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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/17/2024, 8/14/2025, and 9/10/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
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, the separate and distinct structural elements of “at least one imaging component,” at least one radiation component” and “at least one positioning element” combined in a single system as in claim 1 must be shown or the feature(s) canceled from the claim(s). Additionally, the “data processing component” recited in claim 2 must also be shown. 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 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:
“imaging component configured to extract target data” in claim 1, wherein the original specification does not define/disclose the exact structure (see 112a and 112b rejections);
“positioning component configured to position the radiation element” in claim 1, wherein the original specification discloses the positioning component to be a positioning state on page6; and
“data processing component…configured to transfer target data” in claim 2, wherein the original specification discloses the data processing component to be an structure found in the paragraph overlapping pages 19 and 20.
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 (as described above), 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(a)
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 1-12 and 15-19 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. The original specification does not disclose ANY specific structure capable of extracting target data. It does not appear the applicant possessed the claimed invention at the time of filing based on there being no disclosure of any details of the “imaging component.”
Claims 2-12 and 15-19 depend from claim 1 and are rejected based on their association.
Claim Rejections - 35 USC § 112(b)
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 1-12 and 15-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim limitation “imaging component configured to extract target data” 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. The original specification does not disclose ANY specific structure capable of extracting target data, and therefore, the metes and bounds of an “imaging component” cannot be determines. 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.
Claims 2-12 and 15-19 depend from claim 1 and are rejected based on their association.
Claim 11 recites the term “preferably.” It is unclear if this is a required limitation, or an optional limitation and thus the claim is indefinite. It is assumed it is optional.
Claim 12 recites the phrase “such that 6 microns.” This does not make sense.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 13 is directed to a process (Step 1 of MPEP 2106). The claim recites extracting target data from an imaging component and providing a radiation component. These limitations, as currently drafted, recite a process that covers performance of the limitations in the mind. Nothing in the claim precludes the steps from practically being performed in the mind. As a specific example, the brain can extract target data from the eyes (imaging component) and the brain is a radiation component (inherently emitting thermal radiation and ionizing radiation from naturally occurring radioactive elements like potassium-40). No tangible output, therapy, or change is claimed. That is, the claim does not require actually doing anything as a result of the extracting or providing or even specifically describing specialized circuitry or structures. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea (Step 2A in MPEP 2106).
This judicial exception is not integrated into a practical application. As described above, the claims do not attempt to apply the abstract idea to produce any useful/tangible output to a user, to deliver treatment to a patient or to change operation of a device itself. In particular, claim 1 merely recites a generic “imaging component” and a “radiation component.” These additional limitations are recited at a high-level of generality (i.e., as a generic component with no details in the claims). Additionally, the specification goes into no detail of the specific structure of the imaging component. The mere fact that a generic device is recited to perform certain tasks does not make the device "special purpose," based on the Supreme Court's decisions in Alice and Bilski, wherein providing a programmed computer with no further details is insufficient to impart eligibility. The current claims amount to no more than an abstract idea and trying to claim a generic computing device to “apply it." Additionally, data gathering and its generic components have been deemed an “extra-solution activity” that does not amount to an inventive concept when the activity is well-understood and/or conventional (see MPEP 2106.05(g)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea (Step 2B of MPEP 2106).
Additionally, invoking computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See. e.g., Versata Development Group v, SAP America, 793 F.3d 1306, 1335, 115 USPG2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must “play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly"). In this case, as described above, it is possible for the claimed functional language/method steps performed by the “computing device” and “processor” to be carried out mentally and/or manually. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using generic structures to perform certain functional language steps and/or to collect data amounts to no more than mere instructions to apply the exception using a generic computer component or to perform extra-solution activity in a conventional way. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Additionally, a generic “component” that has not been claimed with any specificity is considered by the Examiner to be well-understood, routine and conventional in the art and thus cannot be considered significantly more than the judicial exception. The recited “components” have not been claimed with any specificity and are considered by the Examiner to be well-understood, routine and conventional in the art and thus cannot be considered significantly more than the judicial exception.
Furthermore, the Examiner takes Official Notice that the components broadly and generically disclosed and claimed in the current application are well-understood, routine and conventional in the art for receiving and processing cardiac signals.
Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B of MPEP 2106).
Furthermore, the applicant has not shown that the claimed apparatus is necessarily and inextricably rooted in any specific technologies. For example, in DDR Holdings it was found that the claimed subject matter was significantly more because the abstract method was not just applied on/using the internet but it changed how the internet itself worked. In this case, the applicant’s claims do not change the functioning of the recited patient diagnostic system. Instead, these generic components are merely being used to apply the abstract idea, as in Alice.
While it seems clear that there is not a particular machine required by the claims, it also appears that there is not a particular transformation, either. It has been held that manipulation or signal processing of data to produce new data is NOT a transformation CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360 (Fed. Cir. 1994)).
Finally claim 13 is analogous to the case Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016) which contains the following analysis: Information as such is an intangible. See Microsoft Corp. v. AT & T Corp., 550 U.S. 437, 451 n.12 (2007). Accordingly, we have treated collecting information, including when limited to particular content (which does not change its character as information), as within the realm of abstract ideas. See, e.g., Internet Patents, 790 F.3d at 1349; OIP Techs., Inc. v. Amazon. com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015). In a similar vein, we have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category. See, e.g., TLI Commc’ns, 823 F.3d at 613; Digitech, 758 F.3d at 1351; SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 955 (Fed. Cir. 2014); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Diamond v. Diehr, 450 U.S. 175 (1981). And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. See, e.g., Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014). Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, and not any particular assertedly inventive technology for performing those functions. They are therefore directed to an abstract idea. Applicant should add some sort of active use to the claims, such as applying a SPECIFIC therapy or updating the functioning of the processor based on the determination/comparison.
Additional case law that is relevant to this analysis include Digitech (Organizing and manipulating information through mathematical correlations), and Grams (An algorithm for calculating parameters indicating an abnormal condition).
Therefore, the Examiner must conclude that claim 13 directed to an abstract idea. Regarding the dependent claims, the recited limitations fall under a mental process using the same rationale as above.
Claim 14 recites application of a particular treatment, and thus is eligible under 35 USC 101.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10, 13 and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhawalker et al. (US 2019/0387973, hereinafter Bhawalker).
Regarding claims 1-3, 13, 15, Bhawalker discloses a system and method wherein an imaging component is configured to extract target data (i.e., a picture/map) so that a positioning stage can position a laser diode (“radiation component”) based on the target data to deliver a treatment energy (par. 0013, 0038-0039, 0088, 0154-0155). This is carried out using data processing circuitry (par. 0283).
Regarding claim 4, the power can be between 0.001 and 1000 Watts (table on page 9).
Regarding claims 5 and 16, the beam width is between 100 microns and 500000 microns (table on page 9).
Regarding claim 6, the wavelength is between 200 nm and 20000 nm (table on page 9).
Regarding claim 7, the energy can be over 8kW/cm2 (see table on page 9).
Regarding claims 8, 17 and 18, the table on page 9 says that the power is up to 1000 W/cm2. A watt is equivalent to one Joule/second, thus 1000 W/cm2 is equivalent to 1000 J/cm2.
Claims 1, 2, 6, 7, 9-10, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grossman et al. (WO 2020/003138, hereinafter Grossman).
Regarding claims 1, 2, 9-10, and 13-15, Grossman discloses a system and method wherein an imaging component 207 is configured to extract target data (i.e., a picture/map) so that a positioning stage can position a laser (“radiation component”) based on the target data to deliver an ablative treatment energy to raise the temperature above 44 degrees Celsius and as high as 70 degrees Celsius (par. 0035-0039, 0064, 0067, 0078-0080, 0084, 0150, 0223, 0225). This is carried out using data processing circuitry (par. 0173).
Regarding claim 6, the wavelength is between 532 nm and 1064 nm (par. 0053).
Regarding claim 7, the energy can be over 8kW/cm2 (par. 0030-0031).
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.
Claims 11, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Grossman in view of Smits et al. (US 2012/0215209, hereinafter Smits).
Regarding claims 11, 19 and 20, Grossman discloses ablating tattoo ink with a laser but is silent as to the tattoo ink being fragmented for removal. Smits discloses a laser for ablating tattoo ink, and thus is analogous art with Grossman. Smits discloses that tattoo ink can be fragmented for removal via diffusion (i.e., movement through tunnels). Therefore, it would have been obvious that the ablation taught by Grossman would obviously result in fragmentation of the tattoo ink, the fragments being ejected from the body via any available tunnel, including an ablative tunnel, as taught by Smits.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796