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 Amendment
This Office Action is responsive to the amendment filed on 17 Sep 2025. As directed by the amendment: claims 1-2 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-6 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed 30 Sep 2025, with respect to the objections to the claims have been fully considered and are persuasive in light of the claim amendments. The objections to the claims have been withdrawn.
However, new claim objections are made below, as necessitated by the claim amendments.
Applicant’s arguments, see Remarks, filed 30 Sep 2025, with respect to the claim rejections under 35 U.S.C. 112 regarding “said exchangeable emitter head being removable from the system” and whether the energy divergence system, the collimating lens, and the therapeutic fiber are part of the claimed curing light have been fully considered and are persuasive in light of the claim amendments. These claim rejections under 35 U.S.C. 112 have been withdrawn.
The claim rejection regarding “a therapeutic head that receives energy from the collection fiber and emits said radiant energy as non-collimated light” is maintained, as this limitation still defines the therapeutic head in functional language specifying the desired result without describing the structure that achieves this result.
Applicant’s arguments, see Remarks, filed 30 Sep 2025, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Harlan et al. (US 20190046812 A1), hereinafter Harlan, as explained in further detail below.
No specific arguments were made regarding dependent claims 2-6 and the previously cited prior art references. Therefore, claims 2-6 are also rejected below.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1:
“the” should be added before “radiant energy” in lines 15, 20, and 23
“said radiant emission source” in line 7 should read “the laser module”, consistent with line 3
Appropriate correction is required.
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 limitations are:
Claim 1: “at least one limiting attachment” in line 25 – specification paragraph [0044]
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.
The structure of the therapeutic head recited in claim 1 is unclear because it is defined in functional language specifying the desired result (“receives radiant energy from the collection fiber and emits said radiant energy as non-collimated light”) without describing the structure that achieves this result.
The structure of “at least one limiting attachment” recited in claim 1 (line 25) is unclear because it is defined in functional language specifying the desired result (“limiting”, “selectively attachable to at least one of the emitter heads, over a light exit in the same”) without describing the structure that achieves this result. Furthermore, it is unclear as to what is being limited by the attachment.
Claims 2-6 are also rejected because they are dependent on claim 1.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Harlan et al. (US 20190046812 A1), hereinafter Harlan, in view of Ibsen et al. (US 20090052184 A1, previously cited), hereinafter Ibsen.
Regarding claim 1, Harlan discloses a system combining therapeutic lasers and curing lights (paragraphs [0023], [0028], "In this manner a single device can be used for multiple applications, such as sanitization, disinfection, sterilization, curing, increasing bioactivity, wound treatment, or ablation, by exchanging one of the interchangeable emitter heads for another"), the system comprising:
a laser module capable of emitting radiant energy in multiple, discrete, selectable wavelengths (paragraph [0027], "Light emitting diodes (LEDs), sensors, and control modules are housed in the emitter head 12. The emitter head 12 contains at least one LED 20 for emitting the treatment light. The treatment LED 20 may emit any wavelength, from UV-C to infrared, roughly a range of 200-1400 nm. ... Multiple emitter heads 12 may be provided to cooperate with the handle 11, each one with at least one treatment LED 20 having a different wavelength");
a lens which collects the radiant energy and focuses it into a single beam (paragraph [0028], "The device may have one or more optical devices to shape or manipulate the emitted energy, such as a lens"; paragraph [0042], "One or more lenses may be placed inline with the treatment LED, such as spherical lenses 81, to shape or manipulate the emitted energy"); and
a collection fiber targeted by the single beam to channel the radiant energy from the therapeutic diode laser source (paragraph [0028], "The light may be transmitted through to the end of the tips by optical fiber") and direct the radiant energy towards an exchangeable emitter head (paragraph [0023], plurality of emitter heads 12; paragraph [0027], "Multiple emitter heads 12 may be provided"; paragraphs [0040]-[0041], tips 61-69) mounted upon a handpiece (Fig. 1, paragraph [0027], handle 11), said exchangeable emitter head being removable from the handpiece and selected from a plurality of exchangeable emitter heads selectable to a given purpose (paragraph [0028], "In this manner a single device can be used for multiple applications, such as sanitization, disinfection, sterilization, curing, increasing bioactivity, wound treatment, or ablation, by exchanging one of the interchangeable emitter heads for another"; paragraph [0033]) and said plurality of emitter heads including at least three emitter heads (paragraphs [0040]-[0041], tips 61-69) and said plurality of exchangeable emitter heads including at least three emitter heads (paragraphs [0040]-[0041], tips 61-69) selected from a set of emitter heads consisting of:
a curing head comprising an energy divergence system and a collimating lens, wherein the curing head receives radiant energy from the collection fiber and directs said radiant energy into the energy divergence system (paragraph [0028], "The light may be transmitted through to the end of the tips by optical fiber"), followed by the collimating lens, which then collimates the radiant energy (paragraph [0028], "The device may have one or more optical devices to shape or manipulate the emitted energy, such as a lens or a collimator"; paragraph [0042], "One or more lenses may be placed inline with the treatment LED, such as spherical lenses 81, to shape or manipulate the emitted energy") and emits it as a curing light;
at least one limiting attachment selectively attachable to at least one of the emitter heads, over a light exit in the same (Fig. 12, paragraph [0041], removable tips 61-69 have different shapes);
wherein the emitter head is selected to transform and emit radiant energy according to a given procedure and attached to the system for use (paragraph [0027], "Multiple emitter heads 12 may be provided to cooperate with the handle 11, each one with at least one treatment LED 20 having a different wavelength and having different operational parameters. In this manner a single device can be used for multiple applications, such as sanitization, disinfection, sterilization, curing, increasing bioactivity, wound treatment, or ablation, by exchanging one of the interchangeable emitter heads for another.").
Although Harlan discloses that the system can be used for ablation (paragraph [0027]), Harland does not explicitly disclose a laser head further comprising a therapeutic fiber, which concentrates the radiant energy into a focused, cutting laser.
However, Ibsen also teaches a system combining therapeutic lasers and curing lights (paragraphs [0010], [0020], [0036]-[0037], [0039]) that comprises a laser head comprising a therapeutic fiber, which concentrates the radiant energy into a focused, cutting laser (paragraphs [0048], [0057]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harlan with the teachings of Ibsen to include a laser head further comprising a therapeutic fiber, which concentrates the radiant energy into a focused, cutting laser, because doing so provides better access to tissue in confined areas (Ibsen, paragraph [0003]).
Although Harlan further discloses that the system consists of a therapeutic head (paragraph [0027], "sanitization, disinfection, sterilization, curing, increasing bioactivity, wound treatment"; paragraphs [0041], [0043]), Harlan does not explicitly disclose that the therapeutic head receives radiant energy from the collection fiber and emits said radiant energy as non-collimated light.
However, Ibsen further teaches a therapeutic head that emits the radiant energy as a non-collimated therapeutic light (paragraph [0039], "An attachment at the distal end of the flexible light guide diverges ... the light").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harlan with the teachings of Ibsen so that the therapeutic head emits the radiant energy as a non-collimated therapeutic light, because doing so enables control of the geometry of the light at the attachment on the distal end prior to the light entering the final working end tip (Ibsen, paragraph [0039]).
Regarding claim 2, the system of claim 1 is obvious over Harlan and Ibsen, as explained above. Harlan further discloses that the laser module is capable of emitting radiant energy at a plurality of discrete frequencies (paragraph [0027], "Light emitting diodes (LEDs), sensors, and control modules are housed in the emitter head 12. The emitter head 12 contains at least one LED 20 for emitting the treatment light. The treatment LED 20 may emit any wavelength, from UV-C to infrared, roughly a range of 200-1400 nm. ... Multiple emitter heads 12 may be provided to cooperate with the handle 11, each one with at least one treatment LED 20 having a different wavelength") and the system further comprises a control circuit to select one discrete frequency to emit at a time (paragraph [0032], "The control module 23 ... controls the operational parameters of the device ... Operation parameters include ... wavelength mix").
Regarding claim 3, the system of claim 1 is obvious over Harlan and Ibsen, as explained above. Harlan further discloses that the energy divergence system further comprises at least one energy transmittal fiber optic with a divergent numerical aperture (paragraph [0028], "The light may be transmitted through to the end of the tips by optical fiber").
Regarding claim 4, the system of claim 1 is obvious over Harlan and Ibsen, as explained above. Harlan further discloses that the emitter head includes at least one divergent lens (paragraph [0028], "The device may have one or more optical devices to shape or manipulate the emitted energy, such as a lens"; paragraph [0042], "One or more lenses may be placed inline with the treatment LED, such as spherical lenses 81, to shape or manipulate the emitted energy").
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Harlan et al. (US 20190046812 A1), hereinafter Harlan, in view of Ibsen et al. (US 20090052184 A1, previously cited), hereinafter Ibsen, and further in view of Takagi et al. (CA 2507479 A1, previously cited), hereinafter Takagi.
Regarding claim 5, the system of claim 1 is obvious over Ibsen and Peterson, as explained above. Neither Harlan nor Ibsen explicitly discloses that the system further comprises a coiled fiber optic resident within the handpiece. However, Takagi teaches an optical fiber (Abstract) wherein the optical fiber is coiled (paragraphs [0014], [0037]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harlan and Ibsen with the teachings of Takagi to include a coiled fiber optic resident within the handpiece because doing so enables a more compact structure and reduces bending loss of light (Takagi, paragraph [0014]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Harlan et al. (US 20190046812 A1), hereinafter Harlan, in view of Ibsen et al. (US 20090052184 A1, previously cited), hereinafter Ibsen, and further in view of Koo (KR 20150076793 A, previously cited).
Regarding claim 6, the system of claim 1 is obvious over Harlan and Ibsen, as explained above. Neither Harlan nor Ibsen explicitly discloses that each emitter head in the set of emitter heads is selectively magnetically secured to the handpiece.
However, Koo teaches a replaceable medical handpiece which is allowed to replace various types of head members (Abstract) wherein each head member (Fig. 2, head member 130) is selectively magnetically secured to the handpiece (page 3 of English translation, fourth paragraph from bottom of page, "The first permanent magnet 123 is for facilitating the coupling between the main body 120 and the head member 130."; page 5 of English translation, seventh-tenth paragraphs on page).
It would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Harlan and Ibsen with the teachings of Koo so that each emitter head in the set of emitter heads is selectively magnetically secured to the handpiece, because doing so makes switching head members fast and accurate (Koo, page 5 of English translation, ninth paragraph on page).
Other prior art considered pertinent to the instant application:
DeBenedictis et al. (US 20060095096 A1) discloses a laser treatment system, wherein a set of tips may be interchangeably attached to the treatment system to alter the system parameters and the treatment provided through the individual tips
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 CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796