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 30 Sep 2025. As directed by the amendment: claims 1-2 and 5 have been amended, no claims have been canceled, claims 7-11 have been withdrawn, and no claims have been added. Thus, claims 1-6 are presently pending examination.
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 The objections to the claims have been withdrawn.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 have been fully considered and are persuasive in light of the claim amendments. The claim rejections under 35 U.S.C. 112 have been withdrawn.
However, new claim rejections under 35 U.S.C. 112 are made below, as necessitated by the claim amendments.
Applicant argues
The amendment adds the element of at least one limiting attachment attachable over the light exit of the head. These attachments are described in paragraph 0044 and subsequent paragraphs ("The beam size can also be adjusted by attaching a fixture with different aperture size at beam exit point. The aperture size can be 2, 4, 6, and 8 mm. The fixture can also contact a filter to adjust beam intensity as needed.") While not shown specifically in the curing light embodiment figures, shaping attachment apertures are shown in conjunction with therapeutic light heads, such as component 918 in FIG. 13.
(Remarks, page 7)
Neither paragraph [0044], nor the rest of the specification received on 05 Feb 2025, includes the excerpt quoted by Applicant above. The specification does not disclose that conical exit 918 is “selectively attachable to the emitter head, over a light exit in the same”, as recited in claim 1. Therefore, the amendment of “at least one limiting attachment selectively attachable to the emitter head, over a light exit in the same” is considered new matter, and claim 1 is rejected under 35 U.S.C. 112(a) and (b), as explained in further detail below.
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:
“said” in line 7 should be omitted
“control unit” in line 18 should read “control circuit”, consistent with Applicant’s Remarks, page 4
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 – not described in specification
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.
Claims 1-6 are 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.
As explained above, the claim limitation “at least one limiting attachment” in claim 1 (line 26) invokes 35 U.S.C. 112(f), and thus is limited by their description in the specification. However, the corresponding structure of this claim limitation was not described in the specification. Although the specification discloses conical exit 918, the specification does not explicitly disclose that conical exit 918 is “selectively attachable to the emitter head, over a light exit in the same”, as recited in claim 1. Therefore, the amendment of “at least one limiting attachment selectively attachable to the emitter head, over a light exit in the same” is considered new matter and fails to comply with the written description requirement.
Claims 2-6 are also rejected because they are dependent on claim 1.
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 “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 limitation “at least one limiting attachment” (claim 1, line 25) 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. Although the specification discloses conical exit 918, the specification does not explicitly disclose that conical exit 918 is “selectively attachable to the emitter head, over a light exit in the same”, as recited in claim 1. 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.
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 therapeutic diode laser source 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 and direct the radiant energy towards an emitter head (paragraph [0028], "The light may be transmitted through to the end of the tips by optical fiber") mounted upon a handpiece (Fig. 1, paragraph [0027], handle 11);
the emitter head being selected from a plurality of exchangeable emitter heads (paragraph [0023], plurality of emitter heads 12; paragraph [0027], "Multiple emitter heads 12 may be provided"; paragraphs [0040]-[0041], tips 61-69), each emitter head 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) selected from a set of emitter heads consisting of:
a collimation head further comprising a collimating lens, which 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 (paragraph [0041], "Tip 62 ... is used mainly for polymer curing applications"),
the collimation head further comprising a photo detector which measures intensity of the radiant energy and provides a feedback signal to a control unit which controls the intensity of the radiant energy (paragraph [0031], "one sensor is a proximity sensor 27, which measures the light reflected back to it. The proximity sensor is a LIDAR sensor ... A preferred sensor is a combination a proximity, gesture and ambient light sensor ... The light sensor can detect differences between light reflected back from teeth enamel vs. tissue, permitting treatment parameters to be adjusted accordingly"; paragraph [0032], "A control module 23 is housed in the emitter head 12. The control module 23 is typically a programmable logic device (PLD) or microprocessor and is in electrical communication with the LEDs, the sensors, the display 16, the battery 15, and a memory device"; paragraph [0042], "The sensor controller 80 is electrically connected to the emitter controller 23"); and
a therapeutic head (paragraph [0027], "sanitization, disinfection, sterilization, curing, increasing bioactivity, wound treatment"; paragraphs [0041], [0043]); and
at least one limiting attachment selectively attachable to the emitter head, 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]).
Regarding claim 2, the system of claim 1 is obvious over Harlan and Ibsen, as explained above. Harlan further discloses that the therapeutic diode laser source is a laser module 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 comprising 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 emitter head includes at least one optical fiber (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 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 Peterson (US 20160074144 A1, previously cited).
Regarding claim 5, the system of claim 1 is obvious over Harlan and Ibsen, as explained above. Harlan does not explicitly disclose that the emitter head includes at least one reflector.
However, Peterson teaches a curing light (curing instrument 100) comprising an emitter head including at least one reflector (Fig. 3, paragraph [0039], reflector ring 56).
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 Peterson so that the emitter head includes at least one reflector, because doing so directs the light toward the target surface (Peterson, paragraph [0039]).
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