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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, Species B, in the reply filed on 10/9/25 is acknowledged. Claims 4-5, 8-9, 13-16 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and Species, there being no allowable generic or linking claim.
Claim Interpretation
The claims recite an apparatus with structural limitations and material worked upon by the apparatus. While there is nothing wrong with claiming the material worked upon, such limitations are only given weight to the extent that they limit the structure of the claimed apparatus. See MPEP 2115. See In re Rishoi (94 USPQ 71), In re Smith (3 USPQ 315), and In re Young (25 USPQ 69).
In Rishoi, a film of liquid was claimed as part of an apparatus, it being clear that the liquid film is only present during use of the apparatus. It was held that the liquid film is not a structural limitation and therefore cannot impart patentability to those claims which are otherwise unpatentable. It was further stated that there is no patentable combination between a device and the material upon which it works.
In Smith, a particular web material having an extra length of carbons was claimed as part of an apparatus. The web material is worked upon by the apparatus. The court considered the possibility of combining the specified web with an old machine to provide a patentable combination, but it was held that a person may not patent a combination of a device and material upon which the device works, nor limit other persons from the use of similar material by claiming a device patent.
In Young, a concrete structure upon which an apparatus works was claimed as part of the apparatus. It was held that the inclusion of the material worked upon may not lend patentability to the apparatus.
In view of the cited cases and MPEP 2115, the claimed material worked upon has only been given weight to the extent that such limitations indicate structural limitations of the claimed apparatus.
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 1-3, 6-7 and 10-12 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 “each dispensing unit (4) comprising at least: (a) a socket (41) where to fit a syringe (42)”. Based on this language, it appears the physical presence of the syringe is not expressly required by claim. However, in the interest of expediting prosecution, the examiner will treat the limitations of the syringe. It’s suggested the applicant amend the claim as follows: “each dispensing unit (4) comprising at least: (a) a syringe, socket (41) capable of fitting the [[a]] syringe (42)”.
In claim 1, the limitations ‘the syringe plunger” and “the extruded material” lack proper antecedent basis.
In claim 1, it’s not clear to which of the previously recited syringes, if any, the limitation “of syringe” refers.
In claim 1, it’s not clear how the material is deposited “in the receiving platform”. The examiner suggests replacing “in” with “on”.
In claim 3, it’s not clear to which of the previously recited lightning systems “the lightning system” refers.
Claim 6 recites “to extrude two or more materials, from two or more syringes”. It’s not clear to which of the previously recited materials, or syringes, the limitation refers. In claim 10, the limitation reciting “the platform surface temperature” lacks proper antecedent basis.
Claim 1 recites “”different adaptors”. It’s not clear how, or if, these adaptors are related to the previously recited adaptor.
The claim 11 limitation reciting “diverse depositing surfaces” is indefinite because it’s not clear what types of surfaces are included within the scope of the term “diverse”.
Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 1, 6, 7, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. (Us 2016/0136895) in view of Ikushima (US 2010/0156970) .
As to claim 1, Beyer discloses a 3D bioprinting system comprising:
- a supporting frame (fig 1);
- an extrusion unit (fig 1) with two or more dispensing units, each dispensing unit comprising at least:
- a syringe (para 71, series of syringes) capable of housing a material to be extruded with a dispensing end (inherent to syringes)
- a syringe adapter (100) which cooperates with the dispensing end of the two or more syringes and directs the extruded material from the two or more syringes towards a single nozzle (114, fig 1, para 73); - a receiving platform (118, fig 1, para 71) which receives the extruded material from the single nozzle (para 69-73); - a mechanical system (motorized stage, motors, para 70-71, fig 1) to independently move the extrusion unit and/or the receiving platform in order to three dimensionally deposit the extruded material in the receiving platform (para 68-74, fig 1); - a command unit (para 71) for controlling the motorized mechanism (figs 1, 3, 6, 9, 10, para 27-42, 69-83, 107-121).
Beyer does not disclose each dispensing unit further comprising: a socket where to fit the syringe, wherein the syringe comprises a plunger and a motorized mechanism to move the syringe plunger of syringe; wherien the command unit further controls the mechanical system.
Ikushima discloses a dispensing unit with a syringe 63, a socket where to fit the syringe (supporting device around syringe figs 1-2), wherein the syringe comprises a plunger 7,8 or 55 a motorized mechanism 516/51 to move the syringe plunger of syringe; wherein a command unit 61 further controls the mechanical system as such improves the accuracy and reduces production time (figs 1-2, 5, 10-12, para 27-28 43, 73-83, text description of cited figures).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Beyer such that each dispensing unit further comprising a socket where to fit the syringe, wherein the syringe comprises a plunger and a motorized mechanism to move the syringe plunger of syringe; wherien the command unit further controls the mechanical system as taught by Ikushima above as such achieves the advantages detailed above.
As to claims 6-7, the system further comprising the syringe adapter is configured to extrude two or more materials, from two or more syringes, as a homogeneous, mixed, single material flow (figs 1, 3, 6, para 78-79), wherein the syringe adapter (5) comprises at least two separate channels (204/206) leading to a single mixing chamber (fig 3, para 77) or static mixer (para 77-80 Fig 3).
As to claim 11, Beyer discloses the receiving platform can dock different adapters for allowing the fitting of diverse depositing surfaces, including Petri dishes, well plates, microplates, glass slides, and beakers (fig 1, 4, associated text).
As to claim 12, Beyer discloses the command unit can be controlled by a computerized system (para 71-74).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyer and Ikushima, as applied to claim 1 above, and further in view of Cho et al. (US 2012/0329156).
Beyer and Ikushima do not disclose controlling the syringe temperature as required by blcaim 2. Cho discloses an extrusion unit comprises a heating/cooling mechanism 155/130 for independently controlling each syringe temperature (para 16, 38, 42, fig 2, 3). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Beyer and Ikushima such that the extrusion unit comprises a heating/cooling mechanism for independently controlling each syringe temperature as taught by Cho above as such has a reasonable expectation of success and enables temperature control.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyer and Ikushima, as applied to claim 1 above, and further in view of Wroblesky et al. (US 2016/0046832).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Beyer and Ikushima such that the receiving platform includes a heating/cooling mechanism for controlling the platform surface temperature as taught by Wroblesky (para 125) as such enables temperature control and allows setting time adjustments.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyer and Ikushima, as applied to claim 1 above, and further in view of Murphy et al. (US 2014/0342015).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify Beyer and Ikushima such that the extrusion unit comprises one or more lightning systems, wherein the lightning system comprises lights with wavelengths in the ultraviolet, infrared and the visible spectrum as taught by Murphy (para 156) as such has a reasonable expectation success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER T SCHATZ whose telephone number is (571)272-6038. The examiner can normally be reached Monday through Friday, 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Orlando can be reached at 571-270-5038. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER T SCHATZ/Primary Examiner, Art Unit 1746