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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/06/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “a measurement system for measuring” in line 3 should be amended to read –a measuring system configured for measuring--. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: the phrase “a sample collection device” in line 3 should be amended to read –the sample collection device--. 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:
Limitation “measurement system for measuring” in claim 1. The claim does not recite enough structure that corresponds to the claimed “measurement system”. However, the specification discloses (measurement system may comprise one or more sensors, preferably one or more optical sensors, par.24) which may be interpreted as the structure that correspond to the claimed “measurement system”.
Limitation “means for providing” in claim 1. The claim does not recite enough structure that corresponds to the claimed “means for providing” However, the specification discloses (means for providing a warning signal may comprise an acoustic indicator and/or a visual indicator, par.29 which may be interpreted as the structure that correspond to the claimed “means for providing”.
Limitation “means for direct blood analysis” in claim 10. The claim does not recite enough structure that corresponds to the claimed “means for direct blood analysis” The specification does not disclose any structure that correspond to the claimed “means for direct blood analysis”.
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 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 3, 7-9, 10, 12-14 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 3 recites the limitation "the arrangement" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the surface" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the protruding body" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the casing" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 7, 13 and 14 recite the limitation “and/or”, which render the claims indefinite. One with ordinary skill in the art would not be able to know the scope of the claims, because it is unclear what constitutes the metes and bounds of the invention. Given the multitude of combinations possible, the claims are indefinite because the metes and bounds of the invention cannot be properly ascertained. The Examiner respectfully notes for the purpose of examination the claimed “and/or” will be interpreted as “or”.
Claim 10 recite the limitation “means for direct blood analysis” this limitation is not defined by the claims, which renders the claims indefinite. The specification does not disclose any structural elements that corresponds to the claimed “means for direct blood analysis”. One with ordinary skill in the art would not be able to know what structural elements the claimed “means for direct blood analysis” must or must not include. As broadly as claimed the scope of the claim is indeterminate with respect to the claimed “means for direct blood analysis”. The Examiner respectfully notes for purpose of examination the claimed “means for direct blood analysis” will be interpreted as a processor/controller and/or sensors.
Claim 14 recite the limitation “for example a pin” this limitation is not defined by the claims, which renders the claims indefinite, because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The Examiner respectfully notes for purpose of examination the claimed “for example a pin” in not part of the invention and just an example.
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.
Claim(s) 1-8 and 10-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casavant et al (US 2020/0146606).
As to claim 1, Casavant teaches an electronic module (102 and actuator 104 having electronics 136 in subsystem/casing 135, par.37, par.41 and par.44, fig.1-2, and/or 750 in fig.7, par.61-62) for a sample collection device (housing 106 of device 1, par.34-37, fig.1-2 and 7), comprising:
a measurement system (sensors 144, par.41 and par.47, fig.2) for measuring a volume of collected fluid of a patient in real time and determining when a predefined amount of fluid has been collected (sensors 144 can measure amount of bodily fluid collected, par.48, once the desired amount of bodily fluid is in the reservoir 106, the device 100 can be removed from the skin 103, par.36, indicator 146 may display (a) a green output for a successful withdrawal of bodily fluid, par.52), and
means for providing a warning signal to a user (indicators 146, par.41, par.52, fig.2) when it is determined that the predefined amount of fluid has been collected (indicator 146 may display (a) a green output for a successful withdrawal of bodily fluid, par.52, fig.2)(Examiner respectfully notes that since sensors 144 measures desired amount of fluid in reservoir so it can be interpreted that indicator 146 notifies the user when the desired amount enters the reservoir and it’s time to remove the device from the skin).
As to claim 2, Casavant teaches the electronic module, wherein the electronic module is reusable (102/104 and/or 750 are more than capable of being reusable, par.37 and par.61) and is configured to be attached to, respectively detached from, the sample collection device (102 and 104 are removably attached and detached from 106 par.44, as best seen in fig.1-2 and/or 750 is removably attached and detached from 106, fig.7)(Examiner respectfully notes that 135 and 104/750 does not comprise any piercing needles and can be reused from one device to another, or from one patient to another, and also 1034 and 104 are not glued to housing 102, so they can be removed and reattached to housing 102).
As to claim 3, Casavant teaches the electronic module, wherein the electronic module further comprises:
a casing (electronic casing 135 and/or side walls of 102/104, as best seen in fig.1-2, par.44, and/or outer surface of 750), and
a protruding body (top portion of actuator 104 protruding above casing 135, or 108 protruding from 102, and/or lower protrusion of cap 750, par.36-41 and par.61, fig.1-2 and 7) formed on a surface of the casing, wherein the protruding body comprises:
an activation button (top surface of 104 and/or switch 137, par.44 and par.46, fig.2), for operating a switch that activates the electronic module, and
a window for the arrangement of the measurement system, the measurement system comprising one or more sensors (portion on top surface of 104 having sensors 144 located at, par.48, fig.2).
As to claim 4, Casavant teaches the electronic module, wherein the protruding body is eccentrically located on the surface on which it is formed (104 is eccentric to electronic casing 135 and to housing 102, as best seen in fig.1-2, and/or 108 is eccentrically located at housing 102).
As to claim 5, Casavant teaches the electronic module, wherein the casing and the protruding body are formed in one piece (104, 102, 108 and 135 are formed integrally as best seen in fig.2, par.44 and/or lower protrusion of 750 is one piece with cap 750, fig.7) through injection moulding. (Examiner respectfully notes that since the claims are directed towards a system/product, so the method of making (injection moulding) is not germane to the issue of patentability of the device itself. Therefore, these method-type limitations have not been given patentable weight. Conversely the resultant and/or implied structure necessarily required by the method steps themselves has been given patentable weight.
As to claim 6, Casavant teaches the electronic module, wherein the electronic module further comprises one or more of:
a battery (one or more batteries 142, par.41, fig.2);
a microcontroller (processor 141, par.41, fig.2);
an embedded firmware (medium 140 having a programmed with software and/or firmware, par.42), and
a communication unit (communication components 147 (e.g., transmitters, receivers, and associated communication circuitry), par.41, fig.2), including a wireless communication unit, for communicating with one or more external devices (end of par.41).
As to claim 7, Casavant teaches the electronic module, wherein the means for providing a warning signal comprises an acoustic indicator and/or a visual indicator, the visual indicator comprising a light emitting unit, including a LED light emitting unit (indicator(s) 146 (e.g., light indicators, audible indicators) par.41, par.49, indicator 146 can include a visible indicator (e.g., a light emitting diode), par.52, fig.2)
As to claim 8, Casavant teaches the electronic module, wherein the electronic module further comprises a cover (casing 135 and/or actuator 104, par.44, fig.2 and/or upper surface of cap 750, fig.7), wherein the visual indicator is provided on the cover (indicator 146 is provided within casing 13 and is shown from top surface of actuator 104, par.49, fig.2d).
As to claim 10, Casavant teaches the electronic module, wherein the electronic module further comprises means for direct blood analysis (sensors 144, computer medium 140 and processor 141 measures characteristics of the withdrawn bodily fluid, par.48, par.57, par.58 and par.76, fig.2 and 5).
As to claim 11, Casavant teaches a system for extracting and collecting a sample of a fluid of a patient (system 100 and/or 700, fig.1-2 and 7), comprising: a sample collection device (reservoir 106, par.61, fig.7), and the electronic module (102/104 and/or cap 750 having electronics 136, par.62, fig.1-2 and 7) according
As to claim 12, Casavant teaches the system, wherein the sample collection device comprises an outer shell (outer shell/surface of device 106, fig.7) comprising a pocket configured for housing the protruding body of the casing of the electronic module (upper opening of 106 that houses 108 or lower protrusion of 750, par.61, fig.1-2 and 7).
As to claim 13, Casavant teaches the system, wherein the protruding body and the pocket are configured to have complementary asymmetrical shapes (actuator/switch 104 and upper opening of housing 102 have complementary asymmetrical shapes, or, 108 has asymmetrical shape with opening of 106, and/or lower protrusion of 750 has asymmetrical shape with opening 736, as best seen in fig.2, fig.7) and/or the outer shell of the sample collection device is made of a transparent material.
As to claim 14, Casavant teaches the system, wherein the pocket has rounded edges for providing guidance to the user during insertion of the protruding body into the pocket (round edges of the upper opening of sample collection container 106 that guides protrusion 108 and/or guides lower protrusion of cap 750, as best seen in fig.1-2 and 7) and/or the pocket comprises an activation element, for example a pin.
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, 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) 9 is/are rejected under 35 U.S.C. 103 as being obvious over Casavant et al (US 2020/0146606).
As to claim 9, Casavant teaches, the cover is circular in cross-section (as best seen upper cover surface of 104 is circular, fig.1 and 2d), and the visual indicator is formed in the shape of a ring (indicator 146 is in a shape of a circular ring, as best seen in fig.2d).
Casavant teaches the invention substantially as claimed above, but failed to explicitly teach the visual indicator is formed in the shape of a ring extending around the circumference of a main body portion of the cover.
However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made to design indicator 146 as ring extending around the circumference of a main body portion of the cover because the Applicant has not disclosed that this ring shape provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected visual indicator taught by Casavant’s invention and the Applicant’s invention, to perform equally well with either the indicator taught by Casavant’s invention or the claimed ring shape indicator because both visual indicators would perform the same function of indicating the amount of fluid collected in the device/reservoir.
Therefore, it would have been prima facie obvious to modify visual indicator 146 to obtain the invention as specified in Claim 9 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Casavant. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being obvious over Casavant et al (US 2020/0146606), in view of Swenson et al (US 2008/0319345).
As to claim 15, Casavant teaches protruding body 108 is attached into opening/pocket c 106 and/or lower protrusion of cap 750 is attached to 106 (par.35-37, fig.1-2 and 7), but failed to explicitly teach wherein protruding portions are formed on opposite sides of the pocket, and wherein corresponding undercuts are formed on a respective external surface of opposite sides of the protruding body, to allow snap fitting of the electronic module into the pocket.
However, Swenson teaches a fluid collection device in the same field of endeavor, wherein a first body portion includes ribs/protrusions that snaps fit to a second body portion having corresponding grooves/cuts (par.51, fig.3-4 and 7).
Since snap fit coupling/attachment is well known in fluid collection art, so it would have been obvious to one having an ordinary skill in the art before the filing date of the invention to design the attachment means between 108/lower 750 and the opening of 106 taught by Casavant’s invention, with protrusions and corresponding cuts to allow snap fit attachments, as taught by Swenson’s invention, for the same purpose of securely attaching 108/lower 750 to 106.
Since the Applicant has not disclosed that the protrusions and corresponding undercuts provides an advantage, is used for a particular purpose, or solves a stated problem.
So, one of ordinary skill in the art, furthermore, would have expected the attachment means between 108/lower protrusion of 750 and 106 taught by Casavant’s invention and the Applicant’s invention, to perform equally well with either the attachment means taught by Casavant’s invention or the claimed protrusions and corresponding undercuts because both attachment means would perform the same function of attaching 108/lower protrusion of 750 and 106.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791