Prosecution Insights
Last updated: July 17, 2026
Application No. 18/683,625

PERIPHERALLY INSERTED CENTRAL CATHETERS (PICC) AND METHODS OF USE THEREOF

Non-Final OA §102§103§112
Filed
Feb 14, 2024
Priority
Aug 24, 2021 — provisional 63/236,538 +1 more
Examiner
PONTON, JAMES D
Art Unit
Tech Center
Assignee
Alon Shiri
OA Round
1 (Non-Final)
80%
Grant Probability
Favorable
1-2
OA Rounds
5m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 80% — above average
80%
Career Allowance Rate
449 granted / 560 resolved
+20.2% vs TC avg
Strong +33% interview lift
Without
With
+33.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
38 currently pending
Career history
588
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
60.2%
+20.2% vs TC avg
§102
5.7%
-34.3% vs TC avg
§112
27.1%
-12.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 560 resolved cases

Office Action

§102 §103 §112
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 . Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “duckbill valve for facilitating the separation of the medical substances” of claim 15 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. 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 Objections Claims 1-7, 11-12, and 14-16 are objected to because of the following informalities: As to claim 1, “comprises” in line 3 should read comprising for consistency of grammar. As to claim 15, “lumen for delivering medical substance” should likely read “lumen for delivering [a] medical substance” for grammar. Claim 15 currently ends with a comma instead of a period. Dependent claims inherit the deficiencies of the claims from which they depend. Appropriate correction is required. 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: “a pressure adjustment mechanism configured to regulate a flow rate of the flushing fluid to facilitate circulation…” in claim 14. 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. 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 the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. 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. Claims 1-7, 11-12, 14-16, and 19-26 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 1, usage of “therebetween” in line 5 is unclear as the wording is ambiguous as to whether “therebetween” refers to the distal portion and/or the proximal portion, or more specifically to the distal end face opening, the proximal opening, etc… Claim 1 requires “a valve positioned within the at least one flushing lumen”. It is unclear if this means each flushing lumen (if there is more than one) includes a valve or if a single valve is common to all flushing lumens. Claim 1 recites “the subject’s blood vessel” in line 11. While a blood vessel was previously mentioned, there is no antecedent basis for the subject. Claim 15 introduces “a flushing lumen”. It is unclear if this flushing lumen is considered one of the at least one flushing lumens introduced in claim 1 or if this refers to a different flushing lumen. Claim 15 recites the limitation “the separation of the medical substances” in line 3. Both “the separation of…” and “the medical substances” lack a proper antecedent basis. Claim 15 recites “a lumen comprising a duckbill valve for facilitating the separation of the medical substances”. Due to the lack of disclosure surrounding the duckbill valve (see page 17 of Specification which admits duckbill valves are not shown) it is not clear how a duckbill valve is used to facilitate separation of medical substances. Claim 16 recites the limitation “the medical substance” in line 4. There is insufficient antecedent basis for this limitation in the claim. As to claim 19, usage of “therebetween” in line 6 is unclear as the wording is ambiguous as to whether “therebetween” refers to the distal portion and/or the proximal portion, or more specifically to the distal end face opening, the proximal opening, etc… Claim 19 requires “a valve positioned within the at least one flushing lumen”. It is unclear if this means each flushing lumen (if there is more than one) includes a valve or if a single valve is common to all flushing lumens. Claim 21 recites “wherein analyzing the flushing fluid comprises…”, however, no previous analysis was mentioned. It is believed claim 21 may have been intended to depend from claim 20 which does introduce analyzing the flushing fluid. Claim 22 recites the limitation “the performance quality of the catheter” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 25 recites the limitation “the medical substance” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 26 recites the limitation “the medical substance” in line 3. There is insufficient antecedent basis for this limitation in the claim. Dependent claims inherit the deficiencies of the claim(s) from which they depend. Claim Rejections - 35 USC § 102 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 – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1-3, 6, 7, 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Godfrey (US 4,227,533). As to claim 1, Godfrey discloses a peripherally insertable central catheter (PICC) (10; see Figs. 1-5; the examiner notes that while not explicitly disclosed to be peripherally insertable, this refers to an intended use - Godfrey discloses the following structure and is therefore understood to be capable of being peripherally insertable) comprising a distal portion (14; the examiner notes however that a “portion” is arbitrary and can be interpreted as any portion of the catheter 10 that is distal of the proximal end 12), configured to be inserted into a blood vessel (again, this is intended use, the catheter of Godfrey is fully capable of being inserted into a blood vessel), the distal portion comprises a distal end face opening (18); a proximal portion (12) comprising a proximal opening (interpreted as proximal opening of 48 and/or 16); at least one flushing lumen (48, 16) extended therebetween; and a valve (20) positioned within the at least one flushing lumen, the valve comprises two configurations, an open configuration (see Fig. 1), allowing fluid flow through the distal end face opening, and a closed configuration (see Fig. 2), blocking fluid flow through the distal end face opening (the valve 20 being closed blocks any fluid in lumen 16 from exiting 18), wherein at a closed configuration of the valve, flushing fluid that is inserted to the catheter from the proximal opening thereof, circulates back through the proximal portion and out of the subject’s blood vessel, thereby exiting of flushing fluid through the distal end face opening is prevented (see Figs. 1-2, para beginning line 34 col. 4). As to claim 2, Godfrey discloses the catheter of claim 1, wherein the at least one flushing lumen is further configured to deliver a medical substance to the subject at an open configuration of the valve (see Figs. 1, 3, 4; in an open position of 20, fluid would be capable of flowing form 16 distally through 18). As to claim 3, Godfrey discloses the catheter of claim 1, wherein the at least one flushing lumen is divided into two individual lumens (48 and 16), a first lumen (48) configured to deliver the flushing fluid and a second lumen (16) configured to collect the flushing fluid and direct it to the proximal portion and out of the subject's blood vessel (see para beginning line 53 col. 3). As to claim 6, Godfrey discloses the catheter of claim 1, wherein the valve comprises a sealing flap and/or a shutter configured to controllably seal the distal end face opening (see Figs. 1-2, lines 5-53 col. 4). As to claim 7, Godfrey discloses the device of claim 1, wherein the valve comprises a duckbill valve configured to controllably seal the distal end face opening (see configuration of Figs. 6-10 which includes valve 69 in the form of a duckbill valve). As to claim 12, Godfrey discloses the catheter of claim 1, wherein the flushing fluid circulated back through the proximal portion exits the catheter through the proximal opening and/or through a proximal drain port (this is necessarily true – i.e. the flushing fluid must exit the proximal portion through an opening or drain port otherwise the catheter would not function; also see Figs. 1-2, lines 5-53 col. 4). As to claim 14, Godfrey discloses the catheter of claim 1, further comprising a pressure adjustment mechanism (“syringe pump or the like”) configured to regulate a flow rate of the flushing fluid to facilitate circulation of the flushing fluid through the at least one flushing lumen, back through the proximal portion and out of the catheter (see para beginning line 54 col. 4). Claim(s) 1-7, 12, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slager et al. (US 2017/0072129 A1), hereafter "Slager". As to claim 1, Slager discloses a peripherally insertable central catheter (PICC) (600; see Figs. 6G-6H, para 0002, 0005, 0073) comprising a distal portion (entirety of Fig. 6H), configured to be inserted into a blood vessel (para 0002, 0005), the distal portion comprises a distal end face opening (660); a proximal portion (movable portion 140 depicted in Figs. 1-4B; to be used with the access device 600) comprising a proximal opening (opening which catheter 130 is inserted into; see para 0036); at least one flushing lumen (central lumen of 600 in which 130 is located; see Fig. 6H) extended therebetween; and a valve (665) positioned within the at least one flushing lumen, the valve comprises two configurations, an open configuration, allowing fluid flow through the distal end face opening, and a closed configuration, blocking fluid flow through the distal end face opening (para 0059), wherein at a closed configuration of the valve, flushing fluid that is inserted to the catheter from the proximal opening thereof, circulates back through the proximal portion and out of the subject's blood vessel, thereby exiting of flushing fluid through the distal end face opening is prevented (the examiner notes that this limitation is purely functional and if the distal tip orifice 660 is sealed, than any flushing fluid would circulate back as claimed; also see para 0033 teaching that flushing fluid can be inserted through the catheter (130) or through a port to flush the space between the sleeve and the catheter). As to claim 2, Slager discloses the catheter of claim 1, wherein the at least one flushing lumen is further configured to deliver a medical substance to the subject at an open configuration of the valve (Fig. 6H, para 0059, 0073). As to claim 3, Slager discloses the catheter of claim 1, wherein the at least one flushing lumen is divided into two individual lumens, a first lumen (interior of 600) configured to deliver the flushing fluid (para 0033) and a second lumen (interior of 130) configured to collect the flushing fluid and direct it to the proximal portion and out of the subject's blood vessel (see Figs. 1-4B, para 0033, 0036). As to claim 4, Slager discloses the catheter of claim 1, wherein the valve comprises an inflatable element configured to inflate into dimensions sufficient for sealing the distal end face opening (para 0059). As to claim 5, Slager discloses the catheter of claim 4, further comprising an inflation conduit (670) in fluid flow communication with the inflatable element (Fig. 6H, para 0059). As to claim 6, Slager discloses the catheter of claim 1, wherein the valve comprises a sealing flap and/or a shutter configured to controllably seal the distal end face opening (Fig. 6H, para 0059). As to claim 7, Slager discloses the catheter of claim 1, wherein the valve comprises a duckbill valve configured to controllably seal the distal end face opening (see embodiment of Figs. 6B-6C showing an alternative embodiment for the valve). As to claim 12, Slager discloses the catheter of claim 1, wherein the flushing fluid circulated back through the proximal portion exits the catheter through the proximal opening and/or through a proximal drain port (this is necessarily true – i.e. the flushing fluid must exit the proximal portion through an opening or drain port otherwise the catheter would not function – see para 0033, 0036, 0059). As to claim 19, Slager discloses a method for flushing a peripherally insertable central catheter (PICC), the method comprising: providing a PICC (600; see Figs. 6G-6H, para 0002, 0005, 0073) comprising a distal portion (entirety of Fig. 6H) comprising a distal end face opening (660); a proximal portion (movable portion 140 depicted in Figs. 1-4B; to be used with the access device 600) comprising a proximal opening (opening which catheter 130 is inserted into; see para 0036); at least one flushing lumen (central lumen of 600 in which 130 is located; see Fig. 6H) extended therebetween; and a valve (665) positioned within the at least one flushing lumen (Fig. 6H, para 0059); inserting the distal portion of the PICC into a blood vessel of a subject (para 0002, 0005); shifting the valve to a closed configuration for blocking fluid flow through the distal end face opening (para 0059); and injecting flushing fluid to the catheter from the proximal opening thereof, thereby the flushing fluid circulates back through the proximal portion and out of the catheter such that exiting of flushing fluid through the distal end face opening and into the subject's blood vessel is prevented (see para 0033, 0059). 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 of this title, 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. Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Godfrey in view of Schwartz (US 5,092,844). As to claim 11, Godfrey discloses the catheter of claim 1 as described above, but is silent to an additional individual lumen for delivering a medical substance to the subject at an open configuration of the valve. Schwartz discloses a catheter (20) and teaches “Preferably, the tube 40 also encloses at least one, and most preferably, two additional lumens (not shown)… Additional lumens might be present for delivering medicant to the body vessel 22” (para beginning line 31 col. 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included an additional individual lumen in the catheter of Godfrey as claimed. One would have been motivated to do so in order to deliver medicant to a body vessel (see para beginning line 31 col. 5 of Schwartz). Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slager in view of Schwartz (US 5,092,844). As to claim 11, Slager discloses the catheter of claim 1 as described above, but is silent to an additional individual lumen for delivering a medical substance to the subject at an open configuration of the valve. Schwartz discloses a catheter (20) and teaches “Preferably, the tube 40 also encloses at least one, and most preferably, two additional lumens (not shown)… Additional lumens might be present for delivering medicant to the body vessel 22” (para beginning line 31 col. 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included an additional individual lumen in the catheter of Slager as claimed. One would have been motivated to do so in order to deliver medicant to a body vessel (see para beginning line 31 col. 5 of Schwartz). Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Godfrey in view of Korth et al. (US 5,520,636), hereafter “Korth”. As to claim 16, Godfrey discloses the catheter of claim 1 as described above, but is silent to one or more sensors for monitoring and/or regulating: pressure of the flushing fluid to facilitate pressure regulation; flow capacity of the flushing fluid entering and/or exiting the catheter; and/or flow capacity of the medical substance entering the blood vessel. Korth discloses an apparatus for flushing a urinary bladder (the examiner notes Godfrey also used in the bladder) and teaches “The pressure regulator can be a simple valve controlling the flushing flow, the valve being actuated by a pressure sensor located on the side of the valve which faces the bladder. As described below, such a pressure regulator may be designed in a simple manner to be maintenance-free and, with appropriate adjustment means, allows simple pressure adjustment to the desired level. The pressure regulator operates entirely independently of any clogging of the drain line. If this drain line were fully clogged, the pressure regulator would shut the valve and maintain the pressure in the bladder at the preset level. It is particularly important that the pressure regulator maintains the pressure in the bladder constant regardless of the magnitude of the flushing flow. The magnitude of the flushing flow can be selected in some other way, for instance by suitable control of the drain flow. The pressure regulator is applicable to all flushing methods, especially to continuous, permanent flushing” (para beginning line 48 col. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Godfrey in view of Korth such that Godfrey includes one or more sensors for monitoring and/or regulating: pressure of the flushing fluid to facilitate pressure regulation; flow capacity of the flushing fluid entering and/or exiting the catheter; and/or flow capacity of the medical substance entering the blood vessel. One would have been motivated to do so in order to control an amount of fluid traveling through the catheter (see abstract, para beginning line 48 col. 3). Claim(s) 16 and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slager in view of Cise et al. (US 2003/0125674 A1), hereafter “Cise”. As to claim 16, Slager discloses the catheter of claim 1 as described above, but is silent to one or more sensors for monitoring and/or regulating: pressure of the flushing fluid to facilitate pressure regulation; flow capacity of the flushing fluid entering and/or exiting the catheter; and/or flow capacity of the medical substance entering the blood vessel. Cise discloses an apparatus and method for preventing free flow in a fluid line and teaches “By selectively actuating the engagement members 464, the infusion set 450 and occluder 454, a valve is formed for controlling fluid flow. By applying a pressure sensor or other type of sensor, the valve can be used to regulate flow and flow through the valve can be determined” (para 0141). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Slager such that the catheter includes one or more sensors for monitoring and/or regulating: pressure of the flushing fluid to facilitate pressure regulation; flow capacity of the flushing fluid entering and/or exiting the catheter; and/or flow capacity of the medical substance entering the blood vessel. One would have been motivated to do so as a way to control an amount of fluid that flows through the catheter (see para 0141 of Cise). As to claims 23-26, Slager discloses the method of claim 19 as described above. Slager is silent to the specifics of monitoring and/or regulating pressure of the flushing fluid using one or more sensors (claim 23), monitoring and/or regulating flow capacity of the flushing fluid entering and/or exiting the catheter using one or more sensors (claim 24), monitoring and/or regulating flow capacity of the medical substance entering the blood vessel using one or more sensors (claim 25), and regulating, utilizing a controller, pressure and/or flow capacity of the flushing fluid and/or the medical substance (claim 26). Cise discloses an apparatus and method for preventing free flow in a fluid line and teaches “By selectively actuating the engagement members 464, the infusion set 450 and occluder 454, a valve is formed for controlling fluid flow. By applying a pressure sensor or other type of sensor, the valve can be used to regulate flow and flow through the valve can be determined” (para 0141). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Slager such that the catheter includes one or more sensors and/or controllers for performing any of the functions recited in claims 23-26. One having ordinary skill in the art would have recognized the benefit of providing valves and/or controllers for controlling fluid flow from Cise, and therefore would have been motivated to do so in order to regulate any of said flows (see para 0009, 0072-0074, 0141 of Cise). Allowable Subject Matter Claims 20-22 (assuming claim 21 was intended to depend from claim 20) would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: As to claim 20, Slager discloses the method of claim 19 as described above, but is silent to analyzing the flushing fluid for chemical and/or biological substances indicative of complications and/or infections in combination with the limitations of claim 19. As to claim 22, while Slager discloses the method of claim 19 as described above, Slager is silent to further comprising analyzing one or more parameters associated with a pressure of the flushing fluid exiting and/or entering the catheter for assessing the performance quality of the catheter and/or the flushing fluid in combination with the limitations of claim 19. The examiner notes that no prior art rejections are given for claim 15, however the lack of clarity surrounding this claim has prevented the claim from being considered allowable. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm. 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, Chelsea Stinson can be reached at 571-270-1744. 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. /James D Ponton/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Feb 14, 2024
Application Filed
Jun 05, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
80%
Grant Probability
99%
With Interview (+33.4%)
2y 10m (~5m remaining)
Median Time to Grant
Low
PTA Risk
Based on 560 resolved cases by this examiner. Grant probability derived from career allowance rate.

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