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 without traverse of Group I in the reply filed on 07/06/2026 is acknowledged.
Claims 13-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/06/2026.
Applicant's election with traverse of sub-Species I(g) and sub-Species II(b) in the reply filed on 07/06/2026 is acknowledged. The traversal is on the ground(s) that PCT Rule 13 requires species/inventions to be identified by claims, not figures; and dependent claims constituting different inventions are allowed in the application. Additionally, Applicant does not believe sub-Species II(a) and II(b) are separate and distinct. This is not found persuasive because of the following reasons.
Regarding how the species are identified. There is no stipulation in PCT Rule 13, or any other governing rule, which prevents particular inventions or species from being defined/identified by figures. PCT Rules 13.1/13.4 only dictate an application may only have a single general inventive concept and dependent claims may be used.
Regarding different dependent claims constituting different inventions being allowed in the application, this is true. However, this does not inherently mean the dependent claims have unity of invention, only that the claims may be included in the application. The dependent claims still must have unity of invention to prevent restriction.
Regarding sub-Species II(a) and II(b) not being separate and distinct, this is not a requirement for unity of invention. Regardless, the cup 46 in sub-Species II(a) has significant and distinctly different structural characteristics than the cup 46 in sub-Species II(b). For instance, the cup in Figure 1 shows an opening angle of approximately 90 degrees. Whereas the cup in Figure 4 shows an opening angle of approximately 10 degrees. Additionally, the cup in Figure 1 opens into an additional branch of conduit 44 at an angle offset from the conduit axis. The cup in Figure 4 opens into the conduit at an angle colinear to the conduit axis. As such, the sub-species are clearly separate and distinct.
Applicant states Claim 2 does not read on the elected inventions. However, this does not appear to be the case. Figure 4 shows both configurations, where the needle axis is essentially within needle channel 62, and the portion of needle 100 in conduit 44 is parallel to the portion of the needle in channel 62, placing the needle in the first configuration. Additionally, the distal end of needle 100 may stop in cup 46, which would place the needle in the second configuration. As such, it appears each of Claim 1-12 broadly read on the elected invention/species.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because of the following reasons.
Element 44 appears to be pointing to needle 100, not conduit 44 in Figure 4
Needle 100 is labeled as Element 10, but should be labeled as Element 100 in Figure 4
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 7-9 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 7, the term, “the first plane”, lacks antecedent basis. Additionally, since the term is written in a manner which is commonly used to indicate the term has been previously defined or claimed, it is not clear if Applicant intended for Claim 7 to be dependent on Claim 4, as written, or on Claim 5, which positively claims a first plane. For the purpose of examination, the limitation will be interpreted as though the first plane is first being introduced in Claim 7, where Claim 7 depends on Claim 4, not on Claim 5.
Additionally, the phrase “extending at angle relative to the first plane” should read --extending at an angle relative to a first plane.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fedor (U.S. PGPub 2019/0232035), in view of Dayton (U.S. PGPub 2018/0242958).
As to Claim 1, Fedor teaches a vascular access system (510/550) for accessing a vasculature of a patient (Paragraph 0013), comprising:
a subcutaneous port (510) including a conduit (514/518) defining a non-linear path (as shown in Figure 14C); and
a needle (42)…to traverse (as shown in Figure 14C) the non-linear path of the conduit (514/518)…an axis (the axis through the center of needle 42, as viewed in Figure 14C) of the needle (42).
Fedor does not teach a flexible portion configured to deflect from an axis of the needle.
Dayton describes a flexible needle (600; Figure 6), and teaches a flexible portion (650) configured to deflect from (Paragraph 0049) an axis (the axis through the center of lumen 652, as viewed in Figure 6) of the needle (600).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the flexible portion, as taught by Dayton, in the needle, as taught by Fedor, "to hold multiple configurations with different sizes and stiffnesses can enable the devices to be optimized for travel through tortuous anatomy in the flexible state, and optimized for performing a clinical task when positioned distal to the distal end of the scope in the rigid state (Paragraph 0035).”
As to Claim 2, Fedor, as modified, teaches all the limitations of Claim 1, and continues to teach a distal portion (Fedor 42B) of the needle (Fedor 42, as modified) can transition between a first configuration (Fedor Figure 14C) and a second configuration (similar to how Fedor cannula 40 extends through Fedor conduit 514/518 in Fedor Figure 14C), in the first configuration (Fedor Figure 14C) an axis (the axis through the center of Fedor distal portion 42B, as viewed in Fedor Figure 14C) of the distal portion (Fedor 42B) of the needle (Fedor 42, as modified) extends parallel to (as shown in Figure 14C) the axis (the axis through the center of Fedor needle 42, as viewed in Fedor Figure 14C) of the needle (Fedor 42, as modified), in the second configuration (similar to how Fedor cannula 40 extends through Fedor conduit 514/518 in Fedor Figure 14C) the axis (the axis through the center of Fedor distal portion 42B, as viewed in Fedor Figure 14C) of the distal portion (Fedor 42B) of the needle (Fedor 42, as modified) extends at an angle relative to (see end of paragraph for clarification) the axis (the axis through the center of Fedor needle 42, as viewed in Fedor Figure 14C) of the needle (Fedor 42, as modified). Once the Dayton flexible portion 650 is modified into Fedor needle 42, Fedor needle 42, as modified, will be able to bend similar to how Fedor cannula 40 bends in Fedor Figure 14C, and extend through Fedor conduit 514/518.
As to Claim 3, Fedor, as modified, teaches all the limitations of Claim 1, and continues to teach the flexible portion (Dayton 650) includes a helical slit (Dayton Paragraph 0050 describes Dayton slits 670 as being V-shaped; as such one of ordinary skill in the art would conclude the edges of Dayton slits 670 result in a helical portion of Dayton slits 670) extending through a wall (as shown in Dayton Figure 6) of the needle (Fedor 42, as modified) extends and extending in (as shown in Dayton Figure 6) a spiral path about (the edges of Dayton slits 670 extend in a helical path about the axis of Dayton lumen 652, as viewed in Dayton Figure 6) the axis (the axis through the center of Fedor needle 42, as viewed in Fedor Figure 14C) of the needle (Fedor 42, as modified).
As to Claim 4, Fedor, as modified, teaches all the limitations of Claim 1, and continues to teach the flexible portion (Dayton 650) includes a first plurality of slits (see Dayton Figure 6 below), each slit of the plurality of slits (see Dayton Figure 6 below) extending through a wall (as shown in Dayton Figure 6) of the needle (Fedor 42, as modified) and extending perpendicular to (as shown in Dayton Figure 6) the axis (the axis through the center of Fedor needle 42, as viewed in Fedor Figure 14C) of the needle (Fedor 42, as modified).
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Dayton Figure 6, Modified by Examiner
As to Claim 5, Fedor, as modified, teaches all the limitations of Claims 1 & 4, and continues to teach a mid-point (the mid-point of each of the slits shown in the first plurality of slits in Dayton Figure 6 in the Claim 4 rejection above) of each slit of the first plurality of slits (see Dayton Figure 6 in the Claim 4 rejection above) are aligned (as shown in Dayton Figure 6) with a first radial position (the radial position defining the mid-point of each slit of the first plurality of slits) about the axis (the axis through the center of Fedor needle 42, as viewed in Fedor Figure 14C) of the needle (Fedor 42, as modified), the first plurality of slits (see Dayton Figure 6 in the Claim 4 rejection above) are configured to allow the needle (Fedor 42, as modified) to flex (Dayton Paragraph 0050) from a straight configuration (as shown in Dayton Figure 6) to a deflected configuration (Dayton Paragraph 0050) along a first plane extending parallel to (resulting in the first deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) the axis (the axis through the center of Fedor needle 42, as viewed in Fedor Figure 14C) of the needle (Fedor 42, as modified).
As to Claim 6, Fedor, as modified, teaches all the limitations of Claims 1 & 4-5, and continues to teach a distal tip (Dayton 610; Fedor 42B) includes a bevel (as shown in Dayton Figure 6 and Fedor Figure 14C).
Fedor, as modified, is silent on the placement of the first radial position with respect to the proximal-most edge of the bevel, so does not explicitly teach a proximal-most edge of the bevel being aligned with the first radial position of the needle.
It appears the only difference between Fedor, as modified, and the instant application is the proximal-most edge of the bevel placement with respect to the first radial position of the needle. This is merely a rearrangement of parts (see MPEP 2144.04(VI)(C)), since shifting the position of the proximal-most edge of the bevel with respect to the first radial position of the needle will not modify the operation of the device.
As to Claim 7, Fedor, as modified, teaches all the limitations of Claims 1 & 4, and continues to teach a second plurality of slits (see Dayton Figure 6 in the Claim 4 rejection above), a mid-point (the mid-point of each of the slits shown in the second plurality of slits in Dayton Figure 6 in the Claim 4 rejection above) of the second plurality of slits (see Dayton Figure 6 in the Claim 4 rejection above) is aligned with (as shown in Dayton Figure 6) a second radial position (the radial position defining the mid-point of each slit of the second plurality of slits) about the axis (the axis through the center of Fedor needle 42, as viewed in Fedor Figure 14C) of the needle (Fedor 42, as modified), and configured to allow the needle (Fedor 42, as modified) to flex (Dayton Paragraph 0050) from a straight configuration (as shown in Dayton Figure 6) to a deflected configuration (Dayton Paragraph 0050) along a second plane, the second plane extending parallel to (resulting in the second deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) the axis (the axis through the center of Fedor needle 42, as viewed in Fedor Figure 14C) of the needle (Fedor 42, as modified) and extending at angle (the angle between the first deflection direction and the second deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) relative to (as shown in Dayton Figure 6 in the Claim 4 rejection above) the first plane (resulting in the first deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above).
As to Claim 8, Fedor, as modified, teaches all the limitations of Claims 1, 4 & 7, and continues to teach the angle (the angle between the first deflection direction and the second deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) of the second plane (resulting in the second deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) relative to the first plane (resulting in the first deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) is between 1° and 359° (as shown in Dayton Figure 6 in the Claim 4 rejection above).
As to Claim 9, Fedor, as modified, teaches all the limitations of Claims 1, 4 & 7, and continues to teach the angle (the angle between the first deflection direction and the second deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) of the second plane (resulting in the second deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) relative to the first plane (resulting in the first deflection direction shown in Dayton Figure 6 in the Claim 4 rejection above) is between 15° and 180° (as shown in Dayton Figure 6 in the Claim 4 rejection above).
As to Claim 10, Fedor, as modified, teaches all the limitations of Claim 1, but is silent on the material used to form the needle. As such, Fedor, as modified, does not explicitly teach the needle is formed of a material selected from a group consisting of a metal, alloy, nitinol, plastic, polymer, and a composite.
Dayton continues to teach the needle (100) is formed of a material selected from a group consisting of a metal (Paragraph 0038), alloy, nitinol, plastic, polymer, and a composite.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the needle, as taught by Fedor, as modified, from metal, as taught by Dayton, 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 11, Fedor, as modified, teaches all the limitations of Claim 1, and continues to teach a needle guide (Fedor 550) configured to engage (Paragraph 0106) the port (Fedor 510) when the port (Fedor 510) is disposed subcutaneously (Paragraph 0106), and align the needle (Fedor 42, as modified) with the conduit (Fedor 514/518), the flexible portion (Dayton 650) configured to extend through (Paragraph 0106) a needle channel (Fedor 556) of the needle guide (Fedor 550).
As to Claim 12, Fedor, as modified, teaches all the limitations of Claim 1, and continues to teach a cannula (Fedor 40) disposed on (as shown in Fedor Figure 14C) an outer surface (the outer surface of Fedor 42, as modified) of the needle (Fedor 42, as modified) and slidably engaged therewith (Fedor Paragraph 0099).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ensminger (5,792,123 – Figure 2) teaches a similar subcutaneous port.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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