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 .
Response to Arguments
Applicant’s arguments, see Applicant’s Response, filed 4/28/220226, with respect to the Non Final Office Action mailed on 12/29/2026 have been fully considered and are persuasive. Therefore, all previous rejections are withdrawn in favor of the below rejections.
Election/Restrictions
Newly submitted claims 96-97 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: independent claim 96 recites that the processing unit is configured to perform wavelet analysis which is not in the previously presented independent claim. This is considered to be independent and distinct.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 96-97 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
It is noted that claims 72-88 have also been withdrawn due to a previous restriction requirement.
Drawings
The drawing submitted on 4/28/2026 has been entered.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a biological object (claim 54), the light source (claim 54), processing circuitry (claim 54), a glucose sensor (claim 55), a cardiac output sensor (claim 56), at least one probe (claim 57), a unit for administering (claim 58), an actuator (claim 58), a balloon (claim 58), a multi-lumens catheter (claim 58) and a metabolic monitoring unit (claim 62), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 55 recites the limitation "the level of glycemia measured” in line 3. There is insufficient antecedent basis for this limitation in the claim. This language should read; “a level of glycemia measured”.
Claim 56 recites the limitation "the cardiac output” in line 3. There is insufficient antecedent basis for this limitation in the claim. This language should read; “a cardiac output”.
Claim 62 recites the limitation “the time, the fluence rate” in line 3. There is insufficient antecedent basis for this limitation in the claim. This language should read; “a time, a fluence rate”.
Claim 66 recites “the application of PBM”, this language lacks proper antecedent basis and should read “an application of PBM”.
Claim 71 recites the limitation “the blood” which lacks antecedent basis and should recite “blood”.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“light source” in claim 54
“processing unit” in claim 54 – considered to be a processor which has processing circuitry
“processing circuitry” in claim 54
“metabolic monitoring unit” in claim 62
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.
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 § 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 54 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. Amended claim 54 recites “processing circuitry” which is configured in a specific way based on claim 54 as well as other dependent claims. The specification does not discuss circuitry at all, although a processor would inherently have circuitry the fact that the language requires that the processing circuitry is configured in a specific way results in new matter because circuitry is not discussed in any way.
Claim 54 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for PBM, does not reasonably provide enablement for PBM for all possible biological objects which would necessarily include individual cells, individual cell components (mitochondria, nucleus, ribosomes, cell membranes), organs (heart, lungs, brain, bone etc), blood, lymph tissue and much more. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the full scope of a “biological object” which is commensurate in scope with these claims. If a patent is granted on the claims, with the language “biological object” which is a broad recitation any and all biological objects would be covered by patent terms. The specification simply does not provide an adequate description to allow for all biological objects.
Regarding claim 55: the claim recites “wherein said processing is further configured to adjust a light dose according to the level of glycemia measured by said glucose sensor.” There is no disclosure as to how the processor is specifically configured to adjust light dose based on glycemia measured. This would take hardware and software neither of which are disclosed.
Regarding claim 56: the claim recites “wherein said processing is further configured to adjust a light dose according to the cardiac output measured by said cardiac output sensor.” There is no disclosure as to how the processor is specifically configured to adjust a light dose based on cardiac output. This would take hardware and software neither of which are disclosed.
Regarding claim 57: the claim recites “wherein said processing unit is further configured to adjust a light dose according to said enzyme activity”. There is no disclosure as to how the processor is specifically configured to adjust a light dose based on enzyme activity. This would take hardware and software neither of which are disclosed.
Regarding claim 62: the claim recites “a metabolic monitoring unit, configured to adjust the optical power, the delivery of light, the time, the fluence rate and/or an irradiance based on at least one metabolic parameter reflecting a metabolic activity of the biological object measured by the metabolic monitoring unit.” There is no disclosure as to how a metabolic monitoring unit is specifically configured to adjust optical power, light delivery, time, fluence rate and/or irradiance based on a metabolic parameter. This would take hardware and software neither of which are disclosed.
Regarding claim 66: the claim recites “wherein the processing is configured to predict an optimal time to start the application of PBM based on the at least one metabolic parameter measured by the metabolic monitoring unit”. There is no disclosure as to how the processing unit is specifically configured to predict optimal time to start PBM. This would take hardware and software neither of which are disclosed.
Regarding claim 67: the claim recites “wherein the fact that the processing unit is configured to generate a combined or sequential light comprising at least one potent wavelength and at least one ineffective wavelength when used alone.” There is no disclosure as to how the processing unit is specifically configured to generate combined or sequential light. This would take hardware and software neither of which are disclosed.
Claims 54-57, 62 and 66-67 are rejected based on written description as shown above. With respect to the written description requirement, this requirement is separate and distinct from enablement. The processing unit is considered to be a processor and the language associated with the processor is computer implement claim language. With computer implemented claim language if the hardware and the software are not adequately disclosed or not disclosed at all the language fails to be supported by the written description. The MPEP states, with respect to software lacking adequate written description; “For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.” Further due to the interplay between hardware and software, both the hardware and software must be disclosed. In this case the hardware and software are not disclosed in sufficient detail to allow for one of ordinary skill in the art to determine that the inventors have possession of the claimed invention. Specifically, the MPEP states “It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement”. Therefore due to the lack of written description regarding the hardware and software, there is undue experimentation needed to make and use the invention.
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 54-71 and 89-95 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 54: lines 3-4 recite “a light source configured to deliver light with a temporal evolution of its optical power to the biological object interstitially or endovascularly”. In paragraph 0194 of applicant’s Publication 2023/0364442 (application number 18/029,714) temporal evolution is defined by equation 5. In this same paragraph it is stated: “The temporal evolution of the irradiance E(t)” it is unclear if the temporal evolution recited in claim 54 is the temporal evolution of irradiance E(t) or if this is the temporal evolution of optical power as recited later in the claim. Further, it is not proper to use the language “its” in claim construction. Because the language cannot be interpreted and is unclear it is therefore also indefinite.
Regarding claim 54: lines 8-12 recite “determine the temporal evolution of the optical power to minimize a total treatment time based on a plurality of biological object coefficients, and on light delivery geometry on/in the biological object”. Initially, the language “on a plurality of biological object coefficients” lacks antecedent basis. It is assumed that the biological object is the same biological object presented earlier in the claim and this language should read “determine the temporal evolution of the optical power to minimize a total treatment time based on a plurality of the biological object coefficients, and on light delivery geometry on/in the biological object”. However, this is an assumption and it is not clear if this is the same or a different biological object. Still regarding lines 8-12; the language on light delivery geometry on/in the biological object is not understood. It is unclear how light delivery has a geometry, the light delivery element (light source) could have a geometry however the light delivery language is ambiguous. Further the language “in/on the biological object” is unclear.
Regarding claim 63: the claim recites “wherein the adjustment of the optical power, the delivery of light, the time, the fluence rate and/or the irradiance influences or modifies an amplitude, a frequency of fluctuations and/or a change of the at least one metabolic parameter of the biological object.” It is unclear if the irradiance influences is the same as irradiance from claim 62 therefore antecedent basis cannot be determined. Further because of the multiple and/or statements this claim is indefinite, the language is not understood.
Regarding claim 67: the claim recites “wherein the fact that the processing unit is configured”. The language “the fact that” is improper and should be removed.
The remainder of the claims are also rejected in that they depend from previously rejected claims.
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.
Claims 89-95 are 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. Claims 89-95 each recite a method of using the device of claim 54 without providing any further structural limitations. Each claim is simply using the device differently and therefore does not further limit the structure in any manner. These claims are considered to be intended use limitations. 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 limitations “light source” in claim 54, “processing circuitry” in claim 54, “a unit” in claim 58 and “metabolic monitoring unit” in claim 62 each invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Claim 54 recites “a light source configured to deliver light with a temporal evolution of its optical power to the biological object interstitially or endovascularly”. Initially there is no drawing which specifically labels or otherwise denotes what applicant intends a light source to be. The light source could be an optical fiber, laser, LED or broadband lamp. The specification provides no disclosure as to what applicant intends the light source to be.
Claim 54 recites “processing circuitry, configured to: determine the temporal evolution of the optical power to minimize a total treatment time based on a plurality of biological object coefficients, and on a light delivery geometry on/in the biological object”. The specification contains do drawings of circuitry and/or circuit components (filters, resistors, inductors etc.). Further, it is not disclosed how the inventors intend to design such a circuit which is capable of the intended function of determining the temporal evolution of the optical power to minimize a total treatment time based on a plurality of biological object coefficients, and on a light delivery geometry on/in the biological object.
Claim 62 recites “a metabolic monitoring unit, configured to adjust the power, the delivery of light, the time, the fluence rate and/or an irradiance based on at least one metabolic parameter”. The drawings do not show a metabolic monitoring unit, further the specification does not provide disclosure as to how a metabolic monitoring device or unit would be configured to adjust the power, the delivery of light, the time, the fluence rate and/or an irradiance based on at least one metabolic parameter. This would inherently require both hardware and software which is not disclosed.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
All claims are rejected under 35 U.S.C § 112 and it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions. (In re Steele 305 F.2d 859,134 USPQ 292 (CCPA 1962)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yaroslavsky et al. US 2007/0219604 is considered to be the closest prior art of reference and was used previously as a basis of rejection. However, Yaroslavsky does not disclose the definition applicant has provided for temporal resolution which is based on biological object coefficients and light delivery geometry in/on the biological object. It is noted that this claim language is rejected under 35 USC 112 as specified above, however the special definition of temporal resolution provided in equation 5 of applicants disclosure appears to be unique.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paula J. Stice whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-272-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
Prosecution Insights