DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Amendment, filed 19 May 2026, the status of the claims is as follows:
Claims 21, 22, 24, 26, 30, 32, 35, and 37 are currently amended; and
Claims 1-20, 23, 25, 27-29, 31, 33, 34, 36, 38, and 39 are cancelled.
Election/Restrictions
3. Applicant’s election without traverse of Group I, claims 21-39, in the reply filed on 19 May 2026 is acknowledged.
Claims 1-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
4. 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.
5. 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.
6. 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:
“an imaging element” in claim 1, which is directed to the structure of “… for example, an optical fiber probe or a miniaturized camera.” (see the Specification, filed 28 March 2024, para. [0011]);
“a motorized steering means adapted to” in claim 1;
“an ablation means” in claim 1, which is directed to the structure of “… (e.g., a laser)” (see the Specification, filed 28 March 2024, para. [0017]); and
“said delivery means” in claim 30.
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
7. 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.
8. Claims 21, 22, 24, 26, 30, 32, 35, and 37 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 21, 22, 24, 26, 30, 32, 35, and 37, claim limitation “motorized steering means adapted to” in base claim 21 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The Specification, filed 28 March 2024, para. [0016], discloses the following:
The device can include a compression head; an imaging element coupled to the compression head; a motorized steering means adapted to move the imaging element and the compression head; a pressure network (e.g., a pressure line) adapted to apply positive or negative pressure to the compression head; and a controller adapted to regulate and control the pressure network.
In addition, para. [0017], discloses the following:
In one embodiment, the pressure line and imaging element are integrated with the motorized steering means as part of a steerable compartment of the device.
However, the disclosure does not provide the structural element(s) that performs the function of “deliver fluorescent molecules”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 22, 24, 26, 30, 32, 35, and 37 are rejected due to their dependencies to base claim 21 for the reason stated above.
As to Claim 30, claim limitation “delivery means” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The Specification, filed 28 March 2024, para. [0017], discloses the following:
… In another embodiment, the device also includes a delivery means for delivering therapeutic compounds to a tissue of interest. The delivery means can be further adapted to deliver fluorescent molecules.
However, the disclosure does not provide the structural element(s) that performs the function of “deliver fluorescent molecules”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
9. 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.
10. 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)(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.
11. Claims 21, 22, 24, 26, 30, 32, 35, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al., “Non-destructive vacuum-assisted measurement of lung elastic modulus”, Acta Biomaterialia, Elsevier, Amsterdam, NL, vol. 131, 27 June 2021, pages 370-380, document cited in Information Disclosure Statement, filed 28 March 2024 (“Chen”).
As to Claim 21, Chen teaches the following:
A device (“measurement system”, not labeled) (see fig. 1D) for evaluating stiffness of materials (see “… a non-destructive vacuum-based approach to quantify tissue stiffness.” in “Statement of significance” section on p. 370), comprising:
a compression head (“glass capillary”, not labeled) (see “The vacuum-based stiffness measurement system was constructed by integrating: glass capillary, …” in section “2.5. Vacuum-assisted stiffness measurement system” on p. 372; and see fig. 1D);
an imaging element (“near infrared (NIR) imaging system … consisted of a scientific CMOS camera”, not labeled) coupled to said compression head (“glass capillary”) (see “To visualize distribution of the trypsin/ICG solution, we constructed a near infrared (NIR) imaging system that enabled non-invasive detection of ICG fluorescence signal by imaging through the lung pleura [35-38]. The NIR imaging system consisted of a scientific CMOS camera (Manta G-145 NIR, Allied Vision), camera lens (50 mm C-Series VIS-NIR lens, Edmund Optics), 785-nm laser (MDL-III-785, OptoEngine), and NIR filter set (ICG-B-000, Semrock).” in section “2.8. Near-infrared imaging of whole lungs” on p. 373; and fig. 1D);
a motorized steering means (“micro-manipulator”, not labeled) adapted to move said imaging element (“near infrared (NIR) imaging system”) and said compression head (“glass capillary”) (see “The vacuum-based stiffness measurement system was constructed by integrating: glass capillary, pressure sensor, programmable syringe pump, light sources, custom-built microscopic imaging system, micro-manipulator, …” in section “2.5. Vacuum-assisted stiffness measurement system” on p. 372; and see fig. 1D);
a pressure network (“programmable syringe pump”, not labeled) adapted to apply positive or negative pressure to said compression head (“glass capillary”) (see “The vacuum-based stiffness measurement system was constructed by integrating: glass capillary, pressure sensor, programmable syringe pump, …” in section “2.5. Vacuum-assisted stiffness measurement system” on p. 372; and see fig. 1D); and
a controller (“computer”, not labeled) adapted to regulate and control said pressure network (“programmable syringe pump”) (see “The vacuum-based stiffness measurement system was constructed by integrating: glass capillary, pressure sensor, programmable syringe pump, light sources, custom-built microscopic imaging system, micro-manipulator, and computer.” in section “2.5. Vacuum-assisted stiffness measurement system” on p. 372; and see fig. 1D); and
an ablation means including a laser (“laser”) (see “The laser was transmitted from the laser generator through an optical fiber bundle (MHP910L02, Thorlabs) and focused on samples via an achromatic lens (AC254-100-AB-ML, Thorlabs).” in section “2.7. Fluorescence microscopy” on pp. 372-373; and see fig. 1D) (ablation means is a matter of intended use of the laser, in which the “laser” of Chen is capable of performing depending on how the laser power is adjusted. See “Laser power was adjusted to obtain optimal fluorescence signals, …” in section “2.7. Fluorescence microscopy” on p. 373).
As to Claim 22, Chen teaches the following:
wherein said pressure network (“programmable syringe pump”) comprises a pressure line (see various pressure line tubings in fig. 1D), said pressure line and said imaging element (“near infrared (NIR) imaging system”) being integrated with said motorized steering means (“micro-manipulator”) as part of a steerable compartment of said device (“measurement system”) (see “The vacuum-based stiffness measurement system was constructed by integrating: glass capillary, pressure sensor, programmable syringe pump, light sources, custom-built microscopic imaging system, micro-manipulator, and computer.” in section “2.5. Vacuum-assisted stiffness measurement system” on p. 372; and see fig. 1D).
As to Claim 24, Chen teaches the following:
wherein said imaging element (“near infrared (NIR) imaging system”) comprises an optical fiber probe or a miniaturized camera (“scientific CMOS camera (Manta G-145 NIR, Allied Vision)”, not labeled) (see “To visualize distribution of the trypsin/ICG solution, we constructed a near infrared (NIR) imaging system that enabled non-invasive detection of ICG fluorescence signal by imaging through the lung pleura [35-38]. The NIR imaging system consisted of a scientific CMOS camera (Manta G-145 NIR, Allied Vision), camera lens (50 mm C-Series VIS-NIR lens, Edmund Optics), 785-nm laser (MDL-III-785, OptoEngine), and NIR filter set (ICG-B-000, Semrock).” in section “2.8. Near-infrared imaging of whole lungs” on p. 373; and fig. 1D).
As to Claim 26, Chen teaches the following:
wherein said controller is adapted to regulate pressure applied to said compression head, analyze collected tissue deformation data and calculate tissue stiffness, or said controller utilizes computer vision (see “The vacuum-based stiffness measurement system was constructed by integrating: glass capillary, pressure sensor, programmable syringe pump, light sources, custom-built microscopic imaging system, micro-manipulator, and computer.” in section “2.5. Vacuum-assisted stiffness measurement system” on p. 372; and see fig. 1D).
As to Claim 30, Chen teaches the following:
wherein said delivery means (“emission filter”, not labeled) is further adapted to deliver fluorescent molecules (see “Laser power was adjusted to obtain optimal fluorescence signals, which were passed through an emission filter (ET535/50 m. Chroma) and focused onto the image sensor of the camera via a tube lens (AC254-75-AB-ML, Thorlabs).” in section “2.7. Fluorescence microscopy” on p. 373).
As to Claim 32, Chen teaches the following:
a balloon probe, adapted to be introduced via a syringe needle, wherein said balloon probe can be expanded to monitor pressure and volume at a tissue of interest.
As to Claim 35, Chen teaches the following:
wherein said compression head (“glass capillary”) is a dome-shaped tip, said compression head (“glass capillary”) further including contact electrodes and a force sensor (“pressure sensor”, not labeled) adapted to monitor compression force (“glass capillary”, not labeled) (see “The vacuum-based stiffness measurement system was constructed by integrating: glass capillary, …” in section “2.5. Vacuum-assisted stiffness measurement system” on p. 372; and see fig. 1D).
As to Claim 37, Chen teaches the following:
wherein said controller is adapted to determine elongation length of the tissue of interest (“elongation length (LE)”), deformation length or electrical resistance (see “elongation length (LE)were measured and plotted for …” in section “2.10. Statistical tests” on p. 373).
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 07/04/2026
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