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 with traverse of Species I in the reply filed on 04/10/2026 is acknowledged. The traversal is on the ground(s) that Examiner has not shown sufficient burden, since Examiner did not provide specific showing of different classifications or search strategies. Applicant cites MPEP 808.02 as support for their arguments. This is not found persuasive because 808.02 does not state a specific showing is required, only that a serious burden is established if different classes must be searched or different search strategies must be employed for each defined species. One of ordinary skill in the art would conclude a rounded notch –Species I-- and a planar cut –Species II-- would require different search strategies which are descriptive of each region of weakness structural shape.
The requirement is still deemed proper and is therefore made FINAL.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/10/2026.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 1-12 & 14-20 are objected to because of the following informalities.
Claim 1 should read --An apparatus comprising:
a needle that comprises a distal tip configured to be inserted into a vessel of a patient, the needle defining an outer surface;
a catheter that comprises a distal end and an inner surface that defines a lumen through which the needle extends; and
a longitudinally extending stiffener positioned between the outer surface of the needle and the inner surface of the catheter, the stiffener being configured to move to a distally advanced position relative to the needle to deploy the catheter, the stiffener further being configured to be removed from the catheter along with the needle while in the distally advanced position, the stiffener comprising a region of weakness at which the stiffener is predisposed to bend, wherein the region of weakness is closer to the distal tip of the needle than to a distal tip of the stiffener when the stiffener is in the distally advanced position.—
Claim 2 should read --The apparatus of claim 1, wherein the stiffener is configured to be locked relative to the needle in the distally advanced position and removed from the catheter while locked, wherein the stiffener is more prone to bend laterally at the region of weakness than [[it]]the stiffener is to bend laterally at a length of the stiffener that is at and adjacent to the distal tip of the needle when the stiffener is locked in the distally advanced position, wherein the region of weakness is positioned distal to said length of the stiffener.—
Claim 3 should read --The apparatus of claim 1, wherein the stiffener is configured to move distally relative to the needle to deploy the catheter, and wherein the region of weakness is positioned proximally from [[a]]the distal tip of the stiffener by a distance that is no less than 10 times greater than a maximum diameter of the stiffener.—
Claim 7 should read --The apparatus of claim 6, wherein the region of weakness comprises a notch in a sidewall of the tube.—
Claim 8 should read --The apparatus of claim 7, wherein the notch extends inwardly relative to an outer profile of the tube to a maximum depth and the outer profile of the tube defines an outer diameter, and wherein the maximum depth is no greater than one third a size of the outer diameter.--
Claim 16 should read --The apparatus of claim 15, wherein the stiffener and the needle are configured to be in a longitudinally locked configuration relative to each other when the stiffener and the needle are removed proximally from the catheter.—
Claim 18 should read --The apparatus of claim 1, wherein the stiffener and the needle are in a coupled configuration when both of the stiffener and the needle are removed from the catheter.--
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 9 & 17 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 9, the limitation “the notch is devoid of angled surfaces” is indefinite in light of the specification. When referencing instant application Figure 24, one of ordinary skill in the art would conclude the notch 310 creates a surface which is angle with respect to the outer –an inner—surface of stiffener 106. As such, it is not clear what is meant by the limitation, rendering the claim indefinite.
As to Claim 17, the limitation “the region of weakness is configured to be unsupported by the needle when the stiffener is in the distally advanced position” is indefinite in light of the specification. When referencing instant application Figure 24, one of ordinary skill in the art would conclude needle 104 supports region of weakness 310, since needle 104 supports stiffener 106, and region of weakness 310 is part of stiffener 106.
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 & 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Muse (U.S. PGPub 2018/0339131), in view of Bierman (U.S. PGPub 2019/0351191).
As to Claim 1, Muse teaches an apparatus (800) comprising:
a needle (804) that comprises a distal tip (826) configured to be inserted into a vessel of a patient (Paragraph 0212), the needle (804) defining an outer surface (the radially outer surface of 804, as viewed in Figure 20D);
a catheter (802) that comprises a distal end (816) and an inner surface (893) that defines a lumen (the lumen through which needle 804 and stiffener 806 extend through, as viewed in Figure 20D) through which (as shown in Figure 20D) the needle (804) extends; and
a longitudinally (left and right, as viewed in Figure 20A) extending (as shown in Figure 20A) stiffener (806) positioned between (as shown in Figure 20D) the outer surface (the radially outer surface of 804, as viewed in Figure 20D) of the needle (804) and the inner surface (893) of the catheter (802), the stiffener (806) being configured to move to a distally advanced position (Figure 21D) relative to (as shown between Figures 21D/20D) the needle (804) to deploy (Paragraph 0224) the catheter (802), the stiffener (806) further being configured to be removed from (Paragraph 0221) the catheter (802) along with (Paragraph 0221) the needle (804) while in (Paragraph 0221) the distally advanced position (Figure 21D).
Muse continues to teach a port 882 used as a flash port, but is silent on a region of weakness, so does not explicitly teach the stiffener comprising a region of weakness at which the stiffener is predisposed to bend, wherein the region of weakness is closer to the distal tip of the needle than to the distal tip of the stiffener when the stiffener is in the distally advanced position.
Bierman describes a similar apparatus, and teaches the use of multiple regions (Paragraph 0135) of weakness (74) in the stiffener (36) and needle (32) ports (56).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to have multiple, as taught by Bierman, ports in the stiffener and needle ports, as taught by Muse, to ensure blood flow through the respective openings (Paragraph 0137).
Modifying Bierman into Muse results in the stiffener (Muse 806) comprising a region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) at which the stiffener (Muse 806) is predisposed to bend (Muse Paragraph 0219), wherein the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) is closer to (this is considered an intended use limitation; see end of paragraph for clarification) the distal tip (Muse 826) of the needle (Muse 804) than to the distal tip (Muse 836) of the stiffener (Muse 806) when the stiffener (Muse 806) is in the distally advanced position (Muse Figure 21D). The intention to place the region of weakness in a particular location during operation is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, one of ordinary skill in the art would conclude the region of weakness –a more proximal port of the plurality of ports modified into Muse by Bierman—may be placed immediately adjacent to the needle distal tip in Muse Figure 20D, resulting in the region of weakness being closer to the needle distal tip than the stiffener distal tip.
As to Claim 2, Muse, as modified, teaches all the limitations of Claim 1, and continues to teach the stiffener (Muse 806) is configured to be locked (Paragraph 0233) relative to (once the Muse assembly is locked, as described in Paragraph 0233, the Muse needle 804 and Muse stiffener 806 are removed together, as described in Muse Paragraph 0229, resulting in the Muse stiffener 806 and Muse needle 804 being locked relative to each other during removal) the needle (Muse 804) in the distally advanced position (Muse Figure 21D) and removed from (Muse Paragraph 0229) the catheter (Muse 802) while locked (Muse Figure 23C), wherein the stiffener (Muse 806) is more prone to bend laterally (see end of paragraph for clarification) at the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) than it (Muse 806) is to bend laterally at a length (see Muse Figure 21D below) of the stiffener (Muse 806) that is at and adjacent to the distal tip (Muse 826) of the needle (Muse 804) when the stiffener (Muse 806) is locked (Paragraph 0233) in the distally advanced position (Muse Figure 21D), wherein the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) is positioned (as shown in Muse Figure 21D) distal to (to the right, as viewed in Muse Figure 21D) said length (see Muse Figure 21D below) of the stiffener (Muse 806). Muse Paragraph 0219 describes stiffener 806 as being flexible in lateral dimensions. One of ordinary skill in the art would conclude the stiffener would become easier –more prone—to bend when a portion of the stiffener has less material –i.e., the plurality of ports—when compared to any other portion of the stiffener which does not have material removed. As such, any length of the stiffener between the distal end of the Muse needle and the region of weakness would be less prone to bend laterally than any of the plurality of ports –including the region of weakness-- due to the extra material.
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Muse Figure 21D, Modified by Examiner
As to Claim 4, Muse, as modified, teaches all the limitations of Claim 1, and continues to teach the stiffener (Muse 806) further comprises a flash port (Muse 882) through which blood can flow (Muse Paragraph 0282).
As to Claim 5, Muse, as modified, teaches all the limitations of Claims 1 & 4, and continues to teach the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) is separate from (as shown in Muse Figure 21D in the Claim 2 rejection above) and positioned proximal to (to the left, as viewed in Muse Figure 21D in the Claim 2 rejection above) the flash port (Muse 882).
As to Claim 6, Muse, as modified, teaches all the limitations of Claim 1, and continues to teach the stiffener (Muse 806) comprises an elongated tube (as shown in Muse Figure 20A).
As to Claim 14, Muse, as modified, teaches all the limitations of Claim 1, and continues to teach the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) is positioned (as shown in Muse Figure 21D) distally relative to (to the right, as viewed in Muse Figure 21D in the Claim 2 rejection above) the distal tip (Muse 826) of the needle (Muse 804) when the stiffener (Muse 806) is fully advanced (Muse Figure 21D) relative to (as shown in Muse Figure 21D) the needle (Muse 804).
As to Claim 15, Muse, as modified, teaches all the limitations of Claims 1 & 14, and continues to teach the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) remains (Muse Paragraph 0229; as shown in Muse Figure 1D) at a position (Muse Figure 21D) that is distal to (to the left, as viewed in Muse Figure 21D in the Claim 2 rejection above) the distal tip (Muse 826) of the needle (Muse 804) when the stiffener (Muse 806) and the needle (Muse 804) are removed proximally from (Muse Paragraph 0229) the catheter (Muse 802).
As to Claim 16, Muse, as modified, teaches all the limitations of Claims 1 & 14-15, and continues to teach the stiffener (Muse 806) and the needle (Muse 804) are configured to be in a longitudinally (left and right, as viewed in Muse Figure 22A) locked configuration (Muse Figure 22A) relative to each other (Muse Paragraphs 0229/0233) when they (Muse 806/804) are removed proximally from (Muse Paragraph 0229) the catheter (Muse 802).
As to Claim 17, Muse, as modified, teaches all the limitations of Claim 1, and continues to teach the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) is reinforced by (when considering where the region of weakness is in Muse Figure 21D in the Claim 2 rejection above, one of ordinary skill in the art would conclude the region of weakness is reinforced by Muse needle 804 when in the state shown in Muse Figure 20A) the needle (Muse 804) when the stiffener (Muse 806) is in an initial position (Muse Figure 20A) prior to deployment (Muse Paragraph 0041) of the catheter (Muse 802), and wherein the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) is configured to be unsupported by (as shown in Muse Figure 21D in the Claim 2 rejection above; this is interpreted in line with instant application Figure 24; see 112(b) rejection above) the needle (Muse 804) when the stiffener (Muse 806) is in the distally advanced position (Muse Figure 22A).
As to Claim 18, Muse, as modified, teaches all the limitations of Claim 1, and continues to teach the stiffener (Muse 806) and the needle (Muse 804) are in a coupled configuration (Muse Paragraphs 0229/0233) when both (Muse 804/806) are removed from (Muse Paragraph 0229) the catheter (Muse 802).
As to Claim 19, Muse, as modified, teaches all the limitations of Claim 1, and continues to teach the stiffener (Muse 806) is configured to lock into (Muse Paragraphs 0229/0233) a fixed longitudinal (left and right, as viewed in Muse Figure 22A) position (Muse Figure 22A) relative to the needle (Muse 804) when the stiffener (Muse 806) is fully distally advanced (Muse Figure 21D).
As to Claim 20, Muse, as modified, teaches all the limitations of Claim 1, and continues to teach a rigid columnar portion (the length of stiffener shown in Muse Figure 21D in the Claim 2 rejection above) of the stiffener (Muse 806) extends between the region of weakness (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D) and a portion of the stiffener (Muse 806) that encompasses the needle (Muse 804) when the stiffener (Muse 806) is fully distally advanced (Muse Figure 21D)relative to the needle (Muse 804).
Claims 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Muse, in view of Bierman, further in view of Howell (U.S. PGPub 2022/0362524).
As to Claim 7, Muse, as modified, teaches all the limitations of Claims 1 & 6.
Bierman Paragraph 0096 continues to describe the shape of the region of weakness may be other shapes, but does not teach the region of weakness comprises a notch in the sidewall of the tube.
Howell describes a similar apparatus, and teaches the region of weakness comprises a notch (as shown in Figure 2) in the sidewall (the sidewall of 102, shown in Figure 2) of the tube (102).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the region of weakness, as taught by Muse, as modified, a rounded notch, as taught by Howell, since notches in catheters/needle cover are well-known and yield predictable results, i.e., provide a more laminar flow due to the tapered nature of the notch.
As to Claim 8, Muse, as modified, teaches all the limitations of Claims 1 & 6-7. Muse, as modified, is silent on the relative size of the notch to the diameter of the tube. Additionally, Muse does not show any cross-sections which would allow one of ordinary skill in the art to conclusively state Muse does not teach the respective relationship. As such, Muse, as modified, does not explicitly teach the notch extends inwardly relative to an outer profile of the tube to a maximum depth and the outer profile of the tube defines an outer diameter, and wherein the maximum depth is no greater than one third the size of the outer diameter.
Bierman continues to teach the notch (74) extends inwardly relative to (as shown in Figure 8D) an outer profile (the profile of 76, shown in Figure 8D) of the tube (76) to a maximum depth (see Bierman Figure 8D below) and the outer profile (the profile of 76, shown in Figure 8D) of the tube(76) defines an outer diameter (see Bierman Figure 8D below), and wherein the maximum depth (see Bierman Figure 8D below) is no greater than one third (when viewing Bierman Figure 8D below, one of ordinary skill in the art would conclude the maximum depth is significantly smaller than one third of the outer diameter) the size of the outer diameter (see Bierman Figure 8D below).
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Bierman Figure 8D, Modified by Examiner
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the notch size to tube diameter relationship, as taught by Muse as modified, to be sized, as taught by Bierman, to control the relative volumetric blood flow rate through the notch.
As to Claim 9, Muse, as modified, teaches all the limitations of Claims 1 & 6-7, and continues to teach the notch (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D, modified by Howell to be a notch) is devoid of angled surfaces (as shown in Howell Figure 2). This limitation is interpreted as best understood, where the notch profile in Howell Figure 2 matches the notch profile shown in instant application Figure 24.
As to Claim 10, Muse, as modified, teaches all the limitations of Claims 1 & 6-7, but does not teach the notch is formed by skiving the stiffener with a curved blade. However, this limitation is considered a product-by-process, and "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." Since Muse, as modified, already meets the structural limitations of the claim, how the notch is formed is not considered patentable. See MPEP 2113.
As to Claim 11, Muse, as modified, teaches all the limitations of Claims 1 & 6-7, and continues to teach an entirety of the notch (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D, modified by Howell to be a notch) defines a rounded profile (as shown in Howell Figure 2).
As to Claim 12, Muse, as modified, teaches all the limitations of Claims 1 & 6-7, and continues to teach an entirety of the notch (a more proximal port –Muse 882—of the multiple ports –Bierman Paragraph 0135, as viewed in Muse Figure 20D, modified by Howell to be a notch) defines a semi-circular profile (as shown in Howell Figure 2).
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As to Claim 3, the prior art of record teaches all the limitations of Claim 1, but does not teach “the region of weakness is positioned proximally from a distal tip of the stiffener by a distance that is no less than 10 times greater than a maximum diameter of the stiffener”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 3. The closest art of record is Muse, as modified (cited above). However, Muse, as modified, only states multiple regions of weakness (Bierman Paragraph 0135) may be formed in the stiffener, not how they are spaced apart. It would not be obvious to one of ordinary skill in the art to modify Muse, as modified, without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 2, is neither anticipated nor made obvious by the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shidham (2022/0226613) and Wittes (3,680,562) describe similar apparatuses.
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
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