DEVICE FOR PHOTODYNAMICAL THERAPY OF CANCER

§103 §112 §251

DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Status of Submission This Office action is responsive to the amendment filed on November 14, 2023, which has been entered. Original patent claims 1-18 are canceled. New claims 19-33 are acknowledged and subject to examination. Related Proceedings Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 10,195,459 (hereinafter “the ‘459 patent”) is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application Nos. 61/100767, PCT/IL09/00929 and 13/121552, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of the prior-filed applications provide support for the claimed “copper circuit board”. As such, the filing date for the application at hand is that of the ‘459 patent – Sept, 10, 2014. Application Data Sheet The Application Data Sheet (ADS) filed on November 14, 2023 is defective because the “Domestic Priority Information” section contains errors. Specifically: Prior Application No. 16/525154, Patent No. RE49724 (from which the instant application is a Divisional application of) should also be identified as a reissue of 14/482432, Patent No. 10195459. Correction of the ADS is required in response to the Office Action. The correction of the ADS should be accompanied by a Request for Corrected Filing receipt. Reissue Applications – New Claim Support Claim Status and Statement of Support: The statement of support is insufficient. 37 CFR 1.173(c) states: (c) Status of claims and support for claim changes. Whenever there is an amendment to the claims pursuant to paragraph (b) of this section, there must also be supplied, on pages separate from the pages containing the changes, the status (i.e., pending or canceled), as of the date of the amendment, of all patent claims and of all added claims, and an explanation of the support in the disclosure of the patent for the changes made to the claims. (emphasis added) As such, the amendment filed 11/14/23 containing new claims 19-33 does not comply with 37 CFR 1.173(c) as the remarks failed to provide an explanation of the support in the disclosure of the patent for the changes made to the claims. Specifically, the Applicant states: PNG media_image1.png 684 645 media_image1.png Greyscale PNG media_image2.png 46 489 media_image2.png Greyscale The cited portions listed above fail to provide an explanation of support for the changes made to the claims. In particular, there is no support/explanation found within the original specification with regard to a “copper circuit board”. Addressing the claims lacking support: Claim 19 – Col. 5, Line 65 – Col. 6, Line 3; Col 7, Lines 21-24, 40-45; and Fig. 2. No disclosure of a “copper circuit board”, “LEDs on a copper circuit board” or transferring heat to a copper circuit board is found in the cited portions. Claims 22, 32 and 33 – Col. 7, Lines 21-24. The cited portion lacks disclosure of a “copper circuit board” as claimed. In response to this Office action, Applicant is required to provide a detailed and proper Statement of Support for the new reissue claims filed 11/14/23 that complies with 37 CFR 1.173(c), and also a detailed and proper Statement of Support for any new or amended claims filed in response to this office action. Consent of Assignee/Ownership This application is objected to under 37 CFR § 1.172(a) as lacking a proper written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR § 1.172. See MPEP § 1410.01. The Consent of Assignee filed 2/9/24, signed by Thomas Kerber, lacks a title of a person signing for the assignee. Thomas Kerber is recognized as the inventor of the ‘459 patent. However, a statement under 3.73(c) was filed on 2/9/24 assigning the application to Illumacell Inc. and it is unclear if the signing individual has proper authority to sign on behalf of the assignee. The consent of assignee must be signed by a party authorized to act on behalf of the assignee. For applications filed on or after September 16, 2012, the consent may be signed by the assignee or a patent practitioner of record. For applications filed before September 16, 2012, the consent must be signed by the assignee. Where the assignee is a juristic entity, the consent may be signed by a person in the organization having apparent authority to sign on behalf of the organization, or a person who makes a statement of authorization to act on behalf of the assignee. Parties authorized to act on behalf of the assignee include, an officer (chief executive officer, president, vice-president, secretary, or treasurer), chairman of the board of directors but not the signature of an individual director, and modifications of these basic titles are acceptable, such as vice-president for sales, executive vice-president, assistant treasurer, vice-chairman of the board of directors. Additionally, in foreign countries, a person who holds the title "Manager" or "Director" is normally an officer and is presumed to have the authority to sign on behalf of the organization. A person having a title (administrator, general counsel) that does not clearly set forth that person as an officer of the assignee is not presumed to have authority to sign the submission on behalf of the assignee. See MPEP § 325. A proper assent of the assignee in compliance with 37 CFR §§ 1.172 and 3.73 is required in reply to this Office action. Alternatively, it would be acceptable for a person, other than a recognized office to sign a submission establishing ownership interest, provided the record for the application includes a duly signed statement that the person is empowered to sign a submission establishing ownership interest and/or act on behalf of the assignee. Accordingly, a new submission establishing ownership interest which includes such a statement above, will be considered to be signed by an appropriate official of the assignee. A separately filed paper referencing the previously filed submission establishing ownership interest and containing a proper empowerment statement would also be acceptable. Correction of the Consent of Assignee is required. Use of Form PTO/AIA /53 is encouraged. Improper/Incomplete 37 CFR 3.73(c) This application is objected to under 37 CFR 1.172(a) as the assignee has not established its ownership interest in the patent for which reissue is being requested. An assignee must establish its ownership interest in order to support the consent to a reissue application required by 37 CFR 1.172(a). The assignee's ownership interest is established by: (a) filing in the reissue application evidence of a chain of title from the original owner to the assignee, or (b) specifying in the record of the reissue application where such evidence is recorded in the Office (e.g., reel and frame number, etc.). The submission with respect to (a) and (b) to establish ownership must be signed by a party authorized to act on behalf of the assignee. See MPEP § 1410.01. On the 3.73(c) statement filed on February 9, 2024, the chain of title data (i.e., reel and frame number where evidence is recorded in the Office) is missing. Furthermore, Applicant is advised to list the US Patent Number and filing date thereof on the newly submitted 37 CFR 3.73(c). An appropriate paper satisfying the requirements of 37 CFR 3.73 must be submitted in reply to this Office action. Reissue Oath/Declaration The Reissue Application Declaration By The Inventor (Form PTO/AIA /05) filed on November 14, 2023 has been reviewed and is accepted. 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 following features must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. “copper circuit board” (see claims 19, 22 and 32-33) “silicone space mat” (see claims 30-31) The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "40" and "120" have both been used to designate “the annular structure”. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 110 (See Figs. 4-5). 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 Rejections - 35 USC § 251 The following is a quotation of 35 U.S.C. 251: (a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue. PNG media_image3.png 18 19 media_image3.png Greyscale (b) MULTIPLE REISSUED PATENTS.—The Director may issue several reissued patents for distinct and separate parts of the thing patented, upon demand of the applicant, and upon payment of the required fee for a reissue for each of such reissued patents. PNG media_image3.png 18 19 media_image3.png Greyscale (c) APPLICABILITY OF THIS TITLE.—The provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent, except that application for reissue may be made and sworn to by the assignee of the entire interest if the application does not seek to enlarge the scope of the claims of the original patent or the application for the original patent was filed by the assignee of the entire interest. PNG media_image3.png 18 19 media_image3.png Greyscale (d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS. No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent. New Matter 35 USC 132(a) prohibits any amendment that introduces new matter into the disclosure of the invention. 35 USC 251(a) prohibits the introduction of new matter into the application for reissue. The amendment filed on 11/14/23 is objected to under 35 USC 132(a) and 35 USC 251(a) because it improperly introduces new matter for the reasons given below. GROUND 1: Claims 19-33 are rejected under 35 U.S.C. 251 as being based upon new matter added to the patent for which reissue is sought. The added material which is not supported by the prior patent (the ‘495 patent) is as follows: In new claim 19, a newly added limitation recites “a copper circuit board”, on which a plurality of light emitting diodes are on and to which heat generated by said plurality of light emitting diodes is transferred thereto. The ‘495 patent provides no disclosure or discussion with regard to a “copper circuit board”, nor is a “copper circuit board” illustrated in any of the Figures. In fact, the word “copper” is recited once in the specification of the ‘495 patent. That is, Col. 7, lines 21-24 states: Each segment would contain a 0.005″ thick circuit board with direct LED soldered contact copper to a liquid heat removal chamber with turbulent liquid flow to remove the maximum heat from the segment. (emphasis added). Applicant cited Col. 7, lines 21-24 as support for a “copper circuit board”, however the passage is absent of any teaching or disclosure regarding a “copper circuit board”. Rather, the ‘495 patent appears to be describing the connection between an LED and a liquid heat removal chamber via a soldered contact using copper. Likewise, claims 32-33 recite “wherein the copper circuit board comprises a plurality of copper circuit boards”, which is also not supported by the specification cited by the Applicant. 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. GROUND 2: Claims 19-33 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. For the reasons set forth (see GROUND 1), claims 19, 22 and 32-33 recite a “copper circuit board”. There is no suggestion, disclosure or teaching that the photodynamic therapy system comprises a “copper circuit board” and/or “multiple copper circuit boards”, as claimed. Thus, claims 19, 22 and 32-33, and the dependent claims therefrom fail to comply with the written description requirement. 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. GROUND 3: Claims 19-33 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. Claims 19, 22 and 32-33 recite the limitation “copper circuit board” which is as to what the Applicant intends to claim. Figure 1 illustrates a base plate 130, which appears to equate to segments 40 shown in Figures 2-3, and upon which LEDs 30 are positioned along an inner surface thereof. With a lack of a clear disclosure, it is unclear what Applicant intends to claim with the limitation of a “copper circuit board”. A POSITA would understand copper being a key material in forming pathways, or “traces”, on the circuit board, but not forming the entire backing thereof which is seemingly claimed. Furthermore, the specification refers to platforms or segments (see Col. 7, Lines 10-15) which are disclosed as “containing a circuit board” (see Col. 7, Lines 21-24). Thus, there is a clear distinction between the platforms/segments and the circuit board, but the relationship of both components to the plurality of LEDs is unclear as claimed. Additionally, it is unclear what is meant by claim 32 when reciting “the copper circuit board comprises a plurality of copper circuit boards, and wherein each segment contains one of the plurality of copper circuit boards”. Appropriate clarification and correction is required. Claims 20-33 are rejected as being necessarily dependent upon claim 19. The term “effective amount” in claim 20 is a relative term which renders the claim indefinite. The term “effective amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is considered to be an “effective amount of light” to treat a lesion area, as the lesion undoubtedly varies in size, shape, depth and composition from patient to patient. Claim 23 recites “wherein the luminous surface provided by the plurality of light emitting diodes has an area greater than 10 cm²” which leads to confusion, as the upper limit to the size of the area is not defined, nor is the range within the area recited in claim 1 (i.e. 31.25 cm² to 240 cm²). Claim 29 recites the limitation "high power LEDs of the plurality of light emitting diodes" in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 30-33 are rejected as being necessarily dependent upon claim 29. In view of the lack of clarity and ambiguity regarding the claimed invention, the following art is applied to the claims as best understood by the Examiner with regard to the inventive concept disclosed, in particular a “copper circuit board”: 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. Claim 19-33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Patent Application Publication No. 2005/0158687 to Dahm in view of US Patent Application Publication No. 2011/0184336 to Kerber. In regard to claims 19 and 23, Dahm disclose a photodynamic therapy system for treating cancer, the system comprising: a photodynamic therapy device comprising: a copper circuit board 14 (see Figs. 1a-b and para 0085), and a plurality of light emitting diodes 10 on said copper circuit board for providing a luminous surface, wherein the plurality of light emitting diodes are positionable in proximity of a patient's body (See Figs. 3-4), and wherein the plurality of light emitting diodes are adapted to provide a light fluence to a lesion area to irradiate the lesion area by power density at a skin surface overlaying the lesion area ranging between 200 mW/cm² and 3500 mW/cm² (see para 0089), a passage 34, 35 connected to the copper circuit board for accommodating a coolant to withdraw heat generated by the plurality of light emitting diodes that is transferred to the copper circuit board, wherein the passage fluidically couples to a feeding pipe through which the coolant is supplied to the passage and therein circulated through the passage to remove the heat (See Fig. 5). Dahm discloses that different quantity and sizes of LEDs may be used (see para 0106) but is silent with respect the photodynamic therapeutic device having a luminous surface of a total area from 31.25 cm² to 240 cm² as claimed. It would have been an obvious matter of design choice to provide a luminous surface of a total area from 31.25 cm² to 240 cm², since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Further evidence is provided by Kerber, teaching of an analogous photodynamic therapeutic device having a plurality of segments 40 including LEDs 30 thereon, and which may be having a luminous surface of a total area from 31.25 cm² to 240 cm² (See Figs. 1-3 and Table 1). It would have been obvious to a POSITA to modify the luminous surfaces of Dahm to include the total area as claimed to better adapt and conform to the patient’s body to which treatment is being applied as taught by Kerber. In regard to claim 20, Dahm disclose a photodynamic therapy system, wherein the plurality of light emitting diodes are operable to gradually increase light intensity of the luminous surface over treatment time to provide each of a plurality of measures of depth an effective amount of light until treated (See Figs. 1-5 and para 0086). In regard to claim 21, Dahm disclose a photodynamic therapy system, wherein the plurality of light emitting diodes are operable in an intermittent mode to provide intermitting active and inactive phases of illumination of the luminous surface (See para 0086). Furthermore, Kerber discloses light emitting diodes operable in an intermittent mode (See para 0017). In regard to claim 22, Dahm discloses that different quantity and sizes of LEDs may be used (see para 0106) but is silent with respect wherein the copper circuit board is 0.005" thick. It would have been an obvious matter of design choice to provide a .005” thick copper circuit board since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). In regard to claim 24, Dahm disclose a photodynamic therapy system, wherein, when the coolant is circulated through the passage to remove the heat, the coolant does not directly contact the plurality of light emitting diodes (See Fig. 5 and paras 0085-0090). In regard to claim 25, Dahm disclose a photodynamic therapy system, wherein the plurality of light emitting diodes are distributed along an inner surface of an annular structure (See Figs. 2-5). In regard to claim 26, Dahm disclose a photodynamic therapy system, wherein the plurality of light emitting diodes are grouped in a plurality of cooled units each comprising at least two diodes (See Fig. 2 and para 0087). In regard to claim 27, Dahm disclose a photodynamic therapy system, wherein a length of the annular structure is adjustable to accommodate different patient breast sizes (See para 0087). In regard to claim 28, Dahm disclose a photodynamic therapy system, wherein the photodynamic therapeutic device comprises a plurality of segments (See Figs. 2-5). In regard to claim 29, Dahm disclose a photodynamic therapy system, wherein each segment contains 2 to 40 high power LEDs of the plurality of light emitting diodes and requires up to 100 watts of heat removal (See Fig. 5 and paras 0085-0090). In regard to claims 30-31, Dahm disclose a photodynamic therapy system, wherein the plurality of segments have a clear silicone spacer mat 20 directly in front of the high power LEDs to protect and to remove the possibility of a lens of the high power LEDs directly coming into contact with skin and causing direct heat transfer (See para 0086). It would have been an obvious matter of design choice to provide a 0.3-0.5 cm thick spacer mat since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Furthermore, Kerber discloses the use clear of silicone spacer mat with a thickness of 0.3-0.5 cm (see para 0078). In regard to claims 32, Dahm disclose a photodynamic therapy system, wherein the copper circuit board comprises a plurality of copper circuit boards, and wherein each segment contains one of the plurality of copper circuit boards (see Figs. 1a-b and para 0085), In regard to claim 33, Dahm disclose a photodynamic therapy system, wherein the high power LEDs of each segment are soldered directly to the copper circuit board of the segment (see para 0091). Amendments in Reissue Applications Applicant is notified that any subsequent amendment to the specification, claims or drawings must comply with 37 CFR 1.173(b)-(g). In addition, for reissue applications filed before September 16, 2012, when any substantive amendment is filed in the reissue application, which amendment otherwise places the reissue application in condition for allowance, a supplemental oath/declaration will be required. See MPEP § 1414.01. The provisions of 37 CFR 1.173(b)(1), (d), (f) and (g) govern amendments to the specification (other than the claims) in reissue applications. The following guidance is provided as to the procedure for amending the specification: a) All amendments which include deletions or additions must be made by submission of the entire text of each added or rewritten paragraph containing the bracketing and/or underlining required by 37 CFR 1.173(d). b) An entire paragraph of specification text may be deleted by a statement deleting the paragraph without presentation of the text of the paragraph. c) Applicant must indicate the precise point where each amendment is made. d) All bracketing and underlining is made in comparison to the original patent, not in comparison to any prior amendment in the reissue application. Thus, all paragraphs which are newly added to the specification of the original patent must be submitted as completely underlined each time they are re-submitted in the reissue application. The provisions of 37 CFR 1.173(b)(2), (c)-(e) and (g) govern amendments to the claims in reissue applications. The following guidance is provided as to the procedure for amending the claims: a) For each claim that is being amended, the entire text of the claim must be presented with the bracketing and/or underlining required by 37 CFR 1.173(d). b) For each new claim added to the reissue, the entire text of the added claim must be presented completely underlined. c) A patent claim should be canceled by a direction to cancel that claim. There is no need to present the patent claim surrounded by brackets. d) A new claim (previously added in the reissue) should be canceled by a direction to cancel that claim. e) Pursuant to 37 CFR 1.173(b)(2), each claim that is amended or added should include the appropriate status indicator following the claim number, e.g., “(amended)”, “(twice amended)”, “(new)”, and “(canceled)”. f) Pursuant to 37 CFR 1.173(c), each amendment submitted must set forth the status of all patent claims and all added claims as of the date of the submission. The status to be set forth is whether the claim is pending or canceled. g) Also pursuant to 37 CFR 1.173(c), each claim amendment must be accompanied by an explanation of the support in the patent’s disclosure for all changes made in the claim(s), whether insertions or deletions. h) Pursuant to 37 CFR 1.173(e), original patent claims are never to be renumbered. A patent claim retains its number even if it is canceled in the reissue proceeding, and the numbering of any added claims must begin after the last original patent claim. i) Pursuant to 37 CFR 1.173(g), all bracketing and underlining is made in comparison to the original patent, not in comparison to any prior amendment in the reissue application. The provisions of 37 CFR 1.173(b)(3) govern amendments to the drawings in reissue applications. The following guidance is provided as to the procedure for amending drawings: a) Amending the original or printed patent drawing sheets by physically changing or altering them is not permitted. b) Where a change to the drawings is desired, applicant must submit a replacement sheet for each sheet of drawings containing a figure to be revised. Any replacement sheet must comply with 37 CFR 1.84 and include all of the figures appearing on the original version of the sheet, even if only one figure is being amended. Each figure that is amended must be identified by placing the word “Amended” at the bottom of that figure. Any added figure must be identified as “New”. In the event that a figure is canceled, the figure must be identified as “Canceled” and also surrounded by brackets. c) All changes to the figure(s) must be explained, in detail, beginning on a separate sheet which accompanies the papers including the amendment to the drawings. d) If desired, applicant may include a marked-up copy of any amended drawing figure, including annotations indicating the changes made. Such a marked-up copy must be clearly labeled as “Annotated Marked-up Drawings”, and it must be presented in the amendment or remarks section that explains the change to the drawings. Failure to fully comply with 37 CFR 1.173(b)-(g) will generally result in a notification to applicant that an amendment before final rejection is not completely responsive. Such an amendment after final rejection will not be entered. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW J KASZTEJNA whose telephone number is (571)272-6086. The examiner can normally be reached M-F, 7AM--3PM. 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, Eileen Lillis can be reached on 571-272-6928. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MATTHEW J KASZTEJNA/ Reexamination Specialist, Art Unit 3993 Conferees: /JOSHUA KADING/Reexamination Specialist, Art Unit 3993 /EILEEN D LILLIS/SPRS, Art Unit 3993