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 .
This office action is in response to applicant’s communication of 6/23/2026. Currently claims 1-17 are pending and rejected below.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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) 1-5, and 7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by LUKAC et al. (US 2021/0069756 A1).
Lukac discloses a liquid drug delivery device (as in figures 1-3b for example) configured to deliver a liquid drug (see para [0116] and liquid drug delivery system 26) to a target site from a location near said target site in a living tissue by irradiating said liquid drug with laser light (see para [00117] and laser source 4) at the location near said target site.
Concerning the amended claim language concerning the term “configured to deliver” examiner is reading the term as a functional claim term that describes a device or component constructed to perform a specific funcation. Examiner is of the positon that the structures of Lukac are “configured to deliver liquid to a target site” and contains all positively claimed structures.
Concerning claim 2 and said liquid drug comprises an anti-inflammatory agent, a disinfectant, an analgesic, a local anesthetic, a molecularly targeted drug, and a physiological saline solution (see para [0016] and anti-inflammatory medication).
Concerning claim 3 and wherein said target site is a jawbone (see para [0194] and it is examiners position that a “root canal” or bone cavity would be located at the “jawbone” as this is the structure that holds teeth for a root canal.
Concerning claim 4 and the target site is in a root canal from which dental pulp of a tooth adjacent to the jawbone has been removed (see para [0003], [0017], and [0194]).
Further concerning claims 3-4 the claimed limitations are directed to an apparatus or device, it is examiner’s position that these limitations are a functional intended use type limitation.
Concerning claim 5 and a liquid drug delivery system (as in figures 1-3b for example) comprising: an injector (see liquid delivery system 26 and handpiece 7 for example) for injecting a liquid drug into a location near a target site in a living tissue; and the liquid drug delivery device according to claim 1 (see rejection above of claim 1 and paras [0016]-[0017] and 26 delivery system and laser source 4).
Concerning the amended claim language concerning the term “configured to deliver” examiner is reading the term as a functional claim term that describes a device or component constructed to perform a specific funcation. Examiner is of the positon that the structures of Lukac are an injector “configured to inject a liquid to a target site” and contains all positively claimed structures.
Concerning claim 7 and a liquid drug delivery method comprising steps of: injecting a liquid drug into a location near a target site in a living tissue (see para [0016] and liquid delivery system 26); and delivering said liquid drug to said target site near said target site by irradiating said liquid drug with laser light (see para [0017] and laser source 4 for examples in the device shown in figures 1-3b). Examiner is of the position that the claim language of “from the location near said target site” is a subjective limitations as the distance “from the location near” is not an objective or finite term. Examiner is of the positon that the prior art Lukac location would be “near” as it is close and in the vicinity thereof.
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over LUKAC et al. (US 2021/0069756 A1) in view of Wallinski (US 2021/0353754 A1).
Lukac discloses the claimed invention except for the injector is a prefilled syringe. Wallinski teaches that it is known to use injector is a prefilled syringe as set forth in syringe element 14 and discussed in paragraphs at [0033]-[0037] (and further see figure 3) to provide a well known means to administer the drug fluid in a photodynamic laser therapy to a root canal for efficient and direct application of a medicament to a patient.. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system and method as taught by Lukac with injector is a prefilled syringe as taught by Wallinski, since such a modification would provide the system and method with injector is a prefilled syringe for providing a well known means to administer the drug fluid in a photodynamic laser therapy to a root canal for efficient and direct application of a medicament to a patient.
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Claim(s) 8-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over LUKAC et al. (US 2021/0069756 A1) in view of Wallinski (US 2021/0353754 A1).
Concerning claim 8-9, and 13-14; Lukac in view of Wallinski discloses the claimed invention except for specifically stating that the laser light has a pulse frequency of 1 to 10 pulses per second and/or 3 to 10 pulses per second. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the laser that the laser light at a pulse frequency of 1 to 10 pulses per second and/or 3 to 10 pulses per second, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955). These laser light pulses are well known pulses per second to a PHOSITA in the laser light field and further Lukac discloses any known pulses see para [0021]-[0026] in order to effectively treat a patient and procedure.
Concerning claim 10, and 15, Lukac in view of Wallinski discloses the claimed invention except for the laser light has an intensity of 10 to 30 millijoules. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the laser light have an intensity of 10 to 30 millijoules, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955). These laser light intensity of 10 to 30 millijoules are well known pulses per second to a PHOSITA in the laser light field and further Lukac discloses any known intensity see para [0029]-[0031] in order to effectively treat a patient and procedure discussing power of the laser and device.
Concerning claim 11-12, and 16-17, Lukac in view of Wallinski discloses the claimed invention except for said laser light has a power (intensity x pulse frequency) of 10 to 1000 milliwatts, and/or of 90 to 200 milliwatts. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have said laser light has a power (intensity x pulse frequency) of 10 to 1000 milliwatts, and/or of 90 to 200 milliwatts, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955). These laser light power (intensity x pulse frequency) of 10 to 1000 milliwatts, and/or of 90 to 200 milliwatts are well known pulses per second to a PHOSITA in the laser light field and further Lukac discloses any known power see para [0029]-[0031] in order to effectively treat a patient and procedure discussing power of the laser and device.
Response to Arguments
Applicant's arguments filed 6/23/2026 have been fully considered but they are not persuasive. Applicant argues that the prior art is no “configured to” deliver a liquid drug.
Concerning claim 1 and its dependants, in response to applicant's argument that the prior art is not “configured to”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitation of the claim. Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon.
Concerning the amended claim language concerning the term “configured to deliver” examiner is reading the term as a functional claim term that describes a device or component constructed to perform a specific funcation. Examiner is of the positon that the structures of Lukac are “configured to deliver liquid to a target site” and contains all positively claimed structures.
Concerning claim 7 method and the arguments regarding the language of “from the location near said target site”; examiner is of the position that the claim language of “from the location near said target site” is a subjective limitations as the distance “from the location near” is not an objective or finite term. Examiner is of the positon that the prior art Lukac location would be “near” as it is close and in the vicinity thereof.
The elements disclosed in Lukac, Wallinski, and any obvious modifications thereof, are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made. See rejection discussion above.
It is recommended that applicant amend the claims to greater define structural components in order to distinguish over the prior art of record.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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