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 without traverse of Group 1, drawn to a disposable body fluid sampling device, in the reply filed on 7/3/35 is acknowledged.
Claims 13-18, 36-37, 40, 41, and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/3/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 Objections
Claim 1 is objected to because of the following informalities: it appears Applicant may have not intended to positively recite “and” in line 5 instead of “ecoded”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the recitation of “the device further including an interface for and a vacuum tube, the vacuum tube providing suction necessary to fill the vacuum tube with the blood” appears and is interpreted to recite a vacuum tube interface and a vacuum tube. Although this intent is consistent with the disclosure, Applicant’s attention is directed to and requested to clarify the scope of the claim. Applicant may have intended to positively recite “the device further including a vacuum interface [
Claim 3 is objected to because of the following informalities: it appears Applicant may have intended to positively recite “encoded” in line 3 instead of “ecoded”. Appropriate correction is required.
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.
Claim 3 is 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.
Claim 3 positively recites inter alia “an app running an app running on a computer, the combination adapted for collecting a sample, wherein the computer is encoded with instructions to execute a verification method” further including steps of “recognizing… saving… analyzing video in real-time… and storing the video in tamper-proof manner…”. The claimed subject matter does not appear disclosed in the specification with any sufficient specificity to convey to one of skill in the art that possession was demonstrated. The instant Specification appears devoid of any mention of, for example at least, details regarding computer executable “instructions” and/or programming for a “verification method”, let alone instructions for steps of verification, recognizing, saving, or analyzing. Although some of the functionality may be cursorily mentioned (using applications on a smartphone and storing data for example), the instant Specification does not disclose with any corresponding sufficient detail, the actual required coding, or programming of computer executable instructions the accomplish the claimed computerized functionality. Conversely, the “an app running an app running on a computer, the combination adapted for collecting a sample, wherein the computer is encoded with instructions to execute a verification method” further including steps of “recognizing… saving… analyzing… and storing…” appears to be a black-box .
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 1-3, 5-10 and 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.
Regarding claim 1, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 1, the phrase "optionally auto-sampling" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 1, the phrase "optionally dispending" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “standard” in claim 2 is a relative term which renders the claim indefinite. The term “standard” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A standard medical analysis tube may be embodied in my relative forms, functions, and structures with relative standards that change over time, rendering the scope of the claim indeterminate
Claim 3 recites the limitation "“a sample” in line 2. The scope of the claim is indeterminate with respect to how the sample of claim 3 relates to the claimed “a sample” in claim 1 and/or if it may instead be a digital sample operable within the computer.
Claim 3 recites the limitation "the user/patient" in line 5. There is insufficient antecedent basis for this limitation in the claim. Conversely claim 1 introduced a “user”
Regarding claim 3, the phrase "such as" in at least lines 5 and 7renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3 recites the limitation "the user-patient" in line 5. There is insufficient antecedent basis for this limitation in the claim.
The term “correct” in claim 3 is a relative term which renders the claim indefinite. The term “correct” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Beyond the claims as filed, the instant Specification appears devoid of any recitation of the term “correct”, let alone a “correct execution of the medical process”.
Claim 3 recites the limitation "the physical devices" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "A disposable body fluid sampling device of claim 1" in line 1, rendering the claim indefinite. The scope of the claim is indeterminate as it is unclear and ambiguous whether claim 5 is independent in nature, depends from claim 1, and/or merely refers to claim 1 for completeness. For examination on the merits and consistent with the instant Specification, claim 5 is being treated as depending from claim 1.
The term “sufficient” in claims 6 and 9 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may necessarily be required or excluded and/or what degree of sufficiency is required.
Claim 7 recites the limitation "The device of the above claim" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear what claim(s) and/or features claim 7 is intended to modify. For examination on the merits and consistent with the instant Specification, claim 7 is being treated as depending from claim 6.
Regarding claims 7 and 10, the phrases "preferably within" and “more preferably within” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 9 recites the limitation "The disposable body fluid device of the above claim " in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear what claim(s) and/or features claim 9 is intended to modify. For examination on the merits and consistent with the instant Specification, claim 9 is being treated as depending from claim 8.
Claim 12 recites the limitation "the energy" and “the guiding” in line 3. There is insufficient antecedent basis for this limitation in the claim.
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)(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, 5-10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson (US 2019/0168210 A1).
For claim 1, Anderson discloses a disposable body fluid sampling device providing a non-medically trained user (Figs 7, 12) ([0287-0307]) with the functionalities of (a) sampling a body fluid (into 24), preferably blood, optionally auto-sampling (Figs 7, 12) ([0287-0307]); (b) optionally dispensing one or more droplet(s) of the sampled fluid for immediate analyses (Figs 7, 12) ([0287-0307]); and (c) providing a sample containment chamber filled with a sample of the body fluid for analysis in a medical lab (Figs 7, 12) ([0287-0307]), the device further including an interface for (28) and a vacuum tube (24), the vacuum tube providing suction necessary to fill the vacuum tube with the blood (Figs 7, 12) ([0287-0307]).
For claim 2, Anderson discloses the disposable body fluid sampling device of claim 1, wherein the vacuum tube is a standard medical analysis tube (24) (Figs 7, 12) ([0287-0307]).
For claim 3, Anderson discloses the disposable body fluid sampling device of claim 1 combined with an app running on a computer (iPhone 31) (Figs 7, 12) ([0287-0307]), the combination adapted for collecting a sample (Figs 7, 12) ([0287-0307]), wherein the computer is encoded with instructions to execute a verification method comprising the steps of:
a) recognizing - unique biometric characteristics of the user/patient such as face, scalp, eyes, fingerprints (inherent iPhone 31 characteristics),- physical devices adapted for the execution of the medical process such as cutting device, sampling device, vaccination device, sample container, vaccine container (Figs 7, 12) ([0287-0307])
b) saving a video of the user-patient and the device throughput the entire process together using a camera of the computer (Figs 7, 12) ([0287-0307]);
c) analyzing the video in real time and providing instructions to the user-patient for the correct execution of the medical process (Figs 7, 12) ([0287-0307]); and
d) storing the video in tamper-proof manner in the portable device or in a remotely accessible database through the portable device (Figs 7, 12) ([0287-0307]),
wherein at least one of the physical devices adapted for the execution of the medical process includes at least one visible feature that visibly signals the progress of the medical process (Figs 7, 12) ([0287-0307]).
For claim 5, Anderson discloses the disposable body fluid sampling device of claim 1, having a sample containment chamber (24) made of a material having a thermal inertia permitting the maintenance of sample temperature over a known period of time (Figs 7, 12) ([0287-0307]).
For claim 6, Anderson discloses the disposable body fluid sampling device of claim 5, wherein the thermal inertia is selected to provide a known period of time of storage in an ambient environment sufficient to allow non-refrigerated transport to a collection point (Figs 7, 12) ([0287-0307]).
For claim 7, Anderson discloses the disposable body fluid sampling device of claim 6, wherein the known period of time (Figs 7, 12) ([0287-0307]) is inherently within a range of 1 hour to 2 hours under normal ambient conditions, and preferably within a range of 1 hour to 6 hours, and more preferably within a range of 1 hour to 8 hours.
For claim 8, Anderson discloses the disposable body fluid sampling device of claim 5, including a thermally insulating sleeve (30) configured to be manually or automatically triggered to slide over the sample container chamber (Figs 7, 12) ([0287-0307]).
For claim 9, Anderson discloses the disposable body fluid sampling device of claim 8, wherein the thermal inertia is selected to provide a known period of time sufficient to allow non-refrigerated transport to a collection point (Figs 7, 12) ([0287-0307]).
For claim 10, Anderson discloses the disposable body fluid sampling device of claim 9, wherein the known period of time (Figs 7, 12) ([0287-0307]) is inherently within a range of 1 hour to 2 hours under normal ambient conditions, and preferably within a range of 1 hour to 6 hours, and more preferably within a range of 1 hour to 8 hours.
For claim 12, Anderson discloses a cutting blade (lancet [0287]) made for making a laceration in the skin of a user/patient for the disposable body fluid sampling device of claim 1, wherein the cutting blade construction is made in one piece of material and provides the energy and the guiding for its movement (Figs 7, 12) ([0287-0307]).
Conclusion
The cited prior art made of record on the accompanying PTO-89s and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring a body fluid sampling device to gather and analyze a specimen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791