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 .
Claims Accounting
Applicant' s arguments, filed 03/11/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 03/11/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4 and 10-11 have been amended.
Claims 5-6, 9, and 12-15 have been canceled.
Claims 1-4, 7-8, and 10-11 are the current claims hereby under examination.
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 11 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 11 recites the limitation “the processor uses an algorithm to initiate one or more treatments for a patient having the calculated LSCD score”. There is insufficient written support for this limitation. The closest identified recitation is in pars. [0013] and [0026] of the published application. Pars. [0013] and [0026] discloses “the processor uses an algorithm to identify one or more treatment options for a patient having the calculated LSCD score”. These recitations do not include the processor initiating one or more treatments, but identifying the one or more treatment option. The written description does not include any recitations of a processor capable of initiating or administering any treatments, only identifying treatments to be administered.
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, 7-8, and 10-11 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.
Regarding claim 1, the claim recites “a patient observed to exhibit the presence of limbal stem cell deficiency” in lines 29-30. It is unclear whether this patient is the same patient observed in line 3, or a different patient. It is further unclear how the patient is defined to exhibit the presence of limbal stem cell deficiency. Lines 14-15 of claim 1 recite correlating the observation of (a) with the presence or absence of stage of LCSD in the patient”, however it is unclear if this correlation leads to a determination of the patient exhibiting the presence of limbal stem cell deficiency. Clarification is requested.
For the purposes of examination, “a patient observed to exhibit the presence of limbal stem cell deficiency” is interpreted as “the patient”.
Regarding claim 11, the lack of written description to support the claim limitations “the processor uses an algorithm to initiate one or more treatments for a patient having the calculated LSCD score” renders the claim indefinite. It is unclear how the processor is capable of initiating a treatment. Clarification is requested.
For the purposes of examination, the claim interpreted as “the processor uses an algorithm to control a drug delivery device and initiate one or more treatments for a patient having the calculated LSCD score.”
Further regarding claim 11, the claim recites “the calculated LSCD score” in lines 23-24. There is insufficient antecedent basis for this recitation.
For the purposes of examination, “the calculated LSCD score” is interpreted as “an LCSD score”.
Further regarding claim 11, the claim recites “a patient having the calculated LSCD score” in lines 23-24. It is unclear which patient is being referred to in this recitation. There is no previously recited calculated LSCD score, therefore it is unclear which patient this refers to. There is a previous recitation of an LSCD clinical score in line 18, however, it is not positively recited that this score is a calculated score. Further, the claim recites “assess data obtained from a patient” in line 5. It is unclear whether the patient with the calculated LSCD score is the same patient as recited in line 5 or a different patient. Clarification is requested.
For the purposes of examination, the “a patient having the calculated LSCD score” is interpreted as “the patient”.
Further regarding claim 11, the claim recites “central cornea basal cell density score”, “corneal epithelial thickness score”, and “total corneal nerve fiber length score” in lines 26-27. There is insufficient antecedent basis for these claim limitations.
For the purposes of examination, the claim is interpreted as reciting “wherein the processor uses an observed central cornea basal cell density score, a corneal epithelial thickness score, and a total corneal nerve fiber length score, and the algorithm derives a comprehensive clinical score using a formula as follows:”. This interpretation follows a similar structure as recited in claim 1.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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.
Claims 1-4, 7-8, and 10-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Step 1
Regarding claim 1, the claim recites a series of steps or acts, including correlating the observation of (a) with the presence or absence or stage of LCSD in the patient. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong One
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of observing at least one of the parameters in the patient, correlating the observation of (a) with the presence or absence or stage of LCSD in the patient, observing the various scores in the patient, and deriving a comprehensive clinical score set forth judicial exceptions. The steps of observing of at least one of the parameters in the patient, correlating the observation of (a) with the presence or absence or stage of LCSD in the patient, and observing the various scores in the patient describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. The step of deriving a comprehensive clinical score describes the use of mathematical relationships, mathematical formulas or equations, and mathematical calculations. Thus, the claim is drawn to a Mathematical Concept, which is an Abstract Idea.
Step 2A, Prong Two
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites administering a therapeutic agent to a patient observed to exhibit the presence of limbal stem cell deficiency. The administering a therapeutic agent does not apply, rely on, or use the judicial exception. The administering a therapeutic agent is not based on any claim limitations, and therefore does not integrate the judicial exception. Therefore, the administering is considered insignificant extra-solution activity, and does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the judicial exceptions, nor does the method use a particular machine to perform the Abstract Idea. It is noted that the defining of the stage of LSCD is interpreted as the outcome of the Abstract Idea steps. The stage of LSCD is not relied upon for the administration of the therapeutic agent, and therefore no particular treatment is performed based on the outcome of the Abstract Ideas.
Step 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of administering a therapeutic agent to a patient observed to exhibit the presence of limbal stem cell deficiency. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional treatment activity engaged in by medical professionals prior to Applicant's invention. Furthermore, the administering step does not integrate the results of the previous steps. Therefore, the combination of the claim as a whole (the administering step in combination with the Abstract Ideas) does not amount to significantly more than the exception, as the combination comprises Abstract Ideas and well-understood and conventional treatments.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 11, the device recited in the claim is a generic device comprising generic components configured to perform the Abstract Idea. The processor is a generic computing device configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an Abstract Idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering, details relating to the Abstract Ideas and insignificant extra-solution activity. The observing, correlating, and deriving steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
Regarding claim 1, the closest prior art is identified as Classification of Limbal Stem Cell Deficiency… by Aravena et al. (2019) – previously cited, hereinafter “Aravena” in view of Diagnosis of Limbal Stem Cell Deficiency by Le et al. (2018) – previously cited, hereinafter “Le”, in view of US Patent Publication 2022/0202356 by McAlindon et al. – previously cited, hereinafter “McAlindon”.
Aravena teaches a method of observing the presence, absence or stage of limbal stem cell deficiency (LSCD) in a patient (Abstract, Purpose: Grading the severity (i.e., stage) of LSCD) comprising: (a) in the patient observing at least one of: central corneal basal cell density (Abstract, Purpose: LCSD is based on the extent of clinical presentation and central cornea basal epithelial cell density); limbal basal cell density; central corneal epithelial layer thickness; mean limbal epithelial layer thickness; maximum limbal epithelial layer thickness; total corneal nerve fiber length; corneal nerve fiber density; corneal nerve branch density; basal epithelial cell morphology; and nerve tortuosity coefficient; and (b) correlating the observation of (a) with the presence or absence or stage of LSCD in the patient (Abstract, Purpose: Grading the severity (i.e., stage) of LSCD based on the extent of clinical presentation and central cornea basal epithelial cell density (BCD).); wherein: an increase in a LSCD clinical score correlates with a decrease in central corneal basal cell density (Compared with BCD in control eyes, BCD decreased by 23.0%, 40.4%, and 69.5% in the mild, moderate and severe stages of LSCD classified by the clinical scoring system, respectively.), limbal basal cell density, corneal epithelial layer thickness, mean limbal epithelial layer thickness, maximum limbal epithelial layer thickness, total corneal nerve fiber length, corneal nerve fiber density, corneal nerve branch density, and/or nerve tortuosity coefficient; so that the presence or absence or stage of LSCD in a patient is observed (Abstract, Purpose); wherein: the method comprises observing a clinical score (Abstract, Purpose: LCSD is based on the extent of clinical presentation), and observing a central cornea basal cell density score (Abstract, Methods: “The degree of BCD reduction was given a score of 0 to 3”). Aravena does not teach observing a corneal epithelial thickness score and a total corneal nerve fiber length score.
Le teaches that observations of corneal epithelial thickness (5.1.1.2.1. Corneal and limbal epithelium; “the epithelial thickness at the central cornea is also decreased significantly in patients with LSCD (an average of 20.2% reduction in LSCD eyes). The extent of epithelial thinning is also positively correlated with the degree of LSCD.”) are correlated with LCSD. Le also teaches that morphological changes such as short nerve branches are also observed in patients with LCSD (5.1.1.2.2. Subbasal nerve plexus).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Aravena to include correlating observations of corneal epithelial thickness and total corneal nerve fiber length with the presence or absence or stage of LSCD in the patient, as taught by Le, to provide a more comprehensive assessment of the presence, absence, or stage of LSCD.
Aravena in view of Le does not teach the observations of corneal epithelial thickness and total corneal nerve fiber length being scores.
McAlindon teaches a method for diagnosing the severity of a pathology due to several factors. McAlindon teaches observing an index (i.e., score) indicative of patellar cartilage damage ([0058]), medial and lateral tibiofemoral cartilage damage ([0058]), articular cartilage damage ([0064]) and uses them to generate a composite score ([0085-0086]). Each factor by itself would generally be regarded as insufficient to indicate joint condition by itself. However, when taken together, an unexpected synergy arises with the result that the whole becomes greater than the sum of the parts. Combined scores from individual indexes can provide objective and reliable measure of a condition ([0085]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Aravena in view of Le to comprise observing a corneal epithelial thickness score and a total corneal nerve fiber length score, as combining indexes (i.e., scores) of individual factors can result in a synergy that provides a more objective and reliable measure of the condition, as taught by McAlindon ([0085]).
The combination of Aravena, Le, and McAlindon fails to teach wherein the method derives a comprehensive clinical score using a formula as follows:
[(clinical score/3)*0.2+central cornea basal cell density score*0.3+corneal epithelial thickness score*0.3+total corneal nerve fiber length score*0.2]*4; wherein:
a comprehensive score ≥1 but <5 defines stage 1 LSCD;
a comprehensive score ≥5 but <10 defines stage II LSCD; and
a comprehensive score ≥10 defines stage III LSCD.
Similar limitations are present in claim 11. The limitations of these claims are patentably distinct over the prior art cited in this Office action and any other prior art.
Response to Arguments
Applicant’s arguments, filed 03/11/2026 have been fully considered.
Applicant’s arguments regarding the objection to the drawings is acknowledged. The objections to the drawings are withdrawn.
The amendments to claim 1 overcome the objections of record.
The amendments to the claims overcome the previous rejections of record under 35 U.S.C. 112(b) of claims 1-4, 7-8, and 10-11. The amendments to the claims necessitate new rejections under 35 U.S.C. 112(b) of claims 1-4, 7-8, and 10-11.
The amendments to the claims do not overcome the rejections under 35 U.S.C. 101. Applicant’s assertion that the step of “administering a therapeutic agent to a patient” is directed to a method of treating a specific disease or condition and is generally considered patent-eligible is acknowledged. This assertion is not found persuasive. Treating a specific disease or condition can confer eligibility to a claim if the treating of a specific disease or condition constitutes an additional element that integrates the judicial exception(s) into a practical application (such as effecting a particular treatment based on the judicial exception). The recitation of “administering a therapeutic agent to a patient to a patient observed to exhibit the presence of limbal stem cell deficiency” in lines 29-30 of claim 1 does not integrate the judicial exceptions into a practical application.
The administration of a therapeutic agent is recited as being directed to a patient observed to exhibit limbal stem cell deficiency (LSCD). There are no claim limitations directed towards the determination of whether a patient exhibits LSCD or not, only recitations of “correlating an observation of (a) with the presence or absence or stage of LSCD” and deriving “a comprehensive clinical score”. The comprehensive clinical score can be indicative of a presence of LSCD, as any stage of LSCD can be considered a presence of LSCD. However, the calculation of the comprehensive clinical score only recites three possible outcomes, where each outcome defines a stage of LSCD, and therefore a presence of LSCD. The claim does not reasonably convey how this score is relied upon to determine the administration of the therapeutic agent. Therefore, the recited administration of the therapeutic agent is not based on the comprehensive clinical score.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791