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
Claims 37-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/5/2025.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
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.
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.
Claims 25 and 33 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.
Claim 25 is indefinite because it is unclear how to interpret the limitation “wherein the strip is configured to support the reaction chamber.” This limitation is unclear because the parent claim reads “one reaction chamber housed within the strip;” this limitation suggests that the strip must already be configured to support the reaction chamber. It is unclear what further configuration the claim is trying to describe.
Claim 25 is further indefinite because it used the term “side-view.” This term provides for a relative positioning, wherein it is unclear where “top,” “bottom,” or “side” would exist. There is no reasonable manner for the skilled artisan to understand which dimension is considered the “side.” For all intents and purposes, if the strip is generally translucent or transparent, the claim will be considered fulfilled.
Claim 33 is indefinite because it is unclear how the strip is “curved about the image capture device.” Based upon the specification and claim limitations, the image capture device is a fixed distance away from the test strip, and the test strip lies upon a planar surface. Since there is a gap between the strip and the image capture device, and the strip lies on a planar surface, it is unclear how the strip is “curved about the image capture device.” The instant specification does not improve the clarity of the claimed limitation.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 24-32, 34 and 35 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Myers, et al (Solid-State Sensors, Actuators and Microsystems Workshop, Hilton Head Island, South Carolina, June 8-12, 2014). Myers provides for a device that is used to measure clot contraction, wherein the system is comprised of polyacrylamide strips. See page 320, “Abstract” section. Myers provides for a reaction “chamber” within the strip, wherein the strip is illuminated by a light source. See page 321, Figure 1. Myers indicates that the system used a “Zeiss LSM 700-405 confocal microscope.” See page 322, “Experiment” section. Although this is not explicitly described as having a light source and an aperture, these would be expected elements of a high-quality microscope, such as those produced by Zeiss. Furthermore, the platform of the microscope would necessarily provide for a fixed position from the test strip. Finally, Myers indicates that the strips include platelets, calcium (in the form CaCl2), fibrinogen, and thrombin. See page 322, “Experiment” section.
Myers does not explicitly teach that the microscope has an aperture and that there is an image capture device attached to the microscope. With respect to the former, if it can be shown that the stage of the Zeiss microscope does not have an attached aperture, the ordinary artisan would find it obvious to include one, since these are routinely used for eliminating background noise and stray light in methods that utilize light detection. With respect to the latter, Myers indicates that the platelets were analyzed by a MATLAB script. See page 322, “Platelet Analysis” section. This would suggest that Myers provided some form of image capture device, in order for the MATLAB script to analyze the image data. Based upon a reading of Myers, it appears as though Myers anticipates the claimed apparatus, even though some elements are not explicitly shown in the prior art. However, if it can be shown that these elements are not present in the Myers reference, they would be obvious to include, for the reasons provide above.
With respect to claim 24, Myers appears to teach a device that is consistent with the claimed device. If it can be shown that Myers’ device does not anticipate the claimed device, the claimed device appears to be an obvious variant of that of Myers.
With respect to claims 25 and 26, Myers provides an image of the test strip that appears transparent. See page 321, Figure 1. Based upon the claim limitation, and the interpretation provided in the 35 USC 112(b) rejection, Myers fulfills the limitation.
With respect to claim 27, Myers provides for platelets, calcium, fibrinogen, and thrombin. See page 322, “Experiment” section.
With respect to claim 28, Myers provides test compounds. See page 323, Figure 6. Additionally, since Myers device is used for high-throughput analysis, even if Myers did not state there was a test compound, the ordinary artisan would find it obvious to use a test compound on a platelet contraction testing platform.
With respect to claim 29, based upon Myers description of the apparatus, it appears as though the testing strips are enclosed in a light impermeable enclosure. See page 321, Figure 1. However, even if Myers does not explicitly or implicitly teach this limitation it would be obvious to the ordinary artisan. The ordinary artisan is highly familiar with optical detection methods, and would understand that light leakage would provide for lower signal strength. The ordinary artisan is motivated to provide for the highest signal strength possible.
With respect to claims 30 and 31, Myers provides a microscope as the image acquisition device, wherein the image appears to be digitized, and is then analyzed by MATLAB. See page 322, “Experiment” and “Platelet Analysis” sections. This setup would fulfill the claimed limitation. The limitation essentially describes the distance from the eyepiece to the stage (fixed distance), and wherein the claimed “arm” is consistent with the microscope stage. Furthermore, microscope stages have an adjustable height, thereby fulfilling the limitation of claim 31.
With respect to claim 32, Myers provides for polydimethylsiloxane (PDMS) microfluidic tops. See page 322, “Microfluidic Top” section. Although not explicitly stated, PDMS is translucent.
With respect to claim 34, Myers shows a linear test strip. See page 321, Figure 2.
With respect to claim 35, Myers shows a transparent reaction chamber, wherein the reaction chamber is formed with glass (transparent) coverslips. See page 321, Figure 1; “Fibrinogen Stamped Coverslip” section.
With respect to claim 36, Myers teaches that the data was analyzed by a MATLAB script that measured the fibrinogen dot areas. See page 322, “Platelet Analysis” section. This suggests that the test strips were imaged by some form of digital camera, and the image was processed in a computer. This would suggest that the apparatus of Myers was operably connected to a computer or data processing means. Even if it is shown that Myers’ device was manually controlled, and not “operably connected” to a computer, the instant limitation amounts to an automation step, which would be considered obvious. See MPEP 2144.04(III).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prakhya, et al (Research and Practice in Thrombosis and Haemostatis, 6, e12755, 2022), this reference is by the Applicants, and others, but has a publication date that is after the effective filing date of the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651