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 .
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-7 in the reply filed on 11/10/26 is acknowledged. Applicant’s arguments have not been found convincing, as the limitations relied upon by Applicant are not recited in both groups. Nevertheless, as discussed with Applicant’s representative, Karl Gross, during an oral restriction requirement interview on 1/22/26, both the restriction and the reply were on the basis of unity of invention, while the application is a bypass application. As agreed with Applicant’s representative: a) the restriction of 11/10/25 is superseded by a new restriction (and oral election) based on US application restriction practice (Rule 142), as explained in detail below, and b) Applicant orally elected Group I with traverse.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7, drawn to a laser system, classified in A61N 5/067,0601.
II. Claims 8-16, drawn to a method of detecting characteristics of an in-vivo object in a calcified blood vessel, classified in A61B 5/00,0033,0059.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case: a) the method does not require a catheter or a laser source, or a detection element (see 112f section), and could be practiced by non-invasive devices such as ultrasound, MRI or CT scans, and b) the product need not be used in relation to “in vivo object in a calcified blood vessel”, and could be used in kidney stone lithotripsy, cartilage reshaping, glaucoma treatment, photodynamic therapy treatments, laser treatments within body cavities (e.g. bladder denervation), or in ex-vivo experimentation. Furthermore, the product could be used altogether in non-medical applications, such as curing, marking, texturing, heating, welding, cutting, etching with feedback control in industrial, manufacturing, aerospace, chemical, commercial and/or automotive applications.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the claimed inventions require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) and the claims belong in different statutory categories. In addition, there would be a serious examination burden, because the method claims of Group II would invoke 35 USC 101 (they are only drawn to data gathering without any type of output or integration into a practical application and encompass the entirety of the field of diagnostics as it relates to the “in-vivo object in a calcified blood vessel”).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Karl Gross on 1/22/26 a provisional election was made with traverse to prosecute the invention of Group I, claim Claims 8-16. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Drawings
The drawings are objected to because: a) Fig. 8B is not sufficiently clear for printing, b) Fig. 7C should include labels and c) Fig. 12 should include labels to the axes. 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: “optical delivery element” and “detection element” in claim 1.
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 § 102
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 1-2, 4, and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0251116 by Steinke.
Regarding Claim 1, Steinke teaches a laser system capable of modification of a calcified blood vessel (e.g. abstract: remodeling and/or ablative laser treatment of atherosclerotic plaques), comprising:
a laser source (e.g. abstract, ¶67, Fig. 2: laser 22);
a feedback controller configured to regulate a dosimetry of the laser source to produce spatially and/or temporally modulated laser light (e.g. ¶ 19,68, Fig. 2: analyzer 24 also controls laser 22; ¶ 79-80: automatic modulation of the laser based on feedback, including depth, spot diameter, and location targeting modulation, thus spatial modulation; ¶99: the laser’s parameters, including frequency, delivery time, delivery location, are tunable based on in-situ feedback, thus also teaching temporal modulation; ¶ 106: dynamic dosimetry control via temporal modulation, such as varying duration and duty of energy delivery; ¶74: pulsed lasers alone meet the temporal modulation, as claimed);
a catheter comprising a first optical delivery element adapted to guide the modulated laser light to an in-vivo object in the calcified blood vessel (e.g. title, ¶¶ 5, 67, Fig. 2, Fig. 9A: catheter 12 is capable of being placed inside a blood vessel across from a plaque; ¶ 18, 69: the catheter includes one or more optical fibers for delivery the laser energy); and
a detecting element configured to detect one or more physical, chemical, mechanical and/or dimensional characteristics of an area of the in-vivo object in real-time (e.g. ¶¶ 17, 80-81, 84, 103-104, 106, 109, 114: OCT, spectroscopy, OCR configured to measure tissue characteristics such as, tissue type or atherosclerotic material type, tissue composition, plaque location, plaque shape, plaque composition, flow imaging, optical absorbance characteristics, temperature characteristics etc.),
wherein the feedback controller is configured to process the real-time detected information pertaining to the one or more physical, chemical, mechanical and/or dimensional characteristics of the area in real-time (e.g. ¶¶ 80-81, 94: OCT and spectroscopy based imaging is real-time imaging; ¶ 106, 108: dynamic measurements during application of energy), and
wherein the feedback controller is further configured to regulate in real-time the dosimetry of the laser source based on the real-time-detected information for a controlled formation of a porous structure and/or a zone of denaturized tissue in the in-vivo object (e.g. abstract, ¶¶ 54, 79, 80-81, 94, 112, 106,108,109,116, 118, 122: dynamic closed loop laser control based on real-time OCT imaging during the application of energy for remodeling, and/or hole forming of plaque, that can even be simultaneous).
Regarding Claim 2, Steinke discloses the laser system of claim 1, wherein the one or more physical, chemical, mechanical and/or dimensional characteristics comprise at least one of: a position of the in-vivo object; a composition of the in-vivo object; a dimension of the in-vivo object; a temperature of the in-vivo object and/or of an environment of the in-vivo object; a light scattering induced by the area of the in-vivo object; and a characteristic pertaining to a porous structure and/or a zone of denaturized tissue on the in-vivo object (e.g. ¶¶ 17, 80-81, 84, 103-104, 106, 109, 114: OCT, spectroscopy, OCR configured to measure tissue characteristics such as, tissue type or atherosclerotic material type, tissue composition, plaque location, plaque shape, plaque composition, flow imaging, optical absorbance characteristics, temperature characteristics etc.).
Regarding Claim 4, Steinke discloses the laser system of claim 1, wherein the first optical delivery element comprises a bundle of optical fibers (e.g. ¶17-18: bundle of fibers).
Regarding Claim 6, Steinke discloses the laser system of claim 1, wherein the feedback controller is capable of being coupled to a remote high-performance computer (Note that the computer has not been introduced and positively recited as part of the claimed device, e.g. such as “a system comprising: a controller and a computer, the controller is coupled to the computer”. As such, the claim only requires that the controller is capable of communicating with an external computer, something which is disclosed by Steinke in at least ¶ 68: analyzer has ethernet and internet communication capabilities).
Regarding Claim 7, Steinke discloses the laser system of claim 1, wherein the feedback controller is capable of being connected to a storage device, the storage device storing an offline settings table, wherein the settings table is calculated by a remote high-performance computer (Similar to claim 5, because the claim recites “or is connected” and has not positively introduced the storage device as part of the system, only the capability to connect to such a device is required. As such, Steinke teaches the capability of communication with external computers and their storage devices, including storage devices “storing an offline settings table, wherein the settings table is calculated by a remote high-performance computer”).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Steinke, as applied to Claim 1, in view of US 2021/0038311 by Shelton.
Regarding Claim 3, Steinke teaches the laser system of claim 1, yet does not explicitly teach wherein the feedback controller is configured to control, based on the real-time detected information, a distance between the optical delivery element and the in-vivo object during an irradiation by the laser source.
However, Shelton teaches an analogous laser catheter treatment system, wherein a spectroscopy-based imaging feedback analyzer detects in real-time and controls the distance between the distal end of the fiber and a calcified target in the body (e.g. ¶ 74, 128, 131-132, 173-174, Fig. 10A: distance 1060). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate distance measurements and control between the target tissue and the fiber in a device according to the teachings of Steinke, as taught by Shelton, as this would: a) predictably target and treat the target tissue, b) prevent damage of healthy tissue adjacent the plaque due to the vessel naturally pulsating or the distance between the catheter and the target changing, and c) distance to target is one of the parameters affecting dose delivery, and thus would have been obvious to try and control it for optimal treatment.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Steinke, as applied to Claim 1, in view of US 2016/0184526 by Beyar.
Regarding Claim 5, Steinke discloses the laser system of claim 1, further comprising a balloon configured to be inflated and deflated in the calcified blood vessel (¶¶ 53,58,66: balloon), yet does not explicitly disclose wherein the feedback controller is further configured to control a gas pressure in the balloon.
However, Beyar teaches an analogous intravascular balloon laser catheter which includes centralized control of the laser’s parameters and the balloon’s pressure (e.g. ¶178,260: controller 427 controls both the laser and balloon’s pressure). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate central control of the balloon’s pressure to the analyzer of a system according to the teachings of Steinke, as: a) this would predictably control balloon inflation, b) this would only amount to a selection among limited options (centralized vs. distributed control) that would have been obvious to try, and c) this would reduce reliance on multiple controllers and thus reduce the number of processing parts in the system.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 18/370,800 (reference application) in view of US 9125677 to Sobol.
Regarding Claim 1, Claim 1 of the copending application teaches a laser system capable of modification of a calcified blood vessel (the laser system of the copending application includes essentially the same structures as instant claim 1, and is also capable of activating stem cells, thus would be capable of modifying a calcified blood vessel at least via stem cells, and is explicitly capable of forming pores in Claim 5), comprising:
a laser source (Claim 1: a laser source);
a feedback controller configured to regulate a dosimetry of the laser source to produce spatially and/or temporally modulated laser light (Claim 1: a feedback controller configured to regulate a dosimetry of the laser source to produce spatially and/or temporally modulated laser light);
a first optical delivery element capable of guiding the modulated laser light to an in-vivo object in the calcified blood vessel (Claim 1: a first optical delivery element, also a fiber under 112f, capable of guiding the light to a target tissue); and
a detecting element configured to detect one or more physical, chemical, mechanical and/or dimensional characteristics of an area of the in-vivo object in real-time (Claim 1: detecting element configured to detect one or more physical, chemical, mechanical and/or dimensional characteristics of the area in real-time),
wherein the feedback controller is configured to process the real-time detected information pertaining to the one or more physical, chemical, mechanical and/or dimensional characteristics of the area in real-time, and wherein the feedback controller is further configured to regulate in real-time the dosimetry of the laser source based on the real-time-detected information for a controlled formation of a porous structure and/or a zone of denaturized tissue in the in-vivo object (Claim 1: wherein the feedback controller is configured to regulate in a real-time the dosimetry of the laser source based on the real-time detected information pertaining to the one or more physical, chemical, mechanical and/or structural characteristics in the area for a controlled activation of a stem cell outside of the first part of the area to form a hyaline cartilage tissue; Claim 5: wherein the feedback controller is further configured to regulate the dosimetry of the laser source for a controlled formation of a porous structure on the cartilage tissue and/or another object in the area based on the real-time detected information).
Claim 5 of the copending application does not explicitly disclose a catheter comprising the optical delivery element. However, Sobol teaches the use of a hollow cylinder catheter to lead an optical fiber to a target tissue insider the body, in an analogous laser treatment device (e.g. Fig. 3A: catheter 302). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate a catheter in the device of Claim 5 of the copending application, in order to predictably guide the fiber the target location without damaging the fiber.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/370,733 (reference application) in view of US 2012/0283557 by Berlin.
Regarding Claim 1, Claim 1 of the copending application teaches a laser system capable of modification of a calcified blood vessel (the laser system of the copending application includes essentially the same structures as instant claim 1, and is explicitly capable of modulating porous structures via temperature in Claim 3, thus would be capable of modulating a calcified blood vessel), comprising:
a laser source (Claim 1: a laser source);
a feedback controller configured to regulate a dosimetry of the laser source to produce spatially and/or temporally modulated laser light (Claim 1: a feedback controller configured to regulate a dosimetry of the laser source to produce spatially and/or temporally modulated laser light);
a first optical delivery element capable of guiding the modulated laser light to an in-vivo object in the calcified blood vessel (Claim 1: a first optical delivery element, also a fiber under 112f, capable of guiding the light to a target tissue); and
a detecting element configured to detect one or more physical, chemical, mechanical and/or dimensional characteristics of an area of the in-vivo object in real-time (Claim 1: detecting element configured to detect one or more physical, chemical, mechanical and/or dimensional characteristics of the area in real-time),
wherein the feedback controller is configured to process the real-time detected information pertaining to the one or more physical, chemical, mechanical and/or dimensional characteristics of the area in real-time, and wherein the feedback controller is further configured to regulate in real-time the dosimetry of the laser source based on the real-time-detected information for a controlled formation of a porous structure and/or a zone of denaturized tissue in the in-vivo object (Claim 1: wherein the feedback controller is configured to regulate in a real-time the dosimetry of the laser source based on the real-time detected information pertaining to the one or more physical, chemical, mechanical and/or structural characteristics in the area; Claim 2: the laser source is regulated to modify a porous structure; Claim 3: wherein the modulated laser light is suitable for achieving and/or maintaining a first temperature range and/or a second temperature range in the first area, wherein the porous structure is stabilized in the first temperature range, and the porous structure is destabilized in the second temperature range).
Claim 3 of the copending application does not explicitly disclose a catheter comprising the optical delivery element. However, Berlin teaches the use of a probe catheter to lead an optical fiber to a target tissue insider the body, in an analogous laser treatment device (e.g. ¶50, Fig. 3: catheter 23). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate a catheter in the device of Claim 3 of the copending application, in order to predictably guide the fiber the target location without damaging the fiber.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796