DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species C, embodiment drawn to Figure 4, in the reply filed on 7/8/26 is acknowledged.
Claims 3-5, 9, 14, and 16-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/8/26.
With respect to the withdrawn claims not indicated as such by Applicant in the 7/8/26 reply, the Examiner respectfully notes the following:
Claim 3 is clearly drawn to the description of Figure 3 and/or 5 and non-elected Species B and/or D;
Claims 4-5 are clearly drawn to the description of Figure 6 and non-elected Species E; and
Claim 14 is clearly drawn to the description of Figure 5 and non-elected Species D.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claims 1-2, 6-8, 10-13, and 15 are objected to because of the following informalities: (i) the unnecessary capitalization of terms such as “Flexible Printed Circuit” instead of “flexible printed circuit” and “Bonding” and (ii) the introduction of acronyms without immediate or preceding explanation such as “FPC-sensor” instead of “FPC (flexible printed cirtui)-sensor”. Applicant’s attention is respectfully directed to similar throughout the claims. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: the recitation of “wherein on either side of the Flexible Printed Circuit there is provided with an electromagnetic shielding layer” appears to contain grammatical errors. Applicant may hae intended to positively recited “wherein the flexible printed circuit board is provided with an electromagnetic shielding layer on one side”, or the like. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 positively recites “an artificial intelligence assisted intracranial monitoring system”. Although the claims as filed and instant Specification positively recite “an artificial intelligence assisted intracranial monitoring system”, the disclosure appears devoid of any further description or specificity regarding the “artificial intelligence assisted” nature of the intracranial monitoring system. For example at least, no structure(s), programming and/or relationship(s) are provided with respect to the “artificial intelligence” and the intracranial monitoring system, let alone any sufficient specificity detailing how the intracranial monitoring system may be provided and/or configured with “artificial intelligence”. Conversely, it appears the “artificial intelligence” is a black-box as disclosed. The scope of the claim lacks written description given the lack of sufficient corresponding description.
Claim Rejections - 35 USC § 112(b)
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 1-2, 6-8, 10-13, and 15 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 term “strip-shaped” in claim 1 is a relative term which renders the claim indefinite. The term “strip-shaped” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what “strip-shaped” and/or what degree of “strip-shaped”-ness may be explicitly, implicitly, inherently, and/or inferentially required and/or excluded by the recitation of “strip-shaped”. Depending claims 2, 6-8, 10-13, and 15 inherit and do not remedy the indefiniteness.
The term “COF” in claim 1 is a relative term which renders the claim indefinite. The term “COF” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what “COF” and/or what degree of “COF” may be explicitly, implicitly, inherently, and/or inferentially required and/or excluded by the recitation of “COF”. Depending claims 2, 6-8, 10-13, and 15 inherit and do not remedy the indefiniteness.
The term “bare chips” in claim 1 is a relative term which renders the claim indefinite. The term “bare chips” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what “bare chips” and/or what degree of “bare”ness may be explicitly, implicitly, inherently, and/or inferentially required and/or excluded by the recitation of “bare chips”. Depending claims 2, 6-8, 10-13, and 15 inherit and do not remedy the indefiniteness.
The term “electromagnetically compatible” in claim 1 is a relative term which renders the claim indefinite. The term “electromagnetically compatible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what “electromagnetically compatible” and/or what degree of “electromagnetically compatibility” may be explicitly, implicitly, inherently, and/or inferentially required and/or excluded by the recitation of “electromagnetically compatible”. Depending claims 2, 6-8, 10-13, and 15 inherit and do not remedy the indefiniteness.
The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what “substantially” the same and/or what degree of “substantially” same-ness may be explicitly, implicitly, inherently, and/or inferentially required and/or excluded by the recitation of “substantially”. Depending claims 2, 6-8, 10-13, and 15 inherit and do not remedy the indefiniteness.
Claim 6 recites the limitation "the minimum spacings" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 positively recites “an artificial intelligence assisted intracranial monitoring system”. Although the claims as filed and instant Specification positively recite “an artificial intelligence assisted intracranial monitoring system”, the disclosure appears devoid of any further description or specificity regarding the “artificial intelligence assisted” nature of the intracranial monitoring system. For example at least, no structure(s), programming and/or relationship(s) are provided with respect to the “artificial intelligence” and the intracranial monitoring system, let alone any sufficient specificity detailing how the intracranial monitoring system may be provided and/or configured with “artificial intelligence”. Conversely, it appears the “artificial intelligence” is a black-box as disclosed. The scope of the claim is indeterminate with respect to what may be explicitly, implicitly, inherently, and/or inferentially required and/or excluded by the recitation of “artificial intelligence assisted”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-8, 10-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chan et al. (US 2016/0135749 A1, hereinafter Chan).
For claim 1, Chan discloses a probe assembly (1200) for an intracranial monitoring system (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]), the probe assembly including inter alia:
a catheter (1210) (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]) having a hollow cavity extending between a front end and a rear end of the catheter, the front end being configured to insert into the skull of a monitored person (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]); and
an FPC-sensor (100) integrated probe sealingly arranged within the hollow cavity of the catheter (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]), wherein the FPC-sensor integrated probe comprises:
an absolute pressure sensor chip (120) arranged for monitoring of intracranial pressure of the monitored person (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]);
a temperature sensor chip (114) arranged for monitoring intracranial temperature of the monitored person (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]);
a signal chain chip (126) (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]); and
a strip-shaped Flexible Printed Circuit (110) (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]);
wherein the absolute pressure sensor chip, the temperature sensor chip, and the signal chain chip are COF encapsulated in bare chips onto the Flexible Printed Circuit (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]);
wherein the absolute pressure sensor chip, the temperature sensor chip and the signal chain chip are positioned on the Flexible Printed Circuit such that their operating ambient temperatures are substantially the same (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]);
wherein the Flexible Printed Circuit is designed to further integrate a power line (1242) and a signal transmission line (1246), such that the Flexible Printed Circuit has power transmission and signal transmission function (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]);
wherein the Flexible Printed Circuit is electromagnetically compatible (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]); and
wherein the length of the strip-shaped Flexible Printed Circuit is more than 80 mm (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 2, Chan discloses the probe assembly according to claim 1, wherein the absolute pressure sensor chip, the temperature sensor chip, and the signal chain chip are integrated and encapsulated on an end of the Flexible Printed Circuit which is located at the front end of the catheter (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 6, Chan discloses the probe assembly according to claim 1, wherein the minimum spacings between the absolute pressure sensor chip and the signal chain chip, and between the temperature sensor chip and the signal chain chip, are respectively no greater than 2 mm (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 7, Chan discloses the probe assembly according to claim 1, wherein the width of the strip-shaped Flexible Printed Circuit is less than 3 mm (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 8, Chan discloses the probe assembly according to claim 7, wherein the width of the strip-shaped Flexible Printed Circuit is less than 0.8 mm (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 10, Chan discloses the probe assembly according to claim 1, wherein the probe assembly is constructed such that the absolute pressure sensor protrudes from the front end of the catheter (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 11, Chan discloses the probe assembly according to claim 1, wherein the Flexible Printed Circuit is selected from a group consisting of a single-sided flexible circuit board and a double-sided flexible circuit board, and wherein on either side of the Flexible Printed Circuit there is provided with an electromagnetic shielding layer (314,315) (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 12, Chan discloses the probe assembly according to claim 11, wherein the Flexible Printed Circuit is a double-sided flexible circuit board fabricated from a flexible copper clad laminate (314,315), wherein the absolute pressure sensor chip, the temperature sensor chip, the signal chain chip and the signal transmission line are arranged on a front side of the double-sided flexible circuit board, and the power line is arranged on an opposite back side of the double-sided flexible circuit board (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 13, Chan discloses the probe assembly according to claim 11, wherein the electromagnetic shielding layer is selected from at least one of the following: a silver foil, a copper foil, a silver-containing coating, and a copper coating (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
For claim 15, Chan discloses the probe assembly according to claim 1, wherein the intracranial monitoring system is an artificial intelligence assisted intracranial monitoring system, and wherein the catheter is a neurophysiological monitoring catheter (Figs 1-5, 11-13, especially Figs 12A-12C) ([0064-0093, especially 0087-0093]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring an intracranial physiology monitoring catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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