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 .
Status of Claims
Applicant's arguments, filed 08/28/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicant has canceled claims 5-11 in the response filed on 08/28/2025. Claims 3, 4, and 12-20 continue to be withdrawn per applicant’s election of restriction requirement filed on 05/08/2025.
Applicant has amended the claims, filed 08/28/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant has newly added claims 21-23 in the response filed on 08/28/2025, which have been acknowledged and entered.
Claims 1-2 and 21-23 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/22/2025 is in compliance
with the provision of 37 CFR 1.97. Accordingly, the information disclosure statement is being
considered.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "advancement element" in claim 1.
Three Prong Analysis for Claim 1:
“element” has been interpreted as a generic placeholder for “means” or “step”
“configured to move linearly along the slot between a retracted position and an advanced position” has been interpreted as functional language
There is not sufficient structure recited in the claim to perform the aforementioned function. Therefore, “advancement element” in claim 1 has been interpreted to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Per Applicant’s Specification, the advancement element is herein interpreted to be any element that would allow a person to “pinch or grab” the element so that it can be moved “between the retracted position and the advanced position” [0061].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 23 is 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.
Regarding Claim 23, the claim recites "the lube reducing friction between the instrument and the instrument". It is unclear how there can be friction between the instrument and itself. Therefore, the claim is rendered indefinite. For the purposes of examination, the claim is herein interpreted to read “"the lube reducing friction between the instrument and the septum".
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US Patent Pub. No. 20200016374 - previously cited) in view of Howell (US Patent Pub. No. 20010020153).
Regarding Claim 1, Burkholz discloses an instrument advancement device to advance an instrument into a catheter assembly (delivery device 10 may facilitate delivery of an instrument, such as, for example, a catheter 12, into an intravenous catheter assembly [0032]; figs 1A-1C), the instrument advancement device comprising:
a housing, comprising a proximal end, a distal end, and a slot (a housing 14...the housing may include a distal end 16, a proximal end 18, and a slot 20 [0033]; fig 1A);
an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position (the guide feature 22 may extend through the slot 20. In some embodiments, the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user...the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25 [0034]; guide feature 22 may be generally parallel with the longitudinal axis 27, as illustrated, for example in FIGS. 1A and 1C [0045]; Examiner notes that slot 20 is linear and therefore, the guide feature 22 would move linearly along the slot 20);
a septum disposed within the housing (the delivery device 10 may include a blood control septum 31 [0038]; Examiner notes fig 1C shows blood control septum 31 disposed within housing 14), wherein:
a distal face of the septum is flat (the septum 31 may be disposed proximate or towards the distal end 16 of the delivery device 10 [0038]; Examiner notes fig 1A shows both the distal and proximal face of the septum 31 to be flat);
and an instrument comprising a first end and a second end (a first end 28 of the instrument… a second end 30 of the instrument [0037]; fig 1A), wherein in response to movement of the advancement element from the retracted position to the advanced position, the instrument moves through the septum and the second end of the instrument is advanced beyond the distal end of the housing (the first end 28 of the instrument may be advanced in the distal direction 23 beyond the distal end of the housing 14 in response to the guide feature 22 being partially and/or fully advanced along the slot 20 in the distal direction 23 [0048])
wherein a portion of an inner volume of the housing defines a fluid path (a fluid pathway of the delivery device 10 may include the catheter 12 and the extension tubing 32 [0039]; figs 1A-1C).
Burkholz fails to disclose the fluid path is distal to the septum such that the distal face of the septum faces the fluid path, and with the septum sealing off the fluid path from a remainder of the inner volume of the housing.
However, Howell teaches a “blood seal having a spring-biased septum is provided for preventing the leakage of blood during the placement and use of vascular catheters” (abstract) wherein a portion of an inner volume of a housing defines a fluid path (The branched connector 42 includes a housing 44 and an internal channel 46 through the housing 44. [0033]; Fluids and medications flow into the tube 60, through the branched connector 42 and catheter 12 [0042]; fig 1; Examiner notes a part of the internal channel 46 left of the septum 50 in fig 1 defines a fluid path), with the fluid path distal to a septum such that a distal face of the septum faces the fluid path (fig 1), and with the septum sealing off the fluid path from a remainder of the inner volume of the housing (The housing 44, internal channel 46, and spring-biased septum 50 form a blood seal. [0033]; the vascular access device 10 allows for the placement of a catheter in a patient and subsequent removal of the introducer needle while maintaining a blood seal at the proximal end of the catheter. This allows a medical professional to introduce a catheter into a patient's blood vessel and remove the introducer needle without the need to be concerned about blood leakage. [0029]; fig 1).
Howell is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the instrument advancement device of Burkholz such that the fluid path is distal to the septum such that the distal face of the septum faces the fluid path, and with the septum sealing off the fluid path from a remainder of the inner volume of the housing, as taught by Howell, because doing so would prevent blood leakage during catheter placement/insertion.
Regarding Claim 2, Burkholz in view of Howell teaches the invention as discussed above in claim 1. Burkholz further discloses the distal face of the septum is flat (the septum 31 may be disposed proximate or towards the distal end 16 of the delivery device 10 [0038]; Examiner notes fig 1A shows both the distal and proximal face of the septum 31 to be flat).
Regarding Claim 21, Burkholz in view of Howell teaches the invention as discussed above in claim 1. Burkholz further discloses the housing comprises a side port formed therein (the second end 30 of the instrument may be coupled to extension tubing 32 [0039]; figs 1A-1C), with the side port in fluid communication with the fluid path (a fluid pathway of the delivery device 10 may include the catheter 12 and the extension tubing 32 [0039]; figs 1A-1C). Burkholz in view of Howell fails to teach the side port is formed at a location distal to the septum.
However, Howell teaches a side port is formed at a location distal to the septum (The branched connector 42 includes a housing 44 and an internal channel 46 through the housing 44. Disposed within and substantially blocking the internal channel 46 is a spring-biased septum 50. [0033]) such that the side port does not interface with a blood seal (The housing 44, internal channel 46, and spring-biased septum 50 form a blood seal. [0033]; fig 1), but rather interfaces with a portion of an internal volume of a housing that has access to a blood vessel of a patient (Fluids and medications flow into the tube 60, through the branched connector 42 and catheter 12, and into the blood vessel of the patient. [0042]; fig 1).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the side port of Burkholz in view of Howell such that the side port is formed at a location distal to the septum, as taught by Howell, because it would allow the side port to have access to a blood vessel of a patient to deliver fluids or medications.
Regarding Claim 22, Burkholz in view of Howell teaches the invention as discussed above in claim 2. Burkholz discloses the septum is configured to receive the instrument therethrough (the instrument may penetrate the septum 31 [0038]). Burkholz in view of Howell fails to teach the septum comprises a proximally-facing pocket configured to receive the instrument therethrough.
However, Howell teaches a septum comprises a proximally-facing pocket configured to receive an instrument therethrough (The elastic plug 52 also includes a slit 58 through which the needle 20 passes. It will be appreciated that the slit 58 may be replaced by any of a number of equivalent elements, such as a hole or channel through the elastic plug 52. [0035]; fig 2). Howell also teaches “After the needle 20 is withdrawn, the slit 58 closes to prevent blood leakage.” [0035].
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the instrument advancement device of Burkholz in view of Howell such that the septum comprises a proximally-facing pocket configured to receive the instrument therethrough, as taught by Howell. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US Patent Pub. No. 20200016374 - previously cited) in view of Howell (US Patent Pub. No. 20010020153) as applied to claim 22 above, and further in view of Taylor et al. (US Patent Pub. No. 20040106942) hereinafter Taylor.
Regarding Claim 23, Burkholz in view of Howell teaches the invention as discussed above in claim 22. Burkholz in view of Howell fails to teach the pocket includes a lube disposed therein, the lube reducing friction between the instrument and the septum.
However, Taylor teaches a septum with pockets that include a lube disposed therein, the lube reducing friction between an instrument and the septum (Pockets 88a and 88b are located within septum seal 80 and serve to store lubricants. When an instrument is inserted through aperture 86, septum seal 80 deforms forcing the lubricants to ooze from storage pockets 88a and 88b through apertures 82a and 82b, respectively, thereby lubricating the instrument and facilitating its insertion and manipulation. [0033 of Taylor]; fig 10 of Taylor).
Taylor is considered analogous art to the present invention because it is reasonably pertinent to a problem faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the instrument advancement device of Burkholz in view of Howell such that the pocket includes a lube disposed therein, the lube reducing friction between the instrument and the septum, as taught by Taylor, because doing so would lubricate the instrument and facilitate its insertion and manipulation.
Response to Arguments
Applicant's arguments, see page 6 of Remarks, filed 08/28/2025, with respect to the reconsideration of restriction have been fully considered but they are not persuasive. As stated in the Non-Final Rejection, Claims 1 and 12 have a materially different design, and a reference that applies to claim 1 would not necessarily apply to Claim 12. Claim 1 has specific language regarding the septum; Claim 12 does not. Claim 12 has a lube; Claim 1 does not. Furthermore, the amendments to Claim 1 recite even more specific details about the septum that are not in claim 12. Therefore, the restriction is maintained.
Applicant’s arguments, see pages 6-7 of Remarks, filed 08/28/2025, with respect to the drawing objection have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see pages 7-8 of Remarks, filed 08/28/2025, with respect to the 35 U.S.C 102 rejection of claim 1 have been considered but are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791