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 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 1-22 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.
Claim 1 recites “and a pair of channels disposed along and formed in main body portion” in line 11. It is unclear if the “main body portion” is the same as or different than the “main body portion” recited earlier in the claim. For the purpose of examination, the phrase in line 11 is being interpreted as “and a pair of channels disposed along and formed in the main body portion.” The same indefiniteness issue and interpretation also apply to claim 18.
Regarding claim 2, the phrase “a needle holder” in line 2 renders the claim indefinite. It is unclear if the phrase is referring to the “integral needle holder” recited earlier in the claim. For the purpose of examination, the phrase in line 2 is being interpreted as “the needle holder”.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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.
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaw et al.’764 (US Pub No. 2022/0054764 – cited by Applicant).
Figure 3 of Shaw et al.’764 discloses a blood collection tube holder, the holder comprising: a unitarily molded barrel (22) comprising a cylindrical body portion that defines a barrel cavity (see ABSTRACT, sections [0012], [0052]); a nose end (35) extending from the cylindrical body portion (section [0054]); a needle holder (42, section [0054]); a rear flange (30) disposed around a rear end of the barrel cavity (section [0054]); a slot (28) extending longitudinally along the cylindrical body portion from the nose end to the rear flange (section [0052]), and opposing rails (24,26,34,36) that extend longitudinally along edges of the cylindrical body portion formed by the slot (sections [0011], [0016], [0052], [0055]); and
a needle safety device (14, section [0055]) comprising an activation surface (62), a main body portion (65), a needle tip shield (67), and a pair of channels (64) disposed along and formed in the main body portion (section [0055]), wherein the rails of the barrel are received within channels of the needle safety device to provide a slidable interface between the needle safety device and the barrel between a first retracted position (Figures 4 and 7) that exposes a venipuncture end of a needle for selective use of the blood collection tube holder and a second extended position (Figures 8-10) that positions the needle tip shield at least partially around the venipuncture end of the needle to protect a user from accidental needle sticks after use of the blood collection tube holder (section [0021]).
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 1-7 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al.’764 in view of Clemens et al.’337 (USPN 5,395,337 – cited by Applicant).
Regarding claim 1, Figure 3 of Shaw et al.’764 discloses a blood collection tube holder, the holder comprising: a unitarily molded barrel (22) comprising a cylindrical body portion that defines a barrel cavity (see ABSTRACT, sections [0012], [0052]); a nose end (35) extending from the cylindrical body portion (section [0054]); a rear flange (30) disposed around a rear end of the barrel cavity (section [0054]); a slot (28) extending longitudinally along the cylindrical body portion from the nose end to the rear flange (section [0052]), and opposing rails (24,26,34,36) that extend longitudinally along edges of the cylindrical body portion formed by the slot (sections [0011], [0016], [0052], [0055]);
a needle (18) coupled to the barrel and comprising a venipuncture end (86) extending forwardly from the nose end of the barrel (sections [0052], [0057]); and
a needle safety device (14, section [0055]) comprising an activation surface (62), a main body portion (65), a needle tip shield (67), and a pair of channels (64) disposed along and formed in the main body portion (section [0055]), wherein the rails of the barrel are received within channels of the needle safety device to provide a slidable interface between the needle safety device and the barrel between a first retracted position (Figures 4 and 7) that exposes a venipuncture end of a needle for selective use of the medical device and a second extended position (Figures 8-10) that positions the needle tip shield at least partially around the venipuncture end of the needle to protect a user from accidental needle sticks after use of the medical device (section [0021]).
Shaw et al.’764 discloses all of the elements of the current invention, as discussed above, except for the needle coupled to the barrel comprising a fluid discharge end extending rearwardly within the barrel cavity of the barrel. Clemens et al.’337 teaches use of a needle coupled to a barrel, wherein the needle comprises a venipuncture end extending forwardly from a nose end of the barrel and a fluid discharge end extending rearwardly within a barrel cavity of the barrel (see Figure 9, needle assembly 204). Clemens et al.’337 teaches that it is known in the art to use a fluid discharge end of a venipuncture needle to allow for blood from a punctured vessel to be sampled into an evacuated tube (col. 8, line 4 – col. 9, line 2; col. 9, lines 14-21). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the needle of Shaw et al.’764 to include a fluid discharge end extending rearwardly within the barrel cavity of the barrel as it would allow blood from a punctured vessel to be collected into an evacuated tube.
Regarding claims 2 and 3, Shaw et al.’764 discloses that the nose end comprises an integral needle holder (Figure 3, needle holder 42, section [0054]). Section [0056] of Shaw et al.’764 states that the needle is secured within the needle holder “by using an adhesive or another similarity effective, commercially available means”. Official notice is being taken that it is well known in the art to secure a needle within a needle holder via friction or an interference fit.
Regarding claim 4, while Shaw et al.’764 does not disclose that the needle holder is threadably attached to the barrel to secure the needle to the barrel, Official notice is being taken that it is well known in the art to use a threaded connection means to connect individual components of a syringe.
Regarding claim 5, Figure 3 of Shaw et al.’764 shows that the rails extend in a parallel manner along the cylindrical body portion along which the needle safety device can slide (section [0055]).
Regarding claim 6, Figure 3 shows that the rails extend to and are integral with the rear flange (sections [0012], [0052]).
Regarding claim 7, channels 64 of Figure 3 of Shaw et al.’764 are formed in the main body portion of the needle safety device such that an upper portion of the main body portion extends over the rails of the barrel, and such that a lower portion of the main body portion extends below the rails of the barrel (section [0055]).
Regarding claim 10, Figure 3 of Shaw et al.’764 shows that extended portions of the activation surface of the needle safety device overlap the channels to lock the rails of the barrel within the channels.
Regarding claim 11, each of the rails comprise a rear stop and a slide stop disposed forwardly from the rear stop (sections [0021], [0062], stops 38, 39, 40, 41).
Regarding claim 12, the rear stops and slide stops extend inwardly from the rails (see Figures 3, 8, and 17).
Regarding claim 13, the rear stops are configured to engage ribs on the needle safety device to retain the needle safety device in the first retracted position to expose the venipuncture end of the needle for selective use of the medical device (sections [0021], [0060], [0062]).
Regarding claim 14, the slide stops are configured to engage the ribs on the needle safety device and retain the needle safety device in the second extended position that is forward of the first retracted position to cover up the venipuncture end of the needle after use of the medical device to protect a user from accidental needle sticks after use of the medical device (sections [0021], [0060], [0062]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al.’764, as applied to claim 18.
Shaw et al.’764 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the needle safety device being formed from a clear medical grade polymeric material. Shaw et al.’764 does, however disclose forming the barrel from a clear medical grade polymeric material that is sufficiently transparent to permit a liquid level drawn into the barrel to be plainly viewed by a user (section [0052]). With this teaching by Shaw et al.’764, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the blood collection tube holder of Shaw et al.’764 such that the needle safety device is also formed from a clear medical grade polymeric material, as this would help to allow a user to plainly view any liquid drawn into the barrel.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al.’764, as applied to claim 18, in view of Clemens et al.’337.
Regarding claim 20, Figure 3 of Shaw et al.’764 discloses a needle (18) disposed within the needle holder and comprising a venipuncture end extending forwardly from the nose end of the barrel (sections [0052], [0057]).
Shaw et al.’764 discloses all of the elements of the current invention, as discussed above and in paragraph 5 above, except for the needle comprising a fluid discharge end extending rearwardly within the barrel cavity of the barrel. Clemens et al.’337 teaches use of a needle coupled to a barrel, wherein the needle comprises a venipuncture end extending forwardly from a nose end of the barrel and a fluid discharge end extending rearwardly within a barrel cavity of the barrel (see Figure 9, needle assembly 204). Clemens et al.’337 teaches that it is known in the art to use a fluid discharge end of a venipuncture needle to allow for blood from a punctured vessel to be sampled into an evacuated tube (col. 8, line 4 – col. 9, line 2; col. 9, lines 14-21). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the needle of Shaw et al.’764 to include a fluid discharge end extending rearwardly within the barrel cavity of the barrel as it would allow blood from a punctured vessel to be collected into an evacuated tube.
Regarding claim 21, Figure 3 shows that the rails extend to and are integral with the rear flange (sections [0012], [0052]).
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
Regarding claims 8 and 9, none of the prior art discloses or suggests, either alone or in combination, a lower portion of a main body portion extending into radiused undercut portions formed on an inside of a cylindrical body portion of a barrel, in combination with the other claimed elements.
Regarding claims 15-17, none of the prior art discloses or suggests, either alone or in combination, a barrel comprising two opposing slots disposed on opposite sides of the barrel and extending longitudinally along a cylindrical body portion of the barrel from a nose end to a rear flange of the barrel, wherein each of the two slots comprise opposing rails that extend longitudinally along edges of the cylindrical body portion formed by each of the two slots, in combination with the other claimed elements.
Regarding claim 22, none of the prior art discloses or suggests, either alone or in combination, a barrel comprising two opposing slots disposed on opposite sides of the barrel and extending longitudinally along a cylindrical body portion of the barrel from a nose end to a rear flange of the barrel, wherein each of the two slots comprise opposing rails that extend longitudinally along edges of the cylindrical body portion formed by each of the two slots, in combination with the other claimed elements.
Conclusion
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
