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 07/01/2026 is acknowledged. The traversal is on the ground(s) that Examiner failed to “sufficiently establish how the identified species lack the required technical relationship or fail to share the same or corresponding special technical features”. This is not found persuasive because for the following reasons.
As mentioned in Applicant’s remarks, Unity of Invention is governed by 37 CFR 1.475(a), which describes the group of inventions/species which may be restricted via unity of invention is the claimed inventions. The 05/07/2026 Requirement for Restriction relies on the shared structure between each of independent Claims 1, 13 & 19 to determine the shared technical relationship between each of the claimed inventions/species. Since the cited Martilla reference teaches each of the limitations of Claim 1, there is no claimed shared special technical feature among the claimed inventions/species. As Applicant points out, the particular structure of each of the claimed embedded components is only differentiated in dependent claims. Once the structure of the embedded components is described, the respective structure is no longer considered a shared technical relationship.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-10 & 13-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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 07/01/2026.
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 as follows.
“component” in Claim 1, where the generic placeholder is “component”, the functional language is “configured for use in detecting one or more of…”, and sufficient modifying structure is not provided; instant application Paragraphs 0008-0016 list multiple structure for the component, providing sufficient modifying structure
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-2 & 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to Claim 1, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims the dressing layer comprises at least one embedded component configured for use in detecting…fluid infiltration/extravasation from the catheter…catheter dislodgement…presence of microbes at the IV access site. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain how the at least one embedded component is capable of detecting fluid infiltration/extravasation from the catheter, catheter dislodgement, or the presence of microbes at the IV access site.
The original disclosure only broadly describes the embedded components as detecting fluid infiltration/extravasation from the catheter, catheter dislodgement, or the presence of microbes at the IV access site, but the original disclosure “does not sufficiently describe how the function is performed or the result is achieved.” None of an “algorithm or steps/procedure taken to perform the function [are] described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.” As such, sufficient written description is not provided for the claimed limitation.
Instant application Paragraph 0079 describes how the conductive traces are capable of detecting fluid buildup (infiltration) below the patient’s skin, but makes no effort to distinguish how the conductive traces are capable of determining the buildup is from the catheter specifically. Paragraph 0079 makes no attempt to describe how the traces are capable of detecting extravasation.
See MPEP 2161.01(I).
As to Claim 2, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims the dressing layer comprises at least one embedded component configured for use in detecting one or more of swelling of the IV access site…fluid infiltration/extravasation from the catheter…catheter dislodgement…color changes of the patient’s skin at the IV access site…presence of microbes at the IV access site, and degradation of the dressing layer…wherein the at least one embedded component comprises a plurality of conductive traces. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain how the at least one embedded component is capable of detecting swelling of the IV access site, fluid infiltration/extravasation from the catheter, catheter dislodgement, color changes of the patient’s skin at the IV access site, presence of microbes at the IV access site, or degradation of the dressing layer.
As described in the Claim 1 rejection above, the original disclosure does not provide sufficient support for the embedded component detecting fluid infiltration/extravasation from the catheter, catheter dislodgement, or the presence of microbes at the IV access site, but the original disclosure “does not sufficiently describe how the function is performed or the result is achieved.”
Instant application Paragraph 0093 describes how unelected Species V –shown in Figures 5A/5B—is capable of detecting swelling of the IV access site. However, the original disclosure does not provide sufficient written description for how the conductive traces are capable of detecting swelling of the IV access site.
Instant application Paragraphs 0092/00123/00124 describes how unelected species are capable of detecting color changes of the patient’s skin at the IV access site. However, the original disclosure does not provide sufficient written description for how the conductive traces are capable of detecting color changes of the patient’s skin at the IV access site.
Instant application Paragraphs 00102/00116/00127 describes how unelected species are capable of detecting degradation of the dressing layer. However, the original disclosure does not provide sufficient written description for how the conductive traces are capable of detecting degradation of the dressing layer.
None of an “algorithm or steps/procedure taken to perform the function [are] described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.” As such, sufficient written description is not provided for the claimed limitation.
See MPEP 2161.01(I).
As to Claim 12, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims sending at least one of an audible or visual alert to a care provider. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain how an audible or visual alert is sent to a care provider.
The original disclosure only broadly describes sending at least one of an audible or visual alert to a care provider, but the original disclosure “does not sufficiently describe how the function is performed or the result is achieved.” None of an “algorithm or steps/procedure taken to perform the function [are] described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.” As such, sufficient written description is not provided for the claimed limitation.
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 1-2 & 11-12 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, the limitation “the dressing layer comprises at least one embedded component configured for use in detecting…fluid infiltration/extravasation from the catheter…catheter dislodgement…presence of microbes at the IV access site”, in Lines 4-8, is indefinite. As described in the 112(a) rejection above, sufficient written description was not provided for the functions. As such, it is not clear how the claimed component is capable of detecting catheter dislodgement or the presence of microbes at the IV access site, rendering the claim indefinite.
The phrase “fluid infiltration/extravasation from the catheter”, in Line 6, should read --fluid infiltration/extravasation from a catheter. Although a catheter insertion was described in the preamble, the catheter itself was not positively claimed until Line 6.
As to Claim 2, the limitation “the at least one embedded component comprises a plurality of conductive traces”, in combination with Claim 1, Lines 4-8, is indefinite. As described in the 112(a) rejection above, sufficient written description was not provided for the functions. As such, it is not clear how the claimed component is capable of detecting swelling of the IV access site, fluid infiltration/extravasation from the catheter, catheter dislodgement, color changes of the patient’s skin at the IV access site, presence of microbes at the IV access site, or degradation of the dressing layer, rendering the claim indefinite.
As to Claim 12, the limitation “sending at least one of an audible or visual alert to a care provider”, in Line 7, is indefinite. As described in the 112(a) rejection above, sufficient written description was not provided for the functions. As such, it is not clear how an audible or visual alert is sent to a care provider, rendering the claim indefinite.
The phrase “fluid detection on top of the patient's skin at a skin piercing location”, in Lines 3-4, should read --fluid detection on top of the patient's skin at [[a]]the skin piercing location.
The term “the shutdown”, in Line 6, should read –a
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(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.
Claims 1-2 & 11-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Padmanathan (U.S. PGPub 2023/0052494).
As to Claim 1, Padmanathan teaches a system (2/10) for monitoring an intravenous (IV) access site (Paragraph 0020) for catheter (12) insertion (Paragraph 0020) into (as shown in Figure 1) a patient's skin (Paragraph 0020), the system (2/10) comprising:
a dressing layer (10) configured to cover (as shown in Figure 1) at least a portion of the IV access site (Paragraph 0020),
wherein the dressing layer (10) comprises at least one embedded component (14/16/19) configured for use in detecting one or more of swelling of the IV access site (Paragraph 0028), temperature changes at the IV access site (Paragraph 0026), fluid infiltration/extravasation from the catheter, fluid detection on top of the patient's skin at a skin piercing location, catheter dislodgement, color changes of the patient's skin at the IV access site, presence of microbes at the IV access site, and degradation of the dressing layer. Note – since Padmanathan teaches at least one of the options, the remaining options do not need to be taught.
As to Claim 2, Padmanathan teaches all the limitations of Claim 1, and continues to teach the at least one embedded component (14/16/19) comprises a plurality of conductive traces (as shown in Figure 1 and described in at least Paragraphs 0022/0026/0028).
As to Claim 11, Padmanathan teaches all the limitations of Claim 1, and continues to teach the dressing layer (10) further comprises an integrated power source (Paragraph 0021) and communication electronics (17; Paragraph 0021).
As to Claim 12, Padmanathan teaches all the limitations of Claim 1, and continues to teach based upon the detection of one or more of swelling of the IV access site (Paragraph 0028), temperature changes at the IV access site (Paragraph 0026), fluid infiltration/extravasation from the catheter, fluid detection on top of the patient's skin at a skin piercing location, catheter dislodgement, color changes of the patient's skin at the IV access site, presence of microbes at the IV access site, and degradation of the dressing layer, the system is further configured to initiate at least one of the shutdown of an infusion pump fluidly coupled the catheter and send at least one of an audible or visual alert to a care provider (Paragraph 0037).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Inoue (2020/0324045 – see Figure 1) and Shaltis (2018/0266973 – see Figure 1) teach similar catheter insertion site monitoring systems.
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.
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, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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