DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5) in the reply filed on 03/16/26 is acknowledged. Claims 6-20 in groups II & III are amended and included all claimed subject matter of claim 1. Therefore, claims 6-20 are being rejoined. Currently, claims 1-20 are examined in this office action.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
It is desirable to avoid the submission of long lists of documents if it can be avoided. Clearly irrelevant and marginally pertinent cumulative information should be eliminated. If a long list is submitted, those documents which have been specifically brought to applicant's attention and/or are known to be of most significance should be highlighted. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), affd, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995). See MPEP 2004.
Applicant's duty of disclosure of material and information is not satisfied by presenting a patent examiner with "a mountain of largely irrelevant [material] from which he is presumed to have been able, with his expertise and with adequate time, to have found the critical [material]. It ignores the real world conditions under which examiners work. Applicant has a duty not just to disclose pertinent prior art references but to make a disclosure in such way as not to "bury" it within other disclosures of less relevant prior art; See Golden Valley Microwave Foods Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (N.D. Ind. 1992); Molins PLC v. Textron Inc., 26 USPQ2d 1889, at 1899 (D.Del 1992); Penn Yan Boats, Inc. v. Sea Lark Boats, Inc. et al., 175 USPQ 260, at 272 (S.D. F1. 1972).
The examiner is not afforded the time to thoroughly review each reference of the IDS(es) of 01/18/25 (8 pgs, 24 pgs & 40 pgs) & 12/31/25 (6 pgs, 36 pgs & 37 pgs), given the number of references cited. By initialing each of the cited references on the accompanying 1449 form(s), the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review was made of the cited references.
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 & 8 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.
The limitation “... the retraction direction in a single, uninterrupted motion” in claims 1 & 8 is vague. It is unclear to Examiner that the limitation “a single, uninterrupted motion” is meaning that is being applied for retraction direction only one time, or “a single, uninterrupted motion” is meaning of only needle is being retracted without interrupted motion.
For examining purpose, Examiner interprets that only needle is being retracted without interrupted motion.
The claims 2-5 are being rejected due to their dependency.
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 pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Constantineau et al. (US 2014/0031793).
Regarding claims 1 & 5, Constantineau discloses a transcutaneous access tool insertion and retraction mechanism 101/201/301 in Figs. 1-40, comprising:
Note: The Figs. 1-40 generally support a rejection of the claimed invention; however, Figs. 9-22 are used below as representative to illustrate the mapping.
a needle 234 located within a cannula/catheter 242. Note: the term “cannula” and “catheter” can be interchangeable.
a plurality of sliding members 231/241 comprising:
a first sliding member 231 coupled with the needle 234 and operable to move the needle in an insertion direction (Fig. 15) and in a retraction direction (Fig. 12); and
a second sliding member 241 coupled with the cannula 242 and operable to move the cannula 142 in the insertion direction (Fig. 15); and
a linkage mechanism 251 coupled to the first sliding member 231 of the plurality of sliding members, see Fig. 12, wherein the linkage mechanism 251 is configured to apply a force to the plurality of sliding members 231/241 to move the plurality of sliding members 231/241 including the first sliding member 231 in an insertion direction (Fig. 15) and move only the first sliding member in a retraction direction, Fig. 16, (e.g., the introducer needle thereafter being moved by the torsion spring back to the first introducer needle position to store the introducer needle within the base with the free end of the catheter/cannula remaining disposed externally of the base, see abstract & last paragraph in claim 1 in Constantineau), and
wherein the linkage mechanism 251 comprises a first linkage 253 and a second linkage 254 coupled between a torsion spring 281 and the first sliding member 231 such that, upon deployment, the torsion spring causes the first and second linkages to cooperate to move the first sliding member 231 in the insertion direction (Fig. 15) and the retraction direction (Fig. 14) in a single, uninterrupted motion.
Regarding claim 2, wherein, upon deployment, the first linkage 253 and the second linkage 254 are arranged to rotate relative to each other about a moving pivot (e.g., the linkage 251 in different positions, as shown in Figs. 12, 14 & 16) to move the first sliding member 253 in the insertion direction (Figs. 14-15) and the retraction direction (Figs. 12-13 & 16).
Regarding claim 3, further comprising: a frame 292 & 293 slidably receiving the first and second sliding members 234 & 241, wherein the frame (including multiple elements # 223, 224, 292, 293, 238, 239, 245, 246, 294, 295 & 211, see marked-up Fig. 12 below) is operable to lock the first and second sliding members 231 & 241 in a pre-deployment position (Fig. 12), and to lock (via #238, 239) the second sliding member 241 in a post-deployment position (Fig. 16).
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Regarding claim 4, wherein the frame includes a cam element 292/293 configured to lock the first and second sliding members 231 & 234 in the pre-deployment position, see Fig. 12.
Regarding claim 5, further comprising a release bar 223/224 (or # 211) configured to hold the cam element when the cam element locks the first and second sliding members in the pre-deployment position (Fig. 12) and configured to release the cam element 223/224 (or pressing the bar 211 down, as shown in Fig. 15) to allow the first and second sliding members to move in the insertion direction (Fig. 14-15).
Regarding claim 7, further comprising: a torsion spring 281 coupled to the linkage mechanism 251, wherein the torsion spring 281, when releasing stored energy, is operable to cause the linkage mechanism 251 to apply the force to the plurality of sliding members 231 & 241, see abstract.
Regarding claim 8, wherein the linkage mechanism 251 is configured to: upon deployment, Figs. 14-15, the torsion spring causes a first linkage 253 and a second linkage 254 to cooperate to move the first sliding member 231 in the insertion direction (Fig. 14) and in the retraction direction (Fig. 16) in a single, uninterrupted motion.
Regarding claim 9, wherein the linkage mechanism 251 is configured to: upon deployment, Figs. 14-15, the first linkage 253 and the second linkage 254 are arranged to rotate relative to each other about a moving pivot (e.g., the linkage 251 in different positions, as shown in Figs. 12, 14 & 16) to move the first sliding member in the insertion direction and the retraction direction.
Regarding claim 10, wherein the linkage mechanism comprises: a first linkage 254 and a second linkage 253, wherein the first linkage 254 is coupled to a torsion spring 281 having stored energy 281, the second linkage 253 is connected to the first sliding member 231, and the first linkage 254 and the second linkage 253 have a common pivot point (a middle rotation-point of the linkage 251).
Note: the first and second linkages can be swapped number. For example: the first linkage is equivalent to #253, the second linkage is equivalent to #253.
Regarding claim 11, wherein the plurality of sliding members 231 & 241 further comprises: a second sliding member 241, wherein the second sliding member 241 is configured to couple with a cannula 242 and operable to be moved in the insertion direction by the first sliding member 231.
Regarding claim 12, further comprising: a latch 294/295 configured to prevent the second sliding member 241 from moving in the retraction direction, see Fig. 16.
Regarding claim 13, wherein the linkage mechanism 251 is spring-biased (via a spring 281 and the linkage mechanism 251 can be rotated in different directions).
Regarding claim 15, Constantineau discloses a transcutaneous access tool insertion and retraction mechanism 101/201/301 in Figs. 1-40, comprising:
Note: The Figs. 1-40 generally support a rejection of the claimed invention; however, Figs. 9-22 are used below as representative to illustrate the mapping.
a plurality of sliding members 231 & 241;
a needle 234 located within a cannula/catheter 242, wherein the cannula 242 and needle 234 are coupled to a respective one or more of the plurality of sliding members 231 & 241. Note: the term “cannula” and “catheter” can be interchangeable.
a torsion spring 281, wherein the torsion spring 281 is configured to store energy; and
a linkage mechanism 251 coupled to the torsion 281 spring and coupled to a first sliding member 231 of the plurality of sliding members 231 & 241, wherein the linkage mechanism 251 is configured to apply a force to the plurality of sliding members 231 & 241 to move the plurality of sliding members 231 & 241 including the first sliding member 231 in an insertion direction (Figs. 14-15) and move only the first sliding member 231 in a retraction direction (Fig. 16) when the energy stored in the torsion spring is released, see abstract.
Regarding claim 16, wherein the plurality of sliding members comprises: the first sliding member 231 operable to move in an insertion direction (Figs. 14-15) and a retraction direction (Fig. 16); and a second sliding member 241 operable to move only in the insertion direction, see abstract & Fig. 16.
Regarding claim 17, further comprising: a latch 294/295 configured to lock the second sliding member 241 to prevent the second sliding member from moving in the retraction direction, see Fig. 16.
Regarding claim 18, wherein the linkage mechanism comprises: a first linkage and a second linkage, wherein: the first linkage is coupled to the torsion spring, the second linkage is connected to the first sliding member, and the first linkage and the second linkage have a common pivot point.
Regarding claim 18, wherein the linkage mechanism comprises: a first linkage 254 and a second linkage 253, wherein the first linkage 254 is coupled to a torsion spring 281, the second linkage 253 is connected to the first sliding member 231, and the first linkage 254 and the second linkage 253 have a common pivot point (a middle rotation-point of the linkage 251).
Note: the first and second linkages can be swapped number. For example: the first linkage is equivalent to #253, the second linkage is equivalent to #253.
Regarding claim 19, wherein the needle 234 is configured to move with a first sliding member 231 of the plurality of sliding members.
Regarding claim 20, wherein the cannula 242 is configured to move with a second sliding member 241 of the plurality of sliding members.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights