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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/18/2026 has been entered.
Response to Amendment
The amendment filed 02/18/2026 has been entered. Claims 1-3, 6-7, 11-17, 19-21 are pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
“Engagement means” in claims 1, 16, and 17 are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Page 16, line 29 – Page 17, line 7 of the instant specification describes the engagement means as a change in profile, enlargement, crimping, welding, milling, cold heading, or expanding of the needle.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 3, 6-7, 11-16, 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 2018/0289932) in view of Solar (US 2013/0310767).
Regarding claim 1, Isaacson discloses an intravenous catheter apparatus (20, Fig 2A) comprising: a tubular catheter (24, Fig 2A)having a proximal end and a distal end mounted to a catheter hub (26, Fig 2A); a needle (22, Fig 2A) defining an axial direction (A) has a wall defining a lumen, a bevel and having a needle shaft (34, Fig 2B) with a needle tip (36, Fig 2B) at a distal end and a needle hub (46, Fig 2B) mounted to the proximal end of the needle shaft, wherein the axial direction (A) extends from the proximal end of the needle shaft to the distal end of the needle shaft; a needle guard (50, Fig 2C) arranged movably on the needle shaft (Para 0042-0043; See Figs 2B-C); wherein said needle shaft extends through said tubular catheter such that said needle tip of said needle protrudes from said distal end of said tubular catheter (Para 0039); wherein said needle is provided with an engagement means (54, Fig 2B) adapted to engage with said needle guard in order to prevent said needle guard from sliding off said needle tip (Para 0045); wherein said needle has at least one opening (38, Fig 2B) having at least one slanted cut with a width extending from the circular wall of the needle shaft perpendicular to the axial direction (A) to the lumen of the needle, wherein the engagement means is located at a predetermined distance away from the at least one opening, such that the engagement means is separate from and not physically incorporated within the opening (See Fig 2B).
Isaacson is silent regarding wherein the at least one opening has two sides in that one of the sides is generally straight and the other side is angled, the straight side and the angled side being located at a respective transition between the circular wall of the needle shaft and the at least one opening, wherein the angled side is located spaced apart from the straight side and at an angle relative to the circular wall of the needle shaft of between 0° and 89°, wherein the straight side extends perpendicular to the axial direction (A) from the outer surface of the circular wall of the needle shaft to the interior surface of the circular wall of the needle shaft, and wherein the width of the at least one opening perpendicular to the axial direction (A) either increases in value in the axial direction (A) or decreases in value in the axial direction (A)
Solar teaches an cannula (1204, Fig 12A) wherein said cannula has at least one opening (1212, Fig 12A) having at least one slanted cut with a width extending from the circular wall of the cannula shaft perpendicular to the axial direction (A) to the lumen of the cannula; and wherein the at least one opening has two sides in that one of the sides is generally straight (See annotated Fig 12B) and the other side is angled (See annotated Fig 12B), the straight side and the angled side being located at a respective transition between the circular wall of the cannula shaft and the at least one opening, wherein the angled side is located spaced apart from the straight side and at an angle relative to the circular wall of the cannula shaft of between 0 and 89 degrees (See Fig 12B wherein the angled side is at an acute angle), wherein the straight side extends perpendicular to the axial direction (A) from the outer surface of the circular wall of the needle shaft to the interior surface of the circular wall of the cannula shaft (See Fig 12B), and wherein the width of the at least one opening perpendicular to the axial direction (A) either increases in value in the axial direction (A) or decreases in value in the axial direction (A) (See Fig 12A) (Para 0071).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the opening to be shaped as taught by Solar in order to have an opening that can prevent skiving of tissue when moved in a distal direction (Para 0071).
Regarding claim 2, the modified invention of Isaacson and Solar discloses the at least one opening (1212, Fig 12A -Solar) has the at least one slanted cut at an angle increasing in value opposite to the direction of the needle tip towards the proximal end of the needle (Para 0071 -Solar; the chamfered portion 1213 can extend in the distal direction such that the angle increases away from the tip).
Regarding claim 3, the modified invention of Isaacson and Solar discloses the at least one opening (1212, Fig 12A -Solar) has the at least one slanted cut at an angle increasing in value in the direction of the needle tip towards the distal end of the needle (See Fig 12B -Solar).
Regarding claim 6, the modified invention of Isaacson and Solar discloses the at least one opening (1212, Fig 12A -Solar) has a length and a width of varying dimensions (See Fig 12A - Solar; As the opening is irregularly shaped, the length and width varies depending on the particular slice it is taken at).
Regarding claim 7, the modified invention of Isaacson and Solar discloses the at least one opening (1212, Fig 12A -Solar) has at least one slanted cut comprising a radial cut having a radius wherein the radius of the at least one slanted cut has varying length (See Fig 12A - Solarr; Depending on where the radius is taken alone the opening, the radius will vary)
Regarding claim 11, the modified invention of Isaacson and Solar discloses the at least one slanted cut of the at least one opening (1212, Fig 12A -Solar) has a shape selected from the group consisting oval, elliptical, square, rectangular, triangular, circular, polygonal, and irregular (the shape is at least irregular and thus meets the limitation).
Regarding claim 12, the modified invention of Isaacson and Solar discloses the at least one opening (38, Fig 2B -Isaacson as modified by Solar) can be positioned on the needle shaft so as to face in a direction that is substantially similar to the direction in which the bevel (bevel at tip 36, Fig 2B -Isaacson) of the needle faces (See position of opening 38 and bevel near tip 36 in Fig 2B -Isaacson).
Regarding claim 13, the modified invention of Isaacson and Solar discloses the at least one opening (38, Fig 2B -Isaacson as modified by Solar) is provided closer to the needle tip (See Fig 2B -Isaacson).
Regarding claim 14, the modified invention of Isaacson and Solar discloses the at least one opening (38, Fig 2B -Isaacson as modified by Solar) defines a distance between the needle tip and the at least one opening, and wherein the distance between the needle tip and the at least one opening is arranged such that the opening is covered by the catheter tube (Para 0038 -Isaacson; the opening is arranged such that flashback can be observed, thus the catheter tube must cover the opening 38).
Regarding claim 15, the modified invention of Isaacson and Solar discloses the at least one opening (38, Fig 2B -Isaacson as modified by Solar) can be positioned anywhere from just proximal of the needle tip (36, Fig 2B -Isaacson) to just distal of the catheter hub (See Fig 2B -Isaacson; the opening is near the needle tip).
Regarding claim 16, the modified invention of Isaacson and Solar discloses the at least one opening (38, Fig 2B -Isaacson as modified by Solar) is provided in between the engagement means (54, Fig 2B -Isaacson) and the needle tip (36, Fig 2B - Isaacson) (See Fig 2B -Isaacson).
Regarding claim 19, the modified invention of Isaacson and Solar discloses the needle shaft defines a circumference, and wherein the at least one opening (38, Fig 2B -Isaacson as modified by Solar) is provided anywhere on the circumference of the needle shaft except on the bottom of the needle shaft in a direction opposite to the bevel of the needle (See Fig 2B -Isaacson; the opening is provided on a portion of the circumference facing the same direction as the bevel of the needle).
Regarding claim 20, the modified invention of Isaacson and Solar discloses the at least one opening (38, Fig 2B -Isaacson as modified by Solar) has a shape like a perforation forming an opening of a size being enough to allow a blood flashback therethrough (Para 0038 -Isaacson).
Regarding claim 21, the modified invention of Isaacson and Solar discloses the needle shaft (34, Fig 2B -Isaacson) comprises at least one aperture (distal opening of needle, best seen in Fig 3B) on the needle shaft.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 2018/0289932) in view of Solar (US 2013/0310767) and further in view of Baid (US 2016/0235949).
Regarding claim 17, the modified invention of Isaacson and Solar discloses all of the elements of the invention as discussed above, however, is silent regarding the engagement means is provided in between the needle tip and the opening.
Baid teaches Baid discloses an intravenous catheter apparatus (device of Fig 7) comprising: a tubular catheter (10, Fig 1) having a proximal end (end of catheter near catheter hub 40, Fig 7) and a distal end (end of catheter furthest from catheter hub 40, see Fig 7) mounted to a catheter hub (40, Fig 7); a needle (12, Fig 1) defining an axial direction (A) has a wall defining a lumen (18, Fig 1), a bevel (bevel near tip 14, Fig 7) and having a needle shaft with a needle tip (14, Fig 1) at a distal end and a needle hub (“needle hub”, Para 0007) mounted to the proximal end of the needle shaft; a needle guard (30, Fig 7) arranged movably on the needle shaft; wherein said needle shaft extends through said tubular catheter such that said needle tip of said needle protrudes from said distal end of said tubular catheter (See state depicted in Fig 1); wherein said needle is provided with an engagement means (26, Fig 1) adapted to engage with said needle guard in order to prevent said needle guard from sliding off said needle tip (Abstract); and wherein said needle has at least one opening (28, Fig 1), wherein the engagement means is provided in between the needle tip and the opening (See Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the positions of at least one opening and the engagement means disclosed by Burkholz to have the engagement means provided in between the needle tip and the opening as taught by Baid since Baid teaches that the position of the engagement means and the opening can be swapped (and would produce the same result of providing a stop for the needle guard and opening for flashback as described in Para 0056 and Para 0058) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
Response to Arguments
Applicant’s arguments filed 02/18/2026, on pages 6-8, regarding the 112f claim interpretation have been full considered but are not persuasive. Applicant states that interpretation under 112(f) does not apply if persons of ordinary skill in the art reading the specification understand the term to have sufficiently definite meaning as the name for the structure that performs the function. The term “engagement means” does not have a definite meaning of structure; one would have to turn to the specification to definitively indicate a change in profile, enlargement, crimping, welding, milling, cold heading, or expanding of the needle as the engagement means recited by Applicant.
Applicant again argues that the claim language does not meet the 3-prong analysis. As detailed in the final office action mailed 01/25/2024:
The limitation uses the term “means”
The term means is modified by functional language, “adapted to engage with said needle guard in order to prevent said needle guard from sliding off said needle tip”, and linked by a transition word (i.e., adapted to).
The term “means” is not modified by sufficient structure, material, or acts for performing the claimed function. There is no structure or material claimed that can perform the function noted above. Additionally, the claim fails to provide an act for performing the engagement since it doesn’t describe how it engages. The claim essentially states that the engagement means engages.
Thus, the Examiner maintains the 112(f) interpretation as detailed above.
Applicant’s arguments filed 02/18/2026, on pages 8-9 regarding Shevgoor not teaching the amended claim limitations have been fully considered but are moot in view of the current rejection that relies on Solar to teach the shaped of the opening.
Applicant’s arguments filed 02/18/2026, on pages 9-14 regarding the criticality of the recited opening have been fully considered but are not persuasive. Examiner appreciates the explanation of the functionality of the claimed opening design; however, it does not overcome the current art of record. Specifically, Solar is now relied on to teach the claimed opening and there is sufficient motivation (i.e. preventing skiving as detailed in Para 0071 of Solar) for modifying the opening shape, with a reasonable expectation of success.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Inoue (US 11,596,745) teaches an identical opening (best seen Figs 11-12) in a medical cannula.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
Prosecution Insights