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 without traverse of Invention I (claims 1-45) in the reply filed on 09/10/2026 is acknowledged.
Claim 46 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/10/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 5, 9, 16-17, 20,23, 25-26, 28-30, 32-33, and 35-38 are objected to because of the following informalities:
Claim 1 should be corrected to “a reservoir
Claim 5 should be corrected to “said optical fiber and/or [[a]] said fiber bundle” (line 1).
Claim 9 should be corrected to “[[the]] a distal end of said waveguide, [[the]] a proximal end of said waveguide” (lines 2-3).
Claim 16 should be corrected to “[[the]] a size” (lines 1-2).
Claim 17 should be corrected to “the material” (line 2).
Claim 20 should be corrected to “said at least one optical fiber and/or said at least one fiber bundle” (lines 1-2).
Claim 23 should be corrected to “a source[[,]] and a detector” (lines 2-3).
Claim 25 should be corrected to “at least one parameter of the material printed by said system” (lines 1-2).
Claim 26 recites the limitation “(c) said predefined material comprises a biologically active substance; (d) said predefined material comprises a biologically active substance” in lines 4-5. Either (c) or (d) should be deleted as both are the same.
Claim 28 should be corrected to “an illumination sourcethe area to which the material” (line 2), “at least one sensorthe material” (line 7).
Claim 29 should be corrected to “an additional energy sourcethe material” (line 4).
Claim 30 should be corrected to “said illumination source
Claim 32 should be corrected to “said focusing means is coupled” (line 1), “said at least one optical fiber and/or said at least one fiber bundle” (lines 1-2), “said at least one optical fiber and/or said at least one fiber bundle” (lines 3-4).
Claim 33 should be corrected to “said at least one optical fiber and/or said at least one fiber bundle” (lines 1-2).
Claim 35 should be corrected to “[[the]] a diameter of said at least one optical fiber and/or said at least one fiber bundle” (lines 1-2).
Claim 36 should be corrected to “each of said at least one optical fiber and/or said at least one fiber bundle is in communication with said focusing means” (lines 1-2).
Claim 37 should be corrected to “said at least one optical fiber and/or said at least one fiber bundle” (line 2).
Claim 38 should be corrected to “said at least one optical fiber and/or said at least one fiber bundle” (lines 1-2), “an optical path length of said focusing means is adjustable” (lines 2-3).
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
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 1-45 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.
Claim 1 recites the limitation “the body” in line 15. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation would be interpreted as “a body.”
Claims 2-45 are rejected under 35 U.S.C. 112(b) as being dependent from claim 1.
Claim 2 recites the limitation “distributable material” in line 1. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation “distributable material” means (1) the same as “a doner material within said reservoir “ (claim 1 line 5), (2) the same as “at least one biologically active substance”, (3) another new distributable material. For the purpose of examination, either of these interpretations would read on the claim.
Claim 2 recites the limitation “at least one energy source” in line 5. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation “at least one energy source” means (1) the same as or at least includes “an energy source” (claim 1 line 5), or (2) another new energy source. For the purpose of examination, either of these interpretations would read on the claim.
Claim 15 recites the limitation “a plurality of energy sources” in line 1. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation includes at least “an energy source” (claim 1 line 5), or another new plurality of energy source. For the purpose of examination, either of these interpretations would read on the claim.
Claim 26 recites the limitation “said predefined material” in lines 4 and 5, respectively. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation would be interpreted as “said material.”
Claim 29 recites the limitation “a feedback mechanism” in line 3. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation means (1) the same as “a feedback mechanism” (claim 28 line 4), or (2) another new feedback mechanism. For the purpose of examination, either of these interpretations would read on the claim.
Claim 33 recites the limitation “fast replacement of said focusing means” in lines 2-3. The underlined term “fast” is a relative term which renders the claim indefinite. The term “fast” 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. For the purpose of examination, the limitation would be interpreted as “replacement of said focusing means.”
Claim 34 recites the limitation “multiple focusing means” in line 2. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation “multiple focusing means” means (1) the same as or at least includes “at least one focusing means” (claim 8 line 3), or (2) another new multiple focusing means. For the purpose of examination, either of these interpretations would read on the claim.
Claim 38 recites the limitation “the coupling of the focusing means” in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation would be interpreted as “coupling of the focusing means” in line 1.
Claim 39 recites the limitation “the tissue” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation would be interpreted as “a tissue.”
Claim 40 recites the limitation “said receiving substrate” in line 2. There is insufficient antecedent basis for this limitation in the claim. Also, it is unclear whether the limitation means (1) the same as “an area to which said biologically active substance is to be deposited” (claim 1 lines 13-14), or (2) another new receiving substrate. For the purpose of examination, either of these interpretations would read on the claim.
Claim 41 recites the limitation “ink” in line 3. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation “ink” means (1) the same as “said biologically active substance” (claim 41 line 2), (2) the same as “a donor material “ (claim 1 line 5), or (3) another new ink. For the purpose of examination, either of these interpretations would read on the claim.
Claim 41 recites the limitation “said ink reservoir” in line 3. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation “said ink reservoir” means (1) the same as “a reservoir” (claim 1 line 3), or (2) another new ink reservoir. For the purpose of examination, either of these interpretations would read on the claim.
Claim 41 recites the limitation “said ink channel inlet” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation would be interpreted as “a channel inlet.”
Claim 42 recites the limitation “ink” in line 2. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation “ink” means (1) the same as “said biologically active substance” (claim 42 lines 1-2), (2) the same as “a donor material “ (claim 1 line 5), or (3) another new ink. For the purpose of examination, either of these interpretations would read on the claim.
Claim 42 recites the limitation “said ink reservoir” in line 2. There is ambiguous antecedent basis for this limitation in the claim. It is unclear whether the limitation “said ink reservoir” means (1) the same as “a reservoir” (claim 1 line 3), or (2) another new ink reservoir. For the purpose of examination, either of these interpretations would read on the claim.
Claim 42 recites the limitation “said ink channel inlet” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation would be interpreted as “a channel inlet.”
Claim 44 recites the limitation “the diameter of said at least one orifice is dependent on the LIFT application parameters” in lines 1-2. There are insufficient antecedent bases for these underlined limitations in the claim. For the purpose of examination, the limitation would be interpreted as “a diameter of at least one orifice is dependent on LIFT application parameters” and/or claim 44 is dependent from claim 43, instead of claim 42.
Claim 45 recites the limitation “the laser” in line 1. There is insufficient antecedent basis for this limitation in the claim. Also, it is unclear whether the limitation means (1) the same as “an energy source” (claim 1 line 5), or (2) another laser. For the purpose of examination, either of these interpretations would read on the claim.
Appropriate correction or clarification is required.
Claim 19 recites the limitation “laser parameter controlling means” in line 2. The limitation 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. Instant Specification discloses the claimed function but fails to discloses any corresponding structure or act for performing the claimed function (see Instant Specification: [0092, 0158. 0223], as published in US 20240359498). 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites the limitation “said energy source comprises at least one source selected from the group consisting of a laser; LED, pulsed laser, a heating filament; an electric arc; and an electronic resistance mechanism” in lines 1-3. The limitation “said energy source” is the one “configured to delivery energy to a donor material within said reservoir and thereby initiate a LIFT (i.e., Laser Induced Forward Transfer) process” (claim 1 lines 5-6). Here, the energy source requires at least to be a laser as it should initiate the LIFT process.” However, claim 4 further includes an energy source other than a laser such as the underlined ones - LED, a heating filament; an electric arc; and an electronic resistance mechanism. Thus, claim 4 fails to include all the limitations of claim 1 upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 2-3 and 5-45 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 1, Guillemot (WO 2011107599 A1) discloses a system (bioprinting device 4) for performing substrateless and/or local donor Laser Induced Forward Transfer (LIFT) (fig. 1 and page 11 lines 10-12: LIFT), wherein said system comprises:
a reservoir (a ribbon 6), comprising at least one opening (as shown in fig. 1) (fig. 1 and page 12 line 10: a ribbon 6 forming a reservoir of biological material 2), said reservoir embedded into, in fluid connection with, or incorporated into said medical device (bioprinting station 1) (fig. 1; page 10 line 4 – page 12 line 2: the substrate 3, made either directly of the tissue to be repaired or of any other appropriate support which allows for a subsequent effect or interaction with the cells of the tissue; page 22 lines 10 -24: application to a medical device); and,
an energy source (laser device 10) configured to deliver energy (laser energy) to a donor material (biological material 2) within said reservoir and thereby initiate a LIFT process (page 12, lines 17-26; of note, “a donor material” directed to articles or products worked upon by the claimed apparatus is only given patentable weight to the extent which effects the structure of the claimed invention; see MPEP 2115);
said system is characterized in a manner selected from the group consisting of:
a. said reservoir contains at least one biologically active substance (biological material 2) (fig. 1 and page 12 line 10; of note, “at least one biologically active substance” directed to articles or products worked upon by the claimed apparatus is only given patentable weight to the extent which effects the structure of the claimed invention; see MPEP 2115); and,
b. said reservoir is in fluid connection with at least one source of at least one biologically active substance;
wherein said system additionally comprising [at least one optical fiber and/or at least one fiber bundle in communication with said energy source, such that said energy source is configured to emit energy into said optical fiber or said fiber bundle and to deliver said energy to an area to which said biologically active substance is to be deposited by said LIFT process, so as to facilitate in-situ LIFT] performed inside the body during a procedure such that said biologically active substance is disposed within or onto said area being the body of a patient in need thereof (of note, this limitation “performed inside the body … onto said area being the body of a patent in need thereof” is directed to intended uses or capabilities of the claimed apparatus are only given patentable weight to the extent which effects the structure of the claimed invention; see MPEP 2114).
Guillemot teaches that imaging system 15 can be adapted to reveal an area of interest (page 13 line 23 – page 14 line 2) but the imaging system 15 does not comprises an optical fiber and/or fiber bundles in communication of the energy source for the LIFT process, and thus Guillemot does not specifically teach the bracketed limitation(s) as presented above.
Rogers (US 20130036928 A1) taches a transfer printing process/system using a LFIT process (abstract, [0004]). The system comprises at least one optical fiber and/or at least one fiber bundle in communication with said energy source, such that said energy source is configured to emit energy into said optical fiber or said fiber bundle and to deliver said energy to an area of an ink (fig. 2, [0037, 0096, 0106]), but does not specifically teach that said energy source is configured to deliver said energy [to an area to which said biologically active substance is to be deposited by said LIFT process, so as to facilitate in-situ LIFT]. Here, although the focused area of the laser beam can be adjusted, the energy delivered to the area of ink cannot be delivered to an area to which the ink to be deposited to facilitate said LIFT in-situ.
Grigoropoulos (US 20090130427 A1) teaches a LIFT system (abstract, fig. 5) but is silent about the deficiency limitation.
Similarly, Matsuda (US 5,521,140) teaches a recording unit structure for patterning of a recording material using a laser light source (figs. 1 and 34; abstract) but is silent about the deficiency limitation.
No other prior art of record has been found to disclose or render obvious all the limitations of the claim language as currently presented, by itself or in combination with another prior art of record; therefore, claim 1 would be allowable over the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Patrascioiu et.al., “Liquids microprinting through a novel film-free femtosecond laser based technique” Applied Surface Science, 257 (12), 2011, 5190-5194 (available at https://doi.org/10.1016/j.apsusc.2010.11.093) teaches a laser microprinting technique using a liquid reservoir (abstract, fig. 1).
Nomura (US 20090115820 A1) teaches an inkjet recording apparatus (abstract, fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to INJA SONG whose telephone number is (571)270-1605. The examiner can normally be reached Mon. - Fri. 8 AM - 5 PM.
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/INJA SONG/Primary Examiner, Art Unit 1744
