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 .
Applicant’s preliminary amendments filed on 12/04/2023 are acknowledged.
Claims 1-20 are pending for examination.
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. Such claim limitation(s) is/are: “means for carrying out the method” in claim 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Adequate supports can be found at least in paragraph [0225] of the PGPUB.
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.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are directed to signal per se, which does not fall into the categories of “process”, “machine”, “manufacture” and “composition of matter”. Referring to claim 12, claim 12 recites the limitation, “A computer-readable medium”, which directs the claim to “computer readable medium having computer readable code”. The broadest reasonable interpretation of this phrase includes non-transitory embodiments, such as memory elements (ROM, RAM) and memory media (CDs) as well as transitory embodiments, such as carrier waves encoded with the software steps. However, transitory forms of signals are not statutory (In re Nuijten, 84 USPQ2d 1495). A claim that covers both statutory and non-statutory embodiments embraces subject matter that is improperly directed to non-statutory subject matter. Applicant can amend the limitation to "A non-transitory computer-readable medium” to overcome the rejection.
Claims 9-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 9-12 recite a computer-implemented method, which fall within one of statutory categories (i.e. process) (Step 1: YES).
Step 2A Prong One analysis: Claims 9-12 recite “calculating/ estimating steps (iv), (vi), (vii), (ix) and (x) with mathematical equations/ estimations”. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claims 9-11 recite “…the PACS system of an MRI instrument” (claim 9) and a “data processing apparatus” (claim 10) and associated computer program/ computer-readable medium” (claims 11-12). This judicial exception is not integrated into a practical application because the PACS system of an MRI instrument are not part of the method and are unaffected by how the algorithms/ calculations/ operate (e.g. PACS system of an MRI instrument are merely data source/ provider). Thus, there is no improvement or change in the function of the device (see at least MPEP 2106.05(a), (f) and (g)). And the receiving steps (i), (ii), (iii), (v), and (viii) are considered as data gathering steps to be insignificant extra-solution activity. (Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element(s), when considered separately and in combination, are associated with data gathering steps of insignificant extra-solution activity (see MPEP 2106.05(g)) and mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) and do not improve the functioning of a computer, e.g. an improvement in the application of the mathematical relationship/ equations in determining parameter(s), which is, itself, an abstract idea (see MPEP 2106.05(a)). The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation for parameter(s) (Step 2B: No). Dependent claims do not recite additional elements/ features and do not add significantly more (i.e. an “inventive concept”) to the exception.
For these reasons, there is no inventive concept in the claims, and thus claims 9-12 are ineligible.
Claims 1-5 and 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-5 and 13-20 recite a method, which fall within one of statutory categories (i.e. process) (Step 1: YES).
Step 2A Prong One analysis: Claims 1 and 13 recite “calculating/ estimating and/or comparing steps (v), (vii), (viii), (x), (xi), and/or (xii) with mathematical equations/ estimations”. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claims 1-5 and 13-20 does not recite any specific structure(s)/ element(s). This judicial exception is not integrated into a practical application. And the performing/ administering/ obtaining steps (i), (ii), (iii), (iv), (vi), and (ix) are considered as data gathering steps to be insignificant extra-solution activity (e.g. administered with a manganese contrast agent, or a pharmaceutically acceptable salt…performing MRI measurements before, during and/or after administering the agent… manganese (II) chelate of N,N-bis-(pyridoxal-5-phosphate)-ethylenediamine-N,N'-diacetic acid (MnDPDP) is a well-known contrast agent for use in MRI, see at least abstract; [0006]; [0016]; [0022-0027] of Jynge et al., USPGPUB 2010/0166667). (Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include any additional elements that is sufficient to amount to significantly more than the judicial exception, and the performing/ administering/ obtaining steps (i), (ii), (iii), (iv), (vi), and (ix) are associated with data gathering steps of insignificant extra-solution activity (see MPEP 2106.05(g)). The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation for parameter(s) (Step 2B: No). Dependent claims 2-5 and 14-20 do not recite additional elements/ features and do not add significantly more (i.e. an “inventive concept”) to the exception.
For these reasons, there is no inventive concept in the claims 1-5 and 13-20, and thus claims are ineligible.
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. Claims that depend directly or indirectly from claim(s) 1, 6, 9, 13, and 18 is/are also rejected due to said dependency.
In regard to claims 1, 9 and 13, the claims recite “obtaining an estimate of the ECV for said section of the heart of the subject”. First of all, “the ECV” lacks of sufficient antecedent basis. It is suggested that “an” should be set forth. Secondly, the term “ECV” is not clearly defined in the claims. It is unclear what “ECV” stands for because “ECV” may be an abbreviation of different terms/ medical terms. Clarification is requested by amendments.
In regard to claims 3 and 15, the claims recite “ the contrast agent has a stability constant of 11-17, preferably 14-16”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3 and 15 recite the broad recitation 11-17, and the claim also recites 14-16 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In regard to claim 7, the claim recites “the heart disease…” which lacks of sufficient antecedent basis.
In regard to claim 9, step i) recites “the PACS system of an MRI instrument” which lacks of sufficient antecedent basis. In addition, step ii) recites “the PACS system of an MRI instrument”. It is unclear whether it refers to “the PACS system of an MRI instrument” recited in step i) or it is an additional PACS system of another MRI instrument. If the first, it is suggested “the PACS system of the MRI instrument” should be set forth. Clarification is requested by amendments.
In regard to claim 18, the claim recites “the contrast agent comprising a manganese contrast agent, or a pharmaceutically acceptable salt thereof”. It is unclear whether “a manganese contrast agent or a pharmaceutically acceptable salt thereof” is the same or different agent(s) as the agent(s) recited in claim 13. If they are the same, it appears that the limitations are redundant. If they are different, it is suggested that “first/ second” or similar language should be set forth to better define they are not the same agent. Clarification is requested by amendments.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In regard to claim 7, the claim fails to further limit the subject matter of the claim 6. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jynge et al. (USPGPUB 2010/0166667 – cited above). In regard to claims 6 and 8, Jynge discloses a contrast agent comprising a manganese contrast agent, or a pharmaceutically acceptable salt thereof, wherein the contrast agent has a stability constant of 10-18 and the contrast agent is MnDPDP (MnDPDP, [0016-0020]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jynge teaches “a method of determining the amount of intracellular manganese in the myocardium of an individual pre-administered with a manganese contrast agent, or a pharmaceutically acceptable salt thereof, comprising subjecting said individual to a MRI procedure to assess the signal intensity (SI) of images, or more preferably the longitudinal relaxation rate, R1 throughout said myocardium” (abstract), “the amount of manganese present in a cell is shown to be essentially proportional to the signal intensity (SI) and R.sub.1 values determined by MRI, SI and/or R.sub.1 measurements can be used to provide a quantitative measurement of intracellular manganese and tissue viability/function” ([0018]), “a method of determining the amount of intracellular manganese in the myocardium of an individual pre-administered with a manganese contrast agent, or a pharmaceutically acceptable salt thereof, comprising subjecting said individual to a MRI procedure to assess the signal intensity (SI) of images, or more preferably the longitudinal relaxation rate, R1 throughout said myocardium” ([0019]) and “the compounds as hereinbefore described may be administered at a dosage of from 0.5 to 40 mmol/kg body weight, more preferably 1 to 20 µmol/kg body weight, still more preferably 2 to 12 µmol/kg body weight, e.g. about 5 to 10 µmol/kg body weight. Preferably the compounds are administered by bolus injection or infusion into the systemic vasculature”, ([0068]). Hu et al. (USPN 8,738,114) teaches systems and methods for quantitatively measuring manganese ion efflux in a subject (abstract) comprises the measurements of the change in relaxation rate (Figs. 1 and 3) using Manganese-Enhanced Magnetic Resonance Imaging (Col 11 line 65 – Col 12 line 27) and the use of MnDPDP as contrast agent in MRI (Col 5 line 52 – Col 6 line 17).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791