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 Arguments
Applicant's arguments filed 8/4/2026 regarding the Double Patenting rejection have been fully considered but they are not persuasive. Applicant argues that that the current application and US Patent No. 9,125,677 are not commonly owned and therefore Double Patenting is improper. The Examiner respectfully disagrees. The current application and the Patent share a common inventor (Emil Sobol). MPEP 804 states:
Some commonality of inventorship or (deemed) ownership must exist between two or more patents or applications before consideration can be given to the issue of double patenting. For example, the patents or applications may have the same inventive entity. The patents or applications may also have at least one common (joint) inventor, which covers the situations where at least one patent or application names a sole inventor and the other patent(s) or application(s) names joint inventors and where all the patents or applications name joint inventors.
Since the current application and the Patent share at least one common inventor, Double Patenting is proper.
Applicant’s amendments and arguments filed 8/4/2026 with respect to the 35 USC 112(a) rejection has been fully considered and are persuasive. The USC 112(a) rejection has been withdrawn.
Applicant's arguments filed 8/4/2026 regarding the 102 rejections have been fully considered but they are not persuasive. Applicant argues that claim 1 requires a “setpoint” and that claim 1 requires the feedback controller be configured to control activation of a stem cell.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that there is some sort of programmed “setpoint”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With regard to the limitation of “for a controlled activation of a stem cell outside of the first part of the area to form a hyaline cartilage tissue” this is clearly an intended use/purpose of the feedback controller. The preamble explicitly recites that the system is merely “suitable for a treatment of a cartilage tissue” and not a system that is “configured to” treat a cartilage tissue.” Furthermore, the claim recites that 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.” This configuration is recited to be “FOR a controlled activation of a stem cell outside of the first part of the area to form a hyaline cartilage tissue.” The claim does NOT recite that the feedback controller is configured to control activation of a stem cell. It very clearly states that the feedback controller has structure that must regulate dosimetry based on characteristics. This structure is taught by Sobol, as described in par. 20 of the previous Office Action and again below. This structure can be used FOR a controlled activation of a stem cell outside of the first part of the area to form a hyaline cartilage tissue, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The rejections are still considered proper.
Claim Interpretation
The claims contain many instances of the use of “and/or.” The Examiner considers this to mean “or” unless otherwise stated in the rejection and therefore the prior art only needs to teach one of the alternative limitations found in the claims.
The claims are apparatus claims and are governed by the following principles of law:
"To anticipate a claim, a reference must disclose every element of thechallenged claim and enable one skilled in the art to make the anticipatingsubject matter." PPG Indus. Inc. v. Guardian Indus. Corp, 75 F.3d 1558,1566 (Fed. Cir. 1996).
"[T]he patentability of apparatus or composition claims depends onthe claimed structure, not on the use or purpose of that structure." CatalinaMktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir.2002).
"It is well settled that the recitation of a new intended use for an oldproduct does not make a claim to that old product patentable." In reSchreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
Therefore, any intended uses or desired purposes of the apparatus are not required to be taught by the prior art. For example, claim 1 recites that the laser system is “suitable for a treatment of a cartilage tissue in a joint” and that real-time feedback regulation of the dosimetry of the laser is “for a controlled activation of a stem cell.” Claim 5 recites that the feedback controller is configured to regulate the dosimetry “for a controlled formation of a porous structure.” Claim 6 recites that the optical delivery element is configured to irradiate “to include a formation of a cross-linkage of tissue.” Claim 7 recites that the feedback controller is configured to control the laser source and deliver element “to form a porous structure.” Claim 9 recites that the feedback controller is configured to regulate the laser source or effect exerting element “to activate or deactivate a nerve ending.” The claims do not require these uses/purposes to occur. The claims merely require a system with the structure recited.
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.
Claims 1 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15-17 of U.S. Patent No. 9,125,677. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim 1 anticipates the current claim 1. Patented claim 1 recites a laser source, a feedback controller configured to regulate a dosimetry of the laser to produce laser light, a first optical delivery element to guide the laser light, a detecting element(s) configured to detect information in real-time, and a feedback controller configured to regulate the dosimetry of the laser source in real-time based on the detected information. Therefore, all structural limitations recited in the claim are met.
Patented claims 15-17 anticipate current claim 8.
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sobol et al. (US 2015/0327932, hereinafter Sobol).
Regarding claim 1, Sobol discloses a laser system suitable for treatment of a cartilage tissue in a joint (par. 0011). The laser system includes a laser source 1108 (par. 0076, 0098). A feedback controller 126 is configured to regulate a dosimetry of the laser source to produce spatially and/or temporally modulated laser light (par. 0051). A first optical delivery element 304/305/1120 is configured to guide the laser light to an area in a joint to irradiate a first part of area (par. 0066-0068 and 0073). A detecting element 114 detects information of one or more physical, chemical, mechanical and/or structural characteristics in the area in real-time (par. 0040, 0052). The feedback controller is configured to regulate in real-time the dosimetry of the laser source based on the real-time detected information (par. 0012, 0053, 0077). The dosimetry is capable of a controlled activation of a stem cell outside of the first part of the area to form hyaline cartilage tissue, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, Sobol discloses the dosimetry is regulated to cause stress relaxation in the tissue (par. 0063, 0065).
Regarding claim 3, Sobol discloses a hollow channel element 302 that includes the optical element 304/305 and that can be used to deliver a pre-activated stem cell, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 4, the position of the laser can be adjusted in real-time (par. 0056).
Regarding claim 5, the feedback controller is configured to regulate the dosimetry of the laser, as described above. This can be for an intended use of controlling formation of a porous structure, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 6, the optical delivery element is configured irradiate a first area, as described above. This can be for an intended use of inducing a formation of a cross-linkage of tissue, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 7, the detecting elements 114 are for detecting stress distributions (par. 0025, 0036), and the feedback controller is configured to control the laser source and optical delivery element, as described above. This can be for an intended use of forming a porous structure, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 8 and 9, Sobol discloses a mechanical effect exerting element 1114 that can be controlled by the feedback controller in real-time (par. 0089-0091 and 0098). This can be for an intended use of activating or deactivating a nerve, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 10, the system is attached to a remote high-performance computer 1119 (fig. 11 and par. 0098).
Regarding claim 11, high performance computer 128 calculates a “settings table” which are stored for use (par. 0054).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2022/0022960, US 2022/0173755, US 2019/0175272 and US 6,156,030 all disclose laser systems with feedback controllers that can be used to treat cartilage in a joint, if so desired by a user.
US 2021/0348130 discloses a laser system for activating stem cells to form a hyaline cartilage tissue.
THIS ACTION IS MADE FINAL. 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 Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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
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