DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
MPEP 2111.04 states “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.”. Therefore, the claimed limitations related to “when a decrease is detected” (see last two steps in method claim 1) are considered contingent limitations that are only required to be met when a decrease occurs, i.e. a decrease is detected. Therefore, when an increase is detected or when it is detected that the ratio stays the same, i.e. neither an increase or a decrease, the claim language is met under the BRI of the current claim language.
Claim Objections
Claim 2 is objected to because of the following informalities: The limitation “the step of determining the laser parameters of the laser to be used in the application” should be “the step of determining the parameters of the laser to be used in the photodynamic application” (in order to more closely resemble/match the previously recited step). 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 1-6 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] The following indefiniteness rejections exist for claim 1:
Line 9: “each unit” is indefinite, as it’s unclear which unit or units this refers to, as the claim previously recites both target units and non-target units, so it’s unclear what “each unit” refers to.
Line 10: “in the same environment” is indefinite, as no environment has been previously recited. Furthermore, it’s unclear what is meant by the “same” environment, especially considering that no environment (same or different) has been previously recited.
Line 11: “the minimum time (Ts)” lacks antecedent basis
Line 12: “to remove from their content” is indefinite, as it’s unclear what “their content” is referring to. Additionally, the phrasing of this limitation is grammatically confusing.
Line 13: “the laser fluence (Φ)” is indefinite, as it’s unclear if these refers to a specific laser fluence value or can refer to any laser fluence. If this refers to any/all laser fluence, i.e. inherent to the operation of any laser source, then this should be “a laser fluence (Φ)”. If this refers to a specific laser fluence, then such a laser fluence needs to be previously introduced into the claims to provide proper antecedent basis.
Line 14: “the determined dosing time (td)” is indefinite, because no dosing time (td) has ever been previously recited in the claims, let alone determining such a dosing time.
Line 15: “waiting for time Ts” is indefinite, as Ts has been previous recited as a minimum time Ts, so it’s unclear if this refers to the same minimum time Ts that has been previously recited (if so, this should be recited as “waiting for the minimum time Ts”)
Line 16: “the maximum permissible fluence” is indefinite, as it lacks antecedent basis.
Lines 16-17: “the minimum active fluence” is indefinite, as it lacks antecedent basis.
Line 17: “the unit area wavelength (NIR/SWIR)” is indefinite. First, the term “unit area wavelength” has never been previously recited. Second, the acronym NIR/SWIR has never been previously defined as near-infrared/short wavelength infrared (as disclosed in the specification). Third, because this acronym is recited solely within a parentheses “()”, it’s unclear if these specific wavelengths, i.e. near-infrared or short-wave infrared, are actually required or are merely optional.
Line 17: “by 10 or more whole numbers” is indefinite, as it’s unclear what is meant by this. Is it intended to mean division by the number 10 (or whole numbers greater than 10, e.g. 11, 12, 13, 14, etc.) or does it mean 10 or more random whole numbers (e.g. 3, 9, 17, 21, 34, 55, 102, 157, 199, 250… as long as there are 10 or more whole numbers)? As currently written, it seems to refer to 10 or more numbers, not dividing by 10 (or another whole number greater than 10).
Lines 15-17: the entire limitation “taking microscopic scale images with an imaging system by dividing the difference between the maximum permissible fluence and the minimum active fluence (ΦM - Φm) with the laser in the unit area wavelength (NIR/SWIR) by 10 or more whole numbers”, as a whole, is indefinite. As discussed above, individual terms/phrases within this limitation are indefinite, but the recited equation, as a whole, is indefinite as it’s unclear how this equation relates to taking microscopic scale images with an imaging system. The current claim language seems to state that the microscopic scale images are taken BY performing the recited calculation/equation. However, it is unclear how a formula/equation that subtracts fluences and then divides this difference by 10 has anything to do with how microscopic scale images are taken.
Line 20: “waiting for time Ts” is indefinite, as Ts has been previous recited as a minimum time Ts, so it’s unclear if this refers to the same minimum time Ts that has been previously recited (if so, this should be recited as “waiting for the minimum time Ts”); see explanation for line 15 above.
Line 22: “the imaging and application laser ports” is indefinite as it lacks antecedent basis. No ports have been previously recited in the claims, let alone imaging or application laser ports.
Line 22: “in the relevant target area” is indefinite, as no “target area” has ever been previously presented in the claims, let alone a “relevant” target area.
Line 24: “the most absorbent NIR/SWIR wavelength” is indefinite as it lacks antecedent basis.
Line 25: “entering the ΦM, td values determined for the target organism in the database”. First, while the claimed values (ΦM, td) have been previously recited in the claims, they have never been “determined”, as required by the current claim language. Second, “the database” lacks antecedent basis.
Lines 26-27: “during the laser application, simultaneously taking microscopic images focused on the relevant area in 1s-5s time periods” is indefinite. First, “the laser application” lacks antecedent basis, as no laser application is positively recited. Second, the term “simultaneously” is indefinite, as it’s unclear what it is referring to. It appears as if this is referring to taking multiple microscopic images simultaneously, but it’s unclear if/how multiple microscopic images are taken with a single imaging system. Third, it’s unclear “microscopic images” refer to the previously recited “microscopic scale images” or if these are entirely different microscopic images. Lastly, “the relevant area” lacks antecedent basis.
Line 34: “the count” is indefinite as it lacks antecedent basis. Specifically, the claims previously recite “performing counts” (plural), so it’s unclear if “the count” refers to these counts or a different count altogether.
Line 35: “the laser fluence Φu value” is indefinite, as no such value, specifically Φu has been claimed. While other laser fluence values, e.g. maximum permissible fluence (ΦM) and minimum active fluence (Φm), have been previously recited, this appears to be a different laser fluence value. Therefore, this limitation is unclear, as it’s unclear what laser fluence value this refers to.
Line 35: “the ΔΦ stages” is indefinite as it lacks antecedent basis. It’s unclear what these stages are or what these stages refer to.
Line 35: “the Φu value” is indefinite; see explanation for line 35 above.
Line 36: “the application starting values” is indefinite as it lacks antecedent basis. No application starting values have been previously recited, therefore it’s unclear what these application starting values are or what these application starting values refer to.
Line 37: “obtained” in the claimed context is unclear, as this ratio has never been previously “obtained” in the claims. Is this the same as the “calculated” ratio?
[Claim 2] The limitation “the wavelength” is indefinite, as it’s unclear if this wavelength is the same NIR/SWIR wavelengths previously recited in the claim or if this is a different wavelength altogether.
[Claim 3] This claim is indefinite, as it’s unclear what specific method step(s) must be performed in order to meet the claim language. First and foremost, “wherein it is ensured…” seemingly recites a result/effect, and not an active method step, making the claimed scope unclear. Specifically, what step or steps is/are performed in order to ensure this effect takes place? Furthermore, the limitations “the minimum amount of photosensitizer” and “the content of the non-target units” lack antecedent basis.
[Claim 4] The limitation “during focusing and initial image acquisition” is indefinite, as initial image acquisition has never been previously recited in the claims. Additionally, “the fluence” lacks proper antecedent basis, as it’s unclear which fluence this is referring to. It is noted that multiple fluences and fluences values have been previously recited in the claims, therefore it’s unclear which of these fluence this claimed fluence refers to or if it’s an entirely different fluence.
[Claim 5] It’s unclear if this wavelength is the same NIR/SWIR wavelengths previously recited in the claim or if this is a different wavelength altogether.
Lack of Prior Art Rejection
MPEP 2173.06 states “where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims”. Based on the numerous 112b rejections (above), there is a great deal of uncertainty regarding the scope of the claims and the proper interpretation thereof. Therefore, the examiner takes the position that it would not be proper to apply a prior art rejection. Any amendments would require further search and consideration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2021/0001149 to LaRochelle teaches a similar concept of dose planning for photodynamic therapy.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
Prosecution Insights