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 .
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.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 1 is objected to because of the following informalities: random capitalization such as “Moving” and “Spectrometer”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: appearing to comprise multiple sentences given the recitation the “the sac. Some…” in line 23. Appropriate correction is required.
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 1-4 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.
Claims 1 positively recites the exclusive transitional phrase “consists of” and also recites the inclusive transitional phrase “characterized by”. Claim 1 is indefinite. The scope of the claim is indeterminate with respect to whether or not the transitional phrase is intended to be inclusive or exclusive. See at least MPEP 2111.03. For the purposes of examination on the merits and consistent with the instant disclosure, the claims are being treated on the merits herein as being inclusive or open-ended.
Claim 1 positively recite the inclusive transitional phrase “characterized in that it comprises” followed by an exclusive transitional phrase limitation that “consists of”. Claim 1 is indefinite. Given the issue for claim 1 above, the scope of the claim is indeterminate with respect to whether or not the transitional phrase is intended to be inclusive or exclusive. See at least MPEP 2111.03. For the purposes of examination on the merits and consistent with the instant disclosure, the claims are being treated on the merits herein as being inclusive or open-ended.
Claim 1 positively recites the limitation "the light" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the light source" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the amniotic fluid" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the fiber bundle fluid" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the light carrying arm " in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the sample " in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the center " in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the prepared sample " in line 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the first studies " in line 29. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the information " in line 29. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the intensity" in lines 31-32. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 positively recites the limitation "the duration" in line 32. There is insufficient antecedent basis for this limitation in the claim.
The term “dark measurement” in claim 1 is a relative term which renders the claim indefinite. The term “dark measurement” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may be required and/.or excluded by the relative term, particularly what is explicitly, implicitly, inherently, and/or inferentially required or excluded and/or the required/excluded degree of power considered to be “dark”.
Claim 1 positively recites inter alia “(white)”, “(where the measurement will be taken from the amniotic sac)”, and “(especially between 400nm and 1100nm)”. Claim 1 is indefinite because it is unclear if the limitations in parenthesis are included and excluded by the claim.
The term “as close as possible” in claim 1 is a relative term which renders the claim indefinite. The term “as close as possible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may be required and/.or excluded by the relative term, particularly what is explicitly, implicitly, inherently, and/or inferentially required or excluded and/or the required/excluded degree of power considered to be “close”.
The term “optimum pulse width” in claim 1 is a relative term which renders the claim indefinite. The term “optimum pulse width” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may be required and/.or excluded by the relative term, particularly what is explicitly, implicitly, inherently, and/or inferentially required or excluded and/or the required/excluded degree of power considered to be “optimum”.
Claims 3 and 4 positively recite the inclusive transitional phrase “characterized in that it comprises” followed by an exclusive transitional phrase limitation that “consists of”. Claims 3-4 are indefinite. Given the issue for claim 1 above, the scope of the claim is indeterminate with respect to whether or not the transitional phrase is intended to be inclusive or exclusive. See at least MPEP 2111.03. For the purposes of examination on the merits and consistent with the instant disclosure, the claims are being treated on the merits herein as being inclusive or open-ended.
The term “high-power” in claim 2 is a relative term which renders the claim indefinite. The term “high power” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may be required and/.or excluded by the relative term, particularly what is explicitly, implicitly, inherently, and/or inferentially required or excluded and/or the required/excluded degree of power considered to be “high-power”.
The term “oem spectrometer” in claim 2 is a relative term which renders the claim indefinite. The term “oem spectrometer” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may be required and/.or excluded by the relative term, particularly what is explicitly, implicitly, inherently, and/or inferentially required or excluded and/or the required/excluded degree of power considered to be “oem”.
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 1-4 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).
Independent claim 1 positively recites inter alia “…a probe… relies on the reflection of the light sent from the light source (1) back from the amniotic fluid to the reflection probe (3), which can be positioned in the amniotic sac at different angles of the non-invasive meconium and blood scanning device in the amniotic fluid during the birth process”.
Independent claim 2 and claims 3-4 positively recite “A non-invasive meconium and blood screening device in amniotic fluid during the birth process”.
For claims 1-4, the scope of the claimed invention positively requires a portion of the human body, rendering claims 1-4 non-statutory subject matter.
For the purposes of compact prosecution, the examiner respectfully suggests reciting “…a probe… configured to rely on the reflection of the light sent from the light source (1) back from the amniotic fluid to the reflection probe (3), which is configured to be positioned in the amniotic sac at different angles of the non-invasive meconium and blood scanning device in the amniotic fluid during the birth process”, “A non-invasive meconium and blood screening device configured for screening amniotic fluid during the birth process”, or the like, which appears to obviate the instant rejection.
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) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balberg et al. (US 8,644,900 B2, hereinafter Balberg).
For claim 1, Balberg discloses a process (Figs 1B,3B,3C,4) (Cols 9-33), comprising inter alia:
using a programmable microcontroller (CPU of 120), spectrometer (data acquisition spectrometer functions of 120), reflection probe (101) and a monitor (display of 120) on which the results will be displayed, relies on the reflection of the light sent from the light source back from the amniotic fluid to the reflection probe (Figs 1B,3B,3C,4) (Cols 9-33), which not only can but is positioned in the amniotic sac at different angles of the non-invasive meconium and blood scanning device in the amniotic fluid during the birth process (Figs 1B,3B,3C,4) (Cols 9-33), and the process comprising the steps of inter alia: process steps;
carrying the light sent from the light source (403) by the fiber bundle (403) consisting of 6 fibers (Figs 1B,3B,3C,4) (Cols 9-33), which is the light carrying arm of the reflection probe, and reflecting of light on the sample to be measured (Figs 1B,3B,3C,4) (Cols 9-33),
collecting the light reflected from the sample with the fiber that carries the light reflected to the reflection probe in the center and transmitting the same to the spectrometer (Figs 1B,3B,3C,4) (Cols 9-33),
starting the reflection measurement with dark measurement (Figs 1B,3B,3C,4) (Cols 9-33),
taking a reference measurement from the fiber bundle (6 pieces) that carries the light sent to the reflection probe, from a (white) sample from which the full spectrum of the transmitted light can be reflected back (Figs 1B,3B,3C,4) (Cols 9-33),
after these two measurements are completed, taking a reflection measurement from the prepared sample (where the measurement will be taken from the amniotic sac) (Figs 1B,3B,3C,4) (Cols 9-33),
moving the reflection probe (3) as close as possible to the embryo sac (Figs 1B,3B,3C,4) (Cols 9-33),
sending a beam of light with the optimum pulse width is then sent into the sac (Figs 1B,3B,3C,4) (Cols 9-33), some of the light beam that enters through the sac reflecting off the sac and some reflecting off the amniotic fluid inside (Figs 1B,3B,3C,4) (Cols 9-33),
collecting the light beam reflected on the reflection probe by the reflection probe and sending the same to the Spectrometer (Figs 1B,3B,3C,4) (Cols 9-33),
since the coloration in amniotic fluid is in the visible region, using a spectrometer (6) operating in the visible region (especially between 400nm and 1100nm) in the first studies (Figs 1B,3B,3C,4) (Cols 9-33), transferring the information received from the spectrometer to the computer and analyzing the collected data (Figs 1B,3B,3C,4) (Cols 9-33),
optimizing the position of the reflection probe to the sac, the intensity of the transmitted light and the duration of the pulse (Figs 1B,3B,3C,4) (Cols 9-33).
For claim 2, Balberg discloses a non-invasive meconium and blood screening device in amniotic fluid during the birth process, comprising inter alia:
a high-power RGB LED light source (light source of 120) (Figs 1B,3B,3C,4) (Cols 9-33);
a reflection probe (403), where the transmitted light and the reflected light-carrying fibers (403) are combined (Figs 1B,3B,3C,4) (Cols 9-33) (Figs 1B,3B,3C,4) (Cols 9-33);
an oem spectrometer (data acquisition spectrometer functions of 120) (Figs 1B,3B,3C,4) (Cols 9-33);
a monitor (display of 120) on which the analysis of reflected light is displayed (Figs 1B,3B,3C,4) (Cols 9-33); and
a programmable microcontroller (CPU of 120) (Figs 1B,3B,3C,4) (Cols 9-33).
For claim 3, Balberg discloses the non-invasive meconium and blood screening device in amniotic fluid during the birth process according to claim 2, comprising:
a fiber bundle (403) (Figs 1B,3B,3C,4) (Cols 9-33), which is the component of the reflection probe and consists of 6 fibers (Figs 1B,3B,3C,4) (Cols 9-33), where the light from the light source is carried and the light sent to the reflection probe is carried (Figs 1B,3B,3C,4) (Cols 9-33).
For claim 4, Balberg discloses the non-invasive meconium and blood screening device in amniotic fluid during the birth process according to claim 2, comprising:
fiber (403) (Figs 1B,3B,3C,4) (Cols 9-33), which is a component of the reflection probe and consists of 1 fiber (Figs 1B,3B,3C,4) (Cols 9-33), and the reflected light is carried to the reflection probe, where the reflected light is carried to the spectrometer (Figs 1B,3B,3C,4) (Cols 9-33).
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 and/or methods for spectrally screening amniotic fluid and/or blood.
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