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 .
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:
“operation part” in claims 1 and 10
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 1, 3, 11-14, 16 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.
The claims recite the limitations “the body” and “the main body”. It is unclear what is being referred to as the body fluid and the body into which the chamber is inserted makes it unclear which body is being referred to. In the dependent claims, “main” body is added to what seems to be describing the cartridge component. “main body” and “body” are used interchangeably making it unclear if these are the same part or not. Where the examiner is interpreting for examination that "the body" and "the main body" are both be referring to "the body".
Claims 2-16 are rejected for being dependent upon base claim 1.
Claim limitation “operation part” in claims 1 and 10 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. 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 § 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 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) 1-2, 4-12 are rejected under 35 U.S.C. 103 as being unpatentable over US20190277830A1 (Kim) in light of WO2018132515A1 (Beyerlein).
As to claim 1, Kim teaches body fluid observation device (10, Fig. 1) [0007] comprising:
a chamber (20) having a length in a first horizontal direction and having a user's body fluid received therein [0034] (Fig. 4); and
a body into which the chamber is inserted to monitor the body fluid [0042] (Fig. 4), wherein the body comprises:
a case provided with a chamber insertion hole (14, Fig. 4), into which the chamber is inserted in a front surface of the body (Fig. 4), and
an observation hole (11b shows opening, Fig. 4) provided through a bottom surface of the body to allow observation of the body fluid (11b, Fig. 4);
a light source (52) part positioned above the chamber in the case and emitting light (Fig. 4, [0042]; and
an operation part (50 illumination part, Fig. 4) electrically connected to the light source part (52) to operate the light source part [0016-17], wherein, as the chamber (20) is inserted into the chamber insertion hole (14), the operation part forms an electric closed loop for operating the light source part [0016-17][0054-56].
Kim is silent to: a guide partition extending from the chamber insertion hole in the first horizontal direction to guide the chamber.
However, Beyerlein teaches a guide partition (cartridge guides 130, Fig. 3A) for guiding and holding the cartridge inside the chamber [0249].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kim to include the partition guides of Beyerlein in order to stabilize and secure the sample portion.
As to claim 2, the combination teaches body fluid observation device of claim 1.
The combination is silent to: wherein the chamber comprises a body fluid receiving groove in which a portion for seating the body fluid is received in an upper surface, and wherein in the chamber, at least the body fluid receiving groove is transparent or translucent.
However, the examiner takes official notice that wells, depressions, and grooves are well known in the field and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include a groove in the sheet portion (21 of Kim) where the sample is applied in order to better contain liquid samples and avoid spills resulting in loss of sample.
Kim teaches the sheet as transparent [0046], therefore it would have further been obvious to have the groove be transparent in order to be able to view and image the fluid.
As to claim 4, the combination teaches the body fluid observation device of claim 1.
As to claim 5, the combination teaches the body fluid observation device of claim 3.
As to claim 4, the combination is silent to: wherein the guide partition extends from an end of the first horizontal direction in a second horizontal direction crossing the first horizontal direction, and wherein a shape of the guide partition extending in the second horizontal direction corresponds to a planar shape at an end of the chamber in the first horizontal direction.
As to claim 5, the combination is silent to: wherein in the chamber, the planar shape at the end of the first horizontal direction is asymmetric in both sides thereof with respect to a center line parallel to the first horizontal direction, and wherein a shape of the guide partition extending from the guide partition in the second horizontal direction is asymmetric in both sides thereof with respect to a center line parallel to the first horizontal direction.
As explained previous, Beyerlein teaches a guide partition (130, Fig. 3A) for guiding and holding the cartridge inside the chamber [0249].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the guide partition of Beyerlein in order to secure the sample portion and avoid misalignment, it would have further been obvious to modify the shape and placement of the guide partition in order to align with the shape of the cartridge, as the particular shape and placement of the guide partition appears to be a matter of design choice and would not modify the operation of the device (In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (See MPEP 2144.04).
As to claim 6, the combination teaches the body fluid observation device of claim 1, wherein the operation part (50) comprises an operation switch ([0053] of Kim) to be turned on by being pressed by the chamber while the chamber is inserted into the chamber insertion hole [0053], and to form the electric closed loop [0056].
As to claim 7, the combination teaches the body fluid observation device of claim 6.
Kim is silent to: wherein the operation switch is located on an extension line of the guide partition.
Kim teaches an operation switch driven by detecting the insertion of the sample part (20) ([0053] of Kim). The particular placement the switch appears to be a matter of design choice, shifting the position of the switch would not modify the operation of the device (See MPEP 2144.04 VI. C. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), In re Kuhle , 526 F.2d 553, 188 USPQ 7 (CCPA 1975)). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the switch to be on an extension line of the guide partition to ensure the sample part would come in contact with it upon insertion.
As to claim 8, the combination teaches the body fluid observation device of claim 6, wherein the operation part comprises: a first substrate provided with a circuit pattern (circuit board 51, Fig. 4 of Kim) electrically connected to the light source part [0053]; and a second substrate located under the first substrate (insertion module 55), electrically connected to the first substrate (Fig. 4-5)[0053],
The combination is silent to: and provided with the operation switch disposed thereunder, wherein the operation switch is fixed to overlap on an extension line of the guide partition under the second substrate.
However, Kim teaches an operation switch driven by detecting the insertion of the sample part (20) [0053]. The particular placement the switch appears to be a matter of design choice, shifting the position of the switch would not modify the operation of the device (See MPEP 2144.04 VI. C. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), In re Kuhle , 526 F.2hed 553, 188 USPQ 7 (CCPA 1975)). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the switch to be fixed to overlap on an extension line of the guide partition under the second substrate since if it were aligned with the guide partition it would ensure contact was made upon insertion of the sample part.
As to claim 9, the combination teaches the body fluid observation device of claim 8, wherein the light source part is located in a central portion of the first substrate (52 light source on circuit board 51 Fig. 4 of Kim), and a light transmission hole ([0044] teaches a display window) through which light emitted from the light source part passes is provided in a central portion of the second substrate (display window in upper casing 11 [0044], Fig. 4).
As to claim 10, the combination teaches the body fluid observation device of claim 1, wherein the chamber comprises a chamber electrode (22, Fig. 4) having an electrode pattern of a conductive material ([0045] of Kim), and the operation part comprises a guide electrode ([0045] teaches electrode of insertion module 55) located at a portion of the guide partition corresponding to the chamber electrode so as to form the electric closed loop so that the guide electrode is connected to the chamber electrode upon insertion of the chamber [0056].
As to claim 11, the combination teaches the body fluid observation device of claim 1, wherein the main body further comprises a lens ([0042] teaches test unit 10 with lens group 35, Fig. 4 of Kim) fixedly coupled ([0042] teaches coupling means 1 and user terminal 100, Fig. 3) to the observation hole of the case ([0041] teaches clip hole 5) to enlarge an image of the body fluid ([0042] teaches magnifying means).
As to claim 12, the combination teaches the body fluid observation device of claim 1, further comprising: a main body holder (1, Fig. 3) ([0034] of Kim teaches clip as coupling means) fitted to an outer surface of the body so as to fix the body to a device having a camera ([0034] teaches to couple to the user terminal 100 which takes an image using a camera).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over and US20190277830A1 (Kim) and WO2018132515A1 (Beyerlein) in light of WO2017151642 A1 (Alderete).
As to claim 3, the combination teaches the body fluid observation device of claim 2.
The combination is silent to: wherein the chamber has a guide protrusion formed in a lower surface thereof and protruding downward, and wherein the main body is positioned below the chamber insertion hole and includes a guide groove into which the guide protrusion is inserted in the first horizontal direction as the chamber is inserted into the chamber insertion hole.
However, Aldrete teaches a guide protrusion (locating tabs 422, Fig. 4.2, [0087] teaches which may be configured to align with complimentary components on the cartridge, Fig. 4.1 shows the locating tabs as protruding).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the guides of Alderete in order to properly seat or load the chamber [0087].
Claim(s) 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over WO2018097565A1 (Kim) in light of WO2018132515A1 (Beyerlein) and US20170119357A1 (Hung).
As to claim 13, the combination teaches the body fluid observation device of claim 12.
The combination is silent to: wherein the case of the main body comprises a case coupling groove recessed along an outer circumferential surface of the case of the main body so that the main body holder is coupled thereto, and wherein the main body holder comprises: a coupling wing portion formed in an arc shape to surround the outer circumferential surface of the case of the main body and to be inserted into the case coupling groove; and a body portion extending from a central portion of the coupling wing portion to be coupled to a user terminal.
However, Hung teaches an ovulation tester with a coupling mechanism [0004-0007] (Fig. 5-6). Hung teaches a first groove (24) around the outer wall [0025]. [0028] teaches clamping assembly with peripheral rib (341, Fig. 5-6) corresponding to groove (24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the structure of the combination to include a coupling groove to fit with the clamping mechanism for secure mounting of the device to a cell phone or other user terminal.
As to claim 14, the combination teaches the body fluid observation device of claim 13.
The combination is silent to: wherein the main body comprises a first locking protrusion protruding from a bottom surface of the case coupling groove at both portions adjacent to the chamber insertion hole in the case coupling groove, and a second locking protrusion provided at a portion on an opposite side to the chamber insertion hole in the case coupling groove.
Hung [0028] teaches a variety of locking mechanisms including a fixing protrusion (342, Fig. 5-6) and a hook (26) with a corresponding locking hole (35).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the locking hole and hook of Hung in order to stabilize and secure the device. The particular shape and placement of the grooves and protrusions appear to be a matter of design choice and would not modify the operation of the device (In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (See MPEP 2144.04). Therefore, it would have further been obvious to add a second locking protrusion and have the first and second be on the sides of the chamber to maximize stability and security of the device.
As to claim 15, the combination teaches the body fluid observation device of claim 14.
The combination is silent to: wherein the coupling wing portion comprises a first locking groove provided at both ends of the arc, the first locking groove into which the first locking protrusion is inserted, and a second locking groove provided at a central portion of the arc, the second locking groove into which the second locking protrusion is inserted.
Hung [0028] teaches a variety of locking mechanisms including a fixing protrusion (342, Fig. 5-6) and a hook (26) with a corresponding locking hole (35).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination to include the locking hole and hook of Hung in order to stabilize and secure the device. Further, the particular shape and placement of the grooves and protrusions appear to be a matter of design choice and would not modify the operation of the device (In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (See MPEP 2144.04). Therefore, it would have further been obvious to add a second locking protrusion and try different positions of it in order to maximize stability and security of the device.
As to claim 16, the combination teaches the body fluid observation device of claim 13, wherein the body holder (coupling means 1) comprises a deformation prevention hole (Fig. 6 of Kim shows clip hole 5) at a portion connected to the body portion in the coupling wing portion.
The particular placement the hole appears to be a matter of design choice, shifting the position of the hole would not modify the operation of the device (See MPEP 2144.04 VI. C. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), In re Kuhle , 526 F.2d 553, 188 USPQ 7 (CCPA 1975)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Maya Hendija whose telephone number is (571)272-0269. The examiner can normally be reached M-F 08:00-16:00 (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara Geisel can be reached at (571) 272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAYA HENDIJA/ Examiner, Art Unit 2877 /Michael P LaPage/Primary Examiner, Art Unit 2877