing portion does not, the sealing portion 3 must have an elastic modulus lower than that of the tubing portion).
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Re claim 3, Sanford discloses that the tubing portion is configured to receive the tubing within the lumen (as seen in Fig 2).
Re claim 4, Sanford discloses that the sealing portion is coupled to an inner surface of the lumen (as seen in Fig 2).
Re claim 9, Sanford discloses a method comprising: advancing a tubing 1 (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) toward a connector 2+3 comprising a coupling portion (the portion of body 2 extending distally from the ridge 30, as labeled in annotated Fig A above) with an internal threaded luer connection 32 (Col 3, Line 5) configured to engage with a mating connector (the italicized text constitutes functional language and, therefore, “a mating connector” is not a part of the claimed invention; this limitation is met in view of Col 3, Lines 4-8); engaging the tubing with a tubing portion (the portion of body 2 extending along and proximally from ridge 30, as labeled in annotated Fig A above) of the connector (as seen in Fig 2), wherein the tubing portion extends from an end (to the left in Fig A above) of the coupling portion and is configured to extend away from the mating connector (as seen in Fig 2); and sealingly engaging the tubing with the tubing portion of the connector via a cylindrical sealing portion 3 extending from the end of the coupling portion and at least partially into the tubing portion (as seen in Fig A above) to sealingly engage a lumen of the tubing portion (Col 3, Lines 34-37), the sealing portion comprising a distal end (to the right in Fig A above) at the end of the coupling portion (as seen in Fig A above), a proximal end (to the left in Fig A above), a sealing portion lumen (within which stem 10 resides in Fig 2) therebetween and configured to engage with the tubing (as seen in Fig A above; Col 3, Lines 34-37), wherein a sealing portion elastic modulus is lower than a tubing portion elastic modulus (Col 3, Lines 34-37; since the sealing portion 3 compresses and the tubing portion does not, the sealing portion 3 must have an elastic modulus lower than that of the tubing portion).
Re claim 10, Sanford discloses filling voids defined between the tubing and the tubing portion of the connector via the sealing portion (Col 3, Lines 34-37).
Re claim 11, Sanford discloses advancing the tubing into the lumen of the tubing portion of the connector (as seen in Fig 2).
Re claim 15, Sanford discloses a connector assembly 1+2+3 (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) comprising: a connector 2+3 comprising: a coupling portion (the portion of body 2 extending distal to boss 30, as labeled in annotated Fig A above) comprising an internal threaded luer connection 32 (Col 3, Line 6) configured to engage with a mating connector (the italicized text constitutes functional language and, therefore, “a mating connector” is not a part of the claimed invention; this limitation is met in view of Col 3, Lines 4-8); a tubing portion (the portion of body 2 extending along and proximal to boss 30, as labeled in annotated Fig A above) extending from an end (to the left in Fig A above) of the coupling portion and configured to extend away from the mating connector (as seen in Fig 2), the tubing portion comprising a tubing portion elastic modulus (inherent as every material has an elastic modulus) and the tubing portion defining a connector lumen 22 in fluid communication with the coupling portion (as seen in Fig 1C); and a cylindrical sealing portion 3 extending from the end of the coupling portion and entirely within the tubing portion (as seen in Fig A above) to sealingly engage with the connector lumen of the tubing portion (Col 3, Lines 34-37), the sealing portion comprising a distal end (to the right in Fig A) at the end of the coupling portion (as seen in Fig A above), a proximal end (to the left in Fig A above), a sealing portion lumen (within which stem 10 resides in Fig 2) extending therebetween and configured to engage with the tubing (as seen in Fig 2; Col 3, Lines 34-37), and a sealing portion elastic modulus (inherent as every material has an elastic modulus), wherein the sealing portion elastic modulus is lower than the tubing portion elastic modulus, and the sealing portion is configured to sealingly engage against the tubing (Col 3, Lines 34-37; since the sealing portion 3 compresses and the tubing portion does not, the sealing portion 3 must have an elastic modulus lower than that of the tubing portion); and a tubing 1 defining a tubing lumen 18 (labeled in Fig 1A), wherein the tubing is sealingly engaged with the sealing portion and the tubing lumen is in fluid communication with the connector lumen (Col 3, Lines 34-37).
Re claim 16, Sanford discloses that the tubing comprises an integrated connector 10, wherein the integrated connector is sealingly engaged with the sealing portion of the connector (Col 3, Lines 34-37).
Re claim 17, Sanford discloses that the integrated connector comprises an integrated connector elastic modulus and the integrated connector elastic modulus is greater than the sealing portion elastic modulus (Col 3, Lines 34-37; since the sealing portion 3 compresses and the tubing portion does not, the sealing portion 3 must have an elastic modulus lower than that of the tubing portion).
Re claim 18, Sanford discloses that the integrated connector comprises a tapered geometry (at the distal end thereof, as seen in Fig 1A).
Re claim 20, Sanford discloses that the tubing portion is configured to receive the tubing within the connector lumen (as seen in Fig 2).
Re claim 22, Sanford discloses that the proximal end of the cylindrical sealing portion is distally spaced apart from a proximal end of the tubing portion (as seen in Fig 2).
Re claim 25, Sanford discloses a connector 2+3 (Fig 2; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) comprising: a coupling portion (the portion of body 2 extending distal to boss 30, as labeled in annotated Fig A above) comprising an internal threaded luer connection 32 (Col 3, Line 6) configured to engage with a mating connector (the italicized text constitutes functional language and, therefore, “a mating connector” is not a part of the claimed invention; this limitation is met in view of Col 3, Lines 4-8); a tubing portion (the portion of body 2 extending along and proximal to boss 30, as labeled in annotated Fig A above) extending from an end of the coupling portion and configured to extend away from the mating connector (as seen in Fig 2), the tubing portion comprising a tubing portion elastic modulus (inherent as every material has an elastic modulus) and the tubing portion defining a lumen 22 in fluid communication with the coupling portion (as seen in Fig 1C), wherein the tubing portion is configured to engage with a tubing (the italicized text constitutes functional language and, therefore “a tubing” is not a part of the claimed invention; this limitation is met in view of Fig 2 that shows tubing 1); and a cylindrical sealing portion 3 disposed within the tubing portion (as seen in Fig A above) to sealingly engage the lumen of the tubing portion (Col 3, Lines 34-37), the sealing portion comprising a distal end (to the right in Fig 2) at the end of the coupling portion (as seen in Fig A above), and a sealing portion elastic modulus (inherent as every material has an elastic modulus), wherein the sealing portion elastic modulus is lower than the tubing portion elastic modulus, and the sealing portion is configured to sealingly engage against the tubing (Col 3, Lines 34-37; since the sealing portion 3 compresses and the tubing portion does not, the sealing portion 3 must have an elastic modulus lower than that of the tubing portion).
Re claim 26, Sanford discloses that the proximal end of the cylindrical sealing portion is distally spaced apart from a proximal end of the tubing portion (as seen in Fig A above).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (US Pat 5,489,274) in view of Fangrow (WO 2007/008511).
Re claim 5, Chu discloses all the claimed features except that the sealing portion is comolded with the tubing portion. Fangrow, however, teaches a connector (Fig 18A,18B) comprising a sealing portion 330 that is comolded with a tubing portion 320 (Para 133) for the purpose of attaching the sealing portion to the tubing portion (Para 133). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Chu to include the sealing portion such that it is comolded with the tubing portion, as taught by Fangrow, for the purpose of attaching the sealing portion to the tubing portion (Para 133).
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sanford et al. (US Pat 5,549,583) in view of Fangrow (WO 2007/008511).
Re claim 5, Sanford discloses all the claimed features except that the sealing portion is comolded with the tubing portion. Fangrow, however, teaches a connector (Fig 18A,18B) comprising a sealing portion 330 that is comolded with a tubing portion 320 (Para 133) for the purpose of attaching the sealing portion to the tubing portion (Para 133). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Sanford to include the sealing portion such that it is comolded with the tubing portion, as taught by Fangrow, for the purpose of attaching the sealing portion to the tubing portion (Para 133).
Re claim 13, Sanford discloses all the claimed method steps except comolding the sealing portion with the tubing portion of the connector. Fangrow, however, teaches a connector (Fig 18A,18B) that is formed by comolding a sealing portion 330 with a tubing portion 320 (Para 133) for the purpose of attaching the sealing portion to the tubing portion (Para 133). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Sanford to include comolding the sealing portion with the tubing portion, as taught by Fangrow, for the purpose of attaching the sealing portion to the tubing portion (Para 133).
Claim 19 is rejected under 35 U.S.C. 103 as being obvious over Sanford et al. (US Pat 5,549,583).
Re claim 19, Sanford discloses all the claimed features but is silent as to the material of the sealing portion; therefore, Sanford does not explicitly disclose that the sealing portion comprises an elastomer. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sealing portion to include an elastomer 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 its suitability for the intended use as a matter of obvious design choice. Additionally, this claim has been rejected with art below.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sanford et al. (US Pat 5,549,583) in view of Feng et al. (US Pat 5,290,222).
Re claim 19, Sanford discloses all the claimed features but is silent as to the material of the sealing portion; therefore, Sanford does not explicitly disclose that the sealing portion comprises an elastomer. Feng, however, teaches using a substantially similar sealing portion 120 (Fig 20(a); “o-ring” Col 11, Lines 39-41) comprising an elastomer (Col 11, Lines 39-41) for the purpose of forming a fluid tight closer (Col 11, Lines 55-57). Since this is the same purpose as the sealing portion of Sanford, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Sanford to include the sealing portion such that it comprises an elastomer, as taught by Feng, for the purpose of forming a fluid tight closer (Col 11, Lines 55-57).
Response to Arguments
Applicant’s arguments filed 2/9/2026 have been fully considered but are not persuasive.
Regarding Chu, the new interpretation set forth above establishes new boundaries for the “coupling portion” and the “tubing portion” such that “cylindrical sealing portion extend[s] from the end of the coupling portion” and the “sealing portion comprises a distal end at the end of the coupling portion, a proximal end, a sealing portion extending therebetween and configured to engage with the tubing” as now claimed; the new interpretation is based on the fact that the term “portion” does not define specific boundaries and simply means “a section or quantity within a larger thing; a part of a whole”1.
Regarding Sanford, the interpretation set forth above is the same as that set forth in the last Office Action. Applicant argues that the quad ring 3 (used to read on the claimed “cylindrical sealing portion”) does not “extend[…] from the end of the coupling portion” and does not have “a distal end at the end of the coupling portion” as claimed, but the Examiner respectfully disagrees in view of annotated Fig A that shows the right end (the claimed “distal end” of the cylindrical sealing portion) of the quad ring 3 located at and aligned with the left end (the claimed “end”) of the “coupling portion”. Applicant also argues that quad ring 3 does not have “a sealing portion lumen extending therebetween” as claimed, but the Examiner respectfully disagrees because the inner surface of the quad ring 3 forms a “sealing portion lumen” extending the entire length of the quad ring 3 (as seen in Fig 1B) through which stem 10 of the tubing 1 extends in Fig 2. Therefore, these arguments are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 “portion”. The American Heritage Dictionary of the English Language. <<https://www.ahdictionary.com/word/search.html?q=portion>>
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