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 .
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 January 13, 2023 was considered by the examiner.
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 limitations are: a sensor unit and a control unit in claim 1; a power supply unit in claim 2; a magnetic drive unit in claim 8 and claim 20; and a light source unit in claim 9.
Prong 1: “unit” is a generic placeholder. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: the transition word “for” and “that” are used, followed by functional language:
“a sensor unit for measuring information on a result of decomposing the urea by helicobacter pylori in the decomposition section”;
“a control unit for transmitting the information measured by the sensor unit to the outside”;
“a power supply unit that… supplies power to the control unit”;
“a magnetic drive unit that… controlled by a magnetic field formed outside”;
“a light source unit that… illuminates the decomposition section”.
Prong 3: there is not sufficient structure to modify the generic placeholder “unit”.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The examiner interprets the camera (see specification ¶[0050]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the sensor unit.
There is no corresponding structure in the specification for the control unit, the power supply unit, the magnetic drive unit, or the light source unit.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “a body section into which a gastrointestinal fluid including the helicobacter pylori is selectively introduced” in lines 3-4, which improperly includes a human organism within the scope of the claim. As the device is an ingestible capsule, the gastrointestinal fluid is still within a human organism; therefore, the gastrointestinal fluid is being interpreted to encompass a human organism. Amending the claim to recite “a body section which is configured to selectively introduce a gastrointestinal fluid including the helicobacter pylori” would overcome the present rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claims 2-20 are rejected by virtue of their dependence from claim 1.
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 1-20 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 1 recites “a body section into which a gastrointestinal fluid including the helicobacter pylori is selectively introduced” in lines 3-4, which is indefinite. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. This claim recitation appears to be claiming that only gastrointestinal fluid containing helicobacter pylori is “selectively introduced” into the capsule. However, the diagnostic capsule of the present application does not have that functionality, rather, any gastrointestinal fluid is introduced into the capsule, and then the presence of helicobacter pylori is determined (see specification ¶[0005]-[0006], see also ¶[0061]-[0065] the selective site removal of cover sections). This inconsistency renders claim 1 indefinite. Appropriate correction is required.
Claim 1 recites “helicobacter pylori” in line 8, but it is not clear if this recitation is the same as, related to, or different from the recitation “helicobacter pylori” in line 1. The similar phraseology suggests that they are the same, but the lack of the definite article “the” suggests that they are different. The recitation in line 4 including “the” further supports that these recitations are the same. If the recitations are the same, the present recitation should be “the helicobacter pylori”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, these recitations are being interpreted as the same. In addition, the same inconsistency is present in the preambles of the dependent claims 2-20, which should also be clarified. This is also present in claim 6, line 5, which should also be clarified. Appropriate correction is required.
Claim 1 limitation “control unit” in line 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. There is no corresponding structure in the specification for the control unit. 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 1 recites the limitation "the outside" in line 11. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 2-20 are rejected by virtue of their dependence from claim 1.
Claim 2 limitation “power supply unit” in line 3 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. There is no corresponding structure in the specification for the power supply unit. 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 3 limitation “power supply unit” in line 3 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. There is no corresponding structure in the specification for the power supply unit. 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 8 limitation “magnetic drive unit” in line 3 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. There is no corresponding structure in the specification for the magnetic drive unit. 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 9 limitation “light source unit” in line 3 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. There is no corresponding structure in the specification for the light source unit. 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 10-11 are rejected by virtue of their dependence from claim 9.
Claim 10 recites “an inner space” in line 6, but it is not clear if this recitation is the same as, related to, or different from the recitation “an interior” in claim 9, line 3. The indefinite article “a” suggests that they are different, but the similar phraseology and context of the claim suggest that they are the same. If the recitations are the same, the present recitation should be “the interior”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same. Appropriate correction is required.
Claim 13 recites “the outside of the body section” in lines 3-4, but it is not clear if this recitation is the same as, related to, or different from the recitation “the outside” in claim 1, line 11. The definite article “the” and similar phraseology suggest that they are the same, but the context of the claim suggests that they are different. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as different. Appropriate correction is required.
Claim 15 recites “the decomposition section further includes a swelling gel material as the gastrointestinal fluid is absorbed” in lines 3-4. This limitation is unclear as to what happens “as the gastrointestinal fluid is absorbed”. Amending the recitation to further clarify that the swelling gel material absorbs the gastrointestinal fluid would overcome the present rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
The term “safely” in claim 15 is a relative term which renders the claim indefinite. The term “safely” 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. It is not what criteria indicate that the lid is placed on the decomposition section “safely”, and the specification does not indicate any such criteria or what makes it safe. Therefore, the scope of claim 15 is not clear. Deleting “safely” would overcome the present rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 16 is rejected by virtue of its dependence from claim 15.
The term “safely” in claim 16 is a relative term which renders the claim indefinite. The term “safely” 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. It is not what criteria indicate that the lid is placed on the decomposition section “safely”, and the specification does not indicate any such criteria or what makes it safe. Therefore, the scope of claim 16 is not clear. Deleting “safely” would overcome the present rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 18 recites “the body section has an upper portion in which a plurality of inlets respectively communicating with the plurality of first accommodation spaces are formed” in lines 3-5, which is grammatically awkward and unclear. It is not clear what “are formed” is modifying or what should be formed. Deleting “are formed” would overcome the present rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 18 recites “has partition walls that are formed in the body portion and respectively separate the plurality of first accommodation spaces” in lines 5-6, which is grammatically awkward and unclear. It is not clear what has the partition walls formed therein, the body portion or something else? Further, whether it is the partition walls that separate the plurality of first accommodation spaces. Appropriate correction is required.
Claims 19-20 are rejected by virtue of their dependence from claim 18.
Claim 19 recites “a gastrointestinal fluid” in line 5, but it is not clear if this recitation is the same as, related to, or different from the recitation “a gastrointestinal fluid” in claim 1, line 3. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the gastrointestinal fluid”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same. Appropriate correction is required.
The term “safely” in claim 19 is a relative term which renders the claim indefinite. The term “safely” 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. It is not what criteria indicate that the lid is placed on the decomposition section “safely”, and the specification does not indicate any such criteria or what makes it safe. Therefore, the scope of claim 19 is not clear. Deleting “safely” would overcome the present rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 20 limitation “magnetic drive unit” in line 7 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. There is no corresponding structure in the specification for the magnetic drive unit. 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 20 recites “a plurality of cover sections that are respectively installed at the plurality of inlets of the body section and removed as the cover sections come into contact with the gastrointestinal fluid” in lines 3-6. This recitation appears to connotate that the cover sections are removed once they come into contact with the gastrointestinal fluid. Claim 20 also recites “wherein the control unit removes any one of the plurality of cover sections in a state in which the capsule is moved to any one position in a body by the magnetic drive unit, and then removes another one of the plurality of cover sections in a state in which the capsule is moved to another position” in lines 10-15. This recitation appears to connotate that the cover sections are removed based on the control unit and the capsule’s position within the digestive tract. These two recitations are inconsistent with one another (i.e., two embodiment of cover section removal). The examiner is interpreting that either of these embodiments may be met in order for the entire claim limitations to be met (i.e., the cover sections may be removed by contact with the gastrointestinal fluid or via the controller based on capsule position). Appropriate correction is required.
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.
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.
The succeeding art rejections to the claims under 35 U.S.C. § 102 and 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 1-5 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz et al. (US Patent Application Publication 2014/0296666), hereinafter Rabinovitz, and in view of Palti et al. (US Patent Application Publication 2006/0052667 – cited by Applicant), hereinafter Palti.
Regarding Claim 1, Rabinovitz teaches in-vivo devices, systems, and methods for the detection of blood within in-vivo bodily fluids within the GI-tract via light source/detector modality (see abstract and Fig. 9), in which the device may also be used for detecting H. pylori (see ¶[0129]), and the various aspects of the various embodiments are combinable with one another (see ¶[0359]). Rabinovitz teaches a capsule (see abstract and Fig. 9) for diagnosis of helicobacter pylori (see ¶[0129]), comprising:
a body section (¶[0157] the housing 501; Fig. 9) into which a gastrointestinal fluid including the helicobacter pylori is selectively introduced (¶[0157]-[0159] the gap 502 for allowing GI fluid to flow therewithin; Fig. 9);
a decomposition section that is accommodated in the body section (¶[0157]-[0159] the gap 502 for allowing fluid to flow therewithin; Fig. 9);
a sensor unit for measuring information on a result of the GI fluid in the decomposition section (¶[0157] the illumination sources 503 and the detector 504; Fig. 9); and
a control unit for transmitting the information measured by the sensor unit to the outside (¶[0160]-[0161] the processor 514 for processing the data and the transmitter 515 for transmitting the data to the external receiver).
Rabinovitz is silent that the decomposition section contains urea.
Palti teaches a method and system for in vivo detection of H. pylori (see abstract), in which an in vivo device (capsule) 10 that may utilize an imaging system including the illumination unit 23 and the image sensor 24 for detecting pH, such as via color changing pH sensitive material, based off of the reaction of urea with bacteria urease (from the H. pylori bacteria) to indicate H. pylori presence which is then transmitted from the device (see ¶[0014]-[0016] and ¶[0027]-[0029]; Figs. 1A and 2), in which image data is transmitted from the device (see ¶[0022] and Fig. 1B).
Accordingly, it would have been obvious to implement the pH based H. pylori sensing modality of Palti with the illumination sources 503 and the detector 504 for the H. pylori sensing of Rabinovitz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Rabinovitz teaches detecting H. pylori but not specifically the modality and Palti teaches one such modality of H. pylori detection.
Here, urea is present in the GI fluid, so urea would therefore enter the decomposition section as being present within the GI fluid. As the claim only requires that urea be within the decomposition section, the modified Rabinovitz teaches that element of claim 1.
Regarding Claim 2, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. Rabinovitz further teaches a power supply unit that is accommodated in the body section and supplies power to the control unit (¶[0160] the internal power source 505; Fig. 9).
Regarding Claim 3, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. Rabinovitz further teaches a power supply unit that is installed outside the body section and drives the control unit through a radio frequency identification (RFID) technique (¶[0160] the internal power source 505, ¶[0274] the power source may alternatively be a wireless power receiving unit based on RF power transmission; Fig. 9).
Regarding Claim 4, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. Rabinovitz further teaches the body section has an upper portion formed in a partially open shape (see Fig. 9, the portion of the housing 501 with the gap 502), the decomposition section is formed in an inner space of the body section (see Fig. 9, the inner space of the housing 501 with the gap 502 and the sensors), and the sensor unit and the control unit are formed in the inner space of the body section and arranged in order below the decomposition section (see Fig. 9, the inner space of the housing 501 with the illumination sources 503 and the detector 504, with the processor 514 and the transmitter 515 below).
Regarding Claim 5, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. Rabinovitz further teaches the decomposition section is arranged to be separated from an inlet of the body section (¶[0190]-[0192] the cover 1605 with filter and/or holes 1604 separated from the gap 1602 with the illumination sources 1613 and the light detector 1614; Figs. 16A-16C).
Regarding Claim 7, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. The modified Rabinovitz further teaches the sensor unit measures a pH value of the gastrointestinal fluid that is changed by ammonia generated as the urea is decomposed (see Palti ¶[0014]-[0016] and ¶[0027]-[0029], the in vivo device (capsule) 10 that may utilize the imaging system including the illumination unit 23 and the image sensor 24 for detecting pH, such as via color changing pH sensitive material, based off of the reaction of urea with bacteria urease (from the H. pylori bacteria) to indicate H. pylori presence which is then transmitted from the device; Figs. 1A and 2), and the control unit transmits the measured pH value to the outside (see Rabinovitz ¶[0160]-[0161], the processor 514 for processing the data and the transmitter 515 for transmitting the data to the external receiver).
Regarding Claim 8, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. Rabinovitz further teaches a magnetic drive unit that is accommodated in the body section and controlled by a magnetic field formed outside (¶[0038] the permanent magnet assembly that interacts with an external magnetic field so as to steer the device).
Regarding Claim 9, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. The modified Rabinovitz further teaches a light source unit that is accommodated in an interior of the body section and illuminates the decomposition section (see Rabinovitz ¶[0157], the illumination sources 503; Fig. 9),
wherein the decomposition section further includes an acid-base indicator, and the sensor unit measures image information of the decomposition section illuminated by the light source unit (see Palti ¶[0014]-[0016] and ¶[0027]-[0029], the in vivo device (capsule) 10 that may utilize the imaging system including the illumination unit 23 and the image sensor 24 for detecting pH, such as via color changing pH sensitive material (the acid-base indicator), based off of the reaction of urea with bacteria urease (from the H. pylori bacteria) to indicate H. pylori presence which is then transmitted from the device; Figs. 1A and 2).
Regarding Claim 10, Rabinovitz in view of Palti teaches the device of claim 9 as stated above. The modified Rabinovitz further teaches the light source unit is installed on an inner wall of the body section (see Rabinovitz Fig. 9 and/or Fig. 16B, the illumination sources 503/1613 and the light detector 504/1614 are installed on inside walls of the capsule),
the decomposition section and the sensor unit are arranged in an inner space of the body section (see Rabinovitz Fig. 9 and/or Fig. 16B, the illumination sources 503/1613, the light detector 504/1614, the processor 514, and the transmitter 515 are arranged in an inner space), and
the control unit transmits the image information formed by the sensor unit to the outside as the light source unit illuminates the decomposition section (see Palti ¶[0014]-[0016] and ¶[0027]-[0029], the in vivo device (capsule) 10 that may utilize the imaging system including the illumination unit 23 and the image sensor 24 for detecting pH, such as via color changing pH sensitive material (the acid-base indicator), based off of the reaction of urea with bacteria urease (from the H. pylori bacteria) to indicate H. pylori presence which is then transmitted from the device, Figs. 1A and 2; see Rabinovitz ¶[0160]-[0161], the processor 514 for processing the data and the transmitter 515 for transmitting the data to the external receiver).
Regarding Claim 11, Rabinovitz in view of Palti teaches the device of claim 9 as stated above. The modified Rabinovitz further teaches the image information is one of an actual image of the decomposition section and an RGB value of the decomposition section (see Palti ¶[0022] image data is transmitted from the device; Fig. 1B).
Regarding Claim 12, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. Rabinovitz further teaches a cover section that is installed at an inlet of the body section and removed as the cover section comes into contact with the gastrointestinal fluid (¶[0183]-[0186] the coating 1015 that covers the gap 1012, and may either dissolve after a certain amount of time has passed, or be non-dissolvable, and may be punctured after a certain amount of time has elapsed or externally by medical care personnel; Figs. 14A-14B).
Regarding Claim 13, Rabinovitz in view of Palti teaches the device of claim 12 as stated above. Rabinovitz further teaches the cover section seals the inlet from the outside of the body section (see Figs. 14A-14B, the cover 1015 is outside the body of device 1000).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz in view of Palti as applied to claim 1 above, and in view of Singh et al. (US Patent Application Publication 2018/0164221), hereinafter Singh.
Regarding Claim 6, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. The modified Rabinovitz is silent regarding that the decomposition section further includes a buffer and a bacteriostatic agent that inhibits growth and proliferation of helicobacter pylori.
Singh teaches GI tract detection methods, devices, and systems (see abstract), including taking in a biological sample, such as H. pylori (see ¶[0106]-[0107]), and may utilize a preservative including a buffer (see ¶[1099] Trehalose in solution acts as a buffer) and a bacteriostatic agent (see ¶[1108]-[1110]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the buffer and the bacteriostatic agent of Singh with the modified Rabinovitz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the Trehalose buffer would help stabilize proteins (i.e., the bacteria urease) (see Singh ¶[1099]); and/or (3) the bacteriostatic agent would arrest the bacterial (H. pylori) growth and multiplication, such that the bacteria in the device is representative of the bacterial microflora that was present in the GI tract at the time the bacteria first entered the device (see Singh ¶[1109]).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz in view of Palti as applied to claim 1 above, and in view of Heseltine et al. (WIPO Publication 2021/219891), hereinafter Heseltine.
Regarding Claim 14, Rabinovitz in view of Palti teaches the device of claim 12 as stated above. The modified Rabinovitz is silent regarding that the coating the cover section is formed of a pH-sensitive polymer material.
Heseltine teaches a modular ingestible capsule to gather molecules or fluids at select locations within the body (see abstract and Fig. 1), including the usage of a dissolvable coating 104 that may dissolve when exposed to a particular pH level (see ¶[0049] and ¶[0056]-[0057]; Fig. 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the pH sensitive coating of Heseltine as the coating of the modified Rabinovitz because (1) it is the simple substitution of one known element for another to obtain predictable results and/or (2) the pH sensitive coating can act as an outer protective layer as well as a cover to prevent sample capture until a determined location (see Heseltine ¶[0056]).
Regarding Claim 15, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. Rabinovitz teaches the usage of piston 512 and piston bellows 513 to block and unblock the gap 502 (see ¶[0158]-[0159]; Fig. 9), but the modified Rabinovitz does not specifically teach wherein the decomposition section further includes a swelling gel material as the gastrointestinal fluid is absorbed, and the capsule further includes a sealing lid section that 24 is safely placed on the decomposition section and seals an inlet of the body section as the decomposition section expands.
Heseltine teaches a modular ingestible capsule to gather molecules or fluids at select locations within the body (see abstract and Fig. 1), in which an expandable material 112, such as a hydrogel, positioned within the capsule, may expand when exposed to fluids, pushing cap 114 about the inlet port 110 so as to seal the capsule (¶[0066], ¶[0058]-[0059], and ¶[0075]; Figs. 2-5E).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the expandable material (hydrogel) and sealing cap of Heseltine as the movement and seal in the modified Rabinovitz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) this would allow a sample to be collected, as this would seal the sample compartment, ensuring a “clean” sample can be retrieved after the capsule exits the body (see Heseltine ¶[0049]). Here, the cap (sealing lid) would necessarily be placed on top of the gap decomposition/sensor portion, as otherwise, the capsule (including sensors and electronics) would not be sealed.
Regarding Claim 16, Rabinovitz in view of Palti and Heseltine teaches the device of claim 15 as stated above. The modified Rabinovitz further teaches the body section has an upper portion in which the inlet is formed (see Rabinovitz Fig. 9, the inner space of the housing 501 with the gap 502 and the sensors),
the decomposition section is separated from a lower side of the inlet and is formed in an inner space of the body section (see Rabinovitz ¶[0190]-[0192] the cover 1605 with filter and/or holes 1604 separated from the gap 1602 with the illumination sources 1613 and the light detector 1614; Figs. 16A-16C), and
the sealing lid section is safely placed on an upper portion of the decomposition section (see Heseltine ¶[0066], ¶[0058]-[0059], and ¶[0075], the expandable material 112, such as a hydrogel, positioned within the capsule, may expand when exposed to fluids, pushing cap 114 about the inlet port 110 so as to seal the capsule; Figs. 2-5E). Here, the cap (sealing lid) would necessarily be placed on top of the gap decomposition/sensor portion, as otherwise, the capsule (including sensors and electronics) would not be sealed.
Claims 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz in view of Palti as applied to claim 1 above, and in view of Iddan et al. (US Patent Application Publication 2008/0208077), hereinafter Iddan.
Regarding Claim 17, Rabinovitz in view of Palti teaches the device of claim 1 as stated above. Rabinovitz further teaches the body section has a second accommodation space, the control unit is accommodated in the second accommodation space (see Fig. 9, the portion of the housing 510 with the processor 514 and the transmitter